So many Risperdal lawsuits have been filed that the legal system has created a Risperdal lawsuit multidistrict litigation (MDL) to manage the thousands of Risperdal lawsuits. A pediatric psychiatrist testifying in a Risperdal trial has indicated that the drug may be the best option for treating certain aggressive behaviors in children.

Risperdal is a psychiatric drug, approved to treat schizophrenia, bipolar disorder, and some symptoms of autism. When it was developed, Risperdal was championed as a superior drug to older antipsychotics, since older-generation drugs for schizophrenia often caused extreme sedation. However, Risperdal lawsuits have alleged that Risperdal side effects are serious in their own right.

The current crop of Risperdal lawsuits mostly focus on accusations that Risperdal can cause a condition colloquially called “man boobs” or, more clinically, gynecomastia. With gynecomastia, males experience female-like breast growth.

Risperdal gynecomastia can be extremely embarrassing for patients suffering from the condition. The drug is primarily prescribed to patients with mental illness and autism, a particularly vulnerable population. Additionally, Risperdal gynecomastia may require surgical intervention.

The legal system has created a Risperdal MDL to cope with the growing number of Risperdal lawsuits. An MDL is a process the legal system uses to coordinate similar cases. Since Risperdal lawsuits typically make similar allegations and hinge on similar evidence, Risperdal lawsuits are particularly well-suited for inclusion in an MDL.

One element of MDLs is that early lawsuits, called bellwether trials, hit the legal system first. These bellwether trials help establish precedents that can be applied to the rest of the Risperdal lawsuits in the MDL. Additionally, bellwether Risperdal lawsuits may cause drug maker Janssen Pharmaceuticals to agree to settlements with the remaining Risperdal lawsuit in the MDL based on how the first Risperdal lawsuits turn out.

At present, the Risperdal lawsuits are in this bellwether stage, and lawsuits that could determine the outcome of the larger Risperdal MDL are currently playing out in courtrooms. In one recent Risperdal lawsuit, a pediatric psychiatrist testified in favor of the companies that make Risperdal.

This medical professional stated that Risperdal, even with the risk of gynecomastia was among the best drugs for treating certain aggressive behaviors seen in children with autism. Additionally, the pediatric psychiatrist states that Risperdal now carries a warning regarding Risperdal gynecomastia, possibly preempting claims.

However, one issue that has come up in Risperdal lawsuits is off-label promotion. Under federal law, drug makers must perform tests in accordance with FDA protocols and get approval from the FDA before they can market a drug.

Additionally, drug makers have to get approval for each purpose they intend to market their drug. For example, Risperdal had to get separate approval for schizophrenia, bipolar, and autism symptoms. However, federal law recognizes that sometimes medical science moves faster than FDA approval, and doctors are allowed to prescribe drugs for other conditions based on their best judgment, which is called off-label use.

But it is illegal for drug companies to promote drugs for off-label use. The makers of Risperdal have been fined and sued in separate Risperdal lawsuits for off-label use. This could have a bearing on Risperdal gynecomastia lawsuits, if plaintiffs can convince the courts that Risperdal’s makers aggressively promoted the drug in spite of the risk of Risperdal gynecomastia.