Jackson v. Johnson & Johnson et al
Filing
106
OPINION AND ORDER denying 52 Motion to Exclude Certain Opinions of Dr. Sepulveda-Toro, denying 53 Motion to Exclude Certain Opinions of Dr. Schlafstein, denying 54 Motion to Exclude Certain Opinions of Dr. Thames, granting 72 Motion for E xtension of Time, granting 55 Motion to Exclude Certain Case Specific Opinions of Dr. Fitzgerald, granting in part and denying in part 56 Motion to Limit the Expert Opinions of Dr. Elliott, denying 58 Motion to Exclude Certain Opinions of Dr. Lowman, denying 59 Motion to Exclude Certain Opinions of Dr. Rosenblatt, granting 60 Motion to Exclude Timothy Ulatowski, granting 61 Motion to Exclude the Case-Specific Opinions of Dr. Miklos, denying 89 Motion to Exclude the Case-Specific Opinions of Dr. Zipper, granting in part and denying in part 90 Motion to Exclude Certain Opinions and Testimony of Prof. Dr. Uwe Klinge. Signed by Judge Thomas W. Thrash, Jr. on 1/12/2022. (anc)
Case 1:11-cv-03903-TWT Document 106 Filed 01/12/22 Page 1 of 31
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION
DORIS JACKSON,
Plaintiff,
v.
CIVIL ACTION FILE
NO. 1:11-CV-3903-TWT
JOHNSON & JOHNSON, et al.,
Defendants.
OPINION AND ORDER
This is a products liability case on remand from multidistrict litigation
proceedings. It is before the Court on a number of Daubert motions by the
Parties. For the reasons set forth below, the Court rules as follows:
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Sepulveda-Toro [Doc. 52] is DENIED.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Schlafstein [Doc. 53] is DENIED.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr. Thames
[Doc. 54] is DENIED.
•
The Plaintiff’s Unopposed Motion for Extension of Time [Doc. 72]
is GRANTED.
•
The Defendants’ Motion to Exclude Certain Case Specific
Opinions of Dr. Fitzgerald [Doc. 55] is GRANTED.
•
The Defendants’ Motion to Limit the Expert Opinions of Dr.
Elliott [Doc. 56] is GRANTED in part and DENIED in part.
Case 1:11-cv-03903-TWT Document 106 Filed 01/12/22 Page 2 of 31
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Lowman [Doc. 58] is DENIED.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Rosenblatt [Doc. 59] is DENIED.
•
The Plaintiff’s Motion to Exclude Timothy Ulatowski [Doc. 60] is
GRANTED.
•
The Defendants’ Motion to Exclude the Case-Specific Opinions of
Dr. Miklos [Doc. 61] is GRANTED.
•
The Defendants’ Motion to Exclude the Case-Specific Opinions of
Dr. Zipper [Doc. 89] is DENIED.
•
The Defendants’ Motion to Exclude Certain Opinions and
Testimony of Prof. Dr. Uwe Klinge [Doc. 90] is GRANTED in part
and DENIED in part.
I.
Background
This case is one of many that were consolidated in MDL 2327 in the
United States District Court for the Southern District of West Virginia. (Jan.
21, 2020 Order, at 1, 3.) The Plaintiff, Doris Jackson, suffered from pelvic organ
prolapse. (Compl. ¶ 23.) To treat this condition, the Plaintiff received a Prolift
Anterior and Posterior Pelvic Floor Repair System (“Prolift”), which was
designed, manufactured, and distributed by the Defendants, Johnson &
Johnson (“J&J”) and Ethicon, Inc. (“Ethicon”). (Id. ¶¶ 5, 9, 23.) The Plaintiff
alleges that as a result the Prolift implantation, she has suffered a variety of
physical, emotional, and financial injuries. (Id. ¶ 25.) Consolidated and
coordinated proceedings were completed in the MDL and the case was
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remanded to this district for trial. Both parties have identified numerous
experts, and these experts now face the Daubert challenges detailed below.
II.
Legal Standard
“Under Federal Rule of Evidence 702, expert testimony is admissible if
(1) the expert is qualified to testify regarding the subject of the testimony; (2)
the expert's methodology is sufficiently reliable as determined by the sort of
inquiry mandated in Daubert; and (3) the expert's testimony will assist the
trier of fact in understanding the evidence or determining a fact at issue.”
Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296, 1304 (11th Cir.
2014). The Rules of Evidence require a district judge to undertake a
gatekeeping function to “ensure that any and all scientific testimony or
evidence admitted is not only relevant, but reliable.” Daubert v. Merrill Dow
Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993). “In considering the proffered
expert testimony, a trial judge is mindful the burden of establishing
qualification, reliability, and helpfulness rests on the proponent of the expert
opinion.” Chapman, 766 F.3d at 1304 (internal quotation marks and
punctuation omitted).
III.
Discussion
The Court has reviewed the eleven Daubert motions pending before the
Court and the underlying materials. Some of these experts were the subject of
earlier Daubert motions before the MDL court, and where appropriate, the
Court adopts Judge Goodwin’s rulings. However, Judge Goodwin reserved
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ruling on some issues, allowing this Court to assess these challenges on
remand under Georgia law. Before evaluating the parties’ motions, the Court
pauses to make a general note. Federal Rule of Civil Procedure 26(a) and (e)
require the disclosure of all bases of expert opinions. The experts in this case
are limited to these bases and the contents of their expert reports, and the
Court will decide these motions based on this information. To the extent the
experts provide testimony outside the scope of their reports, the opposing party
may renew their objections at the time the testimony is offerred. See, e.g.,
Mitchell v. Ford Motor Co., 318 F. App’x 821, 824–25 (11th Cir. 2009)
(affirming the district court’s decision to strike additional bases for expert
opinion outside of the scope of the Rule 26 disclosures.) The Court now begins
with the Plaintiff’s experts.
A. The Plaintiff’s Experts
i. Dr. Miklos
Dr. John Miklos is a board-certified OB/GYN with expertise in female
pelvic medicine and reconstructive surgery. (Dr. Miklos Report, at 2.) Along
with his partner, Dr. Miklos performs approximately 450 pelvic floor
reconstruction surgeries annually. (Id. at 5.) In his report, Dr. Miklos reviews
the Plaintiff’s medical history and his independent medical examination of the
Plaintiff. (Id. at 7–15.) Dr. Miklos then conducts what he deems a differential
diagnosis—a procedure for determining the root cause of a condition by “ruling
in” potential causes and then “ruling out” possibilities until one cause remains.
