The issue of U.S. Food and Drug Administration approval and off-label usage could play a major role in the upcoming Risperdal lawsuits. Rules relating to FDA approval could potentially complicate Risperdal lawsuits.

Risperdal is a drug originally approved to treat schizophrenia. Like many psychiatric drugs, it was discovered that the drug could help other disorders. It was eventually approved to treat bipolar disorder, and later aggression and irritability associated with autism. However, the drug has been linked to a disturbing side effect called gynecomastia.

Gynecomastia is the development of female-like breasts in males. It has been alleged that patients who took Risperdal during childhood and their teen years have an increased risk of the disorder, which has led to legal scrutiny, Risperdal lawsuits, and multimillion dollar settlements. But the issue of FDA approval may further complicate the issue.

According to U.S. law, a drug maker must submit a drug for FDA approval before marketing and selling it. This process involves extensive testing for both safety and efficacy. The process is also very specific. When the FDA approves a drug, it is typically approved for one purpose at a time. Though a drug can be approved for more than one purpose, it must be approved separately for each purpose. In the example of Risperdal, it had to be approved separately for schizophrenia, bipolar disorder, and specific autism symptoms.

However, doctors may prescribe a drug for other purposes. This is called “off-label usage.” Doctors may prescribe a drug for off-label use if research studies are moving faster than the FDA approval process and the drug may help their patients. While the practice is legal, a drug company may not promote off-label usage of its drugs.

Risperdal lawsuits allege the manufacturer promoted the drug for several off-label uses, including dementia. Studies have shown that elderly dementia patients taking Risperdal were more likely to die than their peers. Because the makers of Risperdal have had to settle lawsuits and pay fines over this issue has hung heavily over the litigation over gynecomastia.

A type of legal action called multidistrict litigation or MDL has been approved for the Risperdal lawsuits. An MDL is a type of legal action in which individual lawsuits are combined into a single proceeding. In some ways, MDLs are similar to class action lawsuits. In both class action lawsuits and MDLs, a group of plaintiffs allege they have suffered similar harm at the hands of the same defendants. The main difference is that class action lawsuits start out as a group action, while MDLs start out as individual lawsuits that are later combined. Both MDLs and class action lawsuits are designed to help streamline the legal process by combining tens, hundreds, or even thousands, of individual cases into a single legal action.

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