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Testosterone Lawsuits - Heart Attacks & Strokes

The testosterone lawsuit claims that "Low T" products increase the risk of heart attacks, strokes, embolisms, and blood clots; and that the manufacturers misled the public regarding the benefits of these products with fraudulent marketing.

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Why Were Testosterone Lawsuits Filed?

Thousands of lawsuits have been filed against the manufacturers of testosterone therapy replacement products. The lawsuits were consolidated before Judge Matthew F. Kennelly in Illinois federal court, where numerous trials and settlements occurred.

The Key Legal Issues

The lawsuits alleged the manufacturers of testosterone therapy replacement products failed to warn doctors and patients of the link between their products and the increased risk of heart attacks, blood clots, and strokes.

The lawsuits also alleged the manufacturers fraudulently marketed their products for off-label uses not approved by the FDA, such as for fatigue and low sex drive.

Studies have shown the risk of a heart attack or stroke for a user of testosterone replacement products nearly doubles when compared to individuals who don't use these products.


Testosterone Therapy Injuries & Side Effects

Two studies, a paper published in the medical journal PLOS One as well as a paper published online in the Journal of the American Medical Association (JAMA), linked testosterone replacement products to increased risks of cardiovascular events in men.

The study published in the journal PLOS One concluded that men 65 years of age and older who use prescription testosterone therapy products have twice the risk of a heart attack within the first three months of using the products.

The JAMA study also found that senior males who use testosterone replacement products are 30% more likely to suffer from a heart attack, stroke, or death when compared to senior males who do not use the drugs.

Other Serious Side Effects Associated with Testosterone Replacement Products
Worsening symptoms of an enlarged prostate
Increased risk of prostate cancer
Lower sperm count
Swelling of the ankles, feet, or body
Enlarged and painful breasts
Difficulty breathing during sleep
Increased risk of deep vein thrombosis (blood clots in a deep vein) occurring in the legs

Testosterone Lawsuit Settlement Amounts

The various testosterone therapy replacement manufacturers have entered into mass tort settlements. In December 2017, Eli Lilly & Co. agreed to settle 400 federal lawsuits accusing them of misrepresenting the benefits and risks of their testosterone replacement products.

In February 2018, Endo Pharmaceuticals Inc., Auxilium Pharmaceuticals, and GlaxoSmithKline LLC agreed to resolve 1,300 federal lawsuits. In June 2018, Endo Pharmaceuticals announced that it was allocating $200 million toward settling testosterone therapy cases.


Testosterone Replacement Product Recalls & Warnings

As of January 2019, a recall has not been issued for testosterone replacement products. However, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement on March 3, 2015, warning the public that testosterone therapy products are not approved for use in treating low testosterone as a result of aging. The FDA also required that the manufacturers warn about the increased risk of heart attacks and strokes.

The FDA stated the following as part of its mandate: "The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests." Reported in FDA Testosterone Safety Communication.


Why are Testosterone Replacement Therapy Products Utilized

Testosterone therapy drugs are FDA-approved for the treatment of hypogonadism, a medical condition occurring in men where the male sex organs produce little or no testosterone hormone. Testosterone therapy is designed to work by replacing the absent naturally-occurring testosterone that is produced by the body.

Natural testosterone production in the body plays a significant role in male characteristics, mood, and sex drive. Men experiencing low levels of testosterone can have a number of unfavorable symptoms, including fatigue, low libido, and depression.

As men age, they may experience dips in testosterone levels, and it is part of the natural aging process to experience such an event. It is not a reason Testosterone therapy drugs were approved by the FDA, which is specifically for the medical condition hypogonadism.

If you were to discuss low testosterone with a medical professional, he or she would likely tell you that it is a normal part of aging. Unlike women, who experience a relatively sudden shutdown in the production of estrogen around age 50 (menopause), the decrease of testosterone in males is gradual, starting around age 30. By age 45, approximately 40% of all men are affected.

Testosterone therapy is typically administered as a gel, patch, or injection.

