In re Risperdal (Risperidone) Products Liability Litigation (Gynecomastia) Lawsuit

In re Risperdal (Risperidone) Products Liability Litigation (Gynecomastia)

• Type: Products liability mass tort (pharmaceutical)

• Country: United States

• Court: Court of Common Pleas of Philadelphia County, Pennsylvania (MDL)

• Resolved: 2021 (settlement)

Product and manufacturer

Risperdal (risperidone) is an atypical antipsychotic manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J). It is prescribed for schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. The FDA first approved the drug in 1993 for schizophrenia, added a bipolar indication in 2003 and an autism-related indication in 2006; Janssen's patent expired in 2003 and generic versions entered the market. Like other antipsychotics that antagonize dopamine receptors, risperidone elevates prolactin levels, and elevated prolactin was a listed side effect from early on. Prolactin elevation is associated with a set of endocrine effects — in susceptible male patients, including development of breast tissue (gynecomastia), particularly in boys and young men whose hormones are still developing.

Alleged harm

The centralized litigation concerned boys and young men who developed gynecomastia after taking Risperdal. Plaintiffs alleged that J&J was aware of the prolactin-related risk in males as early as 2001, but did not add a specific warning about the risk to the label until 2006, and that in the interim the company promoted the drug for off-label uses in children. The drug's mechanism — dopamine antagonism with resulting prolactin secretion — is well documented in pharmacology, and gynecomastia is a recognized prolactin-related adverse effect; the legal dispute therefore centered on the adequacy and timing of the warning, the marketing of the drug to young male patients, and the individual plaintiffs' treatment histories.

Course of the litigation

Cases were centralized as an MDL in the Court of Common Pleas of Philadelphia County, Pennsylvania. By mid-2016 the docket held roughly 1,500 cases, and the number of claims grew into the tens of thousands by 2017. The 2015–2016 bellwether trials produced verdicts against J&J, and a 2019 jury returned a large punitive damages award against the company in one case; a judge later reduced that punitive award by more than a thousand-fold (per the Risperidone Wikipedia article). The MDL ran in parallel with separate marketing-related proceedings: in 2012 an Arkansas jury returned a verdict against J&J over the downplaying of risks associated with risperidone, which the Arkansas Supreme Court later reversed (per the Risperidone Wikipedia article); in August 2012 J&J settled claims by 36 states concerning the promotion of risperidone and paliperidone for off-label uses including dementia, and in November 2013 it resolved the U.S. Department of Justice's criminal and civil investigations into the drug's marketing (per a U.S. Department of Justice press release, justice.gov).

Resolution

On October 30, 2021, J&J agreed to settle the bulk of the remaining personal-injury cases in the gynecomastia MDL (per Reuters' October 30, 2021 report), resolving the core of the litigation. The settlement followed the warning change the plaintiffs had challenged: the label now carries an explicit warning about the risk of gynecomastia in male patients.

Aftermath

Risperidone remains a commonly prescribed antipsychotic, largely as generics, for its approved indications. The gynecomastia MDL is now cited alongside other warning-and-marketing drug mass torts as an example of a product whose endocrine side effect in a young population drove more than a decade of consolidated litigation, ending in a manufacturer settlement of the consolidated personal-injury docket.