Dave Kessler, a former U.S. Food and Drug Administration (FDA) commissioner, recently testified in Pennsylvania court that Johnson & Johnson has been aware since 2001 that their anti-psychotic medication Risperdal can cause gynecomastia in young men. This is the first Risperdal lawsuit to go to trial before a jury in Pennsylvania, although more than 1,250 Pennsylvania Risperal lawsuits have been centralized in the state’s Court of Common Pleas.

This Risperdal lawsuit in which Kessler testified was originally filed by Austin P., a 20-year-old male who alleges using Risperdal caused him to grow breasts. According to Kessler’s testimony, in 2001 Johnson & Johnson’s drug subsidiary Janssen conducted a study that revealed a link between the use of Risperdal and a patient’s development of gynecomastia. However, the company chose not to reveal its findings or update its warning labels at that time of this alleged discovery. Instead, J&J waited until 2006 to reveal the Ripserdal gynecomastia link,  and as a result many critics claim that the company’s warning didn’t go far enough in informing consumers of the male breast growth side effects.

The 2001 study found that Risperdal caused male breast growth in 3.8 percent of young boys involved in the Risperdal gynecomastia study. Kessler further testified that Johnson & Johnson had been illegally marketing Risperdal as an anti-psychotic for children years before the FDA approved the drug for that particular demographic.

However, J&J’s alleged illegal marketing did not go unnoticed. In 2013, Johnson & Johnson reached a $2.2 billion settlement with the federal government. This Risperdal settlement is one of the largest pharmaceutical settlements on record to date. This settlement resolved claims that Johnson & Johnson illegally marketed Risperdal and several other drugs. A whistleblower in the company helped the federal government gather evidence of the illegal activity by wearing a recording device during company sales representative meetings.

According to the whistleblower, Johnson & Johnson pushed their sales representatives to market Risperdal for off-label (non FDA approved) uses and rewarded bonuses to representatives who made off-label sales. Of the $2.2 billion dollar settlement, $485 million was alloted to pay criminal fines; the remaining $1.72 billion was divided between the federal government, the states, and the various whistleblowers who revealed Johnson & Johnson’s illegal Risperdal marketing activity.

Despite the company’s previous legal entanglements related to the marketing and sales of the popular anti-psychotic drug, J&J and Janssen are now facing thousands of Ripserdal gynecomastia lawsuits, claiming the company failed to fully inform consumers of the male breast growth side effects allegedly caused by Risperdal.

Overview of Gynecomastia Lawsuits

Hundreds of Risperdal lawsuits have been filed against Johnson & Johnson for intentionally and negligently failing to warn the medical community and the general public of the various complications associated with taking Risperdal.

Risperdal is an antipsychotic drug often used to treat schizophrenia, autism, and symptoms of bipolar disorder. Complications associated with taking Risperdal include gynecomastia (also known as male breast growth), painful breasts, nipple pain, and/or nipple discharge. The condition can be painful and may require surgery to correct the Risperdal side effects.

Medical researchers believe that Risperdal may increase levels of prolactin in young males. Prolactin is the hormone responsible for breast growth in women and its is believed cause the unnatural development of breast tissue in young men/children.

The plaintiffs involved in the Risperdal lawsuits are generally young men to who took Risperdal between the ages of 10 and 18. Male breast growth in adolescent males is an embarrassing condition that has caused both physical and mental suffering. The plaintiffs bringing Risperdal lawsuits against J&J hope to recover compensation for their medical bills as well as the pain, suffering, and psychological trauma they experienced due to Risperdal side effects. The number of Risperdal lawsuits being filed in state and federal courts across the nation continues to grow as the side effects of Risperdal become more widely known.