A notice posted at the Complex Litigation Center in Philadelphia indicates a potential step forward in the Risperdal/Gynecomastia litigation.

Risperdal is a psychiatric medication approved for treating schizophrenia, bipolar disorder, and irritability and aggression associated with autism. It is an atypical anti-psychotic. This means the drug belongs to a newer-generation of anti-psychotics, supposedly with fewer side effects. However, it has been alleged that the drugs may have a serious side effect after all, gynecomastia.

Gynecomastia (“man boobs”) is a medical condition in which males grow female-like breasts. The condition can be deeply embarrassing, making males reluctant to seek treatment. Gynecomastia is associated with hormone imbalances, particularly in cases in which a patient has more prolactin than androgens, such as testosterone. Prolactin is the hormone that drives normal breast development in females. Some males develop gynecomastia due to spontaneous hormone imbalances, typically during infancy, puberty, and old age. However, it has been alleged that Risperdal can encourage this condition, particularly when the drug is prescribed to preteens, teens, and young adult males.

One issue that has come up in gynecomastia legislation is off-label usage. Federal law requires drug makers to submit a drug to the U.S. Food and Drug Administration’s rigorous testing and approval process. The law requires drug makers to submit a drug for testing for every proposed illness it can treat. For example, if a drug could treat hay fever and strep throat, the manufacturers would need to get FDA approval for both conditions separately. The law does allow physicians to prescribe a drug for conditions other than those approved by the FDA. For example, if a pilot study indicates that a drug may help with a condition, physicians may make a judgment call and prescribe the drug “off-label.” However, it is illegal for a drug manufacturer to actively promote drugs for off-label uses. If a drug manufacturer does promote a drug for off-label uses, the manufacturer could face lawsuits and government action.

Individual lawsuits have been filed against the manufacturers of Risperdal, alleging the manufacturer did not do enough to warn potential patients of the risk of gynecomastia. Additionally, the lawsuits allege that promoting off-label usage endangered users. More than 430 individual lawsuits have been filed against the makers of Risperdal over gynecomastia.

The Risperdal lawsuits are individual lawsuits, but may be coordinated into a kind of group lawsuit called multidistrict litigation, or MDL. MDL has some similarities to class action lawsuits. MDLs and class action lawsuits allow a group of plaintiffs to seek justice over similar alleged harm. Both MDLs and class action lawsuits are designed to streamline the legal process. The main difference between the two is that class action lawsuits start out as group lawsuits, while MDLs start out as individual lawsuits that are later coordinated into a single legal proceeding.