NEW YORK (Reuters) – Becton Dickinson and Co said on Thursday it has reached a $60 million settlement with the attorneys general of 48 U.S. states and Washington D.C., resolving allegations it concealed the risks of now-discontinued pelvic mesh devices.
The Franklin Lakes, New Jersey-based company said the settlement resolved litigation involving the former CR Bard Inc, which it acquired in 2017.
In related court papers, New York Attorney General Letitia James said CR Bard misrepresented or failed to disclose risks associated with the devices, including chronic pain, vaginal scarring, vaginal shortening, infection and inflammation.
The devices contained synthetic, multi-strand, knitted, or woven mesh intended to be implanted in the pelvic floor to treat stress urinary incontinence or pelvic organ prolapse, which are both common, non-life-threatening conditions.
The U.S. Food and Drug Administration over several years issued multiple notices related to safety of the devices. In 2016, the agency reclassified transvaginal pelvic organ prolapse devices as high risk.
Becton Dickinson denied wrongdoing in agreeing to settle.
The company said it settled to avoid the time and expense of further litigation, has fully reserved for the payout, and complies with all laws and regulations governing its medical products.
James’ office did not immediately respond to a request for comment.
According to a regulatory filing, Becton Dickinson was defending against approximately 575 product liability claims involving its pelvic mesh devices as of June 30.