The mass tort litigation over the antipsychotic Risperdal moves forward with the start of a fifth trial in Pennsylvania. The plaintiff is a Tennessee man who began taking Risperdal in 2003 for psychiatric problems. Within a year of taking Risperdal, the plaintiff began developing male breasts, a condition called gynecomastia. The trial is expected to last several weeks, but has already caused quite a stir.
When the plaintiff began taking Risperdal, it was only approved to treat schizophrenia in adults, and the warning label downplayed the risk of gynecomastia, calling it a rare side effect. However, studies have shown that gynecomastia is a far more frequent side effect than Risperdal’s manufacturers reported to the Food and Drug Administration (FDA).
The trial began with the videotaped deposition of former FDA Commissioner David Kessler. Mr. Keppler testified that Johnson & Johnson manipulated data shown to the FDA to obscure evidence of a link between Risperdal and gynecomastia.
Internal emails from Risperdal’s manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), support Mr. Keppler’s testimony that the company knew about the increased risk of developing gynecomastia, but withheld this information from the FDA.
In 2013, Johnson & Johnson agreed to pay $2.2 billion to settle criminal and civil claims concerning its illegal marketing practices promoting Risperdal for use in children and the elderly. The company might have thought that multi-billion dollar payout would be the end of its trouble with Risperdal, but since then several states have also filed lawsuits against the company for defrauding state Medicaid programs. Additionally, J&J has another 1,500 lawsuits pending in the mass tort litigation.
Previous Risperdal trials have not gone well for J&J, most recently rendering a judgment of $1.75 million for a plaintiff this past November. Having already been slapped with several multimillion dollar verdicts this year in talcum powder and defective hip implants lawsuits, J&J has a lot at stake.