MADIGAN, 36 ATTORNEYS GENERAL REACH LANDMARK SETTLEMENT WITH JANSSEN PHARMACEUTICALS OVER UNLAWFUL MARKETING OF RISPERDAL
Chicago — Attorney General Lisa Madigan joined 36 other attorneys general to announce the largest multistate consumer protection settlement ever with a pharmaceutical company, Janssen Pharmaceuticals Inc., over its unlawful marketing of the antipsychotic drug Risperdal.
The record $181 million settlement with Janssen, a subsidiary of Johnson & Johnson, alleges the company improperly marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega, all antipsychotic drugs. Illinois will receive $8.3 million under the agreement.
In a complaint filed today, Madigan and the other attorneys general allege Janssen engaged in unfair and deceptive practices when it marketed Risperdal “off-label” for certain treatments and conditions that the U.S. Food and Drug Administration has not approved.
The complaint alleges Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations, targeting patients with Alzheimer’s disease, dementia, depression and anxiety, though those uses were not FDA-approved and for which Janssen had not established that Risperdal was safe and effective.
“Janssen falsely marketed this drug to extremely vulnerable patients in spite of any recognized medical evidence that the drug would be safe or effective for individuals with these conditions,” Madigan said.
Following an extensive, four-year investigation, Janssen agreed to change not only how it promotes and markets its antipsychotics but also agreed to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the record-setting payment to the states, the settlement addresses specific concerns identified in the investigation, including restricting Janssen from promoting its antipsychotic drugs for off-label uses.
Additionally, over a five-year period, Janssen must:
Joining Madigan in today’s settlement were attorneys general from: Alabama, Arizona, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.