Carroll v. Boston Scientific Corporation

Filing 105

MEMORANDUM OPINION AND ORDER (Daubert Motions) The 38 Motion to Exclude the Testimony of Michael Thomas Margolis, M.D. is GRANTED in part and DENIED in part; the 40 Motion to Exclude the Opinions and Testimony of Thomas Barker, Ph.D. is GRANT ED; the 44 Motion to Exclude the Opinions and Testimony of Jimmy Mays, Ph.D. is GRANTED; the 50 Motion to Exclude the Opinions and Testimony of Peggy Pence, Ph.D. is GRANTED in part, DENIED in part, and RESERVED in part; the 48 Motion to E xclude the Opinions and Testimony of Russell Dunn, Ph.D. is GRANTED; the 52 Motion to Exclude the Opinions and Testimony of Scott Guelcher, Ph.D. is GRANTED; the 51 Motion to Exclude the Opinions and Testimony of Richard Trepeta, M.D. is GR ANTED in part and DENIED in part; the 57 Motion to Strike and Exclude the Opinions and Testimony of Vladimir Iakovlev, M.D. is GRANTED; the 43 Motion to Exclude the Opinions and Testimony of Jerry Blaivas, M.D. is GRANTED in part and DENIED in part; and the 49 Motion to Exclude the Opinions and Testimony of Richard Bercik, M.D. is GRANTED in part and DENIED in part, as set forth herein. Plaintiff's motions are as follows: the 47 Motion to Exclude the Opinions and Testimony o f Gary L. Winn, Ph.D. is RESERVED; the 45 Motion to Exclude or Limit the Testimony of Christine Brauer, Ph.D. is GRANTED; the 56 Motion to Exclude the Testimony and Opinions of Dr. Stephen Spiegelberg, Ph.D. is GRANTED in part and DENIED in part; the 55 Motion to Exclude the Opinions and Testimony of Stephen F. Badylak, D.V.M., Ph.D., M.D. is DENIED; and 46 Motion to Limit the Opinions and Testimony of Lonny Green, M.D. is GRANTED in part and DENIED in part, as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 5/6/2016. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
CHERYL A. CARROLL,
Plaintiff,
v.

CIVIL ACTION NO. 2:13-cv-11601

BOSTON SCIENTIFIC CORPORATION,
Defendant.
MEMORANDUM OPINION AND ORDER
(Daubert Motions)
Pending before the court are several Daubert motions filed by both the
defendant and the plaintiff. Briefing is complete regarding these motions, and the
motions are now ripe for consideration.
I.

Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel

on Multidistrict Litigation (“MDL”) concerning the use of transvaginal surgical mesh
to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the
seven MDLs, there are more than 75,000 cases currently pending, approximately
19,000 of which are in the Boston Scientific Corporation (“BSC”) MDL, MDL No. 2326.
The parties have retained experts to render opinions regarding the elements of the
case’s various causes of action, and the instant motions involve the parties’ efforts to
exclude or limit the experts’ opinions pursuant to Daubert v. Merrell Dow Pharm.,

Inc., 509 U.S. 579 (1993).
II.

Legal Standard
Under Rule 702 of the Federal Rules of Evidence, expert testimony is

admissible if the expert is “qualified . . . by knowledge, skill, experience, training, or
education” and if his testimony is (1) helpful to the trier of fact in understanding the
evidence or determining a fact in issue; (2) “based upon sufficient facts or data;” and
(3) “the product of reliable principles and methods” that (4) have been reliably applied
“to the facts of the case.” Fed. R. Evid. 702. The Supreme Court has established a twopart test to govern the admissibility of expert testimony under Rule 702: the evidence
is admitted if it “rests on a reliable foundation and is relevant.” Daubert, 509 U.S. at
597. The proponent of expert testimony does not have the burden to “prove” anything
to the court. Md. Cas. Co. v. Therm-O-Disk, Inc., 137 F.3d 780, 783 (4th Cir. 1998).
He or she must, however, “come forward with evidence from which the court can
determine that the proffered testimony is properly admissible.” Id.
The district court is the gatekeeper. “[E]xpert witnesses have the potential to
be both powerful and quite misleading,” so the court must “ensure that any and all
scientific testimony . . . is not only relevant, but reliable.” Cooper v. Smith & Nephew,

Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Westberry v. Gislaved Gummi AB, 178
F.3d 257, 261 (4th Cir. 1999); Daubert, 509 U.S. at 588, 595). In carrying out this role,
I “need not determine that the proffered expert testimony is irrefutable or certainly
correct”—“[a]s with all other admissible evidence, expert testimony is subject to
testing by ‘vigorous cross-examination, presentation of contrary evidence, and careful

2

instruction on the burden of proof.’” United States v. Moreland, 437 F.3d 424, 431
(4th Cir. 2006) (quoting Daubert, 509 U.S. at 596); see also Md. Cas. Co., 137 F.3d at
783 (noting that “[a]ll Daubert demands is that the trial judge make a ‘preliminary
assessment’ of whether the proffered testimony is both reliable . . . and helpful”).

Daubert mentions specific factors to guide the court in making the overall
reliability determinations that apply to expert evidence. These factors include (1)
whether the particular scientific theory “can be (and has been) tested;” (2) whether
the theory “has been subjected to peer review and publication;” (3) the “known or
potential rate of error;” (4) the “existence and maintenance of standards controlling
the technique’s operation;” and (5) whether the technique has achieved “general
acceptance” in the relevant scientific or expert community. United States v. Crisp,
324 F.3d 261, 266 (4th Cir. 2003) (quoting Daubert, 509 U.S. at 593–94). Despite
these factors, “[t]he inquiry to be undertaken by the district court is ‘a flexible one’
focusing on the ‘principles and methodology’ employed by the expert, not on the
conclusions reached.” Westberry, 178 F.3d at 261 (quoting Daubert, 509 U.S. at 594–
95); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) (“[T]he factors
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.” (citation omitted)); Crisp, 324 F.3d at 266 (noting “that testing of
reliability should be flexible and that Daubert’s five factors neither necessarily nor
exclusively apply to every expert”).
With respect to relevance, the second part of the analysis, Daubert further

3

explains:
Expert testimony which does not relate to any issue in the case is not
relevant and, ergo, non-helpful. The consideration has been aptly
described by Judge Becker as one of fit. Fit is not always obvious, and
scientific validity for one purpose is not necessarily scientific validity for
other, unrelated purposes. . . . Rule 702’s helpfulness standard requires
a valid scientific connection to the pertinent inquiry as a precondition to
admissibility.

Daubert, 509 U.S. at 591–92 (citations and quotation marks omitted).
Ultimately, the district court has broad discretion in determining whether to
admit or exclude expert testimony, and the “the trial judge must have considerable
leeway in deciding in a particular case how to go about determining whether
particular expert testimony is reliable.” Cooper, 259 F.3d at 200 (quoting Kumho Tire,
526 U.S. at 152).
III.

