Thousands of men have filed lawsuits against makers of testosterone treatments for injuries ranging from stroke to heart attack. Our team of t-therapy lawyers is constantly working to provide our clients the latest updates on these claims.
Seven manufacturers have been named in t-therapy litigation, which was recently centralized in the Northern District of Illinois. The first case is expected to begin in the fall of 2016. Some legal experts believe these claims will set a precedent in pharmaceutical litigation because t-therapy drugs were heavily marketed to men suffering from so-called “Low T,” which is not an FDA-approved use for these drugs, nor is it a valid medical condition.
Low T is not a recognized disease in any sense of the word – men’s testosterone levels naturally decrease with age, just as women’s estrogen levels naturally decrease. It is simply a part of getting older. Despite this, drug companies spend millions of dollars on direct-to-consumer ads every year that tell men they should consult their doctor about the possibility of Low T. “Borderline Low T,” was a term invented by Big Pharma to profit off the insecurities of aging men.
Over the past decade, t-therapy prescriptions have increased 10-fold in the United States. It is worth noting that the U.S. is one of only three countries in the world (along with Canada and New Zealand) that allows direct-to-consumer advertising for prescription drugs.
In response to this disease mongering, the FDA issued several warnings to t-therapy manufacturers demanding labels be revised so patients and doctors know that these drugs are approved only to treat serious medical conditions such as hypogonadism. The labels, updated in March 2015, also must warn that these drugs carry extreme, life-threatening cardiovascular risks.
Gels, Patches and Shots, Oh My!
The most well-known product at the center of these claims is AndroGel, however, recent studies have shown that short-acting injections carry the greatest risks. One study examined data from half-million new users of t-therapy. Of these, 7% used patches, 37% received injections, and 55% used gels.
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The men who received injections had the greatest risk of cardiovascular side effects (stroke and heart attack), hospitalization, and death. There was no marked difference between patches and gels. This study did not include long-acting forms of t-therapy, which was just recently approved in the U.S.
The shorter-acting forms of injectable t-therapy, which were studied, caused testosterone levels to spike more severely. Researchers suggested that it may be wise for patients to take lower doses of the injections at more frequent office visits. Injections are typically much less expensive than gels or patches, making these findings all the more worrisome.
As mentioned, these drugs should only be prescribed to patients with hypogonadism or other medical conditions that cause dangerously low hormone levels. These drugs are not safe or at all necessary for men experiencing normal testosterone decline.
It’s this kind of sensationalism that has endangered healthy men and led to thousands of life-threatening injuries. The major complaint in the t-therapy litigation regards how heavily Big Pharma marketed these drugs to men who did not suffer from an FDA-approved medical condition. By doing this, drug companies purposefully put men’s lives in danger in order to reap larger profits.
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Reports from the manufacturer of AndroGel illuminates how far Big Pharma was willing to go in its marketing to healthy men. Before AndroGel was approved, the company estimated hypogonadism (again, the only condition approved for t-therapy) affected about one million men. After the gel was approved, the company announced the market grew to about four million. Three years later, in 2003, the company estimated approximately 20 million men were eligible to receive AndroGel.
Hypogonadism is listed as a rare disease by the Office of Rare Diseases, which is part of the National Institutes of Health. To be classified as such, it would have to affect less than 200,000 Americans. This condition is either caused by dysfunction of the gonads or of the brain’s ability to message the gonads. Patients are either born with hypogonadism or develop it from injury or infection. In other words, there is a pronounced difference between naturally declining testosterone and hypogonadism.
Despite this, prescriptions for t-therapy continue to climb upward, driving sales into the billions. The FDA reports that a quarter of men taking t-therapy have never even had their hormone levels tested at all. Men who suffer from symptoms of Low T should consider their lifestyle factors first and foremost before considering a drug. Exercise, even as little as two hours per week, can work wonders for a low sex drive and decrease in muscle mass. T-therapy lawyers are currently investigating claims of serious injury from testosterone injections, patches or gels. We offer free, confidential legal consultations to concerned patients and families nationwide.