Danley v. Bayer Healthcare Pharmaceuticals, Inc.
OPINION & ORDER re: (49 in 7:14-cv-00288-CS, 2688 in 7:13-md-02434-CS-LMS) MOTION TO EXCLUDE THE TESTIMONY OF RICHARD STRASSBERG, M.D. filed by Bayer Pharma AG, Bayer Healthcare Pharmaceuticals Inc., Bayer Healthcare Pharmaceut icals, Inc., Bayer OY, (2694 in 7:13-md-02434-CS-LMS, 48 in 7:13-cv-06586-CS) MOTION TO EXCLUDE THE TESTIMONY OF ROGER C. YOUNG, M.D., PH.D. filed by Bayer Pharma AG, Bayer Healthcare Pharmaceuticals Inc., Bayer Healthcare Phar maceuticals, Inc., Bayer OY, (57 in 7:14-cv-00288-CS, 56 in 7:13-cv-06586-CS, 2724 in 7:13-md-02434-CS-LMS) MOTION to Preclude the Testimony of Dr. David Feigal. filed by Plaintiffs' Liaison Counsel, (52 in 7:13-cv-06586-CS, 53 i n 7:14-cv-00288-CS, 2705 in 7:13-md-02434-CS-LMS) MOTION to Preclude the Testimony of Dena R. Hixon, M.D. filed by Plaintiffs' Liaison Counsel, (2697 in 7:13-md-02434-CS-LMS) MOTION TO EXCLUDE THE TESTIMONY OF APRIL ZAMB ELLI-WEINER, PH.D. filed by Bayer Pharma AG, Bayer Healthcare Pharmaceuticals Inc., Bayer OY, (2685 in 7:13-md-02434-CS-LMS) MOTION TO EXCLUDE THE TESTIMONY OF SUZANNE PARISIAN, M.D. filed by Bayer Pharma AG, Bayer Health care Pharmaceuticals Inc., Bayer OY, (2679 in 7:13-md-02434-CS-LMS) MOTION TO EXCLUDE THE TESTIMONY OF JOHN JARRELL, PH.D., P.E. filed by Bayer Pharma AG, Bayer Healthcare Pharmaceuticals Inc., Bayer OY, (2702 in 7:13-md-02434- CS-LMS) MOTION to Preclude certain opinions of Michelle Collins, Ph.D., and Drs. Vanessa K. Dalton, Jay Goldberg, Steven Goldstein, Geri Hewitt, Marcia C. Javitt, and Michael Policar. filed by Plaintiffs' Liaison Counsel, (2691 in 7:13-md-02434-CS-LMS) MOTION TO EXCLUDE THE TESTIMONY OF SUSAN WRAY, PH.D. filed by Bayer Pharma AG, Bayer Healthcare Pharmaceuticals Inc., Bayer OY. Defendants' and Plaintiffs' motions are granted to the extent set fo rth above and otherwise denied. Specifically: Plaintiffs' Omnibus Motion to Exclude Defendants' Experts is DENIED. Defendants' Motion to Exclude the Testimony of Dr. Young is GRANTED. Defendants' Motion to Exclude the Testimony of Dr. Jarrell is GRANTED. Defendants' Motion to Exclude the Testimony of Dr. Wray is GRANTED. Defendants' Motion to Exclude the Testimony of Dr. Strassberg is GRANTED. Plaintiffs' Motion to Exclude the Testimony of Dr. Feigal is G RANTED IN PART and DENIED IN PART. Plaintiffs' Motion to Exclude the Testimony of Dr. Hixon is GRANTED IN PART and DENIED IN PART. Defendants' Motion to Exclude the Testimony of Dr. Parisian is GRANTED IN PART and DENIED IN PART. Defen dants' Motion to Exclude the Testimony of Dr. Zambelli-Weiner is GRANTED IN PART and DENIED IN PART. The Clerk of Court is respectfully requested to terminate the pending motions (13-MD-2434 Docs. 2679, 2685, 2688, 2691, 2694, 2697, 2702, 2705 and 2724 and 13-MC-2434 Docs. 134, 140, 143, 146, 149 and 152). SO ORDERED. (Signed by Judge Cathy Seibel on 3/8/16) Filed In Associated Cases: 7:13-md-02434-CS-LMS, 7:13-cv-06586-CS, 7:14-cv-00288-CS(yv) . Modified on 3/8/2016 (yv).
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
MIRENA IUD PRODUCTS LIABILITY LITIGATION
This Document Relates To
Danley v. Bayer, 13-CV-6586
Hayes v. Bayer, 14-CV-288
Diogenes P. Kekatos
Seeger Weiss LLP
New York, New York
Plaintiffs’ Liaison Counsel
James R. Ronca
Plaintiffs’ Co-Lead Counsel
Matthew J. McCauley
Parker Waichman LLP
Port Washington, New York
Plaintiffs’ Co-Lead Counsel
Fred Thompson III
Motley Rice LLC
Mt. Pleasant, South Carolina
Plaintiffs’ Co-Lead Counsel
Michael K. Johnson
Kenneth W. Pearson
Rolf T. Fiebiger
Johnson Becker, PLLC
Member of the Plaintiffs’ Steering Committee
Shayna S. Cook
Brian P. O’Donoghue
Christopher J. Cook
Goldman Ismail Tomaselli Brennan & Baum LLP
Lead Counsel for Defendants
OPINION & ORDER
E. James Shepherd
Shook Hardy & Bacon LLP
Counsel for Defendants
William P. Harrington
Bleakley Platt & Schmidt LLP
White Plains, New York
Counsel for Defendants
Table of Contents
Background ............................................................................................................................. 4
Background Applicable to Both Cases ............................................................................ 4
Background Related to Jennifer Danley .......................................................................... 7
Background Related to Christie Hayes ............................................................................ 8
Discussion ............................................................................................................................... 9
Legal Standard ................................................................................................................. 9
Defendants’ Clinical Experts ......................................................................................... 13
Experts’ Qualifications & Opinions ........................................................................... 15
Opinions on Secondary Perforation............................................................................ 22
Opinions on the Mirena Label .................................................................................... 28
Opinions on 2D Versus 3D Ultrasound ...................................................................... 30
Opinions on Epidemiology ......................................................................................... 34
Conflicting Bayer Statements and Documents ........................................................... 35
Plaintiffs’ Causation Experts ......................................................................................... 37
Roger C. Young, M.D., Ph.D. .................................................................................... 37
John Jarrell, Ph.D., P.E. .............................................................................................. 54
Susan Wray, Ph.D....................................................................................................... 68
Richard Strassberg, M.D. ........................................................................................... 85
Defendants’ Regulatory Experts .................................................................................... 93
David Feigal, M.D., M.P.H. ....................................................................................... 93
Dena Hixon, M.D. .................................................................................................... 105
Plaintiffs’ Regulatory Expert – Suzanne Parisian, M.D. ............................................. 116
Plaintiffs’ Epidemiological Expert – April Zambelli-Weiner, Ph.D. .......................... 128
Conclusion ....................................................................................................................... 140
Danley v. Bayer, 13-CV-6856, and Hayes v. Bayer, 14-CV-288, are the first two cases
selected for trial in the In re Mirena IUD Products Liability Litigation multidistrict litigation
(“Mirena MDL”). Plaintiffs have sued three related companies, Bayer Healthcare
Pharmaceuticals, Inc., Bayer Pharma AG and Bayer OY (“Bayer” or “Defendants”), alleging that
Mirena, an intrauterine device (“IUD”) perforated Plaintiffs’ uteruses and caused them injuries,
and that Defendants did not adequately warn Plaintiffs about the risks of Mirena. Plaintiffs
Danley and Hayes have also brought claims alleging design defect and negligence, and are
seeking punitive damages.1
Before the Court is Plaintiffs’ Omnibus Motion to Preclude the Expert Testimony of
Defendants’ Experts Steven Goldstein, M.D., Jay Goldberg, M.D., M.S.C.P., Michael Policar,
M.D., M.P.H., Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M., Vanessa Dalton, M.D., M.P.H.,
Geri Hewitt, M.D., and Marcia Javitt, M.D., F.A.C.R., (Doc. 2702). Plaintiffs also move to
preclude Defendants’ regulatory experts, Dena Hixon, M.D., (Doc. 2705), and David Feigal, Jr.,
M.D., M.P.H., (Doc. 2724). Also before the Court are Defendants’ motions to preclude the
testimony of Plaintiffs’ causation experts Roger Young, M.D., Ph.D., (Doc. 2694), John Jarrell,
Ph.D., P.E., (Doc. 2679), Susan Wray, Ph.D., (Doc. 2691), and Richard Strassberg, M.D., (Doc.
2688). Defendants have also moved to preclude Plaintiffs’ regulatory expert Suzanne Parisian,
M.D., (Doc. 2685), and Plaintiffs’ epidemiological expert April Zambelli-Weiner, Ph.D., (Doc.
Plaintiffs withdrew their claims for manufacturing defect, breach of warranty, fraud, negligent misrepresentation
and violation of state consumer protection statutes. (Docs. 2850 at 2 n.3, 2853 at 32). Unless otherwise noted, all
references to docket numbers refer to docket entries in 13-MD-2434.
Background Applicable to Both Cases
The following facts, which are based on the record generated by these motions and
Defendants’ motions for summary judgment, (Docs. 2756, 2762) – including Defendants’
Local Rule 56.1 Statements and Plaintiffs’ responses thereto, (Docs. 2851 (“Danley 56.1 Stmt.
& Resp.”), 2854 (“Hayes 56.1 Stmt. & Resp.”)),2 and supporting materials – are undisputed
except where noted.3
In 2000 the U.S. Food and Drug Administration (“FDA”) approved the Mirena, a plastic
T-shaped IUD that measures 1.26 by 1.26 inches, as safe and effective for intrauterine
contraception. (Danley 56.1 Stmt. & Resp. ¶¶ 1-2.) Mirena provides contraceptive protection
for up to five years, and has a cylinder in its stem that continuously releases a dose of the
hormone levonorgestrel (“LNG”), (id. ¶ 3), a synthetic progestin. (Declaration of Diogenes P.
Kekatos in Support of Plaintiffs’ Omnibus Motion (“Kekatos Omnibus Decl.”), (Doc. 2704),
Ex. B, General Expert Report of Jay Goldberg, M.D., M.S.C.P. (“Goldberg Report”), at 8.) It
must be prescribed and inserted by a healthcare professional. (Danley Stmt. & Resp. ¶ 4.) The
Mirena has removal threads that permit the user to check its placement. (Id. ¶ 13.)
The Mirena label has undergone four changes to its warning regarding the risk of
perforation since the FDA’s initial approval in 2000.4 (Id. ¶ 6.) The 2009 label, which was in
Defendants submitted separate local Rule 56.1 statements in connection with their summary judgment motions for
the Hayes and Danley cases. The Court uses the Rule 56.1 statement from Danley for purposes of this background
section, and indicates below where case-specific statements are referenced.
Some of the information was submitted under seal. To the extent this information is quoted or discussed, it is
hereby unsealed due to the presumption in favor of public access to information affecting judicial decisions. See In
re Fosamax Prods. Liab. Litig., 807 F. Supp. 2d 168, 173 n.2 (S.D.N.Y. 2011).
In 2000 when the FDA reviewed the Mirena label, it struck the sentence, “There are reports of IUD migration after
insertion,” which was in the initial label submission proposed by Bayer. (Declaration of Christopher J. Cook in
Support of Defendants’ Opposition to Plaintiffs’ Motion to Exclude Proposed Testimony of Dena R. Hixon, M.D.
effect at the time both Ms. Hayes’ and Ms. Danley’s Mirenas were inserted, included a
“Highlights” section on the first page that stated: “Perforation may occur during insertion.
Risk is increased in women with fixed retroverted uteri, during lactation, and postpartum.” (Id.
¶¶ 8-9; Hayes 56.1 Stmt. & Resp. ¶¶ 8-9.) The 2009 label also included a Warnings section
that stated, “Perforation or penetration of the uterine wall or cervix may occur during insertion
although the perforation may not be detected until some time later . . . Delayed detection of
perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal
obstruction, abscesses and erosion of adjacent viscera.” (Danley 56.1 Stmt. & Resp. ¶ 10.) It
further warned that surgical removal might be required if perforation occurred. (Id.) The label
also instructed healthcare providers to teach patients that they should check the Mirena threads
every month, and that a patient should contact her doctor if unable to feel the threads. (Id. ¶
13.) The label additionally instructed healthcare providers to, prior to insertion, give each
patient a copy of the “Patient Information Booklet” that is included with every Mirena, and to
discuss potential side effects and how to feel the Mirena threads. (Id. ¶ 14.) The Patient
Information Booklet states that “Mirena can cause serious side effects,” including embedment
and perforation, without reference to the timing of these potential events. (Id. ¶ 15.) Beginning
in 2005, the warning label for ParaGard, another IUD, included the sentence: “Spontaneous
migration has also been reported.” (Id. ¶ 53.)
The parties agree that Defendants warned against the possibility of uterine perforation
during insertion. (Id. ¶ 9.) They also agree that Defendants did not warn against the possibility
(“Cook Hixon Decl.”), (Doc. 2787), Ex. 1, Amended Regulatory Expert Report of Dena R. Hixon, M.D. (“Hixon
Report”), at 27; id. Ex. 8, at MIR_INDNDA_00010784.) In addition, in 2008 Bayer proposed another change to the
Mirena label, which included language stating that “[p]erforation . . . may occur rarely, most often during insertion
although the perforation may not be detected until some time later.” (Id. Ex. 10, at MIR_INDNDA_00038079.)
The FDA added a comment in a communication to Bayer recommending that Bayer remove the words “rarely” and
“most often” from this section of the warning. (Id.)
that perforation could occur after and unrelated to insertion, which Plaintiffs call “secondary
perforation” or “spontaneous migration.”5 Whether such a possibility exists is at the heart of
their dispute. Plaintiffs and their experts maintain that a properly placed Mirena, with no
perforation related to insertion, is capable of later perforating the uterus and migrating out of it.
(Id. ¶ 56; Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the
Testimony of Roger C. Young, M.D., Ph.D. (“Cook Young Decl.”), (Doc. 2696), Ex. B,
General Causation Expert Report of Roger C. Young, M.D., Ph.D. (“Young Report”), at 6;
Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the
Testimony of Susan Wray, Ph.D. (“Cook Wray Decl.”), (Doc. 2693), Ex. B, General Expert
Report of Dr. Susan Wray, Ph.D. (“Wray Report”), at 22.) Defendants and their experts assert
that Plaintiffs’ theory of secondary perforation has not been proven, and that perforation of the
uterus can only occur upon insertion of a Mirena, although detection of perforation or
migration can occur later. (Danley 56.1 Stmt. & Resp. ¶ 56; Kekatos Omnibus Decl. Ex. A,
General Expert Report of Steven Goldstein, M.D. (“Goldstein Report”), at 23; Kekatos
Omnibus Decl. Ex. F, General Expert Report of Geri D. Hewitt, M.D. (“Hewitt Report”), at
24.) The expert reports and proposed expert testimony discussed below deal primarily with
The parties also dispute the significance and validity of the European Active
Surveillance Study on Intrauterine Devices (“EURAS”) study. EURAS was a study of 61,448
women using Mirena or copper IUDs in six European countries who were followed between
2006 and 2013 to “identify and compare the incidence of uterine perforation and other
medically adverse events associated with levonorgestrel-releasing intrauterine systems . . . and
“Secondary perforation” and “spontaneous migration” will be used interchangeably.
copper intrauterine devices (IUDs) under routine conditions of use in a study population
representative of typical users.” (Declaration of Christopher J. Cook in Support of Defendants’
Motion to Exclude the Testimony of April Zambelli-Weiner, Ph.D. (“Cook Zambelli-Weiner
Decl.”), (Doc. 2699), Ex. E, Klaas Heinemann et al., Risk of Uterine Perforation with
Levonorgestrel-Releasing and Copper Intrauterine Devices in the European Active
Surveillance Study on Intrauterine Devices, 91 Contraception 274, 274 (2015) (hereinafter
“Heinemann 2015”).) The study concluded that uterine perforation was rare, and that there
were no clinically significant differences in perforation rates between IUDs containing LNG
and copper IUDs. (Id. at 274, 278-79.) EURAS was funded by Bayer, (Cook Zambelli-Weiner
Decl. Ex. D, at 1), but overseen by an independent Safety Monitoring and Advisory Council
consisting of “internationally acknowledged experts in the field,” which made
“recommendations and final decisions in all scientific matters” and which approved all study
materials, (id. at 26).
The parties also dispute the capacity of two-dimensional (“2D”) versus threedimensional (“3D”) ultrasound in detecting proper placement of a Mirena and signs of
perforation. Defendants claim that “[t]wo-dimensional ultrasound imaging cannot rule out
damage to the myometrium or a partial perforation at insertion,” while Plaintiffs assert that
Mirena’s label “tells medical providers that they can confirm proper placement of a Mirena by
utilizing 2-D ultrasound.” (Danley 56.1 Stmt. & Resp. ¶ 60.)
Background Related to Jennifer Danley
Jennifer Danley used Mirena for contraception on two separate occasions. Her first
Mirena was inserted on February 14, 2006 and removed without complication on March 4, 2010.
(Danley 56.1 Stmt. & Resp. ¶¶ 16, 17, 26, 27.) Ms. Danley’s second Mirena was inserted by
Victoria Roebuck, a nurse practitioner, on June 29, 2011. (Id. ¶ 31.) On that occasion Ms.
Danley signed a consent form indicating that she had read Mirena literature and had her
questions answered, but Plaintiffs allege that Ms. Danley was not provided the Patient
Information Booklet, (id. ¶ 33), although they concede she had gotten it before her first insertion,
(id. ¶ 25). Immediately after Ms. Danley’s second Mirena was inserted, she underwent a 2D
ultrasound, and the ultrasound report said the IUD was seen “HIGH/RT.” (Id. ¶¶ 35-36.) The
parties dispute whether the ultrasound images show that Ms. Danley’s uterus was perforated at
insertion. (Id. ¶ 39.)
On January 3, 2013, Ms. Danley went to her healthcare provider after a positive home
pregnancy test. (Id. ¶ 41.) Ms. Roebuck could not locate the threads of Ms. Danley’s Mirena,
and an ultrasound from that date showed no IUD in Ms. Danley’s uterus. (Id. ¶ 43.) Ms.
Danley’s providers suspected that the IUD may have perforated Ms. Danley’s uterus and ordered
an X-ray. (Id. ¶ 44.) An X-ray from January 8, 2013 showed the IUD was within Ms. Danley’s
abdominal cavity. (Id. ¶ 45.) Ms. Danley’s Mirena was removed on January 23, 2013 via
laparoscopic surgery. (Id. ¶ 46.)
Background Related to Christie Hayes
Ms. Hayes’ Mirena was inserted by Dr. Merle Robboy on February 3, 2011. (Hayes
56.1 Stmt. & Resp. ¶ 17.) The parties dispute whether Ms. Hayes was provided with the
Patient Information Booklet. (Id. ¶ 14.) Ms. Hayes was under anesthesia and conscious
sedation during the insertion of her Mirena. (Id. ¶ 23.) Ms. Hayes presented to Dr. Robboy on
September 29, 2011 for removal of her Mirena, and during the removal attempt the threads of
Ms. Hayes’ Mirena, which were still visible outside her cervix, broke off. (Id. ¶ 24-25.) Dr.
Robboy noted that the Mirena was likely embedded in the uterine wall. (Id. ¶ 25.) On October
1, 2011, Ms. Hayes presented to Dr. John McHugh for removal of the IUD via hysteroscopy,
which did not locate the Mirena inside Ms. Hayes’ uterus. (Id. ¶¶ 26-27.) On October 26,
2011, Ms. Hayes’ Mirena was found outside her uterus and removed via laparoscopic surgery.
The admissibility of expert testimony is governed principally by Rule 702:
A witness who is qualified as an expert by knowledge, skill, experience, training,
or education may testify in the form of an opinion or otherwise if: (a) the expert’s
scientific, technical, or other specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue; (b) the testimony is based
on sufficient facts or data; (c) the testimony is the product of reliable principles and
methods; and (d) the expert has reliably applied the principles and methods to the
facts of the case.
Fed. R. Evid. 702. The party offering the testimony has the burden of establishing its
admissibility by a preponderance of the evidence. See Fed. R. Evid. 702 advisory committee’s
note; Bourjaily v. United States, 483 U.S. 171, 175-76 (1987). The standard for admissibility is
the same at the summary judgment stage as it is at trial. See Gen. Elec. Co. v. Joiner, 522 U.S.
136, 143 (1997) (“On a motion for summary judgment, disputed issues of fact are resolved
against the moving party . . . . But the question of admissibility of expert testimony is not such an
issue of fact.”).
Rule 702 represents a liberal standard of admissibility for expert opinions, as compared to
the previous and more restrictive standard set out in Frye v. United States, 293 F. 1013, 1014
(D.C. Cir. 1923). See, e.g., Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 588-89 (1993)
(Frye test of general acceptance in the scientific community superseded by the Federal Rules; “a
rigid ‘general acceptance’ requirement would be at odds with the ‘liberal thrust’ of the Federal
Rules and their ‘general approach of relaxing the traditional barriers to “opinion” testimony’”)
(quoting Beech Aircraft Corp. v. Rainey, 488 U.S. 153. 169 (1988)). “Vigorous crossexamination, presentation of contrary evidence, and careful instruction on the burden of proof
are the traditional and appropriate means of attacking shaky but admissible evidence.” Id. at
596. Despite the liberal standard, however, the district court still must ensure that “any and all
scientific testimony or evidence admitted is not only relevant, but reliable.” Id. at 589; see
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999) (Rule 702 requires district courts to
fulfill the “gatekeeping” function of “mak[ing] certain that an expert, whether basing testimony
upon professional studies or personal experience, employs in the courtroom the same level of
intellectual rigor that characterizes the practice of an expert in the relevant field.”).
First, the district court must determine whether an expert is qualified. Qualification “may
be based on ‘a broad range of knowledge, skills, and training.’” In re Fosamax Prods. Liab.
Litig., 645 F. Supp. 2d 164, 172 (S.D.N.Y. 2009) (quoting In re TMI Litig., 193 F.3d 613, 664
(3d Cir. 1999)). Courts within the Second Circuit have “liberally construed expert qualification
requirements.” In re Methyl Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., No. 00-CV1898, 2008 WL 1971538, at *5 (S.D.N.Y. May 7, 2008) (internal quotation marks omitted).
Experts need not conduct studies of their own in order to opine on a topic; a review of
other studies and scientific literature can be enough to qualify experts to testify and to make that
proposed testimony reliable. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1042-43 (2d Cir.
1995) (rejecting argument that because expert had “no experience performing or interpreting air
quality studies” he was not qualified to testify);6 see also Cedar Petrochemicals, Inc. v. Dongbu
In Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 255 (2d Cir. 2005), the Second Circuit limited its prior holding
in McCullock because of the Supreme Court’s decision in Joiner. The Ruggiero court disavowed McCullock’s
statement that “‘[d]isputes as to the strength of [the expert’s] credentials, faults in his use of differential etiology as a
methodology, or lack of textual authority for his opinion, go to the weight, not the admissibility, of his testimony.’”
Hannong Chem. Co., 769 F. Supp. 2d 269, 284 (S.D.N.Y. 2011) (“Experts need not have
actually collected the data on which they base their conclusions in order to be credible.”); In re
Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007) (“If the expert has
educational and experiential qualifications in a general field closely related to the subject matter
in question, the court will not exclude the testimony solely on the ground that the witness lacks
expertise in the specialized areas that are directly pertinent.”) (citing Stagl v. Delta Air Lines,
Inc., 117 F.3d 76, 80 (2d Cir. 1997)).
Next, the district court must evaluate the reliability of proposed expert testimony.
Daubert enumerated a list of factors that, although not constituting a “definitive checklist or
test,” a district court might consider in evaluating whether a proffered expert opinion has the
required indicia of scientific reliability: whether a theory or technique had been and could be
tested, whether it had been subjected to peer review, its error rate, and its degree of acceptance
within the relevant scientific community. Daubert, 509 U.S. at 593-94. Rule 702 also requires a
sufficiently rigorous analytical connection between the expert’s methodology and conclusions.
“[W]hen an expert opinion is based on data, a methodology, or studies that are simply inadequate
to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that
unreliable opinion testimony.” Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 266
(2d Cir. 2002); see Joiner, 522 U.S. at 146 (“[N]othing in either Daubert or the Federal Rules of
Evidence requires a district court to admit opinion evidence which is connected to existing data
Ruggiero, 424 F.3d at 255 (quoting McCullock, 61 F.3d at 1044) (alteration in original). It did so because the Court
in Joiner held that “‘[a] court may conclude that there is simply too great an analytical gap between the data and the
opinion proffered.’” Id. (quoting Joiner, 522 U.S. at 146) (alteration in original). But Ruggiero did not cast doubt
on McCullock’s comment regarding credentials, and courts in this circuit continue to cite it. See, e.g., Cruz v.
Kumho Tire Co., No. 10-CV-219, 2015 WL 2193796, at *5 (N.D.N.Y. May 11, 2015).
only by the ipse dixit of the expert. A court may conclude that there is simply too great an
analytical gap between the data and the opinion proffered.”).
The Daubert factors “may or may not be pertinent in assessing reliability, depending on
the nature of the issue, the expert’s particular expertise, and the subject of his testimony.”
Kumho Tire Co., 522 U.S. at 150 (internal quotation marks omitted). Indeed, expert testimony
may be based on “experience alone—or experience in conjunction with other knowledge, skill,
training or education.” Fed. R. Evid. 702 advisory committee’s note. “In certain fields,
experience is the predominant, if not sole, basis for a great deal of reliable expert testimony.”
Id.; see Kumho Tire Co., 526 U.S. at 156 (“[N]o one denies that an expert might draw a
conclusion from a set of observations based on extensive and specialized experience.”). In all
cases, “the test of reliability is flexible,” and a district court has “the same broad latitude when it
decides how to determine reliability as it enjoys in respect to its ultimate reliability
determination.” Kumho Tire Co., 526 U.S. at 141-42 (emphasis in original and internal
quotation marks omitted).
After determining that a witness is qualified to testify as an expert as to a particular
matter and that the opinion is reliable, Rule 702 requires the district court to determine whether
the expert’s testimony will “help the trier of fact.” Fed. R. Evid. 702. Although expert
testimony can be very persuasive, see Nimely v. City of N.Y., 414 F.3d 381, 397 (2d Cir. 2005),
the testimony is still admissible if it is relevant and helpful. By definition, expert testimony that
“usurp[s] either the role of the trial judge in instructing the jury as to the applicable law or the
role of the jury in applying that law to the facts before it,” United States v. Bilzerian, 926 F.2d
1285, 1294 (2d Cir. 1991), does not “aid the jury in making a decision”; rather, it “undertakes to
tell the jury what result to reach,” and thus “attempts to substitute the expert’s judgment for the
jury’s,” United States v. Duncan, 42 F.3d 97, 101 (2d Cir. 1994) (emphasis omitted).
Plaintiffs seek to exclude nine of Defendants’ experts, and Defendants seek to exclude six
of Plaintiffs’ experts. Each motion and expert is discussed separately below.7
Defendants’ Clinical Experts
Plaintiffs move in one omnibus motion, (Doc. 2702), to preclude seven of Defendants’
experts from testifying on five subjects: (1) secondary perforation; (2) contractility8 or
weakening of the uterus from exposure to the hormone LNG; (3) 2D ultrasound’s ability to
detect proper placement of Mirena inside the uterus; (4) Mirena labeling; and (5)
epidemiological studies including the EURAS IUD study. (Plaintiffs’ Omnibus Memorandum of
Law In Support of Their Motion to Exclude Proposed Testimony of Defendants’ Experts (“Ps’
Omnibus Mem.”), (Doc. 2703), 2.) I first summarize the general contours of the issues.
Plaintiffs and their experts contend that secondary perforation is the phenomenon of an
IUD perforating (puncturing) a uterus that occurs after, and is unrelated to, its insertion. (Ps’
Omnibus Mem. 2-3; Wray Report at 22.) Bayer and its experts opine that perforation can only
occur in connection with the insertion of an IUD, although the perforation may be detected at a
later time. (See, e.g., Goldstein Report at 27-28; Hewitt Report at 24-25.)
Plaintiffs submitted one omnibus motion seeking to exclude seven of Defendants’ experts. (Doc. 2702.) All other
motions to exclude were filed separately and will be discussed individually below.
Uterine contractility refers to contractions of uterine muscles. (Goldstein Report at 25-26.)
Effect of LNG on the Uterus and Uterine Contractions
Plaintiffs and their experts allege that exposure to LNG, released by the Mirena as part of
its contraceptive effect, causes the endometrium (the inner-most layer of the uterus)9 to weaken
and become more susceptible to perforation by an IUD. They posit that uterine contractions
(which occur regularly apart from childbirth) help to propel an IUD through the uterine wall.
(Wray Report at 19-20, 25-26; Young Report at 11-13.) Bayer’s experts dispute the effects of
LNG on the uterus, state that LNG does not have a thinning or weakening effect on the
myometrium (the middle, muscular layer of the uterus through which a migrating Mirena would
have to pass), and maintain that uterine contractions could not force through that wall an IUD
that has not at least partially perforated. (See, e.g., Kekatos Omnibus Decl. Ex. D, General
Expert Report of Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M. (“Collins Report”), at 23-25.)
Bayer’s experts have opined that although 2D ultrasound is still a commonly used
method to detect whether a Mirena has been properly placed – in other words, to determine
whether perforation or damage occurred at insertion – this type of imaging cannot rule out such
damage, and 3D ultrasounds produce higher quality images capable of more detailed detection.
(See, e.g., Kekatos Omnibus Decl. Ex. G, General Expert Report of Marcia C. Javitt, M.D.,
F.A.C.R. (“Javitt Report”), at 4.) Plaintiffs argue that Defendants’ experts should not be allowed
to opine on the superiority of 3D imaging because 2D imaging is capable of detecting proper
placement of an IUD; it is frequently used to ensure proper placement; and Bayer has never
The uterus is comprised of three layers: (1) the inner-most lining (endometrium); (2) the middle muscular layer
(myometrium); and (3) the thin outer layer (perimetrium or serosa). (Medscape, Uterus Anatomy,
http://emedicine.medscape.com/article/1949215-overview (last updated July 22, 2015); Goldberg Report at 3-4;
Wray Report at 3-4, 11; Kekatos Omnibus Decl. Ex. E, General Expert Report of Vanessa K. Dalton, M.D., M.P.H.
(“Dalton Report”), at 4.) The “stroma,” is “the tissue underlying the myometrium,” (Young Report at 11), or “cellrich connective tissue,” (Wray Report at 4).
instructed or recommended that physicians use 3D ultrasounds to detect Mirena. (Ps’ Omnibus
Bayer’s medical experts opine that from a clinical perspective, the Mirena label has
always been adequate to warn of its risks. (See, e.g., Kekatos Omnibus Decl. Ex. C, General
Expert Report of Michael Policar, M.D., M.P.H. (“Policar Report”), at 36.) Plaintiffs argue that
Defendants’ Obstetrics and Gynecology (“OB/GYN”) experts are not qualified to opine on the
adequacy of the Mirena label because they have not worked in a regulatory capacity. (Ps’
Omnibus Mem. 4.)
Bayer’s experts offer opinions regarding the scope and results of the EURAS IUD study.
(See, e.g., Goldberg Report at 17-19.) Plaintiffs argue that Bayer’s OB/GYN experts are not
qualified to opine on the adequacy of the EURAS IUD study because they are not
epidemiologists, biostatisticians or medical scientists. (Ps’ Omnibus Mem. 4.)
Defendants’ experts’ qualifications and opinions are discussed below, followed by an
analysis of each opinion that Plaintiffs seek to exclude.
Experts’ Qualifications & Opinions
Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M.
Dr. Collins is an Associate Professor of nursing, specializing in nurse-midwifery, and a
director of a nurse-midwifery education program at Vanderbilt University’s School of Nursing.
(Collins Report at 1; Declaration of Christopher J. Cook in Support of Defendants’ Opposition to
Plaintiffs’ Omnibus Motion (“Cook Omnibus Decl.”), (Doc. 2773), Ex. 7, Curriculum Vitae of
Michelle Collins (“Collins CV”).) She teaches courses that cover IUD content, including IUD
insertion, and practices part-time in the nurse-midwifery clinical faculty practice. (Collins
Report at 1.) Dr. Collins has prescribed and inserted “hundreds of IUDs,” including ParaGard
and Mirena. (Id.) Dr. Collins wrote a doctoral dissertation examining the effect of progestins,
and one study she used included women with Mirena IUDs. (Id.) She teaches, writes and makes
presentations in her field, including authoring a textbook chapter on hormonal contraception.
(Id.; Collins CV.)
Dr. Collins opines on the benefits and risks of various types of contraception, including
Mirena. (Collins Report at 3-13.) She concludes that the benefits associated with Mirena use
outweigh its risks. (Id. at 26.) Dr. Collins discusses shortcomings associated with 2D ultrasound
imaging of IUDs. (Id. at 18-19.) She additionally concludes that there is no evidence supporting
Plaintiffs’ theory of secondary or delayed perforation, and that perforation can only occur upon
insertion of an IUD. (Id. at 22-25.) She dismisses several theories put forth to show that
secondary perforation is possible, (id. at 23-25), and concludes that Mirena’s label has always
adequately outlined the proper risks from a medical perspective, (id. at 25-26).
Vanessa Dalton, M.D., M.P.H.
Dr. Dalton is a tenured Associate Professor in the Department of Obstetrics and
Gynecology, Division of Gynecology, at the University of Michigan. (Dalton Report at 1; Cook
Omnibus Decl. Ex. 10, Curriculum Vitae of Vanessa Dalton (“Dalton CV”).) She holds
undergraduate, medical and public health degrees. (Dalton Report at 1.) Dr. Dalton has
researched reproductive health services, including contraception, and she has served on
committees for the American Congress of Obstetricians and Gynecologists (“ACOG”). (Id.) Dr.
Dalton leads a weekly family planning clinic and consultative service providing counseling and
provision of contraception, and she supervises or personally places 5 to 10 IUDs in a typical
month. (Id. at 2.) More than half of her clinical practice is in “family planning related services.”
(Id.) She has studied and published on LNG-releasing IUDs and the possible complications from
IUDs in post-partum women. (Cook Omnibus Decl. Exs. 11, 12.)
In her report, Dr. Dalton describes the effectiveness of different types of contraception.
(Dalton Report at 6-18.) She concludes that the EURAS-IUD study provides the best evidence
to show rates of IUD-associated perforation and notes that the study found similar rates of
perforation between LNG-containing IUDs and copper IUDs. (Id. at 20-22.) Dr. Dalton
concludes that Plaintiffs’ theory of spontaneous migration is not supported by evidence and
dismisses possible mechanisms of non-insertion related perforation, including migration through
the fallopian tubes, pressure necrosis, uterine contractions and thinning effects of LNG on the
uterine wall. (Id. at 24-27.) In addition, Dr. Dalton opines that the Mirena label has always
adequately conveyed the risks associated with Mirena. (Id. at 29-31.) She also opines that 2D
ultrasound technology is not always capable of detecting whether a portion of an IUD has
extended into the myometrium. (Id. at 23.)
Jay Goldberg, M.D., M.S.C.P., C.E.F.M.
Dr. Goldberg is a board certified obstetrician/gynecologist and holds leadership positions
in obstetrics and gynecology at Einstein Medical Center in Philadelphia. (Goldberg Report at 1.)
