$2.2 Billion Settlement To Resolve Allegations. According to a press release issued by the Department of Justice Office of Public Affairs, Johnson & Johnson and its subsidiaries will pay $2.2 billion to resolve criminal and civil allegations involving the drugs Risperdal, Invega and Natrecor.
Civil settlements with state and federal governments total $1.72 billion while criminal and forfeiture total $485 million, making it one of the largest health care fraud settlements in US history, the release states.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” Attorney General Eric Holder said in the release.
“This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
According to the release, the government alleged that J&J subsidiary Janssen Pharmaceuticals marketed the antipsychotic drug Risperdal for off-label, or unapproved uses, from March 3, 2002 through December 1, 2003. For the majority of this time period, the U.S. Food and Drug Administration (FDA) had only approved Risperdal to treat schizophrenia.
Allegedly, Janssen misbranded the drug by having sales representatives market it for anxiety, agitation, depression, hostility and confusion. The government accused Janssen of offering incentives for the off-label use of Risperdal.
Janssen pled guilty to marketing Risperdal for psychotic symptoms
Janssen pled guilty to marketing Risperdal for psychotic symptoms and behavioral issues in elderly dementia patients who did not have schizophrenia. The subsidiary will pay a total of $400 million; this includes a $334 million criminal fine and forfeiture of $66 million.
J&J and Janssen agreed to pay a total of $1.391 billion to settle allegations that it submitted false claims to federal health care programs through off-label marketing of Risperdal and Invega, a newer antipsychotic medication that was only approved to treat schizophrenia and schizoaffective disorder. Janssen marketed Invega for off-label uses between 2006 and 2009, the government alleges.
The government alleged in its complaint that Janssen marketed Risperdal as safe and effective for the elderly despite repeated warnings from the FDA, who cautioned that behavioral disturbances in the older population is not necessary an indication of psychotic disorders.
The companies also knowingly downplayed the risk of diabetes associated with Risperdal, the government alleged.
The civil settlements resolve allegations stemming from whistleblower lawsuits filed under the qui tam provision of the False Claims Act.
This act allows individuals to sue on behalf of the government if they have knowledge of fraud or wrongdoing; in successful cases, the whistleblowers are entitled to a portion of the funds recovered.