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Attorney General Ellison announces $60M multistate settlement with C.R. Bard

Minnesota joins group of 48 states in holding C.R. Bard accountable for misrepresenting the risks of its surgical mesh products; C.R. Bard to pay Minnesota over $1 million

 

September 28, 2020



September 25, 2020 (SAINT PAUL) — Minnesota Attorney General Keith Ellison today announced a $60 million multistate settlement with C.R. Bard, Inc. and its parent company Becton, Dickinson and Company over allegations that C.R. Bard deceptively marketed its transvaginal surgical mesh devices, which harmed consumers nationwide.

The settlement, reached between C.R. Bard and the attorneys general of 48 states and the District of Columbia, concludes a multistate investigation into C.R. Bard’s alleged misrepresentations and failure to adequately disclose 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.

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 due to a weakening in their pelvic floor muscles caused by childbirth, age, and other factors.

Thousands of women implanted with surgical mesh have made claims that they suffered serious complications resulting from these devices, including erosion of mesh through organs, pain during sexual intercourse, and voiding dysfunction. Although use of surgical mesh involves the risk of these serious complications and is not proven to be more effective than traditional tissue repair, millions of women were implanted with these devices.

“All Minnesotans should be able to trust that the medical procedures they undergo are safe and reliable. That is basic to affording your life and living with dignity, safety, and respect. But C.R. Bard falsely touted the safety of its surgical mesh products despite the severe risks these products presented,” Attorney General Ellison said. “By reforming C.R. Bard’s practices and holding the company accountable for its misconduct, this settlement is a win for Minnesotans.”

C.R. Bard and its parent company, Becton, Dickinson and Company, have agreed to pay $60 million to the 48 participating states and the District of Columbia. Minnesota’s share of the settlement is approximately $1,016,000. Although C.R. Bard stopped selling transvaginal mesh, the settlement provides injunctive relief, requiring both C.R. Bard and Becton, Dickinson and Company to adhere to certain injunctive terms if they reenter the transvaginal mesh market.

Under the terms of the consent judgment, which will be filed with the Ramsey County District Court, the companies have agreed to strong injunctive relief if they reenter the market, including:

• 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.

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

Attorney General Ellison encourages consumers who have been implanted with a transvaginal surgical mesh device and have questions about this settlement to contact the Minnesota Attorney General’s Office by calling (651) 296-3353 (Metro area) or (800) 657-3787 (Greater Minnesota), or by submitting the complaint form on the Attorney General’s website.

In addition to Minnesota, the multistate group is comprised of 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, Mississippi, Missouri, Montana, Nebraska, Nevada, 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.

 

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