Risperdal Lawsuits Background. On July 11, 2017, the Philadelphia Court of Common Pleas held a status update and discussion on the Risperdal lawsuit file. The purpose was to examine a $70 million verdict that was delivered by a Pennsylvania state court jury in favor of the plaintiff in a Risperdal gynecomastia lawsuit. Johnson & Johnson (J&J), the parent company of Janssen Pharmaceuticals, found the award to be excessive and planned an appeal.
The plaintiff was 13 years-of-age when he was prescribed Risperdal (risperidone) to treat behavioral issues linked to autism. During the Risperdal trial, jurors were told the plaintiff developed male breast tissue (Risperdal gynecomastia) or “man boobs,” after he was prescribed risperidone. The plaintiff alleged at the time, that Janssen falsified or concealed material evidence related to Risperdal’s risk of gynecomastia.
The $70 million award came despite a cap instituted by the state of Tennessee which caps damage awards at $750,000. The plaintiff is a Tennessee resident and thereby, which would normally constrain the Philadelphia jury to find within that Tennessee cap. However, the plaintiff was able to successfully demonstrate misrepresentation or fraudulent misrepresentation on the part of the defendant at trial, thereby allowing the jury to be able to exceed the Tennessee damages cap as it saw fit.
Court documents reveal that during the trial, plaintiffs revealed for the first time, a study called ‘Tab4’ that showed a link between risperidone and the growth of male breast tissue. The allegation is that Janssen did not reveal the study, or the results to the FDA. Risperdal is approved by the U.S. Food and Drug Administration (FDA) for use in adults, adolescents, and children over a certain age.
Increase in Prolactin with Risperdal
In recent years, Risperdal and the development of male breasts is an issue that has garnered much public attention. Enlarged breast tissue is frequently seen in overweight men who have an overabundance of fatty tissue in their pectoral muscle area. The claim is that Risperdal triggers an increase in levels of prolactin, a hormone which is a precursor to breast development.
When Risperdal interacts with the pituitary gland, the levels of prolactin are increased. Prolactin is naturally produced in small amounts in young boys, but increased production may potentially result in male breast development.
The appearance of gynecomastia linked to risperidone use, seems to be unrelated to weight or degree of fitness. In rare instances, males have been known to lactate, or produce fluid through the nipples.
The status update, meanwhile, in Philadelphia will probably be some 3,000 new Risperdal cases filed in Philadelphia in the first three months of 2017. These cases are in addition to the 18,500 cases J&J released in their annual report at the end of January. This puts the number of Risperdal lawsuits higher than 20,000 and mounting.
Indications for RisperdalRisperdal is a widely-used antipsychotic medication, which is normally prescribed to treat extreme mental disorders such as schizophrenia and bipolar disorder in adult patients. This medication may also be prescribed for children with specific forms of autism, along with other mental disorders.
The FDA originally approved Risperdal in 1993 for use in adults. Product labels at the time showed Risperdal gynecomastia was a potential in fewer than one, out of every 1,000 patients. However, the label was updated in 2006 to reflect the possibility for 2.3 patients out of 1,000 to be at risk for gynecomastia. That increase is more than 20 times the initial assessment.
It is significant that Risperdal was only approved for pediatric use relatively recently, years after evidence surfaced concerning an alleged correlation between Risperdal and gynecomastia. A combined federal and state investigation led to allegations that J&J may have illegally marketed Risperdal to children before it was approved to do so.
Initial Benefits of Risperdal
J&J had successfully launched Risperdal when it became known that the drug targets one brain chemical specifically dopamine, instead of the entire brain. Dopamine is responsible for pleasure and reward and Risperdal would allegedly produce ideal mood balance. With this perceived benefit, doctors began prescribing the drug for children for “off-label purposes.” It is not illegal to prescribe drugs for off-label reasons, but it is illegal for companies to promote them for these purposes.
Recent allegations include plaintiffs claiming that J&J did not disclose the potential connection between Risperdal and gynecomastia. Although the link has not been definitively proven, J&J faces major backlash for the Risperdal gynecomastia link.