Ethicon Physiomesh Multi-Layer Design Led To Hernia Complications, Lawsuit Alleges

A product liability lawsuit filed by an Alabama man alleges that the unique, multi-layer design used with the Ethicon Physiomesh patch caused him to experience severe complications following hernia repair, resulting in the need for additional invasive medical procedures due to adverse reactions caused by the mesh. 

In a complaint (PDF) filed this week in the U.S. District Court for the Northern District of Alabama against Johnson & Johnson & it’s Ethicon subsidiary, Bill Tedford indicates that the Physiomesh multi-layer design was unreasonably dangerous and defective, causing permanent injury and damages.

Unlike many other hernia repair products, Ethicon Physiomesh involves five distinct layers, which the manufacturer claimed were designed to improve performance. However, Tedford indicates that the multi-layer Physiomesh coating prevents fluid escape, which can lead to seroma formation, infections and other complications.

Last year, following a higher-than-expected number of adverse event reports involving hernia complications, an Ethicon Physiomesh recall was issued by the manufacturer. While the action was classified as a market withdrawal, the manufacturer removed all products from the market and indicates that it will no longer be sold, since they were unable to identify a solution for the problems.

Tedford indicates that an Ethicon Physiomesh Composite mesh was implanted in his body during a hernia repair in December 2013. However, due to complications and reactions to the hernia mesh, Tedford indicates that he later had to undergo additional invasive medical treatments.

“The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not. Instead, the multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue, and improper healing,” Tedford states in the complaint. “These manufacturing and design defects associated with the Physiomesh were directly and proximately related to the injuries suffered by Plaintiff.”

According to the lawsuit, Tedford had a severe adverse reaction to the Physiomesh, causing serious injury and the need for additional invasive medical treatments that left him with permanent scarring and injuries.

The case joins a growing number of Ethicon Physiomesh lawsuits filed by individuals nationwide who have experienced complications following laparoscopic hernia repair in recent years.

Given the similar questions of fact and law presented in cases  pending throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided last month to establish coordinated pretrial proceedings, centralizing all cases before U.S. District Judge Richard Story in the Northern District of Georgia to reduce duplicative discovery, avoid contradictory pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

Tedford’s case will be transferred to the federal multidistrict litigation (MDL), which currently includes nearly 100 other claims. However, as hernia mesh lawyers continue to review and file additional cases in the coming weeks and months, it is expected that several thousand complaints will ultimately be included in the litigation.