Thursday, 28 March, 2024
HomeMedico-LegalJ&J settles lawsuits over anti-psychotic causing excessive breast tissue in men

J&J settles lawsuits over anti-psychotic causing excessive breast tissue in men

Johnson & Johnson has settled most of the lawsuits it faced by thousands of men who claimed its anti-psychotic drug Risperdal caused them to develop excessive breast tissue, and, reports Reuters, had disclosed it recorded $800m in expenses relating to the agreement.

J&J said on Friday that it reached a settlement in principle in September to resolve “substantially all” of the roughly 9,000 cases faced by the New Jersey-based drugmaker over Risperdal.

The lawsuits generally accused J&J of failing to warn of the risk of a condition called gynecomastia associated with Risperdal, which they said the company marketed for off-label, unapproved uses with children. J&J denied the allegations.

The FDA had approved Risperdal in 1993 to treat schizophrenia and bipolar mania in adults, but it was only in 2006 that its use was approved for irritability associated with autism in children.

In May, the Supreme Court had rejected a bid by the company to overturn a $70m jury verdict against it for its failure to warn about risks associated with off-label uses of Risperdal. The court had turned away J&J’s appeal of a 2019 ruling by the Superior Court of Pennsylvania that upheld the verdict in favour of a Tennessee man who was prescribed the drug at age 4 in 2003.

The company said it reached the agreement with lawyers handling cases including a lawsuit in state court in Philadelphia by Nicholas Murray, a Maryland resident, to whom a jury awarded an $8bn punitive damage award in 2019 that a judge later reduced to $6.8m.

J&J said it accrued $800m in legal expenses in the third quarter related to the settlement.

Reuters adds it is unclear what other cases in the US were part of the accord. Many of the lawsuits were also pending in Pennsylvania, and the company also faced cases in California and Missouri.

The company separately agreed in 2013 to pay $2.2bn to settle US criminal and civil probes into its marketing of Risperdal and two other drugs.

 

J&J settles most Risperdal lawsuits, with $800 million in expenses (Restricted access)

 

See more from MedicalBrief archives:

 

$8bn punitive damages award for man's enlarged breasts

 

Oklahoma judge rules J&J intentionally played down opioid dangers

 

US trial of opioid drug makers' starts over 500,000 overdose deaths

 

 

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