Anywhere between 12 and 38 percent of men 45 years or older suffer from a condition called hypogonadism1, which happens when the body does not produce enough testosterone. Fortunately for those men and others suffering from the potentially serious condition, the U.S. Food and Drug Administration has approved several products for testosterone-replacement therapy.
However, drug companies have falsely marketed their testosterone products as solutions for people with other ailments, including sexual dysfunction, low libido, depression, and more. Thanks to the creation of a misleading diagnosis of “Low T,” the number of men using the hormone has skyrocketed the past few years.
What many men using testosterone didn’t know is that the different products designed to treat hypogonadism may cause serious side effects, such as heart attacks, strokes, blood clots, and more.
More than 25,000 people have filed lawsuits against the makers of various testosterone products that have been used widely for off-label uses. Although four bellwether cases have already made it to trial with verdicts in favor of both sides, thousands of lawsuits are still pending in court.
Find out more about proposed settlements, million-dollar verdicts, and whether you have a case.
Testosterone Replacement Therapy Background
Testosterone is an important hormone in the body. For men, the sex hormone plays a role in regulating sex drive, bone mass, muscle mass, fat distribution, and the production of red blood cells2.
In some cases, the body does not produce enough of the hormone. This condition is called hypogonadism. It can be something someone is born with or develop later in life. In adult men, it can lead to several complications, such as infertility, erectile dysfunction, fatigue, enlarged breasts, osteoporosis, and more.
One of the most common treatment options for hypogonadism is called testosterone replacement therapy. The FDA has approved a variety of drugs and products that provide testosterone to patients affected by hypogonadism, including one of the first injectable testosterone drugs on the market called Depo-Testosterone — which was approved by the FDA in 1979.
Countless men have since used testosterone replacement therapy to successfully treat their hypogonadism and get their lives back on track. Unfortunately, a growing number of people started using the hormone for more purposes than originally intended.
Testosterone currently comes in several different iterations. Here is a breakdown of the most common types.
Testosterone gels are products people can apply to their body to treat hypogonadism. They come in packets or pumps and are applied directly to the skin. One of the most widely used testosterone products is AndroGel, which was developed by Solvay Pharmaceuticals and approved by the FDA in 2000 before being bought by AbbVie in 2010.
Other topical gels include Testim, Fortesta, and Axiron.
One of the first testosterone drugs approved by the FDA was Depo-Testosterone. This form of the hormone is an injectable liquid usually given at clinics. These have been historically abused by those looking to bolster muscle growth.
Other injectable forms are Delatestryl, Aveed, and Testopel.
An alternative to topical gels are patches that provide the hormone to the skin of the body. These are usually applied to the skin every 24 hours in a new spot. One of the most common patches for testosterone replacement therapy is Androderm.
Low Testosterone Treatment Becomes Billion-Dollar Industry
Although testosterone products were originally approved for a very specific use, manufacturers of the products started embarking on an aggressive marketing campaign to promote the hormone as a cure for many common ailments in men. More physicians have been diagnosing men with “Low T,” a vague and general diagnosis that could not be classified as hypogonadism.
The marketing tactics from companies like Pfizer and AbbVie worked. From 2001 to 2011, testosterone use among men 40 years and over nearly quadrupled3. One study reported that nearly one in 25 men in their 60s takes the hormone, according to The New York Times4.
An author of the study told The Times that doctors were becoming more willing to give the hormone to those who didn’t fit the diagnosis of hypogonadism. Instead, men who were taking it were experiencing normal age-related hormonal declines, he said.
By 2013, an estimated 2.3 million American men were receiving testosterone replacement therapy to treat less severe ailments like erectile dysfunction or low sex drive5. Men spend about $2 billion on testosterone every year. The skyrocketing sales can be attributed to the tens of millions of dollars drug manufacturers have poured into marketing campaigns to get people talking about “Low T.”
However, with the growing number of men using the hormone, the dangers of the products have come to light.
Serious Side Effects Associated with Testosterone
These are some of the most serious side effects people taking the hormone have experienced.
Testosterone has been linked to myocardial infarction, more commonly known as heart attack. A study in 2014 found that men over 65, or younger men with heart problems, were at least twice as likely to have a heart attack in the 90 days after being prescribed testosterone compared to those who weren’t taking the hormone6. The researchers described the risk as “substantially increased.”
A more recent study published in JAMA in February 2017 concluded that men treated with testosterone gel for a year were associated with a significantly greater increase of plaque in the arteries, which can build up and cause heart attacks7.
In 2015, the FDA approved a label change to warn of an increased risk of heart attacks8.
Blood clots have also been connected to testosterone therapy. In 2014, the FDA issued a safety announcement that some FDA-approved testosterone products could raise the risk of blood clots, including deep vein thrombosis and pulmonary embolism9. As a result, the FDA changed labels of all testosterone products to reflect the risks.
A 2016 study published in the BMJ found that the risk of blood clots increased by 63 percent in the first six months of starting testosterone therapy10.
Stroke is also a major risk of testosterone products. Studies have found that the products increase the risk of stroke in men. Along with the label changes about the risk of heart attack, the FDA also changed the labels to reflect the risk of stroke.
Exposure to Children
Testosterone gels carry a secondary risk to children who may be exposed to the gel. If a person applies the gel to their body and then comes in contact with a child, the child could suffer serious side effects.
The FDA received at least eight cases of secondary exposure in children by December 2008. These reports prompted the agency to require a black-box warning on AndroGel and Testim that exposure could cause premature development, enlargement of the genitals, aggressive behavior, and more11.
Thousands File Testosterone Lawsuits
As a result of the marketing tactics and hidden side effects, thousands of men have filed lawsuits against the manufacturers of testosterone products. Plaintiffs have accused drugmakers of illegally marketing the hormone to treat conditions that were not approved by the FDA.
On top of the marketing, plaintiffs allege that the companies failed to warn the public about the risks of heart attack, stroke, and blood clots. They also claim the exaggeration of benefits and the downplaying of risks have caused unnecessary injury and even death.
Some of the first lawsuits were filed against Abbott Laboratories and spin-off company AbbVie in 2014 over claims that their AndroGel drug caused injuries. By the end of the year, dozens of lawsuits against additional manufacturers — like Pfizer, Endo International, and Eli Lilly & Co — had been filed and consolidated into a multidistrict litigation by the U.S. Judicial Panel on Multidistrict Litigation.
A judge selected several bellwether cases to head to trial.
Bellwether Trials & Verdicts
At least four cases went to trial in 2017 and 2018.
The first case in June 2017 ended in a mistrial but was later retried in September. Plaintiff Jeffrey Konrad was awarded $140 million by a jury against AbbVie after he suffered a heart attack while using AndroGel12. He had claimed the company knew of the risks but hid them in order to increase profits.
The second case ended with a $150 million award in punitive damages after a jury found in favor of plaintiff Jesse Mitchell’s claim of fraudulent misrepresentation by AbbVie. That verdict was thrown out. A retrial in March 2018 ended with a verdict of more than $3 million after the jury found AndroGel caused his heart attack13.
Two additional cases went in favor of AbbVie.
Testosterone Lawsuit Settlements
While there are still thousands of cases pending against manufacturers, several drugmakers have reached settlements with plaintiffs.
In 2017, Eli Lilly & Co agreed to a global settlement to resolve all the cases filed against it over its testosterone products. The terms of the settlement have not yet been made public.
Drugmakers Endo International, Auxilium Pharmaceuticals, and GlaxoSmithKline also agreed to a tentative deal in February 2018 to settle all the testosterone cases pending in multidistrict litigation13. As part of the settlement, a spokeswoman for Endo said the company would not admit to any wrongdoing or liability.
Status of Testosterone Lawsuits
According to the Judicial Panel on Multidistrict Litigation, there are still 6,061 cases pending in the Illinois district court as of May 201814.
Although drugmakers and plaintiffs have been working toward a resolution, lawyers across the country are still expecting more lawsuits to be filed against makers like AbbVie.
Anyone who has been affected by a testosterone product like AndroGel should contact an attorney to learn more.