Ethicon, a corporate subsidiary of Johnson & Johnson, has faced a number of lawsuits related to the surgical mesh it created and marketed to women who suffered various types of organ prolapse, either due to age or childbirth. The company is still fighting many of those cases, although it settled thousands just this year.
Now, the company is accused of making a defective product intended for patients suffering from hernias. This product too is a type of mesh, and the allegation, similar to the transvaginal mesh lawsuits, asserts the product does not perform as expected, adheres to internal tissue in a way that causes incredible pain and dysfunction, and makes it very difficult to remove during necessary revision surgery.
The hernia mesh goes by the brand name Physiomesh. The latest of these Physiomesh lawsuits was filed in a federal court in Florida. According to the Florida Record, there have only been four of these product liability lawsuits filed so far, but it’s anticipated that many more will follow.
According to court records in Quinn v. Ethicon, plaintiff suffered from a hernia for which she was surgically treated in 2014. This Physiomesh product was implanted in her abdomen. From that point forward, rather than her condition improving, it got substantially worse. Ultimately, she suffered from severe abdominal pain, as well as decreased bowel motility and bowel obstruction. This is both incredibly painful as well as debilitating and embarrassing.
The surgeon who conducted her revision surgery ended up spending hours performing the procedure and was still not able to remove all the offending material, which had become so embedded in her tissue, it was impossible to get out.
In her product liability lawsuit, plaintiff alleges that she suffered not just physical pain but mental anguish and economic loss as a result of these complications. She never would have agreed to undergo the procedure with this product had she known the seriousness of the risks she faced. But such dangers were never expressed to her and, she alleges, were never acknowledged by the company, despite evidence that the leadership was aware of it.
This purported knowledge of the product’s defect is based in part on the fact that the company “voluntarily withdrew” its Physiomesh from the U.S. market in May 2016, following a number of independent studies that revealed a high rate of complications associated with this product. But even before that, plaintiff notes, there were high rates of both patient and surgeon complaints, though those were not enough to convince the company to remove the product and take a closer look at safety.
In fact, as we see in so many of these cases, manufacturers often will press to get their products to market before taking the time to make sure they’re safe for consumers. This goes not just for medical devices, but also motor vehicles, toys, and household appliances. Approval of medical devices by the U.S. Food & Drug Administration is typically contingent on a rigorous testing process (though the company itself does most of the testing) that can take years. However, as was the case here, companies can bypass this process by submitting a 510(k) application, which allows products to skate through the process a whole lot faster if the manufacturer promises the product it’s delivering is substantially equivalent to one already on the market.
Contact the Carolina injury lawyers at the Lee Law Offices by calling 800-887-1965.
Johnson & Johnson’s Ethicon sued over physiomesh product, Nov. 17, 2016, By Chandra Lye, Florida Record
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