Boston Scientific Faces First Federal Transvaginal Mesh Trials

This week Boston Scientific Corp. begins two federal trials over claims from women who say they were injured by the company’s transvaginal mesh devices.

A Charleston, West Virginia, trial includes four women who brought suit over the company’s Obtryx device, used to treat stress urinary incontinence, while a Miami trial involves women implanted with the Pinnacle device, which treats pelvic organ prolapse. Reuters reports that Boston Scientific has been hit with more than 23,000 suits in state and federal courts since public concerns over the devices were first raised six years ago. Federal cases against Boston Scientific and six other companies have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

Plaintiffs in the cases say the devices – poorly designed and made from inferior materials – have led to injuries including pain, bleeding, mesh erosion through the vagina, pain during sexual intercourse, organ perforation, and urinary problems. In April, the Food and Drug Administration (FDA) said it was considering requiring the makers of products used to treat pelvic organ prolapse to submit additional safety data to remain on the market.

Judge Goodwin is committed to speeding the progress of the cases so that this litigation does not drag on for years, as has litigation for asbestos and tobacco. Goodwin has ordered Boston Scientific and C.R. Bard each to prepare hundreds of cases for trial across the country starting as early as next year, Reuters reports. Goodwin originally scheduled a series of trials with individual plaintiff to serve as bellwether trials in the federal litigation, but he abandoned those plans earlier this year, and instead consolidated multiple claims into a single trial, Reuters reports.  This will save time and court resources and Goodwin hopes this approach may facilitate a settlement by giving both sides a clearer picture of the strengths and weaknesses of their cases.

It is unusual for medical device cases to involve more than one plaintiff at a time, given the differences in individuals’ medical histories and their experiences with the device, according to Reuters. But an attorney who has represented plaintiffs in mesh trials against Boston Scientific and Ethicon said the outcome from the group trials could help Boston Scientific and plaintiffs move closer to a resolution.



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