Kaur v. Boston Scientific Corporation

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE
KULWINDER KAUR, )
)
Plaintiff, )
) C.A. No.: N19C-07-117 PEL
v. )
)
BOSTON SCIENTIFIC CORPORATION )
(d/b/a MANSFIELD SCIENTIFIC, INC. & )
MICROVASIVE, INC.), )
)
Defendant. )
Submitted: January 5, 2022
Decided: May 11, 2022
Robert J. Leoni, Esquire, Shelby & Leoni, 221 Main Street, Wilmington, DE
19804, Attorney for Plaintiffs
Colleen D. Shields, Esquire, Eckert, Seamans, Cherin & Mellott LLC, 222
Delaware Avenue, 7th Floor, Wilmington, DE 19801, Attorney for Defendant
Jones, J.
1
Introduction
This opinion constitutes the Court’s decision on Defendant’s, Boston
Scientific Corporation, d/b/a Mansfield Scientific, Inc. & Microvasive, Inc.
(“BSC”), eight (8) Daubert motions. BSC asks this Court to determine whether the
opinions and testimony of the Plaintiff’s experts should be excluded under Delaware
Rule of Evidence 702, Daubert v. Merrell Dow Pharmaceuticals, Inc. and M.G.
Bancorporation, Inc. v. Le Beau.
This is a products liability claim that involves one of Boston Scientific’s
surgical mesh products – the Obtryx. Plaintiff has alleged that this polypropylene
surgical mesh implant – midurethral slings (“MUS”) – which was used by her
surgeon to treat her for stress urinary incontinence (“SUI”) and pelvic organ prolapse
(“POP”) has caused her to experience injuries.
This Court has reviewed both parties’ materials and for the reasons set forth
fully below, this Court GRANTS, in part, and DENIES, in part, BSC’s motions.
Standard of Review
Delaware Rule of Evidence 702 governs the admissibility of expert testimony.
Delaware has adopted the holdings in Daubert v. Merrell Dow Pharmaceuticals
Inc.1 and Kumho Tire Co., Ltd. v. Carmichael 2 to interpret the Delaware Rule. 3 In
1
509 U.S. 579 (1993).
2
526 U.S. 137 (1993).
3
Bowen, 906 A.2d at 794 (citing M.G. Bancorporation, Inc. v. Le Beau, 737 A.2d 513, 522 (Del. 1999)).
2
Daubert and Kumho, the United States Supreme Court interpreted and explained
Federal Rule of Evidence 702, which is “substantially similar” to the Delaware
Rule.4 Delaware Rule 702 states:
A witness who is qualified as an expert by knowledge, skill, experience,
training, or education may testify in the form of an opinion or
otherwise, if: (a) the expert’s scientific, technical, or other specialized
knowledge will help the trier of fact to understand the evidence or to
determine a fact in issue; (b) the testimony is based upon sufficient facts
or data; (c) the testimony is the product of reliable principles and
methods; and (d) the witness has applied the principles and methods
reliably to the facts of the case.5
To be admissible, expert testimony must be “relevant and reliable.” 6 To make
this determination, the trial judge engages in a five-step analysis.7 This analysis
provides that the trial judge finds that:
(1) the witness is qualified as an expert by knowledge, skill,
experience, training, or education;
(2) the evidence is relevant;
(3) the expert’s opinion is based on information reasonably relied
upon by experts in the particular field;
(4) the expert testimony will assist the trier of fact to understand the
evidence or to determine a fact in issue; and
(5) the expert testimony will not create unfair prejudice or confuse or
mislead the jury.8
The burden of establishing that the expert testimony is admissible lies with its
proponent by a preponderance of the evidence.9 “A strong preference exists” for
4
Smack-Dixon v. Walmart Inc., 2021 WL 3012056 (Del. Super. Ct. Jul. 16, 2021) (citing Bowen v. E.I. DuPont de
Nemours & Co., Inc., 906 A.2d 787, 794 (Del. 2006)).
5
D.R.E. 702. See also Smack-Dixon, 2021 WL 3012056 (Del. Super. 2021).
6
Daubert, 508 U.S. at 597.
7
Smack-Dixon, 2021 WL 3012056 at *2 (citing Bowen, 906 A.2d at 795).
8
Id.9
Id.3
admitting expert opinions “when they will assist the trier of fact in understanding
the relevant facts or the evidence.”10
Reliable expert testimony is premised on scientific or specialized knowledge
which requires the testimony to be grounded in scientific methods and procedures
and “supported by appropriate validation – i.e., ‘good grounds,’ based on what is
known.”11
Many scientific, technical, or specialized fields are not subject to peer review
and publication which is why the test of reliability is “flexible.” Rigid application of
the Daubert factors cannot just be engaged to determine testimonial reliability in
every field of expertise.12 Even with all the advances of medical science, the practice
of medicine remains an art, and a diagnosis in the practice of clinical medicine “is
not an exact science.”13
Again, a gatekeeping judge has “broad latitude” to determine whether an
expert’s proffered opinion is based upon the “proper factual foundation and sound
10
Smack-Dixon, 2021 WL 3012056 at * 2 (quoting Delaware ex. Rel. French v. Card Compliant, LLC, 2018 WL
4151288 at *2 (Del. Super. Ct. Aug. 29, 2018) (quoting Normal v. All About Women, P.A., 193 A.2d 726, 730 (Del.
2018)).
11
Daubert, 508 U.S. at 590.
12
Henlopen Hotel v. United Nat’l Ins. Comp., 2020 WL 233333 at *3 (Del. Super. Ct. Jan. 10, 2020).
13
State v. McMullen, 900 A.2d 105, 114 (Del. Super. Ct. 2006). See also Moore v. Ashland Chem., 126 F.3d 679,
688-690 (5th Cir. 1997), vacated on reh’g en banc, 151 F.3d 269 (5th Cir. 1998) (“First, the goals of the disciplines
of clinical medicine and hard Newtonian science are different….Second, the subject matter and conditions of study
are different…Finally, clinical medicine and hard science have marked different methodologies….In sum, hard
Newtonian scientific knowledge…is knowledge of a particular and limited kind….Although clinical medicine
utilizes parts of some hard sciences, clinical medicine and many of its subsidiary fields are not hard sciences….
Consequently, the Daubert factors, which are hard scientific methods selected from the body of hard scientific
knowledge and methodology generally are not appropriate for use in assessing the relevance and reliability of
clinical medical testimony.”). The Fifth Circuit’s discussion of the significant differences between disciplines in
“hard science” and clinical medicine still holds true even though the decision in that case was ultimately vacated. Id.4
methodology.”14 This “proper factual foundation” language has been distilled from
Delaware Rule 702.15 To meet the criterion for a “proper factual foundation,” an
expert’s opinion must be based on “facts” and not “suppositions.”16 When applied
to a medical expert, a causation opinion is admissible when it’s “based on his
analysis of the circumstances … not mere speculation over the cause.”17 And a
proponent need only show by a preponderance of the evidence that her expert’s
opinions are reliable, not that they are correct.18 So, this Court’s Rule 702 reliability
examination must focus on principles and methodology, not on the resultant
conclusions.19
Delaware courts generally recognize that challenges to the “factual basis of
an expert opinion go[] to the credibility of the testimony, not the admissibility, and
it is for the opposing party to challenge … the expert opinion on cross-
examination.”20 “The different depth with which [an expert] pursued particular lines
of investigation and the different assumptions they made are readily subject to cross-
14
Russum v. IPM Development Partnership LLC, 2015 WL 2438599 at *2 (Del. Super. Ct. May 21, 2015).
15
Id.16
Id. at *3.
17
Smack-Dixon, 2021 WL 3012056 at *5 (quoting Norman v. All About Women, P.A., 193 A.3d 726, 732 (Del.
2018).
18
State v. McMullen, 900 A.2d 105, 114 (Del. Super. Ct. 2006) (citing In re Paoli R.R. Yard PCB Litig., 35 F.3d
717, 744 (3d Cir. 1994)).
19
Henlopen Hotel, 2020 WL 233333 at *2 (“At bottom, the Court’s examination of an expert’s opinion must be
solely focused on principles and methodology, not on the conclusions they generate.”) (quoting Tumlinson v.
Advanced Micro Devices, 81 A.3d 1264, 1269 (Del. 2013)).
