A Philadelphia jury ordered Johnson & Johnson in Feb. 2015 to pay $2.5 million to an Alabama man who developed 46 DD breasts as a teenager after taking Risperdal. The jury agreed with the 20-year-old autistic man’s attorneys that the company failed to warn of the gynecomastia “side effect” from the antipsychotic drug Risperdal.
Update: The verdict is on appeal; so no recovery has been made despite the verdict.
First Jury to hear Risperdal Claim
It was the first case related to gynecomastia which went to a jury. Thousands more Risperdal lawsuits are filed in Philadelphia, California, Missouri and elsewhere.
J&J’s Criminal, Civil penalties
Johnson & Johnson paid $2.2 billion to settle federal and state criminal and civil charges in 2013 for illegally marketing Risperdal. Individual lawsuits such as this one are another matter.
Drug injury attorney David Matthews of Matthews & Associates said the jury in Philadelphia heard evidence that was never presented to the FDA by an American drug company. He said the verdict was a result of the company’s failing to warn of Risperdal’s dangers.
Janssen, which maintains several facilities in Philadelphia’s suburbs, said through a spokesman that the company believed “this verdict should be overturned.”
J&J promoted Risperdal for Unapproved Uses
Drug companies are not allowed to promote drugs for unapproved uses, but because doctors can prescribe drugs as they see fit, the companies often promote the drugs to doctors for unapproved purposes. Herein lies a lot of trouble that has led to Johnson & Johnson and other drug companies paying billions of dollars in fines.
Risperdal approved in 1993
Risperdal was first approved by FDA in 1993 to treat adult schizophrenia. Risperdal was not approved for children and adolescents until late 2006.
The trial showed that by 2006, a Janssen sales person had made more than 20 visits to the pediatric neurologist treating the plaintiff in a Birmingham suburb. Risperdal was given to him for the first time when he was eight in 2002. His mother had sought something to help with his autistism-triggered irritability.
Doctor not Warned of Risperdal Gynecomastia
Dr. Jan Mathisen, physician for the plaintiff, testified that he was not informed of data in one Janssen study which suggested gynecomastia could result from Risperdal. He said that had he been aware, he would have raised the issue with the family. When the drug was later approved, in 2006, for children with autism, he said that like many doctors he did not read the entire revised label. He said he would have wanted someone to tell him of the increased risk.
Janssen’s attorneys, meanwhile, told the jury Risperdal’s label adequately conveyed Risperdal risks.
FDA Commissioner David Kessler
Former FDA Commissioner David Kessler testified that Janssen failed to adequately warn patients, doctors, and the FDA after one of the company’s own studies showed higher levels of prolactin, a hormone that can lead to gynecomastia. Kessler noted that if a company sends a sales rep into a doctor’s office, the rep is obliged to give “adequate direction,” to tell a drug’s good as well as bad effects.
Many legal experts, like University of Richmond law professor Carl Tobias, believe J&J might fight Risperdal cases a bit longer. The enormously wealthy company can shrug off billion-dollar fines, so it will likely fight on to defend Risperdal, despite a mountain of evidence against it.