Dive Brief:

• BD will pay $60 million to settle widespread multistate litigation alleging that subsidiary C.R. Bard deceptively marketed transvaginal surgical mesh devices to patients. The company denied any wrongdoing, per a statement.
• The Bard implants were no longer being sold in the U.S. when they came under BD's purview via its $24 billion acquisition of the company in 2017. The discontinued devices were intended to treat pelvic organ prolapse and stress urinary incontinence but were linked to serious complications. FDA last year ordered all remaining versions of the devices in the U.S. off the market.
• The District of Columbia and every U.S. state besides West Virginia and Wyoming are part of the settlement. The effort was led primarily by attorney general offices in California and Washington. Both of those states have reached settlements in the last year with Johnson & Johnson regarding deceptive marketing of similar products.

Dive Insight:

Implantation of pelvic mesh products has become less and less common in recent years amid concerns over safety. Many companies opted to leave the market once FDA in 2016 reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into a higher-risk, more burdensome category requiring premarket approval. Bard stopped selling the devices in the U.S. at the end of that year and followed suit in the EU early last year.

By the time FDA held an advisory committee hearing on the devices' risks and benefits in 2019, and subsequently decided that all remaining versions of the product should be removed from the market, only Danish medtech Coloplast and Boston Scientific were affected.

Litigation tied to years of harm from the devices has continued to work its way through the courts. Ethicon owner J&J has been on the receiving end of much state litigation, paying nearly $10 million to settle with Washington last April, $117 million to settle with 41 states last October, $344 million to settle with California in January, and $4 million to settle with West Virginia in May (a sum that also covered hip replacement systems). Oregon levied its own case against J&J last December.

Boston Scientific reported in its most recent quarterly filing that for over 96% of the 54,000 product liability cases or claims asserted against the company related to transvaginal surgical mesh products the medtech had entered into master settlement agreements or were very close to doing so.