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.
Testosterone replacement products and manufacturers named in lawsuits include:
|Bio T Gel||topical gel||Teva|
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 levels decrease naturally as men age. 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 primary hypogonadism in which the testes have failed to produce enough testosterone. Primary hypogonadism 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.
Testosterone Side Effects
Some of the less severe side effects associated with testosterone use include:
- Increased sex drive
- 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
- Liver damage
- Blood clots
- Prostate cancer
Filing a Testosterone Replacement Lawsuit
Men or loved ones of those who have been injured as a result of use of testosterone replacement medications taken to combat “Low T” or for age-related symptoms, should consult with a testosterone replacement attorney. Some testosterone replacement settlements have already been offered by AbbVie, Endo, Glaxo, Axiron and Actavis but other cases have not been settled but remain in federal, state and local courts.
Men or family members of those who suffered heart attack, stroke or other cardiac event may be eligible for compensation for medical costs, lost wages, pain and suffering or in some cases, punitive damages. There are no guarantees but consultation with a testosterone replacement lawyer may help determine eligibility for compensation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- AbbVie nears settlement in thousands of lawsuits alleging harm by testosterone drug AndroGel, Chicago Tribune (9/2018)
- After setting aside $200M, Endo settles 1,300 testosterone liability lawsuits, FiercePharma (6/2018)
- Actavis Agreed On Global Settlement for About 500 Androderm Lawsuits, Neural IT (7/2018)
- Testosterone therapy: Potential benefits and risks as you age, MayoClinic (12/2017)
- FDA cautions about using testosterone products for low testosterone due to aging, U.S. Food and Drug Administration (3/2015)