Attorney General Gurbir Grewal announced on Thursday that Johnson & Johnson will pay the state more than $3 million as part of a multi-state settlement that resolves allegations Johnson & Johnson misrepresented the safety and effectiveness of a surgical mesh product marketed by its subsidiary Ethicon Inc.
In addition to New Jersey, Grewal said that the settlement involves 40 other states and the District of Columbia. The participating jurisdictions are dividing a total settlement payment by Johnson & Johnson of $116.9 million.
The investigation that led to the settlement centered on allegations Johnson & Johnson 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, according to Grewal.
“All manufacturers and sellers of health care products have duties to avoid making unfounded or misleading claims, and to make required disclosures about the risks,” said Grewal. “When they fail to meet their obligations, we will step in to protect New Jersey consumers and to hold the companies accountable.”
In addition to the settlement payout, Johnson & Johnson and its subsidiary, Ethicon, have agreed to make a number of changes in how they market surgical mesh products and inform health care providers and consumers of the risks.
Under the agreement, Ethicon must comply with the injunctive terms for a five-year period, although revisions to its “Information for Use” package inserts are subject to review by the federal Food and Drug Administration. Given the FDA review requirement, the company has been given 24 months to revise the inserts.