A topical skin gel called Androgel contains the hormone testosterone. Men with low testosterone and the symptoms that accompany it are prescribed the gel (such as hair loss, loss of energy and sex drive, and changes in body composition). It is usually administered to the upper body, allowing the body to absorb testosterone through the skin.
Other testosterone-related compounds, such as androstenedione, function by modifying the body’s precursors to testosterone. Androgel, on the other hand, functions by directly substituting and enhancing the patient’s body’s testosterone levels. In other words, because Androgel includes testosterone, it must be treated carefully.
Lawsuits Involving Testosterone
The makers of testosterone replacement therapy are accused in testosterone lawsuits of failing to disclose dangerous adverse effects. Numerous lawsuits mention the testosterone medication Androgel by Abbvie. Abbvie was required to pay punitive damages of $150 million in 2017. In September 2018, it tentatively resolved 4,200 AndroGel claims, but it kept the settlement amount a secret.
At the height of the testosterone litigation, AbbVie Inc., Eli Lilly & Co., Pfizer Inc., Endo International, and other manufacturers were the targets of more than 25,000 lawsuits. Popular products like AndroGel and Depo-Testosterone were linked in certain cases.
They alleged that males who used the medications suffered from adverse consequences like heart attacks, strokes, or blood clots, known as pulmonary embolism and deep vein thrombosis. With the exception of death, most injuries had to happen within 90 days of using the product for a person to file a lawsuit.
Manufacturers Accused of Various Things
The same claim was made in every federal court lawsuit: producers of testosterone products put healthy men in danger by advertising the hormone for uses other than those permitted by the U.S. Food & Drug Administration, such as treating age-related weariness and sexual dysfunction.
These medications were given FDA approval to treat the medical illness known as hypogonadism, but drug companies heavily promoted them for usage off-label for a condition they purportedly created and called “Low T.”
In lawsuits, testosterone product manufacturers were accused of misrepresenting their products’ safety and efficacy for this off-label use. In reality, the products allegedly offer little to no benefit to men who do not have hypogonadism, and the medications can result in cardiovascular problems and even death.
“Low-T” Advertising
Lawsuits claim that testosterone advertisements imply that Low-T, rather than age or a variety of other factors, is the cause of lower energy levels. Advertisements on websites and television question men if they have lost their energy and feature middle-aged men wishing to return to sports. Men are led to assume that natural indicators of aging indicate a testosterone shortfall through direct-to-consumer marketing quizzes, which persuade them to seek replacement medication.
Manufacturers of testosterone, including Eli Lilly, AbbVie, and others, have come under fire for these and other business practices. Critics claim they haven’t done enough to warn consumers and physicians about possible hazards, even though they helped to develop a $1.6 billion industry for testosterone replacement therapies.
Which Kinds of Risks Are Linked to Androgel?
Androgel has a number of adverse effects, including headaches, nausea, and other symptoms, much like any testosterone-related therapeutic product.
Additional results include:
- Prostate growth
- Responses at the application site
- Higher blood pressure
- Alterations in heart readings and profiles
The chance of children or female partners being exposed to testosterone is another risk of Androgel. Direct contact with the application site or secondary exposure to towels, linens, shirts, etc., may cause this. Particularly, testosterone exposure in childhood might cause the child to undergo early puberty and other permanent alterations.
Additionally, exposure to Androgel when a woman is pregnant can be harmful. Once more, coming into contact with clothing or fibers used by someone who has applied Androgel to their skin can expose you to the drug.
According to a study by a team of experts at the National Cancer Institute, some men who use prescription testosterone therapy have a higher chance of having heart attacks.
According to the study of almost 56,000 patients, heart attacks in men over 65 and patients under 65 with a history of heart disease doubled in the three months following testosterone therapy compared to the year before treatment.
The study also examined whether a rise in desire brought on by elevated testosterone levels put these guys at a higher risk for cardiac issues. The men taking erectile dysfunction medications did not have more heart attacks when the study compared them to a different group of patients on Viagra and Cialis.
Similar findings were found in another study published in the Journal of the American Medical Association, which showed that testosterone therapy increased the risk of stroke, heart attack, and mortality in older men by 29%.
A 2009 federally-funded study that examined whether testosterone gels could help older men build muscle was halted after researchers discovered that some of the study’s participants were experiencing heart attacks and other cardiac issues, adding to the evidence linking testosterone therapy and heart risks.
Lastly, misdiagnosis, wrong prescription, and usage of Androgel for inappropriate or unlawful purposes can all result in legal troubles.
FDA: Testosterone Products’ Labels Must Be Updated to Reflect the Risk of Heart Attacks and Strokes
According to the FDA, the manufacturers of these medications must update their labels to reflect these dangers and make clear the one and only allowed use for the prescriptions.
After reviewing multiple studies that revealed men taking “low T” therapy are at an increased risk for heart attacks and strokes, the FDA ruled in March 2015 that all testosterone replacement medications must have their labels amended.
The organization said that the medications had been overprescribed to males experiencing low testosterone due to aging rather than a linked medical condition in a drug safety communication. The FDA subsequently ruled that the manufacturers of these medications must alter their labels to reflect these dangers and make clear the only allowed purpose for the prescriptions.
Additionally, the FDA advised physicians to only give these medications to males whose low tests confirmed testosterone levels because of hypogonadism or another medical condition.
What Can a Lawsuit Do for Me?
Patients who suffered harm while taking AndroGel or other testosterone therapy may be able to obtain financial compensation for both economic and non-economic damages by bringing a lawsuit.
Compensation for lost wages, medical costs, and pain and suffering may be included.
Legal action can also assist in holding producers accountable for putting harmful and faulty products on the market.
Lawyers are looking into possible legal actions on behalf of men who used AndroGel or other testosterone treatments and experienced any of the following:
- Chest pain (myocardial infarction)
- Stroke
- “Mini-strokes” (transient ischemic attacks)
- Respiratory embolism
- Cardiovascular disease
- Death
Attorneys are looking at individual claims on behalf of individuals who had heart attacks, strokes, and other serious adverse effects while taking the “low-T” drugs, despite some consumers’ calls for class action lawsuits about testosterone therapies.
Do I Need a Lawyer for Assistance with Androgel Issues?
Androgel may be connected to particular injuries and ailments. If you need to register a complaint against Androgel or any other form of testosterone-altering products, you might want to consider hiring a class action attorney.
Your lawyer will be able to represent you throughout the procedure and assist you with filing your claim.