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(Id. at 15.) In his medical opinion, Dr. Miklos opines that the Plaintiff’s
“continued vaginal pain, levator myalgia, dyspareunia, shortened vagina and
chronic vaginal discharge [are] a direct result of Gynecare Prolift mesh.” (Id.
at 19.) In their Motion to Exclude Dr. Miklos, the Defendants raise several
arguments against the admission of his specific causation opinion. As relevant
here, the Defendants argue that Dr. Miklos conducted an unreliable
differential diagnosis by failing to rule in a different mesh implantation, and
as such, his testimony fails to satisfy Rule 702. (Defs.’ Br. in Supp. of Defs.’
Mot. to Exclude Dr. Miklos, at 8–15.) In response, the Plaintiff points to Dr.
Miklos’ deposition testimony to explain how he ruled out the other mesh
implantation and other alternative causes. (Pl.’s Br. in Opp’n to Defs.’ Mot. to
Exclude Dr. Miklos, at 9–13.)1
“When properly conducted, a differential diagnosis can be a reliable
methodology under Daubert.” Guinn v. AstraZeneca Pharm. LP, 602 F.3d
1245, 1253 (11th Cir. 2010). An expert completes a differential diagnosis in
three steps: first, diagnosing a patient’s condition; second, ruling in all possible
causes; and third, ruling out possible causes until one remains. See Chapman,
766 F.3d at 1308. In giving his medical opinion here, Dr. Miklos asserts that
he has conducted a differential diagnosis. (Dr. Miklos Report, at 15.) However,
an expert’s mere statement that he conducted a differential diagnosis does not
The Plaintiff concedes that Dr. Miklos will not testify as to her stress
urinary incontinence, and the Defendants’ Motion is granted as to this issue.
5
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alone demonstrate the process’ reliability, and courts must evaluate the
expert’s methodology before admitting the testimony. Guinn, 602 F.3d at 1253.
“Although a reliable differential diagnosis need not rule out all possible
alternative causes, it must at least consider other factors that could have been
the sole cause of the plaintiff’s injury.” Id. The Eleventh Circuit, in joining
several sister circuits, noted that “an expert must provide a reasonable
explanation as to why he or she has concluded that any alternative cause
suggested by the defense was not the sole cause of the plaintiff’s injury.” Id.
(internal quotation marks and punctuation omitted).
Dr. Miklos conducted an independent medical exam of the Plaintiff, in
which he diagnosed her with “chronic postoperative surgical pain,
dyspareunia, levator myalgia, . . . shortened vagina,” and other conditions.
(Miklos Report, at 14.) Thus, Dr. Miklos successfully completed the first step
of a reliable differential diagnosis. However, in his report, Dr. Miklos fails to
rule in or out both the Plaintiff’s 2007 vaginal hysterectomy and implantation
of a different mesh product, Pelvitex, as potential causes of the Plaintiff’s
conditions. Dr. Miklos’ review of the Plaintiff’s medical history involves three
gynecologic surgeries: the Prolift implantation in October 2006; a vaginal
hysterectomy and Pelvitex implantation in May 2007; and a third surgery in
2010 consisting of, among other things, a lysis of adhesions and a vaginal cuff
revision. (Id. at 8–10.) In detailing his medical opinion, Dr. Miklos “first ruled
in the mesh as a potential cause because of the obvious timing, location and
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presentation of the symptoms after the mesh placement.” (Id. at 18.) Dr. Miklos
then rules out the Plaintiff’s “only preexisting condition” of gastroesophageal
reflux (Id. at 7, 18.) At no point does Dr. Miklos rule in the Pelvitex mesh or
the hysterectomy, instead stating that her pain was “diagnostic of a
complication specific to a transvaginal mesh implant and in this case the
[Prolift.]” (Id. at 18.) By failing to discuss the effect of the other surgical
procedures performed on the Plaintiff and ruling out those surgeries as
possible causes of her pain, Dr. Miklos fails to conduct a proper differential
diagnosis, and his testimony is thus unreliable under Daubert.
The Plaintiff’s brief points to deposition testimony that provides some
explanation for why Dr. Miklos determined that the Prolift alone led to the
Plaintiff’s condition. For example, in his deposition, Dr. Miklos notes that if
the Pelvitex alone was responsible for the pain, it would be limited to the upper
part of the Plaintiff’s vagina and not present throughout, as he has found. (See
Dr. Miklos Dep., at 72:19–74:22.) However, regardless of the substance or
persuasiveness of Dr. Miklos’ explanations, subsequent deposition testimony
cannot resuscitate an otherwise deficient expert report. As the Seventh Circuit
has persuasively noted, Federal Rule of Civil Procedure 26(a)(2) “does not allow
parties to cure deficient expert reports by supplementing them with later
deposition testimony[:]”
The purpose of Rule 26(a)(2) is to provide notice to opposing
counsel—before the deposition—as to what the expert witness
will testify, and this purpose would be completely undermined if
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parties were allowed to cure deficient reports with later
deposition testimony. Allowing parties to cure a deficient report
with later depositions would further undermine a primary goal of
Rule 26(a)(2): to shorten or decrease the need for expert
depositions. After all, the parties' need for expert depositions
would increase if they could use deposition testimony to provide
information they should have initially included in their Rule
26(a)(2) report.
Ciomber v. Coop. Plus, Inc., 527 F.3d 635, 642 (7th Cir. 2008). Because Dr.
Miklos’ report fails to demonstrate a reliable differential diagnosis, his
testimony regarding the cause of the Plaintiff’s condition is excluded.
ii. Dr. Fitzgerald
Dr. Colleen Fitzgerald is board-certified physician who specializes in,
among other things, “women’s pelvic and musculoskeletal rehabilitation[.]”
