Attorney General Chris Koster and 37 other Attorneys General have reached a $181 million settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson, in one of the largest multi-state consumer protection settlements with a pharmaceutical company. Koster’s office said in a press release that the state of Missouri will receive more than $4.3 million from the settlement.
The settlement resolves allegations 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.
Koster said Janssen marketed Risperdal for uses for which the FDA had denied approval. He said that the company sought to increase off-label sales for the drug to treat children despite its knowledge of increased incidence of serious side effects, such as significant weight gain and movement disorders. The company also actively marketed the drug to treat dementia in the elderly, despite the fact that the FDA denied a dementia indication because a company-sponsored study found that patients taking Risperdal had a higher risk of death than those taking a placebo. In addition, Janssen conducted numerous studies on off-label uses of Risperdal that failed to follow proper methodology. Janssen then widely promoted the positive results of these studies, while failing to publish the negative results.
“Our health system does not work properly when drug manufacturers knowingly conceal the ineffectiveness or risks of drugs,” Koster said. “My office will continue to hold pharmaceutical companies accountable for misleading consumers. We will make them change their unlawful business practices when we discover they have cut corners or cheated the system.”
After an extensive four-year investigation, Janssen has agreed to change not only how it promotes and markets its atypical antipsychotics but also to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the significant payment, the settlement 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 the specific risks identified with the drugs in promotional materials;
- Present information about effectiveness and risk in a balanced manner in its promotional materials;
- Require its scientifically trained personnel, rather than 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;
- 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;
- Contractually require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and
- Have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.