Johnson & Johnson subsidiary Janssen Pharmaceutical was ordered to pay $2.5 million in damages to the parents of an autistic boy who claimed the drug company covered up risks associated with its antipsychotic drug Risperdal, leading their son to grow female breasts, a condition known as gynecomastia.
The lawsuit was filed by the family of Austin Pledger, now 20. They claimed their son took Risperdal for five years beginning at age 7, during which he developed gynecomastia. At the time, Risperdal was not approved to treat children but the drug company actively promoted the drug to physicians for pediatric use.
Doctors can prescribe drugs for so-called off-label uses, but drug companies are forbidden to market medications for conditions for which they are not approved. Last year, Johnson & Johnson paid $2.2 billion to settle criminal charges and other allegations for illegal promotion of Risperdal, including pediatric use.
Former FDA Commission Dr. David Kessler testified for the plaintiffs, arguing that Johnson & Johnson and Janssen tried to manipulate data involving gynecomastia risks in some reports involving Risperdal.
“The most important thing to me, as someone who worked for the FDA, as a physician and as someone who served on the boards of pharmaceutical companies, is you tell the truth and you tell the whole truth,” Kessler testified. “Make sure the FDA knows and make sure the doctors know. Tell them the good and the bad.”
Among the evidence presented was a table in an internal Janssen document that the company never submitted to the FDA that allegedly showed a statistically significant connection between Risperdal and gynecomastia.
Gynecomastia is a devastating condition for boys and young men, causing both emotional and physical pain. Treatment usually involves surgeries such as liposuction or mastectomy.
Pledger’s case is the first of about 1,250 Risperdal gynecomastia lawsuits in Philadelphia’s mass trial to go to a jury. One lawsuit was settled midtrial and another was settled the day before jury selection.
Source: Law 360