Johnson & Johnson and its Ethicon division have reached a deal with the attorneys general of 41 states and the District of Columbia, agreeing to settle claims that it deceptively advertised and marketed its transvaginal mesh products. The companies will pay nearly $117 million.
The attorneys general said that a multistate investigation found J&J and Ethicon had “misrepresented or failed to adequately disclose possible adverse effects” to patients and surgeons, and that they were aware of the risks of serious complications from the implants.
Synthetic transvaginal mesh has been used to provide extra support to the pelvic organs of women, to help repair prolapses or to treat stress urinary incontinence. The implants can erode and fray within the body, causing inflammation, pain and infections.
Ethicon was previously ordered by a Philadelphia jury in May to pay $80 million to a woman who suffered complications following a 2008 procedure, including $50 million in punitive damages related to J&J’s descriptions of the product’s risks. A month before in a separate but similar finding, a Philadelphia court issued a woman a $120 million verdict; J&J said it planned to appeal in both cases.
The latest, multistate settlement requires that J&J and Ethicon fully disclose the risks of the mesh products, including that revision surgeries may be necessary to treat future complications, and they must ensure that the training provided to healthcare professionals covers those risks.
Additionally, the companies can no longer claim the mesh stretches or remains soft after implantation—or that “foreign body reactions ‘may’ occur, when studies show that they do, in fact, occur,” as well as that those reactions are temporary, according to the New York state attorney general’s office.
The settlement also tells the companies to refrain from referring to products as FDA approved when that is not the case and to stop claims that the mesh’s risks can be eliminated through surgical experience or technique.
The companies’ $116.9 million payment will be divvied up among the states in different amounts, while the settlement includes no admissions of liability or misconduct. Lawsuits brought by other states are still pending, including California’s, as are suits from thousands of individual women.
J&J and Ethicon previously halted its sales of transvaginal mesh in 2012. Earlier this year, the FDA ordered the two remaining U.S. manufacturers, Boston Scientific and Coloplast, to stop selling and distributing their products nationwide.
In April, the agency said it determined that the mesh was not proven safe and effective for treating pelvic organ prolapse, following their reclassification as higher-risk, Class III devices in 2016.
The devicemakers were required to submit new premarket approval applications, including clinical data evaluating whether the implants were better after three years than repair procedures using native tissue.
The FDA said the evidence was lacking, and though it was not a full-fledged recall, the two companies had to come up with plans to withdraw their products from the market.