In the recent litigation movement against the antipsychotic medication Risperdal, its manufacturer, Janssen Pharmaceuticals, has requested that certain documents containing clinical studies on Risperdal side effects remain sealed during the trials, as well as any risks that were discovered. Janssen states that because these documents are not public record, they were not required for the trial.

Janssen Pharmaceuticals is a subsidiary of Johnson & Johnson, who has also been named as a defendant in many of the Risperdal lawsuits. Most of the respective plaintiffs allege that Risperdal side effects caused their sons to grow breasts (gynecomastia), forcing them to undergo extensive treatment to correct it. Janssen filed the motion in 2011 to conceal documents from the public eye because these documents are instrumental to the company.

In the motion, Janssen stated that the plaintiffs were now in possession of evidence that showed their company misrepresented the findings in clinical studies in relation to the occurrence of gynecomastia from Risperdal. However, the documents that plaintiffs specifically want from the company are under protective order, and will not be handed over willingly.

The litigation movement against Janssen Pharmaceuticals and Johnson & Johnson started several years ago, when a large multidistrict litigation (MDL) was established to centralize the growing number of Risperdal lawsuits being filed. On Nov. 4, 2013, Johnson & Johnson agreed to pay out a $2.5 billion settlement to the U.S. Department of Justice in federal criminal and civil penalties, after the company had been accused of marketing Risperdal and two other drugs for off-label uses.

The U.S. government also charged the company with concealing information regarding the potential Risperdal side effect of gynecomastia.

Risperdal lawsuits are continuing to be filed, and motions to retrieve the documents from Janssen have started. Several Risperdal trials against Janssen and Johnson & Johnson have been set to being early June 2014. Many of the charges include: negligence, false advertising, concealing information, and misrepresenting a product.

Risperdal Complications

Risperdal is currently one of the most popular antipsychotic medications used in the United States; it popularity has risen particularly high amongst pediatric children. It was approved by the FDA in 1993 to treat schizophrenia in adult and adolescent patients, has since been prescribed to over 10 million people; generating over 2.1 billion in sales annually for Janssen Pharmaceutical and Johnson & Johnson. Records show that Risperdal was popularly prescribed to treat pediatric patients with bipolar disorder, when the drug was not approved to do so a decade later.

Risperdal is unique amongst most antipsychotics in its mechanism, because it works by blocking the neurotransmitter dopamine. Dopamine is a brain chemical that primarily coordinates the brain’s motivation, pleasure, movement, and frontal cortex function. Other antipsychotics focus on other chemicals, and aim to stabilize the brain as whole, rather than a steady streamline effect as Risperdal does. Many patients on other these other medications often complain that the drugs leave them physically and emotionally exhausted.

Despite the praise the drug has received for its mechanism and effect, it was recently discovered that Risperdal may cause an extreme side effect in adolescent male patients. This side effect, gynecomastia, has been seen in hundreds of Risperdal lawsuits, with the plaintiffs alleging that there had been no indications of this on the drug’s label, and that they had suffered severe emotional pain and suffering.