Testosterone Therapy: Risks and Litigation By Ava Lawson

Testosterone therapy is FDA approved. The purpose of these drugs involves boosting male sex hormone levels. This condition is known as hypogonadism. And it has been marketed as a lifestyle product to men experiencing the normal effects of aging. And in 2012, manufacturers Abbot Laboratories. Also, AbbVie spent more than $80 million advertising Androgel. So that places it among the most popular testosterone supplements on the U.S. market.

And their ad campaign targets middle-aged men with a “Low T” symptoms checklist that asks:

  • Has your sex drive diminished?
  • Have you been feeling moody?
  • Do you have less energy?
  • Are you experiencing decreased muscle mass or strength?

Doctors say that less energy, a waning libido, and increased body fat are normal facets of aging. So the low testosterone or “Low T” industry largely invented condition called “low T.” After all, testosterone levels naturally start to drop in men after the age of 30. So it’s really normal T.

And only some testosterone patients are actually tested for and diagnosed with hypogonadism. Yet, millions of men now use Low T supplements. Some products have questionable medical benefits. Also, they carry dangerous side effects. And these include an increased risk for heart attacks and stroke. Also, a Drug Reporter article links TRT, and heart attacks. Sadly, strokes and other serious health complications also come into play.

Deceptive testosterone therapy marketing tactics

Androgel remains among America’s best-selling testosterone replacement supplements. And it’s sold as skin patches, creams, injections, and gels. And these include brand products. These include Axiron, Fortesta, Striant, Tesopel, Testim, Bio-T Gel, and Androderm. Also, low T supplements have been promoted as a veritable fountain of youth. And this is done in direct-to-consumer ads. Interestingly, many in the medical community view them as misleading and deceptive.

“The market for testosterone gels evolved because there is an appetite among men and because there is advertising . . . The problem is that no one has proved that it works, and we don’t know the risks.” This is according to Harvard Medical School professor Dr. Joel Finkelstein. And that’s what he told The New York Times in 2013.

Recently, product liability lawsuits were filed against Abbott Laboratories and AbbVie Inc. And plaintiffs allege these companies “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes…while downplaying known adverse and serious health risks.”

The first wave of Androgel lawsuits brought in 2014. And they came on the heels of an FDA announcement. And they said that regulators would be re-examining the risks of testosterone replacement supplements. Most of all this is because new research suggested a higher risk of strokes. Also, cardiovascular injury provesmore common in certain populations of men who used them.

Testosterone side effects and increased heart attack risk

One of the most worrisome published studies on testosterone risks is in January 2014. PLoS One Medical Journal. There, researchers found that men aged 65 and older, as well as younger patients with previously undiagnosed heart disease, had twice the risk of suffering a heart attack from testosterone therapy after just three months.

A separate study published in the New England Journal of Medicine found that topical application of testosterone gel can raise the risk of myocardial infarction. Also, it confirms that stroke and atrial fibrillation can happen more in older men. And some men using Low T products have experienced transient ischemic attacks (TIA).

Of special interest, these are known as mini-strokes. And these remain known precursors to strokes in about 30% of patients. But strokes and adverse cardiovascular events are just a couple of the life-threatening side effects. However, the common link with these strokes is testosterone replacement therapy.

Also, other reported side effects include:

  • Sleep apnea
  • Increased risk for prostate cancer
  • Pulmonary embolism – a potentially deadly blood clot in the lungs
  • Paroxysmal Ventricular Tachycardia (PVT – rapid heart rate)
  • Blood clots and deep vein thrombosis (DVT)
  • Polycythemia (high red blood cell count tied to an increased risk of stroke and heart attack)
  • Death

Lawsuits mount alleging testosterone therapy injuries

Across the country, dozens of testosterone lawsuits have been filed against manufacturers. And these include recent cases against AbbVie Inc., Pfizer, and Auxilium Pharmaceuticals. Plaintiffs contend that no proper warnings were given about the dangers of Low T supplements. And plaintiffs allege a number of debilitating and potentially fatal side effects. And they claim it was from using the gels.

So for example, allegations include victims suffering from heart attacks, and deep vein thrombosis. Other plaintiffs allege strokes, TIAs and pulmonary embolisms are outcomes of TRT. Also several wrongful death suits been brought by family members. Of special concern here, their deceased loved ones died after using testosterone therapy.

To streamline the escalating numbers of similar claims and factual issues, federal suits were centralized in the U.S. District Court for the Northern District of Illinois.

Enter Judge Matthew Kennelly

So now they are before Judge Matthew Kennelly. Also, the Testosterone Replacement Therapy Products Liability Litigation, is classified as MDL 2545. And MDL 2545 began with less than 50 Androgel claims. But now it has amassed over 1,000 low T drug injury cases.

Legal experts predict an expansion of litigation. And this is because more studies point to testosterone and cardiovascular linked risks. But the majority of of 2015 will be focused on general and case-specific discovery processes. And the first bellwether trials, which are 6 Androgel cases, are slated to go before a jury in October of 2016.

Also, claimants want money for medical expenses, lost income, plus reduced earning capacity. Last, they are seeking money for pain and suffering. And that demand is based on failure to warn, fraud, negligence, and unjust enrichment.

Resources:

  1. WebMD, Low Testosterone Therapy: Risks and Benefits http://www.webmd.com/men/features/low-testosterone-therapy-risks-benefits
  2. Androgel.com, Diagnosing Low Testosterone. http://www.androgel.com/diagnosing-low-testosterone
  3. FDA, Evaluating risk of stroke, heart attack and death with FDA-approved testosterone products. http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm

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