PITTSBURGH – The U.S. District Court for the Western District of Pennsylvania has denied a motion to dismiss a lawsuit filed by a man who claimed the defendants used an uncoated lightweight monofilament polypropylene mesh in a hernia operation without first informing him of the potential risks associated with the product.
The defendants are C.R. Bard Inc., Davol Inc. and Becton, Dickinson and Co. According to the Feb. 2 opinion, plaintiff Grant B. Stevens “alleges that defendants had the requisite knowledge, skill and expertise to know that: (1) implanted devices, such as polypropylene mesh, must be chemically inert, noncarcinogenic and able to withstand mechanical stress; and (2) implanted devices, such as polypropylene mesh, must also not be physically modified by tissue fluids, not allow tissue infiltration, not incite an inflammatory or foreign body cell reaction and not produce allergic reactions.”
Stevens claims he was unaware of and was not informed of the complaints, known complications and risks associated with polypropylene mesh - even after he began to experience complications.
Stevens alleged the defendants deliberately failed to disclose the risks associated with polypropylene mesh to plaintiff’s surgeon.
Soon after the surgery, the court said in the opinion that Stevens sought medical treatment, and was “diagnosed with an infection at the incision site, which required wound VAC placement.”
“Plaintiff believes that it was at this point in time that the mesh separated, detached or otherwise failed and became exposed, requiring physicians to trim portions of the mesh protruding from his skin on several occasions,” the opinion said.
The court said that Stevens alleged that his condition “steadily worsened” over a period of May 6, 2015, to Oct. 11, 2016, with the damage allegedly resulting from the mesh implant “eventually becoming 6 to 7 centimeters in diameter.”
“Even at this juncture, plaintiff claims that he was still unaware of the complaints, complications and risks associated with polypropylene mesh, and that he repeatedly sought medical treatment for the worsening protrusion, pain, discomfort and secondary symptoms associated with the Ventralight failure,” according to the opinion.
The court said Stevens was later told in October 2016 that “the Ventralight mesh had failed and needed to be removed.”
Stevens had the mesh taken out on Jan. 27, 2017, the opinion said, and claims that further surgeries may be required to deal with the side effects from the damage caused by the product.
Judge Arthur J. Schwab wrote in the opinion that, despite arguments to the contrary made by the defendants, “given Pennsylvania’s case history with respect to drug manufacturer liability, this court finds that in Pennsylvania, negligence claims are not as limited as defendants suggest.”
Specifically, Schwab wrote “In Pennsylvania, plaintiffs, such as plaintiff herein, may maintain an action sounding in negligence for more than a negligent failure to warn and/or the negligent preparation of a product.”
In the opinion, the court gave the defendants until Feb. 18 to file an answer to Stevens’ complaint.