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Risperdal Gynecomastia Lawsuit Filed in Minnesota District Court

teenage boy back turned small

A Minnesota man recently filed a lawsuit in Minnesota District Court against the makers of the powerful antipsychotic drug Risperdal. The defendants, which include Johnson & Johnson and its wholly-owned subsidiary Ortho-McNeill-Jannsen, are alleged to have unlawfully withheld information about the known risks of gynecomastia (i.e., the development of breast tissue) in men prescribed Risperdal. The plaintiff’s Risperdal lawyers suggest that if he had known of the risks he would have likely pursued an alternative treatment course.

All prescription medications carry a risk of side effects. Typically, the known side effects associated with a drug are printed unambiguously on the packaging or inserted literature in order to properly warn the patient of the potential issues that could arise as a result of taking the particular drug. By issuing these warnings, patients can make an informed decision over whether the risk of the proposed side effect is worth the potential benefits of the drug.

In some cases, however, patients experience side effects that are not disclosed within the drug’s warning labels or literature–such is the case with the Minnesota Risperdal plaintiff.

Details of Risperdal lawsuit filed against Johnson & Johnson

According to the patient’s allegations, he was prescribed the drug Risperdal from the time he was just 11 years old, until he reached the age of 17 in 2011. As a result of his use of Risperdal during this time, the plaintiff alleges he experienced the rapid and unexpected onset of weight gain. In addition, he experienced the development of breast tissue and, eventually, fully-formed breasts – a condition known as gynecomastia.

As a result of this experience, the plaintiff anticipates future medical expenses, including a possible mastectomy (removal of breast tissue). He is also seeking redress for the pain and suffering he endured as a result of his experience with gynecomastia.

Plaintiff highlights alleged marketing deceptions

In his complaint, the plaintiff points to several deceptive and unlawful marketing practices utilized by the Johnson & Johnson company in its promotion of Risperdal. Namely, plaintiff alleges that the defendants engaged in off-label marketing of the drug for the treatment of conditions not expressly approved by the FDA. Further, he asserts that the defendants manipulated the results of clinical trials in favor of Risperdal, failed to disclose the known risks of gynecomastia, allowing untrained ghostwriters to develop literature on Risperdal for publishing in medical journals, failing to report adverse events related to the drug, and engaging in various kickback schemes with researchers, doctors, and consultants.

Johnson & Johnson admits to knowledge of gynecomastia risk

According to widespread reports circulated in February 2014, the ex-chief of the FDA testified to a Philadelphia grand jury confirming Janssen’s knowledge of the known risk of gynecomastia in Risperdal users – some six years before the label was changed to include information about the possibility of male breast growth as a side effect.

At the outset, the drug was approved only for the treatment of adult schizophrenia. However, Janssen urged the FDA consider approval for the treatment of pediatric autism, and went so far as to engage in off-label marketing of the drug to pediatricians and parents enduring the effects of this difficult disease. Until 2006, when the FDA finally approved Risperdal for the treatment of autism, the company had knowledge of the positive correlation to gynecomastia, and failed to properly warn patients until that time, according to the Risperdal lawsuit.