Risperdal lawsuits are personal injury claims against the pharmaceutical company Johnson & Johnson for the side effects of their antipsychotic medication, Risperdal. The drug treats bipolar disorder, schizophrenia, and autism-related irritability, but has been linked to numerous side effects including gynecomastia, a complication that causes boys and men to grow breasts.
There is evidence that the makers of Risperdal, Johnson & Johnson and its subsidiary company Janssen Pharmaceuticals Inc., knew of these risks. Nevertheless, they aggressively marketed the drug to boys who were most at risk of gynecomastia, anyway. Subsequent lawsuits and fines have led to billions of dollars in compensation and penalties.
In this article, our defective drug attorneys look at how Risperdal works, the side effects and medical complications that have been linked to the drug, the evidence that Johnson & Johnson knew of those risks, and how you can recover compensation if you have been impacted by the side effects of Risperdal.
- 1. How does Risperdal work? 1
- 2. Risperdal's side effects 2
- 3. Lawsuits against Johnson & Johnson over Risperdal 2
- 4. Filing a Risperdal lawsuit for improper labeling 3
- 5. Compensation for injuries associated with Risperdal 4
- 6. Punitive damages in Risperdal cases 4
- 7. What to do if you have been hurt by Risperdal 4
1. How does Risperdal work?
By altering a patient's levels of dopamine and serotonin, Risperal was designed to treat a wide variety of psychotic conditions. It was approved by the United States Food and Drug Administration (FDA) for progressively broader treatments, allowing it to be prescribed to adults with:
- Schizophrenia in 1993,
- Manic states associated with bipolar disorder in 2003, and
- Behavioral issues associated with autism in 2006.
In 2007, the FDA approved Risperdal for patients under the age of 18.1
However, Risperdal has also been known for off-label use – prescriptions of the drug for medical and psychotic conditions that Risperdal was not designed to treat. The most common off-label uses include:
- Obsessive-compulsive disorder (OCD),
- Posttraumatic stress disorder (PTSD),
- Eating disorders,
- Personality disorders,
In large part because of the broad range of uses for Risperdal, Johnson & Johnson has made more than $30 billion with the drug.
2. Risperdal's side effects
Risperdal has some significant side effects. The most common include:
- Weight gain,
- Vision problems,
- Movement problems, including restlessness, involuntary twitching, and muscle stiffness.
In addition to these common side effects, Risperdal also comes with a significant risk of some far more serious complications. Some of these can drastically alter a patient and victim's quality of life, and can even be fatal. They include:
- An increased risk for diabetes,
- Severe weight gain,
- Strokes, and
- Suicidal thoughts.
The risk of diabetes and strokes has been especially problematic for the elderly patients who take Risperdal.
However, the side effect that has led to the harshest reaction and numerous lawsuits has been gynecomastia, a medical condition that causes boys and men to grow large breasts. Gynecomastia is connected to the severely increased hormonal levels that Risperdal causes – particularly the hormone prolactin, which is responsible for the production of breast milk in pregnant women. Boys entering puberty are especially susceptible to gynecomastia, yet there is evidence that Johnson & Johnson marketed their drug specifically towards that crowd.
3. Lawsuits against Johnson & Johnson over Risperdal
Numerous lawsuits were filed against Johnson & Johnson once it became clear that there was a connection between Risperdal, the hormonal changes experienced by young people taking the drug, and the side effect gynecomastia. More claims were filed by elderly victims who suffered from dementia and had taken Risperdal, only to suffer from strokes at an alarming high rate.
The evidence that these lawsuits uncovered was damning: Johnson & Johnson had apparently known of the risk that Risperdal posed for young boys and the elderly, but marketed their drug to them, anyway.2
Rather than abiding by the limitations put in place by the FDA's approval of Risperdal that only allowed the drug to be used by adults, Johnson & Johnson's sales division urged pediatricians and geriatric doctors to prescribe Risperdal to children and the elderly. Internal communications at Johnson & Johnson found that parents of children with autism and behavioral issues who were looking for a drug to restrain or reduce their child's outbursts were a key target for selling the drug. So were nursing homes that housed senior citizens with dementia.
These lawsuits have been both civil and criminal in nature.
