Sanders Phillips Grossman Risperdal Not Federally Preempted


A California appeals court reinstated the eligibility of thousands of claimant cases, reversing a lower court’s grant of Johnson & Johnson and it’s subsidiaries’ motion for summary judgment on federal preemption grounds. The decision allows affected Risperdal cases to proceed in the California coordinated proceeding after years of motion practice.

J&J is defending more than 13,000 lawsuits alleging that Risperdal (risperidone) and Invega (paliperidone) cause gynecomastia, a condition where boys grow female breasts. J&J et al. previously won dismissal of several thousand of the pending California cases on the basis of federal preemption. However, the decision by the California 2nd District Court of Appeal reversed the summary judgment and said that plaintiffs’ claims are not preempted. Trial ready cases should now move forward.

“We applaud the court’s decision,” said Marc Grossman, Senior Partner at Sanders Phillips Grossman. “It was the correct ruling on the merits and sets the stage for us to finally obtain justice for our clients, who have suffered one of the worst injuries you can imagine for a young boy.”

When seeking approval of Risperdal to treat irritability associated with autism in children and adolescents, J&J et al. failed to submit a data set known as “table 21.” Table 21 showed that boys on Risperdal had a statistically significant greater risk to suffer gynecomastia. The finding connects the risk to elevated blood prolactin levels, which both Risperdal and Invega significantly increase. Plaintiffs argue that this led to inadequate labeling which misrepresented Risperdal’s gynecomastia risks.

“Table 21 provided additional information with respect to elevated prolactin levels during different time periods,” the court wrote. “As the risperidone label made no mention of the likelihood of developing side effects related to elevated prolactin levels for different time periods, this information demonstrated a risk of greater frequency than reported on the label.”

Timothy Clark, Co-Lead Counsel of the California JCCP Risperdal Litigation and trial attorney with Sanders Phillips Grossman, said that Table 21 is central to plaintiffs’ arguments that the J&J Defendants failed to warn patients, their families, and prescribers of Risperdal and Invega about the drugs’ true risk of gynecomastia. Defendants not only withheld the information from the drug labeling, but also withheld the information from the published literature regarding analysis of the underlying clinical trials.

Risperdal gynecomastia lawsuits are pending across the country, primarily in California, Pennsylvania, Missouri, and South Carolina. Juries already found Janssen liable with verdicts of $2.5 million, $76 million, and $8 billion, and agreed to settle cases before trial. Janssen also paid a $2.2 billion in criminal and civil fines, penalties, and settlements to resolve claims that it illegally marketed Risperdal, Invega, and other drugs. Risperdal and Invega have generated tens of billions of dollars in sales since being approved for sale in the U.S.

Sanders Phillips Grossman represents approximately 10,000 Risperdal claimants. Since 1965, the firm and its affiliates have recovered over $50 billion in verdicts.

Read Court’s Decision