20
Perry v. Berkley, 996 A.2d 1262, 1271 (Del. 2010). See also Hodel v. Ikeda, 2013 WL 226937 at *4 (Del. Super.
Ct. Jan. 18, 2013); Daubert, 509 U.S. 679, 596 (1993) (“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.” (internal citations omitted); Russum, 2015 WL 2438599 at *3.
5
examination and to evaluation by the fact finder for credibility and weight.”21 An
expert’s testimony will only be excluded in the narrow circumstance where he is
shown to have completely neglected the core facts of the case.22 And, under
Delaware Rule 702, a medical doctor’s opinion “based on his own knowledge” and
informed by his review of a patient’s records may certainly be sufficient to clear the
Daubert/Bowen reliability threshold.23
Analysis
General Objections
BSC raises various general objections as to the challenged experts. BSC
asserts that the experts should be precluded from offering narrations of BSC’s
company documents, opinions on BSC’s corporate conduct, and opinions in the form
of legal conclusions.
As has been consistently held by the MDL Court,24 the foregoing topics
exceed the scope of expert witness’s testimony and will not assist the trier of fact.25
Thus, in accord with various courts that have ruled on these issues, this Court will
21
Henlopen Hotel, 2020 WL 233333 at *4; Perry v. Berkley, 996 A.2d at 1271 (noting cross-examination rather
than exclusion can be the proper method of exploring the bases of an expert’s opinion and the weight to be ascribed
thereto).
22
Russum, 2015 WL 2438599 at *3.
23
Smack-Dixon, 2021 WL 3012056 (citing Norman, 193 A.3d at 731-32).
24
The federal multi-district court handling the federal pelvic mesh cases is venued in West Virginia.
25
Sanchez v. Bos. Sci. Corp., 2014 WL 4851989, at *4 (S.D.W.Va. Sept. 29, 2015); Eghnayem v. Bos. Sci. Corp., 57
F.Supp.3d 658, 669 (S.D.W.Va. 2014); Huskey v. Ethicon, Inc., 29 F.Supp.3d 691, 702 (S.D.W.Va. 2014); In re
C.R. Bard, Inc., 948 F.Supp.2d 589, 611, 629 (S.D.W.Va. 2013).
6
not permit the experts to offer their opinions about BSC’s state of mind.26 Nor will
the experts be permitted to offer opinions about the reasonableness of BSC’s
actions.27 As to narratives of BSC’s corporate documents, assuming these opinions
are otherwise admissible, the experts are permitted to offer testimony regarding
BSC’s corporate documents to the limited extent that they relied upon the
documentation to form the basis of their opinions.28
The experts will also be precluded from offering any opinions phrased as legal
conclusions. “[O]pinion testimony that states a legal standard or draws a legal
conclusion by applying law to the facts is generally inadmissible.”29 By allowing
such testimony would be to allow the trier of fact’s fact-finding function to be
usurped and this Court will not allow that.
Bruce Rosenzweig, M.D.
Dr. Rosenzweig is a urogynecologist and a professor of obstetrics and
gynecology in Chicago, Illinois. Plaintiffs offer Dr. Rosenzweig as a general
causation expert on the properties of polypropylene mesh used in the Obtryx, its
reaction when implanted in the body, and the possible complications associated with
their use to treat SUI.
A. Properties of Polypropylene Opinions
26
Sanchez v. Bos. Sci. Corp., 2014 WL 4851989 at *4 (S.D.W.Va Sept. 29, 2015) (citing Huskey v. Ethicon, Inc.,
2015 WL 3362264 at *3 (S.D.W.Va. July 8, 2014); Lewis, et al. v. Ethicon, Inc., 2014 WL 186872 at *6, *21
(S.D.W.Va. Jan. 15, 2014); In re C.R. Bard, Inc., 948 F.Supp.2d 589, 611, 629 (S.D.W.Va. 2013)).
27
Id.28
Sanchez, 2014 WL 4851989 at *4.
29
United States v. Mclver, 470 F.3d 550, 562 (4th Cir. 2006).
7
BSC argues that Dr. Rosenzweig is neither qualified nor are his opinions reliable
on this topic, especially as to his opinions relating to degradation of mesh. Plaintiff
responds that this Court, in a previous ruling, permitted Dr. Rosenzweig to offer his
opinions on this point and that the Court should do the same here.
In Harris v. Bos. Sci. Corp.,30 this Court found Dr. Rosenzweig both qualified to
offer his opinions about polypropylene properties and that his opinions were reliable
under Daubert. As to Dr. Rosenzweig’s qualifications, this Court relied on the
rationale of the Court in Wilkerson v. Bos. Sci. Corp.,31 where the Court explained:
Dr. Rosenzweig’s established background and skills in pelvic surgery,
polypropylene, and the complications associated with degradation
qualify him to opine on the degradation process, even though his
knowledge about the precise biochemical interactions involved might
not be as extensive as that of others… Any gaps in Dr. Rosenzweig’s
knowledge go to his credibility, not his admissibility as an expert.32
Also, BSC argues that Dr. Rosenzweig’s opinions on this point are unreliable.
This Court did not agree with BSC when it raised this argument in Harris and still
does not.33 Dr. Rosenzweig has more than twenty years of experience in examining
patients. In addition to his experience, Dr. Rosenzweig has reviewed an abundance
of medical literature regarding the degradation of polypropylene. In lieu of his
30
C.A. No. N15C-06-216 PEL (Apr. 11, 2017).
31
2015 WL 2087048 (S.D.W.Va. May 5, 2015).
32
Id. at 5.
33
Id. at 6.
8
experience and review, Dr. Rosenzweig’s opinions about polypropylene properties,
including his opinion that mesh degrades, is sufficiently reliable under Daubert.
Based on the foregoing, this Court concludes that Dr. Rosenzweig is qualified to
offer his opinions about the properties of polypropylene, including degradation, and
that these opinions are sufficiently reliable under Daubert.
B. BSC’s Product Testing Opinions
BSC argues that Dr. Rosenzweig is not qualified to offer opinions about BSC’s
product testing. Plaintiff concedes that Dr. Rosenzweig will not be offering these
opinions. Therefore, BSC’s motion on this point is GRANTED.
C. Link Between Cancer and Polypropylene Mesh Opinions
BSC argues that Dr. Rosenzweig’s cancer opinions must be excluded. Plaintiff
does not respond to this argument, and by doing so, foregoes the opportunity to do
so. Moreover, as Plaintiff is not claiming a cancer related injury, the testimony is
irrelevant and unduly prejudicial. Therefore, BSC’s motion on this point is
GRANTED.
D. Material Safety Data Sheet (“MSDS”) Opinions
BSC argues that Dr. Rosenzweig’s opinions on the MSDS are irrelevant and
unhelpful and that he is not qualified to offer such opinions. As noted by BSC, the
MDL Court has routinely excluded these opinions because Dr. Rosenzweig does not
9
possess the proper qualifications to opine on this topic.34 Plaintiff offers no response
relating to Dr. Rosenzweig’s qualifications on this point. Rather, Plaintiff argues that
the opinions are relevant and should be admitted. While that may be true, it means
nothing if Dr. Rosenzweig does not possess the requisite qualifications to offer such
opinions.
The basis for the MDL Court finding Dr. Rosenzweig to be unqualified was based
on his lack of “experience and knowledge necessary to opine on what testing a
manufacturer should perform on his products.”35 In the instant litigation, Plaintiff
has conceded that Dr. Rosenzweig will not be offering his product testing opinions.
But, because Dr. Rosenzweig’s qualifications to opine on product testing relate to
his MSDS opinions, this Court must determine whether Dr. Rosenzweig possesses
the requisite qualifications to opine on product testing.
This Court chooses to follow the lead of the MDL Court and concludes that Dr.
Rosenzweig’s opinions on product testing go beyond the bounds of his expertise. In
Sanchez, the Court explained:
While Dr. Rosenzweig has years of experience operating with
polypropylene mesh products, his expert report does not convey any
similar experience, education, or knowledge about the appropriate
testing a medical device manufacturer should perform on its products
prior to sale. The plaintiff’s response does not allude to any relevant
experiences either. Therefore, I agree with BSC and find Dr.
34
Id. at 9. See also Sederholm v. Bos. Sci. Corp., 2016 WL 3282587 at *10 (S.D.W. Va. Jun. 14, 2016); Flandro v.
