For more information or confidential assistance
se habla español

Risperdal Lawsuit Claims Promotion of Off-Label Use


A resident of Minnesota has filed a Risperdal lawsuit, alleging that the medication resulted in gynecomastia and other severe complications. The lawsuit, which was filed in the U.S. District Court for the District of Minnesota, names Johnson & Johnson Company and Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, as defendants.

The Minnesota man demands compensation from the defendants in excess of $75,000 for his losses, which he alleges are directly related to his use of the medication as prescribed.

Plaintiff cites Risperdal-induced gynecomastia

Risperdal (risperidone) is a second generation, or atypical, antipsychotic medication, similar to such potent drugs as Abilify, Seroquel, and Zyprexa. Risperdal was designed and manufactured as a treatment for the symptoms of schizophrenia. It is thought that the drug works by regulating the level of dopamine in the brain. However, research has shown that the drug also affects the endocrine, metabolic, neurologic, and cerebrovascular systems, as well as organs such as the pancreas and liver. Despite these effects, the drug brought in $2.5 billion for the defendants in 2007 alone.

The plaintiff was first prescribed Risperdal in 2005, at which time he was 11 years old. He used the drug as intended by the manufacturer and by his doctor until he was 17 years of age. According to the lawsuit, he developed gynecomastia as a result of Risperdal. Gynecomastia is a condition in which males develop excessive breast tissue. The plaintiff claims he also suffered from abnormal, rapid weight gain.

According to the complaint, the plaintiff has suffered significant damages as a result of the side effects of Risperdal. He alleges severe bodily and mental injury, pain and suffering, mental anguish, disfigurement, embarrassment, past and future medical expenses, and loss of future earning capacity. The plaintiff believes that he will, at some point, have to undergo a double mastectomy to remove the excess breast tissue.

Lawsuit alleges Risperdal promoted for off-label use

The Risperdal gynecomastia lawsuit points out that the Federal Food, Drug, and Cosmetic Act requires pharmaceutical companies to fully disclose accurate information regarding side effects. These disclosures are supposed to be included on packaging material and promotional material. Furthermore, the act prohibits pharmaceutical companies from minimizing the risks or using misleading information to claim that a drug is safer than comparable drugs on the marketplace.

The plaintiff’s lawsuit alleges that Risperdal marketing violates this act by minimizing the risk of serious adverse events, falsely claiming that the drug was safer than other antipsychotics, and failing to recommend that physicians monitor patients for complications. Furthermore, the complaint alleges that Janssen “engaged in promotional activities… designed to illegally expand the use of Risperdal for off-label uses…so as to increase sales and profits at the expense of the safety, health, and well-being” of the plaintiff and other patients. Although a doctor may legally prescribe a medication for a use other than its FDA-approved use, it is illegal for pharmaceutical companies to promote products for such off-label uses.