There are a variety of treatment options available for addressing Low-T, including skin gel, long-acting pellets, patches, oral inserts, and injections. Gel therapies are the most common — used by approximately 70 percent of patients — followed by injections and patches, which are used by approximately 17 percent and 10 percent of patients, respectively.

Between 1988 and 2011, sales of prescription testosterone increased from approximately $18 million to $1.6 billion. The popularity of these prescriptions is made clearer in the threefold increase of usage of Low-T treatments by men over the age of 40 between 2001 and 2011.

Recently, Low-T therapies have become the focus of legal proceedings related to patients experiencing adverse effects in connection with their treatment. AndroGel, originally manufactured by Unimed Pharmaceuticals, is one of the primary treatment medications for hypogonadism cited in lawsuits. Approved by the FDA in 2000, it is a hydroalcoholic gel intended to be applied to dry, clean skin in the upper body and abdominal areas for absorbance through the skin. It is designed to deliver testosterone for a 24-hour period.

In addition to risks associated with testosterone treatments, AndroGel — currently owned by Abbott Laboratories — has also been identified as having promoted off-label, unapproved uses, such as erectile dysfunction, in order to capitalize on the popularity of Viagra and similar drugs.

Other testosterone therapy products, taking different forms, cited in lawsuits include Androderm, Axiron, Striant, and Testim.

On Jan. 31, 2014, the FDA warned consumers of potential risks associated with testosterone therapy in its release of a safety announcement and asserted plans to conduct more in-depth investigation. This measure was announced after PLOS ONE and the Journal of the American Medical Association (JAMA) released studies illustrating the increased risk of heart attack due to the use of testosterone therapy. The National Cancer Institute also highlighted the increased risk of fatal heart attacks in men with testosterone prescriptions. Studies also brought to light issues of men undergoing testosterone therapy who do not suffer from decreased levels of testosterone.

In the U.S. alone, more than 5 million prescriptions have been written for testosterone treatments. As greater focus is placed on the adverse effects of AndroGel and other Low-T treatments, more claims are being issued. Dozens of active lawsuits are based on companies undermining serious risks associated with Low-T treatments and misrepresenting Low-T products as suitable treatment options for conditions besides hypogonadism. Testosterone Products Liability Litigation, No. 42, JPML in U.S. District Court, Eastern District of Louisiana and AndroGel Product Liability Litigation, MDL Docket No. 36 in U.S. District Court of Illinois are actively pending.