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Johnson & Johnson Admits to Improperly Marketing Prescription Drugs for Unapproved Purposes

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Johnson & Johnson (J&J) and the company’s subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability related to allegations that the drug maker promoted the prescription drugs Risperdal, Invega and Natrecor for unapproved uses, and provided kickbacks to physicians and the nation’s largest long-term care pharmacy provider.

U.S. Attorney General Eric Holder announced the deal on November 4. Holder said J&J improperly marketed Risperdal for treatment of psychotic symptoms in elderly, non-schizophrenic patients. The drug is approved by the U.S. Food and Drug Administration (FDA) only for individuals with schizophrenia. The attorney general also accused J&J of improperly marketing Risperdal and Invega for treatment of dementia. As a result, insurance companies paid for claims they should not have been paying for, according to CNN.com.

All of the cases that culminated in the November 4 settlement arose from whistleblower (qui tam) lawsuits. Approximately $168 million will go to whistleblowers in California, Massachusetts and Pennsylvania who provided evidence of wrongdoing to the federal government’s attention, the Los Angeles Times (LA Times) wrote.

The federal government alleges that for 22 months, J&J and its subsidiaries’ sales forces actively promoted the use of Risperdal and Invega, both antipsychotic medications, in confused and demented elderly patients, despite evidence that showed the drugs could increase the risk for stroke. The alleged sales campaign ended December 31, 2003, the LA Times reported.

In a related claim filed in Pennsylvania, the government alleged that Janssen Pharmaceuticals, a J&J subsidiary, promoted Risperdal as a treatment for dementia in elderly patients, and as treatment for problematic behavior in other patients including children with developmental disabilities from 1999 to 2005. From 2006 to 2009, the government contends, Janssen promoted Invega for use with many of the same populations and lied about the drug’s safety and effectiveness, according to the LA Times.

The government also alleges that J&J’s Scios Inc. subsidiary began aggressively marketing Natrecor in 2001 as treatment for patients with more minor heart failure than those for whom the FDA approved the drug for. Natrecor was approved for patients with acute heart failure who suffered shortness of breath even with minimal activity. According to the government, Scios’ marketing campaign resulted in widespread use as an infusion for heart patients who visited their doctors’ offices once or twice a week for the medication.  Brian Stretch, first assistant U.S. district attorney for the Northern District of California said the infusions were “unsupported by valid scientific evidence,” the LA Times reported.

 

 

 

 

breakinglawsuitnews.com disclaimer: This article: Johnson & Johnson Admits to Improperly Marketing Prescription Drugs for Unapproved Purposes was posted on Wednesday, November 19th, 2014 at 3:47 pm at breakinglawsuitnews.com and is filed under Fraud Lawsuits.

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