The many individuals in the growing testosterone gel class action lawsuit claim that drug makers are aggressively marketing treatments for “low testosterone,” while withholding important safety information from men and the medical community. It’s been alleged that these testosterone replacement therapies cause serious medical problems, including heart attacks, strokes, and thrombolytic events.

The most recent testosterone product lawsuit was filed against Prostrakan, the manufacturers of Fortesta testosterone gel, last week by Demetric Taylor in the Philadelphia Court of Common Pleas. His testosterone gel lawsuit alleges that side effects of Fortesta, his testosterone replacement therapy (TRT), caused him to suffer a heart attack. Moreover, Taylor claims that the company failed to warn about the increased risk of heart attacks and other cardiovascular problems associated with the use of Fortesta.

Fortesta and other testosterone gels like AndroGel, Testim, and Axiron, are designed to treat men diagnosed with insufficient testosterone, or “Low-T” associated with hypogonadism, a medical condition. However, a study published in the Journal of the American Medical Association (JAMA) in August 2013 indicated “that many men who get testosterone prescriptions have no evidence of Low-T.”

According to allegations raised by Taylor in his testosterone product lawsuit and an increasing number of other men throughout the United States, drug makers have encouraged men to seek testosterone treatment if they are experiencing any grumpiness, lack of energy, or fatigue. These symptoms, however, are often part of the natural lowering of testosterone levels all men experience with age. But the marketing worked. Sales of testosterone replacement drugs have increased continuously over the past decade, and it now accounts for more than $2 billion a year in sales.

Testosterone Risks

In 2009, the U.S. Food and Drug Administration issued a black box warning for testosterone prescriptions, but it wasn’t until 2013 that people started to take notice with the publication of two studies.

In November 2013, JAMA published a study that suggested that side effects of Low-T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart conditions.

A study published in PLOSOne in January 2014 found that Low-T treatments could hurt two groups. For men over the age of 65, treatment could double the risk of heart attack regardless of their prior heart conditions. Testosterone treatments could also double the risk for younger men with heart disease.

In response to the findings, the FDA kickstarted a safety review on Jan. 31, 2014, leading numerous media outlets to report on the risks of testosterone replacement therapies.

As men became aware that their heart issues may be related to their use of testosterone products, the number of lawsuits against Fortesta, Androgel, Testim and Axiron started to climb. So many testosterone gel complaints came to light that a class action lawsuit investigation has been launched, and many testosterone gel lawsuits may be consolidated into multidistrict litigation. The victims say the drug makers knew or should have known of the risks, and intentionally hid that information from the medical community, consumers, and public, as a whole.

Status of T-Gel Lawsuits

Of the testosterone replacement therapies available, AndroGel accounts for about 60 percent of the market, so it’s no surprise that most of the current lawsuits involve the use of AndroGel. But cases have been filed against Fortesta, Testim, Axiron and other manufacturers of testosterone gels, creams, patches and injections.

In late March 2014, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to centralize all federal AndroGel cases in one court. Such an action reduces duplicative discovery, helps to avoid conflicting rulings from varying judges, and serves the convenience of the witnesses, parties and courts by creating a multidistrict litigation (MDL) or mass tort.

Several weeks later a second motion was filed by another group of plaintiffs seeking to create an industry-wide MDL. Consolidation of all testosterone drug lawsuits, regardless of which specific medications were used in the case, makes sense as many plaintiffs have used several different testosterone treatments, and all of the testosterone product lawsuits will involve common questions of fact and law.

The JPML is scheduled to meet on May 29 to hear oral arguments for and against consolidation of the testosterone litigation.