Risperdal is one of the most popular antipsychotics in America, climbing its way to fame by being prescribed for off-label purposes. Risperdal soon gained infamy for allegedly causing breast development in young boys, a condition known as Risperdal gynecomastia.

For manufacturing company Johnson & Johnson, Risperdal has been their best-selling antipsychotic medication for over a decade. From 1994 to 2010, Risperdal made up for 97 percent of Johnson & Johnson’s sales, earning $28.9 billion in profits. However, experts criticize that a majority of these sales derived from advertising Risperdal for unapproved purposes. While it is not illegal for doctors to prescribe medication for off-label purposes, it is illegal for companies to advertise them for such purposes.

Risperdal was originally approved in 1993 as a treatment option for adult patients suffering from extreme mental disorders like schizophrenia or bipolar disorder. Later on in 2006, it was approved to treat children with similar conditions, along with certain forms of autism. However, it is important to note that Johnson & Johnson advertised Risperdal for pediatric purposes almost as soon as it was released.

Johnson & Johnson has settled over 1,300 Risperdal lawsuits filed by plaintiffs who suffered one particular Risperdal side effect – gynecomastia. One of the latest Risperdal lawsuits was filed by a young man who reportedly grew breasts as large as 46DD; the plaintiff alleges that he was given no warning of this risk and that the company ultimately failed to protect him. Like many other Risperdal lawsuits, Johnson & Johnson settled this case out of court for an undisclosed settlement amount. Another Risperdal lawsuit is set to begin in Philadelphia on June 22, 2015.

These Risperdal lawsuits span from a severe side effect that allegedly comes with the drug known as gynecomastia. Gynecomastia is the medical abnormality of male breast growth, often caused by a severe hormone imbalance. While it is currently unknown to what may be causing this side effect, experts believe that Risperdal increases the amount of prolactin levels in younger patients; prolactin is the hormone primarily responsible for breast development in adolescent girls.

Overview of Risperdal Gynecomastia Complications

When Risperdal was approved to treat children, it had been backed by numerous medical professionals and several studies. However, further investigation discovered that these doctors had come to this conclusion due to kickbacks they received from the company. For example, a Harvard child psychologist, Joseph Biederman, agreed to go along with Johnson & Johnson’s marketing ambitions for Risperdal in exchange for certain financial perks. Biederman was disciplined by his employer, Massachusetts General Hospital, in 2011 for failing to disclose that the many Risperdal studies were funded by drug companies, which gave him and his coworkers over $4 million.

For the next several years, Johnson & Johnson had settled several massive Risperdal litigation movements that were filed by injured patients and even the federal government. In fact, in 2013 Johnson & Johnson was ordered to pay the federal government $2.2 billion to resolve criminal and civil charges, after investigators found heavy evidence of fraud. Additionally, several FDA members testified that the company knew about the risk of gynecomastia as early as 2001.

Despite the overwhelming evidence, Johnson & Johnson has not taken these allegations lying down. The company has repeatedly stated that this abnormal breast growth was not caused by any Risperdal side effects, but rather that it was due to obesity and puberty. Medical experts argue that it is due to the severe prolactin production increase in the body, allegedly caused by Risperdal.

Treating gynecomastia is not an easy feat for the victims or their families, as this condition often leaves severe mental scarring. Ultimately, the side effects of this gynecomastia can remain for years, and surgery is often needed to remove the excess tissue from the patients.