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

• Decision Date: 10 February 2021
• Docket Number: Case No. 2:18-cv-01509,Case No. 2:18-md-2846
• Citation: 518 F.Supp.3d 1028
• Court: U.S. District Court — Southern District of Ohio
• 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.

518 F.Supp.3d 1028

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-01509

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

Signed February 10, 2021

MOTIONS IN LIMINE OPINION & ORDER No. 11

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 is Defendants’ Motion in Limine No. 14 to Exclude Evidence and Argument Concerning Defendants’ Conduct Postdating Plaintiff's Implant Surgery (ECF No. 215), Plaintiff's Motion in Limine No. 22 to Exclude Any Evidence or Argument Concerning Alleged Negligence or Fault of His Treating Surgeon Dr. Jensen (ECF No. 246), Defendants’ Motion in Limine No. 11 to Exclude Evidence and Argument Related to Pelvic or Transvaginal Mesh Devices (ECF No. 212), and Defendants’ Motion in Limine No. 13 to Limit Evidence and Argument of Other Litigation (ECF No. 214.)

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. 2020 WL 5223363, at *1. 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. 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. 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. at *4. 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, Dr. Jensen. Id. at *5.³ 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 *6–25. Now, various motions in limine and other evidentiary motions are ripe for adjudication.

This opinion addresses Defendants’ Motion in Limine No. 14 (ECF No. 215), Plaintiff's Motion in Limine No. 22 (ECF No. 246), Defendants’ Motion in Limine No. 11 (ECF No. 212), and Defendants’ Motion in Limine No. 13 (ECF No. 214).

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 the moving 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. 14

In Defendants’ motion, they argue that any conduct occurring after Plaintiff's implantation surgeries should be excluded as irrelevant, prejudicial, or as a subsequent remedial measure under Federal Rule of Evidence 407. (ECF No. 215 at PageID #11959–62.) Defendants specified during the hearing on the motion that any of their conduct after Plaintiff's first surgery is inadmissible in light of the Court's summary judgment opinion. (ECF No. 360 at PageID #18823.)⁴

Defendants’ argument that any evidence of Defendants’ conduct after Plaintiff's first surgery is per se irrelevant is a bludgeon when the Federal Rules of Evidence call for a scalpel. Federal courts decline to grant broad motions in limine seeking exclusion of categories of evidence, requiring parties to identify evidence and its uses with specificity. See Sperberg , 519 F.2d at 712. For this reason, the Sixth Circuit has rejected a bright-line, cut-off-date approach to post-injury evidence. Dykes v. Raymark Indus., Inc. , 801 F.2d 810, 818 (6th Cir. 1986) (adopting a "case-by-case approach" to determining the admissibility of "post-injury evidence"). Thus, the Court considers only the evidence that Defendants specify in their motion: Defendants’ responses to the FDA's 2017 483 audit and the DVL-020 study initiated in response to new European regulations. (ECF No. 360 at PageID #18823.)

First, Defendants’ responses to the FDA's 2017 483 audit. What Defendants mean by "responses" is ambiguous, so the Court considers both Defendants’ communications regarding the audit and subsequent actions in response to the audit. Defendants’ communications may be relevant to their knowledge and the reasonableness of their conduct in relation to the Ventralight ST and its implantation in Plaintiff in 2015. The audit summary states that the last inspection was in 2012 and examines Defendants’ actions between 2012 and 2017. (ECF No. 295-2 at PageID #16269–70.) It even describes complaints prior to Plaintiff's surgery. (Id. at PageID #17275 (addressing a complaint dated April 30, 2015).) The audit also examines Defendants’ manufacturing and design operations, as well as a variety of company procedures and policies. (E.g. , id. at PageID #16270–74.) To the extent that the audit and Defendants’ communications address Defendants’ conduct, knowledge, and status of affairs leading up to Plaintiff's surgery, they are relevant. See, e.g. , Musgrave v. Breg, Inc. , No. 2:09–cv–01029, 2011 WL 4502032, at *4 (S.D. Ohio Sept. 28, 2011).⁵

Next, the actions Defendants took in response to the 2017 FDA audit and in response to impending European Regulations, the DVL-020 study. Rule 407 provides that "[w]hen measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove: negligence; culpable conduct; a defect in a product or its design; or a need for a warning or instruction." Fed. R. Evid. 407. This is simple enough.

But the scope of Rule 407 is unclear. In the typical Rule 407 case, an event causes harm to the plaintiff and the defendant acts in response to this...