Dr. Goldberg practices full-time as an OB/GYN and sees many patients for family planning and
contraception. (Id.) He personally inserts several Mirena IUDs per month, and sometimes as
many as five per week. (Id. at 10; Cook Omnibus Decl. Ex. 20, Deposition of Jay Goldberg
(“Goldberg Dep.”), at 57:11-18.) He has published dozens of peer-reviewed articles and is a
manuscript referee for more than a score of medical journals. (Goldberg Report at 2; Cook
Omnibus Decl. Ex. 6, Curriculum Vitae of Jay Goldberg (“Goldberg CV”).) Dr. Goldberg
opines generally on the benefits of contraception and IUDs and the mechanisms by which IUDs
function. (Goldberg Report at 4-10.)
Dr. Goldberg concludes, based on available evidence and the general consensus in the
scientific community, that perforation occurs, or at least initiates, at the time an IUD is inserted.
(Id. at 13-14.) Dr. Goldberg opines that IUDs cannot move independently and dismisses
potential theories by which spontaneous migration could occur. (Id. at 13-14, 23-30.) He also
opines on the limitations of 2D ultrasound in detecting uterine perforation. (Id. at 14-15.) Dr.
Goldberg discusses the EURAS-IUD study, and disagrees with some criticisms levied against it.
(Id. at 17-19.) In addition, Dr. Goldberg concludes that the Mirena label has always adequately
conveyed to prescribing physicians the risks of Mirena. (Id. at 21-23.)
Steven Goldstein, M.D.
Dr. Goldstein is a tenured professor at New York University School of Medicine in the
department of Obstetrics and Gynecology. (Goldstein Report at 1.) Dr. Goldstein is the Director
of Gynecologic Ultrasound and Co-Director of Bone Densitometry and Body Composition. (Id.)
He has a half-time private practice, seeing patients of all ages as a gynecologist, and counsels
and places IUDs. (Id. at 1-2.) Dr. Goldstein has written and edited textbooks on ultrasounds of
the female pelvis, and published articles on 2D-versus-3D ultrasound, including specific
discussions regarding the detection of IUD placement. (See, e.g., Cook Omnibus Decl. Ex. 44.)
Dr. Goldstein opines generally on contraceptive methods, IUDs and the risk of perforation
associated with IUDs. (Goldstein Report at 2-14.) Based on the EURAS-IUD study, he finds
no statistically significant difference in the perforation rate of Mirena compared to other IUDs.
(Id. at 10-14.)
Dr. Goldstein opines that most perforations are not diagnosed until after insertion, (id. at
14-17), and concludes that Plaintiffs’ theory of secondary perforation, and the alleged
mechanisms by which it might occur, are “unproven” and “implausible,” (id. at 23). Dr.
Goldstein opines on the use of 2D and 3D ultrasound in detecting proper Mirena placement, and
concludes that 2D ultrasound cannot rule out injury to or perforation of the myometrium. (Id. at
17-18.) Dr. Goldstein also concludes that Mirena’s label has always adequately informed
clinicians regarding the risks of perforation, and that the label’s varying statements have not
impacted his decision on whether to prescribe Mirena for a patient. (Id. at 19-23.)
Geri Hewitt, M.D.
Dr. Hewitt is an associate professor at Ohio State University College of Medicine in the
OB/GYN and Pediatrics Departments. (Hewitt Report at 1.) Dr. Hewitt supervises and teaches
residents and medical students on the gynecologic and labor and delivery services, and works in
a practice providing the “full range of general adult OB/GYN, including well woman care,
contraception and family planning, obstetrical services, and gynecologic surgery.” (Id.) Dr.
Hewitt counsels patients on contraception, and “routinely place[s]” IUDs. (Id. at 1-2.) She
serves on committees and boards related to OB/GYN services. (Id. at 3.) Her teaching activities
“include both educating trainees about the risks and benefits of IUDs, and training and
supervising IUD placement.” (Id. at 2.) She is co-author of a 2005 article on progestin-only
contraceptives, including Mirena. (Cook Omnibus Decl. Ex. 9.)
Dr. Hewitt opines that spontaneous migration is not possible and that uterine perforation
occurs or at least initiates at the time of insertion. (Hewitt Report at 18-20.) Dr. Hewitt
dismisses theories espousing mechanisms by which a Mirena could spontaneously migrate. (Id.
at 24-29.) She disagrees with Plaintiffs’ epidemiological expert, Dr. Zambelli-Weiner, regarding
her criticisms of the EURAS-IUD study. (Id. at 15-16.) Dr. Hewitt also opines that, as a
prescribing doctor, the Mirena label “has always adequately and appropriately informed
clinicians about the known risk of uterine perforation.” (Id. at 30.)
Marcia Javitt, M.D., F.A.C.R.
Dr. Javitt is the Director of Medical Imaging at the Rambam Health Care Campus in
Haifa, Israel, and served as the Section Head of Body MRI and of Genitourinary Radiology at
Walter Reed Army Medical Center in Washington from 2002 to 2011. (Javitt Report at 1.) She
is trained in Ultrasound, Computed Tomography and MRI, and has over 30 years of experience
in radiology. (Id.) She has written textbooks, book chapters and peer-reviewed articles, focusing
her research on imaging of the female pelvis. (Id.)
Dr. Javitt opines on the imaging of IUDs and the differences between 2D and 3D
ultrasound technology. (Id. at 3-6.) She concludes that 3D ultrasound offers advantages over 2D
ultrasound with respect to localizing IUDs within the uterine cavity. (Id. at 4.) Dr. Javitt opines
that 2D ultrasound cannot always rule out that any portion of an IUD has entered the
myometrium. (Id.) In addition, Dr. Javitt concludes that neither 2D nor 3D ultrasound can rule
out injuries to the uterine wall caused by a uterine sound10 or the instrument used to insert the
IUD when the IUD is normally positioned within the uterine cavity. (Id.)
Michael Policar, M.D., M.P.H.
Dr. Policar is a board certified OB/GYN. (Policar Report at 1.) He also has a Master’s
degree in Public Health. (Id.) Since October 2014, Dr. Policar has worked part-time training
A uterine sound is the metal or plastic instrument used to measure the depth of the uterus during IUD placement.
(Policar Report at 18.)
and supervising OB/GYN residents, mentoring post-residency Family Planning fellows, and
serving on committees at San Francisco General Hospital. (Id. at 3.) Dr. Policar has previously
held senior positions at the Planned Parenthood Federation of America, and as the national
Medical Director was “responsible for creating and updating the clinical Standards and
Guidelines that clinicians in every Planned Parenthood affiliate in the United States were
expected to follow.” (Id. at 1, 3.) He has had an extensive career in OB/GYN, including 34
years of clinical experience in family planning. (Id. at 1-3.) Dr. Policar is also a senior author of
“Contraceptive Technology,” a textbook on family planning. (Id. at 3.) Dr. Policar has inserted
and removed IUDs, including Lippes Loop, Copper 7, Progestasert, ParaGard, Mirena and Skyla
during his career, and he has supervised “between 2-4 Mirena insertions per week over the last
13 years.” (Id. at 4.)
Dr. Policar opines that all perforations occur at the time of the IUD insertion procedure,
although diagnosis may be delayed, and that it is an uncommon but possible scenario that an
embedment that occurred at the time of placement progresses over time to form a complete
perforation via which the IUD could be propelled into the abdominal cavity. (Id. at 20-21, 24.)
Dr. Policar is unaware of any plausible mechanism by which an IUD could spontaneously
migrate out of the uterus, and opines that such a concept is not accepted in the family planning
community. (Id. at 20-21, 24.) In his report, Dr. Policar discusses the benefits of the EURASIUD study and writes that its “clinical import has been widely endorsed within the medical
community.” (Id. at 27.) Dr. Policar additionally opines on the limitations of 2D ultrasound,
noting that 2D ultrasound can fail to diagnose an embedment in some circumstances. (Id. at 32.)
Dr. Policar also concludes that the “Mirena label[s] over time have adequately informed
clinicians of the salient clinical information” and that his understanding of the risks of
perforation remained constant despite changes to the label. (Id. at 36.)
Opinions on Secondary Perforation11
Bayer’s experts’ opinions on secondary perforation, contractility of the uterus and
weakening of the uterus by LNG are closely related and will be discussed together. Plaintiffs
first argue that Bayer’s clinical experts lack the medical experience necessary to opine on these
issues. A general thrust of Plaintiffs’ arguments is that Defendants’ experts have not personally
studied uterine activity upon exposure to LNG or pointed to studies ruling out the possibility of
secondary perforation. Not only is personal study not necessary, see McCullock, 61 F.3d at
1042-43; Cedar Petrochemicals, Inc., 769 F. Supp. 2d at 284; In re Zyprexa, 489 F. Supp. 2d at
282, but Defendants do not dispute that their own experts have not personally conducted such
studies. Further, given that Defendants’ experts are attempting to prove a negative – that
secondary perforation does not exist – pointing to the absence of convincing studies or the
weaknesses of studies on which Plaintiffs rely, and evaluating them in light of their clinical
experience, training and research, is in these circumstances a logical and valid approach. After
all, perforation is, as Defendants point out, a clinical phenomenon. See Huskey v. Ethicon, Inc.,
29 F. Supp. 3d 691, 735 (S.D.W. Va. 2014); Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d
420, 480-82 (E.D.N.Y. 2011); DeKeyser v. Thyssenkrupp Waupaca, Inc., 747 F. Supp. 2d 1043,
1050 (E.D. Wis. 2010). With that in mind, I turn to each expert’s proposed testimony.
Dr. Collins has both academic and clinical experience related to contraception in general
and IUDs in particular. She has the qualifications and expertise in the field of family planning
and OB/GYN necessary to allow her to opine on the efficacy of the Mirena IUD and Plaintiffs’
Because Dr. Javitt’s report opines only on imaging of IUDs, in this and subsequent sections not related to imaging
or radiology, “Bayer’s experts” or “Defendants’ experts” refer only to the six experts who opine on these topics.
theory of secondary perforation under Daubert’s admissibility standard. See Daubert, 509 U.S.
at 589. Furthermore, Dr. Collins’ academic research related to hormones and her dissertation
topic indicate that she is qualified to testify regarding the effect of LNG on the uterus and uterine
contractility. (See Collins Report 1.) Plaintiffs argue that all of Bayer’s experts, including Dr.
Collins, “blindly state that there is no evidence that secondary perforation actually occurs,” (Ps’
Omnibus Mem. 11), but this is not so. Instead, Dr. Collins’ opinions on secondary perforation
(like those of the other experts) are based on her experience as a clinician who has inserted and
instructed others on the insertion of IUDs, and on a review of medical literature.12 (Collins
Report at 21-25.) Although Plaintiffs and their experts may disagree with Dr. Collins’
conclusions, these disagreements are best explored on cross-examination.
Plaintiffs additionally argue that Dr. Collins’ opinion on secondary perforation is not
reliable because she ignored contrary scientific literature and Bayer’s own internal and public
findings. (Ps’ Omnibus Mem. 13.) Potentially conflicting statements by Bayer personnel are
irrelevant for purposes of this Daubert motion.13 Plaintiffs’ argument that Dr. Collins ignored
contradictory scientific literature is unfounded; she specifically addressed the leading study on
which Plaintiffs rely – the Goldstuck study14 – and found it to suffer “from multiple
methodological and analytical flaws that render its conclusions inaccurate.” (Collins Report at
Dr. Collins cites seven studies to support her claim that perforation occurs only at insertion of an IUD. (Collins
Report at 22.
This issue is discussed in more detail below.
The Goldstuck study refers to a 2014 study by Norman D. Goldstuck & Dirk Wildemeersch, Role of Uterine
Forces in Intrauterine Device Embedment, Perforation, and Expulsion, 6 Int’l J. of Women’s Health 735 (2014).
(Compendium of Authorities, (“Compendium”), (Doc. 2819), Ex. 9.) The study’s authors found that measured
perforation forces are from “20 N [Newtons] to 54 N” and calculations showed “the uterus is capable of generating
up to 50 N of myometrial force depending on internal pressure and surface area.” (Id. at 735.) The authors
concluded that “[t]he uterine muscle seems capable of generating enough force to cause an IUD to perforate the
myometrium provided it is applied asymmetrically” and gave a “physical theory for IUD expulsion and secondary
IUD perforation.” (Id.)
24.) The Court expresses no opinion on the validity of the Goldstuck study, but because the
parties so vehemently disagree on its credibility, it is a suitable topic for cross-examination
before a jury. While failure to consider contrary studies may undermine reliability, cf. In re
Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 563 (S.D.N.Y. 2004) (discussing problems of
admissibility when expert failed to consider two epidemiological studies addressing topic at hand
that reached different conclusions from expert), Dr. Collins in fact analyzed conflicting
arguments. Her opinions are also grounded in reliable sources, and because of the complicated
medical nature of Mirena and its effects, her testimony is helpful to a trier of fact and is not
Dr. Dalton’s medical qualifications are sufficient for her to opine on the effect of LNG on
the uterus and Plaintiffs’ theory of secondary migration. See In re Zyprexa, 489 F. Supp. 2d at
282. She has experience practicing as an OB/GYN and has had the opportunity to place and
supervise the placement of many IUDs throughout her career. (Dalton Report at 2.) Although
she has not performed any studies herself, this does not mean she is not qualified to give a
medical opinion using her experience as well as a review of relevant scientific literature. See
McCullock, 61 F.3d at 1042-43. Plaintiffs criticize Dr. Dalton because, in the section of her
report where she concludes that LNG does not cause thinning of the uterine wall, she states only
that she has not seen literature to that effect, rather than citing any study showing that such
thinning does not occur. (Ps’ Omnibus Mem. 17.) But her list of materials considered contains
these studies, (Dalton Report app. B),15 and a lack of specific citation in her report goes to the
For example, Dr. Dalton cites Janina Kaislasuo et al., Intrauterine Contraception: Incidence and Factors
Associated with Uterine Perforation—A Population Based Study, 27 Human Reprod. 2658, 2662 (2012) (Cook
Omnibus Decl. Ex. 23), and Mira Harrison-Woolrych et al., Insertion of Intrauterine Devices: A Comparison of
Experience with Mirena and Multiload Cu 375 During Post-Marketing Monitoring in New Zealand, 116 N.Z. Med.
J. 1, 4 (2003) (Cook Omnibus Decl. Ex. 24), which concluded that perforation incidents were similar for LNGcontaining and copper IUDs. Throughout their reports, Defendants’ experts cite other studies for the proposition
that hormonal IUDs containing LNG have similar rates of perforation as copper IUDs in addition to Kaislasuo and
weight of her opinions, not their admissibility. The fact that these studies are listed shows a
reliable foundation upon which Dr. Dalton based her opinions. See Amorgianos, 303 F.3d at
269. Dr. Dalton’s report regarding spontaneous migration cites scientific literature to support her
claim, and she specifically addresses the Goldstuck study on which Plaintiffs rely. Dr. Dalton’s
opinions are sufficiently reliable to pass muster under Daubert, see Deutsch, 768 F. Supp. 2d at
480-81 (allowing doctors to testify where they based their opinions on their own experiences and
review of literature), and her medical testimony would be helpful to the trier of fact.
Plaintiffs move to exclude Dr. Goldberg’s testimony, arguing that like Defendants’ other
experts, he is not qualified because he has not personally conducted studies related to secondary
perforation and the effect of LNG on the uterus, and that his opinion on secondary perforation is
not based on reliable scientific literature. (Ps’ Omnibus Mem. 10.) Dr. Goldberg opines
generally on uterine perforation, (Goldberg Report at 12-20), and on theories of spontaneous
IUD migration, which he concludes are “just speculative hypotheses, without any sound
scientific basis,” (id. at 23). Dr. Goldberg’s experience as a medical doctor specializing in
OB/GYN and his familiarity and experience in placing and teaching how to place IUDs qualify
him to opine on the effects of LNG on the uterus and on Plaintiffs’ theory of secondary
perforation, and are indicative of the reliability of his opinions. See In re Fosamax, 645 F. Supp.
2d at 181 (finding the “clinical experience of the PSC’s oral maxillofacial experts” to be “highly
indicative of the reliability of their opinions”). As previously discussed, experts need not
perform studies themselves to be qualified to testify. McCullock, 61 F.3d at 1042-43. Moreover,
Harrison-Woolrich. (See Cook Omnibus Decl. Exs. 21-22, Heinemann 2015; Abbey B. Berenson et al.,
Complications and Continuation of Intrauterine Device Use Among Commercially Insured Teenagers, 121
Obstetrics & Gynecology 951 (2013).) If LNG in fact thinned the myometrium (the middle layer of the uterine
wall), they reason, LNG-containing IUDs would have increased rates of perforation. Studies that suggest that there
is no difference between perforation rates of copper IUDs and IUDs containing LNG support Defendants’ experts’
views that LNG does not have an effect on the uterus that makes it more susceptible to perforation.
Dr. Goldberg cites to studies to bolster his claims that LNG does not thin the myometrium, and
he analyzes and finds fault with several studies Plaintiffs cite. (Goldberg Report at 24-29.)
Although Plaintiffs and their experts may take issue with Dr. Goldberg’s conclusions, these
criticisms go to the weight, not the admissibility, of his testimony and are best addressed on
cross-examination. In re Zyprexa, 489 F. Supp. 2d at 285 (“The mere fact that an expert’s
testimony conflicts with the testimony of another expert or scientific study does not control
admissibility.”) (citing Fed. R. Evid. 702 advisory committee’s note (2000)). In addition, Dr.
Goldberg’s medical opinions are helpful to the trier of fact.
Dr. Goldberg may not, however, opine on the impact of “lawsuit-generated scientific
misinformation.” (Goldberg Report at 29-30.)16 The probative value of this opinion is
substantially outweighed by its prejudicial effect. Fed. R. Evid. 403; see Nimely, 414 F.3d at 397
(“[T]he Supreme Court . . . has noted the uniquely important role that Rule 403 has to play in a
district court’s scrutiny of expert testimony, given the unique weight such evidence may have in
a jury’s deliberations.”). Dr. Goldberg’s view on how lawsuits affect women’s contraceptive
choices – assuming it would pass muster under Daubert (a dubious proposition) – is not relevant
to either Plaintiffs’ or Defendants’ theories of these cases, would waste time, and would unfairly
Dr. Goldstein’s opinions related to the effects of LNG on the uterus, uterine contractions
and the possibility of secondary migration are sufficiently reliable and pass muster under Rule
702 and Daubert. Dr. Goldstein’s clinical and academic experience qualify him to opine on
whether LNG can contribute to uterine perforations and whether spontaneous migration can
occur. See McCullock, 61 F.3d at 1043. Dr. Goldstein bases his opinions on his decades of
Although Plaintiffs did not raise this issue, it seems important enough for the Court to address sua sponte. See
United States v. Clark, 822 F. Supp. 990, 1000 n.6 (W.D.N.Y. 1993).
experiences as a doctor and a review of scientific literature. See Deutsch, 768 F. Supp. 2d at
482. Dr. Goldstein cites several studies for the proposition that uterine perforations occur, or at
least initiate, at the time of insertion. (Goldstein Report at 28.) In addition, in his materials list
Dr. Goldstein refers to studies that lend support for the proposition that LNG does not have a
thinning effect on the myometrium, in that perforation rates do not differ between hormonal and
copper IUDs. (See Goldstein Report app. C.) Dr. Goldstein also confronts contradictory studies,
including Goldstuck. Plaintiffs can cross-examine to challenge Dr. Goldstein’s credibility.
Dr. Hewitt is qualified to opine on the theory of spontaneous migration and potential
effects of LNG on the uterus. Her opinion is “based on [her] education, training, experience, and
[her] review of the medical literature.” (Hewitt Report at 24.) She cites several publications to
support her view that spontaneous migration cannot occur. (Id.) This passes muster under
Daubert. See Deutsch, 768 F. Supp. 2d at 480-81. She also confronts conflicting reports and
explains her reasoning for dismissing their conclusions. (Hewitt Report at 25-26, 28-29.) Cf. In
re Rezulin, 309 F. Supp. at 563. In addition, her medical testimony is relevant to this case and
helpful to the trier of fact. The appropriate way for Plaintiffs to challenge Dr. Hewitt’s opinions
is through cross-examination.
Plaintiffs once again miss the mark in arguing that Dr. Policar is not qualified to testify
regarding secondary perforation, uterine contractility or weakening of the uterus by LNG. (Ps’
Omnibus Mem. 10-13, 15-18.) Like Bayer’s other clinical experts, Dr. Policar is a distinguished
practitioner with a long career in OB/GYN practice. He has co-authored a textbook on family
planning titled “Contraceptive Technology,” which is in its twentieth edition. (Policar Report at
3; Cook Omnibus Decl. Ex. 2.) Dr. Policar bases his opinions on his experience and also the
“family planning literature over the past 25 years.” (Policar Report at 20.) His disagreement
with Plaintiffs’ theories regarding perforation unrelated to insertion are grounded in his
experience and in the literature, as is appropriate under Daubert. His testimony is also relevant
to this case and helpful to the trier of fact. Plaintiffs may challenge Dr. Policar’s theories and
opinions on cross-examination. See In re Zyprexa, 489 F. Supp. 2d at 285.
For the reasons stated above, Bayer’s experts have demonstrated the requisite
qualifications, reliability and helpfulness to the trier of fact to pass muster under Rule 702 and
Daubert with respect to Plaintiffs’ theory of secondary perforation, uterine contractility and the
effects of LNG on the uterus. Plaintiffs’ motion to exclude these experts from opining on these
topics is denied.
Opinions on the Mirena Label
Bayer’s clinical experts all share similar backgrounds as healthcare providers who have
experience prescribing and inserting IUDs, and all offer opinions regarding the adequacy of the
Mirena label from the perspective of a medical practitioner who is familiar with Mirena and
similar products. (See Collins Report at 25-26; Goldstein Report at 19-23; Goldberg Report at
21-23; Policar Report at 34-37; Dalton Report at 29-31; Hewitt Report at 29-30.) Plaintiffs argue
that none of Defendants’ experts are qualified to offer an opinion on labeling because they lack
“any education or training with respect to FDA labeling.” (Ps’ Omnibus Mem. 19-20.) But none
of Defendants’ experts opine on FDA regulations or on the adequacy of the Mirena warning
from a regulatory perspective. Rather, they only describe how they as clinicians have perceived
the label and its wording with respect to perforation, and how, if at all, that wording affects their
practices. As Dr. Goldstein said during his deposition:
I would definitely offer an opinion on the label as it pertains to how I, as a
clinician and one who teaches, you know, you graduate seven residents a year
times 30 years, 210 now out-in-practice OB/GYNs, how we do or do not utilize
the label. But as far as from a regulatory point of view, that’s not my area of
(Cook Omnibus Decl. Ex. 19, Deposition of Steven Goldstein (“Goldstein Dep.”), at 76:1-10.)17
Plaintiffs do not cite any cases where a prescribing physician or medical practitioner has been
excluded from opining on how a label is perceived from a clinical medical perspective. The
cases they cite deal generally with the relevance of expert testimony in specialized fields. In
Redman v. John D. Brush Co., 111 F.3d 1174 (4th Cir. 1997), the court found the expert’s
testimony regarding industry standards for burglar-deterrent safes unreliable because he did not
rely on “information of a kind reasonably relied on by experts in the field.” Id. at 1179. Barrett
v. Atlantic Richfield Co., 95 F.3d 375, 382 (5th Cir. 1996), and Nora Beverages, Inc. v. Perrier
Group of America, Inc., 164 F.3d 736, 746 (2d Cir. 1998), are similarly unhelpful for Plaintiffs
because although they stand for the general proposition that an expert must be qualified in a field
related to his expertise and have relevant experience in order to testify, Bayer’s clinical experts
in the current case do have such relevant experience and expertise. See Watkins v. Cook Inc.,
No. 13-CV-20370, 2015 WL 1395773, at *10 (S.D.W. Va. Mar. 25, 2015) (allowing doctor to
opine on label based on knowledge and experience with product, but not on FDA regulations);
Deutsch, 768 F. Supp. 2d at 440 (doctors were qualified to “opine as to the adequacy of the
labels from the perspective of oncologists and prescribing physicians” but not as to whether label
complied with FDA regulations).
Plaintiffs argue that Defendants’ experts should not be allowed to “testify in the absence
of knowledge of the risks of Mirena,” and that because Bayer’s experts “ignore that secondary
Drs. Collins, Dalton, Goldberg, Hewitt and Policar similarly do not opine on the label from a regulatory
perspective, but instead offer opinions based on their knowledge as practicing medical professionals. (Collins
Report at 1, 25-26; Dalton Report at 1-2, 29-31; Goldberg Report at 1, 34-37; Hewitt Report at 1-2, 29-30; Policar
Report at 3-4, 34-37.)
perforation is real, they are not equipped to offer an opinion on the adequacy of the Mirena
labeling.” (Plaintiffs’ Reply Memorandum in Further Support of their Omnibus Motion (“Ps’
Omnibus Reply”), (Doc. 2843), 5.) This argument does not withstand scrutiny. Defendants’
experts do not ignore the argument that secondary perforation exists; rather, through their study
of the literature and their own clinical experiences, they do not find the argument persuasive.
The legitimacy of this claim is obviously hotly contested, and the Court does not offer an opinion
on its validity, but it does not mean that Bayer’s experts should not be able to opine on whether
the label is adequate from a physician’s perspective. It is precisely because Defendants’ experts
believe secondary perforation is not a real phenomenon that they think the label, despite not
warning against it, is adequate – in other words, that the label conveys the legitimate risks of the
product. Because Bayer’s experts have based these opinions on a sound methodology, they have
the requisite qualifications, and their testimony is helpful to the trier of fact, their views are
admissible under Daubert. 509 U.S. at 590-91. Should the jury be convinced that secondary
perforation is possible, it will discount the experts’ opinions about the label accordingly.
Bayer’s clinical experts all have experience in inserting IUDs, including Mirena, and
have familiarity with its label, how it is understood, and how it is discussed with patients.
Plaintiffs’ motion to exclude Bayer’s clinical experts’ testimony regarding those aspects of the
Mirena label is therefore denied. Defendants’ experts may not, however, opine on FDA
regulations or whether the Mirena label complied with them, as these doctors are not qualified as
experts on that subject.
Opinions on 2D Versus 3D Ultrasound
Plaintiffs move to preclude all of Bayer’s experts’ opinions that 2D ultrasound is not
capable of always accurately detecting the presence of a Mirena. Plaintiffs argue that Bayer has
never instructed or recommended that 3D rather than 2D ultrasound is the preferred method of
locating a Mirena. (Ps’ Omnibus Mem. 18-19; Ps’ Omnibus Reply 4-5.) In addition, Plaintiffs
argue that “[t]here is no peer-reviewed literature to support the position that 2D ultrasound is
incapable of detecting the presence of Mirena,” and cite Defendants’ experts’ reports as stating
2D ultrasound is reliable in the IUD/Mirena context. (Ps’ Omnibus Mem. 18.) These arguments
mischaracterize Defendants’ experts’ reports and deposition testimony.18
Bayer’s clinical experts opine generally that 2D ultrasound can show whether an IUD is
present in the uterus, but not necessarily whether a portion of an IUD has extended (or has
become embedded) into the patient’s myometrium. (See Collins Report at 18-19; Dalton Report
at 23; Goldberg Report at 14-15; Goldstein Report at 17-18; Hewitt Report at 19-20; Policar
Report at 32.) With the exception of Dr. Javitt, Defendants’ experts do not offer lengthy
opinions on this topic. These experts do not, as Plaintiffs seem to claim, offer opinions that 3D
ultrasound is the standard of care or that “2D ultrasound is incapable of ensuring Mirena
placement,” (Ps’ Omnibus Mem. 19); they only opine as to the limitations of 2D ultrasound in
detecting perforation of the myometrium. If Plaintiffs disagree with the conclusions of Bayer’s
experts regarding those limitations, counsel may question them on cross-examination. But in
doing so they must bear in mind that saying that 2D ultrasound cannot definitively rule out
embedment or perforation is not the same thing as saying 2D ultrasound is unacceptable or 3D
ultrasound is routinely required.
To the extent Plaintiffs challenge Defendants’ experts’ qualifications to opine on these subjects, the challenge is
rejected. Defendants’ experts, as experienced clinical physicians or medical practitioners, have “educational and
experiential qualifications” in a closely related field that qualify the experts to opine on the issue of imaging IUDs.
In re Zyprexa, 489 F. Supp. 2d at 282. They all have experience inserting IUDs and locating them via ultrasound,
and therefore are familiar with the general practices and limitations of that type of imaging.
In addition, Plaintiffs characterize as “unsupportable” the experts’ views that 2D
ultrasound is incapable of ruling out uterine perforation, (Ps’ Omnibus Reply 4), but this
argument is unavailing not only because Defendants’ experts set forth reliable bases (including
studies) for that opinion, (Javitt Report at 4), but also in light of the fact that several of Plaintiffs’
own experts have said the same thing.19 The fact that Plaintiffs’ own experts agree on the
limitations of 2D ultrasound show Bayer’s experts’ opinions concerning imaging are, at the very
Dr. Javitt, whose opinion focuses on 2D versus 3D ultrasound, is an accomplished
radiologist and has served in leadership positions for national and international radiology
committees that draft practice guidelines. (Javitt Report at 1.) She opines on the differences
between 2D and 3D ultrasound technology, and concludes that a 2D ultrasound may not always
be able to rule out that a portion of an IUD has entered the myometrium. (Id. at 4.) Dr. Javitt
also opines that if the IUD is properly placed in the uterine cavity even 3D ultrasound cannot
rule out injuries to the uterine wall caused by other objects, such as a uterine sound or an IUD
inserter. (Id.) Dr. Javitt reaches this conclusion by analyzing several studies that lend support to
her claims. (Id.) She is sufficiently qualified under Daubert to opine on ultrasound, and her
report and proposed testimony are sufficiently reliable because she bases her opinions on her
experience as a radiologist and on scientific literature. See Amorgianos, 303 F.3d at 266-67.
Again, if Plaintiffs disagree with Dr. Javitt’s conclusions, they can take it up on cross-
(See, e.g., Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the Testimony of
Richard Strassberg, M.D., (“Cook Strassberg Decl.”), (Doc. 2690), Ex. B, Deposition of Richard Strassberg
(“Strassberg Dep.”), at 65:11-14 (“[W]ith a 2-D ultrasound, a portion of the Mirena might be embedded in the
myometrium and you wouldn’t be able to tell; right? [Dr. Strassberg:] Correct.”); Cook Young Decl. Ex. A, 8/19/15
Deposition of Roger Young (“8/19/15 Young Dep.”), at 163:14-17 (“[W]ith a 2D ultrasound, you can’t rule out that
one of the arms is embedded in the myometrium, correct? [Dr. Young:] Correct.”); Cook Wray Decl. Ex. A,
Deposition of Susan Wray (“Wray Dep.”), at 261:8-13 (“And you agree that there are limitations in 2-D ultrasound
such that sometimes it will miss the existence of perforation, correct? [Dr. Wray:] So to that I would have to say,
that is my understanding from the reading, yes.”).)
examination. Their criticisms do not undermine her reliability, but rather go to the weight that
should be given to her testimony. See id. at 267. In addition, Dr. Javitt’s proposed testimony
regarding the technical nature of ultrasound imaging would be helpful to assist a lay person in
understanding the ways in which placement of the Mirena and possible perforations can be
Plaintiffs also argue that because Bayer has never suggested that 3D ultrasound is
necessary to ensure the location of a Mirena, it is “disingenuous” for Bayer’s experts to offer
testimony that 2D ultrasound may not be able to rule out perforation at insertion. (Ps’ Omnibus
Reply 4.) Although Plaintiffs are free to make this point during cross-examination, it does not
warrant preclusion under Daubert. Plaintiffs do not cite any authority for the proposition that
because Defendants never instructed patients or doctors to use one method, experts cannot opine
on limitations of another method, or that their testimony should be excluded in such
circumstances as “disingenuous.” Any discrepancy between Defendants’ statements and their
experts’ views at trial may be fodder for questioning and argument by Plaintiffs, but does not
undermine the admissibility of the opinions. Dr. Javitt acknowledges in her report that when
properly conducted, “2D US [ultrasound] can reliably assess whether an IUD is located in or
near the uterine cavity.” (Javitt Report at 3.) She also points out, however, that even though 2D
ultrasound can determine whether an IUD is in the uterine cavity, it cannot always rule out that
an IUD located in the uterine cavity has also partially entered the myometrium. (Id. at 3-4.)
This distinction seems entirely logical and does not undermine the reliability of Dr. Javitt’s
report or the opinions of other experts regarding 2D versus 3D ultrasound.
Defendants’ experts, who are all experienced medical practitioners with academic and
clinical expertise, are qualified to opine on the narrow issue of the limitations of 2D ultrasound
in detecting perforation. In addition, they base their opinions on peer-reviewed studies. They
thus pass muster under Daubert’s reliability standard. See Daubert, 509 U.S. at 593. These
opinions are also helpful to the trier of fact because they relate to a technical, medical issue that
would be beyond the ken of a lay person. For the reasons stated above, Plaintiffs’ motion to
exclude Defendants’ experts’ testimony on the subject of 2D versus 3D ultrasound is denied. For
the same reasons, Plaintiffs’ motion to exclude Dr. Javitt’s expert testimony is also denied.
Opinions on Epidemiology
Plaintiffs move to exclude Bayer’s clinical experts’ opinions regarding epidemiological
studies, including the EURAS IUD study, because they are not epidemiologists and therefore not
qualified to testify as to these studies. (Ps’ Omnibus Mem. 21-22.) This level of expertise,
however is not required under Daubert. See In re Zyprexa, 489 F. Supp. 2d at 282. Moreover,
medical doctors do not need to be epidemiologists in order to testify regarding epidemiological
studies. See, e.g., In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 11-CV-5304,
2013 WL 1558690, at *6 (D.N.J. Apr. 10, 2013) (doctor qualified to opine on clinical trials even
though he was not an epidemiologist); Lyman v. Pfizer, Inc., No. 09-CV-262, 2012 WL 2971550,
at *3 (D. Vt. July 20, 2012) (“A medical doctor does not have to be an epidemiologist in order to
testify about epidemiological studies.”).
Bayer’s clinical experts’ medical qualifications in the field of OB/GYN, their familiarly
with IUDs, and their experience evaluating (and in some cases conducting) epidemiological
studies as part of their clinical work and research suffice under Daubert and qualify them to
opine on epidemiological studies, including the validity and sufficiency of the EURAS study.
See In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 09CV-10012, 2011 WL 6740363, at *6 (S.D. Ill. Dec. 22, 2011) (doctor’s “extensive experiences
qualife[d] him to give expert opin[ions] about the epidemiological studies that he . . . reviewed”).
Accordingly, Plaintiffs’ motion to exclude Defendants’ experts’ opinions as to epidemiological
studies is denied.
Conflicting Bayer Statements and Documents
Plaintiffs next contend that Defendants’ experts’ testimony should be excluded under
Daubert because it arguably contradicts statements made by Bayer employees. (Ps’ Omnibus
Mem. 14-15.) Plaintiffs do not cite any authority for this proposition. The one case that
Plaintiffs cite in this section of their brief, Hilaire v. DeWalt Industrial Tool Co., 54 F. Supp. 3d
223, 234 (E.D.N.Y. 2014), does not support Plaintiffs’ argument for exclusion based on alleged
contrary statements made by a party. In fact, the court there remarked, echoing Daubert, that
once testimony “has been found to be admissible, the adverse party is free to challenge any
shaky or unreliable testimony,” id. (internal quotation marks omitted), before the jury using
“‘vigorous cross-examination, presentation of contrary evidence, and careful instruction on the
burden of proof,’” id. at 235 (quoting Daubert, 509 U.S. at 596) (emphasis added).
