A U.S. District Judge says thousands of lawsuits in multidistrict litigation (MDL) can more forward with claims that manufacturers of generic testosterone replacement therapies fraudulently promoted the hormones for off-label use. The ruling partially reverses a November decision that those claims were preempted along with others regarding the adequacy of the products’ labeling.
Testosterone treatments are approved by the Food and Drug Administration (FDA) to treat hypogonadism, a condition in which men do not produce enough testosterone due to injury or disease. The lawsuits claim that manufacturers of testosterone supplements marketed their drug for a different condition, which they coined “Low T.” The hormone makers claimed that testosterone therapy could treat symptoms such as low libido, weight gain and muscle loss.
Both brand name and generic testosterone makers are also facing claims that they did not adequately warn that use of the hormones could increase the risk of heart attacks, strokes, blood clots and death. Under current FDA regulations, generic drug companies with abbreviated new drug applications must have the same safety label as their brand-name counterpart and they cannot independently update product labeling with newly acquired safety information.
U.S. District Judge Matthew Kennelly dismissed all claims last November after finding that the state-law claims were preempted. Plaintiffs then asked if the Northern Illinois Federal Court to clarify whether it meant to dismiss all their claims, including the fraud allegations. Kennelly partially granted the motion, saying “defendants’ obligations under state fraud law to refrain from falsely promoting their drugs for unapproved uses do not conflict with their obligations under federal law to maintain their warning labels.”
Kennelly added, “Even if defendants’ ‘off-label‘ advertising and promotion would be considered ‘labeling’ under FDA regulations, this would not change the fact that defendants could refrain from engaging in their allegedly false promotion of their drugs for off-label uses without violating their federal duty to maintain the ‘sameness’ of their labeling. That is, nothing in the approved warning labels for defendants’ drugs requires them to promote those drugs for unapproved off-label uses.”
Source: Courthouse News Service