The multicounty litigation established in New Jersey’s Atlantic County Superior Court for all hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh will soon get underway.
According to an Order dated August 20th, the Court will conduct its first telephone case management conference on October 18th at 1:30 p.m. Matters to be addressed during the conference include the status of discovery and the scheduling of future in-person case management conferences.
Ethicon’s Physiomesh Flexible Composite Mesh is indicated for use in hernia repair surgery. Ethicon obtained U.S. Food & Drug Administration (FDA) clearance to market Physiomesh products via the agency’s 510 (K) approval program, which allows medical devices deemed “substantially equivalent” to previously-approved implants to come to market without the benefit of human testing.
Physiomesh hernia patches feature a unique multi-layer design that incorporates 5 distinct layers: two layers of poliglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film which are coated with a polypropylene mesh. While this construction purportedly prevents or minimizes adhesion and inflammation and facilitates incorporation of the mesh into the body, Physiomesh lawsuit plaintiffs claim that the design actually prevents incorporation and increases the risk that patients will experience serious and painful complications that may result in the need for hernia revision surgery.
Physiomesh Flexible Composite Mesh implants were withdrawn from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the products were associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair. Ethicon has indicated that it will not be returning the devices to the market, as it was unable to determine the cause of these issues.
Though the action was never designated an official hernia mesh recall in the U.S., hospitals and healthcare providers were asked to return any affected Physiomesh devices in their stock to Ethicon.
The New Jersey Supreme Court agreed to centralize the state’s Physiomesh docket in Atlantic County earlier this month, after plaintiffs filed a petition pointing out that the cases shared many common issues of fact and law, as well as defendants and witnesses. While plaintiffs also sought to include hernia mesh lawsuits involving Ethicon’s Proceed Surgical Mesh, Proceed Ventral Patch, Prolene 3D, and the Prolene Hernia System in the multicounty litigation, the Supreme Court opted to limit the proceeding to Physiomesh claims.
Federally-filed Physiomesh lawsuits have also been centralized before a single judge in the U.S. District Court, Northern District of Georgia. That litigation currently includes over 1,378 filings.