United States District Court, S.D. West Virginia, Charleston Division
IN RE ETHICON, INC. PELVIC REPAIR SYSTEMS PRODUCT LIABILITY LITIGATION THIS DOCUMENT RELATES TO cases Identified in the Exhibit Attached Hereto
MEMORANDUM OPINION AND ORDER (DAUBERT MOTION
RE: JAIME L. SEPULVEDA-TORO, M.D.)
R. GOODWIN UNITED STATES DISTRICT JUDGE
before the court is the Motion to Limit the Opinions and
Testimony of Jaime L. Sepulveda-Toro, M. D. [ECF No. 2014]
filed by the plaintiffs. The Motion is now ripe for
consideration because briefing is complete.
case resides in one of seven MDLs assigned to me by the
Judicial Panel on Multidistrict Litigation 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 30, 000 of
which are in this MDL, which involves defendants Johnson
& Johnson and Ethicon, Inc. (collectively
“Ethicon”), among others.
MDL, the court's tasks include “resolv[ing]
pretrial issues in a timely and expeditious manner” and
“resolv[ing] important evidentiary disputes.”
Barbara J. Rothstein & Catherine R. Borden, Fed. Judicial
Ctr., Managing Multidistrict Litigation in Products
Liability Cases 3 (2011). To handle motions to exclude
or to limit expert testimony pursuant to Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993),
the court developed a specific procedure. In Pretrial Order
(“PTO”) No. 217, the court instructed the parties
to file only one Daubert motion per challenged
expert, to file each motion in the main MDL-as opposed to the
individual member cases-and to identify which cases would be
affected by the motion. PTO No. 217, at 4.
plunging into the heart of the Motion, a few preliminary
matters need to be addressed.
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. Bos. Sci.
Corp., No. 2:12-cv-05762, 2014 WL 4851989 (S.D. W.Va.
Sept. 29, 2014); 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). 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 expert testimony
based on its reliability and relevance. In other words, the
parties have comparatively examined expert testimony 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 misplaced, especially when an expert has
issued new reports and given additional deposition testimony.
of my role as gatekeeper for the admission 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
testimony 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 expert testimony 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 expert testimony contained therein.
I have attempted to resolve all possible disputes before
transfer or remand, including those related to the
admissibility of expert testimony pursuant to
Daubert. Nevertheless, in some instances I face
Daubert challenges where my interest in accuracy
counsels reserving ruling until the reliability of the expert
testimony may be evaluated at trial. At trial, the expert
testimony 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 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 testimony 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 rationalizations of expert testimony, and
incomplete deposition transcripts. This, combined with the
above-described 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 can only be achieved through live
witness testimony- not briefing-I will therefore reserve
ruling until expert testimony can be evaluated firsthand.
the parties should be intimately familiar with Rule 702 of
the Federal Rules of Evidence and Daubert, so the
court will not linger for long on these standards.
testimony is admissible if the expert is qualified and if his
or her expert testimony is reliable and relevant. Fed.R.Evid.
702; see also Daubert, 509 U.S. at 597. An expert
may be qualified to offer expert testimony based on his or
her “knowledge, skill, experience, training, or
education.” Fed.R.Evid. 702. Reliability may turn on
the consideration of several factors:
(1) whether a theory or technique can be or has been tested;
(2) whether it has been subjected to peer review and
publication; (3) whether a technique has a high known or
potential rate of error and whether there are standards
controlling its operation; and (4) whether the theory or
technique enjoys general acceptance within a relevant
Cooper v. Smith & Nephew, Inc., 259 F.3d 194,
199 (4th Cir. 2001) (citing Daubert, 509 U.S. at
592-94). But these factors are neither necessary to nor
determinative of reliability in all cases; the inquiry is
flexible and puts “principles and methodology”
above conclusions and outcomes. Daubert, 509 U.S. at
595; see also Kumho Tire Co. v. Carmichael, 525 U.S.
137, 141, 150 (1999). Finally, and simply, relevance turns on
whether the expert testimony relates to any issues in the
case. See, e.g., Daubert, 509 U.S. at
591-92 (discussing relevance and helpfulness).
bottom, the court has broad discretion to determine whether
expert testimony should be admitted or excluded.
Cooper, 259 F.3d at 200.
Sepulveda-Toro is board-certified in obstetrics and
gynecology. His practice focuses on treating female urinary
incontinence and other pelvic floor disorders.
Safety and Efficacy
plaintiffs challenge the reliability of Dr.
Sepulveda-Toro's expert testimony about the safety and
efficacy of the SUI and POP products at issue. Dr.
Sepulveda-Toro's expert testimony is unreliable, the
plaintiffs claim, because he agrees with an FDA
classification that the plaintiffs believe is contradictory
to his testimony, because he stopped using the products after
they were removed from the market, and because he could not
name the five-year studies on SUI products on which he relied
during his deposition. Upon review, each of these arguments
is wholly devoid of merit. I can easily reject the FDA
classification argument because it is based on the
plaintiffs' mischaracterization of Dr.
Sepulveda-Toro's deposition testimony. The use argument
is irrelevant because Dr. Sepulveda-Toro merely stopped using
the products because they were not on the market, not because
they were not safe or effective. The studies argument is
meritless because the report includes citations to long-term
studies, so it does not matter whether Dr. Sepulveda-Toro
could recall the studies during his deposition. So the
plaintiffs' Motion is DENIED on this
plaintiffs claim Dr. Sepulveda-Toro is not qualified to offer
what they characterize as design opinions. But they do not
explain or identify these opinions with sufficient
specificity. This most recent wave of Daubert
motions in this MDL is plagued with some confusion about what
constitutes a design opinion. So some clarification is
necessary before proceeding.
first glance, it seems the plaintiffs want to prevent Dr.
Sepulveda-Toro from providing any opinions that even mention
the word “design.” But the mere utterance of a
single word is not an incantation that transforms an opinion
about one thing into something else.
close, contextual reading of the transvaginal mesh cases
where this issue has been raised before reveals the heart of
the plaintiffs' objections. In this motion-and several
others-the plaintiffs argue that the expert at issue lacks
the particularized skill, knowledge, experience, education,
or training that is necessary to provide opinions about the
process of designing a product. Opinions of this sort
include, for example, opinions about pre-marketing product
testing and product development. But upon review, I find Dr.
Sepulveda-Toro has ...