A Philadelphia jury hit a Johnson & Johnson unit with $2.5 million in damages in a case accusing the drug maker of failing the parents and doctors of an autistic boy about risks associated with the antipsychotic drug Risperdal.
During the trial in the Philadelphia County Court of Common Pleas, the jury heard testimony that Janssen Pharmaceuticals Inc. had worked for years to hide evidence that the drug was linked to abnormal growth of female breast tissue — gynecomastia — in adolescent boys, Law360 reports. The lawsuit was filed in 2012 by the family of a boy who grew large breasts after taking Risperdal for nearly five years, beginning in 2002, when he was seven.
At the time the boy began taking Risperdal, the drug was approved by the U.S. Food and Drug Administration (FDA) only for use in adults. Despite this, the jury was told, Janssen sales representatives repeatedly visited the boy’s pediatric neurologist and gave samples of the drug, Law360 reports. Former FDA commissioner David Kessler testified at the trial that he believed J&J had engaged in a conscious effort to massage data in scientific literature to downplay the association between the drug and gynecomastia. When the drug was ultimately approved for treating behavioral disorders in autistic children in 2006, the label was updated to indicate that that gynecomastia had been seen in 2.3 percent of pediatric patients.
In November 2013, the company 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 admitted criminal misconduct and paid $2.2 billion in criminal fines and forfeiture. While a doctor may prescribe an approved drug for any purpose he or she deems medically appropriate, drug companies are prohibited from marketing or promoting a drug except for approved uses.
More than 1,250 Risperdal-related cases are part of a mass tort docket in Philadelphia, and a second Risperdal trial began on Friday. Law360 reports that some 700 suits have been filed in state court in Los Angeles.