Boston Scientific Loses Federal Case Over Vaginal Mesh Product

Boston Scientific Corp. will have to pay a total of $26.7 million in damages to four women in a court ruling related to its vaginal mesh product.

Following a federal court trial in Miami, Fla., jurors found that the company’s Pinnacle pelvic floor replacement kit had a faulty design and the company failed to effectively warn patients and doctors about the possible risks associated with the device. Pelvic organ implants are used to treat female patients experiencing major discomfort due to pelvic organ prolapse.

This was the first federal trial related to Pinnacle. Others lawsuits are pending.

According to WebMD, pelvic organ prolapse occurs when a pelvic organ—such as the bladder—drops (prolapses) from its normal place and pushes against the walls of the vagina. This can happen when the muscles that hold pelvic organs in place are weakened or stretched from childbirth or surgery. Many women will have some kind of pelvic organ prolapse. It can be uncomfortable or painful, but isn’t usually a big health problem. It doesn’t always get worse. And in some women, it can get better with time.

Boston Scientific officials told Reuters that they disagree with the verdict and have a strong case for post-trial motions and appeal.
Marlborough, Mass.-based Boston Scientific is one of seven companies, including Johnson & Johnson’s Ethicon division and C.R. Bard, faced with lawsuits over similar mesh products. Officials with Endo International plc said in September it the company has set aside $1.6 billion to settle “substantially all” the cases against it and its American Medical Systems unit.

Boston Scientific previously faced three trials in state court over the mesh, resulting in two wins and loss. The loss occurred in September, when a jury in Texas ordered Boston Scientific to pay $73 million to a woman who experienced constant pain after being treated with one of the company’s vaginal-mesh implants for urinary incontinence. The fine later was reduced to $34 million to comply with Texas state laws, but the court maintained that Boston Scientific was liable for gross negligence and a faulty product.

Boston Scientific is currently in another federal trial in West Virginia involving claims from four women implanted with the company’s Obtryx device for stress urinary incontinence.

Boston Scientific currently faces about 23,000 lawsuits over its vaginal-mesh implants in the United States, Canada and U.K. courts.
According to Reuters, during the recent trial in Miami, plaintiffs’ lawyers accused Boston Scientific of failing to perform critical safety studies in a “rush to bring the device to market.” The company denied any wrongdoing and claimed each woman and her doctor were aware of the risks.