Ethicon Physiomesh Problems Led To Inflammation, Migration and Tissue Damage: Lawsuit

A product liability lawsuit filed last week against Johnson & Johnson alleges that problems with Ethicon Physiomesh caused an Arkansas woman to suffer a host of adverse health effects, after her body rejected the hernia mesh implant. 

The complaint (PDF) was filed by Jennifer Stone in the U.S. District Court for the Eastern District of Arkansas on July 31, indicating that the multi-layer coating surrounding the hernia mesh constitutes a defective and unreasonably dangerous design, which caused an inflammatory foreign body response, migration of the patch and damage to surrounding tissue.

Stone indicates that an Ethicon Physiomesh Composite mesh was implanted during a hernia repair surgery in June 2011. However, she indicates that the multi-layer coating featured on the mesh provides a breeding ground for bacteria that can not be eliminated by the body’s immune system, ultimately leading to the need for her to undergo invasive medical treatments and suffer severe pain.

Due to similar reports of Ethicon Physiomesh problems, the manufacturer sent a notice to hospitals and medical providers in various countries announcing a voluntary recall. However, in the United States, the manufacturer instead opted to quietly remove the product from shelves and cease further sales, as part of a “market withdrawal.”

Ethicon Physiomesh is unlike other hernia repair products, as it involves five distinct layers, which the manufacturer claimed were designed to improve performance. However, Stone claims that the multi-layer Physiomesh coating prevents fluid escape, which leads to seroma formation, infections and other complications.

“When affixed to the body’s tissue, the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation, and other complications,” Stone’s lawsuit states. “The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”

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.

Stone’s lawsuit will be transferred to the federal multidistrict litigation (MDL), which currently includes nearly 100 other claims. However, as hernia mesh lawyers continuing 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.