Florida Record

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Johnson & Johnson's Ethicon sued over physiomesh product

By Chandra Lye | Nov 17, 2016

ORLANDO, FLORIDA – A new lawsuit claims more patients have been having problems with medical mesh products.

A patient has filed a lawsuit against Ethicon, a branch of Johnson & Johnson, regarding the company's physiomesh product.

The plaintiff, Joanne Quinn, was surgically treated for hernia in 2014 and the mesh product was implanted into her abdomen. Her condition became worse after the surgery with abdominal pain, diminished bowel motility and bowel obstruction.

Nearly a year later she underwent another surgery to remove the mesh product. The operation took over two hours and the doctor was unable to remove all of the product. Doctors stated that the mesh had become stuck to the abdomen walls and bowels.

In her suit in the U.S. District Court for the Middle District of Florida, Orlando Division, Quinn  claims she has suffered mentally and physically and has had economic loss due to the complications.

She alleges the defendants were aware of the dangers and risks of the product they were marketing.

“Defendants failed to exercise reasonable care in determining the risks and potential adverse consequences of implanting the product into patients,” court documents stated.

Product liability expert and attorney Michael Cerasa said he expected to see this case consolidated with other similar ones.

"What that will involve is a federal judge somewhere in the United States will be appointed to oversee all of the cases nationwide and that is where you will start to see test trials and things of that nature and really see the movement in terms of proving or disproving the allegations,” Cerasa told the Florida Record.

"I expect that this latest Ethicon case will get huge,” he added.

Physiomesh has since been recalled by the federal Food and Drug Administration. The manufacturer issued a voluntary recall in May. The company has given full refunds to healthcare facilities and medical professionals for products returned by Sept. 16. The company said in a statement that the made the decision “following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries."

“Ethicon believes the higher rates to be a multifactorial issue,” the recall notice stated. “Ethicon have [sic] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall Ethicon Physiomesh Composite Mesh from the global market.”

Cerasa said this recall can be evidence for the case but it does not conclude the plaintiff is correct.

“An FDA finding has no definitive bearing on a lawsuit. The suit is still going to be depending primarily on the science and what both sides prove as to whether or not the product is defective. FDA notices or recalls can be used as evidence in the case but they are not determinate as to whether a product would be defective or not in a legal sense,” he explained.

Ethicon declined to comment on the case.

The company has been working in the industry for over 80 years. It began making mesh for hernia patients in 1998. According to its website, it has sponsored the International Hernia Mesh Registry since 2007. It boasts 40 international sites and about 4,300 patients.

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U.S. District Court for the Middle District of Florida, Orlando Division