(Dr. Fitzgerald Report, at 1.) Her expert report suffers from similar deficiencies
as Dr. Miklos’ report. In it, Dr. Fitzgerald states that she has conducted a
differential diagnosis but does not specify the possible causes she ruled in and
her reasons for ruling those causes out. (Id., at 4.) The Eleventh Circuit has
noted that “an expert does not establish the reliability of his techniques or the
validity of his conclusions simply by claiming that he performed a differential
diagnosis on a patient.” McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1253
(11th Cir. 2005). Thus, this Court must evaluate Dr. Fitzgerald’s methodology
as described in her report. After summarizing the Plaintiff’s medical history
and records, Dr. Fitzgerald states that her medical opinion is that the
Plaintiff’s symptoms are “a result of vaginal mesh complications.” (Id. at 16.)
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In addition to not ruling in or out other potential causes, Dr. Fitzgerald fails to
distinguish between the two mesh products implanted in the Plaintiff and does
not rule out the other surgeries as a potential cause of the symptoms. As a
result, Dr. Fitzgerald’s differential diagnosis is unreliable under Daubert.
In responding to the Defendants’ arguments that Dr. Fitzgerald’s
differential diagnosis is unreliable, the Plaintiff makes two arguments in
support of admitting Dr. Fitzgerald’s specific causation testimony. First, the
Plaintiff points to extensive comments made during Dr. Fitzgerald’s deposition
explaining her thought process. (Pl.’s Br. in Opp’n to Defs.’ Mot. to Exclude Dr.
Fitzgerald, at 5–11.) As discussed above, deposition testimony cannot cure a
deficient expert report. Second, the Plaintiff argues that Judge Goodwin, who
presided over the MDL proceedings in this case, previously admitted Dr.
Fitzgerald’s specific causation testimony based on a differential diagnosis in a
similar case. (Id. at 7 (citing Wise v. C.R. Bard, Inc., 2015 WL 521202, at *12
(S.D. W. Va. Feb. 7, 2015)).) However, the MDL Court noted that Dr.
Fitzgerald’s report in that case “include[d] a section ruling out other causes of
pain, such as endometriosis and kidney stones.” Wise, 2015 WL 521202, at *12.
No such section exists in Dr. Fitzgerald’s report here. As a result, Dr.
Fitzgerald’s specific causation testimony as to both the Plaintiff’s pelvic pain
and urinary incontinence is excluded.
iii. Dr. Elliott
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Dr. Elliott is a Professor of Urology specializing in female urology and
reconstructive surgery. (Elliott Report, at 1.) The MDL court previously issued
a ruling on the Defendant’s Motion to Exclude Certain General Opinions of Dr.
Elliott, in which Judge Goodwin ruled on some matters and reserved ruling on
others. See In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig. , 2016 WL
4500766 (S.D. W. Va. Aug. 26, 2016). Where the MDL court made definitive
rulings on the Defendants’ motion, this Court adopts those rulings for the
reasons given in its Order. See id. The MDL court reserved ruling on several
matters: whether Dr. Elliott can opine on alternative procedures that may be
safter that the Defendants’ products; and whether Dr. Elliott can opine on
alternative designs. Id. at 4.
Regarding testimony on alternative procedures, the Defendants argue
that Dr. Elliott’s testimony regarding the availability of other procedures is
irrelevant to the design concept and features of the products here. (Defs.’ Br.
in Supp. of Defs.’ Mot. to Exclude Dr. Elliott, at 4.) The Defendants point to
subsequent rulings on this issue by Judge Goodwin and other cases under
Georgia law to support the notion that alternative procedures go to the treating
physician’s choice of product rather than the design of the product in question.
(Id. at 4–7.) In response, the Plaintiff claims that the availability of alternative
products and procedures “is highly relevant to whether it was negligent for
Ethicon to put its Prolift onto the market[,]” and that Dr. Elliott’s experience
allows him to provide reliable testimony regarding alternative mesh designs.
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(Pl.’s Br. in Opp’n to Defs.’ Mot. to Exclude Dr. Elliott, at 7, 11.) Further, the
Plaintiff urges this Court to adopt the reasoning of Williams v. Ethicon, Inc.,
2021 WL 1087808 (M.D. Ga. Mar. 22, 2021), in which the court applied Georgia
law and denied Ethicon’s motion to exclude Dr. Elliott’s opinions regarding
both alternative designs and procedures. (Id. at 5.)
Under Georgia law, design defect claims are subject to the risk-utility
analysis outlined in Banks v. ICI Americas, Inc., 264 Ga. 732, 736 n.6 (1994).
When considering alternative safe designs, the Georgia Supreme Court
provides the following non-exhaustive list of factors in the risk-utility analysis:
[T]he feasibility of an alternative design; the availability of an
effective substitute for the product which meets the same need
but is safer; the financial cost of the improved design; and the
adverse effects from the alternative.
Id. Thus, Georgia law allows consideration of both alternative product designs
and alternative procedures—in the Supreme Court’s words, effective
substitutes—in evaluating a design defect claim. The Defendants argue that
“effective substitute” represents a “substitute product design,” and the proper
analysis remains limited to alternative designs rather than alternative
procedures. (Defs.’ Reply Br. in Supp. of Defs.’ Mot. to Exclude Dr. Elliott, at
5.) But defining “effective substitute” as a substitute product design renders
this factor surplusage, as consideration of an “alternative design” is already
included in the analysis. Banks, 264 Ga. at 736 n.6. Dr. Elliott is qualified to
discuss these alternative procedures given his robust experience in female
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pelvic surgery. (Elliott Rep., at 1.) As a result, the Defendants’ Motion is denied
as to this issue, and Dr. Elliott may testify as to alternative procedures.
Regarding alternative mesh designs, the MDL court found that Dr.
Elliott was qualified to opine on alternative designs but reserved ruling on
the reliability of Dr. Elliott’s methodology. In re: Ethicon, Inc., 2016 WL 4500766,
at *4 (S.D.W. Va. Aug. 26, 2016). Further, the MDL court noted the contrasting
arguments regarding Dr. Elliott’s sources: the Defendants argued that the
underlying sources did not support his conclusions, while the Plaintiff argued
that Dr. Elliott explained his rationale for relying on those reports. Id. As a
result, the MDL Court found that “the lynchpin of Dr. Elliott’s testimony is
his experience[,]” which Judge Goodwin reserved ruling on. Id. The
Defendants make three arguments against the reliability of Dr. Elliott’s
testimony: first, they argue that he opposes the placement of any mesh in the
vagina and acknowledged studies evaluating lighter products show no
difference in complication frequency; that the medical literature does not
support his opinions; and that his opinion is not supported by his personal
experience. (Defs.’ Br. in Supp. of Defs.’ Mot. to Exclude Dr. Elliott, at 7–15.)