Preliminary Matters

I begin by addressing a few preliminary matters that affect many of the

Daubert motions. First, both parties consistently challenge experts’ opinions as
improper state-of-mind or legal-conclusion testimony. As I have maintained
throughout these MDLs, I will not permit the use of experts to usurp the jury’s factfinding function by allowing an expert to testify as to a party’s knowledge, state of
mind, or whether a party acted reasonably. See, e.g., In re C. R. Bard, Inc., 948 F.
Supp. 2d 589, 611 (S.D. W. Va. 2013) (excluding expert opinions on the defendant’s
knowledge, state of mind, alleged bad acts, failures to act, and corporate conduct and
ethics). The reasonableness of conduct and a party’s then-existing state of mind “are
the sort of questions that lay jurors have been answering without expert assistance

4

from time immemorial,” and therefore, these matters are not appropriate for expert
testimony. Kidder v. Peabody & Co. v. IAG Int’l Acceptance Grp., N.V., 14 F. Supp.
2d 391, 404 (S.D.N.Y. 1998); see also In re Rezulin Prods. Liab. Litig., 309 F. Supp.
2d 531, 546 (S.D.N.Y. 2004) (“Inferences about the intent and motive of parties or
others lie outside the bounds of expert testimony.”).1 Likewise, “opinion testimony
that states a legal standard or draws a legal conclusion by applying law to the facts
is generally inadmissible.” United States v. McIver, 470 F.3d 550, 562 (4th Cir. 2006).
An expert may not state his opinion using “legal terms of art,” such as “defective,”
“unreasonably dangerous,” or “proximate cause.” See Perez v. Townsend Eng’g Co.,
562 F. Supp. 2d 647, 652 (M.D. Pa. 2008).
I have diligently applied these rules to previous expert testimony, and I
continue to apply them in this case. This does not mean that each objection to stateof-mind or legal-conclusion testimony raised in these motions is valid. But I will not
parse the numerous reports and thousand-page depositions for each expert to
determine the validity of these same objections. Instead, the onus is on counsel to
tailor expert testimony at trial in accordance with the above directive. Therefore,
unless otherwise necessary, the remainder of this opinion does not address objections
brought against an expert based on improper state-of-mind or legal-conclusion
testimony.

On a related note, I caution the parties against introducing corporate evidence through expert
witnesses. Although an expert may testify about his review of internal corporate documents solely for
the purpose of explaining the basis for his or her opinions—assuming the opinions are otherwise
admissible—he or she may not be offered solely as a conduit for corporate information. There is no
reason why the plaintiffs require an expert to opine on such facts.
1

5

I also note that several of the Daubert motions concern expert opinions entirely
unrelated to the individual plaintiff at bar. For example, some experts have opined
on general and specific causation with the specific causation portion of the opinion
pertaining to wave plaintiffs other than the plaintiff in this particular case. In
addition, the parties filed a total of fifteen Daubert motions involving, in many
instances, duplicative experts. In an effort to remedy this problem of blanketed,
duplicative Daubert motions, I directed the parties to file disclosures, indicating who,
out of the seventeen challenged experts, they plan to call at trial for each case. See
Pretrial Order No. 121, at 5–6 [ECF No. 58]. Through these disclosures, I hoped to
gain a better understanding of the particular arguments at issue, thereby refining
my Daubert rulings for the benefit of the receiving judge. Rather than aiding the
court in this endeavor, however, the parties effectively ignored the pretrial order,
identifying all seventeen of the challenged experts as probable expert witnesses. See
BSC’s Disclosure Required by Pretrial Order No. 121 [ECF No. 61]; Pl.’s Disclosure
Required by Pretrial Order No. 121 [ECF No. 64]. Without guidance from the parties
to the contrary, I have thus limited my review of the Daubert motions to only those
arguments and opinions related to the instant plaintiff. In other words, I disregard
arguments included in the briefing directed exclusively at other wave plaintiffs and,
consequently, irrelevant to this case.
Finally, I am compelled to comment on the parties’ misuse of my previous

Daubert rulings on several of the experts offered in this case. See generally Sanchez
v. Boston Sci. Corp., No. 2:12-cv-05762, 2014 WL 4851989 (S.D. W. Va. Sept. 29,

6

2014); Tyree v. Boston Sci. Corp., 54 F. Supp. 3d 501 (S.D. W. Va. 2014); Eghnayem

v. Boston Sci. Corp., 57 F. Supp. 3d 658 (S.D. W. Va. 2014). The parties have, for the
most part, structured their Daubert arguments as a response to these prior rulings,
rather than an autonomous challenge to or defense of an expert’s opinion based on its
reliability and relevance. In other words, the parties have comparatively examined
each expert’s opinions and have largely overlooked Daubert’s core considerations for
assessing expert testimony. Although I recognize the tendency of my prior evidentiary
determinations to influence subsequent motions practice, counsels’ expectations that
I align with these previous rulings when faced with a different record are remiss,
especially when an expert has issued new reports and given additional deposition
testimony.
Mindful of my role as gatekeeper of expert testimony, as well as my duty to
“respect[ ] the individuality” of each MDL case, see In re Phenylpropanolamine Prods.

Liab. Litig., 460 F.3d 1217, 1231 (9th Cir. 2006), I refuse to credit Daubert arguments
that simply react to the court’s rulings in Sanchez and its progeny. Indeed, I feel
bound by these earlier cases only to the extent that the expert opinions and Daubert
objections presented to the court then are identical to those presented now.
Otherwise, I assess the parties’ Daubert arguments anew. That is, in light of the
particular opinions and objections currently before me, I assess “whether the
reasoning or methodology underlying the testimony is scientifically valid” and
“whether that reasoning or methodology properly can be applied to the facts in issue.”

Daubert, 509 U.S. at 592–93. Any departure from Sanchez, Eghnayem, or Tyree does

7

not constitute a “reversal” of these decisions and is instead the expected result of the
parties’ submission of updated expert reports and new objections to the opinions
contained therein.
IV.

BSC’s Daubert Motions
In this case, BSC seeks to limit or exclude the expert opinions of Drs. Michael

Thomas Margolis, Thomas Barker, Jimmy Mays, Peggy Pence, Russell Dunn, Scott
Guelcher, Richard Trepeta, Vladimir Iakovlev, Jerry Blaivas, and Richard Bercik.
A. Michael Thomas Margolis, M.D.
BSC seeks to exclude the testimony of Michael Thomas Margolis, M.D. Dr.
Margolis is a pelvic floor surgeon and urogynecologist who offers general causation
opinions in this case.
1. Failure to Consider Studies

First, BSC challenges Dr. Margolis’s failure to consider contrary studies. Dr.
Margolis has explained his methodology for giving less credence to certain studies
than to others. Dr. Margolis states that he has examined other studies that counter
his own opinions. To the extent the defendant challenges the reasons Dr. Margolis
offers for not relying on certain studies, such challenges go to the weight of Dr.
Margolis’s opinions, not their admissibility. The defendant is free to cross-examine
Dr. Margolis regarding studies that cut against his opinions. The defendant’s motion
is DENIED on this point.

Second, BSC challenges Dr. Margolis’s opinion that there is a greater than 50
percent complication rate of pain in women with polypropylene mesh and slings. In

8

his deposition, Dr. Margolis acknowledges that contrary studies exist, and I do not
doubt that Dr. Margolis reviewed contrary studies. However, his methodology may
be flawed if he does not provide an adequate explanation for why he disagrees with
those studies. There is no such explanation in this case. Therefore, Dr. Margolis’s
opinion that more than 50 percent of women implanted with mesh experience pain is
EXCLUDED as unreliable. This aspect of BSC’s motion is GRANTED.

