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Testosterone Lawsuits

testosterone patient with nurseIn recent years, it’s been estimated that one in every 25 men over the age of 60 is taking some form of testosterone therapy. These hormone replacement supplements are only indicated for males who suffer from hypogonadism – a clinically diagnosed condition in which the body fails to produce enough testosterone. Waning levels of testosterone are a natural part of the aging process, and after 30 this male sex hormone begins a gradual decline. Since testosterone helps regulate fat distribution, sex drive, and the ability to gain muscle mass, men in their middle-aged years may often struggle to keep weight off and maintain the healthy libido of their 20’s.

These normal aspects of aging have been transformed into an allegedly fictional syndrome by various makers of testosterone supplements who’ve coined the term “Low T.” AbbVie, Inc., maker of the popular Androgel testosterone supplement, even offers a Low T checklist to help guys determine if they suffer from this treatable syndrome– asking men if they feel moody, suffer from occasional erectile dysfunction or notice a fading sex drive.

AbbVie, along with other drug companies, have cleverly marketed their products as a veritable fountain of youth. But many in the medical community argue that testosterone replacement supplements offer no proven benefits to healthy men, and in fact may put them at risk for heart attack and stroke – potential side effects that have been reported in testosterone studies and alleged in recent lawsuits.

Popular Low T supplements

The U.S. market has been flooded with products to help boost testosterone levels. Available in pills, gels, creams, pellets, injections and patches, some of the more popular brands include:

  • Axiron
  • AndroDerm
  • AndroGel
  • Bio-T Gel
  • Dep-Testosterone
  • Fortesta
  • Tesopel
  • Testim

Among all testosterone replacement brands, gels such as Axiron and Androgel are the most frequently prescribed due in part to their ease of application and the aggressive ad campaigns run by AbbVie. In 2012 alone, the company spent $80 million to promote Androgel, which quickly achieved blockbuster status as one of the most popular medications to enhance one’s “lifestyle.” That same year, AbbVie reaped the financial rewards of $2 billion in Androgel sales.

Marketing tactics called into question

Pervasive marketing by testosterone manufacturers suggested that lagging energy levels and problems in the bedroom were a direct result of Low T, with no mention of other possible factors. Convinced they had a treatable medical condition, thousands of men in their 40s and 50s made doctor appointments asking for Low T therapy in the hopes of regaining their lost vitality. And many physicians were quick to write a prescription without ordering blood tests for hypogonadism – the only FDA-approved use for testosterone therapy.

As Low T product sales continued to climb, researchers began to uncover serious side effects of testosterone therapy, especially among Baby Boomers with a prior history of heart disease. A study in the Journal of the American Medical Association, which looked at veterans taking Low T products reported that patients had a 25.7 percent rate of death, heart attack or stroke, compared to 19.9 percent in men who did not take the supplements.

Research points to testosterone heart attack risks

In 2014, the FDA issued a safety communication stating the agency was investigating the risk of stroke, heart attack and death in men taking testosterone therapy products based on separate studies that each indicated adverse cardiovascular events among men taking the supplements.

Low T side effects and risks have been reported in the following studies:

  • In 2014, a study published in PLoS One reported a connection between testosterone supplements and heart attack risk in both men over 65 and those younger than 65 with a known history of heart problems.  The researchers followed 56,000 men over a 2-year period and found that heart attack risk was nearly doubled.
  • In 2010, research published in the New England Journal of Medicine reported that the risk of a “cardiovascular-related adverse event remained significantly greater among men in the testosterone group than among men in the placebo group.”

Public safety advocates such as Dr. Sidney Wolfe of the watchdog group Public Citizen have urged for stronger warnings regarding Low T supplements. In 2014, Public Citizen petitioned federal health regulators at the FDA to add a black box warning on all testosterone products regarding cardiovascular risks. Thus far, no such actions have been taken by the FDA.

Testosterone and Androgel lawsuits

Low T therapy litigation began last year with only a handful of claims alleging stroke and heart attacks from using Androgel. Over the past 12 months, hundreds have filed suit alleging cardiovascular injury, stroke or even death, bringing the current case load to over 1,000 testosterone lawsuits. Pharmaceutical product liability attorneys are seeking damages on behalf of their clients for medical bills, lost wages, pain and suffering and loss of enjoyment of life.

In June 2014, federal cases were centralized in U.S. District Court for the Northern District of Illinois before Judge Matthew F. Kennelly to streamline pretrial processes. While all cases assert similar injuries and side effects, the products are manufactured by various companies including Abbott and AbbVie, Pfizer, Auxilium Pharmaceuticals, Upjohn and Pharmacia. According to the transfer order, “all actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism.”

The first bellwether trials, which help predict how juries might react to evidence and testimony presented in other similar claims, are slated to start in October 2016. The results of these preliminary hearings are not binding on other plaintiffs, however, but may spark settlement negotiations.

  1. PLOS One, Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men

  2. FDA, FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products

  3. Bloomberg, Abbott Labs Testosterone Suits Consolidated in Chicago