Plaintiffs further criticize Defendants’ experts’ testimony as unreliable for failing to
consider Bayer’s public positions and internal discussions related to secondary perforation. (Ps’
Omnibus Reply 3-4.) To support their argument, Plaintiffs cite only Nimely, 414 F.3d at 396-97,
which broadly states that when expert opinions are “based on data, a methodology, or studies
that are simply inadequate to support the conclusions reached,” that testimony should be
excluded. Although this is certainly true under Daubert, it does not mean that potentially
conflicting statements made by a party necessarily render that party’s expert’s testimony
unreliable. The statements and public positions of Bayer are not scientific literature that an
expert would be expected to confront in the exercise of intellectual rigor in the field. See In re
Rezulin Prods. Liab. Litig., 369 F. Supp. 2d 398, 425 (S.D.N.Y. 2005) (expert testimony
unreliable if expert does not acknowledge or account for “relevant scientific
literature . . . tending to refute the expert’s theory”). Under Daubert and its progeny, it is the role
of the district court to analyze the qualifications of experts, the reliability of the methods used by
an expert, and whether expert testimony will assist the trier of fact, not to weigh conflicting
evidence – let alone conflicting evidence of a non-scientific nature in the form of party
admissions. See Amorgianos v. Nat’l R.R. Passenger Corp., 137 F. Supp. 2d 147, 162 (E.D.N.Y.
2001) (“In assessing the reliability of a proffered expert’s testimony, a district court’s inquiry
under Daubert must focus, not on the substance of the expert’s conclusions, but on whether those
conclusions were generated by a reliable methodology.”), aff’d, 303 F.3d 256.
To whatever extent Defendants’ public or internal statements conflict with its experts’
opinions or its litigation positions in these cases, that will be a problem for Defendants that
Plaintiffs may exploit via cross-examination and argument. But Defendants’ experts’ failure to
confront alleged conflicting statements made by Bayer does not warrant exclusion under
Daubert. See Huskey, 29 F. Supp. 3d at 735 (“The plaintiffs also contend that [the expert’s]
opinion is unreliable because he did not review internal [company] documents that refute his
conclusion . . . [the expert’s] failure to review particular documents goes to the weight of his
opinion, not its admissibility.”).
For the reasons stated above, all seven of Defendants’ experts have the necessary
qualifications and have utilized reliable methods in their opinions as required by Rule 702 and
Daubert, and their testimony will assist the trier of fact. Accordingly, Plaintiffs’ omnibus
motion to exclude Bayer’s clinical experts, (Doc. 2702), is DENIED.
Plaintiffs’ Causation Experts
Defendants move to preclude Drs. Young, Jarrell, Wray and Strassberg from offering
opinions regarding general and specific causation. Each is discussed separately below.
Roger C. Young, M.D., Ph.D.
Defendants move to preclude Dr. Young’s expert testimony relating to his theory of how
secondary perforation of an IUD can occur – his theory of general causation – on the grounds
that the methodology upon which he bases his opinions is unreliable and that he takes
impermissible speculative leaps in forming his conclusions. Dr. Young’s general causation
expert report and proposed testimony are offered by Plaintiffs to show a mechanism by which
perforation of an IUD unrelated to insertion – in other words, secondary perforation or
spontaneous migration – could occur. Dr. Young also offers a specific causation opinion that
secondary perforation did occur in Ms. Danley’s case. (Cook Young Decl. Ex. C, Expert Report
of Roger C. Young, M.D., Ph.D. (“Young Danley Report”).) For the reasons stated below,
Defendants’ motion is GRANTED with respect to both Dr. Young’s general causation opinions
and his specific causation opinions.
In his general causation report, Dr. Young opines on “potential mechanisms of secondary
perforation of Mirena IUDs.” (Young Report at 2.) He sets forth a “[b]iologically plausible
mechanism for IUD uterine perforation” that consists of four steps. (Id. at 10-11.) The
mechanism assumes (at “Step 0”) that the IUD is correctly placed within the uterine cavity. (Id.
at 11.) At Step 1 of Dr. Young’s mechanism, there is “delayed embedding” of the IUD in the
uterine wall, which occurs unrelated to the insertion procedure. (Id.) Dr. Young opines that this
“delayed embedding” is facilitated by “chemical changes of the lining on the uterus caused by
locally high concentrations of levonorgestrel [LNG],” which serves to thin the endometrium,
exposing the underlying musculature and leading to an enhanced foreign body reaction (“FBR”).
(Id. at 12.) According to Dr. Young, this thinning and FBR leads to a “greater likelihood that the
Mirena will experience delayed embedding” in the uterine wall. (Id.) Step 2 in Dr. Young’s
mechanism refers to “penetration of the IUD into the uterine wall to a deeper level than
embedding,” with one part of the IUD “lead[ing] the way” as the IUD penetrates the uterine wall.
(Id. at 13.) Again, at this stage Dr. Young attributes the softening of the connective tissue near
the IUD, caused by LNG, as a significant contributing factor to IUD penetration. (Id.) Dr.
Young asserts that uterine contractions also contribute to penetration of the uterine wall. (Id.)
Step 3 in Dr. Young’s mechanism refers to perforation of the uterus by the IUD, which is
the “phase where the IUD actively penetrates the uterine wall until some portion of the IUD
protrudes through the wall into the abdominal cavity.” (Id. at 14.) Dr. Young opines it is likely
that the Mirena penetrates the uterus “by mechanical and chemical mechanisms.” (Id. at 15.)
The chemical mechanisms relate to the softening of the uterine tissue discussed at Steps 1 and 2,
and the mechanical mechanisms refer to uterine contractions and the force required for the
Mirena to perforate on its own. (Id.) Dr. Young acknowledges that the Mirena actually tends to
reduce contractions, but finds that because it does not eliminate them, they can still contribute to
secondary perforation. (Id.) Dr. Young estimates the amount of force created by the effect of
uterine contractions on the Mirena using the size of Mirena and the force quantities found in one
study examining the uterus and in another examining the heart. (Id. at 15-16.) The final stage in
Dr. Young’s analysis, Step 4, refers to “[t]ransmigration of IUD into abdominal cavity,” which is
when the IUD exits the uterus. (Id. at 16.) Dr. Young opines that once the IUD has partially
penetrated, complete penetration is “accomplished when uterine contractions occur in response
to the presence of a foreign body.” (Id.) Dr. Young’s mechanism is thus based upon the effects
of LNG on the uterus, which he concludes enhances the risk of secondary perforation, and the
forces generated by uterine contractions. (Id.) He additionally concludes that knowledge of
“mechanisms of secondary perforation are well-known” in medical literature. (Id.)
Dr. Young is an experienced doctor specializing in OB/GYN. Dr. Young completed a
residency in OB/GYN in 1986, and has since practiced obstetrics and gynecology in an academic
setting. (Young Report at 3.) Dr. Young has served as a professor at the University of Vermont
School of Medicine, Dartmouth Medical School, the Medical University of South Carolina and
Duke University. (Id.) He is currently a professor at the University of Tennessee Health
Sciences Center. (Id.) Dr. Young also has clinical experience in OB/GYN that has included
caring for patients, supervising residents and teaching clinical medicine to medical students. (Id.
at 4.) Dr. Young has learned, and subsequently taught, “how to place and remove copper 7,
copper T, ParaGard and Mirena IUDs.” (Id. at 6.) Over the course of his 27 years of clinical
practice, Dr. Young has placed or supervised the placement of approximately 300 IUDs. (Id.)
When Dr. Young was the Director of the Division of General Obstetrics and Gynecology at the
University of Vermont, he “created a didactic, a practicum, and brief written test that each
resident was required to complete prior to being able to place an IUD as the primary operator.”
(Id.) In addition, Dr. Young has researched “subcellular, cellular, tissue-level, and organ-level
uterine physiology” with a focus on the “[d]evelopment of function with the hormonal effects of
pregnancy, pre-labor changes, and labor.” (Id. at 3.) He has “written and published 50 articles
or book chapters in peer-reviewed journals, including mathematical simulation computer
programs that describe uterine contractions in pregnancy.” (Id.) Dr. Young has also extensively
researched the functioning of the uterus. (Id.)
Defendants argue that Dr. Young has “no specialized knowledge or experience
concerning Mirena, perforation, or the biomechanics of the non-pregnant uterus.”
(Memorandum of Law in Support of Defendants’ Motion to Exclude the Testimony of Roger C.
Young, M.D., Ph.D. (“Ds’ Young Mem.”) 3.) Dr. Young’s academic and clinical background in
obstetrics and gynecology, however, as well as his specific research on the functioning of the
uterus, including effects of hormones and uterine contractions, make him qualified to opine on
the issue of whether an IUD such as Mirena is capable of perforating a uterus unrelated to
insertion. See In re Zyprexa, 489 F. Supp. 2d at 282. The Court must now determine whether
Dr. Young’s opinion and methodology meet Daubert’s standards of reliability. See Daubert, 509
U.S. at 589; Amorgianos, 303 F.3d at 266.
Defendants move to exclude the testimony of Dr. Young on the grounds that it is
unreliable. (Ds’ Young Mem. 6-9.) Dr. Young’s report and proposed testimony – which purport
to be scientific, and thus the sort of expert testimony to which the four Daubert reliability factors
apply, see Daubert, 509 U.S. at 592-93 – fail to meet any of those four factors. First, Dr.
Young’s mechanism has never been tested or studied in human patients, nor has it undergone
animal or in vitro20 testing. (8/19/15 Young Dep. at 137:7-10, 137:22-138:2.) Dr. Young
acknowledged that it would be very difficult to test his mechanism because one cannot rule out,
using standard techniques, disruption to the endometrial layer or trauma to the stroma upon
In vitro testing refers to testing in “an artificial environment.” Merriam-Webster Online Dictionary 2015,
available at http://www.merriam-webster.com/. This differs from “in vivo” testing, which refers to a situation
occurring “in the living body of a plant or animal.” Id.
insertion, yet the absence of such injury is assumed at Step 0 of his theory. (Id. at 159:15160:20.) Second, Dr. Young’s mechanism has not been “subjected to peer review and
publication,” Daubert, 509 U.S. at 593, nor has it been scrutinized by the scientific community,
(8/19/15 Young Dep. at 138:3-10). Dr. Young has shared his theory only with lawyers, not with
other medical researchers or experts. (8/19/15 Young Dep. at 138:11-17.)Third, Dr. Young’s
mechanism has produced no “known or potential rate of error,” Daubert, 509 U.S. at 594,
because it has not been tested, (8/19/15 Young Dep. at 137:7-10, 137:22-138:2). Finally,
Plaintiffs have not shown that Dr. Young’s proposed mechanism has gained “general
acceptance” within the scientific community. Daubert, 509 U.S. at 594. Dr. Young
acknowledged that he is unaware of anyone in the scientific community who agrees with his
mechanism of perforation, (8/19/15 Young Dep. at 228:16-24), and he only began to investigate
his theory in the context of this litigation, (id. at 138:8-10, 163:21-164:6). See In re Pfizer Inc.
Sec. Litig., No. 04-CV-9866, 2010 WL 1047618, at *6 (S.D.N.Y. Mar. 22, 2010) (expert
testimony regarding mechanism of causation permitted where “deemed plausible and credible in
the relevant medical literature”), as amended (Mar. 29, 2010).
Expert testimony developed solely for litigation can weigh against reliability. See
Eghnayem v. Bos. Sci. Corp., 57 F. Supp. 3d 658, 670 (S.D.W. Va. 2014); In re Rezulin, 369 F.
Supp. 2d at 420, 424. In addition, although the factors outlined in Daubert are not a “definitive
checklist or test,” Daubert, 509 U.S. at 593, “when an expert is offering testimony that is
presented as a scientific conclusion and the expert’s method fails to satisfy any of the factors
identified in Daubert, a court should pause and take a hard look before allowing a jury to
consider it,” In re Methyl Tertiary Butyl Ether (MTBE) Prods. Liab. Litig., 593 F. Supp. 2d 549,
564 (S.D.N.Y. 2008), on reconsideration in part (June 26, 2008) (emphasis in original).
Because Dr. Young’s mechanism does not meet any of the criteria listed in Daubert, the Court
carefully scrutinizes Dr. Young’s proposed testimony and concludes that it lacks a reliable
Expert testimony “must be supported by appropriate validation – i.e., good grounds,
based on what is known.” Daubert, 509 U.S. at 590 (internal quotation marks omitted).
Moreover, an expert, “whether basing testimony upon professional studies or personal
experience, [must] employ in the courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field.” Kumho Tire Co., 526 U.S. at 152.
In the scientific community, “[s]cientific methodology . . . is based on generating hypotheses and
testing them to see if they can be falsified.” Daubert, 509 U.S. at 593. Dr. Young, however, was
given a conclusion by lawyers and worked backwards to hypothesize a mechanism by which it
might occur. (See Young Report at 2) (“I have been asked to offer an opinion as to the potential
mechanisms of secondary perforation of Mirena IUDs.”). No testing of the hypothesis was
conducted. This exercise does not seem to have involved any scientific methodology, but rather
consisted of reverse-engineering a theory to fit the desired outcome. This does not rise to the
level of intellectual rigor employed in the medical or scientific field, see Kumho Tire Co., 526
U.S. at 152, and alone would warrant exclusion. See Faulkner v. Arista Records LLC, 46 F.
Supp. 3d 365, 381 (S.D.N.Y. 2014) (“[M]ethodology . . . aimed at achieving one result . . . is
unreliable, and . . . must be excluded.”); In re Accutane Prods. Liab., 511 F. Supp. 2d 1288, 1296
(M.D. Fla. 2007) (“While [the expert’s] biological theory may be exactly right, at this point it is
merely plausible, not proven, and biological possibility is not proof of causation.”); Golod v. La
Roche, 964 F. Supp. 841, 860-61 (S.D.N.Y. 1997) (“[A]lthough [the expert’s] theory may be
biologically plausible, it does not constitute ‘scientific knowledge’ within the meaning of
Daubert. Instead, it is, at most, scientifically-grounded speculation: an untested and potentially
untestable hypothesis. Although there may be circumstances in which a scientific hypothesis
that is, practically speaking, untestable, would nevertheless be admissible, perhaps because of
general acceptance in the scientific community, this is not such a case.”). Indeed, “the
courtroom is not the place for scientific guesswork, even of the most inspired sort. Law lags
science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996). Dr.
Young’s expert testimony is therefore inadmissible.
Furthermore, apart from the requirement that the opinion constitute “scientific
knowledge,” as opposed to hypothetical speculation, an expert’s analysis must be “reliable at
every step.” Amorgianos, 303 F.3d at 267. Defendants argue that Dr. Young’s mechanism
theory is unreliable because each step requires a “[s]peculative [l]eap.” (Ds’ Young Mem. 918.) At Steps 1 through 4 of his mechanism, Dr. Young cites studies and publications that he
alleges support his theory of the mechanism for secondary perforation. A closer look, however,
shows that Dr. Young draws impermissibly speculative conclusions from these studies that
“exceed the limitations the authors themselves place[d] on the[se] stud[ies].” In re Accutane
Prods. Liab., No. 04-MD-2523, 2009 WL 2496444, at *2 (M.D. Fla. Aug. 11, 2009), aff’d, 378
F. App’x 929 (11th Cir. 2010).
As part of Step 1 of his mechanism, Dr. Young opines that the IUD embeds into the
uterine wall – the myometrium – after, and unrelated to, insertion. (Young Report at 11-12.) Dr.
Young says this is possible due to the uterus’s reaction to the IUD, a foreign body, being inside
it, and the effect of LNG on the uterus. (Id.) Dr. Young relies on the Phillips study21 to bolster
his argument that a FBR takes place when an IUD is present in the uterus, (Young Report at 12),
“Phillips” refers to V. Phillips et al., The Effects of the Levonorgestrel Intrauterine System (Mirena Coil) on
Endometrial Morphology, 56 J. Clinical Pathology 305 (2003). (Compendium Ex. 17.)
and cites to several studies that discuss the effects of LNG on the endometrium, (id. at 11-12; see
Compendium Exs. 4, 6, 17, 18).22 As Dr. Young conceded at his deposition, however, none of
these studies, including Phillips, discusses effects that LNG might have on the myometrium, the
layer of muscle beyond the endometrium through which an IUD must puncture for perforation
and migration to occur. (See Young Report at 11-12; 8/19/15 Young Dep. at 182:7-21.) The
distinction matters because, by his own account, the endometrium and myometrium are distinct
anatomical features: the former is a “thin layer,” (Young Report at 4), composed of “glandular
tissue,” (8/19/15 Young Dep. at 112:15-20), whereas the later is a 1.3-2 cm layer made up of
muscular tissue, (id. at 112:2-14). Moreover, during his deposition Dr. Young could not point to
an article or study that supported the notion that LNG has a foreign body effect on the
myometrium as opposed to the endometrium, (id. at 187:4-188:2; 191:22-194:1), and conceded
that he was not aware of any evidence that LNG thins the myometrium, (id. at 114:9-11). Dr.
Young opines, without explanation or analysis, that “[a]ny inflammation of the endometrium is
going to extend into the myometrium,” based on the small distance (5 microns) and shared blood
supply between the two. (Id. at 182:11-21.) He does not explain why this proximity means that
an outer layer, made of muscle, will react the same way as an inner layer, made of a different
type of tissue, to the presence of a hormone in the cavity the inner layer surrounds. This type of
speculation, whereby the conclusions are linked to studies only by Dr. Young’s say-so, is
impermissible under Daubert. See Joiner, 522 U.S. at 146 (where opinion “is connected to
existing data only by the ipse dixit of the expert,” the “court may conclude that there is simply
too great an analytical gap between the data and the opinion proffered”); see also McClain v.
Metabolife Int’l, Inc., 401 F. 3d 1233, 1244-1245 (11th Cir. 2005) (“The conclusions that [the
Phillips found “stromal inflammatory cell infiltrate” in 59 of 75 cases where individuals were using a LNG
intrauterine system. Phillips, supra note 21, at 305.
expert] draws about ephedrine by analogy . . . are very important to his opinions, but he did not
show the reliability of each of his steps in deducing Metabolife’s toxicity from this analogy.
This is a fatal defect under Daubert.”).23
Additionally, another important piece of Step 1 of Dr. Young’s theory is his conclusion
that uterine cells grow around the IUD, or “remodel,” to attach it to the uterine wall. (8/19/15
Young Dep. at 172:10-173:8; Young Report at 11.) Dr. Young, however, disavowed the one
article he cited to support this claim, and said that it does not actually support that proposition,
(8/19/11 Young Dep. at 172:7-21, 177:24-178:2), and could not point to another study showing
that uterine cells will grow around an IUD like Mirena, (id. at 172:22-173:20.) Dr. Young
testified that he relied on two articles mentioned in his CV involving laboratory studies of cell
growth on scaffolding. (Id. at 173:21-175:6.) Dr. Young’s report does not discuss these studies,
and during his deposition he did not explain why the growth of cells in these studies lends
support to his theory that presence of an IUD leads to cell growth around it in the uterus. Indeed,
he conceded that there are no studies that would support analogizing the two. (Id. at 176:13-22.)
Dr. Young’s analysis in this regard does not rise to the level of intellectual rigor generally seen in
the scientific community, and thus does not meet the requirements of Rule 702 and Daubert.
Step 2 of Dr. Young’s theory refers to penetration of the IUD into the uterine wall to a
deeper level than embedding, a process helped by a softening in connective tissue due to the
increased presence of LNG in the uterus. (Young Report at 13.) Dr. Young primarily relies on
G.S. Anthony et al., Forces Required for Surgical Dilatation of the Pregnant and Non-Pregnant
Extrapolation from studies to support an expert’s conclusions, as well as the use of in vitro versus in vivo studies,
may at times go to the weight and not the admissibility of expert testimony. See In re Ephedra Prods. Liab. Litig.,
393 F. Supp. 2d 181, 189 (S.D.N.Y. 2005) (“[A]nalogy, inference and extrapolation can be sufficiently reliable steps
to warrant admissibility so long as the gaps between the steps are not too great.”). Nonetheless, here, the gaps
between Dr. Young’s theory and the authorities on which he relies are too great to warrant admissibility. He does
not explain why his analogies, inferences and extrapolations are valid in this context.
Human Cervix, 89 British J. Obstetrics & Gynaecology 913 (1982), (Compendium Ex. 2)
(“Anthony study”), for the proposition that progestins such as LNG weaken uterine tissue. The
authors of this study were analyzing the force required to dilate the cervix. The study
specifically found no direct correlation “between circulating levels of [progesterone] and the
cervical resistance in non-pregnant or early pregnant subjects.” (Id. at 915.) Despite this finding
that seemingly contradicts the proposition for which he cites it, Dr. Young believes this study
supports his theory because the authors state that the study found “patients receiving DepoProvera showed a significantly lower level of cervical resistance . . . than did the cycling group.”
(Id. at 915.) Depo-Provera – a birth control shot that contains a progestin – is a different
contraceptive than Mirena. The Anthony study did not attribute the weakening effect of DepoProvera to progestin, and in fact noted that another progestin-containing contraceptive (the
combined oral contraceptive pill) had no such effect. (Id.) To conclude that Mirena would cause
the same effect as Depo-Provera because they both contain progestin – particularly when other
contraceptives also containing progestin had the opposite effect, the effect of Depo-Provera was
not attributed to progestin, and the study found no correlation between progestin levels and that
effect – is to impermissibly draw grossly “overreaching conclusions,” In re Accutane, 2009 WL
2496444, at *2, which are connected solely to the data by Dr. Young’s say-so, see Joiner, 522
U.S. at 146; see also Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672, 681 (M.D.N.C. 2003)
(“[Expert’s] assertion that because bromocriptine is an ergot alkaloid and may behave like other
ergot alkaloids and cause vasoconstriction simply does not support the proposition that Parlodel
causes stroke in postpartum women. Opinions merely expressing ‘possibilities’ do not suffice to
support the admissibility of expert testimony.”) (citing Saldana v. Kmart Corp., 260 F.3d 228,
234 (3d Cir. 2001)).
Moreover, at the end of his Step 2 analysis, Dr. Young acknowledges that LNG actually
decreases the strength and frequency of uterine contractions, but argues that because they are not
eliminated entirely, they still contribute to embedment. (Young Report at 13.) But he does not
account for this diminishing effect in his analysis. “[A]ny theory that fails to explain information
that would otherwise tend to cast doubt on that theory is inherently suspect.” In re Rezulin, 369
F. Supp. 2d at 425. The extrapolations and inferences Dr. Young makes at Step 2 of his analysis
are just too speculative to suffice under Daubert.
At Step 3 of his analysis, Dr. Young relies in part on the Goldstuck study, supra note 14,
to show that uterine contractions have sufficient force to penetrate the uterine wall. (Young
Report at 14-15.) Although Goldstuck presents evidence relating to the force of uterine
contractions in connection with an IUD, Dr. Young conceded that there were errors in the
study’s methods and findings. (8/19/15 Young Dep. at 304:6-307:5.) He said an important value
for measuring uterine contractions that the authors of Goldstuck attributed to another article did
not actually appear in that other article, and described the Goldstuck authors as being
“disingenuous.” (Id. at 304:15-305:11.) Nevertheless, Dr. Young continued to rely at least in
part on the numbers generated by Goldstuck and said, without further explanation, that the
author’s errors “made in one way tended to counterbalance other errors that [the author] made.”
(Id. at 305:19-306:20.) Dr. Young seems to have performed some sort of calculation of his own
to mitigate the errors he found in Goldstuck, (see id. at 303:4-8, 306:13-307:5, 318:10-323:5),
but these calculations do not appear in his report nor were they apparent during his deposition.
When asked to explain where he got some of the figures he used in that calculation, Dr. Young
cited “just kind of my experience working with pregnant and nonpregnant tissue and just in
terms of contractility of uterine tissue,” (id. at 320:23-321:2), and said that he derived these
calculations from his “experience and talking with the people who have done the research, [who]
seem to be getting those values,” (id. at 324:1-10.)24 This does not rise to the level of intellectual
rigor of medical or scientific study, rendering this opinion unreliable. See Joiner, 522 U.S. at
422; In re Rezulin, 369 F. Supp. 2d at 434.
As in Step 2 of his theory, Dr. Young again does not account for the fact that Mirena
actually decreases the strength and frequency of uterine contractions, even though he
acknowledged that Goldstuck did not involve uterine contractions in women with Mirena, further
underscoring his unreliable methodology. See Rezulin, 369 F. Supp. 2d at 425. Dr. Young
ultimately concludes that the contractile force of Mirena is 390 lbs/in², which is sufficient to
penetrate uterine tissue “compared to the amount of force required to penetrate heart muscle . . .
which is approximately . . . 290 lbs/ in².” (Young Report at 15.) The article that Dr. Young cited
for the 290 figure involved a study of pig hearts, which Dr. Young said was an appropriate
equivalent because he had “felt a lot of uteruses that ha[d] been taken out at the time of
hysterectomy, and it feels remarkably like the pig hearts that my grandmother used to buy when I
was a kid. So the softness of these two tissues are very similar.” (8/19/15 Young Dep. at
291:15-24.)25 Such a subjective comparison of muscle of a pig heart to a female uterus creates
“simply too great an analytical gap between the data and the opinion proffered” to pass muster
under Rule 702 and Daubert. Joiner, 522 U.S. at 146. But beyond that, Dr. Young corrected
himself that it was chicken hearts he had felt as a child, and that he had no basis for comparing
In one instance Dr. Young noted that published figures for uterine contractility were based on pregnant tissue, so
to account for the fact that such tissue is more contractile than non-pregnant tissue, he reduced the value. (Young
Dep. at 321:7-20.) But he provided no explanation for why or how he chose the reduced value, which “appears to
have been plucked out of thin air based on vague qualitative notions.” LaserDynamics, Inc. v. Quanta Comput.,
Inc., 694 F.3d 51, 69 (Fed. Cir. 2012).
Although animal studies may be reliable sources, courts must use “caution” “in extrapolating results in tissue
culture to effects in live humans.” In re Rezulin, 369 F. Supp. 2d at 428-29.
uterine tissue to pig hearts. (8/19/15 Young Dep. at 292:21-293:6.) So that aspect of Dr.
Young’s testimony is not even connected to the data by ipse dixit. See Joiner, 522 U.S. at 146.
Assisting the Trier of Fact
In light of their failure to meet the Daubert factors, absence of methodology, reverse
reasoning and analytical gaps, Dr. Young’s general causation opinions do not have sufficient
indicia of reliability to pass muster under Daubert, and therefore they would not be helpful to a
Causation Opinion in Danley
Dr. Young has also authored a case-specific causation opinion for Plaintiff Jennifer
Danley, which Defendants move to exclude as contradictory and unreliable. Defendants also
argue that because Dr. Young has not given a general causation opinion, or relied on another
expert’s general causation opinion, he may not give a specific causation opinion. (Ds’ Young
Mem. 20-21.) The records show that Ms. Danley’s Mirena was inserted on June 29, 2011.
(Cook Young Decl. Ex. I.) An ultrasound was performed to check the position of the Mirena
immediately following placement, and the technician noted that the IUD was seen “HIGH/RT.”26
(Id. Ex. J.) On January 3, 2013, Ms. Danley went to her healthcare provider after she had a
positive home pregnancy test. (Id. Ex. M.) On January 8, 2013, an X-ray was performed that
revealed Ms. Danley’s IUD was located “overlying the left lilac bone.” (Id. Ex. N.) On January
23, 2013, Ms. Danley’s Mirena was removed by a “diagnostic laparoscopy.” (Id. Ex. O.)
The parties dispute the meaning of “HIGH/RT” and whether this indicates that Ms. Danley’s uterus was
perforated at the time of insertion.
Dr. Young opines that Ms. Danley’s second Mirena was inserted on June 29, 2011
without complications and the Mirena was correctly located within the uterine cavity. (Young
Danley Report at 2.) He concludes that Ms. Danley did not experience symptoms at the time of
or immediately after insertion that would suggest that perforation occurred at that time. (Id.) He
also opines that an IUD has little or no contraceptive effect if it is located outside the uterine
cavity, and notes Ms. Danley did not become pregnant until 18 months after insertion. (Id.) Dr.
Young reasons that had Ms. Danley’s uterus been perforated at the time of insertion, resulting in
the Mirena’s placement directly into the abdominal cavity, it “is unlikely it would have taken 18
months for her to become pregnant.” (Id.) Dr. Young thus concludes that the Mirena entered
Ms. Danley’s abdominal cavity during the fall of 2012 due to secondary perforation, requiring an
abdominal laparoscopy to remove the Mirena, which she would not have otherwise needed. (Id.)
Lack of General Causation
Defendants argue that Dr. Young’s specific causation is inadmissible because in his
report on Ms. Danley, Dr. Young did not give a general causation opinion or rely on another
expert’s general causation opinion. (Ds’ Young Mem. 20-21.) “‘General causation is whether a
substance is capable of causing a particular injury or condition in the general population, while
specific causation is whether a substance caused a particular individual’s injury.’” In re Rezulin,
369 F. Supp. 2d at 402 (quoting In re Breast Implant Litig., 11 F. Supp. 2d 1217, 1224 (D. Colo.
1998)).27 In the absence of evidence of general causation, evidence of specific causation is
The Rezulin court also cited Mary Sue Henifin, Howard M. Kipen & Susan R. Poulter, Reference Guide on
Medical Testimony, in Reference Manual on Scientific Evidence 439, 444 (Fed. Jud. Ctr. ed., 2000)), which states
that “[g]eneral causation is established by demonstrating, often through a review of scientific and medical literature,
that exposure to a substance can cause a particular disease (e.g., that smoking cigarettes can cause lung cancer).” In
re Rezulin, 369 F. Supp. 2d at 402; see Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 251 n.1 (2d Cir. 2005)
(“General causation bears on whether the type of injury at issue can be caused or exacerbated by the defendant’s
“irrelevant.” In re Rezulin Prods. Liab. Litig., 441 F. Supp. 2d 567, 578 (S.D.N.Y. 2006).28 “[A]
physician must have some reliable basis for believing that a particular substance is capable of
causing the injury in question in relevant circumstances before concluding that the substance
caused that injury in a particular case.” In re Rezulin, 369 F. Supp. 2d at 438.29 Although Dr.
Young did not cite his mechanism theory for secondary perforation in his specific causation
report, during his deposition he stated that he believed the “transmigration of [Ms. Danley’s]
IUD occurred through [his] mechanism” and that the four steps of his mechanism occurred in
Ms. Danley’s case. (Cook Young Decl. Ex. D, 8/20/15 Deposition of Dr. Roger C. Young
(“8/20/15 Young Dep.”), at 472:17-473:3.)
But because I have found that Dr. Young’s general causation opinion is not based on a
reliable methodology and is therefore inadmissible, his specific causation must also be excluded.
See In re C.R. Bard, Inc., 948 F. Supp. 2d at 605 (“[Expert’s] specific causation opinions are
product. Specific causation bears on whether, in the particular instance, the injury actually was caused or
exacerbated by the defendant’s product.”) (internal quotation marks omitted and emphasis in original).
Plaintiffs have not disputed this proposition. The parties also do not dispute that Ms. Hayes’ and Ms. Danley’s
Mirenas caused her injuries – in both cases the Mirena was located outside their uteruses and had to be removed.
Instead, the parties dispute how that injury occurred – i.e., whether the perforation occurred upon insertion (a risk
against which Defendants warned) or after insertion. Thus, in the context of these cases, evidence of general
causation means evidence that secondary perforation can occur and evidence of specific causation means evidence
that it occurred in the cases of Ms. Hayes and Ms. Danley. See In re Rezulin, 369 F. Supp. 2d at 438 (general or
specific causation relate to “the injury in question in relevant circumstances”).
Put another way, “[a] physician attempting to establish a causal relationship between exposure to a substance and
a particular patient’s illness must ‘demonstrate that the medical and scientific literature provides evidence that in
some circumstances the exposure under consideration can cause the outcome under consideration. This step is
synonymous with establishment of general causation.’” In re Rezulin, 369 F. Supp. at 436 (quoting Henifin et al.,
supra note 27, at 469). Although In re Rezulin concerned toxic tort litigation, this concept that a specific causation
opinion must be based on a reliable general causation opinion logically applies, and has been applied, in cases
involving devices. See, e.g., Norris v. Baxter Healthcare Corp., 397 F.3d 878, 887 (10th Cir. 2005) (“In concluding
that Plaintiff’s systemic injuries were a result of her silicone breast implants, Plaintiff’s experts attempted to
demonstrate specific causation without first demonstrating general causation . . . Plaintiff’s experts agree that, at
best, silicone-associated connective tissue disease is an untested hypothesis. At worst, the link has been tested and
found to be untenable. Therefore, there is no scientific basis for any expert testimony as to its specific presence in
Plaintiff.”); In re C.R. Bard, Inc., 948 F. Supp. 2d 589, 605 (S.D.W. Va. 2013), on reconsideration in part (June 14,
2013) (specific causation opinion in transvaginal mesh case excluded after court found expert’s general causation
opinion, on which specific causation opinion was based, unreliable).
based on her general causation opinions. In other words, her opinion as to each bellwether
plaintiff is that the plaintiff suffered nerve injuries through one or both of the general causation
mechanisms . . . Because I found that [the expert’s] general causation opinions are not based on
reliable methodology and principles, her specific causations opinions – based on her general
causation opinions – should also be excluded.”); Rezulin, 441 F. Supp. 2d at 578 (excluding
experts’ specific causation opinions for failing to offer opinions as to general causation). Dr.
Young’s specific causation opinion is therefore inadmissible on this ground.30
In any event, in addition to being inadmissible because of lack of evidence of general
causation, Dr. Young’s methodology in reaching his conclusion that Ms. Danley experienced a
secondary perforation of her Mirena is not based on a reliable methodology, warranting
exclusion under Daubert. Dr. Young relies on the ultrasound that was taken following the
insertion of Ms. Danley’s Mirena and a lack of any post-insertion symptoms to conclude that the
Mirena “was correctly located within the uterine cavity at this time.” (Young Danley Report at
6.) That the IUD was in the uterine cavity, however, does not mean there was no injury upon
insertion (whether from a sound, the inserter or the IUD). Further, Dr. Young acknowledged that
2D ultrasound cannot rule out the embedment of an arm of the IUD in the myometrium, (8/19/15
Young Dep. at 163:6-17), and that many perforations are asymptomatic, (8/20/15 Young Dep. at
431:13-15). Dr. Young concludes that in Ms. Danley’s case it is more likely than not that
secondary perforation occurred without explaining why hers is unlikely to be a case where 2D
Dr. Young in his Danley report does not refer to other general causation opinions on which he relied in forming
his specific causation opinion. Moreover, even if he had relied on Dr. Jarrell’s and Dr. Wray’s testimony, because I
find that testimony to be inadmissible, see pages 54-85 below, Dr. Young cannot base his opinions on their reports
on general causation.
ultrasound missed an injury or where injury occurred without symptoms. This say-so does not
rise to the level of reliability required under Rule 702 and Daubert.
Moreover, Dr. Young opines that Ms. Danley became pregnant in late 2012 because the
Mirena was in place (producing its contraceptive effects) until it perforated her uterus at that
time, but he fails to account for or consider alternative evidence that could explain why Ms.
Danley did not become pregnant sooner. For example, Dr. Young admitted that he would not
know whether Ms. Danley and her husband were having intercourse while Ms. Danley was
ovulating. (Id. at 424:1-9.) Ms. Danley also used condoms as birth control from 2003 to 2013,
which would include the time her second Mirena was implanted. (Cook Young Decl. Ex. P, at
JDanley-PFS-000080; Cook Young Decl. Ex. L, Deposition of Jennifer Danley (“J. Danley
Dep.”), at 132:10-12.) Ms. Danley was also breastfeeding her baby for seven months following
the insertion of her second Mirena, (J. Danley Dep. at 200:8-15), which Dr. Young
acknowledged would have “some contraceptive effect,” although Dr. Young said the effect
would not be “total,” (8/20/15 Young Danley Dep. at 426:10-15). Dr. Young also acknowledges
that if an IUD’s drug reservoir is still within the myometrium it would have some reduced
contraceptive effect, although he claims, without explanation, that this was not the case for Ms.
Danley, (id. at 428:21-429:6), even though, according to him, it could take “[d]ays or weeks to
years” for an IUD to penetrate into the uterine wall to a deeper level than embedding, (Young
Report at 11). Dr. Young’s failure to give “reasonable explanation[s]” for discounting or
dismissing these alternative possibilities for why Ms. Danley did not become pregnant for 18
months undermines the reliability of his opinions. See Deutsch, 768 F. Supp. 2d at 474 (“[E]ven
though ‘an expert need not rule out every potential cause in order to satisfy Daubert, the expert’s
testimony must at least address obvious alternative causes and provide a reasonable explanation
for dismissing specific alternative factors identified by the defendant.’” (quoting Israel v. Spring
Indus. Inc., 98-CV-5106, 2006 WL 3196956, at *5 (E.D.N.Y. Nov. 3, 2006)).
Defendants’ motion to exclude Dr. Young’s proposed testimony regarding secondary
perforation in the case of Ms. Danley is thus granted.
For the reasons stated above, Defendants’ motion to exclude the proposed testimony and
opinions of Dr. Young in their entirety is GRANTED.
John Jarrell, Ph.D., P.E.
Defendants move to exclude the expert testimony of John Jarrell, Ph.D., P.E. on the
grounds that he is not qualified to opine on the effects of LNG on the uterus, the “sharpness” of
Mirena, or IUDs in general. (Memorandum of Law in Support of Defendants’ Motion to
Exclude the Testimony of John Jarrell, Ph.D., P.E. (“Ds’ Jarrell Mem.”), (Doc. 2680), 3-7.)
Defendants also move to exclude Dr. Jarrell’s testimony on the grounds that it is unreliable and
irrelevant. (Id. at 2-3.)31 For the reasons stated below, Defendants’ motion to exclude Dr.
Jarrell’s testimony is GRANTED.
In their Opposition, (Plaintiffs’ Memorandum of Law in Opposition to Defendants’ Motion to Exclude the
Testimony of John Jarrell, Ph.D., P.E. (“Ps’ Jarrell Opp.”), (Doc. 2774)), Plaintiffs do not oppose Defendants’
argument that Dr. Jarrell should not be allowed to opine on a safer alternative design, and therefore the Court deems
this argument abandoned. Cf. Cowan v. City of Mount Vernon, 95 F. Supp. 3d 624, 645 (S.D.N.Y. 2015) (“Federal
courts may deem a claim abandoned when a party moves for summary judgment on one ground and the party
opposing summary judgment fails to address the argument in any way.”) (internal quotation marks and citation
omitted). In addition, Dr. Jarrell stated at his deposition that he did not propose any safer alternative design in his
expert report, indicating he does not intend to offer an opinion on an alternative safer design. (Declaration of
Christopher J. Cook in Support of Defendants’ Motion to Exclude the Testimony of John Jarrell, Ph.D., P.E. (“Cook
Jarrell Decl.”), (Doc. 2681), Ex. A, Deposition of John Jarrell (“Jarrell Dep.”), at 99:12-15) (“Do you disclose
anywhere in your expert report in which you propose a supposedly safer alternative design of an IUD? [Dr. Jarrell:]
No, I don’t address that.”). Accordingly, the motion is granted insofar as it relates to any opinion of Dr. Jarrell’s
regarding a safer alternative design of the Mirena.
Dr. Jarrell offers five opinions in his expert report. (Cook Jarrell Decl. Ex. B, General
Expert Report of John D. Jarrell, Ph.D., P.E. (“Jarrell Report”), at 3-4.) First, Dr. Jarrell opines
that the hormone that Mirena releases into the uterine cavity, LNG, causes a thinning of the
endometrium, the inner layer of the uterine wall. Second, Dr. Jarrell says the tips of the arms of
the Mirena (the ends of the top of the “T” shape of the plastic device) are relatively sharp when
compared to the smoother, adjacent surfaces of the Mirena. Third, he opines that although the
Mirena generally has flexible arms, these arms become stiff and rigid when loaded in
“constrained conditions,” causing the device to transfer pressures to the uterus in response to
contractions, leading to necrosis (or dead tissue), embedment, and sometimes perforation.
Fourth, Dr. Jarrell states that pressure on uterine tissue, generated by uterine contractions, and
the presence of a rigid Mirena, create sufficient force to lead to the rapid development of
pressure wounds and injury to cells. Finally, Dr. Jarrell opines that an inflammatory response
and FBR occurs when polyethylene and silicone polymers (synthetic materials found in Mirena)
come in contact with “compromised tissues,” enhancing damage and accelerating erosion in the
uterus, and thus increasing the potential for migration. (Id. at 3-4.) In addition, during his
deposition Dr. Jarrell opined that he found a manufacturing defect in the Mirena that he tested.
(Jarrell Dep. at 190:18-191:12, 196:24-197:3.)
Dr. Jarrell is a “multi-discipline engineer specializing in the analysis of complex designs
and failures involving materials, mechanical and biological systems.” (Jarrell Report at 1.) Dr.
Jarrell is “actively involved in engineering analysis, design, product development and research.”
(Id.) Dr. Jarrell has Bachelor’s and Master’s of Science degrees in Materials Science and
Engineering, as well as a Doctorate in Biology, Medical Science and Engineering from Brown
University. (Declaration of Diogenes P. Kekatos in Opposition to Defendants’ Motion to
Exclude the Testimony of John Jarrell, Ph.D., P.E. (“Kekatos Jarrell Decl.”), (Doc. 2775), Ex. A,
Jarrell Report app. B (“Jarrell CV”), at 1.) He has authored “multiple peer-reviewed publications
and abstracts on materials, toxicity, cell interactions with materials, biomaterials, implants and
coatings and a guide book on materials selection, friction and wear for medical device
designers.” (Jarrell Report at 2.) In addition, Dr. Jarrell has U.S. and foreign patents covering
“active biomaterials, siloxane and metal oxide composites, active delivery and medical
Although Dr. Jarrell seems to be an accomplished and experienced biomedical engineer –
he has experience in certain biomaterials and implants – he has no previous experience with
IUDs or hormonal contraception like Mirena. (Jarrell Dep. at 84:7-85:8.)32 Nor does he have
any particular familiarity with the anatomy of the uterus. (Id. at 75:16-77:11 (Dr. Jarrell’s
“training in uterine anatomy” occurred in connection with Mirena and mesh litigation).) Dr.
Jarrell’s experience in engineering and biomaterials perhaps qualifies him to opine on a
mechanism by which a Mirena might perforate a uterus, see In re Zyprexa, 489 F. Supp. 2d at
282, but he is not qualified to opine on the effects of LNG on the uterus because he is not a
medical doctor nor does he have relevant experience or expertise in hormonal contraception or
the effects of hormones on uterine tissue. Dr. Jarrell’s only experience with LNG comes from
reviewing a number of articles supplied to him by Plaintiffs’ counsel, which Dr. Jarrell
Dr. Jarrell said he was familiar with “drug delivery devices for contraception” before becoming involved in this
litigation because he took a course on drug delivery, which included a topic on contraception, at Brown University.
(Jarrell Dep. at 79:22-80:8.) One class in which contraception was a topic would not give a student “expertise” in
that field, and certainly not enough to be able to opine as an expert even under Daubert’s liberal admissibility
subsequently copied and pasted into his expert report. (Jarrell Report at 14-18.) 33 This is not the
level of rigor an expert in the field would apply and does not pass muster under Daubert. See
Mancuso v. Consol. Edison Co. of N.Y., 967 F. Supp. 1437, 1443 (S.D.N.Y. 1997) (finding
expert unqualified because he relied on counsel to supply him with relevant scientific literature
and “subsequently attempted, with dubious success, to qualify himself as [an expert] by a
selective review of the relevant literature”); see also Prohaska v. Sofamor, S.N.C., 138 F. Supp.
2d 422, 437 (W.D.N.Y. 2001) (criticizing “litigation-driven expertise” where expert “relied upon
the plaintiff’s attorney to provide him with the relevant scientific literature”); cf. Arista Records
LLC v. Lime Grp., LLC, No. 06-CV-5936, 2011 WL 1674796, at *17 (S.D.N.Y. May 2, 2011)
(allowing expert where conclusions were “not based on a selective review of a limited universe
of sources strictly for the purposes of preparing to testify”).
Although Dr. Jarrell is not qualified to opine on alleged thinning effects of LNG on the
endometrium, see Amorgianos, 303 F.3d at 267 (expert testimony inadmissible if any step in the
analysis is unreliable), assuming he would rely on Plaintiffs’ other experts for that proposition or
that he does not intend to opine on this issue at trial,34 the Court assesses the reliability of the
subsequent steps of his analysis, and concludes that they do not have sufficient indicia of
reliability under Daubert. See Joiner, 522 U.S. at 146 (“[N]othing in either Daubert or the
Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to
existing data only by the ipse dixit of the expert.”).
At his deposition, Dr. Jarrell said before this litigation he had never considered the effect of LNG on the
endometrium. (Jarrell Dep. at 169:24-170:2.)
Dr. Jarrell stated at his deposition that he did not believe he would be opining at trial that a supposed thin, fragile
endometrium resulting from LNG is part of the mechanism by which an IUD perforates the uterus. (Jarrell Dep. at
Relative Sharpness of Mirena
Dr. Jarrell opines that the “tips of the Mirena arms contain relatively sharp edges
compared to the smoother adjacent surfaces, based on [his] inspection under microscopy and
with metrology.” (Jarrell Report at 18.) The substance of Dr. Jarrell’s “experiment” seems to
have consisted of him squeezing a Mirena with a gloved hand and determining, based on his own
tactile senses, that the tips are “relatively sharp” “compared to the smoother surfaces that are
adjacent to the tips.” (Jarrell Dep. at 185:20-187:5.) Dr. Jarrell based this opinion on his
“inspection and handling of the exemplar Mirena” during which time he observed “relatively
sharp edges.” (Jarrell Report at 18.) Dr. Jarrell relied primarily upon his own senses to
determine the Mirena was “sharp” and compared it to itself, not to other IUDs (or even to other
Mirenas to potentially argue that one Mirena in particular was sharper than others). This is not
scientific and does not amount to reliable expert testimony. See In re C.R. Bard, Inc., 948 F.
Supp. 2d at 604-05 (general causation opinion precluded when it was “based on nothing more
than [the expert’s] personal, unscientific observation and opinion that ‘it’s obvious’ that mesh
arms are sharp and can serrate or tear nerves” and finding such testimony to be “the type of
subjective, conclusory approach that cannot reasonably be assessed for reliability and that Rule
702 is designed to exclude”) (internal quotation marks omitted); In re Rezulin, 309 F. Supp. 2d at
544 (finding that allowing experts “to tender purely subjective views in the guise of expert
opinions” would “border on the absurd”). Dr. Jarrell admitted at his deposition that individuals’
opinions as to whether the Mirena feels sharp could differ. (Jarrell Dep. at 188:12-20.) Dr.
Jarrell was also unable to cite support, peer-reviewed or otherwise, that backs his theory that the
Mirena IUD is sharp. (Jarrell Dep. at 184:22-185:2.) Dr. Jarrell’s methodology is devoid of
objective standards that can be tested by others. Dr. Jarrell’s experiment has not been peer-
reviewed or recreated in any other testing. See Daubert, 509 U.S. at 593-94. It cannot be
recreated or reviewed because he provides no standards by which he measured sharpness.
Further, it was prepared solely for litigation, which by itself does not warrant exclusion, but
weighs against reliability of an expert’s testimony. See In re Rezulin, 369 F. Supp. 2d at 420
(courts may consider “whether an expert’s opinion was developed for litigation,” in addition to
the four Daubert factors).
Plaintiffs try to salvage Dr. Jarrell’s opinions by pointing out that Dr. Jarrell performed
“tactile analysis and evaluation” and “direct observation,” which they argue are “generally
accepted methods used by experts in [Dr. Jarrell’s] field.” (Ps’ Jarrell Opp. 13-14.) The quoted
language apparently refers to Dr. Jarrell touching and looking at the Mirena, something the jury
is capable of doing itself.35 See Andrews v. Metro N. Commuter R.R. Co., 882 F.2d 705, 708 (2d
Cir. 1989) (expert testimony inadmissible if directed to “lay matter which a jury is capable of
understanding and deciding without the expert’s help”). To support their argument that feeling
an item is a reliable methodology, Plaintiffs cite a 1901 article with advice on how a surgeon
should sharpen instruments. (Allen DeVilbiss, Care & Use of Instruments, 36 J. Am. Med.
Ass’n 1099 (1901), Cook Jarrell Decl. Ex. F). While this article does advise that the surgeon feel
his instruments to see if they are sharp, the article nowhere suggests that doing so is a scientific
exercise or otherwise indicates that touching an item would provide sufficient scientific rigor for
expert testimony or is otherwise generally accepted as a method for engineers. Plaintiffs also
cite the Mirena specifications as well as a long report on a copper IUD, neither of which assist
them in addressing the entirely subjective and non-scientific nature of Dr. Jarrell’s “squeeze
Although Dr. Jarrell utilized microscopes to get a closer look at the Mirena and take photographs, such images
cannot demonstrate the relative sharpness of an item, and in any event the jury can look at the same photographs.
test.”36 Because it does not bear indicia of reliability under Daubert, Dr. Jarrell will not be
allowed to opine about the relative sharpness of the Mirena.
In Vitro Mechanical Testing of Mirena
Dr. Jarrell also gives an opinion that the “Mirena design has generally flexible arms” but
that they “become very stiff when loaded in constrained conditions,” which “causes the device to
become very rigid at the tips, allowing the device to transfer high forces and pressures to the
tissues in response to uterine contractions leading to tissue necrosis, embedment and in some
instances, perforation and migration.” (Jarrell Report at 22.) Dr. Jarrell described a “constrained
condition” as corresponding to the top of the Mirena arms contacting the top of the fundus (the
top portion of the uterus opposite the cervix) and the tips of the arms contacting the adjacent
uterine surface. (Id.) Although Dr. Jarrell says the Mirena has “generally flexible arms,” he says
that in a constrained position the arms are unable to flex and became much stiffer. (Id.) To
measure the forces they transfer to uterine tissue in that position, he tested a Mirena in laboratory
equipment apparently intended to mimic the uterus. (Id. at 10-11, 22.) Dr. Jarrell used doublesided tape to affix the tips of the Mirena’s arms to an “abutting block” across the top of the arms
to apply pressure to the Mirena and hold it in place. (Id. at 11; Jarrell Dep. at 234: 2-14.)
The two cases Plaintiffs cite in support of their arguments regarding Dr. Jarrell’s methodology, Figueroa v.
Boston Scientific Corp., 254 F. Supp. 2d 361, 368-69 (S.D.N.Y. 2003), and Lappe v. American Honda Motor Co.,
857 F. Supp. 222, 228 (N.D.N.Y. 1994), aff’d, 101 F.3d 682 (2d Cir. 1996), stand for the proposition that an expert
need not perform all relevant tests or examine all relevant reports or documents in order for his or her testimony to
be sufficiently reliable and therefore admissible. Figueroa relied on McCullock, which has since been discredited,
see Ruggiero, 424 F.3d at 255, and Lappe found that although the expert “may have neglected to perform some
essential tests or measurements,” this goes “to the weight of his testimony, not its admissibility.” 857 F. Supp. at
228 (internal quotation marks omitted). Lappe does not help Plaintiffs because – unlike Dr. Jarrell’s opinion
regarding “sharpness” here – the expert there had relied on facts, investigation and traditional technical expertise.
Id. Moreover, the Lappe court rejected the application of Daubert (then newly decided) to the proffered engineering
testimony. See id. Lappe and Figueroa do not undermine my conclusions that I would not be fulfilling my
gatekeeping function if Dr. Jarrell were allowed to testify regarding his “squeeze test” in front of a jury.
Dr. Jarrell’s constrained testing conditions do not reliably replicate the conditions inside a
woman’s uterus, and therefore render his methodology and the conclusions he draws from it
unreliable. Dr. Jarrell admitted at his deposition that he did not have any basis to suggest that the
way the Mirena became rigid in his experiment occurs in vivo (inside a human being). (Jarrell
Dep. at 228:23-229:2, 318:10-14.)37 Obviously, no tape is used to affix the tips of the Mirena to
the sides of the uterus – indeed, they are not affixed at all – and obviously the top of the arms
does not meet the soft fundus the way it was pressed against the metal abutting block. This
creates “too great an analytical gap between the data and the opinion proffered.” Joiner, 522
U.S. at 146; see Winebarger v. Bos. Sci. Corp., No. 13-CV-28892, 2015 WL 1887222, at *17
(S.D.W. Va. Apr. 24, 2015) (testing that produced certain results at very high temperatures that
could not be replicated in human body, “without [expert] providing any explanation or support
for his opinion,” did not fit facts of case and was therefore irrelevant and unhelpful). It seems
apparent that without affixing the tips of the arms to the pressure plates of his apparatus and
pressing down on the tops of the arms with a hard surface, Dr. Jarrell could not obtain the force
numbers he needed for his theory, so he used that method despite an absence of correlation to
any real-life conditions. This strikes the Court as exactly the sort of unreliable “science” the
Daubert test was intended to weed out. See In re Lipitor (Atorvastatin Calcium) Mktg., Sales
Practices & Prods. Liab. Litig., No. 14-MN-2502, 2015 WL 7422613, at *12 (D.S.C. Nov. 20,
2015) (excluding testimony where expert “played around” with various scenarios until desired
result was reached).
Similarly, Dr. Jarrell’s manual pressure plate testing, which he utilized to get a
“numerical value” for the forces that the Mirena’s arms could resist, (Jarrell Dep. at 223:20-
Dr. Jarrell did not have an opinion on a clinical scenario in which the Mirena arms would be constrained in a
uterus. (Jarrell Dep. at 141:8-10.)
224:19), also does not satisfactorily replicate conditions inside a uterus as it appears Dr. Jarrell
held the Mirena and pushed it against the pressure plate.38 Dr. Jarrell does not provide a
convincing explanation for why his in vitro experiment is a suitable replica for a uterus, and
therefore there is too great of an analytical gap between his mechanical testing and the
environment inside a woman’s uterus, making his testimony both unreliable and unhelpful to a
jury. See Joiner, 522 U.S. at 146.
Defendants also criticize Dr. Jarrell’s report and proposed testimony because his
mechanical test has not been tested by others, let alone peer reviewed, and he does not cite other
support for his methodology or conclusions. (Ds’ Jarrell Mem. 13-14.) Although peer-review
and studies supporting a methodology are not always necessary, see Kumho Tire Co., 526 U.S. at
156, here these factors, when added to the unreliability of Dr. Jarrell’s in vitro mechanical
testing, further weaken the reliability of Dr. Jarrell’s experiment. See Daubert, 509 U.S. at 593.
Plaintiffs’ broad claims that engineers are qualified to opine generally on mechanisms and their
citation to the Reference Manual on Scientific Evidence are unavailing. See McClain, 401 F.3d
at 1244 (finding expert testimony speculative and inadmissible when based upon “broad
principles of pharmacology”); Moore v. Ashland Chem. Inc., 151 F.3d 269, 276 (5th Cir. 1998)
(“The expert’s assurances that he has utilized generally accepted scientific methodology is
insufficient.”).39 Moreover, although Dr. Jarrell’s experiment may be reproducible, this does not
Dr. Jarrell apparently first described these manual tests done on a pressure plate during his deposition, (Jarrell
Dep. at 223:5-7), and photographs of the testing are attached as Exhibit H to the Kekatos Jarrell Declaration. These
photos show Dr. Jarrell “pressing the Mirena against the pressure plate and measuring the forces that the Mirena
sustained under different loading angles, loading conditions” to see “the maximum force it would support.” (Jarrell
Dep. at 338:8-16.)
Walker v. Soo Line Railroad Co., 208 F.3d 581, 589-90 (7th Cir. 2000), which Plaintiffs cite, (Ps’ Jarrell Opp. 1920), to support their argument that Dr. Jarrell should be allowed to testify based on his broad engineering
experience, stands for the proposition that a jury should be able to hear alternative explanations for an event. In that
case, however, the court noted that the expert had “scientifically valid testimony,” something that is lacking here.
Id. at 590. In re Scrap Metal Antitrust Litigation, 527 F.3d 517, 529-30 (6th Cir. 2008), states that it is not the role
alleviate the unreliability caused by the fact that the testing conditions were unlike those present
in a uterus.
In addition, Defendants argue that Dr. Jarrell’s report and testimony are unreliable
because his mechanical testing amounted to an ad hoc test with no written protocol. (Ds’ Jarrell
Mem. 14-15.) Although not necessarily dispositive, the fact that Dr. Jarrell did not have a
written protocol prior to testing the Mirena, (Jarrell Dep. at 56:13-17) – he apparently created it
after the fact, a short time before his deposition, (id. at 133:25-134:22) – again weighs against
admissibility. See Hall v. Bos. Sci. Corp., No. 12-CV-8186, 2015 WL 868907, at *12 (S.D.W.
Va. Feb. 27, 2015) (noting expert’s “failure to adhere to testing standards or a written protocol”
in finding methodology unreliable). Dr. Jarrell’s mechanical testing of the Mirena is not
sufficiently reliable to withstand Daubert scrutiny, and he may not opine on this topic.
Pressure Wound Theory
Without his force calculations, Dr. Jarrell cannot opine that Mirena transfers enough
force to cause pressure wounds. Putting that aside, however, there are other problems with his
proposed pressure-wound testimony.
Dr. Jarrell opines that “[s]ustained pressures between human tissues and rigid objects can
lead to the rapid development of pressure wounds” and that “[t]he rigidity and geometry at the
tips of the Mirena and pressures generated by uterine contractions are sufficient to cause rapid
degradation to soft tissues.” (Jarrell Report at 24.) He also finds that “[a]n inflammatory
response and foreign body reaction occurs when polyethylene (and silicone polymers) come in
contact with compromised tissues and during embedment and migration,” which “enhances
of the district court to choose one version of facts over another, but to “determine whether [the expert testimony]
rests upon a reliable foundation.” Id. This proposition does not help Plaintiffs because Dr. Jarrell’s report and
proposed testimony do not rest upon a reliable foundation.
damage and breakdown of surrounding tissues and accelerates erosion and perforation of tissues,
enhancing the potential for migration.” (Id. at 29.) Dr. Jarrell, albeit a qualified and impressive
engineer, is not qualified to opine on pressure wounds in the uterus based on studies and patent
filings he has read. (Id. at 29-32). In his report, to support his pressure wound opinion, Dr.
Jarrell quotes portions of a study “evaluat[ing] uterine and serum concentrations of LNG,” (id. at
29), a patent filing by Bayer stating the shape of an IUD should have “blunt surfaces and gentle
curves,” (id. at 31) (emphasis in original), and two articles that relate to a foreign body response
and host reactions, (id. at 31-32). Dr. Jarrell does not offer any analysis as to why these sources
support his pressure wound theory or tie them to Mirena, nor has he the relevant expertise to
undertake such an analysis. See Ellis v. YMCA Camp Mohawk, Inc., 615 F. App’x 697, 698 (2d
Cir. 2015) (“Federal Rule of Evidence 702 requires expertise based on specialized knowledge
and experience, not a mere understanding derived from others’ publications.”). Dr. Jarrell is not
a physician nor does he claim to have clinical experience with IUDs. (Jarrell Dep. at 75:3-6,
75:16-18, 82:23-83:5, 84:7-24.) His Ph.D. in biology, medical science and engineering and his
research in biomaterials do not suffice to render him an expert in how the uterus responds to the
presence of Mirena.
Furthermore, because Dr. Jarrell had never heard of perforation before being contacted
about this case, it is safe to say his theory of IUD perforation was created for purposes of this
litigation. (Jarrell Dep. at 85:5-8.) Although a methodology or experiment that is created for
litigation does not automatically require exclusion, such an origin is a factor in assessing
reliability. See In re Rezulin, 369 F. Supp. 2d at 420 (listing whether an expert’s opinion was
developed for litigation as factor for consideration in Daubert analysis); see also Amorgianos,
137 F. Supp. 2d at 190-91 (excluding experts after finding that they had not “tested [the]
hypothesis in any way or subjected it to peer review. Instead, plaintiff’s experts have aired their
hypothesis only in the courtroom and have elected not to share their ideas on this subject with
their peers in the medical and industrial hygienic communities.”). Here, Dr. Jarrell had very
limited experience and exposure to IUDs prior to this litigation, and drafted his report based
upon at least one important study (Goldstuck, see supra note 14) that he received from Plaintiffs’
counsel and of which he had not heard before being retained. (Jarrell Dep. at 266:1-11.) This is
not the level of academic rigor that would be expected of an engineer or doctor in the field. In
addition, Dr. Jarrell’s pressure wound hypothesis has not been tested or peer reviewed, (Id. at
295:19-296:3), and Dr. Jarrell does not point to any convincing evidence of acceptance within
the scientific community. See Golod, 964 F. Supp. at 860 (excluding an expert because his
theory did “not constitute ‘scientific knowledge’ within the meaning of Daubert. Instead, it is, at
most, scientifically-grounded speculation: an untested and potentially untestable hypothesis.”).40
Plaintiffs argue in their Opposition that the Zakin study41 shows that Dr. Jarrell’s
pressure-wound theory is supported within the scientific community. (Ps’ Jarrell Opp. 21.) That
study, however, appears to discuss pressure necrosis from an already-embedded IUD, not
secondary perforation as Plaintiffs posit in this case. More fundamentally, even assuming the
Zakin study could lend some support to Dr. Jarrell’s theory, Dr. Jarrell does not cite this study in
his report, nor is it on his list of documents on which he relied. (Kekatos Jarrell Decl. Ex. A app.
A.) It is not the district court’s purview to analyze the validity of the expert’s conclusions based
on the universe of scientific knowledge, but rather to determine whether the expert’s
The court in Golod noted that there might be instances where an untested or untestable theory may be admissible,
but that they would be where there was general acceptance in the scientific community. See 964 F. Supp. at 860-61.
“Zakin” refers to David Zakin et al., Complete and Partial Uterine Perforation & Embedding following Insertion
of Intrauterine Devices. I. Classification, Complications, Mechanism, Incidence, and Missing String, 36 Obstetrical
& Gynecological Survey 335 (1981). (Kekatos Jarrell Decl. Ex. J.)
methodology was reliable and stands up to the intellectual rigor of the expert’s field. See Kumho
Tire, 526 U.S. at 152. That, unbeknownst to the expert, a study exists that may support his
conclusions does not render his methodology any stronger.
Defendants also argue that Dr. Jarrell’s opinion is unreliable because he based his opinion
on uterine contractions on studies of women not using Mirena or a similar progestin-releasing
IUD. (Ds’ Jarrell Mem. 17-19.) Although this by itself might not warrant exclusion if there
were a scientific basis for applying these studies to women using Mirena, fatal to Dr. Jarrell’s
opinion is his inability to even explain why these studies would be applicable to Mirena users.
When asked where he got the baseline number measuring force of uterine contractions, Dr.
Jarrell stated, “I had to look at the existing literature to get from an engineering standpoint the
ranges of pressures that I could use for calculations, so these were the numbers that were
available in the published literature.” (Jarrell Dep. at 268:12-23). Dr. Jarrell acknowledged that
those figures arose from a study of women not using Mirena, (id. at 268:8-11), and that he did
not know how use of a Mirena would affect them, (id. at 269:9-11 (“How a Mirena influences
those [numbers], I didn’t see the literature giving me numbers of that.”); see id. at 269:14-15 (“If
I had those numbers, I would have used them.”); id. at 292:18-19 (“I don’t know what the
pressures are under Mirena.”)). His lack of access to reliable data does not justify use of
unreliable data, and militates against admission under Daubert. See In re Rezulin, 369 F. Supp.
2d at 426 (“A crucial consideration in evaluating the admissibility of expert testimony is whether
the conclusions flow reliably from the premises.”). Indeed, Dr. Jarrell acknowledged in his
deposition that the LNG in Mirena reduces the force of uterine contractions, (Jarrell Dep. at
256:12-19), but in his analysis he ignored this inconvenient truth. A legitimate scientist or
engineer in the field, knowing he did not have reliable numbers for a stage of his analysis, would
decline to reach a conclusion. Dr. Jarrell’s proceeding when he knew he did not have the proper
basis suggests that his “methodology was aimed at achieving one result,” Faulkner, 46 F. Supp.
3d at 381, which is the sort of science Daubert does not allow.
Dr. Jarrell’s reliance on animal studies, without a sound basis for extrapolating these
studies to human uteruses, is another example where his conclusions do not “flow reliably from
the premises.” In re Rezulin, 369 F. Supp. 2d at 426. Although animal studies can be reliable
bases for expert opinions on humans if there is a scientific basis for such extrapolations, see In re
Fosamax, 645 F. Supp. 2d at 186-87, in this instance Dr. Jarrell could not articulate why these
studies were the appropriate foundation for his pressure wound opinion, (Jarrell Dep. at 294:712). In fact, Dr. Jarrell copied and pasted portions of studies to support his opinion without any
analysis, except that he put certain sections in bold font. (Jarrell Report at 27-29.) Further, the
animal studies involved sustained pressure for hours, (Jarrell Dep. at 263:14-9, 297:13-16),
contrary to uterine contractions, which are measured in seconds, (id. at 263:9-13, 297:17-22).
There are just too many gaps between Dr. Jarrell’s analysis and the conclusions he draws to
permit him to testify under Daubert. See Joiner, 522 U.S. at 144-45. Dr. Jarrell may not offer
opinions on the relative sharpness of Mirena, his mechanical testing hypothesis or his pressure
wound and necrosis theories.
Defendants seek to exclude any opinions Dr. Jarrell might offer regarding alleged
manufacturing defects. (Ds’ Jarrell Mem. 24-25.) At his deposition, Dr. Jarrell offered an
opinion that he found a 70 micron misalignment in the Mirena he tested, which he claimed
exceeded the manufacturing specification of 50 microns. (Jarrell Dep. at 190:18-191:12, 196:24197:3.) Dr. Jarrell was referring to the part of the product where two portions of a mold meet.
(Id. at 190:2-17.) Dr. Jarrell did not offer this opinion in his expert report, but Plaintiffs argue he
should be allowed to testify on this subject because it would be justified and harmless, and
Defendants had the opportunity to question Dr. Jarrell during his deposition. (Ps’ Jarrell Opp.
23-25.) I need not analyze whether there was harm or whether it was justified because Dr.
Jarrell’s deposition testimony shows that he cannot reliably link any alleged misalignment with
perforation, let alone perforation in the Hayes or Danley cases, because Dr. Jarrell did not do any
testing on the specific Mirenas that allegedly caused the injuries in this litigation. Further, Dr.
Jarrell admitted that he did not know of any clinical relevance of the misalignment he identified
in the sample Mirena, nor could he identify support for the proposition that a parting line
mismatch in an IUD was connected to a risk of perforation. (Jarrell Dep. at 194:6-10, 200:6-10,
201:19-24.) Dr. Jarrell’s statements show that his opinion regarding a manufacturing defect is
ultimately irrelevant under Rule 401 because it is not connected to the facts or issues in this case.
See In re Rezulin, 309 F. Supp. 2d at 554 (finding expert testimony not relevant under Rules 401
Assisting the Trier of Fact
Because, as discussed above, Dr. Jarrell is unqualified to testify about his opinion
regarding the effects of LNG on the uterus, and the rest of his opinions are unreliable, his
testimony would not be helpful to a jury.
Accordingly, Defendants’ motion to exclude the testimony of Dr. Jarrell is GRANTED.
Susan Wray, Ph.D.
Defendants move to exclude the expert testimony of Susan Wray, Ph.D. on the ground
that Dr. Wray lacks the qualifications to opine on whether a Mirena can perforate a uterus
unrelated to insertion, on the mechanism by which this could occur, and on the adequacy of the
Mirena label. (Memorandum of Law in Support of Defendants’ Motion to Exclude the
Testimony of Susan Wray, Ph.D. (“Ds’ Wray Mem.”), (Doc. 2692), 1-2.) Defendants argue that
Dr. Wray’s general causation opinion should be excluded because it is unreliable, in that it
contains analytical gaps and is grounded on insufficient data, and that her mechanism opinion
should be excluded because it is based only on her own say-so and lacks an objective basis. (Id.
at 2.) For the reasons stated below, Defendants’ motion is GRANTED.
Dr. Wray opines, based on her expertise and a review of scientific literature, that
“contractions of the myometrium [the muscular middle layer of the uterus] can cause the
transport of the Mirena device through the uterine wall into the peritoneal cavity and beyond
(e.g. bladder, bowel).” (Wray Report at 3.) In addition, Dr. Wray opines that these contractions
of the myometrium are able to transport a Mirena through the uterine wall without there having
been any injury to the uterine wall during insertion. (Id.) It is Dr. Wray’s view that the force of
contractions alone are sufficient to cause a Mirena to migrate out of the uterus. (Id.) As part of
her mechanism opinions, Dr. Wray also opines that “[i]n women with smaller than average width
of their uterine cavity, adolescents and/or the nulliparous [those who have never had
children] . . . disproportion between their uterus and the device size (32mm) . . . will lead to
pressure on the uterine lining” that may not cause immediate damage but over months will cause
erosion of the uterine lining. (Id. at 25). Dr. Wray also opines that decreased estrogen
availability in the myometrium can lead to more perforations, despite proper insertion of the
Mirena, (id. at 25-26), and that the effects of Mirena on the endometrium and myometrium “will
build up over months and years,” (id. at 19).
Dr. Wray is a professor of physiology at the University of Liverpool, where she served as
departmental chair from 2004 to 2008. (Wray Report at 1.) From 2008 to 2013, Dr. Wray was
the Director of the Centre for Better Births at Liverpool Women’s Hospital, and since 2015 she
has served as the co-Director of the Harris-Wellbeing of Women Centre for Preterm Birth
Research. (Id.) As a scientist, Dr. Wray has focused her research on women, neonatal health
and physiology, and she has worked with clinicians on issues related to uterine contractions.
(Id.) Defendants argue that Dr. Wray is not qualified to opine on general causation or the
mechanism by which a Mirena can perforate a uterus unrelated to insertion because she is not a
medical doctor and has no expertise in contraception or IUDs. (Ds’ Wray Mem. 4-5.) At her
deposition, Dr. Wray admitted to not having conducted any research on contraception, (Wray
Dep. at 37:9-11), authored publications on contraceptives, (id. at 37:12-14), or personally
examined, tested or even handled a Mirena, (id. at 43:9-11, 44:9-11).
