The sixth trial against Johnson & Johnson’s Janssen subsidiary concerning its Risperdal anti-psychotic drug is underway in the Philadelphia Court of Common Pleas.
Plaintiff Tommy Moroni of Sargent, Nebraska alleges that he was first prescribed Risperdal in Dec. 2004 to treat his oppositional defiant disorder, anxiety and depression. He took the drug for four years after a doctor diagnosed him with gynecomastia in Nov. 2010. Moroni v. Janssen Pharmaceuticals Inc., case number 130501076, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
2,000 lawsuits filed
Plaintiff attorney Jason Itkin or Arnold & Itkin in Philadelphia argued that Risperdal causes spikes in the prolactin hormone, causing gynecomastia, or the development of female breast tissue.
The litigation has continued for three years, with 2,000 plaintiff cases filed in Philadelphia. 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.
Among the evidence against J&J are:
- Video testimony from former FDA Commissioner David Kessler that J&J manipulated the data shown to the agency to obscure that it causes gynecomastia.
- The FDA approved Risperdal only for treating schizophrenia in adults. The warning label said that gynecomastia was a rare side effect.
- The FDA declined to approve the drug for children in 1997, but in Oct. 2006 approved it to treat symptoms of autism in adolescents.
- Internal emails show company officials saying the drug was worse than its competitors in terms of prolactin elevation.
Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted Risperdal 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.