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Shezad Malik MD JD
Shezad Malik MD JD
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Johnson and Johnson Hammered in First Risperdal Breast Growth Trial

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The jury has spoken loud and clear, sending a strong message in Johnson & Johnson’s Risperdal trial. The Philadelphia panel found that J&J had failed to properly warn that the antipsychotic drug could cause breast development (gynecomastia) in boys and young men, in the first of more than 3,000 similar pending lawsuits.

dallas_dangerous_drugs_attorney$2.5M Risperdal Gynecomastia Jury Verdict

After a month long trial, the jury ordered J&J to pay $2.5 million to Austin Pledger who developed 46DD breasts while taking the antipsychotic drug.

The plaintiff had blamed J&J for knowing that for years that the drug could cause gynecomastia, but hid the data and not informing the FDA. The FDA changed Risperdal’s warning label in 2006, four years after Pledger started taking the drug.

When Pledger’s doctor first prescribed Risperdal, it wasn’t approved for use in children and adolescents.

What is Risperdal Gynecomastia?

Gynecomastia is a medical condition associated with the growth of breast tissue among males. Plaintiffs blame the breast development by the Risperdal medication that resulted in the need for surgical treatment to remove the breasts, causing serious scarring and severe psychological injury from the gynecomastia breast growth.

Justice Department $2.2B Fine

J&J agreed to pay $2.2 billion in 2013 to settle off-label marketing Risperdal allegations by the Justice Department and several U.S. states.

The DOJ found that J&J pushed Risperdal for use in children and teens long before the FDA actually approved any pediatric indications. The company has also faced big judgments in state court under a variety of consumer protection and fraud laws.

Risperdal Failure to Warn About Risk of Gynecomastia

According to the plaintiff’s lawyer, “The jury in Philadelphia heard evidence that was never presented to the FDA by an American drug company. If there was ever a clear failure-to-warn case, this was it.”

More Risperdal Gynecomastia Trials in the Pipeline

The case is one of about 1,250 Risperdal breast growth lawsuits pending against J&J and their Janssen subsidiary in the Philadelphia Court of Common Pleas. Here, all similar complaints that are filed throughout the Pennsylvania state court system are centralized as part of a pharmaceutical mass-tort.

J&J has been quietly settling the Risperdal breast growth claims for years, but the number of cases has continued to grow as more families find out that there may be an association between gynecomastia and Risperdal use as a child.

In the Philadelphia, a series of Risperdal trials are expected to begin this year, which help the parties determine how juries may respond to similar evidence and testimony that is presented throughout the litigation.

A similar California state court Risperdal mass tort docket has been set up to handle the Risperdal claims and lawsuits, filed in California.

The outcomes of these early test trials known as bellwether trials, may facilitate settlement negotiations with J&J to avoid hundreds of individual trials in California and Pennsylvania.