July 30 A Massachusetts jury has cleared Boston Scientific Corp of selling dangerous and defective transvaginal mesh devices, in the first out of more than 20,000 lawsuits waiting to go to trial.
The verdict came Tuesday in a suit brought by Diane Albright, who in 2012 claimed that the Pinnacle device she was implanted with was faulty, causing complications that included pain, bleeding and incontinence.
Following a trial of almost three weeks, jurors found that Boston Scientific was not liable for Albright's injuries.
"While we were disappointed with the verdict, it was a privilege to represent Mrs. Albright and to give a voice to her story," said her lawyer, Fidelma Fitzpatrick of Motley Rice.
Boston Scientific spokeswoman Denise Kaigler said the company was pleased with the trial outcome and stood behind the importance of transvaginal mesh as a treatment option.
Transvaginal mesh devices are used to treat stress urinary incontinence and pelvic organ prolapse.
Albright had claimed that the device's material was biologically incompatible with human tissue, prompting an immune response in some recipients. It could cause the pelvic tissue to break down, creating serious complications and sometimes requiring additional surgery to remove or replace the device, her lawsuit said.
She claimed that Boston Scientific knew about these risks but failed to warn users and their physicians. The company has denied that it was liable for plaintiffs' injuries.
Boston Scientific is facing more than 20,000 claims over the devices, including 1,700 that have been assigned to a single judge in Massachusetts state court and more than 12,000 that have been consolidated before a federal judge in West Virginia, according to a May 8 regulatory filing.
The next trial in Massachusetts is set for Aug. 11, Fitzpatrick said. The first trial in the federal cases is scheduled for Nov. 3.
Several other major medical-device manufacturers are facing claims over similar devices, including C.R. Bard Inc and Johnson & Johnson's Ethicon unit. In April, one defendant, Endo International Plc, said it would pay $830 million to resolve thousands of claims brought against its American Medical Systems subsidiary.
The U.S. Food and Drug Administration issued a safety communication in 2011 saying that reports of serious complications in patients using transvaginal mesh devices were not rare, and that it was continuing to monitor the devices.
The case is Albright v. Boston Scientific Corp, Middlesex County Superior Court, Massachusetts, No. 12-909. (Reporting by Jessica Dye in New York; Editing by Ted Botha and Cynthia Osterman)