Bos. Sci. Corp., 2016 WL 3282734 at *10 (S.D.W. Va. Jun 14, 2016) Griffin v. Bos. Sci. Corp., 2016 WL 3031700at *11-12 (S.D.W. Va. May, 25, 2016).
35
Wilkerson, 2015 WL 2087048 at *7.
10
Rosenzweig unqualified to testify on the adequacy or inadequacy of
BSC’s product testing.36
Similarly here, Dr. Rosenzweig’s expert report and Plaintiff’s response is
lacking with any indicia that he is qualified to offer opinions related to a medical
device manufacturer’s product testing. Dr. Rosenzweig’s lack of qualifications
relating to product testing has led the MDL court to also find him unqualified to offer
his opinions about the MSDS. This Court has no reason to deviate from the MDL
Court’s prior rulings, and thus, Dr. Rosenzweig’s opinions on this point are
excluded.
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.
A. General Causation Opinions
Dr. Iakovlev offers two general causation opinions in the instant litigation: (1)
the various symptoms which pelvic mesh can purportedly cause, such as
inflammation, pain, scarring, or nerve entrapment; and (2) the changes which pelvic
mesh purportedly undergoes in vivo – specifically mechanical deformation of the
36
Id.11
mesh itself and chemical degradation of its polypropylene materials – and how those
changes allegedly contribute to the aforementioned symptoms.
The crux of BSC’s arguments relating to Dr. Iakovlev’s general causation
opinions is his reliance on his own study which BSC advances is “not good science.”
Plaintiff responds that Dr. Iakovlev’s mesh samples are relevant and reliable because
he kept reliable records identifying which samples were Advantage products, as
opposed to transvaginal implants made by another manufacturer.
BSC correctly notes that the MDL Court has routinely excluded Dr. Iakovlev’s
opinions because they are unreliable.37 The rationale for excluding Dr. Iakovlev is
focused on the uncertainty surrounding his study, specifically the polypropylene
mesh samples chosen and provided to him. Dr. Iakovlev is unable to provide any
information about the methodology employed by Plaintiffs’ counsel, who supplied
him with seventy percent of the samples, in choosing the mesh explant samples he
relied upon in his study – the study which now forms the basis of his opinions in the
pelvic mesh litigation. The fact that Dr. Iakovlev study was subjected to publication
and peer-review does not cure this Court’s reliability concerns relating to his study.
“‘[P]ublication (which is but one element of peer review) is not a sine qua non of
37
See In re Bos. Sci. Corp., 2018 WL 2419058 at *2 (S.D.W. Va. May 29, 2018); Trevino v. Bos. Sci. Corp., 2016
WL 2939521 at *30 (S.D.W. Va. May 19, 2106); Young v. Mentor Worldwide, LLC, 312 F.Supp. 765, 772 (E.D.
Ark. 2018).
12
admissibility; it does not necessarily correlate with reliability,’ and is not
dispositive.”38
Further, the samples relied upon by Dr. Iakovlev in his study are of all varying
degrees of mesh. In Young, the Court explained that Dr. Iakovlev’s opinions lack
reliability because there was a specific mesh product at issue but his study involved
39
examination of various polypropylene products. Dr. Iakovlev, by his own
admission, stated that different mesh products cause different types of pathological
changes.40 Similarly, in the instant litigation, there is a specific mesh product at issue
– Obtryx, which contains a monofilament polypropylene mesh.
This Court’s concerns revolving around the uncertainty of Dr. Iakovlev’s study
have been left uncured by his report. As such, this Court, in accord with the MDL
Court and its previous rulings, concludes that Dr. Iakovlev’s opinions on this point
must be excluded for falling short of the reliability standard of Daubert.
Peggy Pence
Dr. Peggy Pence is a clinical and regulatory consultant who provides 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.
A. Premarket Clinical Testing
38
Trevino, 2016 WL 2939521 at *31.
39
Young, 312 F.Supp.3d at 771.
40
Id.
13
BSC argues that Dr. Pence’s opinions regarding the adequacy of BSC’s
premarket clinical testing should be excluded because the methodology she used is
unreliable and not generally accepted for various reasons. Plaintiff responds that Dr.
Pence’s opinions are reliable based on her reliance on GHTF standards, the HAS
study, and NICE standards.
The MDL Court has consistently permitted Dr. Pence to offer her opinions on
this point and this Court chooses to do the same.41 At the outset, this Court notes that
“‘general acceptance’ is not a necessary precondition to the admissibility of
scientific evidence.”42 Rather, Rule 702 “assign[s] to the trial judge the task of
ensuring that an expert’s testimony both rests on a reliable foundation and is relevant
to the task at hand. Pertinent evidence based on scientifically valid principles will
satisfy those demands.”43
Most, if not all, courts that have addressed this issue have relied on the rationale
from Sanchez v. Bos. Sci. Corp.44 In Sanchez, Dr. Pence offered an opinion identical
to the one offered in the instant litigation:
[T]hat BSC should have performed adequate preclinical and clinical
testing and evaluation of the Prefyx Sling, the Solyx SIS, and Uphold
PFR Kits prior to marketing to ensure the devices were reasonably safe
for permanent implantation. By its failure to do so, BSC fell below the
41
See Sanchez v. Bos. Sci. Corp., 2014 WL 48519 at *33-34 (S.D.W.Va. Sept. 29, 2014); Mathison v. Bos. Sci.
Corp., 2015 WL 2124991 at *15-16 (S.D.W.Va. May 6, 2015); Trevino v. Bos. Sci. Corp., 2016 WL 2939521 at
*17-18 (S.D.W.Va. May 19, 2016); Frankum v. Bos. Sci. Corp., 2015 WL 1976952 at *19-20 (S.D.W.Va. May 1,
2015); Carlson v. Bos. Sci. Corp., 2015 WL 1931311 at *24-25 (S.D.W.Va. Apr. 28, 2015).
42
Daubert v. Merrell Dow Pharm., Inc., 508 U.S. 579, 597 (1993).
43
Id.44
2014 WL 4851989 (S.D.W.Va. Sept. 29, 2014).
14
standard of care required of a reasonably prudent medical device
manufacturer[.]45
As in Sanchez, here, Dr. Pence relies on various materials to support her
opinions. This includes the risks associated with polypropylene mesh, statements in
Material Safety Data Sheets provided by the polypropylene supplier in 2004
indicating that polypropylene should not be used for permanent implantation in the
human body, and development history of BSC products.46
BSC takes issue specifically with Dr. Pence’s reliance on the French National
Authority for Health (“HAS”) and the National Institute for Health and Care
Excellence (“NICE”) to substantiate her opinions. However, in Sanchez, the Court’s
previous reliability concerns about Dr. Pence’s premarket testing opinions were
dispelled based on her “bolstered expert report” that included cites to the HAS and
NICE. As to the HAS and NICE, the Court stated:
[Dr. Pence] describes a 2006 study conducted by the [HAS], in which
it evaluated the safety and efficacy of vaginally implanted mesh for the
treatment of genital prolapse. HAS concluded that “the research” and
recommended prospective studies on the anatomical and functional
outcomes of mesh implantation, the mid- to long-term effects, possible
adverse events like erosion, and the management of erosions and
retractions. Dr. Pence also discusses the recommendations of the
[NICE], which include the warning that transvaginal mesh repair
“should be used with special arrangements for clinical governance,
consent and audit or research.”47
45
See Exhibit “B” to Defendant’s Motion to Exclude the Opinions and Testimony of Peggy Pence, PH.D., at 52. See
also Sanchez, 2014 WL 4851989 at *33.
46
See Exhibit “B” to Defendant’s Motion to Exclude the Opinions and Testimony of Peggy Pence, PH.D., at 32-42.
47
Id.15
In following the pattern of the MDL Court, this Court chooses to adopt the
rationale of the Sanchez Court as to the instant litigation. Dr. Pence’s premarket
opinions are “backed by authoritative studies that recommend the performance of
clinical trials and long-term follow-ups before using polypropylene mesh.”48
Therefore, these opinions are admissible and BSC’s motion on this point is
DENIED.
