Testosterone Therapy Lawsuit
Testosterone therapies such as AndroGel are linked to potentially-fatal cardiovascular side effects and are the subject of thousands of lawsuits.
Hundreds of deaths and thousands of injuries are associated with testosterone products.
Sales of testosterone therapies have skyrocketed in recent years in part because manufacturers have been promoting them for uses not approved by the FDA, despite questions about the safety and efficacy of T-therapy. And until recently, manufacturers did not provide product label warnings about cardiovascular risk associated with testosterone use. Federal records show that hundreds of deaths and thousands of injuries are associated with testosterone products.
The ClassAction.com legal team is at the forefront of testosterone therapy litigation and has already filed injury and death claims against testosterone product makers. To see if you qualify for a lawsuit, contact our lawyers for a free case review.
Serious Testosterone Therapy Adverse Side Effects
Testosterone therapy has been shown to increase muscle mass, bone strength, and sexual function. Testosterone use, however, is also associated with the following side effects:
- Heart Attack
- Stroke (including “mini-strokes”)
- Pulmonary embolism
- Cardiovascular disease
- Liver toxicity
- Male infertility
The occurrence of these side effects is well-documented in scientific literature.
- A 2009 study designed to measure whether testosterone could help older men build muscle and strength was ended early because many participants were experiencing heart attacks and other cardiac issues.
- A study published in the prestigious journal JAMA in November 2013 found that older men undergoing testosterone therapy had a nearly 30% increase in mortality, heart attacks, and strokes compared to men not using testosterone.
- A large meta-analysis of testosterone trials published in 2014 linked testosterone use to cardiovascular events.
- New research funded by the National Institutes of Health found that men with preexisting heart disease who used testosterone therapy had twice the rate of heart attacks in the months after beginning therapy.
Types of T-Therapy
Testosterone therapy is sold as gels, patches, injections, creams, capsules, tablets, nasal sprays, under-skin implants, and “buccal systems” (absorbed through the gums). Some of the testosterone products named in lawsuits are:
- Androgel (AbbVie)
- Androderm (Actavis)
- Axiron (Eli Lilly)
- Aveed (Endo Pharmaceuticals)
- Bio-T-Gel (Teva Pharmaceuticals)
- Delatestryl (Endo )
- Depo-Testosterone (Unigen Life Sciences)
- Fortesta (Endo)
- Natesto (Trimel Pharmaceuticals)
- Striant (Auxilium Pharmaceuticals)
- Testim (Auxilum)
- Testopel (Auxilium)
- Vogelxo (Upsher-Smith Laboratories)
FDA Warnings About Testosterone Therapy
The FDA first addressed testosterone products in a 2014 safety communication in which the agency said that it was investigating the risk of stroke, heart attack, and death in men taking testosterone products.
A second FDA drug safety communication was issued in March 2015 and took a stronger tone, creating the requirement that prescription testosterone products carry an updated label that warns about the possible increased risk of heart attacks and strokes. The FDA also made clear that prescription testosterone is only approved for men with a condition called “hypogonadism” that causes unnaturally low testosterone. The agency made this statement because it became aware that many men are being prescribed testosterone due to age-related effects, not because they have a disorder.
In October 2016, the FDA expanded their warning to address testosterone therapy abuse and dependence. The agency warns against additional side effects, like depression, hostility, aggression, liver toxicity, and male infertility.
Questionable Marketing Tactics
During a 15-year period beginning in 2000, testosterone prescriptions jumped sixfold, from less than 1 million to more than 6.5 million.
This huge rise in testosterone prescriptions is attributable to manufacturers promoting their products for uses that they are not FDA-approved for—namely “Low T,” or a range of side effects associated with a natural drop-off in testosterone levels in middle-aged and older men. A Georgetown University Medical Center doctor says that “Low T syndrome is invented by pharmaceutical companies to sell treatment products,” and that the treatment “offers no proven benefits for healthy men.”
“Low T syndrome is invented by pharmaceutical companies to sell treatment products.”
Supporting this assertion is a 3-year study published in JAMA that found many men who are prescribed testosterone do not demonstrate the type of deficiency for which testosterone therapy is FDA-approved. Many men, in fact, according to the study, do not even undergo testing to find out whether they have a testosterone disorder before receiving T-therapy.
Direct-to-consumer advertising helps to explain the surge in testosterone therapy for men who may not even benefit from it. While doctors are free to prescribe drugs as they see fit, testosterone therapy manufacturers have been accused of pushing their therapy for “Low T” symptoms that are not necessarily rooted in low testosterone levels. For example, some advertising campaigns ask men whether they have a lowered libido, a lack of energy, or are feeling sad and/or grumpy—which could be symptoms of depression or simply a bad day. The ads go on to suggest that Low T may be to blame and that men should speak with their doctor about testosterone therapy.
Given the fact that testosterone products have been lined to nearly 4,000 serious complications, including 150 deaths and 2,000 hospitalizations, suggesting that testosterone therapy is appropriate for off-label uses is a dubious—and potentially dangerous—practice.
But the practice of pushing for expanded T-therapy uses is also highly profitable: from 1988 to 2011, testosterone sales jumped from $18 million to $1.6 billion.
Testosterone Mass Tort Lawsuit
Thousands of testosterone lawsuits have been filed against manufacturers that include AbbVie (Androgel), Eli Lilly (Axiron), Endo Pharmaceuticals (Testim), and Actavis Pharma (Androderm). The lawsuits allege that testosterone product manufacturers did not adequately warn about their products’ cardiovascular side effects and that the drugs were improperly marketed and prescribed.
More than 6,000 testosterone therapy lawsuits have been consolidated in U.S. District Court for the Northern District of Illinois. The majority of these lawsuits are filed against AbbVie, Androgel’s drug manufacturer. The first cases are expected to go to trial in June 2017.
T-therapy lawsuits against AbbVie and other manufacturers accuse the companies of:
- Misrepresenting the safety and effectiveness of testosterone replacement therapy
- Failing to adequately warn about testosterone therapy health risks
- Engaging in aggressive and misleading advertising campaigns targeting men for “Low T” syndrome
- Misleading potential users about the prevalence and symptoms of “Low T”
- Downplaying and ignoring known serious, adverse health effects of testosterone therapy
- Bringing to market a product that caused users to physical and emotional impairment, and resulting financial costs
Men who took testosterone therapy and experienced cardiovascular side effects may be eligible for legal action against the product’s manufacturer. People who lost a loved one to a testosterone therapy-related heart attack, stroke, or other side effect may also be lawsuit eligible.
How a Lawsuit Can Help
A testosterone therapy lawsuit can provide compensation for injuries or death caused by testosterone use. Compensation may be provided for medical bills, lost wages, pain and suffering, and other losses. Each lawsuit is different and any compensation recovered will be based on an individual’s specific losses.
What to Do if You Are Affected
If you took testosterone therapy and suffered a stroke, heart attack, or other cardiovascular event—or if a loved one suffered a fatal cardiovascular event after taking testosterone—you are encouraged to speak with ClassAction.com and learn your options.
We work with clients in all 50 states and offer free case reviews.