A lawyer for a boy who allegedly grew breasts from taking Risperdal told a Philadelphia jury last week that Johnson & Johnson illegally marketed the antipsychotic drug to kids as part of a national policy to increase sales to patients beyond the 1 percent of the population who has schizophrenia.
While the plaintiffs painted a picture of a national scheme by Johnson & Johnson subsidiary Janssen Pharmaceuticals to market based on dollars instead of science -- a practice called "off-label marketing" -- Janssen's attorneys emphasized in their opening statements that this case was about one boy and the decision by his doctor to give him what many view as a "miracle" drug.
Opening statements in A.B. v. Janssen Pharmaceuticals were held in Court of Common Pleas in Philadelphia. The case makes for the first of the 86 cases in the court's Risperdal mass torts program to open to a jury. There were eight bellwether cases selected by the parties. The 12-member jury and three alternates in A.B. are hearing a case selected by the defense. Four other cases are scheduled for trial in the coming months.
Attorney Robert Hilliard presented opening statements to the jury on behalf of the plaintiffs, a 17-year-old boy with Asperger's syndrome, and his mother.
"There's just not enough schizophrenics in the United States for them to make enough money," Mr. Hilliard told the jury. He said that caused Janssen to market the drug to treat kids with schizophrenia, which he said was not FDA-approved at the time, but to treat kids with other problems, such as bipolar disorder or behavioral problems.
Mr. Hilliard said the evidence would show that at about the same time A.B. was prescribed Risperdal in 2000 for "conduct disorders," Janssen wrote in an internal marketing report that Risperdal increased the hormone prolactin, which typically causes breast enlargement and milk secretion during pregnancy. This in turn can cause gynecomastia in men, the production of mammary glands, Mr. Hilliard said the marketing report detailed.
Mr. Hilliard told the jury there were three main issues he would prove at trial: The first was Janssen's drug reps were taught to tell doctors the threat of gynecomastia was a problem caused by all second-generation antipsychotic drugs even though, Mr. Hilliard said, Risperdal was the only one to have such an effect.
The second was that Janssen noted on its Risperdal label that the possibility of gynecomastia was "rare," even though its own tests showed that it occurred "more than frequent[ly]."
The third and biggest issue he said was that in 2006, when Janssen again asked the FDA to approve the marketing of Risperdal for the treatment of children, it provided allegedly false data that suggested gynecomastia was not a side effect. The FDA granted approval based on that data, he said.
Laura H. Smith, attorney for Janssen and Johnson & Johnson, said the results of every one of the 18 studies Janssen conducted were turned over to the FDA and were included on the drug's label after the FDA approved the use of Risperdal for children.
Ms. Smith noted several times throughout her opening statements that the FDA approved the drug's use. She also said the case was not about what the world knew or thought of Risperdal, but about what A.B.'s doctor knew of the drug and whether he would have prescribed A.B.'s medication differently had he known.