First Bard Hernia Mesh Bellwether Trial Early August

Jane Akre
|
July 25, 2021

Mesh Medical Device News Desk, July 25, 2021 ~ The first Bard Hernia Mesh Bellwether Trial is set to begin August 2, putting Bard's Ventralight ST hernia mesh on the hot seat.

There are nearly 14,000 other cases filed in this federal multidistrict litigation (MDL) court in Ohio.

 

Jury selection gets underway Monday, August 2 in Ohio for the first bellwether trial of thousands pending naming Bard hernia meshes.  

Steven Johns v CR Bard (Case No. 2:18-md-2846) is filed in federal court in the Southern District of Ohio in Multidistrict Litigation (MDL). The product liability case was initially scheduled for an April trial date which was canceled after a backup in court cases following Covid-19 shutdowns nationwide.

Bard, a New Jersey-based company, faces almost 14,000 hernia mesh product liability cases over its hernia mesh - Ventralex, Ventralight, Prefix, and 3D Max. Previously known as Bard Davol, Davol is a subsidiary of Bard, a Delaware corporation with its principal place of business in Rhode Island.

Becton Dickinson acquired Bard in December 2017. That company has not been joined in this action.

Plaintiff Steven Johns’ trial is a bellwether, one of a dozen chosen from the thousands of cases filed in multidistrict litigation. As of July 15, there were 13,629 cases filed in the Ohio MDL. Steven Johns initially filed his action against Bard in October 2018 in Utah, where he is a resident, but both sides agreed to transfer it to the Ohio MDL.

In 2011 C.R. Bard paid $184 million to settle roughly 3,000 hernia mesh cases involving the company’s Kugel hernia mesh patch.

 

The Johns Case

Johns received the Ventralight ST after experiencing an abdominal bulge in 2014. The treatment for his diagnosed ventral hernia within a diastasis recti was to implant the Ventralight ST Mesh during laparoscopic surgery in August 2015. Several months later, his symptoms returned, and Johns underwent a second laparoscopic surgery in October 2016, where his surgeon removed adhesions.

In both 2016 and 2019 additional hernias were diagnosed. The original mesh was excised, and another Ventralight St was implanted. The Ventralight ST remains in the patient today, and he is facing additional surgeries for chronic pain or other complications.

Johns’ doctor has testified that had he been fully informed by Bard Davol, he would not have used this mesh on his patient.

 

Ventralight ST

Ventralight was cleared for the market by the FDA in July 2010 through the 510(k) process. (See K130968)

Made of polypropylene (PP), it is also composed of polyglycolic acid (PGA) fibers and a bioresorbable coating called Sepra Technology (ST).  The coated side of the mesh is placed against the bowels and other organs, and the uncoated polypropylene is set against the tissue for attachment. 

Plaintiffs contend Bard knew that PP is not suitable for a permanent implant in the human body and that the ST coating resorbs too quickly and that PGA fibers induce an increased inflammatory response.

The cases share common factual questions – whether defects in the Marlex polypropylene (PP) hernia mesh can lead to complications, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections.

At trial, expect to see the Material Safety Data Sheet (MSDS) to be introduced. That is the material warning which accompanies polypropylene in production.

It clearly states, “Do not use this material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids and tissues.”

Bard contends its Ventralight ST mesh device is not defective. It remains on the market.

 

Litigation

Last September, U.S. District Judge Edmund A. Sargus denied a Bard Motion for summary judgment, which could have thrown the case out of court. Judge Sargus also ruled the company cannot say the mesh “is in no way defective” or that the health warnings are sufficient.  The jury may award punitive damages to the plaintiff.

Pre-trial, each side chose several potential cases to go to trial as a bellwether case. Steven Johns v C.R. Bard (Case No. 2:18-cv-01509- EAS-KAJ) was a defense pick.

Counsel for plaintiffs is Levin, Papantonio Timothy M. O’Brien, and Kelsey L. Stokes of Fleming, Nolen & Jez.

Defendant is represented by Reed Smith of Los Angeles and attorney Michael K. Brown.

According to filings in the case, plaintiffs allege negligence, design defect, manufacturing defect, failure to warn, breach of express and implied warranty, fraud, and violation of consumer protection laws.  

Hernia Mesh Trials Upcoming

As of July 15, 20,000 hernia mesh defective product cases were filed in three hernia mesh MDLs -  in Atlanta, Ohio, and New Hampshire.

Multidistrict litigation will be heard in District Court in Georgia (Atlanta) over Ethicon’s Physiomesh, MDL 2782, where 3,582 cases are pending. 

Atrium Medical’s hernia mesh cases will be heard in Concord, New Hampshire, in MDL 2753 with 2,848 actions pending as of July 15, according to the Judicial Panel on Multidistrict Litigation (JPML). 

Additionally, in state court, multi-county litigation in Rhode Island and New Jersey Superior Courts will hear Bard and Ethicon (Proceed mesh) cases.    

With more than one million hernia operations every year in the U.S. and estimates that one-third have complications, the courts could potentially add thousands of actions to these MDLs.

 

Bard First Trial Settled

On the eve of a trial last April, the case of Timothy and Lori Rudd v Davol (PC-2018-0482) was settled.  Mr. Rudd had been implanted with Bard’s Ventralex six years earlier to repair an umbilical hernia. The Rudds were represented by Jonathan Orent and Don Migliori of Motley Rice.

The Rudds live in Rhode Island, where Bard is headquartered.  Davol is a wholly-owned subsidiary of Bard, which supplies Davol with the materials used in making the Ventralex patch.  The Ventralex ST Hernia Patch remains on the market. 

 

LEARN MORE:

MND, First Davol Hernia Mesh Trial Settles on Eve, May 2021

So District of Southern District of Ohio, 2:18-md-2846, Davol Inc./ C.R. Bard

Johns v Bard, Case Text

Johns Summary Judgment Decision

Ohio Case Management order

Bard Ventralight ST mesh, product brochure


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