Regulatory and legal scrutiny over low-T drugs has begun to translate into flagging profits for drug makers.

As all males age, their bodies produce less testosterone as part of the normal aging process. However, some males experience more severe symptoms as their testosterone levels decline, including irritability, declining libido, and exhaustion.

Drug makers have been accused of participating in “disease mongering,” a process of creating demand for a medication by convincing the public that a condition or disease is a greater problem than it is. Drug makers have spent millions, at least, marketing low-T drugs to patients, encouraging them to “talk to their doctor” about symptoms many men experience during aging.

Low-T drug lawsuits have alleged that not only are low-T drugs over-marketed, but that they are potentially dangerous. Adding testosterone can alter blood chemistry in such a way that makes blood clot more readily inside the body. Errant blood clots can lodge in the blood vessels that support vital tissues and organs, causing stroke, some types of heart attack, pulmonary embolism, and other disorders.

Epidemiological studies have found that men taking low-T drugs have an increased risk of stroke, heart attack, and other clot-related problems compared to men who do not use testosterone products. The U.S. Food and Drug Administration (FDA) has mandated changes to the labeling of low-T drugs in recent years to reflect greater awareness of the risk of blood clot-related problems associated with low-T drugs.

Profits from low-T drugs have reportedly crashed after peaking in 2013, due to regulatory scrutiny and lawsuits. Drug makers who produced low-T drugs like AndroGel and Axiron began to suffer from declining sales during this time period. Safety concerns and regulatory action are cited as possible reasons for the declining sales of low-T drugs.

Low-T drug lawsuits allege that the makers of testosterone products were aware—or reasonably should have been aware—of the serious risk of complications like blood clot related problems. These low-T drug lawsuits further allege that not only were drug makers aware of these risks, but that they actively downplayed them, endangering the general public by exposing them to the risk of stroke, pulmonary embolism, and related conditions without adequate warning or safeguards. Low-T drug lawsuits typically seek to recoup the cost of medical care, final expenses, lost wages, legal fees, and other costs allegedly linked to low-T drugs like AndroGel and Axiron.

The various low-T drug lawsuits have been grouped together by the court system into multidistrict litigation or MDL. In MDLs, the court system coordinates similar individual low-T drug lawsuits into a single legal action, functioning similar to a class action suit.

The Low-T Drug MDL is In Re: AndroGel Products Liability Litigation, MDL No. 2545, in the U.S. District Court for the Northern District of Illinois.