Boston Scientific is facing the first federal trials over transvaginal mesh lawsuits, in which women allege that the pelvic mesh device is defective and caused injuries. According to Reuters, the federal trials are taking place in two courts; one in Charleston, West Virginia and the other in Miami, Florida. The trial in Charleston involves four woman implanted with Boston Scientific’s Obtryx transvaginal mesh for stress urinary incontinence while the Miami trial involves women implanted with the Pinnacle for pelvic organ prolapse.
Transvaginal mesh implants are supposed to treat pelvic organ prolapse and stress urinary incontinence by providing additional support to the pelvic wall and muscles. Over the years, however, a number of women reported severe complications, such as pain, bleeding, nerve damage and mesh erosion. According to Reuters, transvaginal mesh devices are now one of the most sued-over medical devices.
Boston Scientific, Johnson & Johnson’s Ethicon unit and C.R. Bard are the three biggest defendants in the transvaginal mesh litigation. Combined, they face 72,000 lawsuits in state and federal courts. Recently, transvaginal mesh maker Endo International’s American Medical Systems said it would reserve $1.6 billion to settle “substantially all suits”.
The devices came under public scrutiny about six years ago, and since then 23,000 state and federal lawsuits have been filed against Boston Scientific. U.S. District Judge Joseph Goodwin in the Southern District of West Virginia is overseeing the consolidated federal litigations against Boston Scientific, as well as six other manufacturers. In order to make the massive litigation more efficient, Judge Goodwin has said that he will use creative approaches, such as placing several similar plaintiffs together for trial. Consolidating claims “may facilitate settlement,” he said, according to Reuters.
Transvaginal mesh implants did not need to undergo clinical testing before being sold and implanted because they were approved through a process called 510(k), a route that is now under intense scrutiny. In April, the U.S. Food and Drug Administration (FDA) said it may require manufacturers to submit additional safety data to continue selling the devices.
So far, Boston Scientific has seen three trials take place over pelvic mesh in state courts. Two found for the company while the third led to a final $34 million verdict for the plaintiff. This award was initially $73 million, but was reduced due to a state law that places a cap on damages.