The Court agrees with the Plaintiff that the Defendants’ first two challenges
above raise issues best handled by the “[v]igorous cross-examination,
presentation of contrary evidence, and careful instruction on the burden of
proof.” Daubert, 509 U.S. at 596. The Defendants’ third arguments requires
more analysis. As the Defendants note, when an expert relies on his
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experience to support the reliability of his claims, the expert “must explain
how that experience leads to the conclusion reached, why that experience is a
sufficient basis for the opinion, and how that experience is reliably applied to
the facts.” United States v. Frazier, 387 F.3d 1244, 1261 (11th Cir. 2004). Dr.
Elliott fails to describe any particular methodology, but instead uses his
experience in the field to read and summarize the findings of medical
literature. While this evidence may be “shaky,” Dr. Elliott is qualified as an
expert and has identified the sources supporting his opinion. Daubert, 509
U.S. at 596; see also Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326
F.3d 1333, 1345 (11th Cir. 2003) (“The identification of such flaws in
generally reliable scientific evidence is precisely the role of crossexamination.”). The Defendants have raised arguments against Dr. Elliott’s
conclusions, and the Court finds that the jury is well-placed to assess those
arguments. As such, the Defendants’ Motion is denied as to Dr. Elliott’s
testimony on alternative design features.
As a final matter regarding Dr. Elliott, the Defendants ask this Court to
exclude any testimony regarding “certain duties owed by a medical device
manufacturer.” (Defs.’ Br. in Supp. of Defs.’ Mot. to Exclude Dr. Elliott, at 15.)
The Plaintiff, in response, argues that Dr. Elliott “plans to testify not on the
legal adequacy of Ethicon’s testing, but rather on whether the clinical studies,
testing and the factual circumstances dictated that additional, longer-term
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testing was needed to ensure the safety and efficacy of the Prolift before
bringing it to market.” (Pl.’s Br. in Opp’n to Def.’s Mot. to Exclude Dr. Elliott,
at 12.) As other courts have found, the “Plaintiff’s distinction is not persuasive.”
Mason v. Ethicon, Inc., 2021 WL 2580165, at *5 (M.D. Fla. Jun. 10, 2021).
While Dr. Elliott can testify as to factual matters such as whether or not
certain testing or studies took place based on the information available to him,
he cannot testify as to the sufficiency of those efforts, and the Defendants’
Motion is granted as to this issue. Further, Dr. Elliott can testify as to the
Prolift’s instructions for use
as limited in Judge Goodwin’s Order on this
issue. (See Def.’s Mot. to Exclude Dr. Elliott, Ex. 2 [Doc. 56-3], at 2.) Thus, the
Defendant’s Motion to Exclude Dr. Elliott is granted in part and denied in part.
iv. Dr. Zipper
Dr. Zipper is a board-certified surgeon specializing in female pelvic
medicine and reconstructive surgery and has “performed over one thousand
mesh and biologic tissue implantations, pelvic organ prolapse procedures, and
a similar numbers of native tissue prolapse surgeries.” (Dr. Zipper Report, at
3.) The MDL court previously ruled on some of the Defendants’ challenges to
Dr. Zipper’s testimony, and the Court adopts that opinion as its own here. See
In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig., 2016 WL 4944991
(S.D. W. Va. Sept. 1, 2016). Judge Goodwin reserved ruling on Dr. Zipper’s
testimony regarding the existence of alternative designs and procedures. Id. at
*2–3. As they did in challenging Dr. Elliott’s testimony, the Defendants argue
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that (1) the availability of alternative surgeries is irrelevant to any potential
design defects in the Prolift and (2) that Dr. Zipper fails to utilize a reliable
methodology in developing his opinion on alternative designs. (Defs.’ Br. in
Supp. of Defs.’ Mot. to Exclude Dr. Zipper, at 4–10.) In response, the Plaintiff
claims that Dr. Zipper’s opinion rests on his expertise and studies he reviewed
comparing the complications of various mesh products.
The Court sees no reason to deviate from its reasoning in evaluating the
Defendants’ challenge to Dr. Elliott. As discussed above, one factor to consider
in design defect cases under Banks is the availability of other procedures that
could achieve the same results with fewer risks. See Banks, 264 Ga. at 736 n.6.
The Defendants highlight Jones v. NordicTrack, Inc., 274 Ga. 115, 118 (2001),
arguing that the Georgia Supreme Court’s decision in that case emphasizes
“the significance of proof of a safer alternative design establishing a design
defect claim.” (Defs.’ Reply Br. in Supp. of Defs.’ Mot. to Exclude Dr. Zipper, at
2.) But the Georgia Supreme Court’s ruling in Jones does not discount the
importance of evidence of a reasonable alternative design by also allowing
consideration of effective substitute procedures in accordance with Banks.
Because this evidence is relevant to the Plaintiff’s design defect claim, the
Court can evaluate Dr. Zipper’s qualifications and his methodology. Dr. Zipper
has performed hundreds of pelvic surgeries and is thus qualified to talk about
his general opinion regarding the comparative efficacy and safety of these
procedures, and his experience and study in this field represents a sufficiently
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reliable basis for his opinions. (Dr. Zipper Report, at 3–21.) Regarding
alternative designs, Dr. Zipper has based his opinion on a review of studies on
these products. (Id. at 175–178.) After a review of these studies, Dr. Zipper
opines that the Prolift is “more defective than other commercially available
meshes.” (Id. at 178.) The Defendants’ arguments amount to an attack on the
sufficiency of the medical literature undergirding his opinions, and the
“identification of such flaws in generally reliable scientific evidence is precisely
the role of cross-examination.” Quiet Tech. DC-8, Inc., 326 F.3d at 1345. As
such, the Defendants’ Motion to Exclude Dr. Zipper’s testimony on these points
is denied.
v. Prof. Dr. Med. Klinge
Dr. Uwe Klinge is hernia surgeon who has utilized similar mesh
products in hernia surgeries outside of the pelvic organ prolapse or stress urinary
incontinence context. (Dr. Klinge Report, at 1.) As a researcher, Dr. Klinge’s
work on hernia meshes was supported by Ethicon and later became part of an
Ethicon product. (Id. at 2.) As a surgeon and researcher involved in the
development of surgical meshes, even outside the specific context of pelvic organ
prolapse, Dr. Klinge is qualified to offer his opinion here.
