Risperdal, a powerful antipsychotic drug, has been the subject of thousands of lawsuits facing pharmaceutical giant Johnson & Johnson.

The company has been accused, not just of selling a drug with serious side effects, but of deliberately enforcing a marketing scheme that targeted children that the drug was not approved to treat in order to boost their sales.

Risperdal was approved by the FDA in 1994 to help manage the manifestations of psychotic disorders in adults. These disorders are severe, often involving hallucinations or delusions. The drug was not approved to treat less severe disorders in adults, and was not approved to treat children at all.

However, Risperdal lawsuits allege that the company chose to market their product off-label in order to achieve their marketing goals.

A powerful expose on Johnson & Johnson’s allegedly sketchy marketing tactics reports that the company had a marketing goal with high numbers to achieve, and knew from the start that it could not be done simply by catering to those with severe psychotic disorders, such as schizophrenia.

In other words, the company knew all along that they would have to market the drug to patients that it was not approved to treat.

Risperdal Risks and Side Effects

In order to achieve their profit goals, the company turned to children, the report says. The FDA had specifically prohibited Johnson & Johnson’s marketing team from promoting Risperdal to doctors for the treatment of children. This warning was due to the likelihood of children developing hormonal disorders.

The company continued sending proposals to the FDA, hoping the agency would allow it to expand the Risperdal label to include children. But the agency found no substantial evidence to support a move to pediatric marketing.

According to the FDA, a drug with side effects like Risperdal’s might be worth the risk if the alternative is suffering through severe psychotic disorders like hallucinations or the urge to commit suicide.

But the side effects of Risperdal may not be worth treating a child acting up in school, especially since there are other medications actually approved for that use.

Data of Risperdal side effects showed involuntary twitches, somnolence (drowsiness), diabetes, vomiting, headaches, and significant weight gain. These side effects were substantial, occurring in large percentages of pediatric patients.

Risperdal Gynecomastia

An Alabama boy involved in a Risperdal lawsuit was given Risperdal due to his autism. As a result, he began growing breasts at the age of 12. The development of man boobs is known as gynecomastia, and can become rather severe. In this case, his breasts eventually measured 46DD.

For hundreds of boys and young men who took Risperdal, the breasts they have developed as a Risperdal side effect became such an issue in their lives that they were forced to go through surgery in order to have the excess glandular tissue removed.

Risperdal Lawsuits

Despite the fact that Risperdal was not approved to treat children, and the fact that the FDA had expressly forbidden Johnson & Johnson to market the drug to children, more than 20 percent of the company’s Risperdal sales were to the pediatric market by 1999.

Evidence in Risperdal lawsuits such as Johnson & Johnson emails, sales training manuals, and business plans showed that the company had special sales units to illegal target doctors that treated children, as well as elderly patients.

As a result of these Risperdal lawsuits, Johnson & Johnson has settled thousands of cases for a total nearing about $3 billion. Unfortunately for the plaintiffs who understandably want to see the company punished for their actions, the pharmaceutical giant’s financial setbacks in these lawsuits aren’t really setbacks at all – they are planned for. Companies like Johnson & Johnson expect these kinds of settlements  and set aside billions to pay them off.

Many people who have suffered from the effects of Risperdal have responded by filing Risperdal lawsuits, hoping to gain some kind of financial compensation in return for their physical, mental, and financial losses.

If you or someone you know was negatively impacted by Risperdal, or is a male who has developed excessive breast tissues due to taking Risperdal, you may be able to file a lawsuit against Johnson and Johnson for failure to adequately warn about Risperdal gynecomastia as a potential side effect of the drug.