U.S. Supreme Court rejects J&J appeal over Risperdal drug
Quote:
The U.S. Supreme Court rejected a bid by Johnson & Johnson to overturn a $70 million jury verdict against the pharmaceutical company for its failure to warn about risks associated with off-label uses of its antipsychotic drug Risperdal.
The court turned away the company’s appeal of a November 2019 ruling by the Superior Court of Pennsylvania that upheld the verdict in favor of a Tennessee man named Adam Yount, who was prescribed the drug at age 4 in 2003.
A jury in the Philadelphia Court of Common Pleas in 2016 found that the company failed to warn Yount’s healthcare providers about the risk of gynecomastia, an enlargement or swelling of breast tissue in males caused by a hormonal imbalance, and that it intentionally falsified, destroyed or concealed evidence in the case.
Warnings contained on drug labels are overseen by the U.S. Food and Drug Administration. But “off-label” uses – to treat patient populations outside of the FDA’s approval or for conditions and dosage beyond the agency’s approval – by doctors are commonplace.
Yount developed gynecomastia at age 5 as a result of taking Risperdal, according to his lawyers. J&J has said that Yount’s doctor discontinued the treatment but that the patient’s mother requested that it be resumed. The drug at the time had not been approved for pediatric use so the label did not include a specific warning about gynecomastia in children.
The FDA 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.
_________________
Professionally Identified and joined WP August 26, 2013
DSM 5: Autism Spectrum Disorder, DSM IV: Aspergers Moderate Severity
It is Autism Acceptance Month
“My autism is not a superpower. It also isn’t some kind of god-forsaken, endless fountain of suffering inflicted on my family. It’s just part of who I am as a person”. - Sara Luterman
17 May 2021, 4:07 pm
