By order of a panel of federal judges, all product liability lawsuits filed in district courts nationwide involving injuries associated with testosterone replacement therapy (TRT) will now to be centralized before one judge in the Northern District of Illinois as part of a multidistrict litigation (MDL).
45 Lawsuits Affected So Far
The ruling impacts a minimum of 45 lawsuits filed against the makers of AndroDerm, AndroGel, Axiron, Depo-Testosterone, Foresta, and Testim. Any future cases involving any testosterone cream, gel, injection, or other prescribed treatment will also be transferred to the MDL.
The rationale behind centralizing the litigation appears to be the fact that all the low T drug lawsuits involve common allegations that the medications caused users to suffer heart attacks, strokes, blood clots, and other cardiovascular injuries. The MDL will also reduce the risk of duplicative discovery, avoid conflicting rulings, and be more convenient for the parties, witnesses, and the courts.
AndroGel Main Culprit
Most of the complaints brought so far involve problems associated with the use of AndroGel, the most widely used testosterone treatment. AndroGel has been used by millions of U.S. men since it was approved by the FDA in 2000, but new studies warn that that the medication may significantly increase the risk of heart attack, stroke, cardiovascular injury, and death.
Although AndroGel is approved only for the treatment of certified low testosterone levels, a study has shown that 43 percent of those given the drug didn’t even have low testosterone levels. Instead, the drug’s manufacturer, AbbVie, is alleged to have been promoting it for common symptoms including stress, fatigue, and low sex drive, netting the company earnings of over $1.15 billion in 2013.
FDA Study
The FDA first announced on January 31, 2014 that it was reviewing the risk of stroke, heart attack, and death among men taking any approved testosterone drugs. The investigation was launched following several studies published in recent months that addressed the potential link between low t drugs and heart attacks.
One such study published by the medical journal PLOSOne in January 2014 found that low testosterone treatments may double the risk of heart attack in younger men with heart disease and in those over 65, regardless of any prior heart conditions. It is expected that several thousand cases will ultimately be included in the low t MDL.
