Boston Scientific failed in its bid to remove punitive damages claims in a pelvic mesh lawsuit this month, Mass Device reports. This case is one out of 15,000 product liability lawsuits filed over the devices, which are used to treat stress urinary incontinence. According to Mass Device, the plaintiff in the case alleged that she suffered multiple complications after being implanted with Boston Scientific’s Advantage Fit device in 2010. In April 2013, she sued for negligence, strict liability for design defect, manufacturing defect and failure to warn, breaches of express and implied warranties and punitive damages.
The device maker argued that the plaintiff did not show evidence of malice or criminal indifference. Based on this argument, Boston Scientific asked Judge Joseph Goodwin of the U.S. District Court for South West Virginia to remove the punitive damages claim. The plaintiff alleged that the company was aware that the polypropylene resin should not have been used for permanent implantation. She referenced a material safety data sheet from the resin’s supplier, Chevron Phillips Chemical, indicating a “medical application caution” not to use the resin “in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” Mass Device reports. Additionally, the plaintiff alleged that Boston was aware that it needed to conduct long-term safety studies assessing use of the material in the pelvic mesh. The complaint alleged that Boston should be held liable for ensuring that the material is used safely in the product.
Judge Goodwin, who is overseeing the transvaginal mesh multidistrict litigations, sided with the Plaintiff. “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,” he wrote, according to Mass Device. “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,”