Former FDA Head to Testify in Risperdal Breast Growth Lawsuit

Tuesday, January 27, 2015

DrugNews reported last year on the wave of male breast growth side effects sweeping minors who were prescribed the antipsychotic drug Risperdal for autism, depression or anxiety.

Now, with the latest trial underway for a boy allegedly affected by Risperdal, the former head of the Food and Drug Administration has been called on to testify about Johnson & Johnson’s marketing of the medication for unapproved purposes.

The trial started last week in Philadelphia, with lawyers representing the family of a 20 year-old young man with autism named Austin Pledger, who was prescribed Risperdal starting at age 7. He subsequently developed gynecomastia, otherwise known as abnormal breast growth. In fact, his breast growth was so severe he would require a mastectomy to reverse it.

Attorneys argued that Risperdal can increase levels of the hormone prolactin, which can cause gynecomastia. They also allege that Johnson & Johnson, who manufactured and sold the drug, kept this risk hidden for years.

Austin’s treating physician Dr. Jan Methisen, then testified that Johnson & Johnson never informed him of the risks of prescribing it to children.

In fact, Johnson & Johnson has been fined hundreds of millions of dollars by several states for illegally promoting Risperdal for “off label” or unapproved uses, including use in children.

It is to this point that former FDA Commissioner David Kessler has been called upon to testify in the case. This isn’t the first time he has been called as a witness in a Risperdal case. However, each time, J&J has settled the case before he was able to deliver his opinion.

Johnson & Johnson has so far settled every Risperdal breast growth case to reach trial. However, with hundreds more victims out there awaiting trial, consumer advocates are calling on the company to arrange a complete settlement for those injured.

Check back with DrugNews for more on this litigation and any new warnings related to Risperdal, or to contact an attorney handling these cases.



Fair, M. J&J Didn’t Warn of Risperdal Breast Growth Risk, Jury Told. Law 360. (January 25, 2015). Retrieved from

Palmer, E. J&J Again Faces Off-Label Marketing Claims in Risperdal Case of Boy Who Grew Breasts. FiercePharma. (January 26, 2015). Retrieved from


Other drugs and devices in the news:

Friday, August 9, 2019
Surgical Stapler
Did Surgical Staple Companies Hide Thousands of Injuries?

This past spring, the FDA issued a warning affecting the millions of patients each year that undergo routine gastrointestinal, gynecologic...

Friday, August 2, 2019
Invokana Gangrene Amputation
Federal Panel Adds Fournier's Gangrene to Crowded Invokana MDL Court

In the latest Invokana lawsuit update, DrugNews has learned that a federal judicial panel has transferred new cases alleging...

Get in touch with us.

Call, email or live chat with us today to see how we can help.

Need a quick answer? Call us!
Reach out to us by email.
live chat with DrugNews
We are here to help now