Johnson & Johnson and it’s Ethicon subsidiary face a wrongful death lawsuit over complications with it’s Physiomesh patch, which became infected following hernia repair surgery, leading to septic shock, respiratory failure and other fatal health problems.

The complaint (PDF) was filed last week by the wife of William Stanley Edwards in the U.S. District Court for the Northern District of Georgia, indicating that design defects associated with the Ethicon Physiomesh were the direct and proximate cause of fatal injuries that developed following hernia repair.

Edwards received a 10 inch by 20 inch Physiomesh patch in June 2015, during treatment for an incarcerated ventral hernia. According to the lawsuit, he had to be readmitted just a couple weeks later, in July 2015, due to severe abdominal pain and other complications. He was readmitted twice that month, eventually being diagnosed as suffering a hematoma and related infection.

In November 2015, Edwards underwent revision surgery to have the infected Ethicon Physiomesh removed, at which time doctors discovered that the patch never incorporated into his tissues, according to the complaint. The Physiomesh was replaced with a biologic form of hernia mesh, but problems continued, including reports of bowel and feces hanging out of the wound, and the wound failing to heal. Edwards underwent continuous care, from November 2015 until the time of his death, with several instances of hospitalization.

Edwards died of septic shock, respiratory failure and acute renal failure, which his wife claims was a result of the infected Ethicon Physiomesh in the wrongful death lawsuit.

The case joins a growing number hernia mesh lawsuits filed over Ethicon Physiomesh, each raising similar allegations that the product was defectively designed, posing an unreasonable risk for consumers.

“The Physiomesh implanted in the Decedent William Stanley Edwards failed to reasonably perform as intended,” his wife’s lawsuit states. “The mesh failed, causing serious injury, had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the Physiomesh was initially implanted to treat.”

In June 2016, Ethicon recalled Physiomesh products from the market worldwide, due to a high rate of problems and revisions among individuals who had the patch implanted, since the manufacturer was unable to identify or correct the underlying cause of the complications.

Although the action was classified as a “market withdrawal” in the United States, Ethicon asked hospitals to return all unused implants and indicated that it does not intend to return the product to the market.

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 to establish coordinated pretrial proceedings in the federal court system, transferring all cases filed nationwide to 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.

As hernia mesh lawyers continuing to review and file additional lawsuits in the coming weeks and months, it is expected that several thousand complaints will be included in the MDL proceedings.

Tags: Ethicon, Hernia, Hernia Mesh, Infection, Johnson & Johnson, Physiomesh, Sepsis, Wrongful Death Lawsuit