Third, BSC challenges Dr. Margolis’s general opinions that complications in
women with polypropylene mesh products are high. Dr. Margolis explains that, when
forming his opinion about the complication rates of a medical procedure, he gives the
benefit of the doubt to the patient. In other words, he assumes the worst-case scenario
and errs on the side of opining as to a higher complication rate to better protect a
patient. This is not a reliable, scientific basis for determining the complication rates
associated with a mesh device. The plaintiff has failed to demonstrate that Dr.
Margolis has sufficient scientific support to opine as to these generalized statements.
Therefore, this testimony is EXCLUDED, and this part of BSC’s motion is
GRANTED.
2. Lack of Scientific Basis
BSC also argues that Dr. Margolis failed to provide any scientific basis for his
other opinions and that he based these opinions on his personal experience alone. The
plaintiff does not address the majority of BSC’s arguments on this point, and I decline
to raise counterarguments for the plaintiff when she has failed to address BSC’s
arguments in her briefing. Dr. Margolis may not solely rely on his personal

9

observations when he seeks to provide broad opinions, such as the infection rate in
women with mesh. The plaintiff has not “come forward with evidence from which the
court can determine that the proffered testimony is properly admissible.” Md. Cas.

Co. v. Therm-O-Disk, Inc., 137 F.3d 780, 783 (4th Cir. 1998). Therefore, the following
opinions from Dr. Margolis are EXCLUDED: (1) that the Burch procedure is more
effective than polypropylene mesh slings; (2) that Xenform slings are more effective
than polypropylene slings; (3) that the infection rate of polypropylene mesh is up to
100 percent; (4) that the complication rate of urethral obstruction is greater than 10
percent with polypropylene mid-urethral slings; and (5) that he has removed 10 to 15
percent of BSC products. These portions of BSC’s motion are GRANTED.
Unlike the above opinions, the plaintiff appears to respond to BSC’s argument
concerning Dr. Margolis’s opinion about a lack of scientific support for the use of
mesh. The plaintiff contends that Dr. Margolis merely opines that there is a lack of

long-term data. Contradictions in testimony should be addressed on crossexamination. 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.”).
Therefore, I do not exclude Dr. Margolis’s opinion on a lack of long-term data on
reliability grounds.2 Therefore, BSC’s motion regarding this opinion is DENIED.

The plaintiffs in prior cases have responded to this same challenge in a different way. See Sanchez,
2014 WL 4851989, at *14; Tyree, 54 F. Supp. 3d at 519–27; Eghnayem, 57 F. Supp. 3d at 676–80.
Instead of focusing on long-term data, those plaintiffs informed the court that Dr. Margolis never
opined that there was no data supporting the benefits of polypropylene mesh, but just that there was
no credible data on this subject. In those cases, I excluded Dr. Margolis’s opinion because “it [was] still
unclear why Dr. Margolis believe[d] th[o]se studies lack[ed] credibility.” Sanchez, 2014 WL 4851989,
2

10

3. Expertise
BSC argues that Dr. Margolis offers opinions outside the scope of his
qualifications on (1) biomaterials; (2) polypropylene degradation; (3) foreign body
reaction; (4) adequate pore size; (5) adequate weight of polypropylene; (6)
biocompatibility of polypropylene; (7) medical device design and development; and/or
(8) marketing. The plaintiff fails to provide any argument addressing how Dr.
Margolis is an expert on any of the above subject matters, beyond the basic assertion
that Dr. Margolis is an established urogynecologist with years of experience with
pelvic mesh products. I will not make arguments for the plaintiff. Therefore, this
aspect of BSC’s motion is GRANTED.
4. Undisclosed Opinions
Finally, BSC argues that Dr. Margolis seeks to offer opinions that were not
disclosed in his expert report and that Dr. Margolis seeks to discuss materials that
were not cited to in his expert report. Testimony on direct examination using such
undisclosed sources as support for his opinions is EXCLUDED on Rule 26 grounds.
However, the court notes that two articles that BSC alleges were not disclosed—

Vaginal Mesh Contraction: Definition, Clinical Presentation and Management and
Surgical Management of Pelvic Organ Prolapse in Women—were included in Dr.
Margolis’s relied-upon list. Dr. Margolis’s testimony on these two articles is not
excluded under Daubert. Therefore, I find that this aspect of BSC’s motion is
GRANTED in part and DENIED in part.

at *14.

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For the reasons stated above, I GRANT in part and DENY in part BSC’s
Motion to Exclude the Testimony of Michael Thomas Margolis, M.D.
B. Thomas H. Barker, Ph.D.
The plaintiff offers Dr. Barker as a biomaterials expert. He seeks to testify as
to general opinions, such as those related to the biocompatibility of polypropylene
mesh, mesh degradation, scar formation, mesh design, and mesh testing.
1. Reliability

a. Mechanical Mismatch
Dr. Barker opines that there is a mechanical mismatch between vaginal tissue
and BSC mesh. I find this opinion to be unreliable. In comparing the elastic moduli
of vaginal tissue to that of mesh in order to support his opinion as to a mismatch, Dr.
Barker relied on a study finding six to seven kilopascals for vaginal tissue. However,
he admits that he has no scientific basis for forming a kilopascal number for BSC
mesh. Such an opinion rests on an unreliable basis. To the extent that Dr. Barker
merely opines that vaginal tissue and polypropylene mesh are not composed of the
same material, such an opinion is not helpful to a jury. Dr. Barker’s opinion that a
mechanical mismatch exists is EXCLUDED.

b. Mechanical Performance Findings
Dr. Barker’s opinions on the clinical consequences resulting from the alleged
mechanical mismatch between the mesh and the human body are EXCLUDED as
unreliable as well. His opinion on the mechanical mismatch generally is excluded,

12

and, thus, any derivative opinions are also unreliable. Such opinions are too
speculative to be deemed reliable under Daubert.
Moreover, with respect to mesh deformation in particular, BSC challenges Dr.
Barker’s opinion that BSC testing revealed approximately 35 percent to 52 percent
of deformation in its mesh samples. However, when questioned about this topic at his
deposition, Dr. Barker admitted that he is unsure whether this testing was done
exclusively on BSC products. This deposition testimony further reveals the
unreliability of Dr. Barker’s methodology. BSC’s motion with respect to Dr. Barker’s
opinions on the clinical effects of a mechanical mismatch between BSC mesh and
vaginal tissue is GRANTED.
In conclusion, BSC’s Motion to Exclude the Opinions and Testimony of Thomas
H. Barker, Ph.D. is GRANTED.
C. Jimmy W. Mays, Ph.D.
Dr. Mays is a Distinguished Professor of Chemistry at the University of
Tennessee who offers general causation opinions on the following issues: (1) the
chemical structure and properties of polypropylene; (2) degradation of polypropylene
by thermo-oxidative processes and in vivo; and (3) the effect of in vivo degradation on
the polypropylene implant.3
BSC argues that Dr. Mays’s opinions should be excluded because his

As an initial matter, BSC attempts to incorporate by reference its Daubert objections to Dr. Mays’s
general causation opinions offered in Sanchez v. Boston Scientific Corp. BSC does not inform the court
what these objections are or attach the Sanchez motion. Further, the expert report offered in Sanchez
was authored by both Dr. Mays and Dr. Gido and is not identical to the report offered in the present
case. Accordingly, I will not address the objections made in Sanchez and instead rule solely on the
issues currently before me.
3

