November 13, 2015 — Men who were injured by the generic testosterone boosters Testopel and Depo-Testosterone cannot pursue claims that drug-makers failed to warn about serious cardiovascular side effects, a federal judge has ruled.
Law360 reports that U.S. District Judge Matthew Kennelly approved a motion to dismiss claims against Pfizer and Auxilium Pharmaceuticals.
Testopel and Depo-Testosterone are “generic” because neither drug is unique. They were both given expedited approval based on their equivalence to other approved testosterone drugs on the market.
Because Testopel and Depo-Testosterone are generics, drug-makers cannot change the label without FDA approval. Therefore, consumers’ state law failure-to-warn claims are preempted because they interfere with federal law.
Brand-name drug-makers do not need approval from the FDA before they can strengthen warning labels.
Over 2,700 lawsuits have been centralized in a Multi-District Litigation (MDL No. 2545) under Judge Kennelly in one federal court in Illinois. Most of those cases involve brand-name drugs like AndroGel.
Concern about the safety of testosterone has grown considerably in recent years. Studies have found that older men on testosterone were more likely to have a deadly heart attack or stroke than men who did not use testosterone.
The FDA opened a safety investigation in January 2014. Six months later, the agency ordered drug-makers to add warnings about the risk of venous blood clots, including pulmonary embolism, deep vein thrombosis, and venous thromboembolism.
In March 2015, the FDA asked drug-makers to add warnings about heart attack and strokes and, start studying long-term risks, and stop marketing testosterone for age-related symptoms attributed to “Low T.”
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