Ohio plaintiff Elaine F. is suing Janssen Pharmaceuticals for the injuries her son suffered after taking their antipsychotic drug Risperdal. Her son, Kristopher D., had been prescribed Risperdal to treat his mental condition and allegedly developed gynecomastia as a result.

Gynecomastia is the occurrence of breast development in adolescent males due to a hormone imbalance, an alleged side effect of Risperdal. Aside from developing breasts, Kristopher reportedly also suffered rapid weight gain and psychological trauma.  He is suing Janssen Pharmaceuticals alongside his mother, claiming that the company deliberately concealed this side effect information to protect the drug’s market value.

According to the Risperdal lawsuit, Kristopher was prescribed Risperdal in 2002, and he had been put on a steady schedule of doses for the past several years. While this medication had proven to work well to treat Kristopher’s mental disorder, he was not aware that he may have been putting himself at risk for gynecomastia. Kristopher and his mother insist that if they had known about the possibility of Risperdal gynecomastia, then they never would have agreed to use Risperdal at the time it was first prescribed.

Illegal Off-Label Marketing of Risperdal

It is important to note that Risperdal had been initially approved exclusively for adult patients in when it was first released in 1993, but was often prescribed to children by doctors for off-label purposes. Several investigations have indicated that Janssen Pharmaceuticals illegally marketed Risperdal to treat children when it was not approved to do so until 2007. While it is not illegal for physicians to prescribe medications for off-label purposes, it is illegal for companies to advertise their products for such uses.

Kristopher and many other young men had been prescribed Risperdal by their physicians after they had been told of the drug’s unique mechanism by the company. Allegedly as a result of taking Risperdal, they developed male breast tissue, sometimes resulting in breasts as big as D-cups.

Overview of Risperdal Complications

Risperdal is an atypical antipsychotic medication that is prescribed to adult and pediatric patients with extreme mental disorders like schizophrenia and bipolar disorders. It is known for very being a fast-acting drug with a unique biological mechanism, which patients and healthcare providers seem to respond positively to.

Unlike many other antipsychotics, Risperdal works by channeling a single, but crucial, brain chemical called dopamine. This chemical is responsible for the brain’s pleasure and reward sensations, which can produce outstanding results if manipulated properly. Risperdal has not only achieved this, but has also proved to have less severe physical side effects on patients because it does not try to stabilize the entire brain.

Despite the positive reception Risperdal has received, its association with gynecomastia has put immense scrutiny on the drug and its manufacturer. While no theories on this occurrence have been proven, medical experts do agree on one central hypothesis. Risperdal naturally increases the production called prolactin in the body, which is primarily responsible for the breast development in young girls. In the adolescent stage of development, children are at a crucial stage of growth and are producing hormones at a very high level. So naturally, when the prolactin levels in these young boys increase, certain mishaps can be expected to occur.

Gynecomastia can be as minor as enlarged nipples to as devastating as large or lactating breasts. Oftentimes, these breasts can only be treated with surgical removal and intense psychological therapy; boys often carry the physical and emotional scars for the rest of their lives. As a result many Risperdal users and their parents have taken legal action against Janssen Pharmaceuticals, seeking compensation for these injuries.

Kristopher and Elaine are suing Janssen Pharmaceuticals for allegedly manufacturing, selling, distributing, and marketing a dangerous drug. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

This Risperdal Gynecomastia Lawsuit is Case No. 2:14-cv-01767-JLG-EPD, in the U.S. District Court for the Southern District of Ohio, Eastern Division.