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, 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.
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.
Source: Medical Product Outsourcing
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