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Following several recent studies suggesting an increased risk of heart attacks from AndroGel and other testosterone treatments, the makers of the popular testosterone gel face a growing number of lawsuits filed this week by men who claim they suffered injuries.
At least four complaints were filed in the U.S. District Court for the Northern District of Illinois on Tuesday, each involving men who claim that they suffered a cardiovascular event after using Androgel for treatment of low testosterone, which may not have actually required a medication.
The Androgel lawsuits were filed on behalf of Michael Gallagher, of Midlothian Virginia (PDF); Steven Myers, of Fort Worth, Texas (PDF); Steve Marino, of Saint Louis, Missouri (PDF); and Kenneth Aurecchia, of Johnston, Rhode Island (PDF). Gallagher indicates that he suffered a heart attack and congestive heart failure, Myers and Aurecchia indicate that they suffered heart attacks, and Marino suffered a stroke. All of the plaintiffs claim that they had no prior history of heart events and allege that the injuries were caused by side effects of AndroGel.
The complaints were brought in the home state for the maker of Androgel, AbbVie, which is a spin-off of Abbott Laboratories.
Gallagher, Myers, Marino and Aurecchia claim that AbbVie essentially created a marketing for “Low T”, which is an industry-created term for low testosterone levels.
The FDA only approved AndroGel testosterone for the treatment of testosterone levels that are low due to a medical condition known as hypogonadism. However, AbbVie and other pharmaceutical companies have used direct-to-consumer advertising to encourage men to seek medical treatment for various symptoms, including lack of energy, weight gain and decreased sex drive, which can be attributed to a number of causes, including the natural aging process.
According to allegations raised in the claims, AbbVie is “disease mongering.” Plaintiffs point out that a quiz on “Low T” made by drug maker describes general symptoms like being “sad or grumpy” and “falling asleep after dinner.” The lawsuits claim that once the quiz gets the men worked up enough they go ask their doctors if this means they are experience Low T.
Even though the commercials for AndroGel mention testing and a number, many doctors never test the actual testosterone levels of their patients or prescribe the treatments when levels are normal.
“As a result of this ‘disease mongering.’ as termed by Dr. Adriene Fugh-Berman of Georgetown University Medical Center, diagnoses of Low T have increased exponentially,” the lawsuits state. “This has directly related to AndroGel’s sales increasing to over $1.37 billion per year.”
The lawsuits also point to the ever-inflating number of men who allegedly have “Low T.”
“In 1999, when Unimed Pharmaceuticals Inc., one of the Defendants’ predecessor companies, asked for FDA approval of AndroGel, it asserted that hypogonadism was estimated to affect approximately ‘”one million American men’,” the lawsuits note. “In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003 the number increased to ‘up to 20 million men.'”
Testosterone Therapy Heart Problems
The claims come on the heels of a number of recent studies warning of an association between testosterone therapy and heart attacks, strokes and wrongful death. Due to the growing concerns, the FDA has launched an investigation into the safety of testosterone products like AndroGel.
In November 2013, a study published in the Journal of the American Medical Association found that side effects of testosterone treatments were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.
That research was followed by another study released last week by the medical journal PLOSOne, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.
On January 31, the FDA announced it is investigating the safety of testosterone therapy, including the potential risk of stroke, heart attack or even death. The agency said the decision to take a new look at the potential side effects of the popular hormone therapy came as a result of the recent studies.
A growing number of testosterone treatment injury lawyers are reviewing potential lawsuits on behalf of men throughout the United States. Therefore, it is expected that the four cases filed yesterday may be just the tip of the iceberg.