Los Angeles, CAIn spite of the fact that testosterone therapy for hypogonadism has carried approval by the US Food and Drug Administration (FDA) for some 20 years now, it was the recent announcement by the federal regulator that it was investigating heart attacks and other unforeseen testosterone side effects that really got the ball rolling in terms of testosterone litigation.
That’s because the testosterone industry appears to have created a monster, by identifying a new market for testosterone therapy for indications other than hypogonadism. The latter is a rare, but sometimes serious condition characterized by extremely low levels of testosterone. For these patients, testosterone supplementation is a worthwhile endeavor and well within the risk profile advocated by the FDA.
For others, whose testosterone levels fluctuate within normal parameters but nonetheless look to testosterone supplementation to boost energy levels or their sexual performance, it can be a risky business that carries the potential for testosterone stroke and even testosterone death.
Plaintiff Evelyn Calvillo lost her husband allegedly to the use of AndroGel, a popular testosterone supplement. Too much testosterone in the bloodstream can increase the production of red blood cells, which equates to a thickening of the blood - a definite risk factor for testosterone heart attack and stroke. Calvillo’s testosterone lawsuit claims that manufacturers failed to properly warn consumers about the potential for serious testosterone side effects.
Calvillo filed her testosterone lawsuit (Evelyn Calvillo v. AbbVie Inc., et al., case number 8:14-cv-01331, in the US District Court for the Central District of California) in July. Defendants included AbbVie Inc. and McKesson Corp., a pharmaceutical distributor based in the Golden State. Abbott Laboratories Inc., the manufacturer of AndroGel, is also named.
AbbVie attempted to have the testosterone lawsuit stayed to await transfer into multidistrict litigation for testosterone in Illinois. AbbVie also had problems with McKesson named as a defendant, holding among other objections that the plaintiff only included McKesson in an attempt to anchor her lawsuit in the state of California.
However, US District Judge Josephine Staton rejected the defendant’s motion and remanded Calvillo’s lawsuit to Orange County Superior Court, as requested by the plaintiff.
“Defendants also argue that, because McKesson is not a defendant in most other testosterone therapy cases, McKesson must not be a ‘necessary party’ to this action,” Judge Staton said in her order.
“Defendants’ assertion regarding other testosterone therapy cases, even if true, has no bearing on this action,” Judge Staton said, in her order earlier this month. “Defendants have not provided any information regarding the facts and circumstances of those cases, much less information demonstrating that McKesson is not a proper party to this action.”
Calvillo had argued that California strict liability laws state that distributors and manufacturers can both be held liable for failing to provide adequate warnings about products.
Last month the FDA convened an expert panel that voted 20-1 to have testosterone labels updated to include the fact that testosterone has not been proven as appropriate to treat conditions associated with aging and the natural dip in testosterone levels that result. The panel noted a lack of convincing evidence, but also noted the need for increased caution nonetheless in order to mitigate and ultimately avoid needless testosterone side effects.
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