Late last week a Delaware jury ordered medical device maker Boston Scientific to pay $100 million to a woman who said she was injured by a transvaginal mesh device.
The jury award contained $25 million in compensatory damages and an additional $75 million in punitive damages, Reuters reports. The devices are the subject of more than 25,000 lawsuits against the company.
The 51-year-old Newark, Delaware woman was implanted with Boston Scientific’s Pinnacle and Advantage Fit transvaginal mesh products in 2009, to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), according to her 2011 lawsuit. The lawsuit claims that the devices caused serious complications. The woman had two additional surgeries to try to fix the problems, but parts of the devices remain in her body and continue to cause her pain, according to Reuters. The jury found that Boston Scientific had been negligent in the design and manufacture of the devices and, further, the company had had failed to warn patients and doctors about potential risks.
An attorney for the plaintiff said complications from the transvaginal mesh implants had “profoundly changed” her life. She hopes this verdict will encourage Boston Scientific and other makers of mesh devices to settle the remaining cases. Boston Scientific plans to appeal, according to Reuters.
This is the first jury verdict since Boston Scientific agreed last month to settle nearly 3,000 lawsuits for $119 million. Last year, a Texas woman was awarded $74 million in a lawsuit alleging the company’s Obtryx sling caused her serious injuries.
Thousands of women implanted with transvaginal mesh devices have sued device makers over injuries that include 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 these devices, but the agency is considering a reclassification that would move transvaginal mesh devices to Class III. The FDA explains that Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices—such things are replacement heart valves—must typically be approved by the FDA before they are marketed. A reclassification for transvaginal mesh devices would subject them to stricter regulatory control.
Last year, Boston Scientific won the first two trials against it, before losing three trials in a row, Reuters reports. Boston Scientific is among seven manufacturers that collectively face an estimated 100,000 lawsuits over transvaginal mesh devices in U.S. federal and state courts. Other major defendants include Johnson & Johnson’s Ethicon unit, C.R. Bard, and Coloplast.