Last week, U.S. District Judge Matthew F. Kennelly, presiding the Testosterone Replacement Therapy (TRT) products liability litigation, denied Actavis Inc.'s motion for summary judgment over one of its testosterone drugs case, stating that the company had a responsibility to warn apart from the U.S. Food and Drug Administration (FDA)-approved package insert.
According to the lawsuit filed, the plaintiff was prescribed the testosterone drug Androderm in July 2015, and he suffered from a stroke in August 2015. The plaintiff alleged that the drug's packaging did not have a warning of the risk of cardiovascular side effects, which was mandated by the FDA and his physician was also not aware of it.
The manufacturer filed a motion arguing that as per the Florida law, the company only needs to include an updated packaging insert, and the physician is a "learned intermediary" who should be warning the patients about the associated risks.
In a November 4 order, Judge Kennelly ruled that "there is ample support for the conclusion that Florida courts would reject Actavis’ narrow interpretation of the duty to warn.” The judge also noted that the company had other means to warn physicians, such as through letters and other communications.
The judge further asserted that the FDA's mandate to provide additional warning gives credence to the case, and some courts have held that a manufacturer can be held liable if adequate warnings are not provided to the doctors.
The lawsuit was part of the Illinois multidistrict litigation, MDL No.:2545, that settled the bulk of claims in 2018. However, the plaintiff had opted out of that settlement.
