Louisiana Supreme Court Overturns $257 Million Risperdal Lawsuit Verdict

In January 2014, a divided Louisiana Supreme Court reversed a decision awarding the state Attorney General $257 million in a Risperdal lawsuit against Janssen Pharmaceuticals and its parent corporation Johnson & Johnson, Inc.

In a 4-3 decision, the Court ruled that the drug manufacturers had not violated Louisiana’s Medicaid anti-fraud statute because the companies’ misleading statements regarding the risks of Risperdal had not been made as part of a “claim for payment made against [state] medical assistance programs.”

Risperdal uses and side effects

Federal law requires pharmaceutical companies to specify a drug’s intended uses when seeking FDA approval for that drug.  The FDA will not approve the medication unless it finds the drug is safe and effective for those uses.  Thereafter, the FDA requires drug labelling to provide true, complete and accurate information about the approved uses and the risks of taking the drug.

In 1993, the FDA approved Risperdal for the treatment of schizophrenia.  Later, the FDA approved the drug’s use for bipolar disorder and, in late 2006, for bipolar disorder and irritability associated with certain types of autism in children.

Risperdal has been tied to a number of very serious side effects, including:

• Neuroleptic Malignant Syndrome, a potentially fatal condition;
• Tardive Dyskinesia (uncontrollable movements of face, tongue and other body parts), a condition with no known treatment that may not disappear even after the patient stops using Risperdal;
• Diabetes and high blood sugar;
• Gynecomastia (abnormal breast growth in males);
• Painful, long-lasting erections;
• Dysmenorrhea (cessation of menstruation);
• Low white blood cell count, which can be life-threatening;
• Persistent restlessness, tremors and muscle stiffness;
• Faintness or light-headedness 

Risperdal lawsuits charge misrepresentation

Although the drug was originally approved only to treat schizophrenia, Risperdal’s manufacturer marketed it extensively for other “off-label” uses.  For example, Janssen sales representatives promoted it to control hostility, agitation, confusion and depression in elderly non-schizophrenic patients with dementia.  The company’s own studies showed that Risperdal increased elderly patients’ risk of stroke and other life-threatening conditions, but marketers downplayed these risks, arguing that the drug could control behavior problems in patients with dementia.  Despite FDA warnings that this marketing was misleading, the companies continued their aggressive sales practices.

In another off-label marketing campaign, the companies marketed Risperdal for use in children to treat such conditions as ADHD, obsessive-compulsive disorder and autism.  Until late 2006, the FDA had not approved Risperdal to treat children for any purpose.  The FDA warned the companies repeatedly to stop promoting such uses — yet the manufacturers continued their forceful marketing.  The FDA also asserted that the companies knew that Risperdal stimulated the production of prolactin in children, which can cause abnormal breast growth and milk production, especially in boys and men.

These off-label promotional campaigns, and misrepresentations of the risks of Risperdal, ultimately led to the Justice Department reaching a $2.2 billion Risperdal settlement in a lawsuit against Johnson & Johnson and Janssen.  The case was one of the largest health-care fraud lawsuits in U.S. history.  The November 2013 settlement included criminal penalties and forfeitures totaling $485 million, and civil recoveries under the federal False Claims Act totaling $1.72 billion.

Hundreds of the cases have been filed charging Risperdal breast growth in males.  The manufacturers have settled several of these gynecomastia lawsuits, in which boys as young as five when they began using Risperdal suffered psychological damage caused by abnormal breast growth as teens.  Many of the lawsuits have not been resolved, however, so the litigation over Risperdal and its harmful side effects will continue for the foreseeable future.

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