United States District Court, S.D. West Virginia, Charleston Division
MEMORANDUM OPINION AND ORDER (PLAINTIFFS' MOTION
R. GOODWIN UNITED STATES DISTRICT JUDGE
before the court is the Plaintiffs' Motion for
Reconsideration Regarding this Court's Order Excluding
the Opinions and Testimony of Vladimir Iakovlev, M.D. on
Specific Causation [ECF No. 94]. The defendant has not
responded to the Motion, and the time for responding has
expired. Therefore, the Motion is ripe for adjudication.
careful consideration, the Motion for Reconsideration [ECF
No. 94] is GRANTED. It is
ORDERED that the Memorandum Opinion and
Order [ECF No. 93] is VACATED. I enter the
current Memorandum Opinion and Order to amend the section of
the previous Order addressing the admissibility of Dr.
Vladimir Iakovlev's specific causation testimony.
before the court are several Daubert motions filed
by both the defendant and the plaintiffs. Briefing is
complete regarding these motions, and the motions are now
ripe for consideration.
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 six remaining active MDLs, there
are nearly 16, 000 cases currently pending, approximately
3800 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).
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 two-part 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.”
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 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
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
respect to relevance, the second part of the analysis,
Daubert further 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
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).
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 fact-finding 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 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.”). 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).
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 state-of-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
note that several of the Daubert motions concern
expert opinions entirely unrelated to the plaintiffs 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 plaintiffs in
this particular case. In addition, the parties filed a total
of sixteen Daubert motions, challenging fifteen
different experts, which, in many instances, involved
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
fifteen challenged experts, they plan to call at trial for
each case. See Pretrial Order No. 121, at 5-6 [ECF
No. 57]. 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 fifteen of the
challenged experts as probable expert witnesses. See
BSC's Disclosure Required by Pretrial Order No. 121 [ECF
No. 60]; Pl.'s Disclosure Required by Pretrial Order No.
121 [ECF No. 61]. 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 plaintiffs. In other words, I
disregard arguments included in the briefing directed
exclusively at other wave plaintiffs and, consequently,
irrelevant to this case.
also 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, 2014); Tyree v. Boston 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). 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.
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 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
these MDLs, I have attempted to resolve all possible disputes
before transfer or remand, including those related to the
admissibility of expert testimony pursuant to Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Nevertheless, in some instances I face Daubert
challenges where my interest in accuracy counsels reserving
ruling until the reliability of an expert's testimonial
opinion may be evaluated at trial. At trial, the opinions
will be tested by precise questions asked and answered. The
alternative of live Daubert hearings is impossible
before transfer or remand because of the numerosity of such
motions in these seven related MDLs. As these MDLs have grown
and the expert testimony has multiplied, I have become
convinced that the critical gatekeeping function permitting
or denying expert opinion testimony on decisive issues in
these cases is best made with a live expert on the witness
stand subject to vigorous examination.
course of examining a multitude of these very similar cases
involving the same fields of expertise, I have faced
irreconcilably divergent expert opinions offered by witnesses
with impeccable credentials, suggesting, to me, an
unreasonable risk of unreliability. The danger-and to my
jaded eye, the near certainty-of the admission of “junk
science” looms large in this mass litigation.
parties regularly present out-of-context statements,
after-the-fact rationalization of opinions, and incomplete
deposition transcripts. This, combined with the parties'
practice of recycling expert testimony, objections, and the
court's prior rulings, creates the perfect storm of
obfuscation. Where further clarity is necessary, I believe it
is only achievable through live witnesses at trial and I
therefore reserve ruling until expert opinions can be
BSC's Daubert Motions
case, BSC seeks to limit or exclude the expert opinions of
Drs. Michael Thomas Margolis, Niall Galloway, Thomas Barker,
Bobby L. Shull, Jimmy Mays, Peggy Pence, Russell Dunn, Scott
Guelcher, Richard Trepeta, and Vladimir Iakovlev.
Michael Thomas Margolis, M.D.
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
Failure to Consider Studies
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.
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 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.
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 plaintiffs have 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
Lack of Scientific Basis
also argues that Dr. Margolis failed to provide any
scientific basis for his other opinions. The plaintiffs do
not address the majority of BSC's arguments on this
point, and I decline to raise counterarguments for the
plaintiffs when they have failed to address BSC's
arguments in their briefing. The plaintiffs have 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
the above opinions, the plaintiffs appear to respond to
BSC's argument concerning Dr. Margolis's opinion
about a lack of scientific support for the use of mesh. The
plaintiffs contend that Dr. Margolis merely opines that there
is a lack of long-term data. Contradictions in
testimony should be addressed on cross-examination. 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. Therefore, BSC's motion regarding
this opinion is DENIED.
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 plaintiffs fail 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 plaintiffs. Therefore, this aspect
of BSC's motion is GRANTED.
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
reasons stated above, I GRANT in part and
DENY in part BSC's Motion to Exclude the
Testimony of Michael Thomas Margolis, M.D.
Niall Galloway, M.D.
defendant seeks to exclude the testimony of Dr. Niall
Galloway. The plaintiffs do not respond to this motion, and I
presume that they concede that Dr. Galloway will not testify
at trial. Thus, the defendant's motion
Thomas H. Barker, Ph.D.
defendant seeks to exclude the testimony of Dr. Thomas
Barker. The plaintiffs do not respond to this motion, and I
presume that they concede that Dr. Barker will not testify at
trial. Thus, the defendant's motion is
Bobby L. Shull, M.D.
defendant seeks to exclude the testimony of Dr. Bobby Shull.
The plaintiffs do not respond to this motion, and I presume
that they concede that Dr. Shull will not testify at trial.
Thus, the defendant's motion is GRANTED.
Jimmy W. Mays, Ph.D.
defendant seeks to exclude the testimony of Dr. Jimmy W.
Mays. The plaintiffs do not respond to this motion, and I
presume that they concede that Dr. Mays will not testify at