NJ Pharmaceutical Company Agrees To $181 Million Settlement To Resolve Off-Label Marketing Allegations

New Jersey Attorney General Jeffrey S. Chiesa

New Jersey Attorney General Jeffrey S. Chiesa

TRENTON – New Jersey will receive more than $5.3 million as a result of its participation in a national settlement with Janssen Pharmaceuticals, Inc., a Mercer County-based subsidiary of Johnson & Johnson, that resolves allegations the company engaged in off-label marketing of antipsychotic drugs, Attorney General Jeffrey S. Chiesa announced today.

According to Chiesa, a total of 37 states including New Jersey have reached a record $181 million dollar settlement with Janssen over the company’s alleged improper marketing of antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

A Complaint, filed today along with a Final Consent Judgment in Superior Court in Mercer County, alleges that Janssen violated the state’s Consumer Fraud Act by engaging in unconscionable commercial practices, deception, false promises and misrepresentations when it marketed Risperdal for unapproved or off-label uses. Risperdal is among a class of drugs known as atypical or second generation antipsychotics. Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses.

The Complaint filed today 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.

Following an extensive, four-year investigation by the participating states, the Titusville-based Janssen has agreed to change not only how it promotes and markets its atypical antipsychotics, but also has agreed to refrain from any false, misleading or deceptive promotion of the drugs.

“This settlement is important to protecting New Jersey consumers because it calls for patients and health care providers to have access to clearer and more objective information about the drugs at issue,” said Chiesa. “It also requires that scientifically-trained professionals — not people whose expertise is marketing and sales — take the lead in generating that information.”

In addition to the record-setting payout by Janssen, the settlement announced today addresses specific concerns identified through the multi-state investigation. The settlement, memorialized in the Final Consent Judgment, restricts Janssen from promoting its atypical antipsychotic drugs for off-label uses that the U.S. Food and Drug Administration has not approved.

In addition, 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;
  • Will 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;
  • 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.

Florida led the multi-state investigation into Janssen’s marketing and promotional practices. In addition to New Jersey, the following states and the District of Columbia also participated: Alabama, Arizona, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.

Deputy Attorney General Lorraine K. Rak, Chief of the Division of Law’s Consumer Fraud Prosecution Section, handled the matter on behalf of the State.

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