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Risperdal cases in California get boost as court says Janssen should have asked feds to change label

LEGAL NEWSLINE

Saturday, November 23, 2024

Risperdal cases in California get boost as court says Janssen should have asked feds to change label

State Court
Risperdal

LOS ANGELES (Legal Newsline) – A California appeals court has dealt a blow to the maker of Risperdal, an antipsychotic that is the subject of thousands of lawsuits that allege it caused young males to grow breast tissue.

On June 3, the Second Appellate District of the Court of Appeal affirmed that a plaintiff couldn’t prove a doctor would have prescribed him something else had there been a different warning on Risperdal but it overturned a ruling that said two plaintiffs’ claims were preempted by the federally approved label.

Janssen Pharmaceutical’s own research showed children who had elevated prolactin after taking Risperdale for 2-3 months were 2.8 times more likely to develop side effects, but the label made no mention of these occurring over different time periods.

This information was enough to seek to change the label, the court ruled.

“Accordingly, Janssen did not meet its burden to show by clear evidence that it fully informed the FDA and, in turn, the FDA rejected a proposed label change (requested by a citizens petition),” Justice Halim Dhanidina wrote.

The appeal involved three separate plaintiffs, and the preemption ruling reinstates the cases of two of those. The third’s remains dismissed because he failed to show his psychiatrist would have heeded more serious warnings of side effects.

“When presented with the results of the individual studies that showed a higher rate of gynecomastia among pediatric patients, the psychiatrist did not indicate whether her decision to prescribe risperidone would have changed,” Dhanidina wrote.

“Rather, the psychiatrist equivocated, stating that, while she would include the higher rate in her risk-benefit analysis, risperidone may have still been the best choice for C.S. At the time, there were only two medications on the market approved to treat C.S.’s symptoms.”

Risperdal lawsuits have been the subjects of multimillion-dollar verdicts, most notably in Philadelphia, where the state’s Complex Litigation Center handles thousands of these cases.

Plaintiffs lawyers have convinced jurors to make Janssen pay for the side effects. In one case, they actually awarded $8 billion in punitive damages to one plaintiff – an amount later slashed to $6.8 million by the trial judge.

Plaintiffs lawyers and Janssen continue to battle over that and other seven-figure verdicts in Pennsylvania’s appeals courts.

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