November 13, 2015 — Law360 reports that a federal judge has rejected failure-to-warn claims involving Testopel and Depo-Testosterone because drug-makers did not have the authority to unilaterally strengthen the labels.
Testopel and Depo-Testosterone were given expedited approval based on their similarity to brand-name testosterone drugs, and are therefore “generic.” Any changes to generic drug labels must be approved by the FDA.
Because generic drug-makers can’t unilaterally warn about new risks, failure-to-warn claims under state law are preempted by federal law. Lawsuits involving brand-name drugs like AndroGel are not affected because the FDA does not need to pre-approve stronger warning labels.
U.S. District Judge Matthew Kennelly dismissed claims accusing Pfizer and Auxilium Pharmaceuticals of failing to adequately warn about the risk of heart attacks and strokes from Testopel or Depo-Testosterone.
Judge Kennelly oversees about 2,700 lawsuits involving nearly a dozen different testosterone therapy products. The cases have been centralized in a federal Multi-District Litigation (MDL No. 2545) in Illinois.
The FDA began investigating the safety of testosterone therapy last year after several studies found higher rates of heart attack, stroke, and death among men over 60.
The agency has ordered drug-makers to add warnings about venous blood clots, pulmonary embolism, deep vein thrombosis, venous thromboembolism, heart attacks, and stroke. The FDA has also asked drug-makers to stop marketing testosterone for age-related symptoms of “Low T” and start studying long-term side effects.