Risperdal is a second generation antipsychotic medication made by Johnson & Johnson. The company also makes a similar drug called Invega. Both are made by the company’s Janssen Pharmaceutical division and are used to treat psychiatric disorders. It is the off-label treatment of attention deficit hyperactivity disorder, or ADHD, in young boys that has led to so many problems, lawsuits, and settlements.

The problem stems from the fact that Risperdal can cause some side effects that can be serious, but that one side effect in particular is problematic for young boys: breast enlargement. Johnson & Johnson has come under fire for pushing the drug for the treatment of ADHD while ignoring the potential consequences for this vulnerable population. Risperdal settlements have resulted from these actions.

What is Risperdal?

Risperdal is a generic drug called risperidone, which was developed in the 1980s to treat psychiatric conditions. As a second generation antipsychotic, it is supposed to be more effective and safer for patients struggling with psychosis. Approved by the U.S. Food and Drug Administration in 1993, Risperdal is indicated for the treatment of schizophrenia in adults and teens and for treating mania in patients with bipolar disorder. In children, it may be used to treat the irritability and aggression of autism spectrum disorders.

Although it is not approved for treating ADHD, doctors may prescribe Risperdal for children struggling with this behavioral disorder. It is legal for doctors to make off-label prescriptions because they are expected to use professional judgement to decide if the benefits of a medication will outweigh the risks associated with it. Children, most often boys, with ADHD struggle with being hyper and impulsive. Risperdal may help bring these symptoms under control, but the evidence is limited and side effects are risky.

Risperdal Side Effects – Gynecomastia

Risperdal is an effective treatment for psychiatric conditions like schizophrenia and mania, and for many patients with these conditions, it can be a lifesaver. On the other hand, it puts patients at risk for a lot of side effects, some serious. To use Risperdal to treat less severe conditions, like ADHD, is a practice being called into question.

Some of the more common side effects possible with Risperdal are weight gain, dry mouth, heartburn, vomiting, diarrhea, constipation, nausea, trouble sleeping, dreams, anxiety, joint pain, and vision problems. A black box warning on Risperdal states that it can cause sudden death in elderly patients showing signs of dementia.

The side effect of Risperdal that has led to so many lawsuits against Johnson & Johnson and settlements for plaintiffs is gynecomastia. This is the enlargement of breast tissue. For young boys being prescribed Risperdal for ADHD, this side effect can be especially problematic. There are no major health concerns with gynecomastia, but there are obviously emotional and psychological repercussions for boys who experience it. They may also be put at risk of further complications when they have to have surgery to remove the excess tissue.

Settlement over Marketing Scandal

Because using Risperdal for boys with ADHD is not approved by the FDA, marketing the drug for that use is illegal. Doctors may make the prescription, but drug companies cannot promote a drug for an off-label use. It puts patients at risk to do so. Plaintiffs bringing suits against Janssen and Johnson & Johnson over Risperdal and gynecomastia claimed that the companies illegally promoted its use in young boys for off-label reasons.

The details of this promotion have been revealed in court cases. Plaintiffs made the case that Johnson & Johnson paid kickbacks to doctors, including consultant fees for learning about the off-label uses for Risperdal. They also claimed that Johnson & Johnson handed out free samples to doctors to be used for children and that the company used sales incentives to help push sales of the drug for off-label uses.

The investigation into how Johnson & Johnson marketed Risperdal for off-label uses went on for years, but ultimately it proved that the company engaged in off-label marketing between 1999 and 2005, and ended in a settlement divided between the federal government and several states. The settlement was for $2.2 billion and was one of the largest such settlements in history at the time.

Settlements for Elderly Patients

The huge settlement over Risperdal was all about off-label promotion, but it was not restricted to use in children. The evidence against Johnson & Johnson also demonstrated that the company was using similar kickbacks and sales incentives to promote Risperdal for elderly patients, knowing of the risks of death in this population.

Part of the scandal included a huge kickback to the largest nursing home pharmacy in the country. In addition to the $2.2 billion settlement Johnson & Johnson also paid separate state settlements: $327 in South Carolina, $5.9 million in Montana, and $158 in Texas.

Individual Risperdal Settlements

In addition to these large settlements won by state governments and the federal government, Johnson & Johnson has also had to pay out to individuals bringing lawsuits against the company. One of the earliest of these cases involved a 21-year-old man who started taking Risperdal at age nine. He developed breasts and needed surgery to have them removed. He also experienced a lot of weight gain and hormonal problems from the drug. Johnson & Johnson settled with him on the first day of the trial, although the amount was not released.

In another example, a young boy experienced extreme gynecomastia after taking Risperdal beginning at eight years old. He had to have surgery to remove the excess tissue and suffered psychological damage as well. The jury awarded him $2.5 million because it found that Johnson & Johnson did not warn him of the risk of gynecomastia and promoted the drug for off-label use. This was the first jury-awarded settlement for Risperdal.

Many more cases have since been made against Johnson & Johnson and Risperdal. The evidence is there that the company illegally promoted the drug and that young boys and elderly patients suffered as a result. If you or a loved one suffered because of Risperdal you can still make a case for a settlement from Johnson & Johnson.