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

Kimberly A. Jolson Magistrate Judge.

EVIDENTIARY MOTIONS OPINION & ORDER NO. 19

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

Before the Court are Plaintiffs' Motions to Exclude the Opinions and Testimony€ of Defense Experts Maureen T.F. Reitman, Sc.D. (ECF No. 84) and Stephen Badylak, D.V.M., Ph.D., M.D. (ECF No. 79), and Defendants' Motion to Exclude the Testimony of Plaintiffs' Expert Jimmy Mays Ph.D. (ECF No. 71). For the reasons that follow, Plaintiffs' motion addressing Dr. Reitman, Sc.D. (ECF No. 84) is GRANTED IN PART, DENIED IN PART, AND DENIED IN PART AS MOOT; Plaintiffs' motion addressing Dr. Badylak (ECF No. 79) is GRANTED IN PART AND DENIED IN PART; and Defendants' motion addressing Dr. Mays (ECF No. 71) is GRANTED IN PART AND DENIED IN PART.

I. Background^[1]

Plaintiffs', Antonio Milanesi and Alicia Morz de Milanesi, case is the second bellwether trial selected from thousands of cases in this multidistrict litigation (“MDL”) against Defendants, C.R. Bard, Inc. and Davol, Inc. The Judicial Panel on Multidistrict Litigation described the cases in this MDL as “shar[ing] common factual questions arising out of allegations that defects in

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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.” (Case No. 2:18-md-02846, ECF No. 1 at PageID #1-2.)^[2] This includes Defendants' Ventralex Hernia Patch, the device implanted in Mr. Milanesi.

The Ventralex is a prescription medical device used for umbilical and small ventral hernia repairs. (ECF No. 167 at PageID #13610.) The small and medium sizes were cleared through the 510(k) premarket notification process by the Food and Drug Administration (“FDA”) in 2002; the Composix Kugel was listed as a predicate device. (Id. at PageID #13611.) The large size was cleared via “a no 510(k) rationale based upon the 510(k) for the Composix Kugel product.” (Id.) The Ventralex has two sides-one of polypropylene mesh and one of permanent expanded polytetrafluoroethylene (“ePTFE”). (Id. at PageID #13610.) The polypropylene mesh side faces the abdominal wall, encouraging tissue to grow into the mesh and thus supporting the hernia repair. The ePTFE side faces the intestines and is designed to minimize tissue attachment, such as adhesions, to the intestines and other viscera. The Ventralex also has a monofilament memory coil ring, which was made of polyethylene terephthalate (“PET”) when it was implanted in Mr. Antonio. The ring is designed to help the patch “pop open” and then “lay flat” against the abdominal wall after the Ventralex is folded and inserted through the incision site during surgical repair of the hernia. (Id.)

Plaintiffs bring this action to recover for injuries sustained as a result of the implantation of Defendants' allegedly defective Ventralex device. Ten years after the implantation of the

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Ventralex, Mr. Milanesi underwent surgery to repair what appeared to be a recurrent hernia but was revealed to be a bowel erosion with a fistula and adhesions, which required a bowel resection. (Id. at PageID #13611-13.) Shortly thereafter, Mr. Milanesi suffered a high-grade post-operative small bowel obstruction that required emergency surgery. (Id. at PageID #13613)

The crux of Plaintiffs' claims is that Defendants knew of the risks presented by the Ventralex device but marketed and sold the device despite these risks and without appropriate warnings. Plaintiffs point to three specific issues with the Ventralex: (1) polypropylene resin oxidatively degrades in vivo, (2) the ePTFE layer contracts more quickly than the polypropylene, which in combination with the too-weak memory coil ring causes the device to fold or buckle or “potato chip, ” leading to the exposure of the bare polypropylene to the bowel, and (3) the ePTFE layer is prone to infection. (Id. at PageID #13613-14.) After summary judgment, the following claims remain for trial: defective design (strict liability), failure to warn (strict liability), negligence, gross negligence, negligent misrepresentation, fraud and fraudulent misrepresentation, fraudulent concealment, loss of consortium, and punitive damages. (Id. at PageID #13616-37.)

The parties have filed their dispositive and Daubert motions, and the motions are now ripe for adjudication, including the present motions.

II. Legal Standard

“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 (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

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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 courts are “almost always better situated during the actual trial to assess the value and utility of evidence.” Jackson v. Cnty. of San Bernardino, 194 F.Supp.3d 1004, 1008 (C.D. Cal. July 5, 2016) (quoting Wilkins v. Kmart Corp., 487 F.Supp.2d 1216, 1218 (D. Kan. 2007)); accord Sperberg v. Goodyear Tire & Rubber Co., 519 F.2d 708, 712 (6th Cir. 1975) (“A better practice is to deal with questions of admissibility of evidence as they arise.”). 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 opinions and testimony to demonstrate “by a preponderance of proof” that the expert evidence is 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) (“The Court [in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), ] explained that Rule 702 displays a ‘liberal thrust' with the ‘general approach of relaxing the traditional barriers to “opinion” testimony.'” (quoting Daubert, 509 U.S. at 588)); 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.”).

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III. Analysis

The district court's role in assessing expert testimony is a “gatekeeping” one, “screening expert testimony” so that only admissible expert testimony is submitted to the jury; its role is not to weigh the expert testimony or determine its truth. United States v. Gissantaner, 990 F.3d 457, 463 (6th Cir. 2021) (quoting Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993)). Expert testimony, testimony given by “[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education, ” is admissible if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue

(b) the testimony is based on sufficient facts or data

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case

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). “First, the witness must be qualified by ‘knowledge, skill, experience, training, or education.' Second, the testimony must be relevant, meaning that it ‘will assist the trier of fact to understand the evidence or to determine a fact in issue.' Third, the testimony must be reliable.” 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)). “[T]he only thing a court

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should be concerned with in determining the qualifications of an expert is whether the expert's knowledge of the subject matter is such that his opinion will likely assist the trier of fact in arriving at the truth. The weight of the expert's testimony must be for the trier of fact.” 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...