First Bard Hernia Trial Postponed Two Weeks

Jane Akre
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April 7, 2021


Mesh Medical Device News Desk, April 7, 2021~ This defective product trial over Bard/ Davol hernia mesh, is the first of thousands of hernia mesh lawsuits waiting to be heard and it puts polypropylene squarely on the hot seat.

Timothy Rudd and his wife, Lori filed a defective product lawsuit against Bard (Davol) in 2018. On or about April 21, their case will go before a jury in Superior Court in Providence, Rhode Island before Associate Justice Richard Licht.

The defendant is represented by Lori Cohen (Greenberg Traurig). (See Rudd v Davol Inc. PC-2018-0482).

Rudd was implanted with Bard’s Ventralex Hernia Patch on or about October 5, 2012 to repair an umbilical hernia. He claims he was not informed of the risks associated with Ventralex.

By 2017, Rudd had an additional surgery to repair the hernia and remove the mesh. During that he was injured severely and permanently, says his complaint, continuing to cause pain and mental anguish. The couple say they also have substantial medical bills.

Tim and Lori live in Rhode Island, where Bard is also headquartered (incorporated in Delaware). Davol Inc. is a wholly owned subsidiary of Bard, which supplies Davol with the materials used in making the Ventralex patch.

Ventralex is still on the market as is the Ventralex ST Hernia Patch.

The trial was set for April 7 but has now been delayed two weeks. It seems that renewing a courtroom schedule after COVID has proven challenging. There are only two courtrooms being used, so the need is backing up.

Jonathan Orent, Motley Rice

The Plaintiff alleges negligence, strict product liability, negligent infliction of emotional distress, intentional infliction of emotional distress, breach of implied warranty, failure to warn, fraud, loss of consortium, and punitive damages.

The case is a plaintiff pick, according to Jonathan Orent, his attorney (Motley Rice), who tells MND, “It is truly my honor to represent Mr. Rudd.”

 

 

What is Ventralex?

Polypropylene degrading, from C. Lewis trial

Ventralex is made of the polymer polypropylene, as most hernia meshes are, however it is multi-layered.

It has two layers of polypropylene (PP) mesh on one side and an expanded layer of polytetrafluoroethylene (ePTFE) on the other. That coated side is supposed to face the intestines. PP mesh has been known to entangle and/or perforate the intestines and bowel causing sepsis and death so avoiding the intestine is important.

You may know PTFE, a thermoplastic polymer, as the formula of Teflon cookware with its non-stick coating because of its high heat resistance, (see the history of Teflon). The “e”  means the ePTFE is softer and requires support.  

In addition, Ventralex contains an ePTFE memory recoil ring which opens up once its inside the body, theoretically flattening the mesh into place.

Bard’s Composix Kugel recalled mesh also contained a memory recoil ring. It eventually became the largest hernia mesh settlement in 2011 at $184 million.

Plaintiffs claim the ring can deform the mesh and cause it to buckle. The ring can break causing problems including bowel perforation.

The Ventralex mesh has a small pore size and weave and a high volume of material, which is incompatible with the body, say the plaintiffs. A small pore size (1mm effective porosity), heavyweight PP mesh allows bacteria to hide from the body’s own immune system in an encasing slime known as biofilm.

Pelvic mesh trials have shown that a 3 mm pore size allows for better integration with the body.

PP is impure, says the complaint, and contains about “’15 additional compounds which are leached from the PP and are toxic to tissue which enhances the inflammatory reaction and the intensity of fibrosis.”

Plaintiffs claim that PP is “biologically incompatible with human tissue and promotes an immune response” in a large subset of the population.  This may be the first time that the biocompatibility of PP mesh has been directly addressed.  

Ventralex is designed to be permanently implanted in the human body “in the intraabdominal space between the subcutaneous tissue and intestines.”

Patients, doctors, consumers, or regulatory agencies were not warned by Bard/Davol about the dangers of polypropylene, says the complaint.

Bard/Davol claims Ventralex is safe, effective, reliable for the treatment of a hernia.

 

MSDS

Readers of Mesh News Desk have seen coverage of the Material Safety Data Sheet or MSDS during pelvic mesh trials. The jurors there were shown the MSDS warning that polypropylene was not to be permanently implanted in the human body or to have any contact with human tissue and fluids! (See Bard warning here)

What is an MSDS?  It is required by the Occupational Safety and Health Administration (OSHA) to warn workers about the chemical, physical, health, and potential environmental hazards of any material so they are properly protected.

FDA Clearance of Ventralex

Ventralex was submitted to the Food and Drug Administration's (FDA) 510(k) to receive clearance to market. The 510(k) submission was received May 2002 and by July 16, roughly two months later, it was cleared to be sold as a Class II medical device.

Named as the “predicate” upon which this approval was made was the Bard Composix Kugel Mesh Patch.  A 510(k) application requires a named "predicate" or substially similar device already marketed upon which this new device is modelled.

The interesting thing about a 510(k) clearance is that even if the “predicate” is removed from the market or found to be defective in a court of law, the clearance stands. There is no review of all of the subsequent devices that named it as a predicate.

The Rudd trial is expected to commence April 21, subject to change.

There are more than 15,000 hernia mesh cases filed in three MDLs around the country naming defendants Ethicon, Bard, and Atrium Medical.

The next hernia mesh trial will be April 19, in the Southern District of Ohio in Columbus before Judge Edmund A. Sargus (case 2:19-md-2846).

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