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J&J to Pay $2.2B to Settle Allegations Over Its Marketing of Risperdal; Parker Waichman LLP Applauds Efforts of Whistleblowers in Helping Compel Resolution
Date:11/5/2013

" rel="nofollow">press release issued today, the FDA noted that it approved Risperdal in 2002 for the treatment of schizophrenia; and in 2003 it extended its approval to include short-term treatment of acute mania and mixed episodes associated with Bipolar 1 disorder. The release also noted that Janssen began to market the drug as a treatment for dementia in the elderly in March 2002, “representing that Risperdal was safe and effective for this unapproved indication and subpopulation.”

Janssen had also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents, the FDA noted in its release, adding that until late 2006, Risperdal was not approved for use in children for any purpose, and that the FDA had repeatedly advised the company that promoting its use in children was problematic and could be evidence of a violation of the law.

Bloomberg noted that the civil settlement involves 45 states and resolves three lawsuits filed by whistleblowers under the False Claims Act, a Civil War-era law allowing private persons to file lawsuits on behalf of the U.S. government. Such lawsuits are also known as “qui tam” actions. Amendments added to the Act in 1986 and later have further incentivized whistleblowers to take action by raising the amounts awarded for damages and fines. Whistleblowers can obtain millions of dollars, or between 15% and 30% of the amount recovered by the government.

Whistleblowers involved in what is the government’s third-largest settlement with a pharmaceutical company, according to the Bloomberg report, will certainly be sharing one of the largest amounts ever awarded in a qui tam case. According to the Justice Department’s press release, whistleblowers involved in litigation in the Eastern District of Pennsylvania (U.S. v. Janssen Pharmaceuticals, Case No: 13-cr-605, U.S. District Court, Eastern District of Pennsylvania (Philadelphia)) will get about $112 million;
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