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Like few other drugs, the antipsychotic Risperdal can treat schizophrenia and bipolar disorder, and reduce irritability and aggressive behavior in autistic children. But like any other drug, Risperdal has side effects, including causing breast enlargement and diminished sexual functioning in young autistic boys.
These side effects have led to a slew of litigation, from patient lawsuits to charges from the Department of Justice. Here is a roundup of all the latest news on those lawsuits, from our archives.
Risperdal use has been linked with increased levels of prolactin, a hormone that, among others things, controls human milk production. The condition, known as gynecomastia, can cause breast enlargement and studies show autistic boys taking Risperdal are twice as likely to develop gynecomastia, and 14 percent more likely to suffer some sexual dysfunction.
Just this year, one of the boys who developed gynecomastia, Andrew Yount, won $70 million from Risperdal's manufacturer, Janssen Pharmaceuticals. The jury in that case heard evidence that Janssen manipulated study data showing that Risperdal was suspected of causing gynecomastia in an effort to downplay the risks to adolescents.
The latest wave of lawsuits claims Janssen knew about the elevated risk for gynecomastia as far back as 2003, but failed to warn patients about the known side effects. They also allege the risk is particular to Risperdal, and that other drug that have similar benefits in autistic patients don't have the same side effects.
The recent side effect lawsuits aren't the only ones involving Risperdal. In 2012, Johnson & Johnson settled a Medicaid fraud lawsuit involving the drug for $158 million. In that case, Texas prosecutors claimed the company made false or misleading statement about the drug's safety, cost, and effectiveness, and also tried to improperly influence health care providers to prescribe the drug.
A year before that, Johnson & Johnson and Janssen paid over $300 million in fines in South Carolina for sending a misleading letter to doctors stating that the drug was better than competitors, as well as understating Risperdal's risk for diabetes on drug sample packaging.
Risperdal's legal troubles stretch all the way back to 2010, when the U.S. Department of Justice charged Johnson & Johnson with marketing and promotion of the drug Risperdal for the off label use of treating dementia in nursing home patients.