October 2, 2020
Forty-eight states, including Utah, have reached a $60 million multistate settlement with C.R. Bard, Inc and its parent company Becton, Dickinson and Company over allegations that Bard downplayed the risk of its transvaginal surgical mesh devices, which harmed consumers nationwide.
This settlement concludes a multistate investigation into C.R. Bard for allegedly misrepresenting and failing to disclose serious and life-altering risks of surgical mesh devices such as chronic pain, scarring and shrinking of bodily tissue, recurring infections, and other complications.
Thousands of women implanted with surgical mesh have made claims that they suffered complications resulting from these devices such as 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.
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. In addition, the companies have agreed 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.
- Ensure that its practices regarding the reporting of patient complaints are consistent with FDA requirements.
In addition to Utah, 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.