On May 8, 2020, the Second District Court of Appeal in California issued a decision that may reinstate potentially hundreds of lawsuits against Johnson & Johnson for its product Risperdal. Readers may recall the Risperdal cases that are pending across the country, with a segment of cases in California, Pennsylvania, Missouri, and South Carolina.
Men, boys, and their families are suing Johnson & Johnson and affiliates (such as Janssen Pharmaceuticals), alleging that the drug Risperdal, used to treat mental illnesses such as schizophrenia and bipolar I disorder, caused gynecomastia.
Previously, Johnson & Johnson had been granted a summary judgment on federal preemption grounds, which halted the California cases from moving forward.
However, the recent May 8 decision reverses that summary judgment decision with respect to two of the plaintiffs, concluding that there was “no clear evidence” that the United States Food and Drug Administration (FDA) would have rejected a revised warning label on the prescription drug, as is required under the United States Supreme Court decision Wyeth v. Levine. “Impossibility preemption requires the drug manufacturer to show that it fully informed the FDA,” Justice Halim Dhanidina wrote in the decision, continuing, “Janssen did not.”
Table 21
In making its decision, the appeals court seemed to focus on “table 21,” a set of data that Johnson & Johnson did not disclose to the FDA which showed a “statistically significant association” between Risperdal and elevated blood prolactin levels.
“Specifically, table 21 tended to show that children who had elevated prolactin after taking risperidone [the generic form of Risperdal] for eight to 12 weeks were 2.8 times more likely to develop prolactin-related side effects, including gynecomastia,” the opinion says. “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 then reported on the label.”
This decision may impact over 300 lawsuits filed by individuals who took Risperdal as children prior to a 2006 label change that did warn of gynecomastia.
Prior Risperdal Verdicts
This may be a financial liability for Johnson and Johnson, as juries in Philadelphia have already found Johnson & Johnson subsidiary Janssen liable with high verdicts of $2.5 million, $70 million, and a record $8 billion. Janssen also paid $2.2 billion in criminal and civil fines, penalties, and settlements to resolve claims that it illegally marketed Risperdal, Invega, and other drugs.
Reactions
Plaintiff-Side
“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.”
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.
Johnson & Johnson
Johnson & Johnson, represented by Faegre Drinker Biddle & Reath in the appeal, downplayed the ruling’s significance in a statement, “The court of appeals largely affirmed the dismissal of the plaintiffs’ case except for a very narrow theory that the company has not seen factually supported in any of the 320 cases that have been stayed pending this ruling. The company is considering whether to seek further review of the court’s limited reversal ruling.”