Janssen Settles Allegations that Risperdal Caused Male Breast Growth. Shortly before the case was set to start trial, Johnson & Johnson subsidiary Janssen Pharmaceuticals settled claims that its antipsychotic drug Risperdal caused excessive breast growth in a young boy. The lawsuit alleged that J&J failed to disclose that Risperdal can cause this condition, known as gynecomastia.
The case would have been the sixth Risperdal gynecomastia case to go to trial. The parties settled for an undisclosed amount. In July, a similar lawsuit went to trial; jurors awarded $70 million to the plaintiff.
The lawsuit was filed on behalf of a plaintiff who was prescribed Risperdal at the age of 7. The medication was prescribed to treat symptoms associated with Asperger’s syndrome, impulse control disorder and oppositional defiance disorder. After a little more than a year, he was taken off Risperdal. Several years later, he resumed taking the drug in generic form and continued treatment for approximately four years.
Like other lawsuits filed into the mass tort, the plaintiff alleges that Risperdal caused abnormal and excessive breast growth. J&J is accused of knowing about this risk, but failing to warn patients or the medical community.
Jury Awards $70 Million Verdict in Risperdal Gynecomastia Case
In July, a Philadelphia jury ordered Janssen to pay $70 million to a Risperdal gynecomastia plaintiff. This verdict is significantly larger than the previous three, which totaled $4.75 million. The Risperdal gynecomastia claim was one of 1,700 pending in the Philadelphia County Court of Common Pleas.
The lawsuit was filed on behalf of a plaintiff who began taking the drug in 2003 to treat psychiatric problems. He was 5 years old at the time, and the FDA had not yet approved the drug for children. In 2013, a lawsuit filed on the boy’s behalf alleged that Risperdal had caused him to develop abnormally large breasts. He was teased and bullied by his peers because of his gynecomastia, the suit alleges.
Risperdal was initially approved for adults with schizophrenia. Later, the U.S. Food and Drug Administration (FDA) expanded the drug’s indications to include pediatric patients and other mental health conditions.
During the trial, jurors were shown a video deposition from former FDA Commissioner David Kessler, who said that J&J manipulated Risperdal clinical data to downplay the risks of gynecomastia. The gynecomastia is thought to be triggered by high levels of prolactin. While prolactin levels rise naturally when boys hit puberty around age 10, this rarely causes breast growth in the absence of pathology. Allegedly, Risperdal can also raise levels of prolactin.
Attorneys for the plaintiff allege that J&J’s own study showed that Risperdal is linked to a risk of gynecomastia. According to Kessler’s testimony, however, the company diluted the data to obscure the risk.
The company allegedly excluded boys over the age of 10 from the number of children who developed gynecomastia but did not exclude these individuals from the overall number of participants in the study. Furthermore, Kessler said, J&J diluted the data further by adding 103 girls without gynecomastia to the total number of study participants.
Because of J&J’s alleged data manipulation, the reported risk of gynecomastia in the study was much lower than experienced, Kessler testified. The company said the trials showed that gynecomastia affected 0.8 percent of participants when the rate was 4.5 percent. Allegedly, there were 22 cases of gynecomastia but J&J only reported 5.
Risperdal Litigation Background
Risperdal was approved by the FDA in 1993 to treat adults with schizophrenia. Later, the agency approved the antipsychotic drug for other indications. Risperdal has faced allegations that it marketed the drug off-label, meaning in ways not approved by the FDA, for children and elderly patients with dementia.
In November 2013, J&J agreed to pay over $2.2 billion to resolve criminal and civil allegations involving Risperdal and other drugs. The federal government had alleged that J&J engaged in off-label marketing and paid illegal kickbacks to physicians and pharmacists.
According to the Department of Justice (DOJ) press release, the government alleged that J&J promoted Risperdal for children even though the company was aware that the drug “posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.”
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania according to the release. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”