While it is a close question, given her lack of familiarity with contraceptives in general,
Mirena in particular, the effect of LNG on the uterus or clinical evaluation of patient symptoms,
Dr. Wray is an expert on uterine physiology, particularly the myometrium and uterine
contractions, (id. at 29:22-30:8; Declaration of Diogenes P. Kekatos in Opposition to
Defendants’ Motion to Exclude the Testimony of Susan Wray, Ph.D. (“Kekatos Wray Decl.”),
(Doc. 2781), Ex. B, Wray Report app. A, Curriculum Vitae of Susan Wray (“Wray CV”), at 19),
which gives her sufficient qualification to opine on a mechanism by which uterine contractions
might cause a Mirena IUD to migrate outside the uterus after proper placement at insertion. See
Hilaire, 54 F. Supp. 3d at 236 (“An expert need not be precluded ‘from testifying merely
because he or she does not possess experience tailored to the precise product or process that is
the subject matter of the dispute.’”) (quoting Yaccarino v. Motor Coach Indus., Inc., No. 03-CV4527, 2006 WL 5230033, at *9 (E.D.N.Y. Sept. 29, 2006)); In re Zyprexa, 489 F. Supp. 2d at
282 (“If the expert has educational and experiential qualifications in a general field closely
related to the subject matter in question, the court will not exclude the testimony solely on the
ground that the witness lacks expertise in the specialized areas that are directly pertinent.”)
(citing Stagl, 117 F.3d at 80); Lappe, 857 F. Supp. at 226 (“In a product liability action, an expert
witness is not strictly confined to his area of practice, but may testify concerning related
applications; a lack of specialization affects the weight of the opinion, not its admissibility.”).
Dr. Wray’s expertise in uterine anatomy, especially the myometrium, is a closely related topic to
migration of IUDs, and therefore qualifies her to give a mechanism opinion.42 Her lack of
specific experience in contraceptives, including IUDs, does not warrant exclusion.
Defendants also claim that Dr. Wray is unqualified to use case reports43 as the basis for
her secondary perforation opinion because such a method requires her to analyze specific patient
cases, which she is unqualified to do because she is not a medical doctor. Defendants’ argument
imposes too high a burden upon experts in medical cases. See Corrigan v. Methodist Hosp., 874
F. Supp. 657, 660 (E.D. Pa. 1995) (“[N]on-medical doctors can testify as to causation of illness if
they have an expertise in that area.”); Hutchison v. Am. Family Mut. Ins. Co., 514 N.W.2d 882,
887-88 (Iowa 1994) (“[W]e refuse to impose barriers to expert testimony other than the basic
requirements of Iowa rule of evidence 702 and those described by the Supreme Court in
Daubert. The criteria for qualifications under rule 702 – knowledge, skill, experience, training,
Defendants cite Mancuso, 967 F. Supp. at 1443, to argue that Dr. Wray became an expert after she was hired by
Plaintiffs. Although this factor goes to Dr. Wray’s reliability, discussed below, Dr. Wray’s background and
experience show that she has been an expert on the uterus for a number of years and that this expertise was not
acquired for this litigation.
A case report is a “type of information used by physicians and medical researchers . . . which is a description of a
particular patient’s clinical history and symptoms.” In re Rezulin, 369 F. Supp. 2d at 406.
or education – are too broad to allow distinctions based on whether or not a proposed expert
belongs to a particular profession or has a particular degree.”); Baroldy v. Ortho Pharm. Corp.,
760 P.2d 574, 588 (Ariz. Ct. App. 1988) (“A non-medical doctor . . . is not precluded from
testifying as to diagnosis and causation solely because he is not a medical doctor.”). Dr. Wray is
therefore qualified to opine on a mechanism of secondary perforation.
Defendants additionally argue that Dr. Wray is not qualified to opine on the adequacy of
Mirena’s label because this is not within her area of expertise. Dr. Wray’s experience as a
physiologist and as an expert on the myometrium do not enable to her opine on the adequacy of
the Mirena label; Dr. Wray even admitted that she is not qualified to offer an opinion on
pharmaceutical labeling in the United States. (Wray Dep. at 66:10-17.) Plaintiffs do not argue
otherwise. She will thus be precluded from testifying on the adequacy of the Mirena label.
In order to satisfy the admissibility standards set forth in Rule 702 and Daubert, the
expert must not only be qualified, but his or her testimony must also be reliable. See Fed. R.
Evid. 702 (testimony must be based on “sufficient facts or data” and “the product of reliable
principles and methods”); Daubert, 509 U.S. at 590 (“Proposed testimony must be supported by
appropriate validation – i.e., good grounds, based on what is known. In short, the requirement
that an expert’s testimony pertain to scientific knowledge establishes a standard of evidentiary
reliability.”) (internal quotation marks omitted). Dr. Wray’s testimony does not satisfy any of
the four factors listed in Daubert to assist district courts in considering whether a proffered
opinion has sufficient indicia of reliability. Daubert, 509 U.S. at 593-94. Her theory of
secondary perforation has not been tested, and therefore has no known error rate. (Wray Dep. at
368:1-12.) Her conclusions have not been subject to peer review; there is no evidence that she
has published her work in journals or elsewhere, or that she even gave any thought to secondary
perforation of IUDs before being retained in this case. (Id. at 49:17-50:13.) Her theory has not
been generally accepted in the scientific community. Textbooks on gynecology and leading
organizations such as the World Health Organization (“WHO”) and ACOG do not support her
opinions regarding secondary perforation.44 Even if there are some members of the medical and
scientific community who agree that secondary perforation is a plausible way by which an IUD
can perforate a uterus, Plaintiffs have not established general acceptance. See Mancuso, 967 F.
Supp. at 1447 (“[A]lthough we decline to rule on whether the literature supports all of plaintiff’s
ailments at this time, we do note that based upon the record before this Court, plaintiffs certainly
have not established that it is generally accepted that PCB exposure could have caused their
symptoms.”). Although the Daubert factors are not a “definitive checklist” for reliability,
Daubert, 509 U.S. at 593, “when an expert is offering testimony that is presented as a scientific
conclusion and the expert’s method fails to satisfy any of the factors identified in Daubert, a
court should pause and take a hard look before allowing a jury to consider it.” In re MTBE, 593
F. Supp. 2d at 564 (emphasis in original). The Court must, therefore, carefully scrutinize the
facts and data upon which Dr. Wray relies and the way she has applied principles and methods to
the facts in order to evaluate the reliability of her opinions.
(See, e.g., Cook Wray Decl. Ex. I, WHO, Family Planning and Population, Intrauterine Devices: What Health
Workers need to know (1997), at 14-15 (“Perforation of the uterus can occur during the IUD insertion procedure if
the IUD or the inserter tube accidentally pierces the uterine wall.”); id. Ex. J, American College of Obstetricians &
Gynecologists, Long-Acting Reversible Contraception (LARC): IUD and Implant, Frequently Asked Questions, at
184 (2014) (“The IUD can perforate (or pierce) the wall of the uterus during insertion.”); id. Ex. L. Gretchen M.
Lentz et al., Comprehensive Gynecology 261 (6th ed. 2012) (“Perforation always occurs at the time of
insertion . . . IUDs correctly inserted entirely within the endometrial cavity do not migrate or wander through the
uterine muscle into the peritoneal cavity.”).)
Dr. Wray’s contention that it is “undisputed” that secondary perforation occurs, without
confronting scientific literature that refutes this notion, casts doubt upon the reliability of her
opinions. See In re Rezulin, 369 F. Supp. 2d at 425 (“[I]f the relevant scientific literature
contains evidence tending to refute the expert’s theory and the expert does not acknowledge or
account for that evidence, the expert’s opinion is unreliable.”). An expert who “discusse[s] only
the evidence that [she] believed would advance the plaintiffs’ position,” does not exhibit “‘the
same level of intellectual rigor that characterizes the practice of an expert in the relevant field.’”
Id. at 426 (quoting Kumho Tire Co., 526 U.S. at 152). Dr. Wray does not discuss any
contradictory evidence, and instead took the occurrence of secondary perforation – the existence
of which is the major dispute of this litigation – as a given.45 (Wray Report at 22.) By assuming,
without any apparent basis, that secondary perforation is an “undisputed” phenomenon, and then
positing a mechanism by which she believes it may occur, Dr. Wray’s indulges in “at most,
scientifically-grounded speculation: an untested and potentially untestable hypothesis.” Golod,
964 F. Supp. at 860.
Like Dr. Young, Dr. Wray came up with a plausible hypothetical mechanism by which
secondary perforation could occur. (See Wray Report at 2 (“I have been asked to consider the
Plaintiffs point to a portion of Dr. Wray’s deposition to argue that she did confront contradictory evidence:
[O]f course there are going to be a mixture of explanations put forward by authors, those of them that are
trying to find or speak to mechanism. Some of that is best explained by secondary perforations. So I’m not
arguing that they [sic] cannot, and is not, primary perforation. But I’m saying all these things taken
together, along with the penetration into other smooth muscle organs . . . is pointing us in a direction that is
entirely consistent with uterine contractility moving Mirena through the uterus perforation, and that is what
I’m calling secondary perforation.
(Wray Dep. at 287:22-288:10.) This does not show that Dr. Wray confronted or distinguished contradictory
evidence regarding the existence of secondary perforation. Instead it seems to indicate that she merely
acknowledged the existence of primary perforation. Moreover, Dr. Wray also stated during her deposition that
although “[you] look at both sides when you’re forming your opinion,” “I wasn’t spending a lot of time trying to
think of reasons why my opinion might not be reasonable once I’ve reached my opinion.” (Id. at 101:9-13.)
mechanisms whereby the Mirena IUS perforates the uterus.”); Wray Dep. at 50:8-13 (“[W]ith
regard to IUDs specifically . . . you first heard the term secondary perforation in the course of
your – you said preparation for your report in this case? [Dr. Wray:] Yes.”); id. at 109:12-22 (Dr.
Wray has not conducted testing to validate her mechanism opinion); id. at 200:10-13 (“plausible”
that strong uterine activity will move IUD through uterine wall); id. at 370:14-16 (secondary
perforation is “plausible mechanism for what occurred there”).)46 As noted earlier, however,
“[s]cientific methodology today is based on generating hypotheses and testing them to see if they
can be falsified.” Daubert, 509 U.S. at 593. It does not meet the “same standards of intellectual
rigor that are demanded in [her] professional work,” Rosen, 78 F.3d at 318-19, to come up with a
theory by which a phenomenon could occur, and leave it at that, which is apparently what Dr.
Wray has done here. See Anderson v. Bristol Myers Squibb Co., No. 95-CV-03, 1998 WL
35178199, at *12 (S.D. Tex. Apr. 20, 1998) (“[A]n opinion that is ‘an insightful, or even an
inspired, hunch’ is not admissible if it lacks scientific rigor; ‘the courtroom is not the place for
scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.’”) (quoting
Rosen, 78 F.3d at 319). As the court in Anderson explained, it is not that experts “are insincere
in their opinions or that their opinions may not some day be validated through scientific research
and experiment; it is simply that the law cannot wait for such a confirmation.” Id.; see In re
Accutane, 511 F. Supp. 2d at 1303 (“This Court’s gate-keeping function is to ensure that
opinions based on mere theory do not reach the jury. . . [An expert’s] opinion may very well be
correct. His conclusions may be proven true. But at this point there is a gap between the data
and the opinions he proffers.”); Dunn, 275 F. Supp. 2d at 684 (“While hypothesis is essential in
the scientific community because it leads to advances in science, speculation in the courtroom
Dr. Wray acknowledged during her deposition that she was not aware of any “medical or scientific organization
that uses the term secondary perforation with regard to IUDs.” (Wray Dep. at 50:16-21.)
cannot aid the fact finder in making a determination of whether liability exists. Ultimately,
speculation is unreliable evidence and is inadmissible.”) (footnote omitted). Like Dr. Young’s,
Dr. Wray’s proposed mechanism of how an IUD might perforate a uterus unrelated to insertion,
which has not been proven and which Dr. Wray created in the context of this case, “is merely a
hypothesis; it may be a very good hypothesis begging for testing and further study, but it is only
an untested hypothesis.” Anderson, 1998 WL 35178199, at *12. It falls into the category of
unreliable speculation that is inadmissible under Daubert, which by itself warrants exclusion of
her testimony. See In re Accutane, 511 F. Supp. 2d at 1296 (“While [the expert’s] biological
theory may be exactly right, at this point it is merely plausible, not proven, and biological
possibility is not proof of causation. [The expert’s] theory does not show the reliability of each
step necessary to make the testimony admissible under Daubert.”).
Dr. Wray also does not explain in her deposition or report why Mirena’s effects on the
endometrium would necessarily impact the risk of perforation of the myometrium, nor could she
identify a theory to support her claim. (Wray Report at 13; Wray Dep. at 328:23-330:15.) In
addition, Dr. Wray takes an immense analytical leap, without adequately explaining the
reasoning or methodology behind it, when she points to uterine activity ushering menstrual flow
down to the cervix or sperm up to the fallopian tube as support for the notion that a Mirena could
be transported through the uterine wall. (Wray Report at 13-14.) While these are examples of
“myometrial activity transporting things beyond the uterus,” (id.), she provides no reason to
think that the movement of bodily fluids through anatomical pathways toward anatomical
openings would shed any light on whether a plastic object could penetrate the muscular
myometrium in the absence of any preexisting damage to that wall. This obvious analytical gap
undermines the reliability of Dr. Wray’s opinions. See Joiner, 522 U.S. at 146.
Dr. Wray’s Sources
Apart from the issues identified above, Defendants also challenge Dr. Wray’s use of the
sources on which she purports to rely. In addition to relying upon her experience and expertise
related to the myometrium and the uterus, Dr. Wray cites articles and multiple case reports to
support her conclusion that a Mirena IUD is capable of secondary perforation. Case reports are
generally disfavored by courts as evidence of causation because they merely describe “‘reported
phenomena without comparison to the rate at which the phenomena occur in the general
population or in a defined control group; [they] do not isolate and exclude potentially alternative
causes; and [they] do not investigate or explain the mechanism of causation.’” Siharath v.
Sandoz Pharm. Corp., 131 F. Supp. 2d 1347, 1361 (N.D. Ga. 2001) (quoting Casey v. Ohio Med.
Prods., 877 F. Supp. 1380, 1385 (N.D. Cal. 1995)), aff’d sub nom. Rider v. Sandoz Pharm.
Corp., 295 F.3d 1194 (11th Cir. 2002); see In re Rezulin, 369 F. Supp. 2d at 406 (“The difficulty
with case reports . . . is distinguishing between association and causation. Simply because a
patient exposed to a particular substance exhibited a set of symptoms does not mean that it was
the substance that caused the symptoms.”).
Although some courts have found case reports to be sufficiently reliable indicators of
causation when they exist in large quantities, see Bee v. Novartis Pharm. Corp., 18 F. Supp. 3d
268, 304-05 (E.D.N.Y. 2014); In re Fosamax, 645 F. Supp. 2d at 184-85, that is not the case
here. Unlike In re Fosamax, in which the court noted there were “hundreds of published case
reports,” 645 F. Supp. 2d at 184, Dr. Wray cites a total of 95 supporting authorities, a fraction of
which are case reports. (Kekatos Wray Decl. Ex. B app. B.) Moreover, unlike the situations in
Bee and In re Fosamax, where the case reports found an association between a particular disease
and a particular drug, several of the case reports Dr. Wray cites acknowledge the possibility that
perforation occurred at insertion but was only detected later when the Mirena had more fully
embedded or migrated out of the uterus. The parties, and Dr. Wray, do not dispute that
perforation can occur at insertion, (Wray Dep. at 287:8-10), and an injury at insertion through
which the Mirena later migrates constitutes primary (not secondary) perforation. (Wray Report
at 21.) It appears that these case reports might be construed to support the theory of secondary
perforation only in that they reveal a temporal lag between insertion and detection of the
migration of the Mirena. Without something more to show that these studies actually involve
secondary perforation, as opposed to a primary perforation that was detected later, Dr. Wray
appears to be relying upon her ipse dixit, which is not a reliable ground for a scientific opinion.
See Joiner, 522 U.S. at 146.
An example of this gap appears in the Chen article,47 cited by Dr. Wray and by Plaintiffs
in their Opposition, (Plaintiffs’ Memorandum of Law in Opposition to Defendants’ Motion to
Exclude the Testimony of Susan Wray, Ph.D. (“Ps’ Wray Opp.”), (Doc. 2780), 14 n.3), which
does not seem to involve secondary perforation. The point of the Chen article is that it
documents “the shortest interval between insertion and proven bowel injury by an IUD.” (Chen
Report at 295.) It describes a copper IUD that was found in the bowel four weeks after insertion.
It describes a painful insertion procedure and post-insertion pain and spotting, all suggesting that
“the uterine perforation most likely occurred during insertion and perforation [sic].” (Id. at 297.)
It thus acknowledges that discovery of migration post-insertion does not mean that perforation
must also have occurred post-insertion. And to read into the author’s use of “most likely” the
conclusion that the author believes that perforation can occur post-insertion, when the article
does not purport to examine the subject, is to place on “one anecdotal case report,” Soldo v.
“Chen” refers to Chih-Ping Chen et al., Ileal Penetration by a Multiload-Cu 375 Intrauterine Contraceptive
Device: A Case Report With Review of the Literature, 58 Contraception 295 (1998). (Compendium Ex. 3.)
Sandoz Pharm. Corp., 244 F. Supp. 2d 434, 541 (W.D. Pa. 2003), far more weight than it can
reasonably bear. See McClain, 401 F.3d at 1244 (expert’s “inclination to draw overreaching
conclusions from self-limiting medical articles,” among other things, showed “speculative nature
of his opinions”).
Indeed, some of the other publications, including controlled studies, on which Dr. Wray
relies undermine her theory. See In re Accutane, 2009 WL 2496444, at *2 (“[W]hen an expert
relies on studies of others, he must not exceed the limitations the authors themselves place on the
study. That is, he must not draw overreaching conclusions.”). Dr. Wray cites the Boortz
article48 after stating, “As discussed in the literature by many experts, perforations of the uterus
may occur at the time of insertion or subsequently.” (Wray Report at 21.) But the Boortz
article’s discussion of uterine perforation does not mention primary or secondary perforation. As
Dr. Wray acknowledged at her deposition, this article relates to radiologic imaging of IUDs that
have migrated out of the uterus, but does not address whether perforation occurred upon
insertion or later. (Wray Dep. at 225:19-227:14.) The Anderson article49 has nothing to do with
IUDs or perforation, and instead, as Dr. Wray acknowledged, (id. at 227:19-228:15), deals
generally with “foreign body reaction to biomaterials” implanted within tissue (not cavities).
(Anderson at 86.) A connection could possibly be made between this article and the uterus’
reaction to an IUD, but Dr. Wray does not make such a connection in her report or in her
deposition. The authors of the Kaislasuo article,50 as Dr. Wray admits, (Wray Dep. at 228:18-
“Boortz” refers to Hillary E. Boortz et al., Migration of Intrauterine Devices: Radiologic Findings & Implications
for Patient Care, 32 RadioGraphics 335 (2012). (Cook Wray Decl. Ex. C.)
“Anderson” refers to James M. Anderson et al., Foreign Body Reaction to Biomaterials, 20 Seminars in
Immunology 86 (2008). (Cook Wray Decl. Ex. D.)
“Kaislasuo” refers to Janina Kaislasuo et al., Uterine Perforation Caused by Intrauterine Devices: Clinical
Course and Treatment, 28 Hum. Reprod. 1546 (2013). (Cook Wray Decl. Ex. E.)
229:2), do not state that secondary perforation is a proven phenomenon. Finally, the authors of
the Zakin article discuss the concept of gradual erosion or secondary perforation, and say that
there is a “difference in opinion regarding the concept of immediate perforation, partial or
incomplete, versus that of a kind of slow erosion,” but concludes that “the consensus favors the
former.” (Zakin, supra note 41, at 344.)
Dr. Wray’s reliance on the 1991 Tang study51 for her opinion that a properly placed
Mirena stimulates uterine contractions, (Wray Dep. at 133:3-19, 143:19-24, 358:8-23), is
similarly misplaced. That study compared the effects of four types of IUDs (including a LNGreleasing IUD like Mirena) in rabbits, and actually found that the LNG-containing IUD had the
lowest level of contractions of the four – even lower than a control group with no IUD. (Tang at
29.) Dr. Wray acknowledged this study did not support her conclusion, but did not offer an
explanation or alternative source for her opinion that Mirena users experience enhanced
contractions. (Wray Dep. at 170:8-21.) She could not locate any other studies involving Mirena,
so fell back to relying upon her “expertise on uterine contractility,” which amounts to ipse dixit.
(Id. at 170:17-171:3.)52
Similarly, Dr. Wray’s citations for the proposition that “uterine peristalsis”53 is “more
chaotic in the presence of an IUD,” and “may be even more so with Mirena use, due to its
“Tang” refers to D.C. Tang & X.R. Wu, Dynamic Changes of Myometrial Activity, Levels of PGF2α and E2 in
Rabbits After Insertion of Four Types of IUDs, 7 Advances in Contraception 29 (1991). (Cook Wray Decl. Ex. N.)
Dr. Wray’s report cites H.O.D. Critchley et al., Progestin Rreceptor Isoforms and Prostaglandin Dehydrogenase
in the Endometrium of Women Using a Levonorgestrel-Releasing Intrauterine System, 13 Hum. Reprod. 1210
(1998), (Compendium Ex. 4), and other articles to support her opinion that “levels of several inflammatory
cytokines have been reported to be increased” in the presence of LNG and that cytokines “are known to stimulate
uterine contractions,” (Wray Report at 10). Although Dr. Wray may be correct that studies show that LNG can
increase inflammatory cytokines, which can “stimulate uterine contractions,” Dr. Wray fails to reconcile this theory
with the results of the Tang study, which more directly involved an LNG-containing IUD like Mirena and came to a
contrary conclusion regarding uterine contractions.
Uterine peristalsis refers to “wave-like uterine contractions that are thought to help move sperm towards the
fallopian tube.” (Wray Dep. at 345:1-7.) Uterine peristalsis is also known as uterine contractility. (Cook Wray
hormonal effects,” (Wray Report at 25), do not hold up under scrutiny. As already discussed, the
Tang study, which is the only study she cites for this proposition that involves a Mirena, did not
find an increase in uterine contractility. (Wray Dep. at 345:16-22.) Another study Dr. Wray
cites for the theory that there is increased chaos of uterine peristalsis with the presence of a
Mirena, Kido 2008, not only did not involve a Mirena but actually found that peristaltic
frequency in IUD users was lower than in the control group, (Kido 2008, supra note 53, at 5657), and that “in the presence of an IUD, uterine peristalsis [is] inhibited.”54 (Id. at 57; Wray
Dep. at 346:17-347:12.) Dr. Wray also cited three other studies that did not involve Mirena
IUDs in support of her opinion. (Wray Dep. at 353:10-354:5, 355:1-12, 357:16-358:7.) Dr.
Wray also cited one study that does not mention IUDs, let alone a Mirena IUD, but only refers to
prostaglandins. (Id. at 354:11-22.) Dr. Wray was unable to explain her reliance on these studies
during her deposition. (Id. at 359:24-361:7.) The absence of Mirena IUDs, or LNG-containing
IUDs, in these studies, and the fact that the Tang and Kido studies seem to contradict Dr. Wray’s
opinions, indicate that Dr. Wray’s conclusions do not “flow reliably from the premises,” which is
a “crucial consideration in evaluating the admissibility of expert testimony.” In re Rezulin, 369
Decl. Ex. O, Aki Kido et al., Intrauterine Devices and Uterine Peristalsis: Evaluation with MRI,” 26 Magnetic
Resonance Imaging 54, 54 (2008) (“Kido 2008”).)
The study itself noted that one of its limitations was that “the kind of IUD used was not the same, and distinction
of IUDs with or without copper was not considered.” (Kido 2008, supra note 53, at 57.) The authors also noted that
they did not consider hormonal measurements, (id. at 58), which Dr. Wray specifically mentioned as having an
effect because Mirena releases hormones, (Wray Report at 25). See In re Accutane, 2009 WL 2496444, at *2
(expert must not exceed the limitations of a study or draw “overreaching conclusions”). Dr. Wray said at her
deposition that Kido 2008 “says that actually the contractions with this IUD are stronger” and also involved a
“change in direction,” (Wray Dep. at 358:12-23), without explaining the study’s language stating uterine peristalsis
was actually lower in the women with IUDs. Further, the study’s authors wrote that “the direction of peristaltic
waves” in IUD users could be “supportive of an attempt to expel the IUD from the uterine cavity,” (Kido 2008,
supra note 53, at 57), which would be through an anatomical opening and not through the uterine wall.
F. Supp. 2d at 426. Dr. Wray takes too great of an analytical leap from these studies to form her
opinion, which therefore warrants exclusion.55 Joiner, 522 U.S. at 146.
Several other of Dr. Wray’s opinions are not grounded in any scientific literature. For
example, Dr. Wray could not identify a study for the proposition that inserting a Mirena into
women with smaller uterine cavities, adolescents and/or nulliparous women leads to pressure on
the uterine lining and erosion of it over time. (Wray Report at 25; Wray Dep. at 342:13-24,
344:4-20.) Dr. Wray seems to imply in her report (and Plaintiffs argue in their Opposition) that
because the FDA has approved another IUD, the Skyla, which is 4 mm smaller than Mirena, the
Mirena must be too large or more likely to perforate in such women. (Wray Report at 25.)
Without an explanation or reasoning, however, that is merely speculation. That a different
product with different specifications is on the market does not tell us anything about what
happens with Mirena. See Kakeh v. United Planning Org., Inc., 587 F. Supp. 2d 125, 130
(D.D.C. Cir. 2008) (“When an expert’s testimony is based on ‘guesswork, speculation or
conjecture,’ it should be excluded.”) (quoting Joy v. Bell Helicopter Textron, Inc., 999 F.2d 549,
568 (D.C. Cir. 1993)). Further, not only does Dr. Wray provide no basis for her pressure/erosion
Plaintiffs are correct that the court in In re Ephedra found that a controlled study was not necessary for an expert’s
general causation opinion to be reliable. See In re Ephedra, 393 F. Supp. 2d at 187-88. That case, however, is
distinguishable from this one. There the court highlighted that “differential etiology” or “differential diagnosis” –
where an expert eliminates all plausible causes but one – can be a sufficiently reliable methodology to opine on
causation. Id. at 187. (Other courts have found that differential diagnosis can only be used to establish specific
causation, not general causation. See In re Rezulin, 369 F. Supp. 2d at 436-37.) Dr. Wray, however, does not
purport to have performed a differential diagnosis or to have used any particular methodology. Further, the Ephedra
court also only allowed the experts to testify that the substance could cause the injury, not that it has been proven
that it does cause the injury. 393 F. Supp. 2d at 186-87. If Dr. Wray were allowed to offer her theory with such a
caveat, it would greatly diminish the helpfulness of her testimony. Finally, the Ephedra court found that in that case
the experts’ inferences were “based on the kind of plausible and suggestive, even if inconclusive, scientific data
generally relied upon by physicians and epidemiologists when they must make a decision of importance in the
absence of conclusive proof.” Id. at 194. There is no showing here that Dr. Wray’s opinion has the sort of basis
accepted in her field, and “there is simply too great an analytical gap between the data and the opinion proffered.”
Joiner, 522 U.S. at 146; see Accutane, 511 F. Supp. 2d at 1296 (finding “biological theory” that is “merely
plausible” inadmissible under Daubert).
theory – it is set forth with no citation – but she does not even attempt to quantify the pressure or
show that it would amount to anything that would have physiological consequences.
Dr. Wray similarly lacks support for the proposition that because of decreased estrogen
availability in the myometrium, Mirena “may produce a myometrium that is contractile but less
extensive and hence weakened and more prone to perforations, despite initial correct and nondamaging insertion of the device.” (Wray Report at 25-26.) Dr. Wray could not identify any
studies or other objective support for this opinion. (Wray Dep. at 362:17-363:19.) Dr. Wray
based her conclusion on what she would expect to happen, but although she is an expert on the
myometrium, she is not an expert on contraceptives, let along LNG-releasing IUDs, or their
effects. (Id. at 37:9-18, 42:20-22, 45:5-7, 45:16-46:6.) This does not pass muster under
Daubert. See McClain, 401 F.3d at 1244. Dr. Wray also lacks support for her assertion that
Mirena’s effects on the endometrium and myometrium “build up over months and years.” (Wray
Report at 19.) She does not cite any sources in her report, and at her deposition she could not
point to a study. (Wray Dep. at 203:1-10, 206:1-8.) This speculation does not have sufficient
indicia of reliability.
Furthermore, Dr. Wray was asked at her deposition to identify specific published case
reports that ruled out damage to the uterine wall during insertion, as well as peer-reviewed
publications stating that changes in the endometrium influence the risk of perforation of the
myometrium. (Wray Dep. at 391:4-392:16.) Dr. Wray could not give examples during her
deposition, and Plaintiffs did not mention any in their papers.
Plaintiffs respond to Defendants’ arguments relating to lack of citation and adequate
support for Dr. Wray’s opinions by pointing to the 95 sources Dr. Wray cites in her report. (Ps’
Wray Opp. 11, 13, 15-16.) Quantity does not equal reliability. Plaintiffs fail to show how these
articles reliably substantiate Dr. Wray’s views. Apart from the case reports and studies discussed
above, which do not reliably bolster Dr. Wray’s opinions, Plaintiffs do not offer other reliable
sources on which Dr. Wray based her conclusions. Plaintiffs cite some articles that are not
helpful, and do not address the substantive arguments put forth by Defendants regarding certain
publications.56 Plaintiffs argue that Defendants’ attacks on the studies and reports on which Dr.
Wray relies are subjects for cross-examination and do not warrant exclusion. (Id. at 16-17.)
Plaintiffs additionally contend that an expert can rely upon a combination of studies to support a
conclusion, quoting Goebel v. Denver & Rio Grande Western Railroad Co., 346 F.3d 987, 993
(10th Cir. 2003). The full quotation from Joiner that the Goebel court cites is that it is “within
the District Court’s discretion to conclude that the studies upon which the experts relied were not
sufficient, whether individually or in combination, to support their conclusions.” Joiner, 522
U.S. at 146-47. Ultimately it is up to the district court to determine if too great an analytical gap
exists between the sources and the expert’s proposed testimony. Too great a gap exists here,
even when looking at the cited studies and case reports in combination. Moreover, it is
Plaintiffs’ burden to prove the reliability of their experts’ opinions, which in Dr. Wray’s case
they have failed to do. See Fed. R. Evid. 702 advisory committee’s note to 2000 amendment;
Bourjaily, 483 U.S. at 175-76.
Created for Litigation
Finally, Dr. Wray had not heard of secondary perforation prior to being consulted in
connection with this litigation, another indication that her opinions lack the reliability to be
Plaintiffs cite Anh Dinh et al., A review of the Endometrial Histologic Effects of Progestins and Progesterone
Receptor Modulators in Reproductive Age Women, 91 Contraception 360 (2015), (Compendium Ex. 6), to support
Dr. Wray’s opinions related to the effects of LNG. (Ps’ Opp. to Exclude Wray 12 n.1.) There is no evidence,
however, that there is a connection between this study, which discusses effects on the endometrium and not the
myometrium, and uterine perforation – a gap that Dr. Wray has left unexplained, as further discussed below.
admissible. See Eghnayem, 57 F. Supp. 3d at 670 (concern that testimony is litigation-driven has
“a role in applying Daubert”); In re Rezulin, 369 F. Supp. 2d at 420 (courts have considered
“whether an expert’s opinion was developed for litigation,” in addition to the four Daubert
factors, in assessing reliability); Awad v. Merck & Co., 99 F. Supp 2d 301, 304 (S.D.N.Y. 1999)
(“[A] significant consideration is whether research was conducted independently or for the sole
purpose of litigation.”), aff’d sub nom. Washburn v. Merck & Co., 213 F.3d 627 (2d Cir. 2000).
Dr. Wray acknowledged at her deposition that the first time she heard of secondary perforation
was after being retained as an expert in this litigation. (Wray Dep. at 50:8-13.) This is but
another factor that demonstrates Dr. Wray’s opinion is not sufficiently reliable under Daubert
and would not stand up in a scientific setting.
Assisting the Trier of Fact
Because Dr. Wray’s opinions do not have sufficient indicia of reliability to pass muster
under Daubert, they would not be helpful to a jury.
For the reasons stated above, Defendants’ motion to exclude the testimony of Susan
Wray, Ph.D. is GRANTED.
Richard Strassberg, M.D.
Defendants move to exclude the opinion of Dr. Strassberg, who has offered a specific
causation opinion for Hayes. Defendants argue that Dr. Strassberg’s opinions are not reliable
because they do not have a reliable foundation and are not based on sufficient facts and data.
(Memorandum of Law in Support of Defendants’ Motion to Exclude the Testimony of Richard
Strassberg, M.D. (“Ds’ Strassberg Mem.”), (Doc. 2689), 3-4.) For the reasons stated below, the
Court finds Dr. Strassberg’s opinion lacking the indicia of reliability required under Daubert,
and therefore Defendants’ motion to preclude him from testifying is GRANTED.
Dr. Strassberg offers five opinions in this three page report. First, Dr. Strassberg opines
that Ms. Hayes was an appropriate candidate for Mirena. Second, he states that the insertion of
Ms. Hayes’ Mirena was done within accepted medical standards and in compliance with the
product’s label and instructions for use. Third, Dr. Strassberg opines that there is no reason to
believe that perforation occurred at the time Ms. Hayes’ Mirena was inserted. Fourth, Dr.
Strassberg states there is no reason to believe that the care and treatment provided to Ms. Hayes
by the healthcare professionals involved in the insertion or removal of her Mirena deviated from
accepted medical standards. Fifth, Dr. Strassberg concludes that after being properly placed, the
Mirena subsequently perforated Ms. Hayes’ uterus. (Cook Strassberg Decl. Ex. A, Case Specific
Expert Report of Richard Strassberg (“Strassberg Report”), at 1-2.) Defendants move to
preclude Dr. Strassberg’s testimony in its entirety, but their arguments address only his third and
fifth opinions, so the Court will do the same.
Dr. Strassberg is an Assistant Professor in the Department of Obstetrics and Gynecology
at the University of Miami School of Medicine. (Strassberg Report at 2.) He has also practiced
as a clinician at several hospitals. (Id.) Dr. Strassberg has served as Chairman of the OB/GYN
Department and of OB Complications at South Miami Hospital. (Id.) He has practiced as a
clinical instructor and has served as President of the Miami Obstetrical-Gynecological Society.
(Id.) Because of his clinical experience related to obstetrics, gynecology and family planning,
Dr. Strassberg is qualified to give an opinion as to whether Ms. Hayes’ Mirena perforated her
uterus at the time of insertion or later. Nonetheless, Rule 702 and Daubert require that in
addition to an expert being qualified, the expert’s testimony must also be reliable. Daubert, 509
U.S. at 590.
Lack of a General Causation Opinion
Defendants argue that Dr. Strassberg’s expert testimony should be excluded because it
lacks a required foundational predicate – a general causation opinion. (Ds’ Strassberg Mem. 46.) As discussed in connection with Dr. Young, in the absence of evidence of general causation,
evidence of specific causation is “irrelevant.” In re Rezulin, 441 F. Supp. 2d at 578. The court
in In re Rezulin in 2005 held that “a physician must have some reliable basis for believing that a
particular substance is capable of causing the injury in question in relevant circumstances before
concluding that the substance caused that injury in a particular case.” 369 F. Supp. 2d at 438.