The Court now turns to the reliability of his proposed testimony.2 The
Defendants make several arguments that this Court should exclude Dr.
2 The Plaintiff concedes that they will abide by the MDL court’s ruling
excluding Dr. Klinge’s opinions as to the Defendants’ knowledge or state of
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Klinge’s testimony regarding alternative designs. In particular, the
Defendants argue that: (1) the alternative mesh product referenced by Dr.
Klinge—PVDF—was not on the market when the Plaintiff received her Prolift
implantation; (2) Dr. Klinge’s opinion is not based on scientific literature; (3)
Dr. Klinge’s opinion is speculative for lack of sufficient testing and data; and
(4) that his testimony does not fit the facts of the case here, as the case-specific
experts did not suggest Dr. Klinge’s suggested alternatives could be used.
(Defs.’ Br. in Supp. of Defs.’ Mot. to Exclude Dr. Klinge at 2–10, 11–12.) The
Court finds the Defendants’ first and fourth arguments unpersuasive. First,
whether or not the PVDF mesh was commercially available at the time of the
Plaintiff’s surgery does not bear on the “feasibility of a safer an equally
efficacious design[.]” Banks, 264 Ga. at 735. Further, the Defendants’
contention that such alternative products could not have lessened the
Plaintiff’s injuries are matters best-suited for the cross-examinations of Dr.
Klinge and any of the Plaintiff’s case-specific experts.
However, the Defendants’ other arguments are more convincing. In
particular, after the Defendants claimed that Dr. Klinge’s opinion’s on PVDF
are not supported by testing or the scientific literature, the Plaintiff appears
to cite a report by Dr. Klinge from a different case, referencing a statement on
page 37 of a 32-page document. (See Pl.’s Br. in Opp’n to Def.’s Mot. to Exclude
mind. (Pl.’s Br. in Opp’n to Defs.’ Mot. to Exclude Dr. Klinge, at 19–20.)
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Dr. Klinge, at 9.) In fact, the only statement of Dr. Klinge’s that appears to
have basis in a scientific study is the statement that Ethicon’s PVDF mesh
experienced less degradation than those made of polypropylene. (Dr. Klinge
Report, at 18–19.) Given Dr. Klinge’s experience, he seems to argue that
polypropylene mesh undergoes more degradation and creates more of an
inflammatory response. (Id. at 19.) Because this is the only opinion regarding
PVDF with reference to scientific studies, this is the extent to which Dr. Klinge
can compare the Defendants’ product at issue with PVDF alternatives.
Regarding his opinions comparing the Prolift with the Ultrapro product, the
Plaintiff again cites Dr. Klinge’s opinions that do not appear in his report for
this case. (See Pl.’s Br. in Opp’n to Def.’s Mot. to Exclude Dr. Klinge, at 14.)
The report includes no statement explicitly opining on Ultrapro’s safety in
comparison to Prolift, and references to depositions of other scientists or
internal documents are not sufficiently reliable under Daubert in this context.
Given these deficiencies, any testimony explicitly comparing the relative safety
of Ultrapro to Prolift is excluded. See Mason, 2021 WL 2580165, at *5 (“While
Dr. Klinge generally discusses what Ethicon knew about Ultrapro mesh, he
does not opine Ultrapro mesh is a safer alternative.”).
Finally, the Defendants seek to exclude Dr. Klinge’s testimony
regarding mesh fraying and particle loss, largely attacking the sufficiency of
the data underlying his opinion. (Defs.’ Br. in Supp. of Defs.’ Mot. to Exclude
Dr. Klinge, at 13–16.) As an example, Dr. Klinge discusses in his report that a
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different type of mesh has an unsealed edge with frayed edges that can harm
patients. (Dr. Klinge Report, at 22–23.) However, the Defendants fault Dr.
Klinge for failing to cite any studies showing the Prolift’s mesh is subject to
fraying. (Defs. Reply Br. in Supp of Defs.’ Mot. to Exclude, at 11.) These are
disputes better settled through testimony and cross-examination. Dr. Klinge’s
report has a sufficiently reliable discussion of potential fraying and the harms
associated with that fraying. (Dr. Klinge Report, at 14–15, 19–23.) The
Defendants can raise these challenges to his testimony and his extrapolation
from other meshes on the stand. Thus, the Defendants’ Motion to Exclude Dr.
Klinge is granted in part and denied in part.
B. The Defendants’ Experts
The Plaintiff has filed six Daubert motions against the Defendants’
proposed experts. Five of these experts are “general experts,” and one is an
alternative general expert offering testimony on the procedures and policies of
the Food and Drug Administration and industry best practices. As with the
Defendants’ Motions, the Court will adopt prior rulings of the MDL court
where appropriate.
i. Dr. Sepulveda-Toro
Dr. Jaime Sepulveda-Toro is a board-certified OB/GYN who specializes
in female pelvic medicine and reconstructive surgery. (Dr. Sepulveda-Toro
Report, at 1.) The MDL court previously ruled on a Motion to Exclude Dr.
Sepulveda-Toro by the Plaintiff, and she asks this Court to adopt that ruling.
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(Pl.’s Mot. to Exclude Dr. Sepulveda-Toro, Ex. B; id. at 1–2.) The Defendants
claim that “despite asking this Court to adopt the MDL Court’s rulings in this
case, Plaintiff ignores certain of those rulings and simply reasserts the exact
arguments made by MDL Plaintiffs that the MDL Court rejected.” (Defs.’ Br.
in Opp’n to Pl.’s Mot. to Exclude Dr. Sepulveda-Toro, at 3.) The Plaintiff does
appear to raise challenges already decided by the MDL court. For example,
Judge Goodwin ruled that Dr. Sepulveda-Toro could testify about the forces
experienced by explanted mesh. (Pl.’s Mot. to Exclude Dr. Sepulveda-Toro, Ex.