Over the period 2011-2014, the testosterone therapy product market grew significantly, largely in part to aggressive marketing campaigns by testosterone therapy manufacturers that generalized the symptoms for low testosterone, and coined the condition as “Low T.”

The manufacturers marketed their products for off-label uses claiming their testosterone replacement therapy products would help to improve sex drive, muscle mass, and bone density in those suffering from low testosterone. One manufacturer, AbbVie, spent more than $75 million in 2012, and $65 million in 2013, marketing its product AndroGel. The total market for these products eventually reached $1.6 billion in 2014


Below are Various Testosterone Therapy Replacement Products

AndroGel 1.62%

A topical testosterone gel that is applied by the user to the upper arms and shoulder. Manufactured by AbbVie Inc., AndroGel is prescribed is available


Testosterone is administered through a transdermal patch that is applied to the skin in the back, stomach, thighs, or arms. Androderm is available in 2 and 4 mg strengths, and is applied daily. Androderm is manufactured by Actavis, Inc. (previously Watson Pharmacueticals), and was approved by the FDA in 1995.


An oral testosterone drug that is taken up to four times a day. Methyltestosterone, the active ingredient found in Android, is similar to natural testosterone that is produced by the body, and belongs to a class of drugs known as androgens.


A topical testosterone product that is applied to the armpits in a manner similar to applying deodorant. Axiron was approved by the FDA in 20120 and is manufactured by Eli Lilly, Inc.


A daily testosterone spray gel that is applied to the front and inner thighs. Fortesta is manufactured by Endo Pharmaceuticals and was approved by the FDA in December 2010.


A mucoadhevise tablet-like system that adheres to the inner cheek or gum to provide the patient with controlled and sustained release of testosterone into the body. The tablet, containing approximately 30 mg of testosterone, slowly releases the hormone into the mucous membranes of the mouth. Originally manufactured by Columbia Laboratories, Inc., Striant was purchased by Auxilium Pharmacueticals in April 2011.


A popularly prescribed testosterone gel that is applied to the shoulders daily. It was approved by the FDA in 2002 and is manufactured by Auxilium Pharmacueticals, Inc.


A testosterone implant that is placed under the skin. The implant, containing approximately 75 mg of testosterone, releases the hormone into a patient’s body for a period of 3-4 months. Testopel was approved by the FDA in 2008 and is manufactured by Auxilium Pharmacueticals, Inc.


Like Android, Testred is also an oral testosterone drug that is taken up to four times a day. Methyltestosterone, the active ingredient found in Testred and Android, is similar to natural testosterone that is produced by the body, and belongs to a class of drugs known as androgens.


Testosterone Lawsuit News

Endo executes master settlement agreement to resolve testosterone lawsuits

Two Endo International subsidiaries, Endo Pharmaceuticals and Auxilium Pharmaceuticals, have executed a definitive master settlement agreement to resolve all known testosterone replacement therapy product liability claims against the company. To read more, click Philadelphia Business Journal

Jury smacks AbbVie with $150M verdict in AndroGel's bellwether Low-T trial

AbbVie took a damaging hit as the first verdict from a series of bellwether AndroGel cases went against the drugmaker to the tune of $150 million. Jurors decided after hearing weeks of testimony that AbbVie isn’t responsible for plaintiff Jesse Mitchell’s 2012 heart attack, nor was it negligent. But the drugmaker did fraudulently misrepresent its product, the jury concluded. To read more, click FiercePharma

Second U.S. jury finds AbbVie misrepresented risks of AndroGel

A U.S. jury on Thursday ordered AbbVie Inc to pay more than $140 million to a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel, causing him to suffer a heart attack. To read more, click Reuters Testosterone Verdict

AbbVie ordered to pay $3.2 million after retrial of lawsuit claiming low-testosterone drug AndroGel caused heart attack

A federal jury ordered AbbVie to pay $3.2 million to an Oregon man who claims the testosterone replacement drug AndroGel caused him to suffer a heart attack, a far smaller penalty than the north suburban drugmaker was dealt the first time the case was tried. To read more, click Chicago Tribune

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