In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig.
| Decision Date | 03 November 2020 |
| Docket Number | Case No. 2:18-cv-01509,Case No. 2:18-md-2846 |
| Citation | 499 F.Supp.3d 505 |
| 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 |
MOTIONS IN LIMINE OPINION AND ORDER NO. 5
Plaintiff Steven Johns and defendants C.R. Bard, Inc. and Davol Inc. filed various motions in limine to exclude evidence and motions to seal exhibits in this case. Now before the Court are (1) Plaintiff's Motion in Limine No. 9 to Exclude Any Evidence or Argument that Ventralight ST or Other "ST" Products are Still on the Market (ECF No. 245); (2) Defendants’ and the Americas Hernia Society Quality Collaborative Foundation's ("AHSQCF") Motions to Seal Exhibit 2 to Plaintiff's Motion in Limine No. 7 and Exhibit A to Plaintiff's Motion in Limine No. 9 (ECF Nos. 250, 255); (3) Defendants’ Motion in Limine No. 5 to Preclude Records, Testimony, Reference, or Argument Concerning FDA Inspections and Third-Party Audits (ECF No. 178); (4) Defendants’ Motion to Seal Exhibits P and K to Plaintiff's Opposition Brief to Defendants’ Motion in Limine No. 5 (ECF No. 194); and (5) Defendants’ Motion in Limine No. 6 to Exclude Any Evidence or Argument Concerning Foreign Regulatory Actions (ECF No. 179).
On September 3, 2020, the Court held a hearing on outstanding motions in limine, including Plaintiff's Motion in Limine No. 9 and Defendants’ Motion in Limine No. 5. (ECF No. 322 at PageID #17285–86.) The Court reserved judgment on these motions. (ECF No. 331 at PageID #17886.) Another motions-in-limine hearing was held on September 10, 2020, and the Court considered additional outstanding motions in limine, such as Defendants’ Motion in Limine No. 6. (ECF No. 345 at PageID #18587–90.) Again, the Court reserved judgment on the motion. (ECF No. 332 at PageID #17887–88.)
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. 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 motions in limine regarding evidence that the Ventralight ST or other ST products are still on the market (ECF No. 245), evidence pertaining to FDA inspections or third-party audits obtained in response to FDA inspections related to the Composix Kugel Hernia Patch (ECF No. 5), and evidence concerning foreign regulatory actions, specifically the British Standards Institution ("BSI") (ECF No. 179). This decision also addresses three related motions to seal. (ECF Nos. 194, 250, 255.)
"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 in advance of trial in order to avoid delay and ensure an evenhanded and expeditious 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. Evidence that is not relevant 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) ().
Plaintiff argues in this motion that the Court should exclude evidence that the Ventralight ST or other ST products are still on the market. (ECF No. 245 at PageID #13118.) According to Plaintiff, this evidence is irrelevant under Rule 401 and unfairly prejudicial and misleading under Rule 403 because the Ventralight ST was allowed to go to market as a result of the § 510(k) approach, which does not address safety. (Id. at PageID #13121). Moreover, the FDA did not possess all pertinent evidence of adverse events because Defendants did not report all adverse event reports known to them, including trend analysis from the AHSQCF. (Id. at PageID #13122–23.) Therefore, the FDA lacked complete information that would have enabled it to decide whether to recall the devices. (Id. ) Defendants respond that the § 510(k) process does address safety and efficacy, that Plaintiff relies on an impermissible "fraud-on-the-FDA" theory, and that excluding evidence showing the ST products are still on the market unduly prejudices Defendants. (ECF No. 265 at PageID #14107–13.)
First, relevance. The fact that the ST products are still on the market is relevant to this case. Plaintiff's Utah design defect claims, based on both strict liability and negligence, require evidence of whether the product was "unreasonably dangerous to the user or consumer or to his property," Brown v. Sears, Roebuck & Co. , 328 F.3d 1274, 1279 (10th Cir. 2003) (citing Ernest W. Hahn, Inc. v. Armco Steel Co. , 601 P.2d 152, 158 (Utah 1979) ) (strict liability), or evidence of what Defendants knew or should have known under the circumstances, see, e.g. Fortune v. Techtronic Indus. N. Am. , 107 F. Supp. 3d 1199, 1204 (D. Utah 2015) (quoting Slisze v. Stanley–Bostitch , 979 P.2d 317, 320 (Utah 1999) ) (negligence); House v. Armour of Am., Inc. , 929 P.2d 340, 343 (Utah 1996) (strict liability). That the ST products remained on the market is probative of safety because it indicates that the FDA has not had any basis for a recall, such as recurrent death or serious injury. See 21 C.F.R. §...
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...interest in full access to the exhibits is slight. See, In re Davol, ¡nc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prod. L·iab. Lit, 499 F.Supp.3d 505 (S.D. Ohio 2020). Therefore, parties' interest in keeping the trade secrets confidential outweighs the public's lesser interest in public ......