Plaintiffs attempt to challenge this proposition by distinguishing the procedural posture of a
different In re Rezulin decision, 441 F. Supp. 2d 567, from 2006, but they do not address the
2005 decision that contained the language quoted above, nor do they seem to seriously quarrel
with the proposition that a specific causation expert must show general causation or rely on a
reliable general causation opinion. (Plaintiffs’ Memorandum of Law in Opposition to
Defendants’ Motion to Exclude the Testimony of Richard Strassberg, M.D. (“Ps’ Strassberg
Opp.”), (Doc. 2778), 5-6.) Rather, they point out that Ms. Hayes intends to rely on other experts
for a general causation opinion. (Id. at 6.) But the problem is that Dr. Strassberg has not relied
on those experts in forming his opinion that the Mirena caused Ms. Hayes’ injuries subsequent
and unrelated to insertion, (Strassberg Dep. at 41:20-42:14), nor has he offered a general
causation opinion himself, (id. at 41:6-13, 42:15-18), creating a gap in the causal chain of his
analysis. See In re Accutane Prods. Liab. Litig., No. 04-MD-2523, 2007 WL 4404176, at *1
(M.D. Fla. Aug. 15, 2007) (permitting specific causation expert to testify based on general
causation opinion of another doctor “if doctors in his profession normally rely upon the opinions
of other experts . . . and if in fact he did rely upon such opinion”); Adams v. Cooper Indus., Inc.,
No. 03-CV-476, 2007 WL 2219212, at *8 (E.D. Ky. July 30, 2007) (excluding opinion where
specific causation expert did not fill gap in analysis or rely on another expert who did); Colon v.
Abbott Labs., 397 F. Supp. 2d 405, 416 (E.D.N.Y. 2005) (specific causation expert excluded in
part because opinion contained a “significant analytic gap . . . between the possibility that infant
formula may cause [a disease] and [the expert’s] conclusion that [certain formula] was actually a
substantial factor in causing [plaintiff’s] diabetes”). Dr. Strassberg’s failure to offer or rely upon
a general causation opinion renders his specific causation opinions without foundation and
Apart from lacking a general causation predicate for his specific causation opinion, Dr.
Strassberg’s report and proposed testimony do not have sufficient indicia of reliability. Dr.
Strassberg’s expert report consists of one page listing his opinions, one page listing his
qualifications, and one page describing Ms. Hayes’ medical records followed by a restatement of
the same opinions listed on the first page. (Strassberg Report at 1-3.) Although Dr. Strassberg is
a qualified OB/GYN, his expert opinion in this instance consists of nothing more than
conclusory statements, which fails under Rule 702 or Daubert. See Hilaire, 54 F. Supp. 3d at
244 (finding expert report lacking sufficient detail for court to consider reliability and
“consist[ing] primarily of conclusory statements”).
Dr. Strassberg’s report does not cite any publications or medical literature in support of
his opinions, and he acknowledged at his deposition that he did not review any medical literature
in reaching them. (Strassberg Dep. at 164:24-165:2.) Moreover, based on his report, the court
cannot determine what caused Dr. Strassberg to formulate his opinions.57 He provides literally
no analysis, explanation or basis for his opinions, which not only violates Federal Rule of Civil
Procedure 26(a)(2)(B)(i) (requiring that expert report contain complete statement of all opinions
and the basis and reasons for them), but which seems to be a classic case of “opinion evidence
that is connected to existing data only by the ipse dixit of the expert,” Joiner, 522 U.S. at 146.
Rule 702 and Daubert “mandate the exclusion” of expert opinion “based on data, a methodology,
or studies that are simply inadequate to support the conclusions reached.” Amorgianos, 303 F.3d
at 266. They must surely also mandate exclusion where there is no data, methodology or study
underlying the opinion at all. For this reason alone, Dr. Strassberg’s opinions must be excluded.
Dr. Strassberg fared little better during his deposition. He attempted to explain his
analysis by saying that he based his opinion that perforation did not occur at insertion on the
inserting doctor’s experience, a note from the doctor describing the procedure as uncomplicated,
the threads of the Mirena being visible after insertion, and post-insertion examination and a
September 29, 2011 ultrasound. (Strassberg Dep. at 222:5-18, 228:8-229:4.) Nonetheless, when
asked specifically how he determined the perforation occurred after insertion, Dr. Strassberg
merely said: “My opinion, just what I said there, that the IUD was properly placed and
subsequently became a perforation. I don’t know how that happened or when it happened,
but . . . my opinion is that the perforation wasn’t caused by the provider at the time of insertion.”
Plaintiffs argue that Dr. Strassberg relied on “differential diagnosis” to opine on the cause and timing of the
perforation of Ms. Hayes’ uterus. (Ps’ Strassberg Opp. 8.) Dr. Strassberg stated no such thing in either his report or
deposition testimony. The cases Plaintiffs cite regarding the validity of differential diagnosis as a methodology are
irrelevant where, as here, the only suggestions that such a methodology was used comes from counsel’s say-so in a
brief. Differential diagnosis involves “‘ruling in’ all scientifically plausible causes of the plaintiff’s injury” and
“then ‘rul[ing] out’ the least plausible causes of injury until the most likely cause remains.” Glastetter v. Novartis
Pharm. Corp., 252 F.3d 986, 989 (8th Cir. 2001); see Ruggiero, 424 F.3d at 254. There is not the slightest
indication that Dr. Strassberg undertook either prong of such an analysis.
(Id. at 224:24-225:6.) Dr. Strassberg is to be commended for his candor in admitting that he
does not know when or how the perforation occurred, but that admission shows his report and
testimony to be unreliable. See R.F.M.A.S., Inc. v. So, 748 F. Supp. 2d 244, 248-49 (S.D.N.Y.
2010) (“Expert testimony that is merely ‘subjective belief or unsupported speculation’ should be
excluded.”) (quoting Daubert, 509 U.S. at 590).
In addition, there are flaws with each of the bases on which Dr. Strassberg rests his
opinion that perforation did not occur at insertion. First, Dr. Strassberg’s reliance on the years of
experience of the inserting physician amounts to speculation. He cites nothing to support his
implication that experienced doctors never inadvertently perforate the uterus upon insertion, and
common sense suggests the opposite, even if perhaps the likelihood of such an event occurring
may be higher with a newer practitioner. The conclusion that Dr. Robboy did not perforate Ms.
Hayes’ uterus because he is experienced is speculation based solely on Dr. Strassberg’s ipse
dixit. See Joiner, 522 U.S. at 146.
Second, that no complications were noted is, by Dr. Strassberg’s own account,
unsurprising, given that Ms. Hayes was under sedation during the insertion of her Mirena and
would not have felt any pain if a perforation occurred. (Strassberg Dep. at 179:2-12.) Likewise,
the inserting doctor’s belief that the Mirena was properly placed is not a reliable basis for
concluding that no perforation occurred upon insertion. No responsible professional would
conclude the insertion procedure in the belief that the Mirena was in the wrong position, and yet
nobody disputes that it sometimes is. Accordingly Dr. Strassberg’s reliance on the fact that the
insertion procedure seemed to be uneventful to indicate that perforation did not occur at insertion
Third, Dr. Strassberg’s reliance on the threads of the Mirena being visible after insertion
does not, by his own account, support his conclusions. Although visible threads can be an
indicator of proper placement, Dr. Strassberg admitted that the visibility of the threads does not
mean that a perforation did not occur and that he could not rely on the visibility of the threads in
September 2011 to conclude that the Mirena was properly placed in February. (Strassberg Dep.
at 191:5-21, 230:11-15.) 58 Fourth, by his own account, Dr. Strassberg was unable to determine
from the September 29, 2011 ultrasound “how much of the IUD [was] in the uterus or 100
percent that it [was in the uterus],” (id. at 196:19-21), and that he could not tell “where the IUD
was,” (id. at 198:1-3), or whether it had perforated. Because each of the facts on which Dr.
Strassberg relied in formulating his opinion that the perforation of Ms. Hayes’ uterus did not
occur at insertion does not reliably support that conclusion, his opinion does not reliably flow
from the data and there is “too great an analytical gap between the data and the opinion
proffered.” Joiner, 522 U.S. at 146.
Finally, while not conclusive, the unreliability of Dr. Strassberg’s opinion is underscored
by the fact that he did not consider alternative factors that may have caused perforation.
Although an expert need not rule out every alternative in forming an opinion, “[a] factor that
courts have considered in Daubert analyses is whether an expert has accounted adequately for
obvious alternative explanations,” which is “appropriate because any theory that fails to explain
information that otherwise would tend to cast doubt on that theory is inherently suspect.” In re
Rezulin, 369 F. Supp. 2d at 425; see In re Fosamax Prods. Liab. Litig., 924 F. Supp. 2d 477, 493
Moreover, as Defendants point out in their brief and as Dr. Strassberg acknowledged at his deposition, (Strassberg
Dep. at 217:22-218:9), because the threads of Ms. Hayes’ Mirena were still visible on September 29, 2011 when an
ultrasound was performed, (Cook Strassberg Decl. Ex. F, at 2), just two days before a hysteroscopy procedure
showed that the Mirena was not in her uterus, (id. Ex. G at 3), the position of the Mirena could not have changed
substantially after the threads were trimmed upon insertion.
(S.D.N.Y. 2013) (“‘While an expert need not rule out every potential cause in order to satisfy
Daubert [sic], the expert’s testimony must at least address obvious alternative causes and provide
a reasonable explanation for dismissing specific alternate factors identified by the defendant.’”)
(quoting Israel, 2006 WL 3196956, at *5).
Dr. Strassberg, however, did not rule out obvious possible alternatives. Ms. Hayes had a
separate procedure immediately before her Mirena was inserted during which the physician
inserted a cannula (tube) and a sharp object (a curette) into her uterus. (Strassberg Dep. at 174:222, 176:14-20.) By his own account this procedure could have perforated the uterus or damaged
the myometrium, (id. at 177:1-5; see id. at 62:1-3), yet Dr. Strassberg did not even consider or
offer an explanation for dismissing this potential alternative cause of perforation, (id. at 217:1719).59 In addition, Dr. Strassberg did not address the fact that a metal sound (a probing
instrument) was inserted into Ms. Hayes’s uterus twice – before and after insertion – which Dr.
Strassberg acknowledged carried a risk of perforation each time. (Id. at 62:1-3, 63:19-64:3.)60
Dr. Strassberg also conceded that it was possible that a partial perforation (where an IUD is
partially inside and partially outside the uterus) or embedment (where a portion of an IUD is
located in the uterus and another portion is in the myometrium) occurred at the time of insertion,
Plaintiffs claim that Dr. Strassberg said there is no increased risk of perforation after the procedure at issue, an
opinion he “[b]ased on literature.” (Strassberg Dep. at 87:4-12.) Plaintiffs ignore, however, that Defendants are not
saying that the procedure increases the risk of perforation from insertion of the Mirena, but rather that the procedure
itself, which involves instruments entering the uterus, poses, as Dr. Strassberg acknowledged, (id. at 87:13-15), a
risk of perforation. Plaintiffs also point to testimony of Dr. Policar, one of Defendants’ experts, to the effect that no
studies have shown that the procedure in question, and sounding (measuring) of the uterus before insertion, increase
the risk of perforation during insertion. (Ps’ Strassberg Opp. 12-14.) Plaintiffs miss the mark, however, because
Defendants’ point is that Dr. Strassberg did not consider the risk from the procedure and sounding themselves.
Plaintiffs point out that Dr. Policar testified that there were no studies showing increased perforation risk in
women whose uteruses were resounded after IUD insertion. (Declaration of Diogenes P. Kekatos in Opposition to
Defendants’ Motion to Exclude the Testimony of Richard Strassberg, M.D. (“Kekatos Strassberg Decl.”), (Doc.
2779), Ex. D, Deposition of Michael Policar, M.D., M.P.H. (“Policar Dep.”), at 20:13-21:15.) This fact does
nothing to salvage Dr. Strassberg’s opinions, because Dr. Strassberg testified that sounding does cause a risk of
uterine perforation, (Strassberg Dep. at 62:1-3), and yet he did not consider whether that might have occurred in Ms.
(id. at 211:14-20, 220:1-15, 225:12-18), but he did not reconcile these possibilities with his
opinions that perforation did not occur upon insertion and that the Mirena was properly placed at
that time. Dr. Strassberg’s failure to at least confront these obvious alternatives render his
opinions unreliable, and reinforce the conclusion that his testimony should be excluded.
Assisting the Trier of Fact
Dr. Strassberg’s opinions do not have a reliable foundation because they are not based on
any theory of general causation and are unreliable, and would therefore not be useful to a jury.61
For the reasons stated above, Defendants’ motion to exclude the testimony of Dr.
Strassberg is GRANTED as to his opinions: (1) that there is no reason to believe that perforation
occurred at the time Ms. Hayes’ Mirena was inserted; and (2) that after being properly placed,
the Mirena subsequently perforated Ms. Hayes’ uterus. The Court expresses no view on whether
the remainder of Dr. Strassberg’s opinions would be relevant or admissible in the absence of the
Defendants’ Regulatory Experts
Plaintiffs move to exclude the proposed testimony of Defendants’ regulatory experts, Dr.
David Feigal, M.D., M.P.H. and Dr. Dena Hixon, M.D.
David Feigal, M.D., M.P.H.
Plaintiffs move to exclude the proposed expert testimony of David Feigal, M.D., M.P.H.
Plaintiffs argue that Dr. Feigal’s opinions are duplicative of those put forth by Dr. Hixon. In
addition, Plaintiffs argue that Dr. Feigal is not qualified to give an opinion on the adequacy of
the Mirena label, has an insufficient basis to opine on the FDA’s willingness to accept different
Because the Court finds Dr. Strassberg’s report and testimony unreliable on several other bases, I need not decide
whether Dr. Strassberg lacked key data necessary (such as 3D ultrasound) to verify his conclusions.
perforation warnings for Mirena, should not be allowed to opine on Bayer’s compliance with
standards, including FDA regulations, and should not be allowed to opine on the FDA’s state of
mind. For the reasons stated below, Plaintiffs’ motion to preclude Dr. Feigal’s testimony is
GRANTED in part and DENIED in part.
In his expert report, Dr. Feigal opines on the adequacy of the Mirena label. He concludes
that the Mirena label’s warnings were “scientifically accurate, concise and adequate to alert
physicians” to the risk of perforation. (Declaration of Diogenes P. Kekatos in Support of
Plaintiffs’ Motion to Exclude Expert Opinion of Dr. David Feigal (“Kekatos Feigal Decl.”),
(Doc. 2726), Ex. 5, Regulatory Expert Report of David W. Feigal, Jr., M.D., M.P.H. (“Feigal
Report”), at 34.) He finds that the essential risk information regarding perforation has always
been present in the label, and that perforation is “clearly associated with insertion.” (Id.) Dr.
Feigal further opines that the FDA in 2000 would not have accepted a warning that there were
reports of migration after insertion, because the FDA, before it approved the Mirena label, struck
language to that effect. (Id.) He concludes that despite variations in the wording, each Mirena
label contained essential information to adequately warn of Mirena’s risks, that Bayer performed
its post-marketing surveillance adequately, and that clinical trials show that Mirena is a very
effective form of birth control, the risks of which are well documented and properly described in
the label. (Id. at 34-35.)
Duplicative Testimony of Dr. Feigal
Plaintiffs argue that Dr. Feigal’s testimony should be excluded because it is duplicative of
Dr. Hixon’s. I need not decide whether admitting Dr. Feigal’s testimony would be
“needlessly . . . cumulative” pursuant to Rule 403 because Defendants have said they will only
be introducing evidence from one of their regulatory experts at any given trial. (Defendants’
Memorandum of Law in Opposition to Plaintiffs’ Motion to Exclude the Proposed Testimony of
David Feigal, Jr., M.D., M.P.H. (“Ds’ Feigal Opp.”), (Doc. 2797), 7-8.) Plaintiffs’ motion with
respect to the cumulative nature of Dr. Feigal’s testimony is therefore denied as moot.
Dr. Feigal is board certified in Internal Medicine and has a Master’s Degree in Public
Health in epidemiology and biostatistics. (Feigal Report at 1.) From 1992 to 2004, Dr. Feigal
held senior positions at the FDA. (Id. at 2.) From 1992 to 1997, he held positions in the FDA’s
Center for Drug Evaluation and Research (“CDER”), where he had authority to “approve
investigational studies of new drugs,” halt studies for safety reasons, approve “new indications
for approved drugs,” approve manufacturing methods, and take compliance actions – all with
respect to anti-viral or anti-infective drugs. (Id.) In these positions, Dr. Feigal was “responsible
for the evaluation of safety and efficacy of new drugs, including the approval process and
continuing oversight of the safety and effectiveness of those drugs after approval.” (Id. at 3.)
From 1997 to 1999, Dr. Feigal served as the Medical Deputy Director of the Center for Biologics
Evaluation and Research, where he was responsible for medical issues associated with blood,
vaccines and therapeutic proteins. (Id. at 2.) From 1999 to 2004, Dr. Feigal was the Director of
the Center for Devices and Radiological Health (“CDRH”), which is responsible for the approval
of new medical devices, (id.), including contraceptive devices, (Declaration of Christopher J.
Cook in Support of Defendants’ Opposition to Plaintiffs’ Motion to Exclude Proposed
Testimony of David W. Feigal, M.D., M.P.H. (“Cook Feigal Decl.”), (Doc. 2798), Ex. 2,
Deposition of David Feigal (“Feigal Dep.”), at 37:2-4). He was also a member of the WHO Task
Force on Contraceptive Methods. (Id. at 36:19-37:1.) Dr. Feigal is familiar with “the process
and criteria utilized by FDA in assessing safety and efficacy, pharmaceutical product labeling
and pharmaceutical manufacturing quality,” and he “participated directly in that process for
years.” (Feigal Report at 3.) Dr. Feigal was also responsible for reviewing and approving
changes to product labels, although none involving IUDs. (Feigal Dep. at 66:5-67:5.)
After his tenure at the FDA, Dr. Feigal taught and participated in research grants at
Arizona State University, where he is currently an adjunct professor in the School of Law.
(Feigal Report at 3.) Dr. Feigal has also held senior positions in two biotech companies, and has
been a consultant in legal cases for the past eleven years, where he has provided expert opinions
and testimony for both plaintiffs and defendants. (Id.)
Plaintiffs do not dispute that Dr. Feigal is qualified to offer opinions regarding the
regulatory workings of the FDA. (Memorandum of Law in Support of Plaintiffs’ Motion to
Exclude the Testimony of Dr. David Feigal (“Ps’ Feigal Mem.”), (Doc. 2725), 4.) They do
argue, however, that because he has never prescribed, inserted, or otherwise worked closely with
Mirenas or other IUDs, he is not qualified to opine on the adequacy of the Mirena label. (Id. at
12-14.) Plaintiffs also argue that Dr. Feigal acquired any relevant expertise related to IUDs
solely in connection with this litigation. (Id. at 12.) Defendants argue that Dr. Feigal does have
relevant experience in contraception and counseling patients about the risks and benefits of
IUDs, and that his experience at the FDA, including reviewing and evaluating regulatory
requirements, makes him qualified to opine on the adequacy of the Mirena label. (Ds’ Feigal
Plaintiffs’ arguments for precluding Dr. Feigal’s testimony fail in the context of a
regulatory expert opining on the adequacy of a label. Although Dr. Feigal is not an OB/GYN,
nor has he prescribed or inserted IUDs, he has had some experience with contraception over the
course of his career. (Feigal Dep. at 17:20-18:8, 19:11-20:13, 40:1-15.) In addition, Dr. Feigal
is opining on the adequacy of the Mirena label from a regulatory perspective – a field in which
he is qualified – which means he does not need to have equally specialized knowledge in a
particular medical field. See In re Depakote, No. 14-CV-847, 2015 WL 4775868, at *7 (S.D. Ill.
Feb. 13, 2015) (“[Expert’s] opinions as to the adequacy of the warning fall within her expertise
since she has been involved with the reviewing, drafting, and interpretation of drug safety data,
and regulation or approval of product labeling for prescription drugs.”); Hilaire, 54 F. Supp. 3d
at 236 (“An expert need not be precluded ‘from testifying merely because he or she does not
possess experience tailored to the precise product or process that is the subject matter of the
dispute.’”) (quoting Yaccarino, 2006 WL 5230033, at *9); In re Zyprexa, 489 F. Supp. 2d at 282
(expert with education and experience in closely related field permitted to testify). Critiques of
Dr. Feigal’s expertise in this regard go to the weight of his testimony, not its admissibility. See
Lemmon v. Wyeth, LLC, No. 04-CV-1302, 2012 WL 2848161, at *10 (E.D. Mo. July 11, 2012)
(“These witnesses have specialized knowledge of the regulatory procedures, pharmaceutical
labeling, FDA standards and practice, governmental statutes and regulations, pharmaceutical
industry customs and practices, administrative rules, internal policies, and other factors that can
assist the trier of fact in determining the adequacy of Defendants’ label warnings. Defendants’
challenge to the testimony of these experts goes more to the weight, rather than the admissibility,
of the evidence.”); Lappe, 857 F. Supp. at 226 (expert may testify as to related applications and
lack of specialization goes to weight, not admissibility).
The Depakote decision is helpful. There the court found that an expert who was not a
medical doctor, and therefore could not prescribe drugs, was qualified to opine on the adequacy
of a drug label because her opinions did not “necessarily center on the prescribing physician’s
subjective interpretation of the . . . label.” In re Depakote, 2015 WL 4775868, at *7 (finding that
the expert’s “opinions [were] based on her knowledge of the federal regulations governing
pharmaceutical drug labels and experience in reviewing, evaluating and communicating safety
information to physicians, including that contained in drug labels”). Dr. Feigal is more qualified
than the expert in Depakote because he is a physician who has practiced and taught internal
medicine. (Feigal Report at 1.)
In re Celexa & Lexapro Prods. Liab. Litig., MDL No. 1736, 2013 WL 791784, at *4
(E.D. Mo. Mar. 4, 2013), is also illuminating. In that case, the defendants argued that one of
plaintiffs’ experts was not qualified to offer an expert opinion “because his job at the FDA did
not include drafting warning labels or statistics, and he ha[d] no specific experience with
antidepressants or suicidality.” Id. The court found these arguments “meritless” because “the
combination of [the expert’s] qualifications and his extensive experience and training in both the
public and private sectors regarding regulatory compliance and safety issues provide[d] him with
specialized knowledge that [would] assist a jury at trial.” Id. Although the defendants, like
Plaintiffs here, “ma[de] much out of the fact that [the expert did] not have any prior experience
with antidepressants and suicidality specifically,” this did not prevent the court from admitting
the expert’s opinions. Id. The court noted that the expert relied on another expert’s report
regarding background information, but the second expert was also not a medical doctor. Id. Dr.
Feigal was able to rely upon his medical training, some familiarity with contraception, and
extensive experience in connection with FDA regulations, in order to opine on the adequacy of
the Mirena label from a regulatory perspective.62 I find these factors in combination sufficient to
The cases that Plaintiffs cite to support their argument that testimony should be excluded where “the expert lacks
any meaningful involvement with the product at issue,” (Ps’ Feigal Mem. 14), did not involve FDA or other
regulatory experts. Opining on regulatory issues in connection with a drug’s label requires expertise in the
regulatory field, unlike, for example, an engineer with no specialized knowledge or training related to laundry
show that Dr. Feigal has adequate expertise and will allow him to so opine. See Argonaut Ins.
Co. v. Samsung Heavy Indus. Co., 929 F. Supp. 2d 159, 168 (N.D.N.Y. 2013) (in connection
with expert testimony “[a] court should look at the totality of the witness’ qualifications in
making [the] assessment”) (internal quotation marks omitted). 63 As long as he does not stray
from his expertise in the regulatory arena into the area of how other physicians might interpret
the label, he will be permitted to testify on the adequacy of the label. Plaintiff’s argument that
Dr. Feigal’s expertise was established solely for this litigation is rejected because Dr. Feigal has
many years of experience as both a doctor and working for the FDA, making him qualified to
opine on the adequacy of the Mirena label under FDA standards, and he is not purporting to have
expertise in contraception in general or IUDs in particular.
Dr. Feigal is not, however, qualified to testify on the existence (or not) of the
phenomenon of secondary perforation, nor is he qualified to opine that mentioning post-insertion
migration in the Mirena warning would not have given healthcare providers useful information.64
Despite having general knowledge about contraception, Dr. Feigal has never prescribed or
inserted an IUD, (Feigal Dep. at 19:8-10, 38:4-8, 20:21-24), nor does he have specialized
equipment seeking to opine on an alternative design for a laundry press. See Barban v. Rheem Textile Sys. Inc., No.
01-CV-8475, 2005 WL 387660, at *3-4 (E.D.N.Y. Feb. 11, 2005), aff’d, 147 F. App’x 222 (2d Cir. 2005).
Plaintiffs’ reliance on the Alloderm decision, in which Dr. Feigal’s testimony was excluded, does not preclude
admission of his testimony here. See In re Alloderm Litig., Nos. 5972-11, 507-12, 1469-12, 2015 WL 5022600 (N.J.
Super. Ct. Law Div. Aug. 14, 2015). Although that court found that Dr. Feigal lacked the particular experience
“necessary to opine as to what kind of product risks and patient morbidities a surgeon would want to know to
conduct a proper risk-utility analysis of the appropriateness of a particular hernia repair product for a particular
patient” and that “logically, Dr. Feigal cannot opine as to what information a surgeon would need with respect to
performing hernia repair,” id. at *6 (emphasis in original), in that case his testimony regarding the FDA had already
been excluded as irrelevant and he was opining only on the information needed by surgeons in performing a
specialized surgery, id. at *4. In other words, what was left of his testimony was untethered to his expertise
regarding FDA requirements. Here, however, Dr. Feigal’s opinions concern the adequacy of the Mirena label from
a regulatory perspective. (Feigal Report at 34.) He is not opining about adequacy from the perspective of a
physician or other provider.
Dr. Feigal opines that “the comment in the . . . proposed labeling regarding ‘reports of migration after insertion,’
adds no additional information to the perforation Warning for healthcare professionals.” (Feigal Report at 23.)
training or expertise involving the uterus or how it is affected by hormones such as LNG, (id. at
30:13-31:5, 36:3-9). Although Dr. Feigal describes himself as an expert in IUDs, (id. at 36:1115), his lack of clinical experience with IUDs indicates otherwise. Dr. Feigal is not qualified to
opine on the existence of secondary perforation or on the adequacy of Mirena’s label from a
clinical perspective. See Dura Auto Sys. of Ind., Inc. v. CTS Corp., 285 F.3d 609, 614 (7th Cir.
2002) (“A scientist, however well credentialed he may be, is not permitted to be the mouthpiece
of a scientist in a different specialty.”); In re Diet Drugs, MDL No. 1203, 2001 WL 454586, at
*7 (E.D. Pa. Feb. 1, 2001) (“[A] party cannot qualify as an expert generally by showing that the
expert has specialized knowledge or training which would qualify him or her to opine on some
other issue.”). Dr. Feigal can review the FDA record with respect to Mirena and explain it to the
jury, including what the FDA and Bayer said and did, what their discussions were, what the
record before the FDA consisted of, what is required by the FDA and – using the methodology
he used at the FDA (reviewing regulatory requirements, data, pharmacovigilance, post-marketing
surveillance, etc.) – whether Defendants met those requirements. He may not, however, opine
on whether secondary perforation exists or what a clinician would have made of an additional
warning regarding it.
FDA’s Interpretation of the Mirena Label
Plaintiffs argue that Dr. Feigal should not be allowed to offer opinions related to the
FDA’s willingness to accept different perforation warnings for Mirena, because he failed to
consider or analyze the label for Progestasert, another progestin-releasing IUD on the market
before Mirena, (Kekatos Feigal Decl. Ex. 8), to which the FDA referred in recommending
warnings for Mirena, (id. Ex. 7), and because he is speculating that the FDA would not have
accepted a stronger label. (Ps’ Feigal Mem. 14-17.)
Dr. Feigal’s failure to analyze the Progestasert label goes to the weight, not the
admissibility, of his testimony. The FDA’s Medical Review for Mirena does contain the
sentence, “Recommended warnings include the warnings that are currently on the USA labels for
the other two USA-approved IUDs,” (Kekatos Feigal Decl. Ex. 7, at 6), and the product
information for Progestasert does contain the sentence, “Partial or total perforation of the uterus
may occur at the time of or after PROGESTASERT system insertion,” (id. Ex. 8 at 618). But the
FDA Medical Review states, in the sentence immediately following that quoted above, that
recommended warnings “include warnings about pelvic infection, ectopic pregnancy, congenital
anomalies, septic abortion, perforation, embedment, and breast cancer.” (id. 7 at 6.) There is no
specific reference to post-insertion perforation. While the fact that the FDA had approved the
Progestasert warning is fair game for cross-examination of Dr. Feigal, and seems to undermine
his conclusion that the FDA would not have permitted such a warning for Mirena (which opinion
I exclude below in any event), in these circumstances his failure to discuss it in his report is not
so glaring as to render his opinion unreliable or inadmissible. See Daubert, 509 U.S. at 596
(“Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the
burden of proof are the traditional and appropriate means of attacking shaky but admissible
evidence.”); Pfizer Inc. v. Teva Pharm. USA, Inc., 461 F. Supp. 2d 271, 279 (D.N.J. 2006)
(finding an expert’s failure to consider some documents “an issue best addressed by crossexamination”).
In connection with Dr. Feigal’s opinion that the FDA would not have approved a Mirena
label with wording that Plaintiffs believe should have been included, Dr. Feigal will not be
permitted to testify as to what type of label the FDA would or would not have ultimately
accepted or rejected. This is impermissible speculation as to the state of mind of the FDA. See
Kruszka v. Novartis Pharm. Corp., 28 F. Supp. 3d 920, 931 (D. Minn. 2014) (“[The experts] may
not proffer an opinion relating to what individuals . . . with the FDA thought with respect to
certain documents or about their motivations.”); Deutsch, 768 F. Supp. 2d at 442 (testimony on
“intent, motives, or states of mind of corporations, regulatory agencies and others have no basis
in any relevant body of knowledge or expertise”) (internal quotation marks omitted).
Nonetheless, he may testify as to what the FDA did, and what it said, based on the documents he
reviewed. Dr. Feigal based his opinion on documents that reflect communications between
Bayer and the FDA, exchanged during multiple label approval processes spanning several years.
(Feigal Report at 20-27.) Dr. Feigal may opine on these documents, including what they mean,
and on commentary provided by the FDA in connection with added and stricken language in the
label. See Kruszka, 28 F. Supp. 3d at 931 (finding that expert testimony on what the FDA and
pharmaceutical company “actually did, rather than thought, [is] properly within the scope of
admissible testimony,” and allowing expert testimony on the reasonableness of defendant’s
interactions with FDA and compliance with FDA regulations); see also In re Levaquin Prods.
Liab. Litig., No. 08-CV-5742, 2011 WL 6888533, at *2 (D. Minn. Dec. 29, 2011) (expert
permitted to testify as to FDA’s intent only in instances where intent was “clearly indicated in
public documents”).65 Dr. Feigal may not testify as to whether the FDA would have rejected or
accepted a specific warning, and Plaintiffs’ motion is thus granted with respect to such
Plaintiffs broadly assert that Dr. Feigal opines on Bayer’s and the FDA’s motives in his Report. (Ps’ Feigal Mem.
10, 17.) Apart from Dr. Feigal’s testimony regarding whether the FDA would have rejected or accepted alternative
labels, which I have already said is impermissible testimony, Dr. Feigal does not appear to offer any other testimony
on the state of mind of Bayer or the FDA. Plaintiffs should object as they see fit at trial if Dr. Feigal strays into
Compliance with FDA Regulations
Although experts cannot “supplant the role of counsel in making argument at trial, and
the role of the jury in interpreting the evidence,” In re Rezulin, 309 F. Supp. 2d at 541, and while
generally “an expert’s testimony on issues of law is inadmissible,” Bilzerian, 926 F.2d at 1294,
courts admit expert testimony regarding companies’ compliance with FDA regulations, see, e.g.,
Wells v. Allergan, Inc., No. 12-CV-973, 2013 WL 7208221, at *1 (W.D. Okla. Feb. 4, 2013)
(finding expert testimony about FDA regulations would not “usurp” the role of the trial judge);
In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 09-MD2100, 2011 WL 6302287, at *25 (S.D. Ill. Dec. 16, 2011) (discussing FDA regulations and
finding that “[t]o the extent [the expert] does offer legal conclusions, the Court finds that [the
expert’s] testimony is permissible because of the complex nature of the process and procedures
and the jury needs assistance understanding it. [The expert’s] testimony will assist the trier of
fact in understanding the federal regulations, and the jury will be instructed that that the Court,
not [the expert] nor any other witness, will instruct the jury on the law in this case.”); In re
Fosamax, 645 F. Supp. 2d at 191 (denying motion to preclude expert from “testifying about
general FDA regulatory requirements and procedures or offering an opinion as to [the
pharmaceutical company’s] compliance therewith”); Pfizer, 461 F. Supp. 2d at 278-79 (finding
admissible expert testimony regarding pharmaceutical company’s “compli[ance] with the FDA’s
statutory and regulatory requirements”).
Admitting expert testimony in this context makes sense given the complicated nature of
FDA regulations, and it would be helpful to the jury to have an expert explain this complex
regulatory process. See In re Fosamax, 645 F. Supp. 2d at 191 (“A lay jury cannot be expected
to understand the complex regulatory framework that informs the standard of care in the
pharmaceutical industry. [The expert’s] assessment of the reasonableness of [the pharmaceutical
company’s] conduct in light of her experience and her understanding of FDA regulations will be
helpful to the jury.”). Moreover, as was the case in the Fosamax MDL, this case is “not
governed by federal regulations but by state law theories of negligence and strict liability.” Id. at
191 n.16. Expert testimony regarding Bayer’s compliance with FDA regulations therefore will
not usurp the Court’s role in explaining the law to the jury, but will assist the jury in determining
whether Bayer “acted as a reasonably prudent pharmaceutical manufacturer.” Id. The parties’
should propose an instruction making clear that the jury must determine the outcome based on
the law as I give it to them, not on the legal views of a witness. See id. Furthermore, “[c]rossexamination and competing expert testimony . . . will ensure that the jury carefully weighs [this
expert’s] testimony.” Id. at 191. Plaintiffs’ motion with respect to Dr. Feigal’s opinions in
connection with Bayer’s compliance with FDA regulatory standards is thus denied.66
Assisting the Trier of Fact
Dr. Feigal’s opinions concerning the complicated regulatory framework of the FDA, the
process by which the FDA approves a pharmaceutical product’s label, and the adequacy of the
Mirena label, would be helpful to a jury in this case. See In re Depakote, 2015 WL 4775868, at
*8 (“[T]his [expert] testimony should be permissible due to the complex nature of the drug
labeling process and procedures, and the jury will need assistance in understanding it.”); In re
Zicam Cold Remedy Mktg., Sales Practices, & Prods. Liab. Litig., No. 09-MD-2096, 2011 WL
798898, at *22 (D. Ariz. Feb. 24, 2011) (“Industry practice and the regulatory framework
governing both prescription and over-the-counter drugs . . . are complex . . . . Expert testimony
could help a jury understand agency rules and procedures. The same is true of industry standards
As discussed below, Defendants’ motion to preclude the testimony of Dr. Parisian on this subject is also denied.
regarding a company’s responsibilities when it learns of consumer health complaints. Because
the concept and practices of pharmacovigilance are intricate and technical, expert testimony may
assist a jury in understanding the process of detecting and responding to safety signals.”). Dr.
