Coakley alleges Janssen illegally marketed drug
By Jessica M. Karmasek – LegalNewsLine.com
August 2, 2011
BOSTON (Legal Newsline) — Drug manufacturer Ortho-McNeil-Janssen is being sued by Attorney General Martha Coakley for illegally marketing Risperdal, an atypical antipsychotic medication.
Coakley’s lawsuit alleges that Janssen promoted the drug to treat elderly dementia and a number of uses in children and adolescents when these uses had not been shown to be safe and effective and had not been approved by the U.S. Food and Drug Administration.
The complaint, filed this week in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.
“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Coakley said in a statement Monday.
“Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”
According to the attorney general’s lawsuit, Janssen’s unfair and deceptive practices included:
* Omitting and/or concealing material facts regarding Risperdal’s efficacy and safety in its communications with Massachusetts health care providers and consumers;
* Concealing, omitting or minimizing the side effects and risks associated with Risperdal’s use;
* Promoting Risperdal to treat elderly dementia without disclosing to prescribers the serious risks associated with Risperdal’s use in dementia patients, including an increased risk of death;
* Promoting Risperdal to treat elderly dementia without disclosing to prescribers that the U.S. Food & Drug Administration had rejected the company’s request to market Risperdal for this use because of unaddressed safety concerns;
* Promoting Risperdal’s use as safe and effective to treat conduct disorder and other conditions in children for more than a decade before receiving FDA approval to market Risperdal to treat any conditions in children;
* Making misleading and deceptive statements to prescribers about Risperdal’s safety, particularly with respect to weight gain and the risk of developing diabetes;
* Paying physicians to participate in sham consulting programs that were, in fact, thinly disguised marketing programs touting unapproved uses; and
* Targeting its sales and marketing efforts to prescribers who rarely, if ever, prescribe Risperdal for its FDA-approved uses, primarily the treatment of schizophrenia and bipolar mood disorder.
According to the attorney general’s complaint, Janssen’s illegal marketing and sales tactics helped the company generate hundreds of millions of dollars in sales in the state.
Citing company documents, Coakley’s lawsuit notes that these illegal tactics helped make Risperdal a market leader in both the children and adolescent and elderly market segments.
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