Physiomesh Hernia Repair Lawsuit Filed Against Ethicon

According to allegations raised in a recently filed product liability lawsuit, problems with a recalled Ethicon Physiomesh hernia repair mesh caused a Florida woman to experience severe complications that will impact her for the remainder of her life.

Joanne Quinn filed a complaint (PDF) late last month in the U.S. District Court for the Middle District of Florida, claiming that Johnson & Johnson and it’s Ethicon subsidiary manufactured and sold an unreasonably dangerous and defective hernia repair product, which was removed from the market worldwide earlier this year amid a high rate of failures and hernia revisions.

The lawsuit indicates that Quinn experienced multiple complications from Ethicon Physiomesh after it was implanted in May 2014 for repair of incisional hernia. Her condition was not remedied by the hernia repair surgery, and actually became progressively worse during the subsequent months, with persistent abdominal pain, diminished bowel motility and bowel obstructions.

In July 2015, Quinn underwent an exploratory laparotomy to have the hernia repair mesh removed, but after more than two hours of surgery, her surgeon declared that it would be impossible to remove the Ethicon Physiomesh due to severe adhesions to the bowels and abdominal wall. As a result, Quinn is left with debris from the mesh stuck to her abdominal wall and bowels, and will likely suffer pain and medical complications for the rest of her life, the lawsuit indicates.

Quinn had Ethicon Physiomesh Flexible Composite Mesh with product code PHY2025V implanted during her hernia repair. This was one of several products included in an Ethicon Physiomesh recall issued in several countries in May 2016, after independent hernia repair registries revealed that the product was associated with a higher-than-expected rate of problems and revision surgery.

The action was classified as a “Market Withdrawal” by the FDA, but Ethicon has required all unexpired products be returned and decided to remove the hernia mesh from the market, after failing identify the cause of the problems or come up with ways surgeons may be able to reduce the recurrence rate.

“Even though Defendants knew or should have known that the [Ethicon Physiomesh] Product created a foreseeable and unreasonable risk of harm to those patients it was implanted, Defendants continued to market the Product in the United States,” according to the complaint, which notes that thousands of the hernia repair mesh products were sold in the U.S. “Defendants did not provide adequate warning or information as to the risks the Product carries including an unreasonably high rate of failure resulting in injury to bodily organs and corrective surgeries.”

The lawsuit claims that the Physiomesh products were defectively designed and manufactured, using materials that are not inert and that react to human tissues, can carry infections and can migrate from the implantation site to other parts of the body. The lawsuit also indicates that the mesh can abrade tissues and fails to actually perform.

Quinn indicates that as a result of the health complications caused by Ethicon Physiomesh used during her hernia repair surgery, she has suffered and will continue to suffer severe pain and difficulties for the rest of her life, noting that she never would have agreed to have Physiomesh implanted if she were aware of the risk.

The case joins a growing number of Ethicon Physiomesh lawsuits filed in courts nationwide on behalf of individuals who have experienced similar problems, with at least one case scheduled for trial to begin as early as January 2018.