Plaintiffs in Risperdal side effects lawsuits are challenging a Pennsylvania judge’s decision barring them from asking for punitive damages, arguing that many of the patients who were injured by the antipsychotic drug were being treated for uses that the Food and Drug Administration (FDA) had not approved. Thus, the plaintiffs claim, the state’s restriction on punitive damages in pharmaceutical liability cases would not apply.
Risperdal (risperidone), manufactured by Johnson & Johnson’s unit Janssen Pharmaceuticals, is approved by the FDA to treat both adults and children with schizophrenia, bipolar disorder and irritability with autism. Prior to 2006, the drug was not approved for pediatric use, though the company had marketed the drug for use in children and adolescents. The drug company also pushed the drug for the treatment of conditions for which it was not approved – such as attention-deficit hyperactivity disorder (ADHD) and anxiety.
Risperdal side effects can be dangerous and include type 2 diabetes, a movement disorder called tardive dyskinesia, and a life-threatening neurological disorder called neuroleptic malignant syndrome.
The drug has also been linked to a gynecomastia, a condition in which adolescent boys grow breast tissue, making the breasts tender or painful and in some cases lactate. The condition can be emotionally scarring for boys, with breasts growing as big as a D cup. Gynocomastia can also cause long-term physical problems including damage to the reproductive organs and an increased risk for breast cancer. Treatment involves surgeries such as liposuction or mastectomy.
The lawsuits allege that Johnson & Johnson and Janssen Pharmaceuticals knew that the drug could cause gynecomestia in adolescent boys but failed to warn doctors or patients of this risk. Plaintiffs are asking the Philadelphia judge to consider that the companies marketed the drug for off-label uses in children and to consider decisions on a case-by-case basis.
Source: Law 360