A federal judge has ruled that punitive damage claims can stand in a product liability lawsuit against device maker Boston Scientific over its pelvic mesh products.
In February 2010, the woman who brought the suit was implanted with Boston Scientific’s Advantage Fit device to treat stress urinary incontinence according to court documents. She claimed that the device resulted in a number of 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, MassDevice reports.
Boston Scientific asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to throw out the punitive damages claim, arguing that the plaintiff has presented no evidence of malice or criminal indifference. But she contended that the company knew the polypropylene resin used in the mesh was not suitable for permanent implantation, citing a material safety data sheet (MSDS) from the resin’s supplier, Chevron Phillips Chemical. The MSDS contained a “medical application caution” that the material not be used “in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” according to court the documents.
The plaintiff also claimed that Boston Scientific “knew it needed to conduct long-term safety studies of the polypropylene material in the Advantage Fit.” A provision of the deal with Chevron Phillips advised Boston Scientific to “make its own determination of the safety and suitability of the polypropylene material,” according to MassDevice. Court filings say it is ultimately Boston Scientific’s responsibility “to ensure that the PSPC polypropylene product is suited to Boston Scientific’s specific application.”
In allowing the punitive damages claim to stand, Judge Goodwin wrote, “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,” according to MassDevice.
Transvaginal mesh devices are used to treat pelvic organ prolapse and stress urinary incontinence. Thousands of women implanted with the devices have sued device makers over injuries including mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The Food and Drug Administration (FDA) has rejected a call for a total ban on pelvic mesh devices, but is considering a reclassification that would move the devices to Class III, the highest risk category, which would subject the devices to stricter regulatory control.
Last year Boston Scientific lost two pelvic mesh trials. In November, a West Virginia jury in awarded $18.5 million to four women for injuries they said were caused by the company’s Obtryx device for stress urinary incontinence. The award included $4 million for “gross negligence,” MassDevice reports. One week earlier, a Miami jury awarded $26.7 million to four women who alleged injuries from Boston Scientific’s Pinnacle device.