C.R. Bard To Pay $60M Over Mesh Lawsuits Filed By 48 States

C.R. Bard To Pay $60M Over Mesh Lawsuits Filed By 48 States

Introduction

Pelvic mesh manufacturer C.R. Bard, a unit of Becton, Dickinson and Company, commonly known as BD, agreed to pay $60 million to resolve lawsuits filed by 48 states and the District of Columbia alleging that the company did not adequately inform women about the side effects related to the surgical mesh devices.

The settlement news was announced by Attorney General Kwame Raoul on September 24 through a press release issued on behalf of a bipartisan coalition of attorneys general. Raoul and the coalition claimed that the manufacturer used deceptive marketing practices to promote its transvaginal mesh products and mislead or failed to adequately disclose serious health risks associated with the implant, which includes the risk of chronic pain, scarring, infections, erosion of the mesh through the vaginal walls, and other complications. The company denied admitting any wrongdoing but agreed to make a settlement.

C.R. Bard has stopped selling its transvaginal mesh products, and if the company wants to re-enter the market, it would have to adhere to certain injunctive terms. As per terms of the settlement, the company is also 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 that includes risk information.
• Disclose sponsorship in clinical studies, clinical data, or pre-clinical data, being published.
• Comply with disclosure requirements before citing any clinical study, clinical data, or pre-clinical data regarding mesh.
• 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.

Illinois will receive more than $1.64 million from the settlement deal. The other participating states include Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, 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.