A Philadelphia jury returned a $2.5 million in damages against a Johnson & Johnson unit in the first verdict over the antipsychotic drug Risperdal’s connections to abnormal breast growth in males. The jury found the drugmaker failed to warn an autistic boy’s parents and physicians of the risks. The verdict came after a lengthy trial in the Philadelphia County Court of Common Pleas. The jury heard evidence that Janssen Pharmaceuticals Inc. had worked for years to obscure evidence that the drug was linked to growth of female breast tissue — a condition known as gynecomastia — in adolescent boys.
While thousands of product liability lawsuits are pending nationwide over Risperdal’s links to gynecomastia, this verdict is the very first. More than 1,250 Risperdal-related cases are lined up as part of a mass tort docket in Philadelphia. A second trial got underway there on Feb. 20. Meanwhile, some 700 suits have been filed in state court in Los Angeles. The family of 20-year-old Austin Pledger filed suit against J&J in April 2012, alleging that the boy grew large breasts after a nearly five-year course of Risperdal treatment beginning in 2002, when he was 7 years of age.
At the time, the drug was approved by the U.S. Food and Drug Administration (FDA) only for use in adults. The jury, however, was told that Janssen sales representatives visited Pledger’s prescribing physician, a pediatric neurologist, multiple times between 2002 and 2004 to distribute samples of the drug. According to testimony in the case, about 20 percent of the Risperdal prescribed before the early 2000s was used in children and adolescents. 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. Previously, the label had said the condition was considered rare.
The trial featured several days of testimony from a former FDA commissioner, David Kessler, who said 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.
The company agreed to admit criminal misconduct and pay $2.2 billion in November 2013, to resolve federal False Claims Act allegations that it paid kickbacks to doctors and illegally promoted three of its drugs, including Risperdal, for off-label use. As part of the accord, J&J unit Janssen will plead guilty to one misdemeanor count of misbranding, for improperly encouraging prescribers to treat dementia with Risperdal despite its being approved only to address schizophrenia when the conduct took place in 2002 and 2003.
In August 2012, the company agreed to pay $181 million to 36 states and Washington, D.C., to resolve similar claims of off-label marketing. Despite facing other sizable damage awards in cases brought by state attorneys general, the company has managed to prevail in several appeals. While Janssen had faced the prospect of a $1.2 billion fine after Arkansas’s attorney general accused the company of making false representations about the drug’s safety in a bid to defraud the state’s Medicaid program, the Arkansas Supreme Court upended the award in March 2014. The Louisiana Supreme Court, meanwhile, struck down a $258 million damages award against Janssen in January 2014, ending similar claims leveled by the attorney general there.
The Plaintiffs are represented in the case by Tom Kline of Kline & Specter PC; and Christopher Gomez of Sheller PC. The case is in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
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