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Companies that sell herbal supplements commonly known as “testosterone boosters”, most of which contain Testofen, face a class action lawsuit that alleges marketing claims about the impact of the products on testosterone levels are bogus.
The complaint (PDF) filed in the U.S. District Court or the Central District of California on May 15, seeks class action status to represent all purchasers of testosterone supplements. The lawsuit seeks damages from a number of different companies that make herbal supplements that claim to increase testosterone levels, including Gencor Nutrients, Inc., GE Nutrients, Inc., General Nutrition Corporation, S&G Properties LLC, Force Factor LLC and others.
The testosterone supplement class action lawsuit was brough by Brian O’Toole, Robert Sokolove and Michael Bitton, alleging that the active ingredient in the products, Testofen, has been shown in several studies not to increase testosterone levels. However, there are more than 20 products on the market claiming it has been clinically proven to do so.
Testofen is an extract created from fenugreek seeds that is allegedly able to increase a male’s testosterone levels. It is often used in supplements that claim they can increase muscle mass and boost male libido. It is also used in supplements claiming to improve erectile dysfunction.
Gencor Nutrients manufactures Testofen, and the company has indicated that it stands by its product.
General Nutrition Centers (GNC) is the exclusive seller of most Testofen products, according to the lawsuit. Those “testosterone boosters” include products like Nugenix, Troxyphen and High T.
The lawsuit alleges that Gencor claims that a clinical trial showed that Testofen increased testosterone levels, but the study, allegedly conducted in 2006, has yet to be published, and the lawsuit claims that while the company says the study can be requested if an email address is provided, such requests are ignored.
The plaintiffs indicate that even the results reported by Gencor show little proof, even if legitimate. The results of the 2006 study, as well as a 2008 study the company eventually provided, were not statistically significant, according to the lawsuit.
The complaint pursues claims for racketeering, violation of consumer protection laws, false advertising, breach of warranty, fraud, negligent misrepresentation, and seeks compensatory damages returning money spent buying Testofen-based products back to consumers, as well as punitive damages.
Testosterone Drug Concerns
The class action comes amid a growing number of testosterone drug lawsuits filed against manufacturers of prescription medications designed to boost testosterone levels, including AndroGel, AndroDerm, Axiron, Testim, Foresta and others.
Concerns over the safety of testosterone treatments have increased in recent months, following a number of studies that suggest the prescription drugs may increase the risk of heart attacks, strokes and sudden death.
In November 2013, a study published in the Journal of the American Medical Association (JAMA) suggested that older users of testosterone drugs experienced more heart attacks, strokes and death. That study was followed by a report published in the medical journal PLoSOne in January 2014, which found that low T drugs may double the risk of heart attack for young men with a prior history of heart disease, as well as for men age 65 and older who had no prior heart problems.
Following these studies the FDA announced that it is reviewing the heart safety of testosterone drugs, and it is widely expected that the regulatory agency will require stronger warnings to ensure that consumers and the medical communmity are aware of the potential risks associated with the medications.
In February 2014, the Endocrine Society warned about the serious concerns raised by recent studies, suggesting men face cardiovascular risks from testosterone drugs, urging doctors to follow their clinical practice guidelines on appropriate use of the medications. The Society called for additional studies to be completed, and suggested that doctors and patients need to discuss the risks and benefits, particularly among men with pre-existing heart disease.
In the federal court system, a motion is currently pending that seeks to consolidate and centralize all cases filed in U.S. District Courts nationwide before one judge for coordinated handling as part of an MDL, or multidistrict litigation. Following coordinated pretrial proceedings and any early “bellwether” trials, if testosterone settlement agreements are not reached to resolve the litigation, hundreds of individual trials may ultimately be scheduled throughout the country.