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Sanchez v. Boston Scientific Corp.

United States District Court, S.D. West Virginia, Charleston Division

June 28, 2018




         Pending 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.

         After 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.

         Pending 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.

         I. Background

         This case resides in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation (“MDL”) concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the 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).

         II. Legal Standard

         Under Rule 702 of the Federal Rules of Evidence, expert testimony is admissible if the expert is “qualified . . . by knowledge, skill, experience, training, or education” and if his testimony is (1) helpful to the trier of fact in understanding the evidence or determining a fact in issue; (2) “based upon sufficient facts or data;” and (3) “the product of reliable principles and methods” that (4) have been reliably applied “to the facts of the case.” Fed.R.Evid. 702. The Supreme Court has established a 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.” Id.

         The district court is the gatekeeper. “[E]xpert witnesses have the potential to be both powerful and quite misleading, ” so the court must “ensure that any and all scientific testimony . . . is not only relevant, but reliable.” Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th Cir. 2001) (citing Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999); Daubert, 509 U.S. at 588, 595). In carrying out this role, I “need not determine that the proffered expert testimony is irrefutable or certainly correct”-“[a]s with all other admissible evidence, expert testimony is subject to testing by ‘vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof.'” United States v. Moreland, 437 F.3d 424, 431 (4th Cir. 2006) (quoting Daubert, 509 U.S. at 596); see also Md. Cas. Co., 137 F.3d at 783 (noting that “[a]ll Daubert demands is that the trial judge make a ‘preliminary assessment' of whether the proffered testimony is both reliable . . . and helpful”).

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

         With respect to relevance, the second part of the analysis, Daubert further explains:

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

Daubert, 509 U.S. at 591-92 (citations and quotation marks omitted).

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

         III. Preliminary Matters

         I begin by addressing a few preliminary matters that affect many of the Daubert motions. First, both parties consistently challenge experts' opinions as improper state-of-mind or legal-conclusion testimony. As I have maintained throughout these MDLs, I will not permit the use of experts to usurp the jury's 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.”).[1] Likewise, “opinion testimony that states a legal standard or draws a legal conclusion by applying law to the facts is generally inadmissible.” United States v. McIver, 470 F.3d 550, 562 (4th Cir. 2006). An expert may not state his opinion using “legal terms of art, ” such as “defective, ” “unreasonably dangerous, ” or “proximate cause.” See Perez v. Townsend Eng'g Co., 562 F.Supp.2d 647, 652 (M.D. Pa. 2008).

         I have diligently applied these rules to previous expert testimony, and I continue to apply them in this case. This does not mean that each objection to 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 testimony.

         I also 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.

         I am 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.

         Mindful of my role as gatekeeper of expert testimony, as well as my duty to “respect[ ] the individuality” of each MDL case, see In re Phenylpropanolamine Prods. Liab. Litig., 460 F.3d 1217, 1231 (9th Cir. 2006), I refuse to credit Daubert arguments that simply react to the court's rulings in Sanchez and its progeny. Indeed, I feel bound by these earlier cases only to the extent that the expert opinions and Daubert objections presented to the court then are identical to those presented now. Otherwise, I assess the parties' Daubert arguments anew. That is, in light of the particular opinions and objections currently before me, I assess “whether the reasoning or methodology underlying the testimony is scientifically valid” and “whether that reasoning or methodology properly can be applied to the facts in issue.” Daubert, 509 U.S. at 592-93. Any departure from Sanchez, Eghnayem, or Tyree does not constitute a “reversal” of these decisions and is instead the expected result of the parties' submission of updated expert reports and new objections to the opinions contained therein.

         Throughout 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.

         In the 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.

         The 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 evaluated firsthand.

         IV. BSC's Daubert Motions

         In this 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.

         A. Michael Thomas Margolis, M.D.

         BSC seeks to exclude the testimony of Michael Thomas Margolis, M.D. Dr. Margolis is a pelvic floor surgeon and urogynecologist who offers general causation opinions in this case.

         1. Failure to Consider Studies

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

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

         Third, BSC challenges Dr. Margolis's general opinions that complications in women with polypropylene mesh products are high. Dr. Margolis explains that, when forming his opinion about the complication rates of a medical procedure, he gives the benefit of the doubt to the patient. In other words, he assumes the worst-case scenario and errs on the side of opining as to a higher complication rate to better protect a patient. This is not a reliable, scientific basis for determining the complication rates associated with a mesh device. The 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 is GRANTED.

         2. Lack of Scientific Basis

         BSC 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 are GRANTED.

         Unlike 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.[2] Therefore, BSC's motion regarding this opinion is DENIED.

         3. Expertise

         BSC argues that Dr. Margolis offers opinions outside the scope of his qualifications on (1) biomaterials; (2) polypropylene degradation; (3) foreign body reaction; (4) adequate pore size; (5) adequate weight of polypropylene; (6) biocompatibility of polypropylene; (7) medical device design and development; and/or (8) marketing. The 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.

         4. Undisclosed Opinions

         Finally, BSC argues that Dr. Margolis seeks to offer opinions that were not disclosed in his expert report and that Dr. Margolis seeks to discuss materials that were not cited to in his expert report. Testimony on direct examination using such undisclosed sources as support for his opinions is EXCLUDED on Rule 26 grounds. However, the court notes that two articles that BSC alleges were not disclosed- Vaginal Mesh Contraction: Definition, Clinical Presentation and Management and Surgical Management of Pelvic Organ Prolapse in Women-were included in Dr. Margolis's relied-upon list. Dr. Margolis's testimony on these two articles is not excluded under Daubert. Therefore, I find that this aspect of BSC's motion is GRANTED in part and DENIED in part.

         For the reasons stated above, I GRANT in part and DENY in part BSC's Motion to Exclude the Testimony of Michael Thomas Margolis, M.D.

         B. Niall Galloway, M.D.

         The 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 GRANTED.

         C. Thomas H. Barker, Ph.D.

         The 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 GRANTED.

         D. Bobby L. Shull, M.D.

         The 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.

         E. Jimmy W. Mays, Ph.D.

         The 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 ...

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