Arkansas Attorney General Leslie Rutledge today announced a settlement of $798,453 from C.R. Bard, Inc. and its parent company Becton, Dickinson and Company for complications experienced by multiple Arkansas women.
In total, the settlement brings $60 million to 48 states and the District of Colombia for the deceptive marketing of transvaginal surgical mesh devices.
The settlement stems from women who suffered serious complications as a result of faulty 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.
“Arkansas women have been deceived by what they believed were safe products by C.R Bard, Inc. and have experienced physical and emotional pain due to this oversight,” said Attorney General Rutledge. “Women should be able to trust the medical products being used on their bodies and know their health and wellness will not be compromised.”
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. 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 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 sponsorship in clinical studies, clinical data, or preclinical data for publication.
-Require consultants to agree to disclose in any public presentation or submission for publication Bard’s sponsorship.
-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.
Joining Arkansas in this multistate settlement are Alabama, Alaska, Arizona, 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, 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.