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thermogravimetric analysis (“TGA”) did not replicate the in vivo environment. Dr.
Mays produced certain results while testing polypropylene at very high
temperatures. He then concluded that the same results will occur inside the human
body at much lower temperatures, but he did not provide any explanation or support
for his opinion. These derivative conclusions are not the product of reliable principles
and methods. Dr. Mays failed to demonstrate a reliable connection between his TGA
results and his conclusions about polypropylene degradation in the human body.
Accordingly, BSC’s Motion to Exclude the Opinions and Testimony of Jimmy W.
Mays, Ph.D. is GRANTED, and Dr. Mays’s general causation opinions based on his
TGA are EXCLUDED.
D. Peggy Pence, Ph.D.
Dr. Pence works as a clinical and regulatory consultant, providing advice,
guidance, and product development services to pharmaceutical/biopharmaceutical
and medical device companies in the areas of strategic planning, preclinical testing,
clinical trials, design and conduct, and regulatory matters involving the FDA.
1. Qualifications
BSC maintains that Dr. Pence’s work as a researcher and consultant on the
development of medical products does not qualify her to opine about the safety and
efficacy of mesh products, as she attempts to do in her expert report. Dr. Pence has
over forty years of experience in the research and development of medical devices.
Over that time, she has accumulated knowledge that is relevant to this case, such as
the design of clinical trials for diseases of the female genital system, the clinical

14

testing of novel medical devices, and the content of product labeling. Accordingly, I
FIND that Dr. Pence is qualified to render the opinions set forth in her expert report.
2. General Objections
I begin by addressing two objections that BSC raises multiple times
throughout its motion, all related to the reliability of the authoritative sources
underlying Dr. Pence’s opinions, which include a 2006 study by the French National
Authority for Health (“HAS”), the recommendations of the National Institute for
Health and Care Excellence (“NICE”), and the various guidance documents drafted
by the Global Harmonization Task Force (“GHTF”).4 BSC has not cited any case
suggesting that the binding effect of industry standards dictates their reliability.
Indeed, the Seventh Circuit Court of Appeals has suggested the opposite:
[T]he relevant question for admissibility purposes is not whether
the . . . guidelines are controlling in the sense of an industry code, or
even how persuasive they are. It is only whether consulting them is a
methodologically sound practice on which to base an expert opinion in
the context of this case.

Lees v. Carthage Coll., 714 F.3d 516, 525 (7th Cir. 2013). Accordingly, I give no import
to the non-binding nature of the HAS, NICE, and GHTF recommendations in my

Daubert analysis and instead focus on whether Dr. Pence’s reliance on these sources
constitutes a methodologically sound practice.

The GHTF, which was conceived in 1992 and replaced by the International Medical Device
Regulators Forum (“IMDRF”) in 2011, represented a partnership between regulatory authorities and
regulated industry and sought to achieve greater uniformity between national medical device
regulatory systems. The European Union, United States, Canada, Australia, and Japan were the
founding members, and these entities, as well as Brazil, China, Japan, and Russia, currently form the
Management Committee of the IMDRF. Dr. Pence relies on several GHTF “Final Documents” in
reaching her opinions.
4

15

BSC also attempts to equate GHTF standards with FDA regulations and
asserts that, like FDA regulations, admission of GHTF standards, which have
“regulatory purpose, history, and focus,” could confuse and mislead the jury. GHTF
standards do not carry the same prejudicial force—the government does not
promulgate them, manufacturers are not bound by them, and jurors are not familiar
with them. Although the FDA appears to have had a limited role in the activities of
the GHTF, that role was not instrumental or definitive, and the work of the GHTF
can be described without reference to the FDA. Accordingly, I FIND BSC’s argument
without merit.
3. Premarket Testing
Generally, BSC contends that none of the studies Dr. Pence relies on support
her opinion that BSC should have performed premarket clinical trials. My review of
the exhibits, however, indicates that several guidance documents supply a basis for
this opinion. Additionally, although the NICE and HAS studies are not as explicit as
the GHTF documents, they both emphasize the importance of clinical trials in
assessing a product’s safety for surgical use. Furthermore, all of these documents
carry the indicia of reliability set forth by Daubert: the conclusions were reached after
documented and validated testing, the results were published, and the testing was
conducted through a defined methodology described in each paper. Therefore, I FIND
Dr. Pence’s consultation of these sources in reaching her opinion both justified and
reliable.
Next, BSC argues that Dr. Pence’s report lacks a discussion of the GHTF

16

standard itself and how Dr. Pence’s application of that standard led her to form the
opinions contained in her report. These remaining arguments go to the weight of Dr.
Pence’s testimony, not its reliability, and are therefore better suited for crossexamination. In conclusion, I DENY BSC’s motion to exclude Dr. Pence’s opinion on
premarket clinical testing.
4. Product Labels
BSC asserts that to the extent Dr. Pence’s opinions on product labeling relate
to BSC’s deviation from the branding requirements of the Food, Drug, and Cosmetic
Act (“FDCA”), they should be excluded. I agree. As I have held several times in the
course of these MDLs, expert testimony about the requirements of the FDCA, which
are not at issue in this case, could lead to more confusion about the state tort claims
than enlightenment. I cannot admit Dr. Pence’s testimony as it relates to the FDCA
or FDA regulations. See Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 755 (S.D.
W. Va. 2014) (agreeing that “alleged shortcomings in FDA procedures are not
probative to a state law products liability claim”). These opinions are EXCLUDED.
This finding, however, does not result in the exclusion of Dr. Pence’s opinion
on product labeling altogether because, unlike in previous cases, Dr. Pence has a
second source of information that is unrelated to the FDA (i.e., the GHTF’s Label and

Instructions for Use for Medical Devices) which I must also consider in my analysis.
The GHTF document on product labels does not state—expressly or otherwise—that
manufacturers should include the severity, frequency, and permanency of adverse
events in a warning, nor does it state that a label should qualify the difficulty of
removing the device. Furthermore, Dr. Pence does not explain how this document
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could be interpreted as such. Seeing no non-FDA grounds for Dr. Pence’s opinion that
BSC should have included this particular information in its labels, I FIND it
unreliable, and it is therefore EXCLUDED.5
With respect to Dr. Pence’s remaining opinions on product labeling, BSC moves
for exclusion because Dr. Pence never spoke to any physicians about this issue. An
expert’s failure to examine a particular source of information is not grounds for
exclusion under Daubert so long as the expert has other “sufficient facts or data” to
support her opinion. Fed. R. Evid. 702. Here, Dr. Pence considered the GHTF’s Label

and Instructions for Use for Medical Devices, the DFU, several BSC internal
documents, and other medical and scientific literature. I find this collection of sources
sufficient for the purposes of Daubert. BSC has ample grounds to cross-examine and
impeach Dr. Pence at trial regarding any perceived oversights in her analysis.
5. Post-Market Vigilance
In arriving at her post-market vigilance opinions, Dr. Pence exclusively
considered data from the FDA’s MAUDE database.6 As I have previously explained,
BSC’s communication, or alleged lack thereof, with the FDA through the MAUDE
database has “no bearing on whether BSC provided adequate warnings or whether
its products were defective.” Sanchez, 2014 WL 4851989, at *36. Any opinion based

BSC raises this objection only to Dr. Pence’s opinions that the label should have included information
on the difficulty of mesh removal and the permanency, severity, and frequency of adverse events. My
holding is therefore limited to these specific opinions as well.
5

“The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters
(manufacturers, importers and device user facilities) and voluntary reporters such as health care
professionals, patients and consumers.” FDA, MAUDE—Manufacturer and User Facility Device
Experience, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm (last visited
April 3, 2016).
6