Feigal’s proposed testimony is relevant to the adequacy of the Mirena label and to Bayer’s
interactions with the FDA regarding Mirena (which in turn relate to the issues of duty, defect and
reasonable care), and a jury would find Dr. Feigal’s regulatory knowledge and expertise helpful.
For those reasons, with the limitations on Dr. Feigal’s testimony related to the existence and
clinical significance of secondary perforation as well as the FDA’s ultimate rejection of
alternative labels for Mirena discussed above, Dr. Feigal’s testimony is otherwise admissible.
For the reasons stated above, Plaintiffs’ motion to exclude the testimony of Dr. Feigal is
therefore GRANTED in part and DENIED in part.
Dena Hixon, M.D.
Plaintiffs move to exclude the proposed testimony of Defendants’ regulatory expert, Dr.
Dena Hixon. Plaintiffs argue that Dr. Hixon did not properly disclose the basis of her opinions
or the facts she considered as required by Federal Rule of Civil Procedure 26(a)(2)(B)(i), and
should therefore be excluded from testifying pursuant to Federal Rule of Civil Procedure
37(c)(1). (Memorandum of Law in Support of Plaintiffs’ Motion to Exclude Proposed
Testimony of Dena R. Hixon, M.D. (“Ps’ Hixon Mem.”), (Doc. 2706), 13-16.) Plaintiffs
additionally argue that Dr. Hixon’s testimony should be excluded under Federal Rule of
Evidence 403,67 and that pursuant to Rule 702 and Daubert, Dr. Hixon should not be allowed to
Plaintiffs also argue that Dr. Hixon should not be permitted to testify because her testimony is unnecessarily
duplicative of Dr. Feigal’s. As discussed with respect to Dr. Feigal, because Defendants will not be offering both
Dr. Feigal’s and Dr. Hixon’s testimony at any given trial, (Defendants’ Memorandum of Law in Opposition to
opine on the FDA’s willingness to accept different perforation warnings for Mirena, Bayer’s
compliance with duties, standards or FDA regulations, or any entity’s motives, intent or state of
mind. For the reasons stated below, Plaintiffs motion to preclude the testimony of Dr. Hixon is
GRANTED in part and DENIED in part.
Dr. Hixon opines generally on the role of the FDA and the regulatory framework in
connection with approving new drugs and labeling. (Hixon Report at 4-12.) Dr. Hixon
concludes, based on her experience as an OB/GYN and as an officer at the FDA, that Bayer met
or exceeded its regulatory responsibilities with respect to Mirena, and that Bayer acted
reasonably in accepting an FDA edit that removed certain language related to the risk of
perforation from the Mirena label in 2000. (Id. at 40-41.)68 Dr. Hixon also opines that the FDA
would not have accepted the words “most often” in the Mirena label in 2008,69 and that the
Mirena warning has at all times been adequate. (Id. at 41.) She concludes that Bayer acted
responsibly in its post-marketing surveillance of Mirena, that the benefits of Mirena outweigh its
risks, and the risk of perforation is well-known to healthcare providers. (Id.)
Plaintiffs’ Motion to Exclude Proposed Testimony of Dena R. Hixon, M.D. (“Ds’ Hixon Opp.”), (Doc. 2786), 17),
Plaintiffs’ motion to exclude Dr. Hixon’s testimony as cumulative and duplicative is denied as moot.
During its review of the Mirena label in 2000, the FDA struck the sentence “There are reports of IUD migration
after insertion” from the label proposal that Bayer submitted. (Cook Hixon Decl. Ex. 8, at
In 2008, Bayer proposed a change to the Mirena label, and included language stating that “[p]erforation . . . may
occur rarely, most often during insertion although the perforation may not be detected until some time later.” (Cook
Hixon Decl. Ex. 10, at MIR_INDNDA_00038079.) The FDA recommended “against using nonspecific terms” and
suggested that Bayer remove the words “rarely” and “most often” from this section of the warning. (Id.) The FDA
directed Bayer to “[c]onsider either no frequency qualifier or a frequency range, derived from studies designed with
follow-up examinations and data collection that would allow an estimate of perforation rate.” (Id.)
Dr. Hixon is a licensed medical doctor who completed residencies in Family Practice and
in Obstetrics and Gynecology and is board-certified by the American Board of Obstetrics and
Gynecology. (Hixon Report at 1.) Dr. Hixon has 13 years of clinical OB/GYN experience,
which included inserting a small number of IUDs. (Id.; Cook Hixon Decl. Ex. 2, Deposition of
Dena Hixon (“Hixon Dep.”), at 23:5-14.) For almost 13 years after her clinical practice, Dr.
Hixon was a Medical Officer in the FDA’s Center for Drug Evaluation and Research, during
which time she served as a primary reviewer and team leader in the Division of Reproductive
and Urologic Drug Products at the Office of New Drugs. (Hixon Report at 1.) Dr. Hixon
reviewed and evaluated information regarding the safety and efficacy of women’s reproductive
health products, including IUDs with a drug releasing component, and other contraceptives. (Id.)
In addition, Dr. Hixon reviewed “postmarketing labeling proposals, safety reports, and
supplemental applications for new indications and/or for labeling changes.” (Id.) Dr. Hixon was
also involved with the regulatory review of Mirena for a period of months in 2000 when its
initial labeling was considered. (Hixon Dep. at 59:18-60:16.) Dr. Hixon’s work as an OB/GYN
and her experience and training as an officer at the FDA qualify her to opine on the regulatory
implications surrounding Mirena and its original and subsequent labels. Plaintiffs do not argue
that Dr. Hixon is unqualified to offer her opinions, except in connection with her opinion
regarding the FDA’s willingness to accept different perforation warnings.
Plaintiffs argue that Dr. Hixon is not qualified to opine on the FDA’s willingness to
accept alternative warning labels for Mirena because she was not aware of certain discussions
that took place between the Defendants and the FDA about the perforation warning, she was not
“in the driver’s seat” in connection with “Changes Being Effected” (the term used to describe the
situation where manufacturers add or strengthen warnings), she had little knowledge about
perforation warnings for other IUDs, and she did not know the FDA’s position regarding the
perforation warning in several hypothetical contexts. (Ps’ Hixon Mem. 17-18.) While I agree,
for reasons discussed earlier and below, that testimony regarding what the FDA would or would
not have done is impermissible, the basis for my view is not Plaintiffs’ challenge to Dr. Hixon’s
qualifications. Dr. Hixon does have experience related to “Changes Being Effected” label
changes, (Hixon Dep. at 82:20-83:2), and even if she did not, if an “expert has educational and
experiential qualifications in a general field closely related to the subject matter in question, the
court will not exclude the testimony solely on the ground that the witness lacks expertise in the
specialized areas that are directly pertinent,” In re Zyprexa, 489 F. Supp. 2d at 282 (citing Stagl,
117 F.3d at 80). Dr. Hixon’s knowledge (or lack thereof) about perforation warnings for other
IUDs, although perhaps a suitable topic for cross-examination, is not grounds for preclusion of a
regulatory expert opining on the adequacy of Mirena’s label and the actions of Bayer based on
the documentary record. That Dr. Hixon was unwilling to offer speculative testimony on the
state of mind of the FDA in hypothetical situations does not disqualify her because such
testimony would be improper in any event.
Dr. Hixon’s Rule 26 Disclosures
Plaintiffs argue that Dr. Hixon’s testimony should be excluded in its entirety because she
has not adequately disclosed the bases for her opinions or the facts that she considered in
forming her opinions, in violation of Federal Rule of Civil Procedure 26(a)(2)(B)(i). (Ps’ Hixon
Mem. 13-14.) Plaintiffs argue that because Dr. Hixon refused to discuss conversations that took
place at the FDA regarding Mirena, including her own conversations in connection with the premarketing regulatory review of Mirena, and because Dr. Hixon failed to name individuals who
were involved in these discussions, Defendants have violated Rule 26, and therefore Dr. Hixon’s
testimony should be excluded as a sanction pursuant to Federal Rule of Civil Procedure 37(c)(1).
Rule 26(a)(2)(B) requires that an expert’s report contain, among other things, “a complete
statement of all opinions the witness will express and the basis and reasons for them” and “the
facts or data considered by the witness in forming” his or her opinions. “[T]he courts have
embraced an objective test that defines ‘considered’ [in Rule 26(a)(2)(B)(ii)] as anything
received, reviewed, read, or authored by the expert, before or in connection with the forming of
his opinion, if the subject matter relates to the facts or opinions expressed.” Euclid Chem. Co. v.
Vector Corrosion Techs., Inc., No. 05-CV-80, 2007 WL 1560277, at *4 (N.D. Ohio May 29,
2007) (footnotes omitted). Under Rule 37(c)(1), “[i]f a party fails to provide information or
identify a witness as required by Rule 26(a) . . . the party is not allowed to use that information
or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was
substantially justified or is harmless.” “Rule 37 is self-executing” and “the non-disclosing party
has the burden to demonstrate that the failure to disclose was substantially justified or that the
failure was harmless.” Atkins v. Cty. of Orange, 372 F. Supp. 2d 377, 395-96 (S.D.N.Y. 2005),
aff’d on other grounds sub nom. Bellotto v. Cty. of Orange, 248 F. App’x 232 (2d Cir. 2007).
The Court has “wide discretion to impose sanctions, including severe sanctions, under [Rule
37].” Design Strategy, Inc. v. Davis, 469 F.3d 284, 294 (2d Cir. 2006).70 Rule 37 does not
require a showing of bad faith in order for sanctions to be imposed, and preclusion is not
The four factors set forth by the Second Circuit in Softel, Inc. v. Dragon Medical & Scientific Communications,
Inc., to determine whether excluding testimony as a sanction is appropriate are not directly applicable here because
they concern a late disclosure. 118 F.3d 955, 961 (2d Cir. 1997). For example, the third factor is “the prejudice
suffered by the opposing party as a result of having to prepare to meet the new testimony,” id., which does not apply
here where Dr. Hixon repeatedly in her deposition refused to disclose certain aspects of her tenure at the FDA, and
Defendants in their Opposition have not offered to disclose the bases of Dr. Hixon’s opinions that she deems
protected by her duty of confidentiality to the FDA.
mandatory even where the district court finds no substantial justification and the failure to
disclose is not harmless. Id. at 296-97.
According to her report, Dr. Hixon based her opinions on her “knowledge of the FDA
regulations, policies and procedures, as well as [her] own training and clinical experience as an
obstetrician gynecologist providing women’s health care and [her] experience at FDA as a
medical officer and regulatory reviewer of Mirena, other IUDs, and other contraceptive
products.” (Hixon Report at 42.) Throughout her report she cites to a number of documents,
including communications between Bayer and the FDA from the time of the initial review of
Mirena and after, to support her opinions regarding the adequacy of Mirena’s label and Bayer’s
post-marketing actions. The only relevant bases of her opinions that Dr. Hixon could possibly be
withholding relate to the time period when she was actively a member of the team reviewing the
Mirena label; she refused to name individuals or disclose specific conversations related to this
particular review. (Hixon Dep. at 58:6-15.) I find no ground, therefore, to exclude under Rule
37(c) any of Dr. Hixon’s testimony relating to the regulatory framework of the FDA or to
Bayer’s actions and the label change that occurred after Dr. Hixon was no longer a part of the
team working on Mirena. I will only consider whether proposed testimony by Dr. Hixon that
could be based on her work as a regulatory reviewer of Mirena should be precluded under Rule
37(c) for the alleged Rule 26 violation.
Although Defendants argue that Dr. Hixon is not basing her testimony on her personal
recollections regarding the Mirena labeling process, Plaintiffs are correct that (as Dr. Hixon
conceded, (Hixon Dep. at 134:23-135:2)) it would be impossible for a witness to divorce herself
from her memories about what occurred during a project in which she was an active participant
and segregate that information from the documentary record in forming her opinions. Moreover,
Dr. Hixon states in her report that she based her opinions, at least in part, on her experience as a
“regulatory reviewer of Mirena.” (Hixon Report at 42.) In addition, she conceded that “there are
some details of [her] involvement with Mirena at FDA that [she was] aware of but [could not]
testify to,” (Hixon Dep. at 53:8-12), and while she maintains that her opinions were based on the
records, she admitted that she “remember[ed] what [she] remember[ed]” and that her
“experiences at FDA with the product” would likely “bleed into” her opinions, (id. at 54:3-5, 1520). Further, “even if the expert avers under oath that he did not actually consider certain
materials in forming his opinion, that will not control,” and instead courts apply an “objective
test” that defines “considered” as any facts or data on the subject matter learned by the expert at
any time before rendering her opinion. Euclid Chem. Co., 2007 WL 1560277, at *3-4. Although
in her report Dr. Hixon does not cite to specific conversations or incidents that occurred as part
of the FDA’s review of Mirena, she was part of that review (which must have considered
whether Bayer met its regulatory responsibilities and whether the Mirena label adequately
warned of the relevant risks) and therefore she was obligated, if she was to serve as an expert, to
disclose the things “considered,” regardless of whether she says she stuck to the documentary
record. See United States v. Dish Network, L.L.C., 297 F.R.D. 589, 596 (C.D. Ill. 2013) (“A
court should not solely credit the subjective representations of the expert when determining what
the expert ‘considered.’”). Dr. Hixon personally participated in determining whether Bayer
complied with regulations, acted reasonably or effectively warned, but because she cannot
segregate that experience from her expert opinions on these subjects, and because she will not
fully disclose many facts underlying her personal participation, such as the contents of
conversations, she will not be allowed to testify as to the FDA’s actions in connection with the
Mirena label during the time she was involved – specifically, from submission of its New Drug
Application (“NDA”) on January 31, 2000 through December 5, 2000 when the final label edits
were sent from the FDA to Bayer. (See Hixon Report at 20-22; Hixon Dep. at 59:18-63:14;
Cook Hixon Decl. Ex. 4 (NDA 21-225 for Mirena); Cook Hixon Decl. Ex. 8 (NDA 21-225 Final
Label Edits for Mirena).)
Allowing Dr. Hixon to testify without having fully disclosed the bases for her opinions is
harmful to Plaintiffs because they cannot effectively cross-examine her. See Fid. Nat’l Title Ins.
Co. of N.Y. v. Intercounty Nat’l Title Ins. Co., 412 F.3d 745, 751 (7th Cir. 2005) (expert must
disclose materials reviewed “even if in the end he does not rely on them in formulating his expert
opinion, because such materials often contain effective ammunition for cross-examination”).
During her deposition, Dr. Hixon refused to discuss “who said what or who did what” during the
FDA review process, (Hixon Dep. at 134:4-6), yet she stated that she “remember[ed] discussions
that the remainder of the information in the label [apart from the stricken language regarding
reports of IUD migration after insertion] includ[ed] not only the perforation warning but
throughout the label was adequate to warn about the risk of perforation,” and that “the term
‘migration’ was not well-defined and it was not felt to add to the inserter’s understanding of
perforation and how to manage it,” (Hixon Dep. at 138:1-19). Plaintiffs’ inability to crossexamine Dr. Hixon regarding, or find other witnesses to, these discussions is not harmless.
Moreover, a jury would likely afford Dr. Hixon’s testimony added credence because she was
present during the FDA’s Mirena review and would be perceived as having inside information.
Allowing her to testify without allowing Plaintiffs an effective cross-examination would be
harmful because Plaintiffs would not be able to undermine this added credibility.
Nor have Defendants shown the failure to disclose to be substantially justified. Dr.
Hixon’s personal unwillingness to divulge names of individuals involved in the regulatory
review of Mirena or specific discussions that took place may be justified in light of her duty of
confidentiality to the FDA.71 Nonetheless, it is Bayer’s burden to show that its failure to disclose
its expert’s basis is substantially justified in the context of this case, and it has failed to do so.
See Wright v. Aargo Sec. Servs., Inc., No. 99-CV-9115, 2001 WL 1035139, at *2 (S.D.N.Y.
Sept. 7, 2001). Defendants have not offered a reason why they chose Dr. Hixon as a regulatory
expert when they knew she could not fully disclose the bases of her opinions. Plaintiffs should
not be unfairly prejudiced because Defendants chose to retain an expert who participated directly
in some of the events at issue but cannot discuss them.
Further, I find that the probative value of Dr. Hixon’s testimony about events involving
the FDA when she was reviewing Mirena is substantially outweighed by a danger of unfair
prejudice.” See Fed. R. Evid. 403. “‘Expert evidence can be both powerful and quite misleading
because of the difficulty in evaluating it,’” Price v. Fox Entm’t Grp., Inc., 499 F. Supp. 2d 382,
387 (S.D.N.Y. 2007) (quoting Daubert, 509 U.S. at 595), and in connection with Dr. Hixon’s
testimony, Plaintiffs cannot (as discussed above) effectively cross-examine her or dissipate the
aura of credibility from her “insider” testimony. See United States v. Deutsch, 987 F.2d 878, 884
(2d Cir. 1993) (“[T]he probative value of this evidence is lessened by the inability of the other
party to cross-examine.”); Gill v. Arab Bank, PLC, 893 F. Supp. 2d 523, 541-42 (E.D.N.Y. 2012)
(expert testimony excluded where “[m]uch, if not all, of [the expert’s] testimony [was] based on
facts developed through confidential . . . investigations” and the opposing party was unable to
The FDA’s staff manual directs employees not to disclose “nonpublic information,” which includes information
not available under the Freedom of Information Act. (Cook Hixon Decl. Ex. 17.) Information related to individuals
in the “predecisional” phase of an agency’s regulatory review is protected by the deliberative process privilege,
which seeks to “assure that subordinates within [a government] agency will feel free to provide the decisionmaker
with their uninhibited opinions and recommendations without fear of later being subject to public ridicule or
criticism.” Coastal States Gas Corp. v. Dep’t of Energy, 617 F.2d 854, 866 (D.C. Cir. 1980).
Dr. Hixon’s testimony relating to the FDA’s review of Mirena’s NDA in 2000 is thus
excluded pursuant to Rule 37(c)(1) and in any event is also inadmissible under Rule 403.
Plaintiffs additionally argue that Dr. Hixon’s testimony should also be excluded under
Rule 702 and Daubert because her testimony is not sufficiently reliable.
FDA’s Willingness to Accept a Different Perforation
Warning and State of Mind Testimony
As discussed in greater detail in connection with Dr. Feigal, expert testimony related to a
company’s or agency’s state of mind, motives or intent is impermissible. See In re Rezulin, 309
F. Supp. 2d at 546. Dr. Hixon is not allowed to opine on an entity’s intent or state of mind that is
not “clearly indicated in public documents.” In re Levaquin, 2011 WL 6888533, at *2. Dr.
Hixon will be permitted to testify to the same extent as Dr. Feigal. She may explain and opine
on documents or communications between Bayer and the FDA and on public filings relating to
Mirena (except to the extent I have already limited her admissible testimony under Rule 37(c)
and Rule 403).
In her report, Dr. Hixon wrote that the “FDA would not accept the words ‘most often’ in
the Mirena perforation warning” in 2008. (Hixon Report at 41). Dr. Hixon may describe what
language the FDA struck, what it said regarding why it struck that language, and what
recommendations it made for Defendants to consider, but it will go too far (and is unnecessary)
to say the FDA at that time “would not accept” that language under any circumstances. That the
FDA “recommend[ed]” against using non-specific terms and suggested that Defendants
“[c]onsider either no frequency qualifier or a frequency range,” (Cook Hixon Decl. Ex. 10, at
MIR_INDNDA_00038079), does not mean that it necessarily would have refused “most often”
had Defendants pushed back or provided more information. Dr. Hixon may not opine on what
type of label the FDA would have hypothetically accepted or rejected, as this is impermissible
state of mind testimony. See Kruszka, 28 F. Supp. 3d at 931; Deutsch, 768 F. Supp. 2d at 442.
Defense counsel may argue to the jury that the FDA’s conduct in 2008 shows that it would not
have accepted a warning regarding perforation after insertion, and Plaintiffs’ counsel may argue
to the contrary, and the jurors will decide what inference is justified. But experts will not draw
that inference for them.
Compliance with FDA Regulations
Dr. Hixon opines that Bayer’s conduct comported with FDA rules and regulations. Dr.
Hixon’s thirteen years of experience working at the FDA qualify her to opine on the FDA’s
regulatory framework and Bayer’s compliance therewith. As previously discussed in connection
with Dr. Feigal, courts have consistently found that expert testimony regarding FDA regulations
and a company’s compliance under that regulatory scheme is admissible. See, e.g., Wells, 2013
WL 7208221, at *1; In re Yasmin & YAZ, 2011 WL 6302287, at *25; In re Fosamax, 645 F.
Supp. 2d at 191; Pfizer, 461 F. Supp. 2d at 278-79. Furthermore, in this case, as in Fosamax, the
ultimate issues a jury will decide relate to state law claims of strict liability and negligence, not
FDA regulatory violations. See In re Fosamax, 645 F. Supp. 2d at 191 n.16. For these reasons,
the Court will (as discussed below) permit Plaintiffs’ expert to offer opinions that Defendants did
not comply with FDA requirements, and Dr. Hixon’s testimony regarding Bayer’s compliance
with FDA regulations is likewise admissible.
Helpfulness to the Trier of Fact
Like that of Dr. Feigal (and Plaintiffs’ expert Dr. Parisian), Dr. Hixon’s testimony – to
the extent that it is otherwise admissible – is helpful to the trier of fact because of the complex
nature of the FDA framework. Expert testimony from a regulatory expert on complicated
schemes like the FDA’s statutory framework, as well as opinions on the adequacy of a drug’s
label and the reasonableness of a pharmaceutical company’s conduct, are useful in assisting the
trier of fact. See In re Depakote, 2015 WL 4775868, at *8; In re Zicam, 2011 WL 798898, at
For the reasons stated above, Plaintiffs’ motion to preclude Dr. Hixon’s testimony is
GRANTED in part and DENIED in part.
Plaintiffs’ Regulatory Expert – Suzanne Parisian, M.D.
Defendants move to exclude the proposed testimony of Suzanne Parisian, M.D.
Defendants argue that Dr. Parisian is not qualified to opine on causation and other scientific
issues related to Mirena, foreign regulatory issues, and potential alternative designs.
(Memorandum of Law in Support of Defendants’ Motion to Exclude the Testimony of Suzanne
Parisian, M.D. (“Ds’ Parisian Mem.”), (Doc. 2686), 5-11.) Defendants also argue that Dr.
Parisian’s narrative of the regulatory history involving Mirena is not a proper subject of expert
testimony, that Dr. Parisian offers improper legal conclusions that Bayer violated the Food,
Drug, and Cosmetic Act (“FDCA”) and related regulations, and that Dr. Parisian improperly
speculates about Bayer’s and the FDA’s knowledge, motives and state of mind. (Id. at 11-15.)
In addition, Defendants argue that Dr. Parisian’s labeling and pharmacovigilance opinions are
unreliable. (Id. at 15-24.) For the reasons stated below, Defendants motion is GRANTED in
part and DENIED and in part.
Dr. Parisian provides four opinions: (1) that the manufacturer of a drug, not the FDA, is
responsible for ensuring the drug’s safety and the adequacy of the drug’s label and warnings,
(Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the Testimony
of Suzanne Parisian, M.D. (“Cook Parisian Decl.”), (Doc. 2687), Ex. B, Expert Report of
Suzanne Parisian, M.D. (“Parisian Report”), at 14-28); (2) that Defendants had access to
information to support a label change reflecting the risk of migration as a result of perforation
unrelated to insertion, (id. at 28-62); (3) that Defendants’ pharmacovigilance techniques for
monitoring the safety of Mirena were flawed and failed to adequately address the reported postmarket risks, (id. at 62-75); and (4) that Bayer failed to consider and implement safer alternative
designs for Mirena, (id. at 75-78).
Dr. Parisian has previously practiced medicine as a general practitioner, emergency
physician and pathologist, and is currently licensed to practice medicine in Arizona and Virginia,
although she has not treated a live patient since 1988 and has not practiced pathology since the
1990s. (Parisian Report at 6; Cook Parisian Decl. Ex. A, Deposition of Suzanne Parisian
(“Parisian Dep.”), at 49:5-15.) From 1991 to 1995, Dr. Parisian was a Commissioned Officer in
the United States Public Health Service, and was assigned to the Center for Devices and
Radiological Health at the FDA, where she served as a medical officer in the Office of Health
Affairs from 1991 to 1993 and Chief Medical Officer in the Office of Device Evaluation from
1993 to 1995. (Parisian Report at 6-7.) Dr. Parisian “helped broadly cover both pre-market
evaluation and post-market compliance issues, with an emphasis on post-market issues for
products sold in the United States.” (Id. at 7.)
Dr. Parisian was responsible for reviewing adverse event reports (“AERs”) submitted by
manufacturers, product recalls, labeling, and communications from manufacturers to physicians
and the public regarding the performance of FDA-regulated products. (Id.) She also assisted in
authoring FDA-issued Safety Alerts and was responsible for publicity in connection with causes
of injury, issues with the performance of devices, and risks to public health. (Id.) After leaving
the FDA in 1995, Dr. Parisian founded a consulting firm specializing in matters involving the
FDA, the regulation of medical products, and public health. (Id. at 10.) As president of the
company, Dr. Parisian helps, among other things, to design and market new medical products,
“present marketing applications to FDA,” and “draft product labeling.” (Id.) She has authored a
graduate-level textbook and lectured to the industry on the FDA, and she has served as an expert,
primarily for plaintiffs. (Id.; Parisian Dep. at 23:7-29:5.)
Defendants argue that Dr. Parisian lacks the expertise to opine on medical causation
related to Plaintiffs’ theory of secondary perforation – that a Mirena can migrate out of the uterus
unrelated to insertion – and other scientific issues related to the Mirena IUD. (Ds’ Parisian
Mem. 6-10.) Dr. Parisian is a medical doctor, but she has no expertise or special skills related to
the uterus or IUDs, nor is she a gynecologist. (Parisian Dep. at 49:21-50:9, 103:24-104:23.)
Because she does not have specialized expertise in this area, she will not be permitted to testify
or give an opinion that a Mirena can perforate the uterus unrelated to insertion – which she
asserted implicitly in her report and which she discussed during her deposition. See Dura Auto.
Sys., 285 F.3d at 614 (“A scientist, however well credentialed he may be, is not permitted to be
the mouthpiece of a scientist in a different specialty. That would not be responsible science.”).72
Dr. Parisian has been barred from testifying on general causation in a number of other cases. See, e.g., Bartoli v.
Novartis Pharm. Corp., No. 13-CV-724, 2014 WL 1515870, at *7 (M.D. Pa. Apr. 17, 2014); Rowland v. Novartis
Pharm. Corp., 9 F. Supp. 3d 553, 562 (W.D. Pa. 2014); Deutsch, 768 F. Supp. 2d at 469; Oakberg v. Zimmer, Inc.,
No. 03-CV-47, 2004 WL 5503779, at *2 (D. Mont. Nov. 23, 2004); Linsley v. C.R. Bard, Inc., No. 98-CV-2007,
2000 WL 343358, at *5 (E.D. La. Mar. 30, 2000).
Dr. Parisian’s relevant experience and expertise are in the field of FDA regulations, and her
testimony will thus be limited to that field.73
Although seemingly more regulatory in nature, Dr. Parisian’s testimony related to “causal
association” – as this term is used pursuant to 21 C.F.R. § 201.57(c)(6)(i)74 – is also inadmissible
because Plaintiffs have not “sufficiently differentiate[d]” testimony related to causal association
from general medical causation. Rowland, 9 F. Supp. 3d at 562 (excluding Dr. Parisian from
offering “causation testimony of any kind”); see Dopson-Troutt v. Novartis Pharm. Corp., No.
06-CV-1708, 2013 WL 1344755, at *3 (M.D. Fla. Apr. 2, 2013) (excluding Dr. Parisian from
offering opinions regarding “causal association” because Plaintiffs did not “meaningfully
distinguish” it from medical causation).75 Defendants’ motion with respect to testimony relating
to medical causation or regulatory causation is granted.76
Plaintiffs argue that Dr. Parisian “will not give opinion testimony on the issue of medical causation.” (Plaintiffs’
Memorandum of Law in Opposition to Defendants’ Motion to Exclude the Testimony of Suzanne Parisian, M.D.
(“Ps’ Parisian Opp.”), (Doc. 2776), 9.) Dr. Parisian’s report and deposition, however, seem to suggest in several
instances that she may give such testimony, at least implicitly. Moreover, Plaintiffs cite cases and attempt to
distinguish Defendants’ cases to counter Defendants’ argument that Dr. Parisian’s testimony on causation is
inadmissible, (id. at 9-10), an effort that would seem to be unnecessary if she were not being offered to opine on
medical causation. In any event, should Dr. Parisian attempt to give testimony on medical causation, such testimony
21 C.F.R. § 201.57(c)(6)(i) provides that a drug’s “labeling must be revised to include a warning about a clinically
significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship
need not have been definitely established.”
Plaintiffs cite one New Jersey Superior Court case where Dr. Parisian was permitted to testify on regulatory
causation. (Ps’ Parisian Opp. 17.) The court in Meng v. Novartis Pharmaceuticals Corp., (Declaration of Diogenes
P. Kekatos in Opposition to Defendants’ Motion to Exclude the Testimony of Suzanne Parisian, M.D. (“Kekatos
Parisian Decl.”), (Doc. 2777), Ex. 6), broadly permitted Dr. Parisian to testify as to any FDA regulations. In this
case, however, I find Dr. Parisian’s medical knowledge and experience with respect to contraception and IUDs
insufficient to qualify her to testify on causation.
This means Dr. Parisian will not be permitted to testify that the Mirena label should have been changed to warn of
secondary perforation, because she is not qualified to say either that that risk was clinically significant or that there
was reasonable evidence of causal association. Although she could in theory have relied on the opinions of other
experts in that regard, and gone on to explain what Defendants should have done when confronted with reasonable
evidence of causal association between the device and a clinically significant risk, she did not do so here; indeed,
she did not read the reports of any of the other experts prior to writing her report. (Parisian Dep. at 60:7-15, 92:1793:3.) Dr. Parisian included Dr. Zambelli-Weiner’s report in her list of documents considered, but she
acknowledged that she had not actually seen the report. (Id. at 60:20-61:6.) Accordingly, Dr. Parisian may testify
Defendants also argue that Dr. Parisian is not qualified to testify on the implications of
epidemiological studies, including the EURAS study. (Ds’ Parisian Mem. 8-9.) While she was
at the FDA, Dr. Parisian helped design and issue an epidemiological study, she received training
from an epidemiologist, and her work involved analyzing research pharmaceutical companies
conducted. (Parisian Report at 7-9.) At her deposition, Dr. Parisian acknowledged that she is
not an epidemiologist, but that she has been involved with epidemiological studies. (Parisian
Dep. at 126:9-12.) This experience is sufficient to allow her to analyze studies and reports and
rely on them in forming her opinions. See In re Zyprexa, 489 F. Supp. 2d at 282 (“If the expert
has educational and experiential qualifications in a general field closely related to the subject
matter in question, the court will not exclude the testimony solely on the ground that the witness
lacks expertise in the specialized areas that are directly pertinent.”) (citing Stagl, 117 F.3d at 80);
see also In re NuvaRing Prods. Liab. Litig., No. 08-MD-1964, 2013 WL 791835, at *3 (E.D.
Mo. Mar. 4, 2013) (“Dr. Parisian [is] qualified within the field of epidemiology and to analyze
conclusions of other scientific experts and rely on them when forming her own opinions.”); In re
Yasmin & YAZ, 2011 WL 6302287, at *20 (“[B]ased upon Dr. Parisian’s education and
experience, including training in epidemiology while at the FDA, it would appear reasonable for
Dr. Parisian to rely on epidemiological . . . experts to support her opinions.”). Because of Dr.
Parisian’s experience with epidemiology, Defendants’ motion with respect to her testifying about
or relying upon epidemiological studies, including the EURAS study, is denied.
Dr. Parisian will not be allowed to opine on foreign regulatory issues. Dr. Parisian is
admittedly not an expert in the laws of foreign jurisdictions, and therefore is not qualified to
as to what Defendants should have done in terms of investigation based on the post-marketing information available
to them, but may not opine that that information amounted to evidence of causal association sufficient to warrant a
testify on those subjects. (Parisian Dep. at 124:23-126:8.) There is no reason to believe that the
regulatory framework of Canada or Germany is similar to the FDA’s system. Moreover, Dr.
Parisian’s report and proposed testimony in this area is a recitation of reports and regulatory
actions, with little or no analysis, which is not proper expert testimony because it is not helpful to
the trier of fact. See In re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323, 1336 (S.D. Fla.
2010) (finding Dr. Parisian’s testimony on “foreign regulatory matters” inadmissible); In re
Rezulin, 309 F. Supp. 2d at 553 (finding that plaintiffs’ experts are not “appropriate vehicles” for
introduction of evidence related to foreign regulatory actions because subject of that testimony is
a lay matter). If Plaintiffs wish to submit evidence to show that Bayer was on notice of adverse
events they may do so, if the evidence proves to be otherwise admissible, but not through Dr.
Parisian. And if Dr. Parisian wants to refer to the fact of a particular foreign regulatory action as
evidence of information available to Defendants on the basis of which a regulatory obligation in
the U.S. was triggered, she may do so. But she may neither summarize foreign regulatory
history nor imply that an action required abroad was necessarily required in the U.S.
Defendants’ motion to preclude opinions on foreign regulatory issues is granted.
Dr. Parisian is also not qualified to opine on potential alternative, safer designs for
Mirena, including the Skyla IUD or an IUD described in a patent application.77 Opinion Four in
Dr. Parisian’s report is therefore wholly inadmissible. Dr. Parisian is not an engineer, nor has
she ever designed IUDs, nor does she have any particular expertise in IUDs. (Parisian Dep. at
53:7-11.) Dr. Parisian is an expert in the field of FDA regulations, and her testimony will be
In any event, Plaintiffs state that Dr. Parisian is not going to testify that “any particular product or design was
safer than Mirena.” (Ps’ Parisian Opp. 22.) To the extent Plaintiffs plan to have Dr. Parisian testify “that Bayer had
the ability to look at alternative designs,” (id.), that point seems too obvious for expert testimony to be necessary or
thus limited to that field. Defendants’ motion with respect to proposed testimony by Dr. Parisian
regarding safer alternatives to Mirena is granted.
Defendants argue that Dr. Parisian’s testimony of Mirena’s regulatory history is an
impermissible narrative or regurgitation of facts. In her report, Dr. Parisian writes at length
about the regulatory history of Mirena and internal communications among Bayer personnel and
between Bayer and the FDA. (See, e.g., Parisian Report at 32-33, 35, 43-44.) To the extent Dr.
Parisian “is simply rehashing otherwise admissible evidence about which [she] has no personal
knowledge, such evidence – taken on its own – is inadmissible.” Highland Capital Mgmt., L.P.
v. Schneider, 379 F. Supp. 2d 461, 468-69 (S.D.N.Y. 2005); see In re Rezulin, 309 F. Supp. 2d at
551 (excluding expert testimony on historical and regulatory background of drug that is just as
easily understood by jury if submitted through percipient witness). Dr. Parisian may rely upon
the regulatory history of Mirena, as well as documents reflecting communications between Bayer
and the FDA and internal Bayer communications, in forming her regulatory opinions, but she
may not present these documents to the jury with no analysis or merely “read, selectively quote
from, or ‘regurgitate’ the evidence.” In re Fosamax, 645 F. Supp. 2d at 192 (quoting In re
Prempro Prods. Liab. Litig., 554 F. Supp. 2d 871, 880, 886 (E.D. Ark. 2008), aff’d in relevant
part, 586 F.3d 547 (8th Cir. 2009)). Defendants’ motion with respect to Dr. Parisian’s narrative
testimony is granted insofar as she merely repeats facts, as opposed to using documents and
background to opine on the FDA, the adequacy of Mirena’s label and the reasonableness of
Bayer’s conduct pursuant to FDA regulations.
