Testosterone therapy is used to treat low testosterone levels or “Low-T” in men. It has been linked to serious side effects including heart attack, stroke, and prostate cancer.
Testosterone is a naturally occurring steroid hormone that is produced by the body in both men and women. It is one of the sex hormones which stimulates secondary sex characteristics in males such as facial and body hair growth and increased muscle mass. It is also present in lower levels in women and is important for the regulation of the reproductive system.
As men age, testosterone levels begin to fall which can result in loss of muscle, fatigue, and loss of sex drive. Many men have turned to testosterone replacement for “Low-T” and while testosterone is a natural substance, replacement therapy can be dangerous for some people. Thousands of men using testosterone replacement have experienced serious side effects and manufacturers of “Low-T” products are facing thousands of lawsuits due to injuries caused by testosterone therapy.
Testosterone replacement products are medications which contain testosterone steroids. Though testosterone is a naturally occurring hormone, medications used as testosterone replacement have a number of side effects. Some of these side effects may be serious or even life-threatening.
Stroke and Heart Attack
Results of a study published in a 2013 edition of JAMA (Journal of the American Medical Association), indicated that testosterone replacement therapy may be associated with an increased risk of heart attack or stroke which may lead to death. In January of 2014, the Food and Drug Administration (FDA) issued a safety notice which stated that the agency was monitoring testosterone replacement products and the potential for serious side effects.
In 2015, the FDA updated safety information on all testosterone products to strengthen warnings about the potential risks of heart attack and stroke. The agency also emphasized the lack of safety information regarding testosterone use as replacement for levels which had fallen naturally due to aging. Testosterone replacement for “Low-T” due to aging is not an approved reason for use and though physicians may prescribe medications for “off-label” uses, it has not been studied for this purpose.
Prostate cancer is the second most common form of cancer in men. Testosterone administration has been linked to an increased risk of prostate cancer. Prescribing information of testosterone products used for replacement indicates that it should not be used in men who have or who are at risk for prostate cancer.
While it has been widely believed that testosterone replacement therapy may increase the risk of prostate cancer, some studies have questioned the connection. A 2015 review of a data collected over a 25 year period concluded that there was no definitive increase in risk however, the authors indicated that more studies may be needed.
Testosterone Replacement Therapy
Testosterone is approved by the FDA for medicinal use for replacement in those who have low levels due to a medical condition is known as hypogonadism.
Hypogonadotropic hypogonadism occurs when the male gonads or testes do not produce enough testosterone. It is usually due to a malfunction of the hypothalamus or pituitary gland but may be a problem with the testes themselves.
Testosterone therapy has not been approved for “age-related” hypogonadism, or for testosterone levels that have decreased due to use of other medications. It is not approved to treat what is commonly called “Low-T”.
Many health supplements are available which claim to “boost” testosterone levels. These products are sold in drug stores, supermarkets, health food stores, and online marketplaces and claim to boost or encourage the body to make more testosterone. These products are not evaluated by the FDA for safety in treating low testosterone levels. No recognized scientific evidence has shown that “natural” testosterone supplements are effective.
Dietary supplements are regulated by the FDA but are not allowed to contain ingredients classified as “drugs”. Testosterone is also separately regulated by the Drug Enforcement Agency as a controlled substance which is subject to abuse and dependence. Nutritional supplement manufacturers which have been shown to sell dietary products containing actual testosterone steroids have been found to be in violation of federal law and are subject to severe penalties.
Testosterone Replacement Products
Testosterone replacement medications come in a number of dosage forms including oral formulations like tablets, intramuscular injections and transdermal patches and gels to be placed on the skin. The most common forms of testosterone replacement products used for “Low-T” or testosterone replacement in age-related low testosterone levels are injectable or transdermal formulations.
