NEW YORK (Reuters) - Becton Dickinson and Co agreed to pay $60 million to resolve allegations by the attorneys general of 48 U.S. states and Washington D.C. that its CR Bard unit concealed the risks of its now-discontinued transvaginal pelvic mesh devices.
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, pain during intercourse, 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 several notices about the devices’ safety, and in 2016 reclassified transvaginal pelvic organ prolapse devices as “high risk.”
CR Bard stopped selling the devices in the United States in 2016, one year before it was acquired by Becton Dickinson for about $25 billion.
“While CR Bard was putting income before the health of customers in need of care, women were put in danger,” James said in a statement.
Becton Dickinson is based in Franklin Lakes, New Jersey.
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 governing its medical products.
According to a regulatory filing, Becton Dickinson was defending against approximately 575 product liability claims involving its pelvic mesh devices as of June 30.
Reporting by Jonathan Stempel in New York; Editing by Steve Orlofsky, Bill Berkrot and Tom Brown
Our Standards: The Thomson Reuters Trust Principles.