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Attorney General DeWine, 36 Attorneys General Reach $181 Million Settlement with Pharmaceutical Company


(COLUMBUS, Ohio) -- In the largest multi-state consumer protection settlement with a pharmaceutical company, Attorney General Mike DeWine announced today that he and 36 other attorneys general reached a record $181 million settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. Attorney General DeWine alleges that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega.

Ohio is set to receive more than $7.8 million from the settlement. The payment will be placed in the Consumer Protection Enforcement Fund to support the Ohio Attorney General's consumer protection efforts.

"Consumers expect that the information they are being given about a product or service is trustworthy, especially when it comes to medication for themselves and their families," said Attorney General DeWine. "That's why this settlement ensuring the proper representation of these drugs is so important."

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.

After an extensive four-year investigation, Janssen agreed to change not only how it promotes and markets its atypical antipsychotic drugs but also 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, presented today to the Court for approval, 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 antipsychotic drugs 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 antipsychotic products;
  • 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.

Media Contacts:

Dan Tierney: 614-466-3840
Mark Moretti: 614-466-3840

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