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Testosterone Side Effects: Centralization for Some Lawsuits Hinges on Ruling

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Chicago, ILA request by plaintiffs to review a ruling in late 2015 fell below the radar, but nonetheless speaks to allegations of potential health issues related to Testosterone side effects and alleged efforts by manufacturers to spin a natural aspect of aging in healthy men into a disease for the purposes of selling testosterone supplements.

Plaintiffs claim in their testosterone lawsuit that supplements manufactured by the defendants increased the risk for testosterone heart attack, as well as testosterone stroke together with other cardiovascular issues.

Testosterone supplements have been around for decades as a necessary medical intervention for men suffering from hypogonadism, which is the medical term for chronically low levels of testosterone. The latter presents its own serious health risks, and for such patients, the benefits of testosterone supplementation outweigh the risks of testosterone side effects impacting the heart that could lead, in extreme cases, to testosterone death.

However, in recent years, manufacturers have tapped into the ongoing pursuit of the elusive fountain of youth amongst boomers seeking to turn back the clock. Cognizant of flagging energy and reduced libido, consumers lose sight of testosterone loss as a normal process of aging and instead appear to have bought into claims that testosterone supplementation is the answer for so-called “Low-T.” In truth, testosterone supplementation by otherwise healthy males could foster needless cardiovascular risks, or so it is alleged.

What’s more, plaintiffs claim that testosterone manufacturers were not forthcoming in stating those risks on product labeling or in marketing materials.

In December of last year, plaintiffs embroiled in a testosterone side effects lawsuit urged a federal judge in Illinois to stay an earlier ruling dismissing defendants Pfizer and Auxilium Pharmaceuticals Inc., a unit of Endo Pharmaceuticals, from multidistrict litigation in the face of alleged evidence the companies were allowed to update their labels by the US Food and Drug Administration (FDA).

The defendants held that the FDA does not permit manufacturers of generic drugs to unilaterally change the warnings on drug labels. To that end, in November of last year, US District Judge Matthew Kennelly ruled that Pfizer and Auxilium could not be held responsible in the false labeling testosterone lawsuit as only manufacturers of brand-name drugs are permitted to update their labels without FDA permission via the “changes being effected” process.

However, according to court documents, plaintiffs claim to have unearthed evidence that Pfizer attempted to unilaterally change the label on its AndroGel generic Depo-Testosterone on two occasions, in 1991 and again in 1996.

“If, as this court found, the question is how FDA understands and interprets the CBE regulations, evidence of how FDA interpreted them and acted on them in the past with respect to one of the specific drugs at issue here is surely relevant, especially in the absence of any statement or guidance from the FDA directly on point,” the plaintiffs wrote.

The plaintiffs also note that allegations that manufacturers created the so-called “Low-T” disease for their own benefit were not addressed in the ruling. Plaintiffs alleged that manufacturers promoted AndroGel and similar testosterone products as a handy remedy for a disease that didn’t exist.

Hundreds of testosterone lawsuit cases are centralized in Chicago. The case is In re: Testosterone Replacement Therapy Products Liability Litigation, Case Number 1:14-cv-01748, MDL number 2545, in the US District Court for the Northern District of Illinois.

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READER COMMENTS

Posted by

on
As one with advanced prostate cancer, I am currently on hormonal therapy. What hormonal therapy does is attempt to stop the production of testosterone in the body. Testosterone helps the prostate cancer cells continue to grow.

So I guess my question is: Won't taking supplements to increase testosterone in the body also tremendously elevate the chances for prostate cancer in men?

Posted by

on
I tried to gain muscle and get lean for years.. until I realised that I suffered from low testosterone.. I feel that this is one of the most under-addressed problems men face today..but you can do something about it. I managed to double my active testosterone naturally, gaining 15lbs of lean muscle by following The Man Diet.. I feel so much better day to day and I have even been able to get to 9 percent bodyfat. For those interested I found a helpful review on the program at www.zappohealth.com/tmd1. I'm still eating the foods I love, but I am so much leaner.

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