In this Corner, “Defective Design”
On one hand, Physiomesh was approved in April 2010 under the FDA’s 510(k) fast-track process because it was similar to products Ethicon already had on the market. On the other hand, Ethicon voluntarily recalled one of those products, Proceed surgical mesh, only six months later because layers of the mesh separated after it was implanted. In 2016, Ethicon also voluntarily recalled Physiomesh Flexible Composite Mesh after independent studies noted unusually high failure rates. Ethicon was unable to say why.
But plaintiffs in the consolidated cases may have the answer, contending that “the multi-layer coating [on the mesh] … prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications. In addition, the polypropylene mesh portion of the Physiomesh was insufficient to withstand normal abdominal forces, which often resulted in herniation through the mesh itself, recurrent hernia formation and/or rupture and deformation of the mesh itself.” The patch folded, moved and caused further damage.
And, In This Corner, “Intervening Cause”
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As the Physiomesh hernia patch lawsuits go to trial, patients and their attorneys will closely monitor the court’s reaction to the defective design and intervening cause arguments. Much hangs in the balance.