J&J Settles Anti-psychotic Drug Risperdal Lawsuits With $800 Million In Expenses

Johnson & Johnson JNJ says it has settled most of the lawsuits in the anti-psychotic drug Risperdal cases and has recorded $800 million in expenses in connection with the agreement.

The medical devices and pharmaceuticals maker had almost 9000 cases over the Risperdal drug, and it accrued the entire legal expenses in the third quarter.   

According to the lawsuits, J&J failed to warn of the risk of a condition called gynecomastia (an enlargement of the breast tissue in men or boys), associated with Risperdal.

The lawsuits accused the company of marketing the drug for off-label, unapproved uses with children. However, the J&J denied the allegations.

In 2013, the company agreed to pay $2.2 billion to settle U.S. criminal and civil probes into its marketing of Risperdal and two other drugs.

The U.S. Supreme Court this year rejected J&J’s bid to overturn a $70 million jury verdict against the company for its failure to warn about risks associated with the drug. The suit was filed by a Tennessee man who was prescribed the drug at age 4 in 2003. 

The U.S. Food and Drug Administration approved Risperdal in 1993 to treat schizophrenia and bipolar mania in adults. It wasn't until 2006 that approval was granted for the treatment of irritability associated with autism in children.

Last week, J&J and its Janssen Pharmaceutical Companies reached a $291.8 million settlement with the Texas state government that resolves its opioid-related claims against the companies.

The drugmakers were accused of downplaying the addictive properties of its opioid products and aggressively marketing them to physicians and patients.

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