B, at 9.) However, the Plaintiff seeks to have this testimony excluded. (Id. at
6.) After review, this Court adopts the well-reasoned rulings of Judge Goodwin
as its own. However, the Court provides one clarification. Judge Goodwin
denied the Plaintiff’s challenge as it related to Dr. Sepulveda-Toro’s design
opinions, finding that his report did not express “any opinions about the
process of designing a product.” (Id., Ex. B, at 7.) Here, it appears the Plaintiff
seeks to exclude Dr. Sepulveda-Toro’s opinion as to the adequacy of the pelvic
organ prolapse products’ designs because he “is not a biomedical engineer[,] nor
did he play any role in the design of the medical devices at issue.” (Id. at 4.)
Though he is not a biomedical engineer, he is a physician with deep experience
using these devices. Insofar as his Report includes opinions regarding the
product’s design and defects, these references are supported by peer-reviewed
studies and his own experience. (See Dr. Sepulveda-Toro Report, at 15, 18.)
Thus, Dr. Sepulveda-Toro can opine on the design and lack of defects from his
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experience. However, the Court reminds the parties that the experts’
testimonies are limited to the confines of their reports, and subsequent
challenges may be made to testimony as to matters not discussed in the Report.
Judge Goodwin reserved ruling on Dr. Sepulveda-Toro’s proposed
testimony regarding the adequacy of Ethicon’s product brochures. (Pl.’s Mot.
to Exclude Dr. Sepulveda-Toro, Ex. B, at 8–9.) The Plaintiff faults Dr.
Sepulveda-Toro for lacking experience in drafting these types of brochures. (Id.
at 5–6.) But that experience is unnecessary to describe his understanding of
potential risks and defects associated with the Defendants’ products and
determine whether the brochures address those risks. As such, the Plaintiff’s
Motion is denied as to this issue.3
ii. Dr. Schlafstein
Dr. Barry Schlafstein is an OB/GYN specializing in female pelvic
medicine and reconstructive surgery. (Dr. Schlafstein Report, at 2.) In addition
to his practice, Dr. Schlafstein also serves as a Clinical Assistant Professor at
the Medical College of Georgia. (Id.) He has deep experience utilizing both
surgical and non-surgical interventions in treating pelvic organ prolapse. (Id.
Judge Goodwin reserved ruling on two other issues in a section he
entitled “Recurring Issues” and included in many other Daubert rulings. (Pl.’s
Mot. to Exclude Dr. Sepulveda-Toro, Ex. B, at 12–13.) Because those issues
appear irrelevant here, any challenge on those grounds is denied as moot.
Where the issues described in Judge Goodwin’s “Recurring Issues” section are
not explicitly raised with regards to the experts in these proceedings, the Court
denies those challenges as moot. Should those issues recur in the course of
these proceedings, the parties may raise challenges addressing those issues.
21
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at 3.) As with Dr. Sepulveda-Toro, the Plaintiff notes Judge Goodwin’s previous
Daubert ruling with regards to Dr. Schlafstein’s testimony and asks this Court
to adopt that order. (Pl.’s Mot. to Exclude Dr. Schlafstein, at 1–2.) Further, the
Plaintiff asks this Court to exclude “any opinions related to design of the
subject products” offered by Dr. Schlafstein. (Id. at 5.) The Defendants also ask
this Court to adopt the MDL court’s previous Daubert ruling on Dr. Schlafstein
and argue that Judge Goodwin’s ruling already settled the scope of Dr.
Schlafstein’s opinions related “to the clinical risks and benefits of these
products[.]” (Defs.’ Br. in Opp’n to Pl.’s Mot. to Exclude Dr. Schlafstein, at 2–
4.)
After review, the Court adopts Judge Goodwin’s well-reasoned Daubert
ruling as to Dr. Schlafstein. This Court shares Judge Goodwin’s confusion as
to the Plaintiff’s definition of “design opinions,” as the Plaintiff does not specify
what types of design opinions she seeks to exclude. The Defendants note that
“Dr. Schlafstein’s opinions go to the clinical safety and effectiveness of Prolift.”
(Id. at 4.) In his report, Dr. Schlafstein does offer opinions as to potential flaws
in the mesh’s properties and bases these opinions on his clinical experience.
(Dr. Schlafstein Report, at 19.) To the extent the Plaintiff challenges these
opinions, her motion is denied. As a physician and professor, Dr. Schlafstein’s
experience is sufficiently reliable to allow him to testify as to the clinical risks
and benefits of using Prolift and his understanding of the scientific literature
on the topic. As he notes in his report, he “does not profess to be an expert in”
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product design, and he does not appear to offer opinions based on factors
outside of his clinical experience and review of the scientific literature on these
devices. If his testimony escapes the boundaries of his report and relevant
experience, the Plaintiff may raise a subsequent challenge to that testimony.
Until such a time, the Plaintiff’s Motion to Exclude Dr. Schlafstein is denied.
iii. Dr. Thames
Dr. Shelby Thames is a polymer chemist offered by the Defendants to
testify “regarding Prolene, the proprietary blend of polypropylene used in
Ethicon’s devices indicated for the treatment of pelvic organ prolapse,
including Prolift.” (Defs.’ Br. in Opp’n to Pl.’s Mot. to Exclude Dr. Thames, at
1–2.) The Plaintiff seeks to exclude two areas of Dr. Thames’ potential
testimony. First, the Plaintiff argues that Dr. Thames should not be permitted
to provide “opinions with respect to Ethicon’s compliance with design control
and risk management standards.” (Pl.’s Mot. to Exclude Dr. Thames, at 5.)
However, the Plaintiff does not identify specific opinions on this topic from Dr.
Thames’ report, and the Defendants argue that this challenge should be denied
as moot because those opinions do not exist. (Defs.’ Br. in Opp’n to Pl.’s Mot. to
Exclude Dr. Thames, at 3–4.) The Plaintiff does not address these arguments
in her reply brief. As a result, the Court denies her motion as to design control
and risk management standards as moot. Second, the Plaintiff seeks to exclude
Dr. Thames’ testimony regarding the Prolift’s alleged in vivo degradation that
conflicts with the testimony of Ethicon’s corporate witness. (Pl.’s Mot. to
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Exclude Dr. Thames, at 7.) In her view, because Dr. Thames’ “opinions
concerning Prolene’s propensity to degrade wholly contradict the testimony of
Ethicon’s corporate representative,” those opinions should be excluded. (Id. at
10.) But the Plaintiff does not identify any binding precedent for treating the
opinions of corporate representatives as equivalent to judicial admissions.
