Johns v. CR Bard (In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig.)
Decision Date | 28 June 2021 |
Docket Number | Case No. 2:18-cv-1509,Case No. 2:18-md-2846 |
Citation | 546 F.Supp.3d 679 |
Parties | IN RE: DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION This document relates to: Johns v. CR Bard et al. |
Court | U.S. District Court — Southern District of Ohio |
EVIDENTIARY MOTIONS OPINION AND ORDER NO. 13
This Opinion addresses Plaintiff's Motion to Exclude the Opinions and Testimony of Defense Expert Stephen Badylak, D.V.M., Ph.D., M.D. (ECF No. 96) and Plaintiff's Motion to Strike the Supplemental Opinions and Report of Defense Expert Stephen Badylak (ECF No. 408). For the reasons that follow, Plaintiff's motions are both GRANTED IN PART AND DENIED IN PART .
This case is the first bellwether trial, selected from thousands of cases in this multidistrict litigation ("MDL"), alleging "that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions." In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig. , Nos. 2:18-md-2486, 2:18-cv-01509, 2020 WL 5223363, at *1 (S. D. Ohio Sept. 1, 2020). This includes the Ventralight ST, the device implanted in Plaintiff. The Ventralight ST is a prescription medical device used for hernia repairs. The Food and Drug Administration ("FDA") cleared it for use through the premarket notification 510(k) process in 2010 and later cleared it for use with the Echo Positioning System in 2011. It is a multicomponent device made of a mesh that consists of polypropylene, polyglycolic acid fibers, and a bioresorbable coating called "Sepra Technology" ("ST"). The ST-coated side of the mesh is placed against organs, such as the bowels, while the uncoated polypropylene side is placed against the fascia because the uncoated side maximizes tissue attachment and thus supports the hernia repair. Id. at *1–2.
Plaintiff brings this action to recover for injuries sustained as a result of the implantation of Defendants’ allegedly defective Ventralight ST device. Id. at *4. Plaintiff claims that Defendants knew that polypropylene is unsuitable for permanent implantation in the human body. Id. at *2–4. The crux of Plaintiff's claims is that the ST coating on the Ventralight ST resorbs too quickly. Id. at *13. This leads to the exposure of bare polypropylene to internal organs and tissues, increasing the risk of potential complications. Plaintiff alleges that this occurrence led to omental adhesions after his laparoscopic hernia repair surgery in 2015. The following claims remain for trial: design defect, under negligence and strict liability theories; failure to warn, under negligence and strict liability theories; breach of express warranty; breach of implied warranty; breach of implied warranty of merchantability; negligent misrepresentation; and punitive damages. Id. at *6–25.
Plaintiff filed a motion to exclude Dr. Badylak's opinions and testimony based on Dr. Badylak's initial expert report. (ECF No. 96.) Dr. Badylak provided his second supplemental expert report on June 12, 2020, which included opinions related to the presence of the ST coating, a hydrogel coating, on photomicrographs of slides from Defendants’ clinical animal study on the Ventralight ST. (ECF No. 408-1 at PageID #21343.) Later, Plaintiff filed a motion to strike Dr. Badylak's second supplemental report because it contained undisclosed opinions, which the Court denied. (ECF No. 372 at PageID #4838.) However, the Court permitted Plaintiff's expert, Dr. Nagy, to submit a rebuttal report and allowed both Dr. Badylak and Dr. Nagy to be re-deposed on their ST-coating opinions. (Id. ) Dr. Badylak then submitted a rebuttal report to Dr. Nagy's rebuttal report. (ECF No. 413-5.) Plaintiff filed another motion to strike Dr. Badylak's ST-coating opinions in Dr. Badylak's second supplemental expert report. (ECF No. 408.) Oral argument was held on the motion to exclude and the second motion to strike. (ECF No. 437 at PageID #22661.) The motions to exclude and strike Dr. Badylak's opinions are now ripe for adjudication.
