C.R. Bard, Inc, a medical device maker, has been told by a federal judge in Ohio that its Ventralight ST hernia mesh cannot be argued as a lifesaving device in a forthcoming bellwether trial.
According to Law360.com, the judge ruled that Bard nor its subsidiary, Davol, Inc., failed to point out any evidence that supports the label’s lifesaving assertion. The bellwether trial stems from Bard being accused of concealing design defects of its hernia mesh.
Law360 quoted the federal judge’s order, which says, “Without much fussing, federal courts have permitted ‘lifesaving’ characterizations if there is some evidence in the record to support the label.”
The judge continued, “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.”
The forthcoming first hernia mesh bellwether trial, which may have a profound impact on future hernia mesh cases, has been delayed because of the coronavirus pandemic. The plaintiff in the first trial is Steven Johns. Johns sued Bard and Davol in October 2018.
Per Law360.com, Johns’ lawsuit alleges that the companies knew and concealed that their product’s polypropylene mesh is not a viable long-term hernia treatment, because the devices’ so-called “Sepra Technology” coating allegedly breaks down and is absorbed by the body too quickly.
Consequently, internal organs and other tissues become exposed to the polypropylene, risking injury and other complications. Thus far, there are three multidistrict litigation (MDLs), encompassing roughly 15,000 lawsuits.
In addition to denying the ‘lifesaving’ claim, the judge asserted that the defendants attempted to exclude several pieces of evidence from trial. This includes data related to medical device reports, the amount of devices sold or implanted and a comparative analysis of adverse events. The judge also denied Bard’s attempt to exclude certain medical device reports and complaints related to patients other than Johns.
According to DrugWatch.com, as of October 2020, there were 9,394 lawsuits pending over different brands of Bard subsidiary, Davol, polypropylene mesh products. The panel for Bard Davol MDL established the litigation on Aug. 2, 2018. In addition to Ventralight SL, the other Bard/Davol models of mesh involved in this specific MDL include: PerFix Mesh, 3DMax Mesh, Ventralex Patch, Ventralex ST Mesh, Sepramesh IP Composite Mesh, Composix E/X Mesh, Composix L/P, Marlex, Bard Mesh Dart, Ventrio ST, Ventrio patch, Visilex, Sperma-Tex, Kugel Hernia Patch, Modified Kugel Hernia Patch, and Composix Kugel Hernia Patch.