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In re Ethicon, Inc. Pelvic Repair Systems Product Liability Litigation

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

March 29, 2017




         Pending before the court are the plaintiffs' two identical motions entitled Motion to Limit the Opinions and Testimony of Dr. Salil Khandwala, M.D. [ECF Nos. 2420 and 2423] filed on July 21, 2016. Also pending before the court is the plaintiffs' Amended Motion to Limit the Opinions and Testimony of Dr. Salil Khandwala, M.D. [ECF No. 2469]. The court ORDERS that the plaintiffs' Motions [ECF Nos. 2420 and 2423] are DENIED as moot. For reasons appearing to the court, the court ORDERS that the Memorandum Opinion and Order (Daubert Motion re: Salil Khandwala, M.D.) [ECF No. 2728] (“Prior Order”) entered on September 2, 2016, as to the Ethicon Wave 1 cases is ADOPTED in the Wave 2 cases identified in Exhibit A.[1] The Prior Order is attached hereto as Exhibit B.

         Importantly, the court notes that the expert opinions proffered in Wave 1 are in almost every respect identical to those proffered here. The court has found, however, that with each entered Order, the experts in these cases attempt to bolster or fine-tune the support for their opinions, but the opinions themselves do not change. Accordingly, the court will refrain from engaging in the extremely inefficient practice of continuously reexamining the qualifications, reliability, and relevance of dozens of experts and their numerous opinions. While the parties continue to challenge even the slightest alteration to the underlying support for an expert's opinion, the court's review of the parties' arguments reveals that these refreshed Daubert challenges are different from previous arguments by only the very slightest of degrees. The court FINDS that to the extent that the parties raise arguments not previously addressed by the court's Prior Order, the trial judge may easily resolve these issues at trial without the need for further briefing or an evidentiary hearing. Accordingly, the court ORDERS that to the extent that the parties raise Daubert challenges not previously addressed in the court's Prior Order-fully adopted herein-those challenges are RESERVED for trial.

         The court DIRECTS the Clerk to file a copy of this Order Adopting Memorandum Opinion and Order in 2:12-md-2327 and in the Ethicon Wave 2 cases identified in the Exhibit attached hereto.

         EXHIBIT A


Defense Expert Name

Plaintiff Name

Case No.

Khandwala, Salil

Khandwala, Salil

Khandwala, Salil


Khandwala, Salil

Chase, Alvette


Khandwala, Salil

Lindberg, Patricia


Khandwala, Salil

Smallwood, Nancy


Khandwala, Salil

Meyer, Linda


Khandwala, Salil

Lambert, Corrie Ann


Khandwala, Salil

Pieper, Laura



         Pending before the court is the Motion to Exclude or Limit the Opinions and Testimony of Dr. Salil Khandwala, M.D. [ECF No. 2003] filed by the plaintiffs. The Motion is now ripe for consideration because briefing is complete.

         I. Background

         This 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.

         In this 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.[1]

         II. Preliminary Matters

         Before plunging into the heart of the Motion, a few preliminary matters need to be addressed.

         I am compelled to comment on the parties' misuse of my previous Daubert rulings on several of the experts offered in this case. See generally Sanchez v. 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.

         Mindful 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.

         Finally, 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.

         In the 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.

         The 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-and I will therefore reserve ruling until the expert testimony can be evaluated firsthand.

         III. ...

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