The lawsuit was filed by Patrick Miller, a man from Sussex County, New Jersey. He started taking Axiron in September 2012, when he was 54 years old. On October 3, 2012, he had a heart attack.
The lawsuit accuses Eli Lilly & Co. failing to adequately warn about the risk of heart attacks. He says he never would have taken Axiron if his doctor had been properly warned about cardiovascular risks associated with testosterone therapy.
Eli Lilly is also accused of engaging in an aggressive “disease awareness campaign” to warn men that they might have low testosterone (“Low T”) if they experience fatigue, sexual dysfunction, depressed mood, loss of muscle mass, or other symptoms.
Axiron is only FDA-approved for men with hypogonadism, a relatively rare medical condition that may be caused by genetic disorders, chemotherapy side effects, or damaged testicles.
According to the complaint:
“[Eli Lilly] manufactured, sold and promoted these drugs to treat a non-existent medical condition that the company calls ‘Low T’ … In essence, the defendant marketed and sold testosterone as a lifestyle drug meant to make men feel younger and increase libido.”
Hundreds of lawsuits involving Axiron and other testosterone products have been centralized in Illinois federal court since June.
The FDA began investigating cardiovascular side effects in January, after two studies found higher rates of heart attacks, stroke, and death among older men. Recently, an advisory panel to the FDA concluded that evidence of risk was inconclusive, but benefits of testosterone for “age-related hypogonadism” were also unclear.
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