Johnson & Johnson is facing Risperdal lawsuits on several fronts over various concerns with their drug.

Risperdal (Risperidone) is an atypical antipsychotic. This means that it belongs to a newer generation of antipsychotic drugs, intended to have fewer side effects than older antipsychotics. Older antipsychotics, such as Thorazine, had sedation and fatigue as major side effects.

Risperdal was originally intended to treat schizophrenia. However, like many psychiatric drugs, other uses were found for the drug. It was eventually approved by the U.S. Food and Drug Administration to treat bipolar disorder, as well as aggression and irritability associated with autism. However, it has been associated with a number of serious side effects, including gynecomastia.

Gynecomastia is a condition in which a male grows female-like breasts. It can occur without drugs, typically when levels of prolactin, a hormone, are abnormally high in males. Males are most likely to develop gynecomastia when they are infants, preteens, and the end of middle age, ages when individuals’ hormone levels are in flux. However, certain drugs, including Rispderal, have been known to increase prolactin levels, allegedly increasing a person’s risk of gynecomastia. Of cases with known causes, drugs are a major cause of gynecomastia.

One issue that has come up with Risperdal lawsuits is the issue of off-label usage. Under U.S. law, drug makers can only market a drug for purposes for which they have thoroughly tested a drug. A drug maker has to get FDA approval for each condition or disease that a drug may treat. Drug companies are forbidden from marketing drugs for unapproved purposes. Physicians are, however, allowed to use drugs for other purposes, called “off-label uses.” Medical professionals may make these decisions with their patients based on early research that has not yet gone through FDA approval.

Risperdal’s manufacturers have faced Risperdal lawsuits and other legal action on several fronts. This has been over issues including sales practices (i.e. off-label uses) as well as safety issues like gynecomastia. This has resulted billions in fines and settlements over. Additionally, Risperdal gynecomastia lawsuits may take the form of a multidistrict litigation or MDL. MDLs are a type of group lawsuit, similar to class action lawsuits. In both MDLs and class action lawsuits, a group of people allege that they suffered similar damages at the hands of the same defendant. Class action lawsuits and MDLs are designed to streamline the legal system by combing dozens, hundreds, or even thousands of individual suits into a single legal procedure. An MDL over the gynecomastia issue is currently under consideration in the Philadelphia Court of Common Pleas.

The Rispderal MDL is In re: Risperdal Litigation, Case No. 100300296, in the Philadelphia Court of Common Pleas.