Philadelphia, PAAs the debate over testosterone side effects continues to heat up, two new lawsuits within a week have appeared in Philadelphia. While there are various manufacturers and brands of the testosterone gels, creams and patches that have become the rage in recent years, Auxilium Pharmaceuticals’ Testim is a target for both.
To that end, Testim will be tested in court by plaintiff Robert Olivetti of Scranton, as will AndroGel, manufactured and marketed by AbbeVie, a subsidiary of Abbott Laboratories. Olivetti, who launched the lawsuit with his wife Marion as a co-plaintiff, allege that Olivetti’s use of AndroGel and Testim led to a testosterone heart attack he suffered in 2012, which required a coronary bypass.
Earlier in the month, Edwin and Eileen Rios filed suit against Auxilium, together with co-defendant GlaxoSmithKline. The latter is a co-promotion partner with Auxilium with regard to the marketing of Testim. Edwin Rios suffered a testosterone heart attack of his own in 2013. He alleges Testim to be the cause.
In the Rios action, the plaintiffs allege that “defendants, jointly or individually, represented to the public at large and to the medical profession, through word, actions and deeds, including extensive direct-to-consumer advertising and physician-detailing, that Testim was safe and effective for its intended use.”
Low testosterone, or “Low-T,” is a phenomenon that appears very different today, when compared with how it was viewed in past decades. While testosterone levels naturally diminish in men as they age, there are nonetheless rare cases of extremely low testosterone related to conditions such as hypogonadism and undescended testes that have historically required testosterone supplementation in men suffering from serious testosterone depletion.
And as long as testosterone supplementation has been around, there has always been the potential for testosterone side effects.
However, fast-forward to today, and one finds an environment rampant with claims of testosterone deficiency - together with manufacturers allegedly stumbling all over themselves marketing various testosterone gels and creams that are available to men looking to increase their energy levels, and even their sexual virility, during their middle years.
Allegations abound of prescriptions issued for testosterone supplementation without first determining actual testosterone levels via the requisite blood test. Websites are available to prompt prospective testosterone patients to self-diagnose the potential for low testosterone, then take those symptoms to a doctor and lobby for supplementation. Manufacturers, in recent years, have aggressively promoted their wares without, according to many a testosterone lawsuit, properly warning about the risks.
Those risks, according to various studies, suggest a risk for testosterone stroke, as well as heart attack. There is even an alleged risk for testosterone death, in serious cases, linked to the use of testosterone gels et al.
Aside from various lawsuits, the US Food and Drug Administration (FDA) announced at the beginning of the year that it was reviewing testosterone gels, creams and patches with regard to potential health and safety issues. Health advocates, such as Public Citizen, are advocating for a black box warning. And lawsuits continue to emerge, alleging that manufacturers have downplayed the various testosterone side effects - and if said manufacturers didn’t know about adverse reactions such as testosterone heart attack, then they should have.
And yet, there are camps who advocate for testosterone supplementation, noting that the latter has its place and is not a threat, but indeed remains a help to those with serious testosterone depletion that can be just as hazardous, say the advocates of testosterone, as the overuse of supplementation. That position puts testosterone advocates at odds with critics who maintain testosterone supplementation remains a threat to cardiovascular health.
There is little doubt, however, that the so-called “Low-T” debate has their motors running…
Olivetti et al v. Auxilium Pharmaceuticals Inc. et al, is Case No. 140303508.
Rios et al v. Auxilium Pharmaceuticals Inc. et al, is Case No. 140302537. Both cases reside in the Court of Common Pleas of Philadelphia County.
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