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.

 

Sources:

Fair, M. J&J Didn’t Warn of Risperdal Breast Growth Risk, Jury Told. Law 360. (January 25, 2015). Retrieved from http://www.law360.com/lifesciences/articles/615043?nl_pk=83e33034-cf7d-4fc2-9414-39cf205540e6&utm_source=newsletter&utm_medium=email&utm_campaign=lifesciences

Palmer, E. J&J Again Faces Off-Label Marketing Claims in Risperdal Case of Boy Who Grew Breasts. FiercePharma. (January 26, 2015). Retrieved from
http://www.fiercepharma.com/story/jj-again-faces-label-marketing-claims-risperdal-case-boy-who-grew-breasts/2015-01-26

risperdal
risperdal
antipsychotic

Other drugs and devices in the news:

Thursday, January 17, 2019
3M Earplugs
3M Knowingly Harms Troops: Supplies Defective Combat Earplugs

Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.

Monday, October 8, 2018
Essure
FDA Adds Restrictions to Use of Essure Birth Control Implants

The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.

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.
We are here to help now