A 67-year-old Philadelphia man with no history of cardiovascular problems has filed a lawsuit against the makers of his testosterone replacement product claiming the drug caused him to suffer a heart attack. The lawsuit states that the injury was caused by the “exogenously administered testosterone-containing Testim,” a prescription drug made by Auxilium Pharmaceuticals and GlaxoSmithKline.
Edwin Rios had been using Testim for a year when he had the heart attack. Testosterone replacement products are designed to boost the hormone’s levels in men who are experiencing symptoms of low testosterone such as weight gain, mood swings, and low libido. Testim was approved by the Food and Drug Administration (FDA) in 2002.
In recent years, pharmaceutical companies have launched marketing campaigns urging men to talk with their doctors to see if they have for “Low T” and may be candidates for testosterone supplements. The campaigns were a huge success, resulting in booming sales of products including Testim, AndroGel and Axiron.
The short-term benefits of testosterone therapy were promising, however the long-term effects were more difficult to gauge – until recently. Two recent studies showed that testosterone therapy puts men at a much greater risk of having a heart attack, stroke or dying from any cause. The studies prompted the FDA to launch an investigation into the health risks associated with the products. The Endocrine Society is even pushing for a black box warning to be added to the labels of testosterone treatments.
Rios’ lawsuit claims that the drug companies knew that testosterone levels decline as men age, and that the pharmaceutical industry “contrived” the diagnosis of “Low T” all the while knowing that it was a “recipe for grievous harm in the form of cardiovascular events.”
Rios is suing for strict liability, negligence, breach of implied and expressed warranties, fraud and recklessness, and negligent misrepresentation.
Source: The Philadelphia Record