On Friday, Johnson & Johnson said in a filing with the US Securities and Exchange Commission that it had reached a settlement to resolve all of the roughly 9,000 cases that it faced over its anti-psychotic drug Risperdal.
The lawsuits generally accused Johnson & Johnson of failing to warn consumers of the risk of gynecomastia, a condition associated with Risperdal, which they say Johnson & Johnson marketed for off-label, unapproved uses with children. However, Johnson & Johnson denied the claims.
Risperdal was approved by the US Food and Drug Administration in 1993 to help treat bipolar mania and schizophrenia in adults. In 2006, the drug was also approved to help treat irritability associated with autism in children. In 2013, Johnson & Johnson separately agreed to pay $2.2 billion to settle US criminal and civil probes into its marketing of the drug as well as two others.
In May this year, the US Supreme Court rejected a bid by the company to overturn a $70 million jury verdict against it for failing to warn consumers about the risks associated with off-label uses of Risperdal. The court dismissed Johnson & Johnson’s appeal of a 2019 ruling by the Superior Court of Pennsylvania that upheld the verdict in favour of a man from Tennessee who had been prescribed Risperdal in 2003 when he was just four years old.
