Under certain circumstances, males may grow female-like breasts or “man boobs.” Physicians call this condition gynecomastia. This can be shocking and confusing for males in this situation, which can have a variety of causes.

Gynecomastia has what statisticians call a “trimodal” peak of incidence. This means that three groups of men are most likely to experience this disorder — newborns, adolescents, and men over fifty. The epidemiology of the disorder is not fully understood, but it does appear to be getting more common.

In 2006, more than 14,000 gynecomastia patients underwent surgery to correct the disorder.

Many cases appear for no apparent reason. However, it is believed that many cases in the three peak ages of the disorder have to do with hormone imbalances. Newborns may have elevated levels of female hormones since they have just spent nine months living in a female body. Similarly, hormone imbalances are not uncommon in adolescents. Lastly, declining testosterone levels in older men may also trigger the disorders.

However, a major cause is exposure to various chemicals. For example, organophosphates, a dangerous class of chemicals found in both pesticides and chemical weapons, have been known to trigger gynecomastia. Many cases of gynecomastia can also be traced to drugs, including steroids and Risperdal (Risperidone).

Risperdal has been approved by the U.S. Food and Drug Administration to treat schizophrenia, bipolar disorder, and aggression/irritability due to autism. While drugs like Risperdal can be a godsend for those suffering from debilitating psychiatric issues, the drug has also been linked to an increased risk of developing gynecomastia. This has lead to dozens, if not hundreds of Risperdal lawsuits being filed against Janssen Pharmaceuticals, a Johnson & Johnson subsidiary.

Risperdal Lawsuits

One issue that has repeatedly come up in Risperdal litigation is the issue of off-label uses. Under federal law, a drug can only be marketed if the drug’s manufacturers have tested the drug according to FDA standards. These tests are for both safety and efficacy. However, whenever a drug is submitted for FDA approval, that approval is only for the conditions tested. This means that the FDA only approves a drug for one disease or condition at a time. If a company wants to market a drug for more than one purpose, it must apply for approval for each purpose.

But in some cases, preliminary work may show that a drug can be a useful tool to treat other illnesses. In these cases, physicians are allowed to prescribe the drug for off-label uses so long as the physician has cause to believe the drug could benefit their patient.

That being said, drug companies are forbidden from advertising drugs for off-label uses. Physicians usually learn about these uses through peer-reviewed journal articles and preliminary clinical trials. It has been alleged — and become a sticking point in Risperdal lawsuits — that the makers of the drug aggressively promoted the drug for off-label uses.

Risperdal lawsuits may take the form of a Multi-District Litigation (MDL), also called Mass Torts. Mass Torts are a type a group lawsuit, similar to a class action lawsuit. Both class action lawsuits and Mass Torts involve a group of people alleging that they have suffered similar harms at the hand of the same defendant. The main difference is that class action lawsuits all plaintiffs join onto the same lawsuit, while Mass Torts remain individual lawsuits that are able to benefit from the same resources.