A Philadelphia jury has awarded $2.5 million in damages to a family that alleged drug maker Janssen Pharmaceuticals failed to warn them and their son’s doctors of risks associated with the antipsychotic drug Risperdal.
The jury heard testimony that Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, worked for years to hide evidence that the drug was linked to abnormal growth of female breast tissue — gynecomastia — in adolescent boys. The case was heard in the Philadelphia County Court of Common Pleas. The lawsuit was filed in 2012 by the family of an autistic boy who grew large breasts after taking Risperdal for nearly five years, beginning in 2002, when he was seven, Law360 reports.
When the boy began taking Risperdal, the drug was only approved for adult use by the U.S. Food and Drug Administration (FDA). But, according to trial testimony, Janssen sales representatives repeatedly visited the boy’s pediatric neurologist and gave the doctor samples of the drug, Law360 reports. Among those who testified was former FDA commissioner David Kessler, who said he believed Johnson & Johnson had engaged in a conscious effort to downplay data in the scientific literature showing an association between Risperdal and gynecomastia. The drug was ultimately approved for treating behavioral disorders in autistic children in 2006, with an updated label indicating that gynecomastia had been seen in 2.3 percent of pediatric patients.
In November 2013, Janssen settled federal False Claims Act allegations that it used kickbacks and perks to doctors to illegally promote off-label use of three of its drugs, including Risperdal. The company paid $2.2 billion in criminal fines and forfeiture to the federal government and state governments and admitted criminal misconduct, Law360 reports. Under the law, a doctor may prescribe an FDA-approved drug for any purpose he or she deems medically appropriate, but drug companies are prohibited from marketing or promoting a drug except for approved uses.
According to Law 360, more than 1,250 Risperdal-related cases are part of a mass tort docket in Philadelphia, and some 700 suits have been filed in state court in Los Angeles. A second Risperdal trial began In Philadelphia last Friday.