Risperdal lawsuits have proliferated in recent years. Plaintiffs claim that Johnson & Johnson, manufacturer of the second generation anti-psychotic drug, hid serious side effects, diabetes and gynecomastia (the growth of breasts in males), and promoted its use in unapproved circumstances. The FDA approved Risperdal for use by adults in 1993, but it was not until 2006 that is use was approved for children. Risperdal’s packaging was also updated in 2006 to state that 2.3% of male adolescents developed gynecomastia.
Johnson & Johnson was also found to have distributed Risperdal for use with elderly patients, a second unapproved use of the drug. In 2005, the FDA issued a strong “black box” warning that that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The box also warns the drug is not approved for use in patients with dementia-related psychosis. Allegations that Johnson & Johnson marketed the drug aggressively for use by children as early as 1994 resulted in a U.S. Department of Justice investigation and the subsequent payment of massive fines. In 2013 in one of the largest health care fraud settlements on record Johnson & Johnson agreed to pay over $2.2 billion in criminal and civil penalties. While doctors are free to prescribe drugs for off-label purposes, the drugs may not be marketed for such use by the manufacturer.
The Status of Risperdal Lawsuits
As of September 2017 there were 6,082 Risperdal lawsuits pending in the Philadelphia Court of Common pleas. That number had grown by over 500 since early June. There have been several trials and settlements in Risperdal lawsuits, including one $70 million verdict. Pennsylvania has been a popular venue for complex tort litigation. That trend may soon come to an end as a result of a June Supreme Court decision that stated that either plaintiffs or defendants must have some significant connection to the trial venue (BRISTOL-MYERS SQUIBB CO. v. SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, ET AL.) In August 53 Risperdal cases were dismissed in Missouri for that reason. Johnson & Johnson has not yet signaled whether the company will seek similar dismissals in Pennsylvania.
The U.S. Food and Drug Administration (FDA) approved Risperdal to treat the following conditions:
- Schizophrenia in adults and adolescents
- Bipolar disorder in adults and adolescents
- Autism spectrum disorder in children and adolescents
Off-label refers to uses that are not approved by the FDA. Risperdal has been prescribed off-label to treat conditions including: