All because of testosterone side effects - or so it is alleged. The complaint, filed by plaintiffs Michael and Beatriz Seaburn in late November, accuses the manufacturers of failing to warn consumers that use of testosterone supplements carried the risk for cardiovascular events, such as testosterone heart attack or testosterone stroke.
Testosterone supplements have been around for decades and approved to treat men with hypogonadism - in other words, levels of testosterone that are dangerously low or even non-existent. For these patients, the US Food and Drug Administration (FDA) decreed that any risks associated with testosterone supplements were outweighed by the benefits for such patients.
Then along came the “Low-T” phenomenon - essentially a marketing ploy by manufacturers of testosterone gels and other related supplements that appealed to the aging baby boomer experiencing ebbing energy levels. Low-T, and the products advertised to treat it, has become a pathway of sorts to the fountain of youth - and consumers, together with their doctors, appear to have bought into it.
Flagging energy, libido and testosterone levels that ebb and flow is a normal process of aging. However, manufacturers of testosterone supplements would have consumers believe that such symptoms are appropriately treatable with a product approved only for a serious medical condition: hypogonadism.
Use of testosterone supplements can result in an over-production of red blood cells, which can thicken the blood and lead to stroke or heart attack - even testosterone death.
“Defendant provided millions of men with a scripted and contrived ‘Doctor Discussion Guide’ for the purpose of encouraging men to actively view their symptoms of aging as a ‘syndrome’ or ‘disease’ or ‘condition’ related to or caused by their diminished testosterone levels, and to seek treatment for the normal aging process with Testim, a prescription testosterone-containing medication of unproven safety or effectiveness,” Seaburn wrote in his complaint. Testim is a product originally manufactured and marketed by Auxilium Pharmaceuticals Inc., before the latter was acquired by Endo Pharmaceuticals this past January. Seaburn used both Testim and AndroGel manufactured by AbbVie Inc.
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According to the testosterone lawsuit, Seaburn commenced use of both Testim and AndroGel topical in mid-2005 and suffered two heart attacks within the next two years. He claims pain, emotional anguish, loss of consortium and economic loss. Included in his testosterone lawsuit are claims of strict liability, negligence, breach of implied and express warranty, fraud and recklessness, and negligent misrepresentation.
The testosterone lawsuit is Michael Seaburn v. Endo Pharmaceuticals et al., Case Number 151103699, in the Court of Common Pleas of Philadelphia County.