Trial has been scheduled for April 2016 in the state of Kentucky's complaint against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals Inc., in regard to the corporations' alleged misbranded promotion of the antipsychotic drug Risperdal (risperidone). J&J reported the trial timeline in its most recent quarterly report to the U.S. Securities and Exchange Commission.
Filed in Jefferson County Circuit Court, the Kentucky lawsuit further alleged that J&J concealed Risperdal's risks from Kentucky consumers and from Kentucky physicians.
After the state filed its original complaint in 2013, Kentucky Attorney General Jack Conway said the action "... sends a clear message to pharmaceutical drug companies that they will not endanger the lives and health of the citizens of the Commonwealth. We will not stand idly by as a drug company profits from endangering the very people it is supposed to help."
In a statement, the state of Kentucky explained, "The Attorney General's lawsuit alleges that J&J knew, yet concealed from consumers, that Risperdal carried an increased risk of dangerous side effects including clinically significant weight gain, diabetes, hyperglycemia (high blood sugar), hyperprolactinemia (high blood levels of prolactin) and gynecomastia (male breast development), and cerebrovascular adverse events including stroke and increased risk of death in the elderly with dementia."
Kentucky is one of several states with individual Risperdal lawsuits against J&J. Collectively, 45 states and the U.S. Justice Department settled with J&J in November 2013. The corporation agreed then to pay more than $2.2 billion to resolve criminal and civil liability concerning numerous allegations, among them that it promoted Risperdal for uses that the U.S. Food and Drug Administration did not approve. The civil settlements alone with the federal government and the states totaled $1.72 billion, according to the U.S. Justice Department.
From 1999 through 2005, Janssen, according to the U.S. attorney general's statement, "instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children."
Allegedly, J&J knew that Risperdal posed certain risks to children, including "the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production," according to the federal government's claim.
The risk of elevated prolactin, which has been linked to gynecomastia or the development of female-like breasts in males, has been at the heart of about 3,000 pending Risperdal lawsuits.
In many instances, Risperdal gynecomastia victims have had to undergo surgery to remove the excess breast tissue. Risperdal lawsuits generally petition a court to compensate the victims for medical expenses, including surgery costs if necessary, and for other losses.
Victims have filed many Risperdal lawsuits before a mass tort program that a Philadelphia-based Commonwealth of Pennsylvania trial court established.
Studies have confirmed the Risperdal gynecomastia link. For instance, the journal Systematic Reviews published in October 2014 a paper that researchers mostly from Canada submitted in regard to second-generation antipsychotics, or SGAs, such as Risperdal. Risperidone is the generic version of Risperdal.
"SGAs elevate serum prolactin via dopamine antagonism ," the authors wrote. "Studies have shown that risperidone, for example, may elevate prolactin to a greater extent and more frequently than other SGAs in pediatric and adult populations . Prolonged and substantial elevation of prolactin is associated with a number of adverse effects. Direct effects of elevated prolactin on breast tissue may lead to galactorrhea in women and gynecomastia in men ."
Risperdal gynecomastia lawsuits can still be filed. Someone diagnosed with gynecomastia after using Risperdal, or his parents, should consult an experienced pharmaceutical injury attorney.