A federal court recently ruled that medical device maker C.R. Bard cannot call Ventralight mesh a “lifesaving device” during the first trial to be heard over allegations the company hid significant design defects in the hernia mesh implant from patients and doctors.

Thousands of patients implanted with Bard’s Ventralight ST mesh filed hernia mesh lawsuits against the medical device company and its subsidiary, Devol, Inc. after allegedly suffering severe hernia mesh side effects, including pain, swelling, adhesions, infections, and bowel obstructions. The patients claim that the mesh was defectively designed because it degrades and is absorbed by the body soon after implantation.

These cases were consolidated into multidistrict litigation and the first is set to go to trial. According to legal news source, Law 360, C.R. Bard argued that it should be permitted to call the hernia mesh a “lifesaving device” during the trial. However, U.S. District Court Judge Edmund A. Sargus Jr. disagreed.

“Without much fussing, federal courts have permitted ‘lifesaving’ characterizations if there is some evidence in the record to support the label,” Judge Sargus stated in his order. “Defendants point to no such evidence here. … If defendants can point to testimony that stands for the proposition that untreated hernias may cause death, the court will revisit this ruling.”

Judge Sargus also shot down an attempt by a nonprofit focused on abdominal health care issues to exclude data it collected from the trial. Reportedly, the group argued that the data was not risk-adjusted and could be misleading; however, the judge concluded that the jury could work out the significance of the evidence at trial.

Reportedly, several other evidentiary issues still need to be resolved before this first Ventralight ST mesh lawsuit goes to trial.

Hernia Mesh Claims

Indeed, thousands of patients say that they were injured by Bard’s hernia mesh. Patients claim that the Ventralight mesh is incompatible with human tissue. Further, lawsuits allege that Bard knew or should have known about the design defects in its mesh, pointing to scientific evidence that the company had access to that showed patients had a negative immune response to the mesh.

In addition, the lawsuits allege that the company did not conduct enough research to determine whether its product was safe.

“Defendants were fully aware of the dangers defective products they were placing into the stream of commerce posed to their customers, specifically the Bard Ventralight ST polypropylene mesh, which has been shown to pose an unreasonable risk of human body inflammation, granuloma formation, foreign body reaction, excessive scar tissue formation and long-term complications,” states one of the lawsuits.

According to C.R. Bard’s website, the mesh is made from Sepra® technology boasting “bioreabsorbable” fibers, and a 30 day reabsorption period.

The plaintiff in this first trial, as well as thousands of others claim that they suffered severe side effects after being implanted with the mesh. These side effects were not only physical, but included mental anguish. Patients claim that they have and will likely need to undergo medical treatment as a result of Bard’s mesh in the future, including surgery to remove and/or replace the mesh.

Is Hernia Mesh Safe?

According to UCI Health, there are a number of problems that have been associated with hernia mesh, including pain, infections, bleeding, fluid buildup, bleeding, adhesion, and perforation. In fact, UCI Health notes that problems with surgical mesh has led to several FDA recalls.

The Ventralight Mesh Lawsuit is Johns v. CR Bard et al., Case No. 2:18-cv-01509, and the Ventralight MDL is In re: Davol Inc./C.R. Bard Inc. Polypropylene Hernia Mesh Products Liability Litigation, Case No. 2:18- md-02846, both in the U.S. District Court for the Southern District of Ohio.