Risperdal Lawsuit Plaintiff Given Leave to Amend Off-Label Marketing Claims Against Generic Drug Maker

Published on October 4, 2017 by Sandy Liebhard

A Risperdal lawsuit plaintiff will be permitted to amend his off-label marketing claims against two generic drug makers, after a Texas federal judge found that the allegations were inadequately pled.

According to HarrisMartin.com, Malcom Wydermyer alleges that his use of Risperdal and generic risperidone caused him to develop gynecomastia, a condition marked by the excessive growth of breast tissue in men and boys. He further claimed that the defendants improperly marketed the drugs for off-label indications, leading to his injuries.

The two generic drug makers named in the lawsuit – Zydus Pharmaceuticals Inc. and Par Pharmaceutical Companies – moved to have the off-label marketing claims dismissed, arguing, among other things, that the claims were preempted, barred by the learned intermediary doctrine, and inadequately pled.

In July, U.S. Magistrate Judge K. Nicole Mitchell of the Eastern District of Texas issued a report finding that the off-label promotion allegations were not preempted or barred. However, she  did recommend that the allegations be dismissed on the grounds that they inadequately pled, as the plaintiff had not sufficiently identified the promotional activities taken by defendants or their agents. Finally, Judge Mitchell recommended that the plaintiff be permitted to amend his complaint to cure those deficiencies.

U.S. District Judge Robert W. Schroeder III adopted Judge Mitchell’s recommendations in an Order dated September 12, 2017.

What is Risperdal?

Risperdal is an atypical antipsychotic approved to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. It is also frequently prescribed off-label to treat children with ADHD.

Risperdal was first approved by the U.S. Food & Drug Administration (FDA) in 1993. Its approved indications were expanded to certain pediatric uses in October 2006. That same month, the drug’s prescribing information was updated to note that 2.3% of male adolescents treated with Risperdal had developed gynecomastia. Prior to that, the Risperdal label characterized the condition as a rare side effect that appeared in less than 1 in 1,000 patients.

The first generic version of Risperdal was cleared by the FDA in July 2008.

In November 2013, the U.S. Department of Justice (DOJ) announced that Johnson & Johnson and its Janssen Pharmaceuticals unit had agreed to pay $2.2 billion to settle charges that they improperly marketed Risperdal and other medications. While the companies pled guilty to illegally promoting the drug for off-label use in elderly dementia patients, they did not admit to allegations that they had illegally marketed Risperdal for use in children prior to 2006.

Risperdal Gynecomastia Litigation

According to Johnson & Johnson’s most recent quarterly earnings report, more than 13,000 Risperdal lawsuits have been filed on behalf of patients who suffered gynecomastia and other side effects allegedly related to its use.

One of the country’s largest Risperdal litigations is currently underway in the Philadelphia Court of Common Pleas in Pennsylvania, where seven gynecomastia lawsuits have already gone to trial. Four of these cases resulted in plaintiffs’ verdicts and damage awards ranging from $500,000 to $70 million.

Two Risperdal lawsuits were dismissed midtrial, while another ended with a partial verdict for the defense. Several other Pennsylvania gynecomastia cases have settled just before trials were to begin.