B. BSC’s Product Labeling
BSC argues that Dr. Pence improperly relies on FDA and GHTF standards that
do not substantiate her opinions about the alleged inadequacy of BSC’s pelvic mesh
product labeling. The MDL Court has consistently excluded Dr. Pence’s opinions
on this topic because they are unreliable under Daubert.49 Plaintiff responds that this
Court should admit Dr. Pence’s opinions because she has bolstered her report from
the time the MDL Court had rejected her opinions.
The bolstering Plaintiff is referring to is Dr. Pence’s reliance on the GHTF
standards. Despite Plaintiff’s position, this Court finds that Dr. Pence’s reliance on
non-FDA standard does nothing to “bolster” her report and her opinions remain
unreliable for the purposes of Daubert. In so finding, this Court adopts the rationale
48
Id.49
Sanchez v. Bos. Sci. Corp., 2014 WL 4851989 (S.D.W.Va. Sept. 29, 2014). See also Eghnayem v. Bos. Sci. Corp.,
57 F.Supp.3d 658, 696-97 (S.D.W.Va. 2014); Tyree v. Bos. Sci. Corp., 2015 WL 5486694 at *28 (S.D.W.Va. Oct.
29, 2014).
16
of the Court in Carlson v. Bos. Sci. Corp.50 The Carlson Court explained: “[t]he
GHTF document on product labels does not state—expressly or otherwise – that
manufacturers should include the severity, frequency, and/or permanency of adverse
event in a warning, nor does it state that a label should qualify the difficulty of
removing the device.”51 Further, in both Carlson and the instant litigation, Dr. Pence
testified during her deposition that no non-FDA standard “gets to that level of
specificity.”52 This Court concludes that Dr. Pence’s opinions on this point remain
unreliable for Daubert purposes and are excluded.
As to Dr. Pence’s reliance on FDA standards, this Court again finds the Sanchez
Court’s rationale to be instructive. In Sanchez, Dr. Pence offered identical opinions
to the ones offered in the present litigation. The Sanchez Court excluded these
opinions as unreliable and explained:
Indeed, Dr. Pence cites to various publications and data throughout her
report. However, the information she references – literature and data on
the reported complications associated with Pinnacle mesh – does not go
to the heart of her opinions – that BSC failed to meet the “standard of
care required of a medical device manufacturer” in its deficient labeling
of its products….In other words, although this authority demonstrates
that complications occurred, it does not provide any guidance as to
whether these complications should have been included as warning in
the Pinnacle’s IFU. Eliminating this peripheral information, Dr. Pence
is left with ipse dixit sources like “the standard of care”… and “a matter
of ethics” …, both of which fall short of Daubert’s reliability prong.53
50
2015 WL 1931311 (S.D.W.Va. Apr. 28, 2015).
51
Id. at 26.
52
See Exhibit “C” to Defendant’s Motion to Exclude the Opinions and Testimony of Peggy Pence, PH.D., at 261.
53
2014 WL 4851989 at *35 (internal citations omitted).
17
Based on the foregoing and finding no reason to ignore the rationale articulated
by the Sanchez Court, Dr. Pence’s opinions about BSC’s product labeling lacks a
reliable basis and are excluded.
C. BSC’s Postmarket Vigilance
BSC argues that the methodology underlying Dr. Pence’s opinions is not reliable
– specifically, her reliance on the FDA MAUDE Database and GHTF documents.
Plaintiff responds that Dr. Pence’s opinions should not be excluded because she
relied on industry standards rather than FDA documents.
First, whether BSC violated FDCA reporting requirements is of “minimal
relevance” to the present litigation.54 Plaintiff has not asserted any claim concerning
the FDA and FDCA reporting requirements. Second, any opinion by Dr. Pence, or
any expert, that BSC did or did not comply with the FDCA constitutes a legal
conclusion which exceeds the scope of expert testimony and is generally
inadmissible.55 Lastly, the probative value of testimony concerning the regulations
of the FDCA is far outweighed by the substantial risk of confusing and misleading
the jury.56
Next, this Court addresses Dr. Pence’s opinions which she relied in whole, or in
part, on the MAUDE Database. The MDL Court in Carlson found the MAUDE
54
Sanchez, 2014 WL 4851989 at *36.
55
Carlson, 2015 WL 1931311 at *27.
56
Id.18
Database to be an unreliable source. In excluding Dr. Pence’s opinions on this topic,
the Court stated that “[h]ow and to what end Dr. Pence uses the data [from the
MAUDE Database] is inapposite... because further investigation into the MAUDE
database reveals that it is unreliable, at least for the purposes of Daubert.” 57 The
Court had this to say of the MAUDE database and its unreliability:
The MAUDE system is a “passive surveillance system” that does not
account for the “potential submission of incomplete, inaccurate,
untimely, unverified, or biased data.” … As such, the data has not been
reviewed for accuracy at all, let alone peer-reviewed, and the court has
no way to determine the rate of error associated with Dr. Pence’s use of
it. In addition, given that FDA warns users that the data alone “cannot
be interpreted or used in isolation to reach conclusions about the
existence, severity, or frequency of problems associated with devices,”
[] I can readily conclude that … application of the data to reach a
scientific conclusion about a manufacturer’s conduct is not generally
accepted in the scientific or medical community.58
The Court further stated that despite “BSC’s communication, or alleged lack
thereof, with the FDA through the MAUDE database[, this] has ‘no bearing on
whether BSC provided adequate warnings or whether its products were
defective.’”59 This Court has no reason to ignore the rationale of the Carlson court
as to Dr. Pence’s opinions about BSC’s postmarket vigilance. As such, this Court
chooses to adopt the Carlson Court’s rationale in the instant litigation and excludes
Dr. Pence’s opinions because they fall short of the Daubert reliability standard.
57
Id.58
Id.59
Id.19
D. Dr. Pence’s Qualifications
BSC next argues that Dr. Pence’s opinions far exceed the scope of her
“knowledge, skill, experience, training, or education[,]” required by Rule 702.
Plaintiff responds that Dr. Pence has been found to be qualified in numerous other
cases and that her qualifications have not since changed. Upon this Court’s own
review of the relevant case law, no court has found that Dr. Pence lacks the
qualifications necessary to qualify as an expert.60 Additionally, Dr. Pence has
appeared the most out of any expert within the multi-district litigation.61
Thus, this Court concludes that Dr. Pence is no less qualified to offer her opinions
in the instant litigation than she was in the prior eight instances the MDL Court found
her to be qualified. Therefore, BSC’s request that Dr. Pence’s opinions be excluded
based on lack of Dr. Pence’s qualifications is DENIED.
E. Cancer Opinions
BSC argues that Dr. Pence’s opinions regarding the carcinogenicity of
polypropylene mesh must be excluded because she is unqualified to do so and her
opinions are otherwise unreliable and irrelevant. Plaintiff does not respond to this
60
See Nunez v. Coloplast Corp., 2020 WL 2315077 at *6 (S.D. Fla. May 11, 2020) (“The Court sees no reason to
second-guess the MDL Court’s eight instances of finding Dr. Pence qualified as an expert.”) (emphasis added)). See
also Armstrong v. Bos. Sci. Corp., 2018 WL 3824375 at *5 (S.D.W.Va. Aug. 10, 2018); Heatherly v. Bos. Sci.
Corp., 2018 WL 3797507 at *7 (S.D.W.Va. Aug. 9, 2018); Waltman v. Bos. Sci. Corp., 2016 WL 3198322 at *9
(S.D.W.Va. Jun. 8, 2016); In re Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig., 2016 WL 4493685 at *3
(S.D.W.Va. Aug. 5, 2016); Carlson v. Bos. Sci. Corp., 2015 WL 1931311 at *28 (S.D.W.Va. Apr. 28, 2015);
Eghnayem v. Bos. Sci. Corp., 57 F.Supp. 3d 658, 698 (S.D.W.Va. 2014); Tyree v. Bos. Sci. Corp., 54 F.Supp. 3d
501, 541 (S.D.W.Va. 2014).
61
Id.20
argument and foregoes the opportunity to do so. Therefore, BSC’s motion on this
point is GRANTED.