The civil lawsuits have been personal injury claims that have been based on products liability law. These claims have argued that Johnson & Johnson knew of the risks associated with Risperdal, but failed to warn doctors and patients. Some of them have included:
- A $70 million verdict against Johnson & Johnson to the family of a boy who was prescribed Risperdal at the age of 5 and suffered from gynecomastia,3
- A $2.5 million verdict for an autistic man who took Risperdal as a boy and developed size 46 DD breasts.4
Additionally, Johnson & Johnson has faced criminal charges for healthcare fraud and deceptive practices. A settlement with the Department of Justice included a $2.2 billion fine.5
4. Filing a Risperdal lawsuit for improper labeling
If you have taken Risperdal and suffered from its side effects, you could be owed compensatory damages that are meant to reimburse you for the losses you have sustained through no fault of your own. You can pursue these rights by filing a personal injury lawsuit.
Personal injury lawsuits related to Risperdal have largely relied on products liability law. Specifically, Risperdal lawsuits claim that the drug's improper labeling and deceptive business tactics failed to warn doctors and patients of the drug's serious side effects.
Drug manufacturers, like Johnson & Johnson, have a legal duty to correctly advertise their drugs and comply with the FDA's requirements so the drug is only used for approved purposes. Breaching this legal duty can lead to Johnson & Johnson being held liable for the damages that it causes. Typically, this duty is breached if:
- The label does not warn doctors of side effects and hidden dangers of the drug,
- The warning label is misleading about the dangers associated with the drug,
- The warning label is vague or difficult to understand,
- The drug is marketed to patients and doctors as a treatment for an unapproved use.
Risperdal lawsuits, however, often go further. They frequently claim that Johnson & Johnson:
- Actively covered up indications that Risperdal was dangerous to children and the elderly,
- Sought out pediatricians and geriatric doctors and urged them to prescribe the drug,
- Promoted off-label use for Risperdal.
5. Compensation for injuries associated with Risperdal
If you or a loved one has suffered from the complications and side effects of Risperdal, you may be entitled to recover compensation for your losses. This includes both your economic damages as well as your non-economic damages.
Your economic damages are those that are easily distilled into a dollar amount. They include:
- Medical expenses accrued from your recovery,
- Anticipated future costs of medical care,
- Lost wages, income, business loss, or other professional repercussions of your injuries and recovery,
- Any reduced ability to earn an income that is associated with your injury,
- Other out-of-pocket expenses that you have had to cover and that are associated with your injuries, like the costs of a modification to your home or car.
Meanwhile, your non-economic damages are those that are not easily stated in a dollar amount. They include:
- Physical pain from your medical condition and injury,
- Mental and emotional suffering and anguish, including your loss of life's enjoyments.
In a typical Risperdal lawsuit, the non-economic damages that gynecomastia victims recover are a larger share of the verdict than in other types of personal injury cases: The mental anguish caused by the severe social stigmatization of gynecomastia for teenage boys often overwhelms the financial toll of a corrective surgery.
6. Punitive damages in Risperdal cases
While compensatory damages are meant to compensate the victims of negligent or intentional acts, punitive damages are meant to punish the wrongdoer. In personal injury cases, punitive damages are rare because most of these injuries are accidental, and the negligence that leads to accidents is almost never so heinous to warrant punitive measures.
However, Risperdal cases have flirted with winning punitive damage awards due to Johnson & Johnson's particularly egregious conduct.6
7. What to do if you have been hurt by Risperdal
If you or a loved one is suffering from a side effect of Risperdal, you should consult a doctor, first. Medical complications associated with Risperdal can be difficult to detect, but they can also be minimized and corrected with prompt medical attention.
Once you have seen a doctor and determined the best course of action, seeing a personal injury attorney and discussing your legal options is often an important move to make. The costs – both financial and emotional – of suffering from Risperdal's complications are not insignificant.
You deserve to be compensated for them.
Call our defective drug lawyers at (855) 396-0370 or contact us online for a free initial consultation that can help you make an informed decision about your future.
See generally, Steven Brill, “America's Most Admired Lawbreaker,” Huffington Post Highline (September 15, 2015).>
Jef Feeley, “J&J Hit With $70 Million Risperdal Verdict Over Male Breasts,” Bloomberg (July 1, 2016).>
Ed Silverman, “Johnson & Johnson Loses Trial Over Risperdal and Male Breasts,” The Wall Street Journal (February 24, 2015).>
Department of Justice, “Johnson & Johnson to Pay More than $2.2 Billion to Resolve Criminal and Civil Investigations,” (November 4, 2013).>
See, e.g., Pledger v. Janssen Pharmaceuticals, Inc., 2018 Pa. Super. Ct. 398.>