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A federal judge has dismissed racketeering and fraud charges filed against a number of testosterone drug manufacturers, finding that the allegations raised in a class action lawsuit were not specific enough to move forward.
The case was brought by Medical Mutual of Ohio (MMO), which filed a class action lawsuit against nearly all testosterone drug manufacturers for illegal marketing of the medications for treatment of medical conditions that are not approved by the FDA, alleging that the companies that violated the Racketeer Influence and Corrupt Organizations (RICO) act, which was originally designed to target organized crime.
In the federal court system, all product liability lawsuits filed over side effects of testosterone replacement therapy are centralized for pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, regardless of which specific drug is involved in the case.
There are currently nearly 3,500 Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits and other complaints pending before Judge Kennelly, most of which involve former users who allege that testosterone replacement therapy caused them to suffer a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other cardiovascular injury while using the medications.
On February 3, Judge Kennelly issued a memorandum opinion and order (PDF), rejecting parts of the drug maker’s argument that the entire case should be dismissed, but agreeing that the RICO act violation claims were currently unsupported. However, he gave the plaintiffs until March 3 to resubmit the lawsuit with more information on allegations of illegal marketing of testosterone replacement therapy (TRT) drugs.
“Plaintiff’s allegations do not describe with sufficient particularity the circumstances of any misrepresentations that a defendant allegedly made directly to plaintiff,” Judge Kennelly ruled. “Because, as discussed, all of its RICO claims hinge on the existence of such misrepresentations, plaintiff has not alleged any of its RICO claims with the particularity (the law) requires. The Court therefore dismisses the substantive RICO claims, with leave to amend.”
The testosterone drug class action lawsuit filed by MMO reflects a belief among numerous critics that the entire “low T” drug industry has been manufactured by aggressive marketing that encouraged use of the medications among men without any real medical need.
Instead of promoting their medications for treatment of low testosterone caused by a medical condition, such as hypogonadism, television advertisements and other promotions have encouraged men to seek medical treatment for a “condition known as low T” if they experience any number of symptoms associated with natural drops in testosterone levels as all men age, such as decreased energy levels, reduced strength and diminished sex drive.
Litigation over the testosterone blood clot risks emerged in November 2013, when a study published in the Journal of the American Medical Association (JAMA) found that certain men who began taking testosterone drugs following coronary angiography may be more likely to suffer cardiovascular events.
That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.
In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.
The FDA announced a warning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between testosterone drugs and heart problems. In addition, the agency encouraged doctors not to prescribe testosterone drugs for so-called “life-style” reasons, such as addressing decreased energy levels or sexual drive experienced by most men as they get older.
As part of the MDL proceedings before Judge Kennelly, a small group of Androgel lawsuits are currently being prepared for early trial dates. Known as bellwether cases, these trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.
Following a series of bellwether trials in the MDL, if testosterone drug settlements are not reached by the drug manufacturers, hundreds of individual cases may be remanded back to U.S. District Courts throughout the country for individual trial dates.
Tags: Abbott Laboratories, AbbVie, Actavis, AndroGel, Auxilium Pharmaceuticals, Axiron, Endo Pharmaceuticals, Fortesta, GlaxoSmithKline, Heart Attack, Stroke, Testim, Testosterone, Watson Pharmaceuticals