Boston Scientific wins first vaginal mesh case to go to trial

Boston Scientific ($BSX) scored a victory in its ongoing transvaginal mesh saga, winning the first case to go to trial in Massachusetts state court.

A jury found that the company was not responsible for injuries sustained by Diane Albright, a patient who claimed that Boston Scientific's Pinnacle transvaginal mesh implant was faulty and caused complications such as pain, bleeding, and incontinence, Bloomberg reports. Massachusetts jurors also rejected Albright's claim that company officials failed to warn her about risks associated with the device, which treats stress urinary incontinence and pelvic organ prolapse.

"We are pleased with the outcome," Boston Scientific spokeswoman Denise Kaigler told the news outlet in an email. "Patient safety is of the utmost importance to Boston Scientific and we dedicate significant resources to deliver safe, high-quality products."

The Marlborough, MA-based company still faces more than 20,000 lawsuits related to its transvaginal mesh products, including 12,000 cases consolidated before a federal judge in West Virginia and 1,700 cases assigned to a single judge in Massachusetts state court, according to a May 8 regulatory filing. Fidelma Fitzpatrick, Albright's attorney, told Reuters that the next trial in Massachusetts is set for Aug. 11, and the first trial in the federal cases is scheduled for Nov. 3.

Boston Scientific is not the only company embroiled in legal battles over vaginal mesh devices. Devicemakers such as Johnson & Johnson ($JNJ), C.R. Bard ($BCR), Coloplast and Endo Health Solutions ($ENDP) also face lawsuits related to mesh products, although some companies recently resolved outstanding claims. In March, Danish devicemaker Coloplast shelled out $16 million to settle lawsuits claiming it injured women with vaginal-mesh inserts. In May, Endo said it would pay $830 million to settle 20,000 lawsuits, a "substantial majority" of its vaginal mesh-related cases.

Other companies are resisting a global settlement and continue to deal with legal pushback. In February, Johnson & Johnson's Ethicon arm scored a small victory when a federal district judge in Charleston, WV, ruled that the company's pelvic mesh product did not cause injury. But the following month, a Texas jury ordered the devicemaker to pony up $1.2 million in damages to a 64-year-old woman who alleged that the product was defectively designed.

Meanwhile, the FDA continues to weigh in on the product's safety and push for heightened regulatory standards. In 2012, the agency ordered postmarket surveillance studies to address safety and effectiveness concerns. In May, regulators proposed reclassifying vaginal mesh products and subjecting them to a more stringent approval process.

- here's the Bloomberg story
- read more from Reuters
- and here's Boston Scientific's 8-K filing