18

on data collected in the MAUDE database, which acts as an arm of the FDA, is not
helpful to the jury and is therefore inadmissible. See Fed. R. Evid. 702 (stating that
the expert’s specialized knowledge must “help the trier of fact to understand the
evidence or to determine a fact in issue”). Because Dr. Pence’s opinion on post-market
vigilance appears to be entirely based on data—or lack thereof—found in the MAUDE
database, I find it unreliable. Without a reliable basis, Dr. Pence’s opinion on BSC’s
inadequate post-market vigilance is EXCLUDED, and BSC’s motion on this matter
is GRANTED.
6. Final Caveat: Relevance
BSC argues that several of the standards Dr. Pence relies on were not
published until after the device at issue was marketed, making those standards
irrelevant to this case. I RESERVE ruling on this matter until trial.
In sum, BSC’s Motion to Exclude the Opinions and Testimony of Peggy Pence,
Ph.D. is GRANTED in part, DENIED in part, and RESERVED in part. BSC’s
objection to Dr. Pence’s opinions on the alleged carcinogenicity of polypropylene,
uncontested by the plaintiff, is GRANTED.
E. Russell Dunn, Ph.D.
Dr. Dunn is a registered professional engineer and the president and founder
of Polymer Chemical Technologies LLC, a company that focuses on process and
product design issues, process and product safety, and polymer product analysis.
BSC argues that Dr. Dunn is not qualified to offer opinions concerning the
design, risk management, or manufacture of polypropylene mesh devices. Dr. Dunn’s

19

company, Polymer Chemical Technologies LLC, has been involved in over 200
projects focusing on polymer product design; however, none of these projects has
involved a medical device. Dr. Dunn also teaches five different chemical engineering
courses at Vanderbilt University; however, he has never taught a course specific to
medical devices or polypropylene. Similarly, Dr. Dunn states that he has a
tremendous amount of experience assessing risk through Failure Mode and Effects
Analysis (“FMEA”), but then admits that he has never been involved in developing
an FMEA for a medical device. Finally, Dr. Dunn has authored many publications
throughout his career; however, not one of these publications examines medical
devices or how polypropylene behaves as part of a medical device.
All of Dr. Dunn’s opinions are premised on his belief that the polypropylene
mesh in BSC’s devices will undergo oxidative degradation in the body, yet Dr. Dunn
admits that he is not an expert in biomaterials or biocompatibility and that he is not
qualified to opine on the way polypropylene may affect the body physiologically. I find
that Dr. Dunn does not have the requisite skill, knowledge, training, education, or
experience to qualify as an expert in this case, and his opinions are EXCLUDED.
Accordingly, BSC’s Motion to Exclude the Opinions and Testimony of Russell Dunn,
Ph.D. is GRANTED.
F. Scott Guelcher, Ph.D.
Dr. Guelcher is a chemical engineer offered by the plaintiff to opine on how the
human body responds to polypropylene once it is implanted and the reactions that
occur on the surface of the implant. Dr. Guelcher’s opinions—to the extent they are

20

based on Dr. Dunn’s testing—are EXCLUDED because Dr. Dunn’s testing is
unreliable. Dr. Dunn’s in vitro testing failed to follow the written protocol he relied
upon in developing his test—the very protocol that Dr. Guelcher developed.
Specifically, Dr. Dunn could not account for why he changed the testing solution once
a week when the protocol called for changing the solution once every three days.
Further, Dr. Dunn stated in his deposition that he would only use his testing to show
the general behavior of polypropylene mesh in an in vitro oxidizing medium—not to
extend what that means inside the body. Dr. Dunn’s testing lacks sufficient indicia of
reliability. Therefore, BSC’s Motion to Exclude the Opinions and Testimony of Scott
Guelcher, Ph.D. is GRANTED.
G. Richard Trepeta, M.D.
Richard Trepeta, M.D., is, among other things, a board-certified pathologist
and a Fellow with the College of American Pathologists and the International Society
for the Study of Vulvovaginal Disease.
1. Qualifications

First, BSC objects to Dr. Trepeta’s opinion testimony on the properties of
polypropylene mesh. Given Dr. Trepeta’s knowledge and experience as an anatomical
and clinical pathologist, I find him qualified to testify about mesh degradation, mesh
shrinkage, and mesh migration, and I therefore DENY BSC’s motion in this respect.

Second, BSC objects to Dr. Trepeta’s testimony on the human clinical response
to mesh implants. Dr. Trepeta’s extensive experience and knowledge in the field of
pathology qualify him to submit these opinions. Part of pathology involves reaching

21

a diagnosis through clinical and pathologic correlation. Dr. Trepeta frequently
engages in this process by providing clinical consultations to physicians, which
require him to examine clinical information (through specimens, reports, or physician
findings) and reach a pathologic diagnosis about a patient. Dr. Trepeta’s
understanding and application of the pathologic process qualify him to opine on the
causal relationship between transvaginal mesh implantation and tissue response.
Therefore, I DENY BSC’s motion as to Dr. Trepeta’s qualifications on this point.
2. Reliability and Relevance
BSC raises two objections to the reliability and relevance of Dr. Trepeta’s
opinion testimony.

a. Reliability
BSC contends that Dr. Trepeta’s method of using pathology reports to
formulate his opinions is unreliable. Dr. Trepeta used various resources to reach his
expert opinion: (1) he has studied over fifty mesh explant samples in his private
practice; (2) he has studied the medical literature on mesh implantation and
determined that his pathological findings corresponded with the published research
on mesh erosion and exposure in the vaginal wall; and (3) he has reviewed twentyfour pathology reports that he received from the plaintiff’s counsel and ascertained
that the pathology reports of excised Boston Scientific products are consistent with
the acute, sub-acute, and chronic categories of the disease process.
Dr. Trepeta’s review of the pathology reports has a fatal deficiency—it lacked
standards to govern the process of selecting the sample of pathology reports to be

22

evaluated. The plaintiff does not explain how or why she chose these twenty-four
reports for Dr. Trepeta’s review, and without such an explanation, I have no way of
assessing the potential rate of error or the presence of bias. Accordingly, Dr. Trepeta’s
opinions derived solely from his review of the twenty-four pathology reports are
EXCLUDED. BSC is free to cross-examine Dr. Trepeta at trial to ensure the basis of
his opinions is consistent with the court’s ruling.

b. Litigation Driven
BSC argues Dr. Trepeta’s opinions are unreliable because they are litigation
driven. I will not exclude an expert on the sole basis that the opinion arose during
litigation, so long as it is otherwise reliable. BSC’s Motion is DENIED on this point.
In conclusion, Dr. Trepeta’s general causation opinions are admitted except for
his opinions based on the pathologic reports selected by the plaintiff’s counsel for his
review, which are excluded. Accordingly, BSC’s Motion to Exclude the Opinions and
Testimony of Dr. Trepeta is GRANTED in part and DENIED in part.
H. Vladimir Iakovlev, M.D.
Dr. Iakovlev is an anatomical pathologist and director of Cytopathology at the
Department of Laboratory Medicine at St. Michael’s Hospital in Toronto, Canada.
1. General Causation
BSC contends that this court should exclude Dr. Iakovlev’s opinions on
specimens other than the plaintiff’s. Dr. Iakovlev’s general causation opinions are
based largely on his examination of the mesh explant samples in his personal data
pool. However, Dr. Iakovlev provides no information on how the mesh explants were
chosen or prepared for examination. Dr. Iakovlev testified that plaintiff’s counsel
23

provided approximately 70 percent of the transvaginal mesh explants, but he does
not know how those explants were chosen or what methodology counsel employed.
Accordingly, BSC’s motion on this matter is GRANTED, and Dr. Iakovlev’s
general causation opinions based on his data pool are EXCLUDED.
2. Specific Causation
It is unclear whether Dr. Iakovlev intends to offer a specific causation opinion
in this case because the court has not been provided with an expert report from Dr.
Iakovlev specific to this plaintiff. In this case, there is no evidence that Dr. Iakovlev
examined the plaintiff's explanted mesh, performed a physical examination, or
otherwise conducted a differential diagnosis. Assuming Dr. Iakovlev seeks to offer
specific causation opinions, such opinions are not sufficiently reliable under Daubert
and are thus EXCLUDED.
In conclusion, BSC’s Motion to Strike and Exclude the Opinions and Testimony
of Vladimir Iakovlev, M.D. is GRANTED.
I. Jerry Blaivas, M.D.
Dr. Blaivas is a pelvic surgeon and urologist. The plaintiff offers Dr. Blaivas to
opine as to general causation. He renders several opinions, including those related to
the complications associated with polypropylene mesh slings and the Obtryx, the
safety and efficacy of synthetic slings as compared to non-mesh procedures, and BSC’s
warnings to physicians and patients.

