Whether the drug makers failed to properly warn doctors and the public about the side effects of Risperdal is the issue being litigated in Philadelphia this winter. Over 1200 cases have been consolidated in a mass tort action filed there, and the first case began in late January.
Risperdal is an antipsychotic drug made by Janssen Pharmaceuticals, which is a subsidiary company of Johnson & Johnson. Johnson & Johnson has already been fined billions of dollars in a settlement for charges that the company illegally marketed Risperdal. In a joint investigation with the U.S. Department of Justice and several states, the government found that the makers aggressively marketed doctors to prescribe Risperdal for unapproved uses, specifically for children with disabilities and the elderly with dementia.
The first case being tried in Philadelphia involves a 20 year-old male who is autistic. He took Risperdal when he was 8 years-old and later developed “large female breasts.” The growths appear to be permanent, with the only way to remove them being a mastectomy.
Risperdal has been found to cause a condition called gynecomastia, which causes boys to grow female breast tissue. The suit alleges that the makers knew that Risperdal carried risks of gynecomastia that comparable drugs did not have, yet they didn’t notify the US Food and Drug Administration. The suit also alleges that Janssen engaged in the all-too common practice of designing its own studies to try to show less side effects.
Janssen had claimed that the risk of developing gynecomastia in boys was less than one in 1,000, when the suit alleges the risk is much higher, occurring at a rate of 3-4 in 100.
The plaintiffs have introduced several studies alleged to be in Janssen’s possession. One study found that 87% of children who took Risperdal had elevated levels of the hormone prolactin –this is the hormone that causes breast growth in boys, and also causes girls to lactate prematurely. Another study allegedly in Janssen’s possession showed that of 419 young males taking Risperdal, 23 developed gynecomastia. Of those 23, 16 cases were “probably related to the drug” and 15 of the 16 patients still had the condition at the end of the study.
The plaintiff’s doctor prescribed Risperdal to treat the boy’s behaviors such as screaming, head-banging and acting out violently, even though the FDA had not approved Risperdal for use in children.