The complainant was a 17 year old boy, represented by his legal counsel, complained that he grew breasts after taking Risperdal. He claimed that the company Johnson & Johnson has been marketing illegally this antipsychotic drug to people in their campaign to increase sales beyond the 1% of population with schizophrenia.
The plaintiffs described a picture of Johnson & Johnson subsidiary Janssen Pharmaceutical whose main interest is marketing products for its dollar profit not what science is suppose accomplish. The defendant claimed that the boy’s doctors decided to give him what they considered what as a miracle drug.
The hearing was held in the Court of Common Pleas in Philadelphia; which is marked as the first of the 86 cases filed in court concerning Risperdal. There will be eight other cases to be heard by a 12-member jury and three alternates in A.B.. Four other cases are scheduled for trial in the coming months.
The lawyer of the claimant stated that there is not enough cases of schizophrenics in the United State that caused Janssen to market the drug to treat kids with schizophrenia. The drug is not approved by FDA at the time, but was approved to treat kids with other problems, such as bipolar disorder or behavioral problems. But at this time they placed Risperdal in the market for conduct disorder.
In the internal marketing report, Janssen stated that Risperdal has the prolactin hormone prolactin that causes breast enlargement and milk secretion during pregnancy. If imbibed by the male, it causes gynecomastia that is the growth of the mammary glands.
The prosecuting attorney told that three main issues will be proven at trial: The first was that its drug reps told doctors of the risk of gynecomastia due to second-generation antipsychotic drugs; although they know only Risperdal was the only one having such an effect.
The second was that Janssen placed in the Risperdal label that the possibility of gynecomastia was very rare; although the tests conducted showed that it happens often.
The third and the most relevant issue he said was that in 2006, when Janssen was asking again the FDA to approve Risperdal for the treatment of children, it provided false data that made no mention of gynecomastia as a side effect. The FDA granted approval based on that data, he said.
Laura H. Smith, defense counsel for Janssen and Johnson & Johnson, claimed that the outcomes of the 18 studies Janssen conducted by the company were submitted to the FDA and the effects were stated in the drug’s label. After which, it got FDA approval for children’s use.
Ms. Smith was always emphasizing in her defense that FDA approved the use of the drugs. She said that the physician of the claimant has full knowledge of the drug’s effect and prescribed it to the boy.
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