Bard’s 'Lifesaving' Assertion Over Hernia Mesh Barred

Bard’s 'Lifesaving' Assertion Over Hernia Mesh Barred

Introduction

Earlier this month, U.S. District Judge Edmund A. Sargus Jr., presiding over C.R. Bard Inc.'s hernia mesh lawsuits, ruled that the manufacturer cannot present its Ventralight ST device as "lifesaving" during the upcoming bellwether trial.

According to the ruling on four motions in limine, the judge noted that the federal courts permitted 'lifesaving' characterizations if there was some evidence in the record to support the label. However, no such evidence was pointed by the defendants, and the court will relook at the ruling if the defendants can point to testimony that supports the proposition.

The first bellwether jury trial that is scheduled to begin on April 19, 2021, involves a plaintiff who sued Bard and its subsidiary in October 2018. The lawsuit alleges that the companies knew and withheld that the hernia mesh products were not a viable long-term hernia treatment. It further alleged that the "Sepra Technology" coating breaks down and is absorbed by the body too quickly, exposing the internal organs and other tissues to the polypropylene and increasing the risk of complications.

The Abdominal Core Health Quality Collaborative (ACHQC), formerly known as the Americas Hernia Society Quality Collaborative (AHSQC), also filed a motion arguing that its report on the device should be excluded from the trial's evidence as the data is not risk-adjusted. The judge denied the motion stating that the court has permanently sealed the reports so that they can only be reviewed by three individuals.

The judge also denied the defendants' attempt to exclude evidence concerning medical device reports and complaints related to other patients but partially allowed them to present percentages or comparative analysis of adverse events rates through witnesses.

Currently, C.R. Bard is facing more than 8,000 product liability litigations against its products, which include Bard Ventralight, Bard Ventralex, Bard Perfix, Bard 3DMax, and other similar mesh systems. Each lawsuit claim that the company sold defective products in the market, which has resulted in plaintiffs suffering from painful and debilitating complications.