24

1. Opinion that Polypropylene Mid-Urethral Slings Are Not Safe in the
Treatment of SUI
BSC challenges Dr. Blaivas’s opinion that polypropylene mid-urethral slings
are not safe in the treatment of SUI. I EXCLUDE Dr. Blaivas’s opinion because Dr.
Blaivas applied standards different than those he applies in his medical practice. In
his deposition, Dr. Blaivas was confronted with a statement he had previously made
in a peer-reviewed article that contradicts his safety opinion proffered in this case.
Dr. Blaivas explains that “I phrase my words differently in the peer-reviewed
literature than I do in the legal literature because it’s two different sets of rules.”
Blaivas Dep. 391:20–24, Dec. 15, 2014. He states, “I can offer a different opinion with
a reasonable degree of medical certainty than I can in the peer-reviewed literature
which requires, in my judgment, a higher degree of certainty than a reasonable
degree.” Id. at 391:14–19.
The above deposition testimony plainly reveals that Dr. Blaivas employed less
intellectual rigor in forming this opinion as an expert witness than he employs when
writing studies in his field. Such admission renders Dr. Blaivas’s methodology
unreliable. As a result, BSC’s motion with respect to this opinion is GRANTED.
2. Opinion on Design of Polypropylene Mesh Slings
Next, BSC challenges Dr. Blaivas’s opinion on the design of polypropylene
mesh slings. I agree with BSC that Dr. Blaivas lacks qualifications to be deemed an
expert in the design of a medical device. The plaintiff contends that Dr. Blaivas’s
surgical experience with similar slings renders him qualified. This experience alone,

25

however, insufficiently establishes his design qualifications. Thus, his opinions
related to product design are EXCLUDED.
3. BSC Alleges that Dr. Blaivas Seeks to Offer Opinions Outside Area of
Expertise
BSC argues that Dr. Blaivas seeks to offer opinions on mesh shrinkage,
degradation, and the MSDS that are outside his area of expertise. Above, I exclude
Dr. Blaivas’s opinion that polypropylene mid-urethral slings are not safe in the
treatment of SUI on reliability grounds. Therefore, I need not address Dr. Blaivas’s
qualifications on shrinkage and degradation.
As for the MSDS, BSC seeks to exclude Dr. Blaivas’s opinion that the
polypropylene mesh used in the Obtryx, Obtryx Curved, and Obtryx Halo was never
meant to be implanted inside the human body per the MSDS. The plaintiff fails to
respond to this argument, and I presume that the plaintiff concedes that Dr. Blaivas
will not offer such an opinion at trial. I decline to raise counterarguments on her
behalf. Thus, BSC’s motion with respect to Dr. Blaivas’s MSDS opinion is GRANTED.
4. Specific Causation
Although BSC argues that Dr. Blaivas’s specific causation opinions should be
excluded, Dr. Blaivas is not a specific causation expert in this case. Therefore, BSC’s
motion with respect to this matter is DENIED.
In conclusion, BSC’s Motion to Exclude the Opinions and Testimony of Jerry
Blaivas, M.D. is GRANTED in part and DENIED in part.
J. Richard Bercik, M.D.
Dr. Bercik is a urogynecologist and surgeon with extensive experience using
26

polypropylene mesh products.
1. Polypropylene Properties
BSC argues that Dr. Bercik is not qualified to offer opinions regarding
stiffness, porosity, bridging fibrosis, scar-plate formation, or degradation because Dr.
Bercik is not a biomaterials expert. Dr. Bercik has performed over 2,000 surgeries
implanting POP and SUI mesh devices, and he has performed over 250 surgeries
removing pelvic floor synthetic mesh. The plaintiff concedes that Dr. Bercik will not
be asked to provide chemical explanations regarding stiffness, porosity, etc. Instead,
the plaintiff states that Dr. Bercik’s opinions will not go beyond reporting the clinical
effects Dr. Bercik has seen in his practice and review of the scientific literature. I
FIND that Dr. Bercik is qualified to discuss these matters as it relates to his clinical
experience. BSC’s motion is DENIED on this point.
2. Labeling Opinions
The plaintiff states that Dr. Bercik will not testify at trial regarding the
adequacy of the warnings found in the Obtryx DFU. Accordingly, BSC’s motion as to
this matter is GRANTED.
3. Degradation
BSC next argues that Dr. Bercik’s opinion that polypropylene degradation has
occurred in the plaintiff is not helpful to a jury because Dr. Bercik did not personally
examine the plaintiff’s mesh explant, but instead relied on a pathology report from
another expert. Rule 703 of the Federal Rules of Evidence states, “An expert may
base an opinion on facts or data in the case that the expert has been made aware of

27

or personally observed. If experts in the particular field would reasonably rely on
those kinds of facts or data in forming an opinion on the subject, they need to be
admissible for the opinion to be admitted.” I FIND that Dr. Bercik may reasonably
rely on expert pathology reports to assist him in forming his opinion. BSC’s motion
on this point is DENIED.
4. Specific Causation
BSC argues that Dr. Bercik’s specific causation opinions should be excluded as
unreliable; however, BSC raises concerns for opinions relating to four plaintiffs—
none of whom is the plaintiff in this case. Accordingly, BSC’s motion is DENIED on
this point.
In sum, BSC’s Motion to Exclude the Testimony of Dr. Bercik, M.D. is
GRANTED in part and DENIED in part.
V.

The Plaintiff’s Daubert Motions
In this case, the plaintiff seeks to limit or exclude the expert opinions of Drs.

Gary L. Winn, Christine Brauer, Stephen Spiegelberg, Stephen F. Badylak, and
Lonny Green.
A. Gary L. Winn, Ph.D.
Dr. Winn is a professor in Industrial and Management Systems Engineering
in the Safety Management program at West Virginia University. Dr. Winn offers
expert opinions with regard to the nature and purpose of Material Safety Data Sheets
(MSDS) generally, and specifically as to the MSDS for the polypropylene used by BSC
in the manufacture of its pelvic mesh products. The plaintiff argues that Dr. Winn’s

28

opinions should be excluded entirely, consistent with this court’s decisions in Tyree
and Eghnayem because his expert report is identical to the reports filed and excluded
in those two cases.7 BSC has not presented any new arguments to convince me that
Dr. Winn is warranted as an independent expert. However, I acknowledge the
potential need for rebuttal testimony based on what the plaintiff presents at trial.
Accordingly, I RESERVE ruling on the admissibility of Dr. Winn’s expert opinions for
trial.
B. Christine Brauer, Ph.D.
Dr. Brauer is the President of Brauer Device Consultants LLC, where she
provides consulting services to the medical device industry regarding FDA regulatory
requirements. The plaintiff seeks to exclude both of Dr. Brauer’s expert reports filed
on November 21, 2014. The first report (“FDA report”) focuses on the FDA regulatory
framework for surgical devices, and the second report (“supplemental report”) focuses
on industry standards that a manufacturer of a medical device must meet. I have
repeatedly and thoroughly considered the admissibility of the FDA’s 510(k) process,

