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

• Decision Date: 01 September 2020
• Docket Number: Case No. 2:18-md-2846
• 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, Case No. 2:18-cv-01509
• Court: U.S. District Court — Southern District of Ohio

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-cv-01509

Case No. 2:18-md-2846

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO EASTERN DIVISION

September 1, 2020

JUDGE EDMUND A. SARGUS, JR.

Magistrate Judge Kimberly A. Jolson

DISPOSITIVE MOTIONS ORDER NO. 1

Bard's Motion for Summary Judgment

This matter is before the Court on Defendants Davol Inc. and C.R. Bard, Inc.'s (collectively "Bard") Motion for Summary Judgment (ECF No. 29), Plaintiff's Opposition (ECF Nos. 69 and 165)¹ and Bard's Reply (ECF No. 90). For the reasons set forth below, the Court GRANTS IN PART AND DENIES IN PART Bard's Motion.

I.

Plaintiff Steven Johns' case is the first bellwether trial of the thousands of cases brought against Bard in this multidistrict litigation ("MDL"). The Judicial Panel on Multidistrict Litigation described the cases in this MDL as follows:

All of the actions share common factual questions arising out of allegations 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.

(Transfer Order, MDL 2846 ECF No. 1.)

A. Ventralight ST Product

Ventralight ST is a prescription medical device used for hernia repair and is one of Bard's products at issue in this MDL. The FDA cleared it for use through the 510k process on July 15, 2010, and later cleared it for use with the Echo positioning system on April 1, 2011. (See FDA website, 510k Premarket Notification Database, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN3/pmn.cfm (last visited March 25, 2020); see also Instructions for Use ("IFU") ECF No. 29-4.) It is a multicomponent device made of a mesh of polypropylene, polyglycolic acid (PGA) fibers, and a bioresorbable coating called Sepra Technology ("ST"). (Id.)² The bioresorbable coated side of the mesh is placed against organs, such as the bowels, while the uncoated polypropylene side is placed to maximize tissue attachment to support the hernia repair. (Id.)

Plaintiff contends that Bard knew the component parts of the mesh were dangerous and unsafe for use in medical devices. (Pl's Opp. to Mot. for Summary Judgment at 1, ECF No. 165.) According to Plaintiff, Bard knew that polypropylene is not suitable for permanent implantation in the human body, that the ST coating resorbs too quickly, and that the PGA fibers created an increased inflammatory response. (Id.)

1. Polypropylene

Plaintiff contends Bard ignored warnings about the safety of the polypropylene materials Bard used to make their hernia mesh devices. (Id. at 2.) For example, the polypropylene material from which the Ventralight ST mesh was manufactured came with a Material Safety Data Sheet ("MSDS") containing a "MEDICAL APPLICATION CAUTION" stating "Do not use this [ ] material in medical applications involving permanent implantation in the human body orpermanent contact with internal body fluids and tissues," as well as a statement of the "Incompatibility With Other Materials," stating the material "may react with oxygen and strong oxidizing agents . . ." (See Babansee Rep. at 15-16.) Additionally, the manufacturer of the Marlex polypropylene resin used in the Ventralight ST device, Phillips Sumika, sent its customers a written "Technical Service Memorandum" warning that strong oxidizing agents "can chemically attack Marlex polypropylene causing degradation of the resin" and "eventual embrittlement of the resin." (Id. at 16.) According to Plaintiff, Bard nonetheless continued to source polypropylene for its mesh devices, and was actively trying to hide its use from various manufacturers as early as 1997. (See Darois Dep. 174, ECF No. 165-5.)

2. ST Coating

Plaintiff further contends that Bard knew the ST coating on its Ventralight ST devices absorbs quicker than it claimed, and too quickly to provide benefit. (Pl.'s Opp. at 4.) According to Bard's surgeon training materials, "in an intra-abdominal repair, placing polypropylene is dangerous because aggressive in-growth into visceral tissues like bowel[sic] can result in obstruction and fistulae." (See ECF No. 165-10; see also LaFever Dep. 377-381, ECF No. 165-6.) Davol's former Vice President of Research & Development testified that bare polypropylene should not be place intaperitoneally without a barrier. (See Darois Dep. 102:6-22, ECF No. 165-5.)

Instead, according to Plaintiff, either a permanent non-polypropylene layer (such as "ePTFE") or a resorbable layer (such as the ST coating) is necessary to ensure that the peritoneum heals over and covers the mesh patch. As of the 2000s, Bard had multiple products with ePTFE barriers, but sought to develop a resorbable barrier device for its hernia franchise. Instead of creating a resorbable barrier from scratch, Bard acquired the rights in December 2007to Genzyme's Sepramesh IP product and its Sepra Technology, which Genzyme used in the Seprafilm coating of its Sepramesh products. (LaFever Dep. 385-387.) Bard used the Sepra Technology to develop its own line of resorbable barrier products with ST coating including the Ventralight ST. (See Reitman Rep. at 21, ECF No. 29-5.)