More than 25,000 lawsuits have been filed against manufacturers of testosterone replacement medications including:
Androderm Patch (Allergan)
Androderm Gel (Allergan)
Axirom (Eli Lilly & Co)
Testim Gel (Endo)
In recent years, a number of men have used testosterone replacement due to age-related testosterone decline. Despite the knowledge that decreasing testosterone levels are a normal fact of aging, many men desire to “feel young” and have become a target for “Low T” marketing.
Correspondingly, there has been a significant increase in the numbers of serious adverse events, including heart attack, stroke, and death caused by testosterone replacement therapy. Thousands of these men or their loved ones have filed lawsuits against drug manufacturers for their injuries. Some of the lawsuits have been settled while others are still pending in federal, state or local courts.
Testosterone Therapy Multidistrict Litigation
Over 25,000 federal testosterone lawsuits were consolidated into multidistrict litigation (MDL) case 2545 in the U.S. District Court for the Northern District of Illinois. MDL cases are formed when a large number of similar lawsuits are filed. This allows both plaintiffs and defendants to pool their resources and documents to streamline the court process.
In MDL cases, a few trials known as “bellwether” cases will be tried before the others. The outcome of a bellwether trial, decided by a jury will help to determine how other cases may be expected to be decided. In many cases, a successful bellwether trial will prompt manufacturers to offer a settlement amount to participants, to avoid a lengthy trial process.
Testosterone Therapy Trials and Settlements
A number of bellwether trials have taken place for testosterone replacement products, with mixed results. A number of the settlements have also been offered.
- June 2017 – the first bellwether trial naming AbbVie as a defendant was declared a mistrial due to a hospitalization of an attorney
- July 2017 – a second bellwether trial against AbbVie resulted in a jury award to the plaintiff of $150 million
- August 2017 – In the third AbbVie bellwether trial, federal jurors ruled for the manufacturer in an AndroGel case.
- October 2017 – AbbVie was ordered to pay $140 million to a plaintiff who suffered a heart attack after using AndroGel
- November 2017 – A bellwether trial against Endo was decided in favor of the manufacturer
- December 2017 – the $150 million verdict against AbbVie was thrown out by an Illinois judge
- December 2017 – Eli Lilly & Co reached a settlement agreement with 500 plaintiffs
- January 2018 – An AndroGel bellwether trial ended in a verdict for the defendant, AbbVie’
- March 2018 – the retrial for the $150 million jury award which had been thrown out was decided for the plaintiff and the jury awarded $3.2 million
- May 2018 – AbbVie won its fifth AndroGel bellwether trial
- June 2018 – Endo International offered to settle about 1,300 lawsuits for $200 million for users of Testim Gel.
- June 2018 – A sixth bellwether trial ended in favor of AbbVie
About 6,000 federal testosterone cases remain unsettled and more may be pending in state and local courts.
Testosterone Therapy Lawsuit Compensation
In medical injury lawsuits, plaintiffs often seek compensation for injuries which required hospitalization, resulted in high medical costs or left the victim with a disability. Loved ones may be eligible for compensation in the event of wrongful death caused by a drug.
People who have suffered a heart attack or stroke or loved ones of those who died after using testosterone replacement therapy may be eligible for compensation for:
- medical costs
- lost wages
- future medical costs
- pain and suffering
In some cases, if it can be proven that manufacturers knew of the risks but continued to sell or market the drug, companies can be held responsible for punitive damages.
Each case is unique and must be examined separately. There are no guarantees but those who have suffered harm after using testosterone replacement therapy should have their case evaluated by legal experts.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- After setting aside $200M, Endo settles 1,300 testosterone liability lawsuits, Fierce Pharma 6/2018
- Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels, JAMA-Journal of the American Medical Association 11/2013
- Endo, GlaxoSmithKline close to settling testosterone liability cases, Fierce Pharma 2/2018
- FDA Drug Safety Communication: FDA evaluating the risk of stroke, heart attack and death with FDA-approved testosterone products, U.S. Food and Drug Administration 1/2014
- FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging, U.S. Food and Drug Administration 3/2015