One manufacturer of a testosterone replacement drug is opposing the move to create one federal multidistrict litigation (MDL) for all testosterone lawsuits. However, most testosterone replacement drug manufacturers have already filed a response of support for the mass tort.

In a response filed by Auxilium Pharmaceuticals Inc., the drug manufacturer opposed an industry-wide MDL because it has only been named in seven federal cases. The other named testosterone replacement drug makers — AbbVie Inc., Abbott Laboratories, Eli Lilly and Co., Lilly USA LLC and Endo Pharmaceuticals — all supported the centralization of all pending testosterone replacement therapy lawsuits.

Most of the 74 testosterone therapy lawsuits filed throughout the federal court system allege that men suffered heart attack, stroke, blood clot or other injuries caused by the testosterone replacement drugs.

Androgel accounts for 60 percent of the market for testosterone replacement therapy, explaining why it is named in most of the testosterone replacement lawsuits. Other testosterone lawsuits involved AndroDerm, Testim, Axiron, Foresta, DepoTestosterone and/or other low-T drugs.

Testosterone lawsuits filed against the drug manufacturers are currently being organized into a type of group litigation called multidistrict litigation (MDL) or mass tort. MDLs are similar to class action lawsuits in that they involve a group of people who allege that they have suffered similar harm at the hands of the same defendant.

The main difference is that class action lawsuits start out as group lawsuits, while MDLs start as individual cases which are later coordinated into a single legal action. This process is overseen by the U.S. Judicial Panel on Multidistrict Litigation (JPML). MDLs are more common than class action lawsuits for drug lawsuits, since people who file drug lawsuits tend to have injuries that vary, making a single lawsuit unrealistic.

Like individual lawsuits, MDLs may have multiple related defendants. However, Auxilium says that they should not be included in the MDL since there are several differences between their testosterone products and the others under legal scrutiny.

Testosterone Product Lawsuits

Most of the testosterone replacement lawsuits center on inadequate warnings of possible side effects of testosterone replacement drugs.

In November 2013, a study was published in the Journal of the American Medical Association that had suggested there was a correlation between testosterone and an increased risk of heart attack, stroke, or even death among older men that had a previous heart problem.

In January 2014, the medical journal PLOS ONE published a study that found reason to believe that testosterone treatments may double the risk of heart attack in young men with heart disease and men over the age of 65, regardless of their heart condition.

After the publication of these studies, the U.S. Food and Drug Administration (FDA) initiated a safety review of Androgel and other testosterone treatment therapies.

Currently, testosterone injury lawyers are reviewing hundreds of testosterone gel lawsuits with thousands estimated to be filed as more studies are carried out that continue to raise concern about the actual link between testosterone, heart attacks, and stroke.

The JPML will hear oral arguments on the motion to establish the Testosterone Replacement Drug MDL on May 29, 2014 in Chicago, Ill.