Johnson & Johnson will pay $181 million to resolve claims by 36 states, including New York, that it improperly marketed and advertised the antipsychotic drugs Risperdal and Invega.
J&J and its Janssen unit settled claims that it promoted the drugs from 1998 through 2004 for uses not approved by the Food and Drug Administration. New York Attorney General Eric Schneiderman said Thursday the accord is the largest multistate consumer protection pharmaceutical settlement.
"This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules," Schneiderman said in a statement.
J&J agreed it won't promote the drugs for off-label uses or make false claims about them. The company said Aug. 2 that it separately agreed in principle to settle three False Claims Act lawsuits. They involve Medicaid-related claims for Risperdal, Invega and the heart-failure drug Natrecor, as well as kickback allegations involving Omnicare Inc. J&J will pay as much as $2.2 billion, according to people familiar with the matter.
The company, based in New Brunswick, N.J., settled "to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process," it said in a statement.
J&J didn't admit wrongdoing or pay a fine or penalty.
"We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness," Michael Yang, Janssen's president, said in a statement.
The states separately filed lawsuits that made similar claims about how J&J made false and deceptive claims over Risperdal and Invega and promoted them for off-label uses The company promoted Risperdal for Alzheimer's disease, dementia, depression and anxiety, when it wasn't approved for such uses, states claimed.
"Janssen promoted Risperdal for use in children, even though Risperdal has not been established to be safe and effective in children," according to New York's complaint.