Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) developed the atypical antipsychotic Risperdal in 1993. It was originally FDA approved for the treatment of psychotic episodes brought on from schizophrenia (and the various subtypes). Since its development the drug has also been approved to help treat the symptoms of bipolar disorder, schizophrenia in youth, and irritability in autistic children. While the drug does help to suppress the dopamine and serotonin receptors in the patient’s brain, it may also lead to some unintended side effects, such as gynecomastia. These side effects have led to legal issues for Johnson & Johnson lately.
Until the 1990’s, Clozapine was the only atypical antipsychotic available (although rarely used due to the side effects). In 1993 Janssen Pharmaceuticals, which is owned by the parent company Johnson & Johnson, developed the drug risperidone, and Risperdal came on the scene.
For the first 10 years, Risperdal was hugely popular (and profitable) for the treatment of schizophrenia. And while the FDA had only approved the drug for the treatment of that one disease, many doctors were prescribing it for off-label conditions. Those taking the drug for conditions other than schizophrenia often saw an increase in the severe side effects.
In 2003 the drug was approved for treatment of bipolar disorder. In 2006 the FDA approved the drug for the treatment of irritability in children with autism. 2007 saw approval for the treatment of schizophrenia in children aged 10-17. This approval put Risperdal in the position as the only drug available to treat schizophrenic youth.
Both Risperdal and Invega have a major problem: they can cause breast growth in males. To make matters worse, this severe side effect was never fully disclosed to the public before the drugs were approved by the FDA. This has led to a number of Janssen lawsuits.
Some of these conditions are very rare. However, some are common enough to be a big issue while taking the drug. One of those that has reared its head lately is gynecomastia, the development of breasts. Male youths are prone to this adverse side effect; the consequences can be long lasting.
Male youths that experience gynecomastia will notice that their breasts have become increasingly swollen, and may be painful to the touch. As the condition progresses, noticeable breast growth may occur. In some cases the breast growth results in galactorrhea, or the production of milk from the breasts.
While the enlargement of male breasts is not necessarily physically harmful, the result could have lasting effects on the psychological health of the patient. Low self-esteem and shaming can result, and when these are coupled with the underlying psychological issues that already exist, the results can be devastating to the patient’s mental well-being.
Johnson & Johnson has seen billions of dollars from the sale of this one drug alone. It has helped them maintain their spot as the largest drug company in the world (with 2012 sales of over $67 billion). Risperdal alone has brought the company many billions of dollars ($4.5 billion just in 2007), and continues to bring substantial profits to this pharmaceutical giant. These profits came as a result of allegedly hiding the fact that the drug was known to cause adolescent males to develop breasts.
In 1999 Aaron Banks started using Risperdal at the age of 9. For the next five years he was on a regimen of the antipsychotic. At this point in time, Risperdal was not approved for use in minors; in fact, it was not approved for anyone under the age of 18 until 2003. As a result of using the drug, Aaron suffered from gynecomastia, that is, he grew female breasts. He would later require surgery to remove the breasts.
In 2012, at the age of 21, Aaron filed a lawsuit against Johnson & Johnson due to psychological trauma that he suffered during his youth from the shaming, bullying, and shunning that resulted from being a boy with breasts. Rather than defend their drug, Johnson & Johnson did something unheard of: they settled on the first day of trials. This settlement resulted in the company paying as much as $2.2 billion.
Banks’ lawsuit was not the only one Johnson & Johnson were being faced with. The company had just agreed to pay $181 million to plaintiffs in 36 states regarding misleading advertisement for Risperdal and Invega for off-label uses (treatment of disorders not approved by the FDA). In April of 2012 a judge in Arkansas found the company to be in violation of misleading advertising. A South Carolina judge found the same thing in June 2011. While Aaron Banks’ case was the most popular, it certainly was not the first or the last.