August 31, 2012
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Johnson & Johnson agreed to pay $181 million in consumer fraud suit

Johnson & Johnson will pay $181 million to 36 states and the District of Columbia to resolve claims that the company’s subsidiary, Janssen Pharmaceuticals Inc., improperly marketed the antipsychotic drug risperidone.

Janssen Pharmaceuticals was accused of promoting off-label uses of risperidone (Risperdal) between 1998 and 2004. Prosecutors said the drug company marketed risperidone for indications that were not approved by the FDA, including treatment of bipolar disorder in children and adolescents, dementia in elderly patients, depression and anxiety. Janssen Pharmaceuticals was also accused of concealing risks associated with the drug and hosting sham consulting programs for physicians to promote off-label uses.

As part of the settlement, Janssen Pharmaceuticals agreed not to mischaracterize the use of risperidone and one of its related drugs, paliperidone (Invega), in the future. The company also agreed not to misrepresent the findings from its clinical trials.

New York Attorney General Eric Schneiderman said the agreement represents the largest multistate consumer protection settlement with a pharmaceutical company. As part of the settlement, New York will receive $9 million.

“This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules,” Schneiderman said in a press release.

Janssen Pharmaceuticals said the settlement was not an admission of wrongdoing or violation of any law or regulation.

“We have chosen this path to achieve a prompt and full resolution of these claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness,” Michael Yang, president of Janssen Pharmaceuticals, said in a statement.

The multistate settlement was unrelated to a larger pending settlement with the US Justice Department, which also involves the sale of risperidone.