Instead, the Plaintiff cites various district court opinions supporting such a
rule. (Id. at 7–10; Pl.’s Reply Br. in Supp. of Pl.’s Mot. to Exclude Dr. Thames,
at 2–3.) The Court finds that no such rule exists in the Eleventh Circuit, and
it will not create one here. If Dr. Thames’ testimony differs from that of the
corporate representative, the Plaintiff can seek to impeach the witness’
credibility or seek discovery sanctions for failure to adequately prepare the
corporate representative. See, e.g., Federal Deposit Ins. Corp. v. Hutchins,
2013 WL 12109446, at *6 n.11 (N.D. Ga. Oct. 25, 2013). Thus, the Plaintiff’s
motion is denied.
iv. Dr. Lowman
Dr. Joye Lowman is a board-certified OB/GYN with a subspecialty in
female pelvic medicine and reconstructive surgery. (Dr. Lowman General
Report, at 1.) She has performed over 2800 prolapse surgeries, 150 of which
have utilized the Prolift device. (Id. at 2.) The Defendants are offering Dr.
Lowman as both a general and case-specific expert here, and Judge Goodwin
previously issued a narrow ruling on her general opinions, which this Court
adopts. See In re: Ethicon, Inc., 2016 WL 4962342 (S.D. W. Va. Aug. 25, 2016).
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In that order, Judge Goodwin reserved ruling on whether to exclude Dr.
Lowman’s testimony regarding “an encounter with a colleague whose patient
died during an abdominal sacral colpopexy.” Id. at *3. The Defendants claim
that this specific anecdote will not be offered at trial. (Defs.’ Br. in Opp’n to
Pl.’s Mot. to Exclude Dr. Lowman, at 11.) Accordingly, the Plaintiff’s motion is
denied as moot as to this issue.
In her Motion, the Plaintiff raises several new challenges to Dr.
Lowman’s proposed testimony. First, the Plaintiff asks this Court to exclude
Dr. Lowman’s testimony that Dr. Tackitt, the Plaintiff’s surgeon, did not rely
on the information for use during Plaintiff's treatment. (Pl.’s Mot. to Exclude
Dr. Lowman, at 4–7.) In her view, Dr. Lowman lacks a reliable methodology
for opining that Dr. Tackitt did not rely on the information for uses, especially
in light of Dr. Tackitt’s testimony that he did rely on the information for uses.
(Id. at 5–7.) In response, the Defendants seek to clarify the scope of Dr.
Lowman’s testimony on this topic, claiming that Dr. Lowman will testify that
“she believes Dr. Tackitt did not rely solely on the Prolift [information for use]
because he used a surgical technique that was not outlined in the [information
for use].” (Defs.’ Br. in Opp’n to Pl.’s Mot. to Exclude Dr. Lowman, at 5.) To the
extent Dr. Lowman’s testimony is limited in the manner described by the
Defendants—that Dr. Tackitt utilized a surgical procedure in the Plaintiff’s
case that was not included in the information for uses—the Plaintiff’s Motion
is denied. Dr. Lowman has sufficient experience to provide relevant and
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reliable testimony about the occurrence of a surgical procedure and whether
that procedure is included in an information for use. Any further testimony
regarding the extent of Dr. Tackitt’s reliance, or lack thereof, on the
information for uses shall be excluded. This reasoning aligns with the MDL
court’s rulings allowing experts to testify not to the adequacy of the
information for use but rather about the known risks of these procedures and
whether the information for uses describe those risks.4
Second, the Plaintiff challenges Dr. Lowman’s case-specific causation
opinion, arguing that she failed to perform a proper and reliable differential
diagnosis. (Pl.’s Mot. to Exclude Dr. Lowman at 7–11.) In particular, the
Plaintiff’s argues that Dr. Lowman’s failure to rule out her Prolift surgery as
a cause of her symptoms renders her opinion unreliable. (Id. at 11.) In
response, the Defendants claim that the Plaintiff misunderstands their burden
here, and that Dr. Lowman need not conduct a differential diagnosis at all.
(Defs.’ Br. in Opp’n to Pl.’s Mot. to Exclude Dr. Lowman, at 7.) According to the
Defendants, defense experts must merely raise plausible potential causes that
cast doubt on the Plaintiff’s experts. (Id.) Further, the Defendants claim the
MDL Court has issued rulings to this effect in other cases from this MDL. (Id.,
The Plaintiff seeks the exclusion of Dr. Lowman’s testimony as to the
adequacy of the information for uses, and the Defendants claim that Dr.
Lowman will not offer such testimony. (Pl.’s Mot. to Exclude Dr. Lowman, at
14–15; Defs.’ Br. in Opp’n to Pl.’s Mot to Exclude Dr. Lowman, at 2.) As such,
the Plaintiff’s Motion is denied as moot as to this issue.
26
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Ex. 3, at 4–5.) The Court finds the Defendants’ argument persuasive. The
Defendants have no burden to establish causation here. As such, the defense
experts are “tasked with giving testimony that affects the weight and
potentially the admissibility of the plaintiffs’ specific causation expert.” ( Id.,
Ex. 3, at 4.) Testimony from a defense expert based on her clinical experience
and knowledge following a review of the relevant materials is sufficiently
reliable and relevant to admit here, and after reviewing her Case-Specific
Report, the Court finds Dr. Lowman’s analysis satisfies this standard. As such,
Dr. Lowman’s case-specific causation testimony shall be admitted, and the
Plaintiff’s motions as to this issue is denied.
Finally, the Plaintiff argues that this Court should exclude Dr.
Lowman’s critical opinions of Dr. Tackitt’s surgical technique during the
Plaintiff’s second pelvic mesh surgery. (Pl.’s Mot. to Exclude Dr. Lowman, at
11–13.) The Plaintiff challenges Dr. Lowman’s criticisms because she “could
not point to any material whatsoever that provided any reliable basis for her
criticism of” Dr. Tackitt’s surgical technique while implanting the Pelvitex
mesh. (Id. at 12.) The Defendants respond by noting that Dr. Lowman’s opinion
is that Dr. Tackitt’s surgical technique, which involved suturing two different
mesh products together, was entirely novel and thus could not be supported by
literature. (Defs.’ Br. in Opp’n to Pl.’s Mot. to Exclude Dr. Lowman, at 9–10.)