7

In Tyree, I ruled as follows:
In his expert report, Dr. Winn describes (1) the development of the hazard
communication standard; (2) the standardization of the content of MSDSs; and (3) uses
of MSDSs in the field. Dr. Winn concludes that raw polypropylene is not hazardous
based on anecdotal evidence involving other MSDSs; and therefore, the 2004 Chevron
Phillips MSDS is extraneous. Although I believe that the warning provided in the
MSDS is relevant, I do not believe an expert is required to discuss MSDSs generally or
the issue of whether polypropylene requires an MSDS because of its hazardous nature.
A narrative review of the history and development of MSDSs and who uses them in
the field is not helpful to the jury. The pertinent issue is that the MSDS contained a
warning (Medical Application Caution) allegedly not heeded by BSC, not that an
MSDS itself existed. This warning from the supplier could have taken any form.
Accordingly, I FIND that Dr. Winn’s opinions regarding MSDSs should be excluded in
their entirety.

2014 WL 5320566, at *63; see also Eghnayem, 2014 WL 5461991, at *61 (quoting Tyree).

29

and I have consistently found that the 510(k) process does not relate to safety or
efficacy. Therefore, the parties may not present evidence regarding the 510(k)
clearance process or subsequent FDA enforcement actions. Accordingly, the plaintiff’s
motion with regard to Dr. Brauer’s FDA report is GRANTED, and her opinions set
forth in that report are EXCLUDED.
With regard to the supplemental report, the plaintiff contends that it is
nothing more than her FDA report under a different cloak. I agree. Reading the two
reports side by side, it appears that Dr. Brauer “supplemented” her report by
removing references to the FDA and substituting the term “industry standard”
instead. This “industry standard” clearly describes the FDA 510(k) process, which Dr.
Brauer admits in her deposition. There is far too much overlap between Dr. Brauer’s
FDA report and supplemental report to avoid a regulatory mini-trial, which I have
repeatedly and consistently held would confuse and mislead the jury. Accordingly,
the plaintiff’s Motion to Exclude or Limit the Testimony of Christine Brauer, Ph.D.
is GRANTED, and Dr. Brauer’s opinions are EXCLUDED in their entirety.
C. Stephen Spiegelberg, Ph.D.
Dr. Spiegelberg is the president and co-founder of Cambridge Polymer Group
Inc., where he directs a team of scientists who perform contract research, analytical
testing, and device development for the biomedical and polymer communities.
1. Position Statements
First, the plaintiff argues that Dr. Spiegelberg’s opinions regarding position
statements should be excluded because (1) they are not contained in his expert report;
(2) he is not qualified to offer such opinions; and (3) he lacks any reliable methodology.
30

Upon review, I agree with BSC that Dr. Spiegelberg does not in fact offer the opinions
the plaintiff seeks to exclude. Accordingly, the plaintiff’s motion with regard to
position statements is GRANTED.
2. FDA
Next, the plaintiff contends that Dr. Spiegelberg is unqualified to opine on the
FDA 510(k) clearance process and that such opinions should be excluded as
irrelevant. In response, BSC concedes that Dr. Spiegelberg will not offer opinions on
the FDA 510(k) clearance process. Accordingly, the plaintiff’s motion with regard to
the FDA is GRANTED.
BSC limits its concession by arguing that Dr. Spiegelberg is qualified to opine
on ISO standards based on his experience in the field of medical device analysis and
design. I agree. Dr. Spiegelberg’s current work revolves around medical device
development and consultation. He is also the Task Force Chairman for the American
Society for Testing and Materials (“ASTM”), which establishes standards involving
the cleanliness of biomedical devices and characterization methods for polymers.
Consulting on the development of new medical products requires familiarity with the
applicable industry standards. Therefore, to the extent Dr. Spiegelberg intends to
opine on ISO standards without referencing the FDA, I find him qualified to do so.
Accordingly, the plaintiff’s motion with regard to Dr. Spiegelberg’s qualifications is
DENIED.
3. Black Specks or Spots
Next, the plaintiff argues that Dr. Spiegelberg’s opinions regarding black
specks in BSC’s mesh are unfounded and unreliable. In his expert report, Dr.
31

Spiegelberg states that the “black spots” are actually reflections of light on the curves
of the mesh when pictures are taken, rather than inclusions or defects in the mesh.
The plaintiff contends that Dr. Spiegelberg’s findings are unreliable because he did
not review the photographs supplied by the plaintiff’s expert, Dr. Dunn, nor did he
take his own photographs. Whether Dr. Spiegelberg took his own photographs does
not sufficiently undermine the reliability of his analysis here. Challenges to Dr.
Spiegelberg’s ultimate conclusion with regard to the nature of the black spots are
better suited for cross-examination. Accordingly, the plaintiff’s motion with regard to
black specks or spots is DENIED.
4. FTIR and EDS
Last, the plaintiff seeks to limit Dr. Spiegelberg’s general causation opinions
based on his Fourier Transform Infrared Spectroscopy (“FTIR”) and Electron
Dispersive Spectroscopy (“EDS”) testing. However, the plaintiff points out that Dr.
Spiegelberg’s admissions regarding the limitations of these testings may also be
grounds for cross-examination and thus seeks only qualification or explanation of the
limitations inherent to the testing in order to avoid misleading or confusing the jury.
The plaintiff will have the opportunity to adequately highlight these limitations at
trial upon cross-examination. Accordingly, the plaintiff’s motion with regard to Dr.
Spiegelberg’s FTIR and EDS testing is DENIED.
In sum, the plaintiff’s Motion to Exclude the Testimony and Opinions of Dr.
Stephen Spiegelberg, Ph.D. is GRANTED in part and DENIED in part.
D. Stephen F. Badylak, D.V.M., Ph.D., M.D.
Dr. Badylak is the Deputy Director of the McGowan Institute for Regenerative
32

Medicine, Director of the Center for Preclinical Studies, and a tenured professor with
the Department of Surgery at the University of Pittsburgh.
1. Risk-Benefit Analysis or Safety and Efficacy
The plaintiff contends that Dr. Badylak should be precluded from opining on
the safety and efficacy of polypropylene mesh devices because he has not reviewed
the applicable scientific literature and he has no clinical experience using these
devices. Dr. Badylak’s expert report indicates that he reviewed more than 200
relevant scientific publications, including more than twenty publications evaluating
the safety and efficacy of BSC devices. Furthermore, Dr. Badylak explains that he is
more familiar with the body of literature reviewing the safety and efficacy of surgical
mesh generally, versus literature specific to any one device. This explanation does
not undermine his qualifications but instead clarifies his approach. If there are
certain device-specific publications that Dr. Badylak failed to review in preparing his
expert report, the plaintiff is free to ask him about those publications on crossexamination.
Similarly, the plaintiff’s arguments regarding Dr. Badylak’s clinical experience
are also without merit. Dr. Badylak has extensive experience in the field of
biomaterials, including the design of implantable surgical mesh devices. Accordingly,
the plaintiff’s motion with regard to Dr. Badylak’s safety and efficacy opinions is
DENIED.
2. Degradation
The plaintiff argues that Dr. Badylak’s opinions with regard to oxidative
degradation based on the scientific literature are unreliable because he contradicted
33

