Risperdal subject of $2.2 billion settlement

NEW YORK (Legal Newsline) - A $2.2 billion multi-state and federal settlement was announced Monday with Johnson & Johnson and Janssen Pharmaceuticals to resolve civil and criminal allegations.

Johnson & Johnson and Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, allegedly promoted the sale and use of Invega and Risperdal for uses not approved by the U.S. Food and Drug Administration. The pharmaceutical manufacturers also allegedly introduced Invega and Risperdal into interstate commerce.

"Parents of children with hyperactivity disorders and other vulnerable patients should be able to trust their doctor's advice without fear that drug companies are manipulating their physician's judgment," New York Attorney General Eric Schneiderman said in a statement. "This settlement should serve as a warning to pharmaceutical corporations: the illegal promotion of drugs for off-label uses must stop. This landmark agreement holds companies accountable for practices that put patients in danger, and reaffirms one set of rules for the pharmaceutical giants-and it goes even further by ensuring that corporations stop rewarding doctors for prescribing certain drugs."

California's share of the national settlement is $89 million, which is the largest recovery ever for California from a national civil settlement regarding atypical antipsychotic drugs.

"Motivated by profit, these companies made false claims that jeopardized the health of California's most vulnerable patients, including children and senior citizens-and left California taxpayers with the bill," California AG Kamala Harris said in a statement. "Today's record settlement reinforces the California Department of Justice's commitment to rooting out this kind of greed wherever we find it."

Illinois will receive nearly $24 million.

"Janssen illegally marketed its drugs to vulnerable patients, including children and seniors, and fraudulently billed the state's Medicaid program for these drugs at taxpayers' expense," Illinois AG Lisa Madigan said.
Invega and Risperdal are anti-psychotic medications approved by the FDA to treat bipolar I disorder and schizophrenia. Johnson & Johnson and Janssen allegedly marketed Risperdal and Invega for off-label uses and made false and misleading statements about the safety and efficacy of the medications. The companies also allegedly paid illegal kickbacks to healthcare professionals and long-term care pharmacies to induce them to prescribe or promote Risperdal to patient populations for which there was no FDA approval, including children.

Under the terms of the settlement, the state of New York will receive $138 million. Johnson & Johnson and Janssen will pay more than $523 million to state Medicaid programs and more than $749 million for federal healthcare programs. The companies will also enter into a corporate integrity agreement with the U.S. Department of Health and Human Services' Office of the Inspector General.

Additionally, Janssen will pay $400 million in criminal fines and forfeitures.

Bryan Cohen contributed to this report.