F. Disclosures BSC Allegedly Failed to Make62
BSC argues that Dr. Pence’s opinion, that BSC did not conduct appropriate
testing or disclose information to the FDA as part of the process, should be excluded
because it is preempted under Buckman Co. v. Plaintiffs Legal Committee63 and
PLIVA v. Mensing.64 Plaintiff argues that she is not pursuing any state-law fraud
claims against BSC and thus Buckman and PLIVA are not applicable. The relevance
of Dr. Pence’s opinions, Plaintiff argues, relates to BSC’s ongoing and continuing
course of action as to the manufacture and sale of the Obtryx sling.
At the outset, this Court finds that Dr. Pence’s opinions are not preempted under
Buckman and PLIVA because, as correctly noted by Plaintiff, she is not pursuing any
state-law fraud claim against BSC. However, this Court still finds that Dr. Pence’s
opinions must be excluded. In In re Ethicon, Inc.,65 Dr. Pence’s opinions about
“whether Ethicon violated particular sections of the FDCA or failed to furnish
information to the FDA[,]” were excluded.66 The Court stated that there were no
62
As this Court has already stated with respect to Dr. Parisian and her opinions involving discussion of the FDA,
despite this Court’s decision on the Daubert issue, Dr. Parisian’s opinions may or may not be found to be admissible
based on any respective Motion in Limine filed by the parties. The issues raised by the parties in the Motions in
Limine will be addressed in a separate opinion.
63
531 U.S. 341 (2001).
64
564 U.S. 604 (2011).
65
2014 WL 186872 (S.D.W.Va. Jan 15, 2014).
66
Id. at 19.
21
facts in issue under Rule 702 because Plaintiffs had not raised any FDA related
claims.67 Further, as to Plaintiffs’ failure to warn and breach of warranties claims,
the court stated that that the opinions would not help the jury but rather confuse and
mislead them.68
This Court finds that by allowing Dr. Pence to offer her opinions regarding BSC’s
alleged failure to adequately test and disclose certain information to the FDA during
the 510(k) process would run afoul of Rule 401 and 702 of the Delaware Rules of
Evidence. This testimony not only lacks probative value but is likely to confuse a
jury. In Bowling v. C.R. Bard, Inc.,69 the Court explained:
Because the section 510(k) clearance process does not speak directly to
safety and efficacy, it is of negligible probative value….Delving into
complex and lengthy testimony about regulatory compliance could
inflate the perceived importance of compliance and lead jurors “to
erroneously conclude that regulatory compliance proved safety.”70
Based on the foregoing, Dr. Pence’s opinions about disclosures BSC’s allegedly
failed to make are excluded because they are not relevant and ergo not helpful to the
jury.
67
Id.
68
Id.
69
2017 WL 1113314 (S.D.W.Va. Mar. 23, 2017).
70
Id. at 3.
22
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.
A. Delaware’s “fit” Requirement
BSC argues that Dr. Dunn’s opinions do not satisfy Delaware’s “fit”
requirement. Specifically, that Dr. Dunn’s opinions will not be helpful to the jury
because they are irrelevant as he is unable to apply any of his opinions to Plaintiff
or her claims. Plaintiff responds that Dr. Dunn, with his testimony, will address the
fundamental issue in this litigation – the Obtryx and its alleged defective design –
and that an understanding of this issue is critical to understanding Plaintiff’s injuries
and how they occurred.
At the outset, this Court notes that it has already addressed Dr. Dunn’s
opinions in this context in separate litigation.71 In Harris, the parties relied on the
same expert report of Dr. Dunn that the parties in the instant litigation rely upon.
Thus, this Court will choose to adopt its holding in Harris where it explained:
All right. I’m going to grant this motion because Dr. Dunn’s testimony
did not turn out the way that we expected it to in drawing that causal
connection with the plaintiff, and not hearing anything different with
regard to this plaintiff, I find that he is not—that his testimony is not
71
Motion Hearing, Harris v. Bos. Sci. Corp., N15C-06-216 PEL. See also Exhibit “K” to Defendant’s Motion to
Exclude the Opinions and Testimony of Peggy Pence, PH.D.
23
relevant and also cumulative. So, I am going to grant the Motion to
Exclude Dr. Dunn’s testimony on this case.72
As in Harris, absent from Plaintiff’s Response is any causal connection
between Dr. Dunn’s opinions and her claims in the instant litigation, making Dr.
Dunn’s testimony wholly irrelevant. If this Court were to permit Dr. Dunn to testify
then it would be allowing cumulative and irrelevant evidence to be admitted, and
that this Court will not do. Therefore, Dr. Dunn’s opinions are excluded, in full.
Scott Guelcher
Dr. Guelcher is a chemical engineer offered by 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.
BSC raises various arguments regarding Dr. Guelcher’s proffered opinions.
BSC advances that: (1) Dr. Guelcher’s opinions would not assist the trier of fact; (2)
that his opinion regarding oxidative degradation and its in vivo effects are unreliable;
and (3) that his opinions are beyond his field of expertise.
This Court on two previously occasions has addressed Dr. Guelcher’ s
opinions. Most recently, this Court permitted Dr. Guelcher to offer his opinions in
Harris v. Bos. Sci. Corp.73 In so doing, the Court relied on its prior ruling in Barba
v. Bos. Sci. Corp.74 In short, Dr. Guelcher has been permitted to testify generally
72
Motion Hearing, at 56-57, Harris v. Bos. Sci. Corp., N15C-06-216 PEL (Del. Super. Ct. Apr. 11, 2017).
73
Exhibit “B” to Defendant’s Motion to Exclude the Opinions and Testimony of Scott Guelcher, PH.D.
74
Exhibit “C” to Defendant’s Motion to Exclude the Opinions and Testimony of Scott Guelcher, PH.D.
24
about polypropylene oxidative degradation. However, as to Dr. Guelcher’s opinions
about complications that stem from degradation, these opinions have been excluded.
This Court in Harris explained:
I am going to let Dr. Guelcher testify as I permitted him to testify in the
Barb[a] case. The Boston Scientific objections go to the weight of the
evidence, but as to the Barb[a] case, I am not going to permit Dr.
Guelcher to testify, for example, that degradation leads to certain
complications. In other words, he can’t testify degradation leads to pain,
for example, because that’s outside of his area of expertise. A
foundation will have to be laid that his opinions are based on the fact
that there are chemical changes in polypropylene products when placed
in a dynamic environment and that the human body is a dynamic
environment. Also, to make it clear, I’m not going to let him
specifically discuss what happens in the pelvis, because he’s not done
any work in that area.75
Similarly, in the instant litigation, most of BSC’s objections go to the weight
of the evidence. But the credibility of Dr. Guelcher and his opinions are outside the
bounds of this Court’s gatekeeping function on a Daubert motion. As such, this
Court chooses to follow its prior rulings in Barba and Harris. This Court
reemphasizes that Dr. Guelcher is qualified to offer his general opinions about
polypropylene oxidative degradation. But, to the extent his opinions relate to
75
Exhibit “B” to Defendant’s Motion to Exclude the Opinions and Testimony of Scott Guelcher, PH.D., at 63. See
also Exhibit “K” to Defendant’s Motion to Exclude the Opinions and Testimony of Scott Guelcher, PH.D (“All
right. What he started to say is not objectionable. He said it can cause pain and – but if you are anticipating that he’s
going to say it causes vaginal pain or something specific to gynecology, I think that’s a fair objection. But what he
said now is appropriate.”) Id. at 124.
25
specifics – including complications stemming from degradation – such opinions go
beyond Dr. Guelcher’s field of expertise, and thus, are excluded.
Based on the foregoing, BSC’s motion is GRANTED, in part, and DENIED,
in part.76
Suzanne Parisian, M.D.
Dr. Parisian is a pathologist who works as a regulatory consultant and intends
to testify on behalf of Plaintiff.
A. Legal Conclusions
This Court has already addressed in a previous section of this opinion that
experts are generally precluded from offering opinions in the form of legal
conclusions. However, this Court finds that, specifically as it relates to Dr. Parisian,
a further explanation is required.