Reasonableness of Bayer’s Conduct Under FDA Regulations
Dr. Parisian’s experience as an officer at the FDA qualifies her to opine on the
background of the FDA, its functions, and the FDA’s regulatory framework. See Lemons v.
Novartis Pharm. Corp., 849 F. Supp. 2d 608, 614 (W.D.N.C. 2012) (allowing Dr. Parisian to
testify on “the role, process, and function of FDA and the responsibilities of pharmaceutical drug
sponsors”). As is the case with Defendants’ regulatory experts Drs. Feigal and Hixon, this type
of expert testimony on the complex FDA framework is helpful to a jury. Defendants argue,
however, that Dr. Parisian should be excluded from testifying that Bayer violated the FDCA and
related regulations. (Ds’ Parisian Mem. 12-13.) The Court finds Defendants’ arguments
As discussed in more detail with respect to Dr. Feigal, although generally experts cannot
offer opinions on legal matters, see United States v. Lumpkin, 192 F.3d 280, 289 (2d Cir. 1999)
(expert testimony inadmissible if it “usurp[s] either the role of the trial judge in instructing the
jury as to the applicable law or the role of the jury in applying that law to the facts before it”)
(internal quotation marks and alteration omitted), the testimony of regulatory experts on the
reasonableness of a pharmaceutical company’s conduct in light of the complex nature of the
FDA framework is helpful to a jury. See In re Fosamax, 645 F. Supp. 2d at 191 (denying motion
to “preclude Dr. Parisian from testifying about general FDA regulatory requirements and
procedures or offering an opinion as to [the pharmaceutical company’s] compliance therewith”).
The Fosamax court found that “Dr. Parisian’s assessment of the reasonableness of [the
pharmaceutical company’s] conduct in light of her experience and her understanding of FDA
regulations will be helpful to the jury.” Id. (citing several cases allowing Dr. Parisian to testify
in this vein). Moreover, because this case involves state law claims of negligence and strict
liability, Dr. Parisian’s testimony regarding compliance with FDA regulations does not usurp the
role of the jury, but rather merely helps them understand a complicated statutory framework. See
id. at 191 n.16.78 To the extent Bayer seeks to preclude Dr. Parisian from testifying about
Bayer’s compliance with FDA regulations, the motion is denied.
State of Mind Testimony
Defendants also seek to preclude Dr. Parisian from testifying as to the state of mind,
knowledge or motives of Bayer and the FDA. (Ds’ Parisian Mem. 13-15.) Defendants are
correct that an expert’s testimony on the “intent, motives or states of mind of corporations,
regulatory agencies and others” is inadmissible. In re Rezulin, 309 F. Supp. 3d at 546. Plaintiffs
contend, however, that Dr. Parisian will not offer opinions regarding Bayer’s motive, intent or
state of mind and that she simply relies on internal company documents in forming her opinion
that Bayer did not comply with its duties in accordance with regulatory requirements. (Ps’
Parisian Opp. 12-14.) In her report, however, Dr. Parisian seems to impermissibly speculate on
Bayer’s or the FDA’s state of mind or intent. For example, on page 33 of her report, Dr. Parisian
writes, “[T]he ‘project lead’ seemed concerned about maintaining timelines rather than taking
the time necessary for addressing the safety of the United States Mirena user and providing an
adequate label.” Dr. Parisian has no expertise in divining the concerns or motives of others, and
may not opine on such topics. See In re Trasylol, 709 F. Supp. 2d at 1346. To the extent
Plaintiffs want the jury to draw inferences about intent or motive from Defendants’ statements,
that is a matter for argument. Nonetheless, Dr. Parisian may opine on what documents in
Bayer’s possession said – in other words, on what Bayer “knew” in the sense of what
The Court will instruct the jury, if applicable under relevant state law, that evidence of violation of FDA standards
may be evidence of, but does not necessarily establish, negligence. In addition, if there is any dispute as to what
FDA regulations are applicable to Mirena, the issue can be raised with the Court, and the Court will outline the
relevant statutes and regulations for the jury.
information was in its possession – or on the FDA’s or Bayer’s intent to the extent it is “clearly
indicated in public documents.” In re Levaquin, 2011 WL 6888533, at *2. She may also opine
on what the FDA would have done in a typical situation when presented with a set of facts.79
Defendants’ motion with respect to state of mind testimony is therefore granted to the extent Dr.
Parisian opines on the motives, intent or state of mind of an entity that is not set forth in
documents or grounded in specific, objectively knowable facts.
Defendants argue that Dr. Parisian did not use a reliable methodology to reach her
opinions regarding the adequacy of the Mirena label and Bayer’s pharmacovigilance policies.
(Ds’ Parisian Mem. 15-24.) Defendants, however, attempt to force Dr. Parisian’s opinions into
the four-factor mold set forth by Daubert that governs scientific expert opinions but is not
applicable to a non-scientific regulatory expert. See Kumho Tire Co., 526 U.S. at 150 (“[F]actors
identified in Daubert may or may not be pertinent in assessing reliability, depending on the
nature of the issue, the expert’s particular expertise, and the subject of his testimony.”) (internal
quotation marks omitted); id. at 156 (“[N]o one denies that an expert might draw a conclusion
from a set of observations based on extensive and specialized experience.”); In re Fosamax, 645
F. Supp. 2d at 190 (“An expert is permitted to draw a conclusion from a set of observations
based on extensive and specialized experience.”). None of the four factors listed in Daubert
apply to Dr. Parisian, which makes sense because she is not purporting to be a scientist giving a
scientific opinion. See Pritchett v. I-Flow Corp., No. 09-CV-2433, 2012 WL 1059948, at *8 (D.
With respect to the ParaGard label, Dr. Parisian can opine on the type of information that the FDA normally
would require in order to accept or reject a label change and on what triggers a company’s obligation to seek a label
change, but she cannot testify as to whether the FDA would have approved language in the Mirena label simply
because the ParaGard label has similar language, given that she has no knowledge regarding what prompted
ParaGard’s label change. (Parisian Dep. at 222:23-224:4.)
Colo. Mar. 28, 2012) (finding that Dr. Parisian’s opinions were not “manifestly scientific in
nature”). Her regulatory opinions are based upon her training and experience, as well as a
review of “pertinent portions of the regulatory filings,” In re Fosamax, 645 F. Supp. 2d at 19091, and Bayer’s internal documents, which is the same methodology she would have employed
as an officer at the FDA, see Forman v. Novartis Pharm. Corp., 794 F. Supp. 2d 382, 384
(E.D.N.Y. 2011) (finding Dr. Parisian’s reliance on regulatory filings, internal documents and
medical literature sufficiently reliable to opine on the reasonableness of the pharmaceutical
company’s conduct with respect to the FDA). This is permitted under Daubert.80 I will discuss
Dr. Parisian’s opinions on the adequacy of the Mirena label and Bayer’s pharmacovigilance in
Adequacy of Mirena Label
Defendants argue that Dr. Parisian used an unreliable methodology to reach her
conclusions about Mirena’s labeling and that her opinions are based on unreliable and
speculative data. (Ds’ Parisian Mem. 16-23.) As discussed above, Dr. Parisian has relied on her
training and experience at the FDA to form her opinions regarding the adequacy of the Mirena
label, which is a reliable methodology. See In re Fosamax, 645 F. Supp. 2d at 190-91; see also
Pritchett, 2012 WL 1059948, at *8 (“Dr. Parisian’s opinions . . . are primarily based on her
public-sector work experience in applying federal statutes and regulations to medical
devices . . . . Contrary to Defendant’s assertion, Dr. Parisian does not fail to use any
methodology; her methodology is her training and experience in applying applicable regulations
to medical devices.”). Dr. Parisian will be permitted to opine on the adequacy of the Mirena
The Fosamax court found admissible Dr. Parisian’s “conclusions about [a pharmaceutical company’s] conduct
based on her review of pertinent portions of the regulatory filings for [a drug] and [the pharmaceutical company’s]
internal company documents,” which was “the methodology [Dr. Parisian] applied as a Medical Officer, and [which
was applied by the pharmaceutical company’s] regulatory experts.” In re Fosamax, 645 F. Supp. 2d at 190-91.
label from a regulatory, not a medical, perspective, which is squarely within her area of
expertise. Although Defendants argue that Dr. Parisian is not qualified to rely upon adverse
event reports, this issue does not require exclusion of her testimony. Dr. Parisian may rely on
adverse event reports or other submissions from Bayer to the FDA to show the extent of Bayer’s
knowledge of certain events and what this might have required it to do from a regulatory
perspective. Defendants may cross-examine Dr. Parisian on her qualifications and whether she
drew proper inferences from these adverse event reports, but her opinions on the adequacy of the
Mirena label are sufficiently reliable that they do not warrant exclusion.81 Defendants’ motion to
exclude Dr. Parisian’s testimony on the adequacy of the Mirena label is denied.
Defendants also argue that Dr. Parisian’s third opinion on pharmacovigilance82 is
unreliable and should be excluded. (Ds’ Parisian Mem. 23-24.) Dr. Parisian may opine on the
reasonableness of Bayer’s conduct in monitoring and evaluating adverse events associated with
Mirena based upon her experience at the FDA, how companies typically react to post-marketing
adverse events, and relevant FDA regulations. This third opinion in her report, however, largely
consists of copied and pasted statements from internal Bayer documents. (Parisian Report at 6275.) As previously discussed, Dr. Parisian will not be permitted to offer narrative testimony that
merely relays the contents of documents without any expert analysis. Such testimony, if
Other courts have permitted Dr. Parisian to opine on the adequacy of a drug’s label in similar situations. See, e.g.,
Rowland, 9 F. Supp. 3d at 562 (finding that courts involved in the Zometa litigation uniformly allowed Dr. Parisian
to testify on the “adequacy of Zometa warnings and labels”); Taylor v. Novartis Pharm. Corp., No. 06-CV-61337,
2013 WL 5118945, at *8 (S.D. Fla. Apr. 22, 2013) (limiting Dr. Parisian’s testimony to “FDA labeling”); NuvaRing,
2013 WL 791835, at *3 (finding Dr. Parisian qualified “to offer testimony concerning FDA regulatory and labeling
Merriam-Webster defines pharmacovigilance as “the monitoring, evaluation, and prevention of adverse effects
associated with the administration of medicines.” Merriam-Webster Online Dictionary 2015, available at
otherwise admissible, is best presented through fact witnesses. Dr. Parisian, therefore, will be
allowed to opine on the reasonableness of Bayer’s pharmacovigilance policies under the FDA’s
regulatory framework, but she will not be permitted to simply recite or regurgitate documents
and speculate on Bayer’s motives based on these documents. Dr. Parisian must also limit her
testimony to implications involving the FDA, as she is not qualified to testify generally about
medical standards. Defendants’ motion with respect to Dr. Parisian’s pharmacovigilance opinion
is thus granted in part and denied in part.
Assisting the Trier of Fact
As discussed above and in the discussion relating to Drs. Feigal and Hixon, Dr. Parisian’s
testimony regarding the complex FDA regulatory framework, Bayer’s compliance with FDA
regulations, and the adequacy of the Mirena label are relevant to this case and would be helpful
to a jury. Therefore, except for the limitations on Dr. Parisian’s testimony already outlined, Dr.
Parisian will be allowed to opine on the FDA regime generally, Bayer’s conduct in complying
with regulatory standards, and the adequacy of the Mirena label.
For the reasons stated above, Defendants’ motion to exclude the testimony of Dr. Parisian
is GRANTED in part and DENIED in part.
Plaintiffs’ Epidemiological Expert – April Zambelli-Weiner, Ph.D.
Defendants move to exclude the proposed testimony of Plaintiffs’ epidemiological
expert, April Zambelli-Weiner. As a threshold matter, Defendants contend that the EURAS83
EURAS is the short form for the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD),
which was a prospective cohort study that followed 61,448 women in six European countries between 2006 and
2013. (Heinemann 2015 at 275.) The objectives of the study were to identify and compare uterine perforation and
adverse events associated with LNG-releasing IUDs and copper IUDs. (Id.) The study was funded by Bayer, (Cook
Zambelli-Weiner Decl. Ex. D, at 1), and overseen by an independent Safety Monitoring and Advisory Council made
up of experts in the field who approved all study materials, (id. at 26).
study on which she opines is not relevant to Plaintiffs’ claims in this litigation. Defendants
further argue that Dr. Zambelli-Weiner is not qualified to offer opinions on general causation
related to secondary perforation, the efficacy of diagnostic imaging in uterine perforation
detection, pharmacovigilance, Mirena’s label, or Bayer’s interactions with foreign regulatory
authorities. Defendants also argue that her opinions are based on unreliable methodologies.
Defendants additionally argue that Dr. Zambelli-Weiner’s opinions regarding Bayer’s “ethical”
obligations and state of mind should be precluded. For the reasons stated below, Defendants’
motion to preclude the testimony of Dr. Zambelli-Weiner is GRANTED in part and DENIED in
Dr. Zambelli-Weiner gives six opinions in her expert report, all related to the EURAS
study: (1) information was available to Bayer before the design and implementation of the
EURAS study that secondary perforation was a serious safety signal warranting further
investigation; (2) the EURAS study suffered from methodological limitations that compromised
the internal and external validity of the study and limits the inferences that can be drawn from it,
including perforation rates; (3) the EURAS study was not properly designed to detect
perforations over the lifecycle of Mirena with a high degree of sensitivity or to discriminate
between primary and secondary perforation; (4) the EURAS study was not designed to advance
the understanding of mechanisms of insertion-related and non-insertion-related perforation; (5)
the EURAS extension was underpowered from its inception to test perforation rates of Mirena
compared to copper IUDs within a reasonable margin; and (6) despite its methodological
limitations, the EURAS study provides evidence that Mirena use is associated with a
significantly increased risk of perforation compared to copper IUDs. (Cook Zambelli-Weiner
Decl. Ex. A, General Expert Report of Dr. April Zambelli-Weiner, Ph.D. (“Zambelli-Weiner
Report”), at 2.)
Dr. Zambelli-Weiner has a Bachelor’s degree in Chemistry and English, a Master’s of
Public Health degree in Epidemiology and Community Health, and a Ph.D. in Epidemiology and
Human Genetics. (Zambelli-Weiner Report at 3.) She has more than 15 years of experience in
epidemiologic research, including reading, mentoring, publishing and applied work. (Id.) Dr.
Zambelli-Weiner has “participated in the design and implementation of large clinical, population
and family-based studies, including the collection of primary data in clinical settings and in the
field,” and she has performed reviews and conducted research for both public and private clients.
(Id.) Defendants do not move to exclude Dr. Zambelli-Weiner “from offering certain of her
criticisms of EURAS that arguably fall within her background as an epidemiologist.”
(Memorandum of Law in Support of Defendants’ Motion to Exclude the Testimony of April
Zambelli-Weiner, Ph.D. (“Ds’ Zambelli-Weiner Mem.”), (Doc. 2698), 1.) In light of
Defendants’ position and Dr. Zambelli-Weiner’s qualifications in epidemiology, her opinions
criticizing the methodology and design of the EURAS study, and describing the shortcomings in
the study’s findings, are admissible under Rule 702 and Daubert. Defendants’ arguments to
preclude other opinions of Dr. Zambelli-Weiner are discussed below.
Defendants argue as a threshold matter that all of Dr. Zambelli-Weiner’s opinions
regarding the EURAS study are irrelevant pursuant to Federal Rule of Evidence 401 because the
opinions do not advance Plaintiffs’ claims in this litigation. (Ds’ Zambelli-Weiner Mem. 1 n.1.)
Defendants are correct that expert testimony must be relevant to be admissible, United States v.
Khan, 787 F.2d 28, 34 (2d Cir. 1986), but in this case both parties mention and seem to be
relying, to some extent, on the results of the EURAS study. If neither Plaintiffs nor Defendants
choose to rely upon the EURAS study, Dr. Zambelli-Weiner’s testimony will be moot. To the
extent it is mentioned, however, Dr. Zambelli-Weiner will be allowed to opine on the study, with
the limitations on her proposed testimony discussed below.
General Causation and Secondary Perforation
Dr. Zambelli-Weiner is not qualified to opine on general causation or a mechanism for
secondary perforation. During her deposition, Dr. Zambelli-Weiner stated both that she is not
qualified to opine on a mechanism of secondary perforation and that she does not intend to offer
an opinion on general causation. (Cook Zambelli-Weiner Decl. Ex. B, Deposition of April
Zambelli-Weiner (“Zambelli-Weiner Dep.”), at 90:10-14; 333:22-334:9.) Plaintiffs argue that
Dr. Zambelli-Weiner is not offering such opinions, but that she is opining, “based upon a review
of case reports, adverse event data and relevant scientific and medical literature,” that there was
information available to indicate that a number of IUD users experience perforations unrelated to
insertion. (Plaintiffs’ Memorandum of Law in Opposition to Defendants’ Motion to Exclude the
Testimony of April Zambelli-Weiner, Ph.D. (“Ps’ Zambelli-Weiner Opp.”), (Doc. 2784), 5.)
Dr. Zambelli-Weiner is not permitted to opine on how, why or whether secondary
perforation occurs, which Dr. Zambelli-Weiner concedes are not opinions she intends to offer.
(Zambelli-Weiner Dep. at 90:10-14.) Nonetheless, Dr. Zambelli-Weiner is qualified and will be
permitted to opine from an epidemiological perspective, based on information available when the
EURAS study was being designed and implemented, that a well-designed study should have
taken the possibility of secondary perforation into account. “Epidemiology is the study of the
relationship between exposures and diseases in large populations.” In re Fosamax, 645 F. Supp.
2d at 187. The “disease” in question here is secondary perforation. Dr. Zambelli-Weiner does
not attempt to prove it actually occurs, but rather she opines that there was evidence, in case
reports and case series, that “established a safety signal for secondary IUD uterine-perforation
beginning more than 20 years prior to the design of the EURAS study.” (Zambelli-Weiner
Report at 7.) Based on this available evidence in case reports and literature, which was
sufficiently suggestive of the possibility of secondary perforation, Dr. Zambelli-Weiner
concluded that a study purporting to examine perforation should not have been constructed in a
way that did not distinguish between insertion-related and non-insertion-related events.
Evaluating the design of studies falls squarely within the wheelhouse of an epidemiologist. See
Deutsch, 768 F. Supp. 2d at 455 (“As a pharmacoepidemiologist, designing, executing,
analyzing, and evaluating studies on [the relationship between a pharmaceutical drug and a
disease] is precisely [the expert’s] area of expertise.”); In re Seroquel Prods. Liab. Litig., No. 06MD-1769, 2009 WL 3806436, at *6-7 (M.D. Fla. July 20, 2009) (allowing epidemiologist to
opine on design and execution of defendants’ studies). Thus, although Dr. Zambelli-Weiner will
not be permitted to testify as to whether secondary perforation exists or how it occurs, she will be
allowed to opine that there was evidence (such as case reports and other literature) that were
sufficiently suggestive of it that it should have been taken into account in the design of the
Defendants further argue that Dr. Zambelli-Weiner’s opinion that the time from insertion
to the detection of perforation is a “surrogate measure of secondary perforation” is inadmissible.
(Ds’ Zambelli-Weiner Mem. 7-9.) The Court agrees that Dr. Zambelli-Weiner does not base this
opinion on a reliable methodology. She bases what she described as this “logical concept” on
nothing more than her conjecture that the temporal lag between insertion and detection suggests
that the perforation occurs later. (Zambelli-Weiner Dep. at 144:11-145:8.) This type of
speculative testimony based only on Dr. Zambelli-Weiner’s say-so is impermissible. See Joiner,
522 U.S. at 146 (“[N]othing in either Daubert or the Federal Rules of Evidence requires a district
court to admit opinion evidence that is connected to existing data only by the ipse dixit of the
expert.”). Plaintiffs are correct that an expert is often qualified to opine in a related field, and an
epidemiologist does not need to be an expert in a particular field to analyze the data or studies
showing a relationship between a drug and a disease. See Deutsch, 768 F. Supp. 2d at 455. In
this instance, however, Dr. Zambelli-Weiner is not basing her opinions on an analysis of data or
studies, but rather on what she describes as a “logical concept,” which does not pass muster
under Rule 702 or Daubert. If her opinion is based on simple common sense, it is not helpful;
the jury does not need expert opinion because its common sense will suffice. And if the jury
needs expert opinion because common sense will not suffice, it must come from an expert who is
applying her expertise. Dr. Zambelli-Weiner is not doing so where she attributes her opinion to
simple logic rather than any application of principles of epidemiology.
Diagnostic Imaging Opinions
Defendants move to exclude Dr. Zambelli-Weiner’s opinions on the efficacy of
diagnostic imaging in detecting uterine perforation. (Ds’ Zambelli-Weiner Mem. 9-13.) Dr.
Zambelli-Weiner criticized the EURAS study for not utilizing diagnostic imaging post-insertion
and again twelve months later. (See, e.g., Zambelli-Weiner Report at 22-23.) Despite
Defendants’ arguments that Dr. Zambelli-Weiner is not qualified to discuss diagnostic imaging
because she is not a doctor or clinician, in the context of critiquing an epidemiological study it is
within her expertise to discuss basic methods used in studies to evaluate results. (ZambelliWeiner Dep. at 187:10-20) (“What is true is that I’m not a clinician. I certainly can evaluate and
recommend and design studies that use diagnostic criteria, which are used in regular practice by
Bayer’s own experts.”). Opining that diagnostic imaging could have improved a study, for
example, seems to fall squarely within an epidemiologist’s area of expertise, even if the
epidemiologist is not an expert in ultrasound. See Deutsch, 768 F. Supp. 2d at 455. If one were
to accept Defendants’ arguments, an epidemiologist would have to be an expert in every area of
medical testing used in a study in order to opine on that study.84
Moreover, Bayer’s argument that Dr. Zambelli-Weiner fails to meet the four Daubert
factors is not persuasive. Dr. Zambelli-Weiner is not offering a scientific opinion; she is opining
that had diagnostic imaging – a general method used to evaluate patients in studies – been used
in EURAS, the study would have produced more “robust, actionable results.” (Zambelli-Weiner
Report at 18.) The Daubert factors are not appropriate in every context. See Kumho Tire Co.,
526 U.S. at 150 (“[F]actors identified in Daubert may or may not be pertinent in assessing
reliability . . . .”); UMG Recordings, Inc. v. Lindor, 531 F. Supp. 2d 453, 457 (E.D.N.Y. 2007)
(“The Daubert factors . . . were intended as suggestions, and are not appropriate for every type of
expert testimony.”) (citing Daubert, 509 U.S. at 593). Dr. Zambelli-Weiner may not, however,
opine that including an imaging protocol in EURAS would have shown a specific value of
perforation rates, in this case “~2/1000 insertions.” (Zambelli-Weiner Report at 18.) Dr.
Zambelli-Weiner does not adequately explain why the results of one study that she cites in her
report, (id.), would necessarily be the results had there been more imaging in EURAS, and
during her deposition she declined to “wed [herself] to a particular number,” (Zambelli-Weiner
Dep. at 268:12-17). Dr. Zambelli-Weiner thus can opine generally on how imaging might affect
Dr. Zambelli-Weiner may opine on whether imaging would have improved the study, but she may not opine on
what kinds of imaging can or cannot rule out injury to the uterus upon insertion. If the jury concludes, based on
other evidence, that no imaging can rule out such an injury, it will discount Dr. Zambelli-Weiner’s testimony
a study like EURAS, but she may not opine on a particular statistic that would have resulted
because she has provided no basis, other than her own say-so, as for why that specific number
would result (and also backed away from that number). See Golod, 964 F. Supp. at 861 (“‘[T]he
courtroom is not the place for scientific guesswork, even of the most inspired sort. Law lags
science; it does not lead it.’”) (quoting Rosen, 78 F.3d at 319) (alteration in original).
Defendants argue that Dr. Zambelli-Weiner is not qualified to render pharmacovigilance
opinions and that those opinions are not reliable. (Ds’ Zambelli-Weiner Mem. 13-18.) Plaintiffs
concede that Dr. Zambelli-Weiner is “not a pharmacovigilance expert and will offer no opinions
related to such processes,” but argue that she is an “expert on the collection, analysis and
interpretation of data” and should therefore be allowed to opine on data derived from Bayer’s
pharmacovigilance processes. (Ps’ Zambelli-Weiner Opp. 13.) Dr. Zambelli-Weiner will not be
permitted to opine on whether Bayer’s pharmacovigilance practices were adequate because this
is outside the scope of her expertise. It falls within her area of expertise, however, to testify on
whether, from an epidemiological point of view and given the information that existed at the
time, the EURAS study was properly designed. See In re Silicone Gel Breasts Implants Prods.
Liab. Litig., 318 F. Supp. 2d 879, 895-96 (C.D. Cal. 2004) (epidemiologist “with extensive
experience in designing, conducting and analyzing epidemiological studies” had credentials
“specific to an inquiry about the methodological soundness of Defendants’ epidemiological
data,” and was “qualified to evaluate and explain the available epidemiological evidence
concerning breast implants,” and thus his “analysis of the existing epidemiological evidence
[was] admissible”). Dr. Zambelli-Weiner cannot opine on whether Bayer’s pharmacovigilance
was good or bad, but she can testify whether the information collected via that
pharmacovigilance was properly evaluated.
In addition to being outside the scope of her expertise, Dr. Zambelli-Weiner’s opinions
relating to the adequacy of Bayer’s pharmacovigilance efforts are not based on a sound
methodology. Much of her opinions consist of her interpretations of internal Bayer documents,
including emails, which in her view reflect confusion over internal coding. (Zambelli-Weiner
Report at 8-14; Zambelli-Weiner Dep. at 219:8-20.) Dr. Zambelli-Weiner does not have any
special expertise that gives her particular insight into these emails or what was going on at Bayer
at the time, nor can she “read minds.” In re Fosamax, 645 F. Supp. 2d at 192. It is
impermissible for experts to opine on the state of mind or motives of corporations or regulatory
bodies. In re Rezulin, 309 F. Supp. 2d at 546. Dr. Zambelli-Weiner admitted that she did not
know how Bayer analyzed perforation events it received in connection with Mirena, (ZambelliWeiner Dep. at 206:11-207:7), which makes her testimony on this point speculative and
unhelpful to a jury. See In re Fosamax, 645 F. Supp. 2d at 194 (excluding opinion by expert as
lacking foundation “because he d[id] not know what types of animal testing [the pharmaceutical
company] conducted with Fosamax”). Defendants’ motion with respect to an opinion on the
adequacy of Bayer’s pharmacovigilance by Dr. Zambelli-Weiner is granted, but she can testify
as to what an epidemiologist trying to design a good study would do with the information that
Bayer had. She may not evaluate Bayer’s internal coding system or its pharmacovigilance but
can explain what, epidemiologically speaking, one should do when one has data like what Bayer
had in its possession at the time.
Bayer’s “Ethical” Obligations
Dr. Zambelli-Weiner may not opine on broad, undefined obligations that she believes
Bayer failed to follow. (See, e.g., Zambelli-Weiner Report at 10 (“Bayer had an obligation to
monitor potential safety issues and to investigate them further.”); id. (“[S]afety signals should
have spurred further investigation in well-designed studies even in the absence of regulatory
involvement.”).) Dr. Zambelli-Weiner does not seem to be basing her opinions of Bayer’s
obligations on any objective factors. She is not qualified to opine on – nor does she purport to
use – FDA or any other objective standards, and we are left with a vague notion that in her
personal opinion Bayer’s conduct was inadequate. This is impermissible expert testimony. See
In re Rezulin, 309 F. Supp. 2d at 543 (experts’ opinions “concerning purported ethical standards
[were] based on their personal, subjective views” and were therefore mere speculation and
inadmissible under Rule 702); Pantaleo v. Hayes, No. 08-CV-6419, 2013 WL 5213690, at *4
(N.D. Ill. Sept. 17, 2013) (finding inadmissible expert testimony “based only on her personal
opinion of what she believes defendants should have done as opposed to what they were required
to do”); Johnson v. Wyeth LLC, No. 10-CV-2690, 2012 WL 1204081, at *2 (D. Ariz. Apr. 11,
2012) (because plaintiff could not “point to any objective standard” relied upon by experts, their
opinions amounted to nothing more than “‘subjective belief or unsupported speculation’”)
(quoting Daubert, 509 U.S. at 590). Defendants’ motion with respect to Dr. Zambelli-Weiner’s
opinions on the adequacy of Bayer’s conduct in light of amorphous ethical standards is granted.85
Dr. Zambelli-Weiner may opine on what a good epidemiologist should have done to construct an effective study
or to properly analyze data, to the extent these opinions are tied to specific professional standards, but she may not
opine generally about what Bayer should have done beyond what applicable regulatory or particular professional
Dr. Zambelli-Weiner will not be allowed to opine on the adequacy of the Mirena label.
Plaintiffs state that Dr. Zambelli-Weiner will not be offering any such opinion, but argue she
should be permitted to testify on the content of the label as it “relates to the correlation between
the Mirena label and design of the EURAS study.” (Ps’ Zambelli-Weiner Opp. 16.) It is not
clear what testimony Plaintiffs are attempting to describe. In her report, in any event, Dr.
Zambelli-Weiner writes that “[c]ertain aspects of the MIRENA® label appear to be questioned
by case reports in the literature,” which seems to be an opinion on the inadequacy of the label.
(Zambelli-Weiner Report at 7.) Dr. Zambelli-Weiner is not qualified to offer an opinion on
Mirena’s label as she is not a medical doctor, clinician or regulatory expert, and acknowledged
that she is not an expert on labeling. (Zambelli-Weiner Dep. at 38:16-18, 162:14-24, 164:1-8.)
Defendants’ motion with respect to opinions on labeling is granted.
Foreign Regulatory Action
Defendants argue that Dr. Zambelli-Weiner’s proposed testimony regarding the German
regulatory equivalent of the FDA, the Federal Institute for Drugs and Medical Devices
(“BfArM”), and Bayer’s interactions with BfArM, should be excluded. (Ds’ Zambelli-Weiner
Mem. 21-24.) For example, in her report, Dr. Zambelli-Weiner mentions that “BfArM also
sought some insight into the mechanism of IUD related uterine perforations” and referred to
“BfArM concerns” that “Bayer did not investigate.” (Zambelli-Weiner Report at 7.) As
discussed in connection with Dr. Parisian, experts are not the “appropriate vehicles” to introduce
evidence regarding foreign regulatory actions, In re Rezulin, 309 F. Supp. 3d at 553, unless
perhaps the expert has specialized expertise in a foreign regulatory body and its requirements.
Dr. Zambelli-Weiner has no such expertise. She admitted that she is not a regulatory expert.
(Zambelli-Weiner Dep. at 377:23-24.) Moreover, Dr. Zambelli-Weiner cannot opine on the state
of mind of BfArM, because any such testimony would be purely speculative and is
impermissible. See In re Rezulin, 309 F. Supp. 3d at 546; In re Fosamax, 645 F. Supp. 2d at
192.86 To the extent Bayer’s interactions with BfArM cast light on what Bayer knew and when it
knew it, direct evidence of those interactions may be introduced to the extent relevant, but not
under the guise of expert opinion and not via an epidemiologist – except to the extent (if at all)
that BfArM provided data to Bayer that it took into account in designing the study, or should
In addition, Dr. Zambelli-Weiner’s testimony regarding foreign regulators is excluded
under Federal Rule of Evidence 403 because its probative value is substantially outweighed by
its likelihood of confusing the jury.87 Because this litigation is based on U.S. law, and because
evidence regarding the FDA will be admitted, the actions taken by foreign regulatory agencies
are not particularly probative and likely will be confusing. Except as just described, Dr.
Zambelli-Weiner will not be allowed to opine on the actions of BfArM, and Defendants’ motion
to exclude her testimony on this issue is granted.
To the extent BfArM said what its state of mind was, testimony about it would not be speculative, but to the same
extent expert testimony would not be needed.
Courts have found that evidence of foreign regulatory actions in products liability litigation is properly excluded
as irrelevant and/or confusing. See, e.g., Deviner v. Electrolux Motor, AB, 844 F.2d 769, 773 (11th Cir. 1988) (“The
District Court’s desire to avoid confusing the jury with Swedish law and statistics cannot rightly be described as
abuse of discretion . . . .”); In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 950, 965 (D. Minn. 2009) (“[A]ny
discussion of foreign regulatory actions is irrelevant to the current litigation and should therefore be excluded.”); In
re Seroquel Prods. Liab. Litig., No. 06-MD-1769, 2009 WL 223140, at *6 (M.D. Fla. Jan. 30, 2009) (“[W]hatever
minimal relevance the foreign regulatory actions might have is clearly overwhelmed by the likelihood of jury
confusion.”), aff’d, 601 F. Supp. 2d 1313 (M.D. Fla. 2009); In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1054
(D. Minn. 2007) (“[A]llowing the admission of evidence of foreign regulatory actions, in a case that is governed by
domestic law, would likely cause jury confusion.”).
Helpfulness to Trier of Fact
Despite the limitations set forth above, Dr. Zambelli-Weiner’s testimony regarding the
EURAS study, including her description of what it did and did not test and her criticisms of it,
based on her training and experience as an epidemiologist, would be helpful to a jury. Dr.
Zambelli-Weiner may therefore offer opinions regarding the breadth and scope of the EURAS
study, and what she believes are shortcomings of the study and its findings. She is qualified to
render these opinions, which are both reliable and relevant, if the parties discuss the EURAS
study. If Defendants disagree with Dr. Zambelli-Weiner’s conclusions regarding the study, they
can cross-examine her or offer contradictory testimony.
For the reasons stated above, Defendants’ motion to preclude the testimony of Dr.
Zambelli-Weiner is GRANTED in part and DENIED in part.
For the foregoing reasons, Defendants’ and Plaintiffs’ motions are granted to the extent
set forth above and otherwise denied. Specifically:
Plaintiffs’ Omnibus Motion to Exclude Defendants’ Experts is DENIED.
Defendants’ Motion to Exclude the Testimony of Dr. Young is GRANTED.
Defendants’ Motion to Exclude the Testimony of Dr. Jarrell is GRANTED.
Defendants’ Motion to Exclude the Testimony of Dr. Wray is GRANTED.
Defendants’ Motion to Exclude the Testimony of Dr. Strassberg is GRANTED.
Plaintiffs’ Motion to Exclude the Testimony of Dr. Feigal is GRANTED IN PART and
DENIED IN PART.
Plaintiffs’ Motion to Exclude the Testimony of Dr. Hixon is GRANTED IN PART and
DENIED IN PART.
Defendants’ Motion to Exclude the Testimony of Dr. Parisian is GRANTED IN PART
and DENIED IN PART.
Defendants’ Motion to Exclude the Testimony of Dr. Zambelli-Weiner is GRANTED IN
PART and DENIED IN PART.
The Clerk of Court is respectfully requested to terminate the pending motions (13-MD-
2434 Docs. 2679, 2685, 2688, 2691, 2694, 2697, 2702, 2705 and 2724 and 13-MC-2434 Docs.
134, 140, 143, 146, 149 and 152).
Dated: March 8, 2016
White Plains, New York
CATHY SEIBEL, U.S.D.J.