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AG Nessel Announces $60M Multistate Settlement with Surgical Mesh Provider CR Bard
September 24, 2020
LANSING – Attorney General Dana Nessel today announced that Michigan is to receive more than $1.37 million following a multistate settlement with C.R. Bard Inc. and its parent company Becton, Dickinson and Co. for the deceptive marketing of transvaginal surgical mesh devices. The full settlement requires the companies to pay a total of $60 million to all 48 participating states and the District of Columbia.
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.
Compensation is being provided to victims through private litigation. 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.
The attorneys general allege that C.R. Bard misrepresented or failed 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.
“Companies that fail to accurately represent their products to consumers are violating our laws, and some are potentially putting the health of their clients at risk, as was the case with C.R. Bard,” Nessel said. “The dangers associated with the surgical mesh product were not clearly communicated to the millions of women who used it and suffered from complications as a result. We must hold accountable businesses that fail to disclose crucial information to the public, and that’s what this settlement achieves.”
In a separate effort, Attorney General Nessel’s office last year secured nearly $3.27 million for the state in a previous settlement with Johnson & Johnson and its subsidiary Ethicon Inc. to resolve allegations that those entities also conducted deceptive marketing of transvaginal surgical mesh devices.
C.R. Bard and its parent company, Becton, Dickinson and Co., have agreed to pay $60 million to the 48 participating states and the District of Columbia. Although C.R. Bard stopped selling transvaginal mesh, the settlement provides injunctive relief, requiring both C.R. Bard and its parent company to adhere to certain injunctive terms if they reenter the transvaginal mesh market.
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 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 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 Food and Drug Administration requirements.
Joining Michigan 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, Minnesota, 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.