C.R. Bard, Inc. and Davol, Inc. continue to face a growing number of hernia mesh lawsuits in courts throughout the United States, with recent filings in Louisiana and Mississippi.
According to a complaint filed in the U.S. District Court, Southern District of Mississippi, on January 2nd, Patrick Dove received an 8-cm circular Bard Ventralex patch in March 2014. He was forced to undergo hernia revision surgery last June due to complications and severe pain. (Case No. 3:18-cv-00003-CWR-FKB)
Like other products involved in the growing, nationwide hernia mesh litigation, the Bard Ventralex patch was brought to market via the U.S. Food & Drug Administration’s (FDA) 510(k) program, which does require a device to undergo human clinical trials if its design is based on a predicate product that previously underwent the agency’s standard pre-market approval process.
According to Dove’s hernia mesh lawsuit, Ventralex features a bilayer construction consisting of a self-expanding patch that contains two layers of polypropylene mesh stitched with polytetrafluorethylene monofilament to an expanded polytetrafluoroethylene sheet. The mesh component contains a “fully absorbable” recoil ring using SorbaFlex Memory Technology, an absorbable polydioxanone monofilament.
Dove alleges that Bard’s hernia mesh ismade of materials that are biologically incompatible with human tissue.
“Defendants knew that the technology used in the laminate layers would delaminate as evidenced by folding, shriveling, curling up on edges, and generally causing a separation of layers of the patch,” the complaint states.
“The scientific evidence Defendant knew or should have known of demonstrates that the mesh is incompatible with human tissue and often causes a negative immune response in patients implanted with the Bard Ventralex, including Plaintiff. The Ventralex patch is constructed with a polypropylene monofilament containing a resin-based polypropylene not suitable for human implantation,” it continues.
According to a complaint filed on November 22nd in Louisiana’s Orleans Parish Civil District Court, Reginald Sanders was implanted with a Bard hernia mesh device in November 2004. He began to experience discomfort and pain near the surgical site shortly after the procedure. (Case No. 2017-11264)
In 2013, surgery to treat an abdominal abscess revealed that the repair site had become infected, allegedly due to the negligence of Bard and Davol.
The hernia mesh lawsuit accuses the companies of negligence and failure to manufacture a safe product.
C.R. Bard and Davol are not the only medical device manufacturers involved in the nationwide hernia mesh litigation.
Johnson & Johnson and its Ethicon, Inc. subsidiary have been named defendants in dozens of Physiomesh lawsuits, following a worldwide market withdrawal of certain Physiomesh Flexible Composite mesh implants in March 2016. The majority of those hernia mesh cases have been centralized in a multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
A multidistrict litigation has also been established in the U.S. District Court, District of New Hampshire, for product liability claims involving Atrium Medical’s C-Qur hernia mesh implant.