By Susan Engstrom
The settlement resolves claims that the company failed to disclose the risks and side-effects of the device.
Medical device manufacturer C.R. Bard, Inc. (Bard) and its parent company, Becton, Dickinson and Company (BD), have entered into a settlement agreement with 48 states and the District of Columbia to resolve allegations that Bard deceptively marketed trans vaginal surgical mesh devices to patients (California Attorney General Press Release, September 24, 2020).
Surgical mesh is a synthetic woven fabric that is 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 age, childbirth, and other factors.
According to California Attorney General Xavier Becerra, Bard misled patients and neglected to disclose the risks and/or side-effects of its mesh products, such as chronic pain, scarring, shrinking of body tissue, pain during sexual relations, and recurring infections. As a result, thousands of women who were implanted with the device have suffered serious complications, Becerra asserted.
Settlement terms. Bard stopped selling and promoting its surgical mesh products in the United States by December 31, 2016. Under the terms of the settlement, Bard and BD will be subject to several injunctive terms if they re-enter the domestic surgical mesh market. Among other things, the companies will be required to:
- Disclose complications related to the use of mesh in any training that includes risk information;
- Ensure that their practices regarding the reporting of patient complaints of adverse events are consistent with the Food and Drug Administration’s requirements for Medical Device Reporting;
- Include descriptions of complications in terms reasonably understandable to a patient in marketing materials that are intended to reach patients or consumers;
- Include a list of complications in all marketing materials that address the subject of complications;
- Adequately inform and 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;
- Disclose sponsorship or any potential conflicts of interest 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 Bard 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; and
- Register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
Participating states. The investigation that resulted in the settlement was led by California and Washington along with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas. Joining this multi state settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.
Allocation of funds. The $60-million settlement will be divided among the participating states and the District of Columbia, with California receiving $5.02 million. Several other attorneys general also issued press releases reporting their jurisdiction’s share of the total. Florida, for example, will receive $2.9 million; Illinois, $1.64 million; Michigan, $1.37 million; Missouri, $1 million; New Jersey, $1.28 million; and Virginia, $1.25 million.
BD statement. BD released the following statement in response to the settlement: "Ensuring the safety and quality of our products has always been the top priority at BD. In addition, BD fully complies with all laws and regulations for the medical products the company manufactures, markets and distributes. Bard and BD have denied any wrongdoing and all allegations included in the litigation and chose to settle the matter to avoid the time and expense of further litigation."
Companies: C.R. Bard, Inc.; Becton, Dickinson and Company
MainStory: TopStory SettlementAgreementsNews MedicalDevicesNews
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