The Largest Award Made in a Risperdal Gynecomastia Trial. In the largest award yet made in a Risperdal gynecomastia trial, last week a Philadelphia jury awarded $70 million to a Tennessee boy who developed female breasts (gynecomastia) after taking the antipsychotic drug Risperdal.
This case was the fifth Risperdal gynecomastia case to be tried in Philadelphia, and this verdict is many times larger than previous awards: in three of four earlier cases, verdicts ranged from $500,000 to $2.2 million, Philly.com reports.
During the trial, lawyers for the boy argued that scientists working for Janssen were well aware of the gynecomastia risk and sought to downplay the risks. Janssen disputed the allegation and said physicians were fully informed of the drug’s potential side effects. One attorney said, “The jury got angry at these people; they don’t take responsibility.”
Janssen, a subsidiary of Johnson & Johnson, disputed that Risperdal had caused the boy to develop breasts and the company said it would appeal the verdict, according to Philly.com. In a post-verdict statement Janssen expressed sympathy for the plaintiff, but said, “the plaintiff’s physical condition was not caused by using the medication.” Janssen said that the boy “benefited from using Risperdal,” and that the drug had helped millions of patients.
At the time the boy began taking Risperdal, the drug was approved only for use by adults. During the trial, attorneys alleged that Janssen downplayed the risks in an effort to market the drug for use in children and adolescents.
The boy’s attorneys told the jury that Janssen had manipulated
The boy’s attorneys told the jury that Janssen had manipulated study data showing that Risperdal was suspected of causing gynecomastia, the development of female breast tissue in young males, to downplay the risks.
The Food and Drug Administration (FDA) approved Risperdal (risperidone) for treating schizophrenia and bipolar disorder. But attorneys say the drug maker worked to expand Risperdal uses and the drug became a $3-billion-a-year drug in part because the drug maker pushed its use in elderly people with dementia and children with behavioral problems and autism.
Critics say the evidence shows that many of those uses were not warranted. The FDA had specifically declined approval for use of Risperdal in elderly dementia patients and the agency also noted that the drug was associated with strokes in elderly patients.
Though gynecomastia is not in itself considered a medically serious condition, it can cause emotional distress for boys who develop female breasts. They are often teased or bullied because of their appearance. Boys and young men with female breasts will try to avoid locker rooms, swimming pools, and situations where males normally go shirtless.
Most of the boys who experience gynecomastia already suffer social problems because of the mental illness for which they are taking Risperdal and gynecomastia adds to the boy’s distress. These boys and young men may need surgery-liposuction or mastectomy-to restore a normal male appearance.
In 2013, following a Justice Department investigation, Janssen paid $2.2 billion in civil and criminal penalties to settle charges that it improperly marketed Risperdal for use in elderly nursing home patients to control agitation, confusion, and other symptoms of dementia.