April 21 In Providence County Superior Court was to be the setting for Rudd v. Davol. [PC-2018-0482]. But instead of facing the jury, Davol agreed to settle the case. The amount is unknown.
Jonathan Orent of Motley Rice only verified to Mesh News Desk that the case settled prior to trial.
Timothy Rudd and his wife, Lori had waited for their day in court for more than a year as court closures over Covid-19 delayed and denied justice.
The Rudds filed their products liability case in 2018. Mr. Rudd had been implanted with Ventralex six years earlier to repair an umbilical hernia. He claims he was not informed of the risks associated with the polypropylene (PP) mesh implant.
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 Plaintiff alleged 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.
Ventralex is made of the same polymer, polypropylene, that make up most surgical mesh, however Ventralex 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 perforating 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 that 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, and reliable for the treatment of a hernia.
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 in handling the material in the workplace.
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 substantially 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, as was in this case, the clearance still stands. There is no review of all of the subsequent devices that named it as a predicate.
Currently there are 3,423 Ethicon (Johnson & Johnson) Physiomesh Hernia mesh cases pending in Georgia district court.
Ohio district court has 11,787 pending against Davol or C.R. Bard.
Atrium Medical is facing 2,667 C-Qur cases pending in District Court.