Risperdal lawsuits are numerous and have cost Johnson & Johnson a lot of money. Risperdal and a similar drug Invega are second generation antipsychotics made by Janssen Pharmaceuticals, a division of Johnson & Johnson. The U.S. Food and Drug Administration (FDA) approved Risperdal in 1993 and Invega in 2006. These medications are supposed to be safer than older antipsychotics, but they have caused some serious issues for many patients who want justice.
Johnson & Johnson has faced the high cost of lawsuits and settlements over these drugs, after making a fortune selling them. Lawsuits over breast enlargement in boys, muscle disorders, and illegal marketing as well as failing to communicate all the risks of the drugs have led to some settlements while others are ongoing. If you have a case to make over either of these drugs, a lawyer could help you take the next step.
Risperdal and Invega: Second Generation Antipsychotics
Risperdal is a generic drug called risperidone that Janssen started investigating in the 1980s and which comes in oral tablet form and injections. Invega is the drug called paliperidone that is similar to risperidone. It comes in several forms including an extended release tablet, a long-lasting injection, and a third form, another injection that lasts even longer.
Both medications are used to treat psychiatric disorders including schizophrenia and mania in bipolar. They are approved to be used for these conditions in patients aged 13 and older. Younger children and teens may be given Risperdal to treat the severe mood swings and aggression that sometimes comes with autism spectrum disorders.
Off-label, some doctors have started to prescribe Risperdal to children with attention deficit hyperactivity disorder, or ADHD. It may help with symptoms like hyperactivity and impulsiveness. This is not an approved use for the drug, but doctors are allowed to prescribe it off-label at their own discretion.
Gynecomastia a Major Reason for Risperdal Lawsuits
A lot of lawsuits have been filed against Johnson & Johnson and Janssen over Risperdal mainly. Most of these have resulted from a side effect called gynecomastia. This is a condition characterized by breast growth, which happened in many young boys taking Risperdal. Why this happens is not fully understood, but is thought to be related to the fact that the medication stimulates prolactin, the hormone that allows women to develop breast milk.
The physical health concerns of gynecomastia are minor to non-existent, but the psychological and emotional damage can be serious. Young boys growing breasts have been psychologically damaged by the phenomenon, and have faced bullying and ridicule. Some of these boys faced permanent breast growth and mastectomies to remove the extra tissue.
Plaintiffs filing lawsuits because of gynecomastia claim that Janssen and Johnson & Johnson illegally promoted the use of Risperdal in children before it was allowed by the FDA. While doctors can prescribe drugs off-label, it is illegal for drug makers to promote these uses in any kind of marketing or advertising. The recent use of Risperdal in children with ADHD may be a result of a push by the drug company.
The lawsuits making these claims have argued that Johnson & Johnson carefully planned a method for off-label promotion: the company handed out thousands of samples free to doctors, they created sales incentives to push sales representatives to push the drug for off-label uses, and they paid doctors consultant fees to learn about off-label uses and to use Risperdal for children.
Other Reasons for Lawsuits
Off-label marketing of Risperdal to kids is not the only problem that Johnson & Johnson and Janssen have run into in lawsuits. Both Risperdal and Invega have black box warnings, the FDA’s strongest warning for drug packaging, that states the drugs can increase the risk of dying in elderly patients who have symptoms of dementia. The announcement came in 2006 after the FDA analyzed the results of multiple trials. The agency found that this particular group of patients had a nearly two percent increased risk of dying while taking these drugs.
Risperdal had been in use long before the 2006 warning, which means that many elderly patients suffered and even died because of a failure to warn. This is another reason that some people have filed lawsuits against Johnson & Johnson. Even after the 2006 warning, plaintiffs in recent cases claim that the company engaged in off-label marketing to elderly patients. Practices the company is accused of include kickbacks to pharmacies that provided nursing homes with Risperdal.
Thousands of lawsuits have been filed against the maker of Invega and Risperdal and many of these cases have been settled in favor of plaintiffs. Most of these wins were in cases in which Johnson & Johnson and Janssen were found to have marketed the drugs to the vulnerable patients like children and the elderly with dementia.
The biggest settlement was for $2.2 billion after a long investigation into these illegal marketing practices. The settlement went to the federal government as well as several states suing the company. Johnson & Johnson also settled several state cases for the same reasons including paying $327 in South Carolina, $158 million in Texas, and $5.9 million in Montana.
In addition to these large, government cases, Johnson & Johnson has had to settle multiple individual cases brought by patients who suffered. One of the earliest of these was brought by a young man who had been prescribed Risperdal before it was approved for children. He developed gynecomastia, weight gain, and hormonal problems and had to have surgery to remove breast tissue. The case was settled on the very first day in court.
Some of these individual cases went before a jury, including the case of a young man whose breasts grew to a very large size after taking Risperdal starting at the age of eight. The jury found that Johnson & Johnson was negligent, had failed to warn patients of the risk, and had practiced illegal marketing. The young man won a $2.5 million settlement.
These are just a few examples of the cases and the money that Johnson & Johnson has been forced to pay because of Risperdal and Invega. Young boys and elderly patients, some of the more vulnerable groups of patients were treated badly by a major drug company. To make more money selling medications Johnson & Johnson engaged in illegal practices and put these people at risk, causing untold harm. If you took either of these medications, or someone you loved did, and suffered as a result, you may still be able to make your case and seek compensation. With the help of a lawyer you may be able to make your case in court.