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BOSTON—Drugmaker Ortho-McNeil-Janssen generated hundreds of millions of dollars of sales in Massachusetts by illegally marketing the antipsychotic drug Risperdal, Attorney General Martha Coakley (D) alleged in a lawsuit filed in state court Aug. 1 (Massachusetts v. Ortho-McNeil-Janssen, Mass. Super. Ct., No. 11-2811, filed 8/1/11).
The complaint filed in Massachusetts Superior Court accuses the company (part of Johnson & Johnson) of violating the state consumer protection law by promoting Risperdal (risperidone) for treatment of elderly dementia and for pediatric treatment—uses that were neither approved by the U.S. Food and Drug Administration nor demonstrated to be safe and effective.
Janssen also made misleading and deceptive statements to health professionals about appropriate use of Risperdal, failed to disclose risks associated with its use, paid physicians to participate in sham consulting programs, and targeted its sales and marketing to prescribers who rarely prescribed the product for its approved uses, the lawsuit alleged.
By minimizing the risks associated with the use of Risperdal for unapproved treatment, “Janssen, over a period of many years, put profits ahead of patient safety,’’ the complaint stated.
The lawsuit seeks “disgorgement of ill-gotten gains” and civil penalties of $5,000 “for each and every violation’’ of state law.
“We are prepared to vigorously defend ourselves against these claims,” the company said in a statement. “We are committed to ethical business practices and have policies in place to ensure that our products are only promoted for their FDA-approved indications.”
Janssen has faced litigation in at least 13 other states over its marketing of Risperdal.
Earlier this year, a South Carolina judge ordered Janssen to pay more than $327 million following a jury verdict against the company (110 HCDR, 6/8/11). That case was brought by the South Carolina state government.
And in October 2010, a Louisiana jury returned a $257.67 million verdict against Janssen for making misrepresentations about Risperdal, in a case brought by the state (199 HCDR, 10/18/10).
“Janssen's promotion of Risperdal for off-label uses and its failure to disclose risks associated with Risperdal made the drug a top-selling treatment for certain conditions notwithstanding the lack of scientific evidence that Risperdal could be safely used to treat these conditions,” the Massachusetts lawsuit stated.
The company promoted the product's use for children and adolescents from September 1997 through September 2006 without disclosing that FDA had rejected a proposed pediatric indication, and from 1994 onward it promoted use of Risperdal to treat dementia in elderly patients even though it had not been approved for such use, the complaint said.
Janssen also illegally marketed Risperdal to treat depression, anxiety, obsessive compulsive disorder, post-traumatic stress disorder, and Alzheimer's disease, none of which were FDA-approved uses, the complaint added.
By Rick Valliere
Text of the complaint is at http://op.bna.com/hl.nsf/r?Open=bbrk-8kcrf7 .
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