In reply, the Plaintiff casts Dr. Lowman’s opinion regarding Dr. Tackitt’s
surgical technique “is the epitome of an opinion based on ipse dixit . . . .” (Pl.’s
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Reply Br. in Supp. of Pl.’s Mot. to Exclude Dr. Lowman, at 6.) But Dr.
Lowman’s criticisms are not pure ipse dixit. In her report, she explains the
potential risks of this technique: “Performing the procedure in this manner will
place the meshes on excessive tension, which can cause the mesh to bunch of
be pulled taught and can lead to pain.” (Dr. Lowman’s Case-Specific Report, at
43.) As such, there is no significant “analytical gap between the data and the
opinion proffered[,]” and such an opinion is admissible based on Dr. Lowman’s
surgical experience and stated analysis. General Elec. Co. v. Joiner, 522 U.S.
136, 146 (1997). As such, the Plaintiff’s Motion to Exclude Dr. Lowman is
denied.
v. Dr. Rosenblatt
Dr. Peter Rosenblatt is a board-certified urologist specializing in Female
Pelvic Medicine and Reconstructive Surgery. (Defs.’ Br. in Opp’n to Pl.’s Mot.
to Exclude Dr. Rosenblatt, at 1–2.) The Plaintiff seeks the exclusion of his
testimony on two topics: Dr. Rosenblatt’s opinions regarding the safety and
efficacy of mesh and testimony regarding the complication rates of patients in
his practice. (PL.’s Mot. to Exclude Dr. Rosenblatt, at 4, 11.) However, the
Plaintiff brought a nearly identical challenge to Dr. Rosenblatt’s safety and
efficacy testimony in the course of the MDL proceedings, which Judge Goodwin
denied. In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig., MDL 2327,
Doc. 2428, at 4–9; id., Doc. 3553, at 10. The Court adopts that ruling, and the
Plaintiff’s motion is denied as to this issue. With regards to testimony
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regarding the complication rates, the Defendants note that complication rates
were not included in Dr. Rosenblatt’s report, nor do they intend to ask him
about those rates. (Defs.’ Br. in Opp’n to Pl.’s Mot. to Exclude Dr. Rosenblatt,
at 9.) Acknowledging this limitation, the Defendants argue that “Dr.
Rosenblatt should be allowed to discuss his vast clinical experience with pelvic
mesh products, which may include general descriptors of the occurrence of
complications or revision procedures in the context of explaining their safety
and efficacy.” (Id. at 9.) Assuming Dr. Rosenblatt does not attempt to quantify
the complication rates in his practice in such a way that would lead the jury to
believe his estimates are based on anything more than his personal clinical
experience, the Plaintiff’s Motion is denied. The Court also notes that Dr.
Rosenblatt is limited to opinions included in his report, and any testimony
outside of those previously offered could be subject to subsequent Daubert
challenges.
vi. Mr. Ulatowski
Timothy Ulatowski served 36 years at the FDA and is now a consultant
on medical device regulations, FDA procedures, and industry best practices.
(Ulatowski Report, at 4.) The Defendants have submitted Ulatowski “as an
alternative retained expert that the defense would have used in place of one of
their Court[-]limited five (5) retained experts, but for Judge Goodwin’s ruling
that FDA evidence is excluded.” (Pl.’s Mot. to Exclude Mr. Ulatowski, Ex. A, at
2.) If Judge Goodwin’s previous ruling on FDA evidence “is revisited or
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reversed, then Defendants reserve the right to substitute Mr. Ulatowski in as
a retained expert.” (Id.) The Court finds no reason or occasion to revisit Judge
Goodwin’s previous rulings on FDA evidence. The Defendants argue that
“[u]nless and until this Court allows FDA evidence, . . . it is premature to rule
on Plaintiff’s challenges to Mr. Ulatowski.” (Defs.’ Br. in Opp’n to Pl.’s Mot. to
Exclude Mr. Ulatowski, at 3.) However, to the extent Ulatowski’s proposed
testimony exclusively relates to matters involving the FDA evidence, Judge
Goodwin’s previous rulings on the matter require this Court to grant the
motion. Any concerns about improper arguments by the Plaintiff requiring a
rebuttal from Mr. Ulatowski can be settled by motions in limine. See Williams,
2021 WL 1087808, at *4 n.5 (reaching the same conclusion).
IV.
Conclusion
For the reasons set forth above, the Court rules as follows:
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Sepulveda-Toro [Doc. 52] is DENIED.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Schlafstein [Doc. 53] is DENIED.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr. Thames
[Doc. 54] is DENIED.
•
The Plaintiff’s Unopposed Motion for Extension of Time [Doc. 72]
is GRANTED.
•
The Defendants’ Motion to Exclude Certain Case Specific
Opinions of Dr. Fitzgerald [Doc. 55] is GRANTED.
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Case 1:11-cv-03903-TWT Document 106 Filed 01/12/22 Page 31 of 31
•
The Defendants’ Motion to Limit the Expert Opinions of Dr.
Elliott [Doc. 56] is GRANTED in part and DENIED in part.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Lowman [Doc. 58] is DENIED.
•
The Plaintiff’s Motion to Exclude Certain Opinions of Dr.
Rosenblatt [Doc. 59] is DENIED.
•
The Plaintiff’s Motion to Exclude Timothy Ulatowski [Doc. 60] is
GRANTED.
•
The Defendants’ Motion to Exclude the Case-Specific Opinions of
Dr. Miklos [Doc. 61] is GRANTED.
•
The Defendants’ Motion to Exclude the Case-Specific Opinions of
Dr. Zipper [Doc. 89] is DENIED.
•
The Defendants’ Motion to Exclude Certain Opinions and
Testimony of Prof. Dr. Uwe Klinge [Doc. 90] is GRANTED in part
and DENIED in part.
SO ORDERED, this
12th
day of January, 2022.
______________________________
THOMAS W. THRASH, JR.
United States District Judge
31
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