Plaintiff contends that Bard's internal documents show Bard knew prior to the license acquisition that the ST coating on Genzyme's devices "was flawed and would resorb too quickly to provide the claimed benefits in preventing adhesions and promoting proper incorporation." (Pl.'s Opp. at 6.) Bard's internal documents criticized the Sepramesh devices because the hydrogel barriers resorbed within 7 or 14 days. For example, a 2006 memorandum listed the following as weaknesses of the Genzyme Sepramesh IP: "[h]ydrated gel resorbs in 14 days. Not enough time for reperitonealization . . . Mesh is exposed after adhesion barrier resorbs." (See MPPE-01496875, ECF No. 165-9.) Additionally, Davol received an animal study from Genzyme in October 2006 observing adhesions in the animals and that "the hydrogel was 95% resorbed at 2 wks." (MPPE- 09154074-075, ECF No. 165-11.) During the due diligence period for the acquisition, however, Bard noted that Genzyme did not have data supporting its claim that the ST hydrogel coating lasted even 14 days. (See MPPE-03745210, ECF No. 165-12; MPPE-00555916, ECF No. 165-13.)

According to Plaintiff, concerns regarding the early resorption of the hydrogel coating carried over into Bard's resorbable barrier ST products. On July 14, 2015, Bard sent its sales force an open letter signed by Davol's Vice President of Regulatory Affairs addressing concerns about the safety of the ST coatings, in light of a petition by a non-profit consumer advocacy group, Public Citizen, to the FDA to withdraw approval of Seprafilm in the United States. The letter explained the history of Genzyme's Seprafilm and Bard's ST product family and stated that"the petition does not question any hernia mesh products containing the Sepra® Technology (ST)" and "there are a number of factors that separate the use of Seprafilm alone from the use of Sepra technology in a hernia mesh material." (MPPE-12417607-608, ECF No. 165-14.) The letter also stated "please note that the Sepra hydrogel is broken down by the body and resorbed very quickly. It is essentially gone in 7 days and excreted in the urine within 28 days." (Id.) That same day, a sales manager replied to the letter voicing the following concerns:

Not to hit the panic button or anything - but this letter says the barrier 'Is essentially gone in 7 days'.. But in the family brochure it says 'the hydrogel barrier resorbs within 30 days providing visceral protection during the critical healing period'.

I know we've always said it lasts for up to 30 days, if we start saying 7 days, it may compromise surgeons' opinions of how effective the barrier is.

(Id.) On July 17, 2015, the sales and global marketing teams were emailed the following:

We made a slight clarification to the "Sepra" resorption profile statement on page 2 of the original letter. Please note that per the Seprafilm IFU, it is broken down by the body and resorbs within 7 days. Davol's Sepra Technology coating becomes a hydrated gel that resorbs within 30 days.

(MPPE-06255412-416, ECF No. 165-15.) In August 2015, the sales teams was notified that Davol decided to cease the use of the Davol ST customer letter, and that if customers asked about the citizen petition, the sales team should respond that the petition did not involve Davol products and to not comment further. (Id.) A revised FAQ sent to the team in September 2015 stated that "Seprafilm and the Sepra Technology (ST) used on Davol meshes are not the same formulations" and again stated that the citizen petition was specific to Seprafilm and not Davol's ST line of hernia mesh. (Id.) There was no mention of the resorption rate for the Sepra coating.

When asked about the "Dear Valued Customer" letter and the reference to the 7-day absorption period, former Davol President Dan LaFever testified:

Q: My question to you is simply this: Have you ever seen claim data that shows that the ST resorption window is, in fact, 14 days?

A: I have never seen that data. I don't even know if it's clinically relevant. But I have not seen that data.

Q: And certainly not 30 days; is that true?

A: I have never seen data on seven, 14, 30. That's for Roger Darois and Robin Drago to deal with, now Tom Hutchinson, who went from quality to regulatory later on. But he's making a claim that can be substantiated with data, and that's the - - that's the only option that he has, because those are the only substantiated, tested claims.

Q: Is the seven days?

A: Yes.

(LaFever Dep. 441:17-442:13.) The Instructions for Use ("IFU") for the Ventralight ST product state:

The visceral side of the mesh is bioresorbable coating that separates the mesh from underlying issue and visceral

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