Thousands of men who used testosterone replacement products for Low-T may have suffered heart attack, stroke and other life-threatening side effects and have filed lawsuits against testosterone manufacturers.
In 2014, the Food and Drug Administration (FDA) began investigating major adverse events associated with testosterone replacement, after two academic studies indicated a two- or three-times greater likelihood for heart attack and stroke risk for men older than 65 as well as men younger than 65 with a history of cardiac events.
A number of manufacturers are in the spotlight as patients have suffered critical injuries after using their testosterone replacement products. Thousands of men and family members of those who used Low-T testosterone products have filed lawsuits against these manufacturers.
Seeger Weiss partner Dave Buchanan served as trial counsel in first three bellwether trials in this multidistrict litigation concerning cardiovascular injuries suffered by men following their use of prescription testosterone products, which resulted in more than $290 million in initial verdicts for two plaintiffs who suffered heart attacks following use of testosterone-replacement product AndroGel.
Testosterone replacement products and manufacturers named in lawsuits include:
| Brand | Form | Manufacturer |
| AndroGel | topical gel | AbbVie |
| Androderm | transdermal patch | Actavis |
| Testim | topical gel | Endo |
| Testopel | topical solution | Endo |
| Bio T Gel | topical gel | Teva |
| Delaestryl | injection | Endo |
| Depo Testosterone | injection | Pfizer |
| Fortesta | topical gel | Endo |
| Striant | buccal tablet | Endo |
Testosterone Lawsuits on the Rise After Allegations of Possible Injury
Thousands of federal testosterone lawsuits have already been filed and consolidated into multi-district litigation. The attorneys for the plaintiffs claimed that these manufacturers encouraged the use of testosterone without appropriately testing for low testosterone levels, aggressively marketed this dangerous product to aging men, minimized severe side effects like stroke, death and heart attack and failed to adequately warn of potential side effects.
Plaintiffs and their families may be able to recover actual damages and punitive damages. Thousands of lawsuits associated with testosterone replacement products have already been filed and more may be expected.
About Testosterone Therapy
Testosterone replacement therapy is not approved for falling levels associated with normal aging. Many men have taken it for this reason and may have suffered unnecessary risks. Testosterone replacement is approved for a condition known as hypogonadism, which occurs when the testes have failed to produce enough testosterone. Hypo can be a result of injury, toxicity or genetic defects but is not a result of normal aging.
Doctors are allowed to prescribe medication for unapproved or “off-label” uses but manufacturers are prohibited from promoting them. Even though testosterone is not approved for “Low T” associated with aging, testosterone products may have been promoted for off-label uses.
Testosterone replacement therapy is available in topical gel, solution or patches and as an injection. Millions of prescriptions have been written in the U.S. testosterone replacement therapy and up to 3% of men over age 40 have used testosterone for “Low-T”. Currently, more than $2 billion is being spent on this kind of testosterone therapy every year and the market may reach $5 billion annually by 2017.
Testosterone replacement therapy has been linked to a number of severe side effects like stroke, death, heart attack or blood clots. Most of these men who used testosterone replacement did not ever have a testosterone blood lab test taken to prove their testosterone levels were low. Men who took the medication without a clear need, were placed at additional risk for serious side effects.
In 2014, the Food and Drug Administration released a safety announcement warning, telling customers about the potential risks of testosterone therapy, including a two or three-fold increase in the chance of cardiovascular event such as heart attack or stroke. Many men and their family members who suffered from a life-threatening side effect of testosterone therapy have filed lawsuits as a result of their injuries.
AndroGel for Testosterone Replacement Therapy
AndroGel is a topical gel formulation of testosterone replacement medication intended to be applied to the skin daily. It is approved to treat low testosterone levels associated with primary hypogonadism which can cause low testosterone levels. Though it can be used as an “off-label” treatment, manufacturers cannot promote their products for unapproved reasons. AbbVie and other manufacturers have been accused of marketing their products for “Low-T”, an unapproved use.
“Low-T” advertising implies that decreasing testosterone levels are responsible for normal symptoms of aging and encourages use of AndroGel and other medications to increase energy levels, sex drive and restore muscle tone. Declining testosterone levels are a natural function of aging and many of the men who used AndroGel for “Low-T” never had their testosterone levels tested. They may not have had abnormal testosterone levels and may have been placed at unnecessary risk for life-threatening side effects.
In 2014, the Food and Drug Administration (FDA) issued a warning that told consumers about the potential risk of AndroGel and other testosterone replacement therapy. The announcement warned that men who use testosterone replacement may have a two or three-fold increase in the risk for blood clots which can cause stroke or heart attack.
Testosterone Side Effects
Some of the less severe side effects associated with testosterone use include:
- Increased sex drive
- Hypertension
- Weight gain
- Oily skin and acne
- Sleep apnea
- Prostate enlargement
- Headache and hot flushes
- Increased body hair growth
- Aggressive behavior
Severe or serious side effects associated with testosterone use include:
- Heart attack
- Stroke
- Liver damage
- Blood clots
- Prostate cancer
AndroGel Side Effects
Some of the common side effects associated with AndroGel use include:
- Increased sex drive
- Increased aggression
- Increased body hair growth
- Oily skin and acne
- Hypertension
- Weight gain
- Sleep apnea
- Prostate enlargement
- Headache and hot flushes
Severe or more serious side effects associated with AndroGel include:
- Blood clots
- Heart attack
- Stroke
- Liver damage
- Prostate cancer
Manufacturers of testosterone replacement therapy medications have faced thousands of lawsuits for heart attack, stroke, blood clots and other serious injuries. Past settlements for drug injury lawsuits have included compensation for medical costs, lost wages, pain and suffering and in some cases, wrongful death.