Attorney General Ford, 48 States Announce $60 Million Settlement With C.R. Bard for Deceptive Marketing of Surgical Mesh Devices


September 24, 2020

Carson City, NV – Today, Nevada Attorney General Aaron D. Ford announced a $60 million bipartisan, multistate settlement with C.R. Bard, Inc. and its parent company Becton, Dickinson and Company. In addition to providing financial relief to impacted states, C.R. Bard and Becton, Dickinson and Company are required to abide by certain terms if they reenter the transvaginal mesh market. Nevada’s share of the settlement is $803,620. 

Today’s settlement results from allegations that C.R. Bard misrepresented or failed to adequately disclose to women the serious and life-altering risks of surgical mesh devices, such as chronic pain, scarring and shrinking of bodily tissue, painful sexual relations, and recurring infections, among other complications. 

“When making important decisions about their healthcare, patients must be fully informed of all of the risks,” saidAG Ford. “My office helps protect Nevadans by holding companies accountable for failing to disclose risks and complications of products.”

Surgical mesh is a synthetic knitted or woven fabric that is permanently implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. These are common conditions faced by women because of a weakening in their pelvic floor muscles caused by childbirth, age and other factors. 

This settlement follows an October 2019 multistate settlement with Johnson & Johnson and its subsidiary Ethicon Inc. to pay nearly $117 million for their deceptive marketing of transvaginal surgical mesh devices.   

Today’s multistate effort was prompted after women throughout the nation who were implanted with surgical mesh made claims that they suffered serious complications resulting from these devices, including erosion of mesh through organs, pain during sexual intercourse and voiding dysfunction.

Under the terms of the settlement, the companies are required to:

Provide patients with understandable descriptions of complications in marketing materials;

Include a list of certain complications in all marketing materials that address complications;

Disclose complications related to the use of mesh in any training provided that includes risk information;

Disclose sponsorship in clinical studies, clinical data or preclinical data for publication;

Refrain from citing to any clinical study, clinical data, or preclinical data regarding mesh, for which the company has not complied with the disclosure requirements;

Require consultants to agree to disclose in any public presentation or submission for publication Bard’s sponsorship of the contracted for activity;

Register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov;

Train independent contractors, agents, and employees who sell, market, or promote mesh, regarding their obligations to report all patient complaints and adverse events to the company; and

Ensure that its practices regarding the reporting of patient complaints are consistent with FDA requirements.

Joining Nevada in this multistate settlement are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington and Wisconsin.

The settlement agreement is attached

 

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