Attorney General J.B. Van Hollen and 36 Other Attorneys General Reach a Landmark $200 Million Settlement with Janssen Pharmaceuticals, Inc., a Subsidiary of Johnson & Johnson

Wisconsin's share of the settlement is $4,267,876.

MADISON — Attorney General J.B. Van Hollen announced today that he and 36 other state Attorneys General reached a record $200 million dollar settlement with Janssen Pharmaceuticals, Inc. (a subsidiary of Johnson and Johnson) as part of the largest multi-state consumer protection settlement with a pharmaceutical company to date. Wisconsin's share of the monetary settlement is $4,267,876.

Attorney General Van Hollen alleges that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega. Filed today, the complaint alleges that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for unapproved or off-label uses. Risperdal is among a class of drugs known as atypical or second generation antipsychotics.

“This settlement sends a strong message that the State of Wisconsin will not tolerate the masking, withholding, or failure to disclose negative information contained in scientific studies concerning the safety and efficacy of a drug,” Attorney General Van Hollen said.

After an extensive four-year investigation, Janssen agreed to change how it promotes and markets its atypical antipsychotics, and it agreed to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the record-setting payment, the settlement targets specific concerns identified in the investigation. The settlement agreement restricts Janssen from promoting its atypical antipsychotic drugs for “off-label” uses that the U.S. Food and Drug Administration (“FDA”) has not approved. Additionally, for a five-year period, Janssen:

• Must clearly and conspicuously disclose, in promotional materials for atypical antipsychotic products, the specific risks identified in the black-box warning on its product labels;
• Must present information about effectiveness and risk in a balanced manner in its promotional materials;
• Shall not promote its atypical antipsychotics using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
• Shall require its scientifically trained personnel, rather that its sales and marketing personnel, to develop the medical content of scientific communications to address requests for information from health care providers regarding Janssen's atypical antipsychotics;
• Must refrain from providing samples of its atypical antipsychotics to health care providers whose clinical practices are inconsistent with the FDA-approved labeling of those atypical antipsychotics;
• Must not use grants to promote its atypical antipsychotics nor condition medical education funding on Janssen's approval of speakers or program content;
• Must contractually require medical education providers to disclose Janssen's financial support of their programs and any financial relationship with faculty and speakers; and
• Must have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.

Federal Law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses. The complaint alleges that Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations, targeting patients with Alzheimer's disease, dementia, depression, and anxiety, when these uses were not FDA-approved and for which Janssen had not established that Risperdal was safe and effective.

“Deceptive marketing in the sale of pharmaceuticals is unlawful,” Van Hollen said. “And this action and settlement make clear that Wisconsin will pursue pharmaceutical companies that misrepresent the risks and efficacy of the drugs they market.”

The Attorney General from Florida led the investigation into Janssen's marketing and promotional practices. The Attorneys General of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, 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.

Assistant Attorney General Lara Sutherlin handled the case for the State of Wisconsin.

Please find copies of the Final Judgment and Consent Judgment, and the Summons and Complaint available at the following links: