Pelvic Mesh Company to Pay $60 Million Over Deceptive Marketing
Becton, Dickenson and Company (BD), a New Jersey medical device manufacturing outfit, agreed to pay $60 million in a settlement to resolve allegations of deceptive marketing tactics including minimizing serious risks related to the company’s now-discontinued transvaginal pelvic mesh devices. The settlement comes after attorneys general of 48 U.S. states, in addition to Washington, D.C., alleged that the company’s CR Bard unit intentionally concealed known risks associated with the pelvic mesh devices.
Court documents reveal the New York Attorney General, Letitia James, stated CR Bard misrepresented or failed to disclose numerous risks associated with their pelvic mesh devices. Such risks, according to the court filings, included chronic pain, vaginal scarring, pain during sexual intercourse, infection, and inflammation. The devices contained synthetic, multi-strand, knitted, or woven mesh intended to be implanted in the pelvic floor. The devices were designed to treat stress urinary incontinence or pelvic organ prolapse, which are both common, non-life-threatening conditions.
Under the terms of the settlement, CR Bard will pay $60 million to the 48 states and the District of Columbia. Wyoming and Georgia are the only states to not have participated in the case, filed yesterday in California state court.
California Attorney General, Xavier Becerra, and Washington state Attorney General, Bob Ferguson, issued a statement Thursday indicating that CR Bard concealed or misled women regarding several potential life-altering risks and other serious medical complications associated with the mesh devices.
“Women should be able to trust that the health products they use are safe,” Becerra said. “Misleading patients and neglecting to disclose risks or side effects of medical products is dangerous, irresponsible, even deadly. Bard was caught engaging in these shameful practices, and for that, they now pay.”
The U.S. Food and Drug Administration (FDA) issued multiple notices concerning the safety of the devices over the course of several years. In 2016, the government agency reclassified the transvaginal devices as “high risk.”
CR Bard discontinued selling the devices in the U.S. in 2016, one year prior to Becton Dickinson acquiring the company for a reported $25 billion. In a public statement, New York Attorney General, Leticia James, said, “While CR Bard was putting income before the health of customers in need of care, women were put in danger.”
Though all wrongdoing has been denied, the company indicated the significant settlement offer was agreed upon in an effort to avoid the time and expense that would’ve been required throughout further litigation. Moreover, the company indicated it has reserved all necessary funds that will go towards the damages awards. Becton Dickenson also issued a statement declaring that they fully comply with all state and federal laws governing the medical products produced by the company.
“Ensuring the safety and quality of our products has always been the top priority at BD,” the company said. “In addition, BD fully complies with all laws and regulations for the medical products the company manufactures, markets, and distributes.”
Approximately 575 product liability claims related to the faulty pelvic mesh devices have been filed as of June 30.
California’s complaint said that CR Bard failed to disclose that complications from its pelvic mesh devices could be permanent even after surgical intervention.
“CR Bard’s surgical mesh products are intended to be permanent implants and were designed for integration into the body and tissue ingrowth, making them difficult, if not impossible, to surgically remove,” the state said in the complaint. “CR Bard misrepresented or failed to disclose that removal of one or more of its surgical mesh devices may not be possible, and that additional surgeries may not resolve complications.”
In the complaint the state also alleged that Bard actually attempted to misdirect responsibility for the presented risks by contending they were the result of doctor error or surgical technique.
“Thousands of women implanted with surgical mesh have suffered serious complications resulting from these devices,” the state said.