An Aug. 7 ruling by a federal district court in New York raised the issue of whether a drug company is culpable of "misbranding" a drug, in violation of federal regulations, when the company markets the drug for a purpose unapproved by the U.S. Food and Drug Administration. The case did not address in any way U.S. Justice Department and FDA proceedings in regard to the antipsychotic Risperdal, but it did address the broader issue of how far a drug company can go in the so-called "off-label" marketing of its product.
The case centered on Amarin, the maker of a drug called Vascepa, a product which, according to its FDA-approved prescribing information, is "indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia."
"Triglycerides are a type of fat found in your blood," according to the U.S. National Institutes of Health.
Amarin battled the FDA on First Amendment free-speech grounds over whether the company can promote the drug for a purpose different than that for which the FDA has approved it.
In a part of the decision, the court explained, "The specific statements Amarin seeks to make are derived largely from an FDA-approved study of Vascepa's off-label use and from writings by the FDA itself on that subject. Amarin therefore contends, and the FDA largely but not wholly concedes, that the statements Amarin seeks to make are truthful and non-misleading."
The bottom line is this: The manufacturer can market off-label this particular drug - and the ruling applies only to one drug - to the extent that the claims are "truthful and nonmisleading."
FDA officials are probably examining its previous attempts to thwart off-label drug promotion through the prism of this month's ruling. The U.S. Justice Department's settlement with the maker of Risperdal could be one such instance.
Risperdal is an antipsychotic which, according to the prescribing information that the U.S. Food and Drug Administration approved in April 2014, is used for the following purposes:
- Treatment of schizophrenia
- As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with bipolar I disorder
- Treatment of irritability associated with autistic disorder
Its manufacturer, Janssen, is embroiled in Risperdal lawsuits centered on Risperdal's alleged link to the onset of gynecomastia, a condition in which males develop enlarged breasts. In some situations, victims had to undergo surgery to remove the excess breast tissue.
In 2010, at a Mass Tort court in Pennsylvania, alleged Risperdal victims asserted, among numerous claims, that the manufacturer violated the law "by omitting information concerning these risks" from Risperdal's labeling and package insert and by "distributing promotional materials that were false and misleading in that they minimized the risks of these serious adverse events, failed to advise physicians to monitor patients for these adverse events, and otherwise falsely claimed that [Risperdal] was safer and more efficacious than other antipsychotic medications on the market."
Janssen caved under the weight of the U.S. Justice Department in November 2013. Its parent company, Johnson & Johnson, agreed to pay $2.2 billion to settle criminal and civil liability related to many acts, including, according to a Justice Department statement, promoting Risperdal and other drugs "for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation's largest long-term care pharmacy provider."
As the Attorney General's Office statement reads, from 1999 through 2005, "Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen's Key Base Business Goals was to grow and protect the drug's market share with child/adolescent patients."
The statement continues, "Janssen 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."
Sometimes, drug companies go too far, as the federal government sees it. When this happens, victims have a right to seek counsel and to hold these corporations accountable. A law firm with considerable experience in handling pharmaceutical injury lawsuits, such as Reich & Binstock, is an option. At the very least, a man or boy who used Risperdal and who since was diagnosed with gynecomastia should consult an attorney and determine what his legal rights are.