Risperdal is the brand name for the generic drug risperidrone, a potent antipsychotic drug mainly used to treat schizophrenia, bipolar disorder, and autism. But Risperdal, which was approved by the U.S. Food and Drug Administration in 1994, has been found liable or admitted blame for several side effects.
Risperdal is a "second-generation" antipsychotic drug, made and sold by Johnson & Johnson, that earned the company billions of dollars in sales before generic versions became available. The drug has been linked to increased risk of strokes and death in elderly dementia patients, seizures, weight gain and diabetes.
But perhaps the most widely-reported side effect of Risperdal has occurred in young men and boys. It is a condition called gynecomastia, or the enlargement of male breast tissue. Although gynecomastia is non-cancerous, the growth of male breasts can be painful, cause severe embarrassment, and lasting psycho-social harm. Surgery may be required to correct the condition.
What is Gynecomastia?
Gynecomastia is an enlargement of breast tissue in males. While some adolescent boys may have some breast development during puberty, gynecomastia may also arise as an abnormal condition associated with disease or as a side-effect of Risperdal and some other medications. Boys and young men who have developed gynecomastia may experience pain or nipple discharge.
Lawsuits have alleged that Risperdal increases levels of prolactin, a hormone which stimulates breast development in women. Young men who are displaying increased levels of this hormone may develop gynecomastia.
A study published in the Journal of Clinical Psychopharmacology states that risperidone "administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia."
There has been a flurry of Risperdal lawsuits, verdicts, and state fines in recent years. In 2012, an Arkansas jury determined that Johnson & Johnson downplayed and hid risks associated with Risperdal.
The trial judge ordered Johnson & Johnson to pay more than $1.2 billion in fines for nearly 240,000 violations of the state's Medicaid fraud law. Each violation carried a fine of $5,000. The company was also fined $11 million for more than 4,500 violations of the state’s deceptive practices laws.
Similar fines, lawsuits, and settlements have been occurred in federal courts around the country.
2013 Risperdal Settlement
On November 4, 2013, Johnson & Johnson agreed to resolve criminal and civil investigations into the marketing of Risperdal and other widely-prescribed medications by paying over $2.2 billion. This was one of the largest penalties ever levied against a company for healthcare fraud.
According to the agreement, Johnson & Johnson pled guilty to misbranding Risperdal for unapproved uses, as well as for paying kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes.
Johnson & Johnson and Product Liability
Under product liability law, products are generally required to meet the ordinary expectations of consumers. As a result of its marketing actions, Johnson & Johnson has been held liable for injuries, pain, and suffering. If you or a loved one has experienced any unusual or painful medical conditions after taking Risperdal, you should first contact your doctor or other healthcare professional.
Get Reimbursed for Your Injuries: Find Out How with a Free Initial Legal Review
Most drugs involve certain side effects that a patient and his/her physician can weigh against the merits of the drug. But when serious side effects are not acknowledged by the company, it can negatively impact peoples' lives. You can't change what happened, but you can secure the money you deserve to help pay for the costs you have endured. A good first step is to meet with an experienced attorney for a free initial claim evaluation.
Contact a qualified product liability attorney to make sure your rights are protected.