In less than a month, AbbVie, the manufacturer of the top selling testosterone replacement therapy (TRT) drug AndroGel, was slapped with two verdicts totaling just under $300 million, Reuters reports. The verdicts were awarded to two plaintiffs in a multidistrict litigation (MDL) in which more than 6,000 claims are pending against AbbVie and other TRT drug manufacturers, according to the U.S. Judicial Panel on Multidistrict Litigation. At the heart of the MDL is the claim that manufacturers failured to warn about cardiovascular risks and misrepresented the drugs’ uses.
It is no wonder expansion of the TRT market has slowed and recent market growth estimates have dropped.
In 2015, the global market for the drug was estimated to reach approximately $2 billion by 2024, but the most recent forecast for the market shows a negative compounding annual growth rate of -4.2 percent by 2024. According to Bloomberg, factors such as patent challenges have led to the slowdown in the industry. However, the outlet also reported that sales for AndroGel began sliding when regulators demanded the product be accompanied by stronger warnings.
The prescription-only drugs were first approved by the Food and Drug Administration (FDA) as treatment to increase testosterone levels in men with hypogonadism. Men suffering from the condition do not produce enough of the male hormone due to disease or injury, resulting in symptoms such as low libido, muscle loss, and fertility issues.
However, the drugs came with significant and life-threatening risks.
As Beasley Allen previously reported, in 2014, an FDA investigation confirmed findings from two studies linking the drugs to significantly higher risk of stroke, heart attack and death. Further evidence showed that the drugs may also cause dangerous blood clots in the legs, known as deep vein thrombosis, which can lead to pulmonary embolism.
In response to its findings, the FDA ordered drug manufacturers to update their safety labels to include a new warning for deep vein thrombosis blood clotting. The new warning was in addition to an existing warning of increased blood clot risk related to a condition called polycythemia.
Despite the health risks to men, TRT manufacturers were determined to expand the market.
Although TRT drugs were never approved by the FDA to treat age-related decreases in testosterone levels, the drugmakers invented a condition called Low-T and aggressively marketed the drugs to men who sought medical advice for erectile dysfunction. Manufacturers promised the drugs would restore men’s vitality.
In March, a study published by the Journal of the American Medical Association (JAMA) confirmed a direct link between the industry’s aggressive marketing through television ads and “greater testosterone testing, new initiation, and initiation without recent… testing.”
Aggressive marketing tactics also included paying doctors to promote the drug. Beasley Allen previously explained that AbbVie paid more than $20 million to 191,555 doctors from August 2013 to December 2015 to promote its testosterone replacement drug, AndroGel. AbbVie’s fraudulent marketing practices was cited as the reason a jury awarded one of the plaintiffs, mentioned above, $150 million in punitive damages.
In September, MPR reported that Eli Lily is discontinuing two of its Axiron testosterone replacement therapy solutions and its authorized generic testosterone solution. However, the drugmaker rejects the notion that the move is connected to the health risks and legal trouble surrounding the product. Other testosterone replacement therapies remain available in patches, topical solutions, topical gels, tablets, injections and pellets. Brand names include Androgel, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim and Testopel.
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If you or a loved one has suffered a heart attack or stroke while taking testosterone supplements, or if someone you love has died, you can contact Matthew Teague, a lawyer in the firm’s Personal Injury and Product Liability Section at 800-898-2034 or by email at Matt.firstname.lastname@example.org. More information about testosterone replacement drugs or replacement therapy can be found at our Low Testosterone page
U.S. Judicial Panel on Multidistrict Litigation