New Jersey resident Patrick Miller was 54 when he started using Axiron, a testosterone replacement product used to treat men who have low levels of the hormone in their blood. A month later, on Oct. 3, 2012, he had a heart attack.
Thirteen months later, the Journal of the American Medical Association (JAMA) published a study that found men who used testosterone treatments have a 30 percent increased risk of having a heart attack, stroke or dying. And, in January 2014, the journal PLOS One found a two-fold increased risk of heart attack among older men in the first 90 days of testosterone treatment. Younger men with cardiovascular disease had a two- to three-fold increased risk of heart attack in the first three months of treatment.
Miller filed a lawsuit in federal court in Newark, N.J., claiming that Eli Lilly put users at risk by aggressively marketing its testosterone therapy and did not adequately warn about the risk of heart attacks and strokes. Miller’s lawsuit claims that had his doctor known the risks associated with the treatment, he would have never prescribed the drug to Miller.
Miller’s lawsuit alleges that Eli Lilly’s advertising of Axiron for so-called “Low T” lured men to ask their doctors for the treatment to quell symptoms such as low libido, muscle loss, weight gain and fatigue. The drug is indicated for men with hypogonadism, a condition in which an injury or defect prevents the testes from producing enough testosterone.
Miller’s lawsuit claims that Eli Lilly promoted the drug for off-label use for “Low T,” a condition that pharmaceutical companies made up. Furthermore, his lawsuit states, “low testosterone is not a disease recognized by the medical community. Instead, it is a normal result of the aging process.”
Axiron brought in $178 million in revenue in 2013. Lilly spent $122 million marketing the drug that year; 70 percent of that was on direct-to-consumer advertising.
In January, the Food and Drug Administration (FDA) announced it was investigating cardiovascular risks associated with testosterone replacement therapies. In June, the U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of all lawsuits against companies that manufacture testosterone supplements, including AbbVie, Abbott Laboratories, Actavis and Auxilium Pharmaceuticals, Endo Pharmaceuticals, and Pfizer.
Source: New Jersey Law Journal