himself during his deposition by acknowledging the “phenomenon” of oxidative
reactions. However, the plaintiff omits Dr. Badylak’s subsequent testimony, where
he states that he does not believe that oxidative reactions at the surface of
polypropylene results in the degradation that causes further problems. Upon review
of the deposition, I do not find Dr. Badylak’s testimony sufficiently contradictory to
undermine the reliability of his expert opinions. Accordingly, the plaintiff’s motion
with regard to degradation is DENIED.
The plaintiff’s Motion to Exclude the Opinions and Testimony of Stephen F.
Badylak, D.V.M., Ph.D., M.D. is thus DENIED.
E. Lonny Green, M.D.
Dr. Green is a board certified urologist whose practice is largely focused on the
treatment of female urinary incontinence and who has extensive experience with the
Obtryx. Dr. Green opines that mid-urethral slings, like the Obtryx, are the standard
of care in the treatment of SUI.
1. Obtryx DFU
First, the plaintiff argues that Dr. Green is not qualified to offer opinions on
the Obtryx DFU because he has never written a DFU and could not describe the
general requirements for a DFU during his deposition.
In the past, I allowed a doctor to testify that the DFU was inadequate because
it failed to warn against risks the doctor observed in his or her own practice. In
contrast, now I must determine whether the same kind of doctor is instead qualified
to offer his expert opinion that the warnings were in fact adequate. There is a clear

34

distinction. The plaintiff’s experts observed certain risks and complications in their
practice and then sought to opine that those risks should have been included in the
product warnings. In the present case, BSC’s experts have observed certain risks and
complications in their practice, which are warned of in the DFU, and therefore deduce
that there are no other possible risks or complications that should have been included.
The plaintiff’s experts address a discrete risk which they have personally observed,
while BSC’s experts’ opinions attempt to encompass all possible risks, none of which
they have personally observed. Accordingly, I FIND that without additional expertise
in the specific area of product warnings, a doctor, such as a urologist or
urogynecologist, is not qualified to opine that a product warning was adequate,
merely because it included risks he has observed in his own practice.
Dr. Green fails to address the significance of complications he has not seen in
his practice, and which are not warned of in the DFU. In his deposition, Dr. Green
admits he has never drafted a DFU for a medical device or pharmaceutical. Although
Dr. Green indicates he has “expertise” in the process of writing patient handouts
warning against drug complications, his experience appears to be limited to his
review and distribution of these handouts, rather than contribution to the drafting.
Accordingly, I FIND that Dr. Green is not qualified to opine on the adequacy of
product warnings, and therefore, his opinions related to the Obtryx DFU are
EXCLUDED.

35

2. FDA 510(k) Clearance
BSC concedes that Dr. Green will not offer opinions on the FDA 510(k)
clearance process. Accordingly, the plaintiff’s motion is GRANTED. Furthermore, I
have repeatedly held that the probative value of FDA evidence is substantially
outweighed by the risk of jury confusion. Therefore, to the extent Dr. Green seeks to
offer other expert opinions on the FDA, such opinions are likewise EXCLUDED.
3. Physical Properties of Polypropylene

a. Qualifications
The plaintiff argues that Dr. Green is not qualified to opine that the Obtryx
does not shrink, contract, degrade, or cause systemic infections. I disagree. A lack of
personal experience performing pathology research on polypropylene explants does
not necessarily render Dr. Green unqualified under Rule 702 to offer opinions on the
suitability of the Obtryx device.
Dr. Green has performed almost 3,000 sling procedures, and his clinical
practice has largely focused on the treatment of female urinary incontinence over the
last twenty years. Further, Dr. Green cites numerous studies and academic papers
throughout his expert report to support his opinion that the Obtryx is both safe and
effective. I therefore FIND that Dr. Green is qualified to offer the opinion that the
Obtryx mesh does not shrink, contract, degrade, or cause systemic infections. The
plaintiff’s motion is DENIED on this point.

36

b. Reliability
The plaintiff also argues that Dr. Green has not utilized any method to reach
the conclusions outlined in his report. Dr. Green plans to testify that he has not seen
evidence of polypropylene degradation, systemic infection, or other unexpected
reactions and that the Obtryx has proven to be safe and efficacious for the treatment
of female SUI. Dr. Green’s opinion is partially based on the fact that he has observed
minimal complications in his clinical practice. Obviously, this type of opinion is not
subject to testing or peer review. Additionally, Dr. Green explains that his clinical
experience with the Obtryx is on par with the findings in the studies he cites
throughout his expert report. Therefore, I FIND Dr. Green’s clinical experience and
review of the scientific literature are sufficiently reliable bases in forming this
particular opinion. The plaintiff’s motion is DENIED on this point.
For the above reasons, the plaintiff’s Motion to Exclude the Opinions and
Testimony of Lonny Green, M.D. is GRANTED in part and DENIED in part.
VI.

Effect of Daubert Ruling
I emphasize that my rulings excluding expert opinions under Rule 702 and

Daubert are dispositive of their potential admissibility in these cases, but my rulings
not to exclude expert opinions are not dispositive of their admissibility at trial. In
other words, to the extent that certain opinions might be cumulative or might confuse
or mislead the jury, they may still be excluded under Rule 403 or some other
evidentiary rule. I will take up these issues as they arise.

37

VII.

Conclusion

For the reasons discussed above, my rulings on BSC’s motions are as follows:
Motion to Exclude the Testimony of Michael Thomas Margolis, M.D. [ECF No. 38] is
GRANTED in part and DENIED in part; Motion to Exclude the Opinions and
Testimony of Thomas Barker, Ph.D. [ECF No. 40] is GRANTED; Motion to Exclude
the Opinions and Testimony of Jimmy Mays, Ph.D. [ECF No. 44] is GRANTED;
Motion to Exclude the Opinions and Testimony of Peggy Pence, Ph.D. [ECF No. 50]
is GRANTED in part, DENIED in part, and RESERVED in part; Motion to Exclude
the Opinions and Testimony of Russell Dunn, Ph.D. [ECF No. 48] is GRANTED;
Motion to Exclude the Opinions and Testimony of Scott Guelcher, Ph.D. [ECF No. 52]
is GRANTED; Motion to Exclude the Opinions and Testimony of Richard Trepeta,
M.D. [ECF No. 51] is GRANTED in part and DENIED in part; Motion to Strike and
Exclude the Opinions and Testimony of Vladimir Iakovlev, M.D. [ECF No. 57] is
GRANTED; Motion to Exclude the Opinions and Testimony of Jerry Blaivas, M.D.
[ECF No. 43] is GRANTED in part and DENIED in part; and Motion to Exclude the
Opinions and Testimony of Richard Bercik, M.D. [ECF No. 49] is GRANTED in part
and DENIED in part.
My rulings on the plaintiff’s motions are as follows: Motion to Exclude the
Opinions and Testimony of Gary L. Winn, Ph.D. [ECF No. 47] is RESERVED; Motion
to Exclude or Limit the Testimony of Christine Brauer, Ph.D. [ECF No. 45] is
GRANTED; Motion to Exclude the Testimony and Opinions of Dr. Stephen
Spiegelberg, Ph.D. [ECF No. 56] is GRANTED in part and DENIED in part; Motion

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to Exclude the Opinions and Testimony of Stephen F. Badylak, D.V.M., Ph.D., M.D.
[ECF No. 55] is DENIED; and Motion to Limit the Opinions and Testimony of Lonny
Green, M.D. [ECF No. 46] is GRANTED in part and DENIED in part.
The court DIRECTS the Clerk to send a copy of this Order to counsel of record
and any unrepresented party.
ENTER:

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May 6, 2016