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August 30, 2012

Miller and 36 Attorneys General Reach Landmark $181 Million Settlement with Janssen Pharmaceuticals

(DES MOINES, Iowa) In the largest multistate consumer protection settlement with a pharmaceutical company, Attorney General Tom Miller and 36 other attorneys general today reached a record $181 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson, after the attorneys general alleged that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

Janssen will pay the state $3,357,633.

District Judge Mary Pat Gunderson approved the settlement, through a consent judgment, filed today in Polk County District Court.  In a petition also filed today, Miller alleged 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 is a significant settlement that sends an important message to the entire pharmaceutical industry.  We cannot and will not tolerate any company improperly marketing its drugs by overstating or misstating their use, their effectiveness or their safety,” Miller said.

After an extensive four-year investigation, Janssen agreed to change how it promotes and markets its atypical antipsychotics, and also agreed to refrain from any false, misleading or deceptive promotion of the drugs.  In addition to the record setting national payment of $181,047,437, 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 petition 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.

“If a pharmaceutical company contends that a product is safe and effective for treating anything other than an FDA-approved use, there are clear federal laws and regulations that set forth a process, and these rules protect the public,” Miller said.  “Cutting corners and bending rules can put people at serious risk.”

In addition to Miller, 35 attorneys general of the following states, plus the District of Columbia, participated in the settlement: Alabama, Arizona, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Indiana, 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.  Florida Attorney General Pam Bondi led the investigation into Janssen’s marketing and promotional practices.

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