Johnson & Johnson must pay $8 billion in punitive damages to a man who previously won $680,000 over his claims that it failed to warn that young men using its antipsychotic drug Risperdal could grow breasts, a Philadelphia jury said on Tuesday.
The Philadelphia Court of Common Pleas jury's verdict in favor of Nicholas Murray came in the first case in which a Pennsylvania jury had been able to consider awarding punitive damages in one of thousands of Risperdal cases pending in the state.
J&J and a lawyer for Murray did not immediately comment on the verdict.
The extremely large punitive damages award is likely to be reduced on the grounds that it violates due process.
In a 2003 case, the U.S. Supreme Court threw out a $145 million punitive damage award and held that, "few awards exceeding a single-digit ratio between punitive and compensatory damages, to a significant degree, will satisfy due process."
Murray, like other male plaintiffs in the mass tort litigation over Risperdal, alleges that he developed breasts after being prescribed the medicine when he was a minor. The U.S. Food and Drug Administration approved the drug in late 1993 for treating schizophrenia and episodes of bipolar mania in adults.
Plaintiffs claim that J&J failed to warn of the risk of gynecomastia, the development of enlarged breasts in males, associated with Risperdal, which they say the company marketed for unapproved uses with children.
In his lawsuit, Murray, now 26, alleged that he developed breasts after his doctors began prescribing him Risperdal off-label in 2003 after a psychologist diagnosed him with autism spectrum disorder. Doctors are allowed to prescribe medicines as they see fit, while companies are only allowed to promote their drugs for approved uses.
Johnson & Johnson released the following statement:
This award is grossly disproportionate with the initial compensatory award in this case, and the Company is confident it will be overturned.
This award for a single plaintiff stands in stark contrast with the initial $680,000 compensatory award and is a clear violation of due process. United States Supreme Court precedent dictates that punitive damages awards that are a double-digit multiplier of the compensatory award should be set aside.
The Company was precluded from presenting a meaningful defense due to the Court's exclusion of key evidence. As a result, the jury did not hear evidence as to how the label for RISPERDAL® clearly and appropriately outlined the risks associated with the medicine, or the benefits RISPERDAL® provides to patients with serious mental illness. Further, the plaintiff's attorneys failed to present any evidence that the plaintiff was actually harmed by the alleged conduct.
This decision is inconsistent with multiple determinations outside of Philadelphia regarding the adequacy of the RISPERDAL® labeling, the medicine's efficacy, and findings in support of the Company.
We will be immediately moving to set aside this excessive and unfounded verdict.