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

• Decision Date: 11 January 2021
• Docket Number: Case No. 2:18-cv-1509,Case No. 2:18-md-2846
• Citation: 512 F.Supp.3d 803
• 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

512 F.Supp.3d 803

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 January 11, 2021

MOTIONS IN LIMINE OPINION AND ORDER NO. 10

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 Defendants’ Motion in Limine No. 3 to Exclude Reference to Irrelevant Bard Devices (ECF No. 176), Defendants’ Motion in Limine No. 1 to Preclude any Evidence or Argument Concerning the Composix Kugel Ring Breaks and Recall (ECF No. 174), and Defendants’ Motion to Seal Exhibits D, E, F, and G to Plaintiff's Supplemental Brief in Opposition to Defendants’ Motion in Limine No. 1. (ECF No. 342.)

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.) The Court bifurcated the trial into two separate phases, one for liability and one for punitive damages if Defendants are found liable. (ECF No. 330 at PageID #17883.) Now various motions in limine and other evidentiary motions are ripe for adjudication.

This opinion addresses four motions in limine that, broadly speaking, challenge the admissibility of evidence related to other devices (ECF Nos. 174, 176), as well as a related motion to seal (ECF No. 342). At the hearings on September 3 and September 10, 2020, the Court reserved judgment on part or all of each motion. (ECF No. 331 at PageID #17884; ECF No. 332 at PageID #17888.)

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 ("[A] court is almost always better situated during the actual trial to assess the value and utility of evidence."). 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. Defendants’ Motion in Limine No. 3

In their motion, Defendants urge this Court to exclude references to other Bard devices. (ECF No. 176.) The Court granted this motion in limine on the basis that such evidence was character evidence forbidden by Rule 404. (ECF No. 322 at PageID# 17273; ECF No. 331 at PageID #17885.) However, the parties were permitted to brief whether this evidence is admissible as an exception to the rule against character evidence provided in Rule 404(b)(2). (ECF No. 322 at PageID# 17273; ECF No. 331 at PageID #17885.)

Rule 404(a) prohibits character or propensity evidence, "[e]vidence of a person's character or character trait" used "to prove that on a particular occasion the person acted in accordance with the character or trait." Fed. R. Evid. 404(a).⁴ Rule 404(b) prohibits evidence of other acts "to show that on a particular occasion the person acted in accordance with the character." Fed. R. Evid. 404(b)(1). In other words, the Federal Rules of Evidence do not permit parties to introduce evidence that tempts a jury to conclude that because a party acted badly before, he must have acted badly this time as well. Old Chief v. United States , 519 U.S. 172, 180–82, 117 S.Ct. 644, 136 L.Ed.2d 574 (1997). Rule 404(b)(2) provides exceptions to this general rule. Parties may introduce evidence of other crimes, wrongs or acts "for another purpose such as proving motive, opportunity, intent, preparation, plan, knowledge, identity, absence of mistake, or lack of accident." Fed. R. Evid. 404(b)(2).

The Sixth Circuit applies Rule 404(b) through a three-step process. This test requires that "(1) the ‘other act’ actually occurred, (2) the evidence is offered for a permissible purpose, and (3) its probative value is not substantially outweighed by unfair prejudice." United States v. Carter , 779 F.3d 623, 625 (6th Cir. 2015) (quoting United States v. De Oleo , 697 F.3d 338, 434 (6th Cir. 2012) ). A second tripartite inquiry defines the second prong. Evidence is offered for a permissible purpose when (1) the purpose is one delineated by Rule 404(b)(2), "(2) that purpose is in issue, and (3)" the evidence is probative of that purpose. United States v. Hardy , 643 F.3d 143, 150–51 (6th Cir. 2011) (quoting United States v. Jenkins , 345 F.3d 928, 937 (6th Cir. 2003) ); United States v. Hazelwood , 979 F.3d 398, 411 (6th Cir. 2020) (quoting United States v. LaVictor , 848 F.3d 428, 445–46 (6th Cir. 2017) ). The gist of this approach is that the evidence of other acts must be consistent with Federal Rules of Evidence 104(b) (stating that when evidence depends on a fact, sufficient proof must be submitted to show the fact exists,), 401, 403, and 404(b)(2) to be admissible.

In his supplemental briefing, Plaintiff clarified that he seeks to introduce this evidence to demonstrate Defendants’ knowledge that polypropylene should not be used in permanently implantable device based on previous evaluations, Defendants withholding of Material...