BSC takes issue with three opinions offered by Dr. Parisian in her report that:
• BSC failed to meet its “duties to the FDA, physicians or patients;
• BSC’s marketing claims constitute “misbranding…not permitted by
Defendant’s 510(k) and…not permitted by the Federal Food, Drug and
Cosmetics Act”; and
• BSC’s “insertion accessories were non-exempt class II accessories to a
class II device, namely surgical mesh, making them regulated also as a
76
This Court notes that the MDL Court has routinely excluded Dr. Guelcher as an expert in this litigation. However,
this is so because BSC argued, and the MDL Court agreed, that Dr. Guelcher’s opinions were unreliable because
they were based on the unreliable testing of another Plaintiff expert, Dr. Russell Dunn. However, in the instant
litigation, BSC does not assert that Dr. Guelcher’s opinions are unreliable because of his reliance on Dr. Dunn’s
testing. Here, BSC argues that Dr. Guelcher is not qualified. This Court chooses to follow its own previous rulings
as it relates to Dr. Guelcher’s opinions. This Court also notes that the MDL Court’s decisions excluding Dr.
Guelcher as a witness were available to this Court at the time it issued its ruling in Harris. See Winebarger v. Bos.
Sci. Corp., 2015 WL 1887222 at *25 (S.D.W.Va. Apr. 24, 2015); Sederholm v. Bos. Sci. Corp., 2016 WL 3282587at *6 (S.D.W.Va. Jun. 14, 2016); Wilkerson v. Bos. Sci. Corp., 2015 WL 2087048 at *19 (S.D.W.Va. May 5, 2015);
Trevino v. Bos. Sci. Corp., 2016 WL 2939521 at *21 (S.D.W.Va. May 19, 2016).
26
class II device requiring 510(k) clearance by the FDA prior to
marketing.”
•
BSC argues that these opinions constitute impermissible legal conclusions and
should be excluded. In support, BSC cites to Pritchett v. I-Flow Corp.,77 where the
Court precluded Dr. Parisian from offering a host of her opinions because they were
“legal conclusions … outside of Dr. Parisian’s area of expertise and improperly
invades the provinces of both the jury and the court.”78 This Court finds that the
opinions BSC takes issue within the present litigation and those excluded in Pritchett
are distinguishable, with one exception. In Pritchett, Plaintiff sought to offer Dr.
Parisian’s opinion that “I-Flow’s promotional activities misbranded both its own
501(k) cleared pain pumps as well as other pharmaceutical manufacturer’s NDA
(ANDA) approved drugs.”79 Here, Plaintiffs seek to offer Dr. Parisian’s opinion that:
Defendant’s marketing would imply to physicians that its introduction
of ‘de-tang’ (heat melting on the edges with an iron) provides a possible
added benefit that would help reduce the sling’s risk of erosion (i.e.
improved safety). This was not a claim that had been cleared by the
FDA for Defendant’s pubourethral surgical mesh and is only one
example of misbranding. Misbranding is not permitted by Defendant’s
510(k) and it is not permitted by the Federal Food, Drug and Cosmetic
Act.80
This Court finds this opinion to be nearly identical to the one offered in
Pritchett, and thus, will not permit Dr. Parisian to offer it. As to Dr. Parisian’s other
77
2012 WL 1059948 (D. Colo. Mar. 28, 2012).
78
Id. at 7.
79
Id.
80
See Exhibit “A,” to Plaintiff’s Response to Defendant’s Motion to Exclude the Opinions and Testimony of
Suzanne Parisian, M.D., at ¶ 76.
27
opinions that BSC contests, this Court finds those opinions do not constitute
impermissible legal conclusions. As Plaintiffs point out in their Response Brief, the
In re Fosamax81 Court permitted Dr. Parisian to testify about the regulatory process,
FDA guidelines, and labeling as to the product at issue. In doing so, the Court
explained that the applicable law to the case was state law and Dr. Parisian’s
testimony was about federal regulations.82 The Court found that this testimony
would be helpful to the jury in determining whether the defendant acted as a
reasonably prudent manufacturer.83 Similarly, here, state law applies to Plaintiff’s
claims and Dr. Parisian’s testimony regarding the FDA will be helpful to a jury to
determine an ultimate fact at issue – whether BSC acted as a reasonably prudent
medical device manufacturer.
Based on the foregoing, this Court concludes that Dr. Parisian is permitted to
offer the opinions previously stated except for her conclusion about misbranding,
which she is not permitted to offer at trial as it constitutes an impermissible legal
conclusion.
B. Medical Causation and Scientific Opinions
BSC argues that Dr. Parisian is not qualified to offer medical causation and
scientific opinions. Plaintiff concedes that Dr. Parisian will not be offering these
81
645 F.Supp.3d 164 (S.D.N.Y. 2009).
82
Id. at n.16.
83
Id.
28
opinions.84 Therefore, BSC’s motion on this point is GRANTED and the opinions
are excluded.
C. Adequacy of BSC’s Labeling
BSC argues that Dr. Parisian is not qualified to opine on the adequacy of
BSC’s warnings to physicians. Plaintiff responds that Dr. Parisian is well-qualified
to offer these opinions and courts have routinely allowed her to do so. BSC cites to
Reece v. Astrazeneca Pharmaceuticals, LP 85 in support but this Court does not find
that decision relevant on this set of facts.86 Instead, this Court finds persuasive the
various courts’ decisions finding Dr. Parisian to be well-qualified to offer her
opinions about the adequacy of BSC’s labeling.
84
Even if Plaintiffs sought to offer Dr. Parisian’s medical causation opinions, this Court would preclude them from
doing so. As stated by the Court in Georges v. Novartis Pharmaceuticals Corp., “Dr. Parisian’s expertise lies in
issues relating to the FDA, and not in issues relating to the diagnosis or treatment of disease. As such, she is not
qualified to offer any testimony relating to the cause or diagnosis of Plaintiff’s or any other patient’s ONJ. Further,
allowing her to testify as to causal association would confuse the issue of causation and impermissibly allow the jury
to rely on Dr. Parisian’s opinions regarding the cause of Plaintiff’s ONJ. The danger of unfair prejudice outweighs
the probative value of this evidence.” 2012 WL 9064768 at *10 (C.D. Cal. Nov. 2, 2012).
85
500 F.Supp.2d 736 (S.D. Ohio 2007).
86
In Reece, the Court precluded Dr. Parisian from offering the opinion that the defendant did not provide adequate
warnings and labels because “the special population of patients with chronic muscle pain … may not be able to
report unexplained muscle pain, tenderness or weakness, and defendants should have advised physicians regarding
the risks of delay for detection of rhabdomyolysis and renal failure in patients with chronic muscle pain.” Id. at
745.The Court stated that while Dr. Parisian “is a medical doctor, plaintiff has not demonstrated that there is
anything in Dr Parisian’s background or training that qualifies her to testify as an expert on chronic pain patients,
rhabdomyolysis, or renal failure.” Id. Plaintiffs have not sought to offer any such opinions in the present litigation
and BSC hasn’t alleged as much.
29
In Bartoli v. Novartis Pharmaceuticals Corp.,87 the Court permitted Dr.
Parisian to offer her labeling opinions finding that the methodology she relied upon
was reliable.88 Further, the Court in In re Nuvaring89 explained:
I find that Dr. Parisian’s knowledge, skill, experience, training, and
education qualify her to offer testimony concerning FDA regulatory
and labeling issues. Dr. Parisian’s FDA and pharmaceutical consulting
experience, as well as the knowledge gained through researching and
authoring her book on FDA regulations, provide her with specialized
knowledge that will assist the jury in this case. These qualifications are
further bolstered by the eighteen years Dr. Parisian has spent
conducting reviews and analyses of FDA regulations in the context of
providing expert testimony in drug litigation.90
In Rowland v. Novartis Pharmaceuticals Corp.,91 the Court also permitted Dr.
Parisian’s testimony about labeling “with the exception of any testimony as to what
prescribing oncology physicians would have done had they received different
warnings from Zometa.”92 The Court stated that by allowing such testimony “would
require an impermissible degree of speculation from Dr. Parisian, as she is not an
oncologist.”93
Based on the foregoing, this Court is satisfied that Dr. Parisian is well-
qualified to offer her opinions about the adequacy of BSC’s labeling. However, like
87
2014 WL 1515870 (M.D. Pa. Apr. 17, 2014).
88
Id. at 7 (internal citations omitted). See also Forman v. Novartis Pharmaceuticals Corp., 794 F.Supp.2d 282, 384
(E.D.N.Y. 2011); Lemons v. Novartis Pharmaceuticals Corp., 849 F.Supp.3d 608, 615 (W.D.N.C. 2012); In re
Nuvaring Prods. Liab. Litig., 2013 WL 791835 at *3 (E.D.Mo. Mar. 4, 2013); Barnes v. Orthofix Intern. NV, 2012
WL 191224 at *5 (W.D. Wash. May 23, 2013).
