An autistic Alabama patient was the center of a recent lawsuit in Philadelphia, which ended in late February with the patient being awarded $2.5 million in damages. The patient, now an adult, took the medication as a child for treatment of ADHD, or Attention Deficit Hyperactivity Disorder.

Johnson & Johnson’s Jannsen Pharmaceuticals runs their Risperdal division and the companies now have numerous lawsuits to contend with. They previously settled criminal and civil charges brought against them by state and federal entities.

 

Risperdal lawsuit, causing gynecomastia in male patients.

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Failure To Warn Charges

With drug manufacturers, the FDA requires that they clearly list all possible side effects from their products so that doctors and patients alike have full knowledge of potential side effects.

The FDA even has a special phone number for reporting adverse events that can be called by doctors or patients to help keep track of side effects and complications, including allergic reactions, to any FDA approved medication on the market.

In Johnson & Johnson’s case, they have been accused of failing to warn about the possibility for gynecomastia to develop in male children, teens, and adults. The federal government found them guilty of those charges and forced them to pay $2.2 billion in damages in 2013 for illegal marketing of the drug.

 

Patient With Clear Case of Gynecomastia from Risperdal

J & J is now dealing with lawsuits from patients, such as the 20-year old autistic man in this first case. The Alabama man developed 46 DD breasts as a direct result of taking the drug. His doctor, pharmacist, and parents were unaware that taking the drug could result in gynecomastia.

During the Philadelphia trial, the patient’s doctor, Jan Mathisen, stated that he was never made aware of one particular study done by Jannsen in which the potential for development of gynecomastia was suggested as a direct result of taking Risperdal.

Dr. Mathisen further testified that he, and other colleagues, did not read the full length of the revised warning label when Jannsen updated it with this new, possible side effect. He said that if he had known of the risks, he would have discussed the matter with the patient’s parents.

Jannsen Pharmaceuticals and Johnson & Johnson intend to file an appeal and feel that it should be overturned due to the evidence they presented that adequate warning was given to healthcare providers.

 

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Reference:

http://articles.philly.com/2015-02-26/business/59504754_1_risperdal-janssen-johnson-johnson

*RISPERDAL® and RISPERDAL® CONSTA® are registered trademarks of Janssen Pharmaceuticals, Inc. We are in no way affiliated with the treatment of patients affected by the lawsuits regarding this matter. We do not endorse that surgery is the right option for all patients affected by this medication.