Share:

Posted by Marilyn McGoldrick on Nov 15, 2013 12:05:00 PM

Although only approved by the Food and Drug Administration for certain patients with specific psychiatric disorders, Johnson & Johnson marketed Risperdal for a variety of non-approved, “off label,” uses. This marketing resulted in widespread use of Risperdal by individuals with other mental health issues.

Healthcare giant Johnson & Johnson has now agreed to pay over $2.2 billion to settle civil and criminal probes over its marketing practices for its once best-selling drug. This civil settlement involved the U.S. Justice Department and 45 states. It resolved three lawsuits brought by a team of four whistleblowers under the False Claims Act.

The antipsychotic Risperdal was approved in 1993 for the treatment of psychotic disorders in adults. J&Js subsidiary Janssen Pharmaceuticals also decided to market Risperdal as a treatment for schizophrenia, acute mania, and bipolar disorder. Among the off-label uses, the drug was prescribed for elderly patients suffering from dementia (see last year’s Boston Globe’s two-part series on this practice). It was also later approved for use on children with behavioral problems.

The allegations against Johnson & Johnson included off-label marketing (meaning uses not approved by the FDA) and kickbacks to doctors and pharmacists, including Omnicare Inc., the largest nursing home pharmacy. Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, pleaded guilty to criminal charges related to the misbranding of the drug for uses not approved by the FDA.

This is the third highest fine paid by a pharmaceutical company. In 2012, GlaxoSmithKline agreed to pay $3 billion and plead guilty to criminal charges regarding its antidepressants Paxil and Wellbutrin, and the diabetes drug Avandia. Pfizer, in 2009, paid a fine of $2.3 billion to resolve an investigation into the marketing of painkiller Bextra and other drugs.

Nonetheless, the threat of such larges payments have had little effect on the pharmaceutical industry’s marketing practices. It seems that the enormous profits to be earned from off-label marketing still outweigh the threat of civil and criminal charges years down the road.

How can Thornton Law Firm attorneys help you? We’ve represented victims of defective drugs and medical devices for three decades. Thornton Law Firm attorneys also represent whistleblowers in off-label marketing cases under the False Claims Act. Share your story with us by calling 1-888-341-1405, or click this link to send us your information so we can give you a free and confidential evaluation of your case.