89
2013 WL 791835 (E.D. Mo. Mar. 4, 2013).
90
Id. at 3.
91
9 F.Supp. 3d 553 (W.D. Pa. 2014).
92
Id. at 562.
93
Id.
30
in Rowland, this Court will not permit Dr. Parisian to offer any opinions about what
physicians would have done had BSC’s labeling contained different warnings. Dr.
Parisian is a regulatory expert, not a surgeon, and thus such testimony exceeds her
expertise.
D. Reliability of Dr. Parisian’s Opinions
BSC argues that Dr. Parisian’s opinions are not supported by any regulatory
authority and are therefore unreliable. Plaintiff responds that Dr. Parisian’s review
and analysis of BSC documents and FDA materials make her opinions about BSC’s
conduct and whether it comported with industry standards and regulatory guidelines
a proper subject of expert testimony in this litigation.
Dr. Parisian’s report and accompanying curriculum vitae demonstrate her
extensive knowledge, skill, experience, and training which she derived from her
tenure with the FDA.94 In her various roles within the Agency, it is clear that Dr.
Parisian is well-versed as it relates to medical devices and the requirements and
standards the manufacturers of those products must satisfy.95
In Dr. Parisian’s report, she states that she has used the same methodology in
forming her opinions for the instant litigation that she had “at the FDA to analyze
pre-and post-market documentation for [BSC’s] design, development and promotion
94
See Exhibit “A” and “B” to Plaintiff’s Response to Defendant’s Motion to Exclude the Opinions and Testimony
of Suzanne Parisian.
95
See Exhibit “A” to Plaintiff’s Response to Defendant’s Motion to Exclude the Opinions and Testimony of
Suzanne Parisian at ¶¶ 3,4,6,8.
31
for commercial Sling Systems for treatment of symptoms of [SUI] and [POP].”96
Further, Dr. Parisian states that she reviewed the following documents: BSC’s
documents and testimonies obtained through this litigation; FDA publicly available
documents; and medical literature. 97
BSC argues that when Dr. Parisian departs from the FDA regulatory scheme
her opinions are unfounded personal opinions about industry standards. But this
Court does not agree. “An imperfect fit between the expert’s knowledge and
experience and the issues before the court impacts the weight given to the expert’s
testimony, not it’s admissibility.”98 In fact, in Baldonado v. Wyeth,99 the Court
concluded that the challenges raised by the defendant, while significant, went to the
weight of Dr. Parisian’s opinions rather than admissibility.100 In reaching its
conclusion, the Baldonado Court provided a detailed analysis similar to the
foregoing analysis by this Court.101
Therefore, this Court is satisfied that Dr. Parisian’s opinions are sufficiently
reliable for the purposes of Daubert. BSC may raise any challenges as to the weight
of these opinions at trial during Dr. Parisians’ cross-examination.
E. Disclosures BSC’s Allegedly Failed to Make
96
Id. at ¶16.
97
Id. at ¶ 17.
98
Radiance Foundation, Inc. v. National Ass’n for the Advancement for Colored People, 27 F.Supp.3d 671, 674
(E.D. Va. 2013).
99
2012 WL 323420 (N.D. Ill. Aug. 6, 2012).
100
Id. at 7.
101
Id. at 5-7.
32
BSC argues that Dr. Parisian’s opinions about disclosures it allegedly failed
to make to the FDA during the 501(k) process are preempted by Buckman. Plaintiff
responds that Buckman does not apply in the instant litigation and that Dr. Parisian’s
opinions relate directly to the negligence and products liability claims.
The admissibility of the regulation process was addressed by this Court in
Barba v. Bos. Sci. Corp.102 In that case, this Court acknowledged that the MDL
rulings, consistently excluding this type of evidence, would make the case “much
cleaner.”103 However, this Court noted that it was unable to follow the MDL rulings
because “regulatory evidence, regardless of the extent or comprehensive nature of
the process, consistently has been allowed in Delaware state court toxic tort cases. I
don’t know of one incident where it has been excluded.” In finding this evidence to
ultimately be admissible, this Court explained:
It is clear that the regulation process and whether or not defendant has
complied with that process is one factor that the jury can consider as to
whether the defendant breached the standard of care. However, [I do]
not want this to become prolonged testimony and evidence. Less is
more. I advise counsel that you need to focus on the process, not the
detailed regulations.
In fairly short order you were able to describe for me in layman’s terms
the various levels of this review and what the review in this case
constituted and what it didn’t constitute. So, keep it simple. It’s possible
to keep this issue clean as to the various levels of FDA review …. And
even defendants acknowledge that this is only one factor that goes to
consideration of their compliance with the duty.
102
Motion in Limine Transcript, Barba v. Bos. Sci. Corp., N15C-08-050 (Del. Super. Ct. Jun. 26, 2014).
103
Id. at 37.
33
Now, having said that, this is the way that I am going to go and I feel
that this is at the level of a ruling that I make because I feel that this is
the only ruling I can make consistent with Delaware law. Defendants
know that it opens the door to plaintiff saying you did not give the FDA
everything they needed to give you this clearance or notification, so I’m
certainly going to allow that.
And in light of this, I’m going to have to give the plaintiffs leeway on
that, that’s just all there is to it, because that’s the way it works. So,
unless defendants are willing to voluntarily waive the discussion of
approval process, the door is open.
Now, that brings me to a couple things. First of all, the defendant’s
motion for fraud on the FDA, I understand that that is not a stand-alone
cause of action by law. I am referring in this motion, I think consistent
with what I’ve just said, if there is evidence that Boston Scientific
somehow manipulated the FDA approval procedure, didn’t provide
information they were supposed to provide, provided false or
misleading information, well that information is now going to be
relevant, that evidence is going to be admitted. But I’m not saying that
there is a separate count for fraud on the FDA, I don’t know if that’s
what the motion encompassed, but I think you understand where I’m
going with that.104
Based on the foregoing, this Court chooses to follow its rationale articulated
in Barba. Dr. Parisian’s opinions are not preempted by Buckman and she may offer
her opinions about the disclosures BSC allegedly failed to make during the
regulatory process.
Michael Thomas Margolis, M.D.
Dr. Margolis is a pelvic floor surgeon and urogynecologist. He seeks to offer
several opinions regarding polypropylene mesh slings, alternative procedures, and
complications associated with mesh products.
104
Id. at 37-39 (emphasis added).
34
I. General Causation Opinions
A. Reliability of Opinions
BSC argues that Dr. Margolis’ opinions should be excluded because they are
unreliable based on his “biased and incomplete” review of the medical literature
regarding polypropylene transvaginal mesh and mid-urethral slings. Plaintiff
responds that Dr. Margolis’ opinions are reliable because they are based on scientific
literature and his experience. This Court will address each argument in turn.105
1. Use of Polypropylene Mid-Urethral Slings as Safe and Effective for
SUI.
Dr. Margolis opines that polypropylene slings are not safe and effective for
the treatment of SUI. BSC argues that Dr. Margolis in forming this opinion failed to
consider contrary evidence and employed an inconsistent methodology in his
literature analysis. As such, it is BSC’s position that Dr. Margolis’ opinions are
unreliable. BSC’s arguments go to the weight of Dr. Margolis’ opinions, not their
admissibility. This Court finds that Dr. Margolis, in forming his general causation
opinions, has considered the contrary medical literature. Therefore, BSC’s motion
is DENIED and Dr. Margolis is permitted to offer his opinion on the safety and
effectiveness of the use of polypropylene mid-urethral slings for SUI.
105
A very similar motion was filed and decided in Sanchez v. Bos. Sci. Corp., 2014 WL 4851989 (S.D.W.Va. Sept.
29, 2014) and Flores-Banda v. Bos. Sci. Corp., No. 2:13-CV-04434, attached as Exhibit “G” to Defendant’s Motion
to Exclude the Opinions and Testimony of Thomas Margolis, M.D. This Court draws liberally from these decisions.
See also Tyree v. Bos. Sci. Corp., 54 F.Supp.3d 501 (S.D.W.Va. 2014); Eghnayem v. Bos. Sci. Corp., 57 F.Supp.3d
658 (S.D.W.Va. 2014).
