Sharon Kay Pelkey was implanted with Boston Scientific’s Advantage Fit device for treating stress urinary incontinence in February 2010 in Virginia, according to court documents. Pelkey claimed that the implantation resulted in multiple complications, prompting her to sue Boston Scientific in April 2013 for negligence, strict liability for design defect, manufacturing defect, and failure to warn, breaches of express and implied warranties and punitive damages, according to the documents.
Boston asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to toss the punitive damages claim, arguing that Pelkey presented no evidence of malice or criminal indifference.
Pelkey contended that the company knew the polypropylene resin used to make the mesh was not meant for permanent implantation, citing a material safety data sheet from the resin’s supplier, Chevron Phillips Chemical. The MSDS contained a "medical application caution" not to use the material "in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues," according to the documents.
Pelkey also alleged that Boston "knew it needed to conduct long-term safety studies of the polypropylene material in the Advantage Fit," citing a provision of the supply deal with Chevron Phillips cautioning Boston to "make its own determination of the safety and suitability of the polypropylene material," court filings show.
“It is the ultimate responsibility of Boston Scientific to ensure that the PSPC polypropylene product is suited to Boston Scientific’s specific application," according to the filings.
Goodwin agreed with Pelkey, allowing the punitive damages claim to stand.
"Despite the MSDS warning and the admonition from BSC’s polypropylene supplier to conduct its own tests, an internal BSC document indicates that BSC sponsored no clinical studies on the Advantage Fit before selling the device to the public. Furthermore, BSC never warned through its directions for use that the Advantage Fit was made of a component that was not safe for permanent implantation in the human body," Goodwin wrote
"In light of the MSDS warning and BSC’s failure to conduct clinical testing, a reasonable jury could find that BSC acted in conscious disregard of Ms. Pelkey’s rights, or acted with reckless indifference to the consequences. A reasonable jury could also find that BSC knew that the Advantage Fit ‘probably would cause injury to another,’ and that BSC was aware of the danger involved with placing the Advantage Fit into the stream of commerce," he wrote.
Late last year Boston Scientific lost a pair of pelvic mesh trials. A West Virginia jury in November awarded 4 women $18.5 million for injuries they said were caused by the Massachusetts-based company’s Obtryx device for stress urinary incontinence, including $4 million for "gross negligence." That verdict came one week after a Miami jury awarded $26.7 million to 4 women implanted with the company’s Pinnacle device for pelvic organ prolapse.