Sharon Kay Pelkey’s case has been permitted to stand by Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia. Boston Scientific had asked Judge Goodwin to toss the punitive damages claim, arguing that Pelkey presented no evidence of malice or criminal indifference. Pelkey was implanted with the company’s Advantage Fit pelvic mesh device in February 2010 to treat stress urinary incontinence (SUI), according to court documents obtained by Mass Device. Pelkey claims she suffered numerous complications as a result of the implantation, prompting her to sue Boston Scientific in April 2013. The lawsuit alleges negligence, strict liability for design defect, manufacturing defect, failure to warn, breaches of express and implied warranties and punitive damages.
Court documents show Pelkey accused Boston Scientific of knowing the polypropylene resin used to make the mesh was not suitable for permanent implantation and cited a material safety data sheet from the material’s supplier, Chevron Phillips Chemical. The data included a warning that the resin should not be used “in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues, according to Mass Device.
Pelky also alleges that Boston Scientific “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 the firm to “make its own determination of the safety and suitability of the polypropylene material,” court filings viewed by Mass Device show. Judge Goodwin agreed and ruled that the punitive damages claim could stand, Mass Device reported.
“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.
Last November, a West Virginia jury awarded four women $18.5 million for injuries they said were caused by the company’s Obtryx device for SUI. The award included $4 million for “gross negligence.” Just a week before that, a Miami jury awarded $26.7 million to four other women implanted with the company’s Pinnacle device for pelvic organ prolapse, according to Mass Device.