Litigation over Risperdal, a medication used to treat mental disorders such as schizophrenia, severe mood and manic bipolar disorders and depression when used with certain antidepressants, has been ongoing for several years. Manufactured by Janssen, a subsidiary of pharmaceutical giant, Johnson & Johnson, the drug was approved for use by the US Food and Drug Administration (FDA) in 1993. Since the early 1990s, the drug was also being prescribed to children suffering from attention deficit disorder and obsessive compulsive disorder and to stem irritable behavior in children with autism.
Risperdal Male Breast Enlargement Allegations
Studies have since shown that Risperdal may increase the levels of prolactin, a hormone that promotes the growth of breast tissue in women. In males, the drug has led to the enlargement of male breasts or a condition called gynecomastia. In the lawsuits filed against Johnson & Johnson, claimants have reported pain and nipple discharge.
Although some patients have been treated with liposuction, more severe cases have required mastectomies, a surgical procedure that removes the breast and excess tissue.
Common side effects of Risperdal use include:
- Stomach pain
- Constipation or diarrhea
- Blurry vision
- Weight gain
Less common but more serious side effects include:
- Drastic changes in blood pressure
- Neuroleptic malignant syndrome—a serious brain disorder
- Uncontrolled involuntary movements
- Increased cholesterol
- High blood sugar with increased risk of developing type 2 diabetes
- Enlarged breast development in young males requiring mastectomies
- Stroke in elderly patients
Ongoing Risperdal Litigation and Settlements
Not all states have been successful in its suits against J & J. Suits filed by the states of West Virginia, Louisiana and South Carolina have been dismissed or had their verdicts reduced. Kentucky and Mississippi have ongoing suits.
In February of 2015, however, Johnson & Johnson was ordered to pay $2.5 million by a Philadelphia jury in a case which the plaintiff alleged that he developed gynecomastia after being prescribed the drug for behavior issues arising from his autism diagnosis as a child. According to the plaintiff’s attorney, the man developed size 46 DD breasts.
In 2012, a Texas court found that Johnson and Johnson had engaged in unlawful activity related to “off-labeling,” a practice where the manufacturer uses certain marketing tactics including kickbacks to encourage doctors to prescribe its drug for uses not FDA-approved. Johnson and Johnson was forced to pay $158 million to the state. The lawsuit had also alleged Medicaid overpayments.
In 2015, the Department of Justice fined Johnson and Johnson $2.2 billion to settle criminal and civil investigations into its marketing schemes, which also involved off-label use for elderly patients with dementia.
Unlike other personal injury lawsuits involving defective drugs, there is no class action suit regarding Risperdal, though over 200 claims filed in Philadelphia have been referred to a single judge for centralized management. The diverse nature of the injuries claimed by the plaintiffs may not lend itself to a class action. If the present trend toward the filing of more claims continues, then MDL or multi-district litigation may result where all claims are consolidated. Unlike a class action, however, each Risperdal claim is resolved on its merits and any damages awarded dependent on the circumstances unique to that case.