35
2. Complication Rates in Women with Polypropylene
Next, BSC argues that Dr. Margolis’ methodology for his opinions that
complication rates with polypropylene vaginal mesh products are high is unreliable.
Specifically, Dr. Margolis opined during his deposition that more than 50% of
women with polypropylene mesh experience pain. 106
When Dr. Margolis was confronted with other studies showing pain rates
lower than the 50% rate that he testified to during his deposition, he characterized
his disagreement with the lower rates as “not biologically plausible[,]” and “that’s
not what I’ve seen, read[,] studied, [and] observed.”107 However, absent a more
adequate explanation as to why he disagrees with these studies, Dr. Margolis’
opinions on this point lack the indicia of reliability that is required by Daubert.108
Therefore, BSC’s motion on this point is GRANTED and Dr. Margolis’ opinions on
this point are excluded.
3. Complication Rate of Pain Due to Polypropylene Mesh
Dr. Margolis also offered his opinion that 25% of women experience
dyspareunia as a result of vaginally-placed polypropylene mesh used to treat pelvic
organ prolapse.109 Again, when Dr. Margolis was confronted with studies that show
106
Exhibit “B” to Defendant’s Motion to Exclude the Opinions and Testimony of Michael Thomas Margolis, M.D.,
at 230:11-16. See also Exhibit “A” to Defendant’s Motion to Exclude the Opinions and Testimony of Michael
Thomas Margolis, M.D., at 9.
107
Exhibit “B” to Defendant’s Motion to Exclude the Opinions and Testimony of Michael Thomas Margolis, M.D.,
at 239-8:13.
108
See Exhibit “G” to Defendant’s Motion to Exclude the Opinions and Testimony of Michael Thomas Margolis,
M.D., at 10. See also Sanchez v. Bos. Sci. Corp., 2014 WL 485189 at *12-13 (S.D.W.Va. Sept. 29, 2014).
109
Id. at 255-24:25, 256-1:2
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a lower percentage of dyspareunia rates he stated, “I don’t think they’re
representative of the true rate in the population, in the general population.”110 When
further pressed why he did not think they were representative of the true rate he
stated, “I don’t know I just don’t think they’re representative.”111
When Dr. Margolis was confronted with the Shah and Badlani study where
the dyspareunia rate was noted as low as 6.2%, he stated that the percentage was
reasonable “[i]n this study. But I have to take – I’m going to give the benefit of the
doubt to the patient.”112
This methodology of Dr. Margolis – giving the patients the “benefit of the
doubt” has consistently been rejected by the MDL Court.113 In Flores-Banda v. Bos.
Sci. Corp.,114 the Court explained that “[i]n other words, [Dr. Margolis] 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.”115 This Court agrees with the
MDL Court and finds that Dr. Margolis’ methodology of giving the patient the
“benefit of the doubt” is not sufficiently reliable for purposes of Daubert. Therefore,
110
Id. at 256-12:18
111
Id. at 256-21:22
112
Id. at 259-3:9 (emphasis added).
113
See Exhibit “G” to Defendant’s Motion to Exclude the Opinions and Testimony of Thomas Margolis, M.D., at
10. See also Sanchez, 2014 WL 4851989 at *13-14.
114
See Exhibit “G” to Defendant’s Motion to Exclude the Opinions and Testimony of Thomas Margolis, M.D.
115
Id. at 11.
37
BSC’s motion on this point is GRANTED and Dr. Margolis’ opinions on this point
are excluded.
4. Safer Alternative Designs
BSC challenges Dr. Margolis’ opinion on safer alternative designs.
Specifically, BSC challenges Dr. Margolis’ opinions that the Burch procedure and
the Xenform slings are more effective than polypropylene mid-urethral slings.
The basis for BSC’s challenge is that there is no medical support for either of
these opinion and that it is based on Dr. Margolis’ own personal opinion. This exact
argument was addressed by the MDL Court in Sanchez v. Bos. Sci. Corp.116 and
rejected.
This Court will follow the MDL decision, and therefore, BSC’s motion on this
point is DENIED.
5. Uncontested Challenges
BSC also raises challenges to various other opinions offered by Dr. Margolis
including: (1) that the infection rate of polypropylene mesh is up to 100%; (2) that
the complication rate of urethral obstruction is greater than 10% with polypropylene
mid-urethral slings; and (3) that he has removed 10 to 15% of BSC products. Plaintiff
provides no response to this argument in their Brief and, as such, waive the
opportunity to do so.
116
2014 WL 4851989 (S.D. W.Va. Sept. 29, 2014).
38
Plaintiff does offer a response to BSC’s position that Dr. Margolis’ opinions
are unreliable because he failed to consider three specific long-term studies
evaluating cure rates, complications, and adverse events. However, as this Court has
already noted, it will not consider credibility arguments on a Daubert motion. The
Court’s role at this stage of the litigation is to determine the admissibility of Dr.
Margolis’ opinions and any credibility concerns BSC has may more appropriately
be raised during cross-examination.
Based on the foregoing, BSC’s motion is GRANTED, in part, and DENIED,
in part.
B. Qualifications
BSC argues that various opinions that Dr. Margolis offers are outside his field
of expertise as a surgeon and urogynecologist. Specifically, BSC takes issue with
Dr. Margolis’ qualifications to opine on: (1) biomaterials, medical device design
and development; and or (3) marketing. Plaintiff has conceded that Dr. Margolis
will not be offering opinions on these topics, and therefore, BSC’s motion on these
points is GRANTED.
II. Specific Causation Opinions
In addition to being identified as a general expert, Dr .Margolis has also been
identified as a case specific expert in Ms. Kaur’s case. BSC has filed a number of
challenges to Dr. Margolis in his capacity as a case specific expert.
39
First, BSC moves to exclude any opinion testimony from Dr. Margolis
regarding Plaintiff’s failure to warn claims because, according to BSC, Dr. Margolis
failed to provide any case specific opinion on that topic.117 Plaintiff responds that
Dr. Margolis has fully disclosed his opinions on the adequacy of BSC’s Directions
for Use for the Obtryx device in his general expert report.
Based on this Court’s own review of Dr. Margolis’ reports containing his
general and specific opinions relating to Plaintiff’s case, it is apparent that BSC has
been put on adequate notice of Dr. Margolis’ failure to warn opinions.118 This is
especially the case in the instant litigation where the Plaintiff has abandoned her
failure to warn claims and any testimony of Dr. Margolis touching on this issue is
limited to Plaintiff’s punitive damages claim.
Next, BSC requests that any opinion testimony outside of Dr. Margolis’ areas
of expertise be excluded. Plaintiff responds by conceding that Dr. Margolis will not
be offering opinions in the areas of biomaterials, medical device design and
development,119 and marketing. Thus, BSC’s motion on this point is GRANTED and
these opinions are excluded. As to Dr. Margolis’ opinions regarding “foreign body
reaction” and degradation of mesh, this Court is without sufficient information at
117
The Court make no decision at this point on whether the testimony is relevant to these claims.
118
See Exhibits “C” and “D” to Plaintiff’s Response in Opposition to Defendant’s Motion to Exclude Specific-
Causation Testimony of Michael Thomas, Margolis, M.D.
119
Medical device design does not include testimony on alternative design.
40
this time and reserves ruling on this issue until a more complete trial record is
developed.
Next, BSC argues that Dr. Margolis’s specific causation opinions relating to
Plaintiff’s alleged injuries fail to “fit” the facts of the case and are nothing more than
ipse dixit. Specifically, BSC challenges his opinions relating to alleged defects of
the Obtryx because he fails to provide a basis and explanation for his decision and
whether Plaintiff actually experienced any alleged defects. However, in reading Dr.
Margolis’ general and specific causation reports together, this Court finds that Dr.
Margolis has, in fact, provided a sufficient explanation and basis for his opinions.
However, as it relates to alleged defects of the Obtryx, this Court limits Dr. Margolis’
opinions to only those defects actually experienced by the Plaintiff. Testimony
regarding other alleged defects of the Obtryx not suffered by the Plaintiff is not
relevant to the instant litigation, and even if relevant, would be prejudicial and lend
to confuse the jury.
IT IS SO ORDERED this 11th day of May, 2022.
/s/ Francis J. Jones, Jr.,
Francis J. Jones, Judge
41