"Neither the Federal Rules of Evidence nor the Federal Rules of Civil Procedure explicitly authorize a court to rule on an evidentiary motion in limine. " In re E.I. du Pont de Nemours & Co. C-8 Pers. Injury Litig. , 348 F. Supp. 3d 698, 721 (S.D. Ohio 2016). The practice of ruling on such motions "has developed pursuant to the district court's inherent authority to manage the course of trials." Luce v. United States , 469 U.S. 38, 41 n.4, 105 S.Ct. 460, 83 L.Ed.2d 443 (1984). "The purpose of a motion in limine is to allow a court to rule on issues pertaining to evidence prior to trial to avoid delay and ensure an evenhanded and expedient trial." In re E.I. du Pont , 348 F. Supp. 3d at 721 (citing Ind. Ins. Co. v. Gen. Elec. Co. , 326 F. Supp. 2d 844, 846 (N.D. Ohio 2004) ). However, courts are generally reluctant to grant broad exclusions of evidence before trial because "a court is almost always better situated during the actual trial to assess the value and utility of evidence." Koch v. Koch Indus., Inc. , 2 F. Supp. 2d 1385, 1388 (D. Kan. 1998) ; accord Sperberg v. Goodyear Tire & Rubber Co. , 519 F.2d 708, 712 (6th Cir. 1975) (). Unless a party proves that the evidence is clearly inadmissible on all potential grounds—a demanding requirement—"evidentiary rulings should be deferred until trial so that questions of foundation, relevancy and potential prejudice may be resolved in proper context." In re E.I. du Pont , 348 F. Supp. 3d at 721 (quoting Ind. Ins. Co. , 326 F. Supp. 2d at 846 ). The denial, in whole or in part, of a motion in limine does not give a party license to admit all evidence contemplated by the motion; it simply means that the Court cannot adjudicate the motion outside of the trial context. Ind. Ins. Co. , 326 F. Supp. 2d at 846.
The burden is on the party offering the expert testimony to demonstrate by a preponderance of proof that the opinions of their experts are admissible.
Nelson v. Tenn. Gas Pipeline Co. , 243 F.3d 244, 251 (6th Cir. 2001). Any doubts regarding the admissibility of an expert's testimony should be resolved in favor of admissibility. See Jahn v. Equine Servs., PSC , 233 F.3d 382, 388 (6th Cir. 2000) ; Fed. R. Evid. 702 advisory committee's note to 2000 amendment ("A review of the case law after Daubert shows that the rejection of expert testimony is the exception rather than the rule.").
Expert testimony, i.e. testimony given by "[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education," is admissible if:
Fed. R. Evid. 702. In this circuit, "[t]he Rule 702 analysis proceeds in three stages." United States v. Rios , 830 F.3d 403, 413 (6th Cir. 2016). In re Scrap Metal Antitrust Litig. , 527 F.3d 517, 529 (6th Cir. 2008) (quoting Fed. R. Evid. 702.).
First, an expert witness must be qualified by "knowledge, skill, experience, training, or education." Fed. R. Evid. 702. "[T]he issue with regard to expert testimony is not the qualifications of a witness in the abstract, but whether those qualifications provide a foundation for a witness to answer a specific question." Madej v. Maiden , 951 F.3d 364, 370 (6th Cir. 2020) (quoting Berry v. City of Detroit , 25 F.3d 1342, 1351 (6th Cir. 1994) ). Mannino v. Int'l Mfg. Co. , 650 F.2d 846, 851 (6th Cir. 1981). A party's expert need only meet the " ‘minimal qualifications’ requirement—not one who could teach a graduate seminar on the subject." Burgett v. Troy-Bilt LLC , 579 F. App'x 372, 377 (6th Cir. 2014) (quoting Mannino , 650 F.2d at 851 ); see also Dilts v. United Grp. Servs., LLC , 500 F. App'x 440, 446 (6th Cir. 2012) ().
Second, expert testimony must be relevant. Expert testimony is relevant if it will "help the trier of fact to understand the evidence or to determine a fact in issue." Bradley v. Ameristep, Inc. , 800 F.3d 205, 208 (6th Cir. 2015) (quoting United States v. Freeman , 730 F.3d 590, 599–600 (6th Cir. 2013) ); see also Fed. R. Evid. 702(a). "Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non-helpful."
Daubert v. Merrell Dow Pharms., Inc. , 509 U.S. 579, 591, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) (quoting 3 J. Weinstein & M. Berger, Weinstein's Evidence ¶ 702[02], p. 702–18 (1988)). "This requirement has been...
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