Ethicon Resists Bid to Centralize Physiomesh Hernia Lawsuits

Published on April 18, 2017 by Sandy Liebhard

Ethicon, Inc. has indicated its opposition to a proposal that would centralize all federally-filed hernia mesh lawsuits involving its Physiomesh Flexible Composite Mesh product in a single jurisdiction. In a response filed last week with the U.S. Judicial Panel on Multidistrict Litigation (JPML), the company asserted that the cases were too individualized to warrant consolidation.

Ethicon has been named a defendant in dozens of Physiomesh lawsuits, all of which were filed on behalf of plaintiffs who say they suffered adhesions, perforations, infections, mesh erosion and other debilitating complications due to the product’s allegedly defective design.  In a Motion for Transfer filed with the JPML in March, plaintiffs predicted that hundreds of similar claims would be filed against Ethicon in the near future, and argued that centralization in a single U.S. District Court would allow the cases to proceed more efficiently through the system.

In its April 13^th Response, Ethicon pointed to the wide range of injuries cited in the lawsuits and argued that each of the cases would involve individualized questions of fact.

“Although Plaintiffs may point to hernia recurrence as the common injury that binds these cases together, a closer look at the complaints shows a wide variety of alleged injuries, such as abdominal abscesses and intestinal fistula, bowel puncture, erosion and bowel resection, bowel adhesions, fistula and infection, and recurrent inguinal hernia,” the Response states.

Physiomesh Background

Ethicon’s Physiomesh Flexible Composite Mesh line was brought to market in 2010 and received regulatory clearance via the U.S. Food & Drug Administration’s (FDA) 510(k) program. This program allows a medical device to come to market without the benefit of human clinical trials, so long as a manufacturer can demonstrate that it is “substantially equivalent” to a product that was previously approved by the agency.

Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.  Ethicon was unable to determine the cause of this issue but noted that it could be due to product characteristics, as well as operative and patient factors.

While the action was not granted recall status in the U.S., Ethicon did ask hospitals to return any unused Physiomesh patches affected by the action. The company indicated that it would not seek to return the affected products to the market.