June 19, 2014 — Attorneys for victims of Risperdal (risperidone) are asking a Philadelphia judge to reconsider a decision banning them from seeking punitive damages against Johnson & Johnson and its Janssen Pharmaceuticals unit, according to Law360.
Last month, a judge granted drug-makers immunity from punitive damages under the New Jersey Product Liability Act. However, attorneys argue that the law does not apply because plaintiffs were injured by “off-label” uses of Risperdal that were never approved by the FDA.
According to the brief:
“That a drug is approved for ‘x’ does not mean it is approved for ‘q.’ When a drug is approved for ‘x’ condition, and prescribed for ‘x’ condition, New Jersey’s bar on punitive damages may or may not apply with respect to that use. But the bar does not apply when a drug is used for an indication the FDA did not approve.”
In November 2013, J&J and Janssen agreed to pay $2.2 billion to the U.S. Department of Justice to settle investigations into illegal marketing of Risperdal and two other drugs. Prosecutors accused drug-makers of promoting Risperdal in children between 1999-2005. The first pediatric indications were approved in October 2006.
Attorneys for J&J have also argued that hundreds of Risperdal lawsuits are time-barred because the statute of limitations began in October 2006. Plaintiffs argue that these rules should not apply because evidence of illegal marketing did not surface until recently.
The lawsuits are currently consolidated as part of a mass-tort program in the Philadelphia Court of Common Pleas. Over 500 lawsuits are now pending against J&J and Janssen. Many of the claims involve men who were prescribed Risperdal “off-label” as children and developed gynecomastia, type-2 diabetes, and other side effects.