A division of Johnson & Johnson has agreed to pay $181 million, one of the largest settlements of its kind, to 36 states and the District of Columbia to resolve allegations that the company inappropriately marketed its antipsychotic drugs Risperdal and Invega.
As part of the settlement, state attorneys general said J&J's Janssen Pharmaceuticals division has agreed not to provide samples of the drugs to healthcare providers whose work is inconsistent with uses of the drugs approved by the Food and Drug Administration, and to have questions about the drugs from healthcare providers answered by its scientifically trained staff instead of marketing personnel.
The company said in a statement
that it did not admit wrong-doing in settling the multistate litigation.
“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,” Janssen President Michael Yang said in a statement.
The states' lawsuit, which was unsealed and then settled Thursday, accused the company of using unfair and deceptive practices to market Risperdal and Invega to doctors who treat patients with Alzheimer's disease, dementia, depression and anxiety, though the FDA had not approved the drug to treat those conditions.
“This landmark settlement holds Janssen accountable for its actions and sends a message to all pharmaceutical companies that these practices will not be tolerated,” says a statement from Florida Attorney General Pam Bondi
, whose state led the investigation and negotiations with the company.
The settlement does not affect three other ongoing False Claims Act cases that the Justice Department is investigating regarding marketing, pricing and sales of Risperdal and other drugs.
The company reported in filings with the Securities and Exchange Commission
on Aug. 2 that it had reached an agreement in principle with the Justice Department to settle those cases. People familiar with those negotiations
said in June that the company could pay as much as $2.2 billion to settle its Risperdal cases.