In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig.

• Citation: 505 F.Supp.3d 770
• Decision Date: 03 December 2020
• Docket Number: Case No. 2:18-md-2846, Case No. 2:18-cv-1509
• 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

505 F.Supp.3d 770

IN RE: DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION This document relates to: Johns v. CR Bard et al.

Case No. 2:18-md-2846

Case No. 2:18-cv-1509

United States District Court, S.D. Ohio, Eastern Division.

Signed December 3, 2020

MOTIONS IN LIMINE OPINION AND ORDER NO. 7

EDMUND A. SARGUS, JR., UNITED STATES DISTRICT JUDGE

Plaintiff Steven Johns and Defendants C.R. Bard, Inc. and Davol, Inc. filed various motions in limine to exclude evidence in this case. Now before the Court are nonparty the Americas Hernia Society Quality Collaborative Foundation's ("AHSQCF") Motion in Limine Re: Use of Reports Prepared by AHSQCF (ECF No. 180), Defendants’ Motion in Limine No. 12 to Exclude Evidence and Argument Concerning Medical Device Reports and Complaints related to Patients Other than Plaintiff (ECF No. 213), Plaintiff's Motion in Limine No. 23 to Exclude Arguments and Evidence Relating to the Number of Devices Sold or Implanted, or that Hernia

Mesh Products are Lifesaving Devices (ECF No. 247), and Plaintiff's Motion in Limine No. 7 to Exclude Any Percentage or Comparative Analysis of Adverse Events (ECF No. 243). The Court reserved judgment on these motions and stated this written decision was to follow. (ECF No. 332 at PageID #17887; ECF No. 345 at PageID #18586.)

I. Background¹

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, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections." (No. 2:18-md-02846, ECF No. 1 at PageID #1–2.)² This includes the Ventralight ST, the device implanted in Plaintiff. The Ventralight ST is a prescription medical device used for hernia repairs. (ECF No. 309 at PageID #16717.) 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, which consists of polypropylene, polyglycolic acid ("PGA") 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. )

Plaintiff brings this action to recover for injuries sustained as a result of the implantation of Defendants’ allegedly defective Ventralight ST device. Plaintiff claims that Defendants knew that polypropylene is unsuitable for permanent implantation in the human body and that the PGA fibers created an increased inflammatory response. (Id. ) The crux of Plaintiff's claims is that the ST coating on Ventralight ST devices resorbs too quickly. 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 adhesions were diagnosed during a subsequent laparoscopic surgery in October 2016 by Plaintiff's implanting surgeon. (Id. at PageID #16740, 16746.)³ After summary judgment, 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 PageID #16727–65.) Now, various motions in limine and other evidentiary motions are ripe for adjudication.

This opinion addresses four motions in limine that concern the use of data—data from AHSQCF, the use of Medical Device Reports ("MDRs"), tallies of the number of Ventralight ST devices sold and implanted, and percentages and comparative analytics of adverse events. (ECF Nos. 180, 213, 247, 243 (respectively).) On August 27, 2020, the Court considered AHSQCF's motion in limine and Plaintiff's Motion in Limine No. 7 and ordered Plaintiff to submit the AHSQCF data it planned to admit at trial, outlining the purposes for which it would be used. (ECF No. 306 at PageID #16688; ECF No. 311 at PageID# 16818–24.) The Court addressed these two motions in limine, along with Defendants’ Motion in Limine No. 12, regarding MDRs, and Plaintiff's Motion in Limine No. 23, concerning sales and implantation numbers, during a second hearing on September 10, 2020. (ECF No. 345 at PageID #18567–87.) Plaintiff was also ordered to submit examples of the MDRs, (id. at PageID #18577–79), and the parties were then permitted to submit supplemental briefing regarding the MDRs, (ECF Nos. 348–50). The Court reserved judgment upon these four motions. (ECF No. 332 at PageID #17887.)

II. Legal Standards

"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." Ind. Ins. Co. , 326 F. Supp. 2d at 846 ; see also Koch , 2 F. Supp. 2d at 1388. 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.

Relevant evidence is "evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." Fed. R. Evid. 401. "Irrelevant evidence is" inadmissible. Fed. R. Evid. 402. A court may exclude relevant evidence under Federal Rule of Evidence 403 "if its probative value is substantially outweighed by a danger of ... unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence." Fed. R. Evid. 403. Evidentiary rulings are made subject to the district court's sound discretion. Frye v. CSX Trans., Inc. , 933 F.3d 591, 598 (6th Cir. 2019) ; see also Paschal v. Flagstar Bank , 295 F.3d 565, 576 (6th Cir. 2002) ("In reviewing the trial court's decision for an abuse of discretion, the appellate court must view the evidence in the light most favorable to its proponent, giving the evidence its maximum reasonable probative force and its minimum reasonable prejudicial value.").

III. Analysis

A. AHSQCF's Motion in Limine Re: Use of Reports Prepared by AHSQCF

AHSQCF, a nonparty to this litigation, initially filed its motion in limine arguing that because Plaintiff had not specified how he would use AHSQCF's reports pursuant to Magistrate Judge Jolson's March 16, 2020 order, Plaintiff did not need the reports for litigation and an order prohibiting their use was appropriate. (ECF No. 180 at PageID #10652.) Plaintiff maintains that he has complied with the order and points to his counsel's email stating that AHSQCF's reports would be "use[d] as any other longitudinal outcomes analysis and real-time claims data," such as "comparison of adverse event [sic] for products involving Sepra Technology versus non-ST products," among others. (ECF No. 200 at PageID #11621.) Ultimately, the Court ordered Plaintiff to submit for in camera review the AHSQCF reports it intended to use and for Plaintiff to specify the uses at trial for this evidence. (ECF No. 306 at PageID #16688, ECF No. 311 at PageID #16820.) AHSQCF also argues that the Plaintiffs’ Steering Committee ("PSC") should be ordered to pay the value of a licensing fee to AHSQCF if its reports are permitted to be admitted.

1. Admissibility

Plaintiff plans to use the AHSQCF data to demonstrate three facts. First, Plaintiff claims that Defendants had knowledge that the method used to implant the Ventralight ST in Plaintiff, laparoscopic intra-peritoneal mesh placement or intra-peritoneal onlay mesh ("IPOM") procedures, had a higher likelihood of causing adhesions. Second, the five-year longitudinal data shows that this method of implantation for the Ventralight ST has no benefits over other methods in terms of patient pain, hernia

recurrence, and adhesions. Finally, the thirty-day data regarding IPOM procedures with Sepramesh devices generally shows that the IPOM procedure has no better benefits than other methods in relation to hernia recurrence, seroma formation, and patient pain. (ECF No. 316 at PageID #16874–78.) In response, AHSQCF contends that these uses are prohibited in light of this Court's summary...