Boston Scientific Settles More than 370 Transvaginal Mesh Lawsuits

Published on January 8, 2018 by Sandy Liebhard

Boston Scientific has agreed to settle around 378 transvaginal mesh lawsuits, according to court papers released last month in the U.S. District Court, Southern District of West Virginia.

Joint motions seeking dismissal of the claims – which had been in litigation for about 5 years — were filed by the company and plaintiffs on December 13, 2017. The motions were granted the following day.

Details of the transvaginal mesh settlements have not been disclosed.

Boston Scientific Transvaginal Mesh Settlements

Boston Scientific is just one of several medical device manufacturers who have been accused of marketing defective vaginal mesh to treat women suffering from pelvic organ prolapse and stress urinary incontinence. A number of cases involving the company’s implants have gone to trial in state and federal courts around the country, with various juries rendering verdicts for plaintiffs and defendants.

Boston Scientific announced its first transvaginal mesh settlement in April 2015, when it agreed to resolve 2,970 cases for about $119 million. At the time, the company was facing more than 25,000 vaginal mesh lawsuits nationwide. In a recent filing with the U.S. Securities and Exchange Commission, Boston Scientific acknowledged that it had been named a defendant in approximately 48,500 product liability claims involving its transvaginal mesh devices.

“As of October 25, 2017, we have entered into master settlement agreements in principle or are in final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 44,000 cases and claims,” the filing stated. “These master settlement agreements provide that the settlement and distribution of settlement funds to participating claimants are conditional upon, among other things, achieving minimum required claimant participation thresholds. Of the approximately 44,000 cases and claims, approximately 15,500 have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.”

Transvaginal Mesh Litigation

The litigation surrounding transvaginal mesh began to gain momentum in 2008, after the U.S. Food & Drug Administration (FDA) began investigating an increasing number of reports linking the products to serious and life-changing complications. In July 2011, the agency warned that transvaginal mesh complications associated with prolapse repair were not rare, a change from its previous position on the issue.

In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. This program allows devices to come to market without the benefit of human clinical trials as long as a manufacturer can show that the new product is “substantially equivalent” to a device that was already subject to the agency’s more stringent premarket approval process.

Other medical device makers involved in the massive transvaginal mesh litigation include Johnson & Johnson’s Ethicon, Inc. subsidiary, American Medical Systems, Inc., C.R. Bard, Inc., Coloplast Corp. and Cook Medical, Inc. Of 31 cases that have gone to trial nationwide, 22 have produced plaintiffs’ verdicts in excess of $1 million. While a large percentage of claims have been settled, thousands of transvaginal mesh lawsuits remain to be litigated.

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