A $1.2 billion Risperdal lawsuit verdict was reversed by the Arkansas Supreme Court in March.  The court ruled in favor of the defendant companies Johnson & Johnson and Janssen Pharmaceuticals because the plaintiff team had relied on the “wrong law” for the allegations. The settlement was ultimately dismissed.

The $1.2 billion Risperdal settlement had been previously reached in a lower Arkansas court in case brought by Attorney General Dustin McDaniel. McDaniel represented thousands of patients and families who had been negatively impacted by off-label marketing of Risperdal. In direct result of using the drug, some victims allegedly developed gynecomastia and other Risperdal side effects.

However, Johnson & Johnson and subsidiary Janssen Pharmaceuticals appealed the ruling.  The court ruled in favor of the companies because the charges not only included negligence and liability, but the plaintiffs had also accused the companies of violating Arkansas’ state Medicaid fraud statute.

The state had used a law governing healthcare facilities pertaining to state regulations, the Medicaid fraud statute, to convince the lower court that the companies had conducted deceptive practices to sell Risperdal.  However, the Arkansas Supreme Court overturned this ruling because the pharmaceutical companies were not healthcare facilities, which made the Medicaid allegation invalid.

McDaniel said he was disappointed in the court’s decision because he and the rest of his team were certain that the evidence gathered would give the Attorney General’s Office the authority to penalize the companies for deceiving the public, and putting patients at risk. It remains to be seen whether or not any additional legal action will be taken with this case.

Overview of Risperdal Complications

Risperdal is a popular antipsychotic medication which is prescribed to adolescent and adult patients. 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 its parent company Johnson & Johnson. Despite the drug’s popularity, there has been considerable litigation against the drug and its manufacturers, pertaining to certain side effects and marketing tactics. Many male patients who had taken Risperdal had developed male breast tissue, nipple soreness, and even discharge; many of these cases resulted in surgical intervention and psychological therapy.

In the litigation process, records from the companies showed that Risperdal was often prescribed to treat pediatric patients with bipolar disorder, when the drug had not been approved for that use.  Risperdal is unique among antipsychotics in its mechanism, because it works by blocking the neurotransmitter dopamine. Dopamine is the brain chemical that controls the brain’s motivation, pleasure, movement, and frontal cortex function. Because the drug only focused on one chemical, Risperdal became popular among patients due to the lack of severe physical and mental side effects.

However, gynecomastia was soon discovered to be a side effect of the drug, which has led to hundreds of product liability lawsuits, with the plaintiffs alleging that there had been no indications of this on the drug’s label.