Eight cases involving the antipsychotic drug Risperdal are set for trial against Janssen Pharmaceuticals in the Philadelphia Court of Common Pleas, with the company settling cases even as it denies that the drug causes disfiguring gynecomastia in boys.
Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has caused gynecomastia, or the development of female breast tissue, according to leading plaintiff’s lawyer Derek T. Braslow of Pogust, Braslow & Millrood in Conshohocken, PA. This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.
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The litigation has been continuing for three years, with 2,000 plaintiff cases filed in Philadelphia and the next trial set for January. Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July. Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000. In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.
Fined $2.2 Billion
Janssen, a subsidiary of Johnson & Johnson, never got approval to market the drug for minors. Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted the drug to older adults, children and people with developmental disabilities, according to the Justice Department.
Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.
Former commissioner of the U.S. Food & Drug Administration (FDA) David Kessler testified in 2015 that the company hid information about the gynecomastia risk as early as 6 years before it changed the drug’s label to include the injury, which is characterized by abnormal breast tissue growth in adolescent boys and young men. He also told the jury that Janssen failed to inform physicians of the gynecomastia risk associated with the drug.
Scientific research supports claims that Risperdal may cause gynecomastia in boys. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology indicated that risperidone, which is the generic of Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”
Braslow said that J&J has been settling Risperdal cases, but the amounts are not disclosed. The highest settlements are for boys who undergo double mastectomy. He advised plaintiff lawyers to focus on cases involving prescriptions written from 2000 to 2006.
Risperdal has carried a black-box warning by the FDA since September 2006 to warn about the increased risk of death in elderly patients with dementia-related psychosis. In addition to the increased risk of death in the elderly, Risperdal has added warnings associated with Tardive Dyskinesia, which is the development of abnormal facial, shoulder and limb movements that a patient cannot control.