A Pennsylvania judge has refused to reverse an earlier decision and allow Risperdal plaintiffs to pursue punitive damages in the multidistrict litigation (MDL) against the drug. This decision affects hundreds of Risperdal lawsuits alleging the drug’s label was inadequate and that Risperdal users suffered side effects as result.

In an order recently made public, Judge Arnold New reaffirmed his stance on the Risperdal MDL, stating that plaintiffs cannot seek punitive damages in the product liability lawsuits against Janssen Pharmaceuticals. New cited the New Jersey Product Liability Act, which bars punitive damages in cases involving drugs that have been approved by the FDA.

The plaintiffs argued that New Jersey’s law should not apply to their Risperdal lawsuits, because many of them had been treated with Risperdal for off-label purposes, which is not covered by the New Jersey law. Judge New disagreed, and reaffirmed his stance after analyzing the plaintiffs’ arguments. Additionally, the judge denied a request to certify the matter for an immediate appeal.

The Risperdal mass tort docket currently consists of 600 individual Risperdal lawsuits alleging that Janssen and its parent company, Johnson & Johnson, had known about the side effects of Risperdal but had chosen to conceal them from the public. The allegations made against the companies involve male adolescent patients who had taken the medication and developed gynecomastia, or male breast tissue, as a result. While the defendants argue that they updated Risperdal warning labels to include gynecomastia in 2006, the plaintiffs argued that this warning was not sufficient.

In June, Janssen spokeswoman Robyn Frenza stated that the company stood by the warnings it provided to consumers, noting the “plain text of the Risperdal label as of October 2006 clearly identified the potential side effect of gynecomastia” and saying the company was “prepared to vigorously defend ourselves against these claims”.

The case is In re: Risperdal Litigation, Case No. 100300296, in the Pennsylvania Court of Common Pleas, in the County of Philadelphia.

Overview of Risperdal Complications

Risperdal is currently one of the most popular antipsychotic medications used in the United States. Its popularity has risen highest in pediatric patients. It was originally approved by the FDA in 1993 to treat schizophrenia in adult and adolescent patients, but in 2006 was approved to treat abnormal psychotic disorders in children. Since its release, Risperdal has been prescribed to more than 10 million people, generating more than $2.1 billion in annual sales for Janssen. Risperdal is unique compared to other antipsychotics because it levels the brain’s dopamine level, which controls the brain’s motivation, pleasure, movement, and frontal cortex function. Other anti-psychotics often focus on leveling the entire brain, making the physical and emotional side effects much more severe, leading to Risperdal’s popularity.

Despite the drug’s popularity, Risperdal lawsuits became an issue for the company once allegations of gynecomastia became publicly known. Gynecomastia is the abnormal development of breasts in male patients, which can cause sore nipples, lactation, and psychological trauma. Surgical intervention is often required. Many male patients alleged that they started developing breasts after ingesting the medication, but had been given no warning of it beforehand.