Janssen Pharmaceuticals and Johnson & Johnson continue to face regulatory actions and hundreds of civil claims over its allegedly off-label marketing for Risperdal.

Risperdal, also known under its generic name Risperidone, is now FDA-approved as a treatment for bipolar disorder and schizophrenia, and also for autism-spectrum disorders in children and adolescents. Originally approved in the 1990s, it was not approved for any use in young patients until 2006.

Study Shows Risperdal Gynecomastia Link

Study data shows Risperdal tends to increase levels of prolactin, a hormone related to breast development. In male patients of any age, this increase in prolactin can lead to gynecomastia, or Risperdal male breast growth.

Based on that scientific evidence, manufacturers Janssen Pharmaceuticals and its parent company Johnson & Johnson have been facing ponderous amounts of litigation from both private plaintiffs and from federal and state regulatory authorities. These efforts frequently focus on the companies’ efforts to promote Risperdal for off-label use in children without prior FDA approval for that use.

Risperdal Litigation

The first private Risperdal lawsuit to go to trial settled quickly. The plaintiff in that action recalled being prescribed Risperdal at age nine, at a time when the drug was not approved for use in children. He later developed gynecomastia severe enough to require surgical correction. J&J settled that claim on the first day of trial for an undisclosed amount.

Risperdal was also the subject of a large investigation by federal and state governments into Janssen and J&J’s marketing practices. The U.S. Department of Justice looked into allegations that from as early as 1994 to 2005, the companies had unlawfully promoted Risperdal for use in younger patients before the FDA had approved the drug for use in any patients other than adults. The investigation culminated in a 2013 settlement worth up to $2.2 billion, the largest settlement of its kind at the time.

Investigators found that J&J had offered doctors incentives like travel and consulting contracts in exchange for prescribing Risperdal. There was also evidence that J&J had encouraged sales representatives to promote off-label uses of Risperdal directly to doctors.

Individual states have also waged successful prosecution for improper marketing. South Carolina won a $327 million penalty in a false marketing Risperdal lawsuit. A later case brought by Texas settled for $158 million, and a Risperdal lawsuit by Montana settled for $5.9 million.

On the private side, Janssen and J&J have been facing over a thousand civil Risperdal lawsuits around the country. In February 2015, the first Risperdal lawsuit to be tried before a jury yielded a $2.5 million verdict in the plaintiff’s favor. The plaintiff had begun taking Risperdal at age eight and eventually developed pronounced gynecomastia as a teenager.

In that trial a biochemist for J&J testified that the FDA never saw certain study results showing a link between Risperdal and abnormal hormone levels.

These documents included tables from a 2003 study that showed a relationship between Risperdal use and the development of gynecomastia. The tables were not included in the final draft of the Janssen-funded study, which concluded it found no link between Risperdal and elevated levels of prolactin.