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After suffering heart attacks, strokes and other heart-related events after receiving testosterone therapy, men are filing lawsuits against the maker of Androgel and other Low-T product manufacturers. A federal multidistrict litigation (MDL) is established in Illinois.
Testosterone products, which are prescribed to treat low testosterone (“Low T”) in men, have become popular among young men seeking physical enhancement and older men who want to counter signs of aging. But there is growing concern that these products have serious side effects and long-term risks, particularly related to the heart.
Men who suffer cardiac arrest, stroke, other heart-related issues or other adverse side effects after using testosterone products or supplements are beginning to file lawsuits, saying they were not properly warned of the risks.
As the medical community learns more about adverse events from Low T therapies, drugmakers’ statements about risks and benefits will come under more scrutiny.
Depending on how pharmaceutical companies market their products to specific populations, such as elderly men or healthy men with no history of hypogonadism (low testosterone), they could face allegations that they made misleading statements about the benefits of their Low T drugs.
In March 2015, the agency issued a safety warning that testosterone drugs may increase the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. Over 1,000 lawsuits filed by men who say testosterone drugs caused their cardiovascular problems are pending in federal court.
In the U.S. population, 3 to 7 seven percent of men have hypogonadism.
Symptoms of the testosterone deficiency include infertility, low libido and fatigue.
Many doctors and patients have embraced claims that the drugs can also offer benefits, such as increased energy and strength for workouts.
|Several products are prescribed to treat low testosterone, including:|
There are already concerns about the risks that testosterone therapies pose for older men. According to a report from the Washington Times, Boston University School of Medicine researchers stopped a study of testosterone therapy use in older men in 2010. Compared with subjects taking a placebo, men taking the testosterone drugs were five times as likely to experience severe heart problems such as congestive heart failure.
Some critics are concerned that there is no proof that the drugs benefit healthy men. In particular, some doctors feel there should be more agreement about what constitutes a normal testosterone level. Since testosterone therapies are not proven treatments, they caution that risks may outweigh benefits for healthy men.
In June 2013, Dr. Adriane Fugh-Berman of Georgetown University Medical Center told USA Today that testosterone therapy “offers no proven benefits for healthy men. Low T syndrome is invented by pharmaceutical companies to sell treatment products.”
Pretrial hearings before Judge Matthew F. Kennelly are progressing after a federal judicial panel created a multidistrict litigation (MDL) for testosterone and moved 44 cases to the U.S. District Court for the Northern District of Illinois. Discovery is also underway, and Kennelly has rule that he will seal any documents that reveal trade secrets. More than 1,000 cases are part of the MDL.
The defendants currently include Abbott, AbbVie, Auxilium Pharmaceuticals, Pfizer, and Pharmacia & Upjohn. Plaintiffs’ attorneys predict the number of testosterone lawsuits will number in the thousands.
In issuing its order, the panel stated: “All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions will share factual questions regarding general causation and the background science regarding the role of testosterone in the aging body … as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.”
While the controversy continues, it’s clear that drugmakers are reaping the rewards of successful marketing of testosterone treatments. But at least one Low T drugmaker has reportedly come under fire for its marketing practices.
According to a report by McClatchy, a whistleblower lawsuit filed in federal court in Texas alleges that Solvay Pharmaceuticals, formerly Unimed Pharmaceuticals, used improper sales practices to market AndroGel.
The U.S. Food and Drug Administration (FDA) approved AndroGel to treat hypogonadism, but the drugmaker allegedly recruited doctors to help AndroGel “ride (the) coattails of Viagra” by encouraging them to screen patients seeking Viagra for low testosterone. A former sales manager involved in the lawsuit attributes AndroGel’s high sales to the company’s decision to promote the drug for off-label uses even though it isn’t approved to treat erectile dysfunction (ED) like Viagra is.
|Details about Unimed Pharmaceuticals:|
|In 1999, it reportedly projected treating a market of 1 million men for hypogonadism.|
|By the time the drug was approved in 2000, it estimated its market at up to 5 million men.|
|By 2003, corporate managers had reportedly expanded that number to 20 million men. (There are an estimated 116 million adult men in the U.S.)|
|Abbott Laboratories is AndroGel’s current owner.|
Serious health risks and aggressive marketing for off-label purposes frequently form a recipe for negligence and widespread pharmaceutical injuries.
Pharmaceutical companies that hurry to market a drug without proper approvals often end up accused of inadequate testing or concealing risks.
When they fail to protect consumers and warn about those risks, they may be held legally liable for any injuries that result from their negligence.
More than 1,000 men filed lawsuits related to testosterone therapy. In February 2014, five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel.
Defendants misrepresented AndroGel as a safe and effective treatment for hypogonadism despite causing serious side effects such as heart attacks, strokes and thrombolytic events.
Despite lacking “any reasonable grounds” for believing AndroGel was safe, defendants used “an aggressive award-winning direct-to-consumer and physician marketing and advertising campaign” to convince men to discuss testosterone therapy with their doctors.
Instead of adequately warning consumers about AndroGel’s risks, defendants engaged in “disease mongering” to increase sales.