Franklin Lakes-based company C.R. Bard, a medical technology company, will pay the State of New Jersey more than $1.28 million as part of a settlement resolving a multi-state investigation of the company for allegedly misrepresenting the safety and effectiveness of surgical mesh products. The total settlement payment of $60 million is being divided among 48 States and the District of Columbia. Bard and its parent company, Becton Dickinson, also agreed to restrictions on future marketing practices.
“Healthcare companies have a duty to avoid making unfounded or misleading claims about their products, and a duty to make required discloses about their risks,” said Attorney General Gurbir Grewal. “Our ability to trust that medical products are safe depends on companies living up to those responsibilities. When companies fail to meet their fundamental obligations, we will take action to protect New Jersey consumers and hold them accountable.”
The investigation that led to the settlement centered on allegations that Bard violated state consumer protection laws by making misleading claims about, and failing to disclose the risks associated with, a surgical mesh product used to treat women who suffer from conditions known as stress urinary incontinence and pelvic organ prolapse. These conditions can occur when the pelvic musculature becomes weakened — often in the aftermath of childbirth or surgery — causing the pelvic organs to become displaced and causing discomfort, as well as other problems. In cases where treatment involves the use of surgical mesh, the mesh product is implanted transvaginally to support weakened pelvic organs. Potentially serious and life-altering complications from the implantation of surgical mesh have included the erosion of the mesh device through organs, the distortion of sexual organs, chronic pain, painful sexual intercourse, and recurring infections. Bard allegedly knew women who underwent such implants could potentially experience such complications but did not fully provide that information to consumers or to surgeons who implanted the mesh.
The sale and promotion of Bard’s surgical mesh products in the U.S. was ceased by the end of 2016. The settlement announced Thursday puts restrictions on Bard if the company chooses to reenter the domestic surgical mesh market. The terms will be effective for 10 years from the date of Bard’s first sale of surgical mesh after its reentry to the market, or until 20 years from the effective date of the agreement, whichever is earlier. Among other requirements, Bard will be required to include descriptions of complications in terms reasonably understandable to a patient in marketing materials that are intended to reach patients or consumers.
Bard is the second company to enter into a settlement with New Jersey and other States concerning misleading claims and failure to disclose risks and complications associated with surgical mesh. In October of 2019, Johnson & Johnson entered into a multi-state settlement to resolve similar allegations about misrepresentations of the safety and effectiveness of surgical mesh marketed by its subsidiary Ethicon, Inc. Under that settlement, Johnson & Johnson agreed to pay the State of New Jersey more than $3 million and to comply with similar terms. States participating in that lawsuit divided a total settlement payment by Johnson & Johnson of $116.9 million.