The first Risperdal bellwether trial is scheduled for May 13 in a Philadelphia court. This trial is the first in a series of Risperdal lawsuits alleging gynecomastia development and injuries.

Gynecomastia is a condition in which breast growth occurs in men. It is an infamous condition, and a well-known side effect of Risperdal. Most of the plaintiffs in the Risperdal lawsuits allege that they were forced to undergo liposuction or mastectomies to remove excess breast tissue, as well as sustaining severe psychological and emotional distress.

The trial will take place at the Complex Litigation Center at the Philadelphia City Hall. According to court documents, a mass tort Risperdal lawsuit movement is currently underway in the Philadelphia Court of Common Pleas in Pennsylvania.

This mass tort involves more than 350 Risperdal gynecomastia lawsuits consolidated in the Risperdal multidistrict litigation (MDL) or mass tort. The company at the center of all the Risperdal lawsuits is Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. The Risperdal lawsuits allege that the companies concealed the risk of gynecomastia from patients, physicians and the general public to preserve the company’s profit margin.

Janssen had also been accused of hiding this side effect from the U.S. Food and Drug Administration (FDA), in order to ensure the drug’s approval. Risperdal is an atypical antipsychotic medication that was approved to treat bipolar disorder, schizophrenia and irritability in autistic children and adolescents. However, according to the U.S. Justice Department, Janssen began marketing Risperdal for off-label purposes in March 2002 when it was advertised as a safe and effective treatment for dementia patients.

When this action was discovered, the FDA states that it does not exercise power over the discretion of a physicians’ decisions in prescribing medications. However, when a pharmaceutical company advertises a drug for an unapproved purpose, it is in violation of federal law. The FDA warned Janssen and Johnson & Johnson that its Risperdal marketing practices were dishonest and misleading.

In November 2013, a whistleblower lawsuit was filed against Janssen, which initiated an investigation launched by the FDA. The investigation resulted in criminal charges being brought forward by the Justice Department. Janssen pled guilty and agreed to pay $400 million in criminal fines, and paid a separate civil settlement of $1.25 billion.

With the date of the first Risperdal bellwether trial set, both parties prepare and anticipate the results of the trial. According to court documents, approximately 80 Risperdal gynecomastia lawsuits have been settled in the Pennsylvania court.

Overview of Risperdal Complications

Across the country, families are filing lawsuits against Janssen and Johnson & Johnson on behalf of their young male children who had taken Risperdal and developed gynecomastia. Risperdal is manufactured by Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, and was originally approved by the FDA in 1993. It was later approved in 2007 to treat schizophrenia in children ages 13 to 17 and bipolar disorder in children ages 10 through 17. Johnson & Johnson allegedly promoted Risperdal for pediatric use shortly after its release.

Due to the gynecomastia side effect caused by Risperdal, Johnson & Johnson paid one of the largest healthcare fraud settlements in the history of the United States. Despite the recent negative media attention, Risperdal remains one of the most popular antipsychotic medications in the country. Many experts attribute the success of this drug to its unique mechanism — Risperdal channels the brain’s dopamine chemical to control the patient’s mood swings.