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Testosterone Therapy Lawsuits Centralized

Testosterone Therapy LawsuitsAll testosterone therapy lawsuits filed in U.S. District Courts nationwide, alleging injuries because of Low T treatments, will now go before one judge in the Northern District of Illinois in centralized litigation known as “multidistrict litigation” or MDL.

This move comes on the heels of June 6 order by a panel of federal judges, the U.S. Judicial Panel on Multidistrict Litigation (JPML), which gives jurisdictional handling to U.S. District Judge Matthew F. Kennelly during pretrial proceedings.

At least 45 such “low T” product liability lawsuits against the makers of AndroGel, Axiron, Testim, Foresta, AndroGerm and Depo-Testosterone will undergo this transfer, with the expectation that all future cases pertaining to prescription gel, cream, injection or other prescription treatments to replace testosterone will, too.

Allegations in low T drug lawsuits

Plaintiffs in these cases all report similar serious cardiovascular complications linked to various treatments boosting testosterone levels.  Alleged injuries include heart attacks, strokes, blood clots and other heart-related issues, most of them attributed to the use of the most widely used low T treatment AndroGel; but other low T drugs, including Axiron, Testim, AndroDerm and Depo-Testosterone will also have their time in the limelight of the courtroom, too, for allegedly causing some of these same dangerous side effects.

Industry-wide consolidation of low T drugs

The panel of judges considered a number of options for dealing with an influx of testosterone therapy lawsuits in a May 29 hearing, one of which would have been to litigate the AndroGel cases separately.  The consensus, however, was to centralize litigation on an industry-wide basis following suggestions that related cases will number in the thousands, and because plaintiffs alleging AndroGel injuries were in many cases using other low T treatments as well.

This rationale, along with the factor that all of the lawsuits apparently ask common questions regarding causation and the science of testosterone in ageing bodies, made an industry-wide consolidation of Low T injury lawsuits “the best solution,” according to the judges’ order.

Studies highlight dangers of testosterone replacement therapies

In the meantime, the U.S. Food and Drug Administration (FDA) is continuing to study the cardiovascular risks of low T treatments in the wake of the latest findings from a study published in the Journal of the American Medical Association (JAMA) in November 2013 and another in the medical journal PLOSOne in January 2014.

Both studies contain important implications for men of all ages who resort to low T treatments for natural, aging-related conditions.  The JAMA study found that older men with pre-existing heart problems experience a significantly heightened risk of heart attack, stroke and even death when taking low T drugs.  The PLOSOne findings suggested that younger men on testosterone replacement drugs, in addition to men over the age of 65—regardless of their prior health history or prior reported cardiovascular problems—doubled their risk for heart attack.

For the time being, and until more research sheds further light on these most recent findings, the FDA is refraining from tighter regulations on the testosterone replacement industry, saying in a press releases that “patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals.”

  1. Transfer Order, AndroGel Products, U.S. Judicial Panel on Multidistrict Litigation, http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2545-Initial_Transfer-05-14.pdf
  2. Yahoo Health, “Study: ‘Low T’ Therapy Increases Heart Attack, Stroke Risk in Men,” http://health.yahoo.net/experts/dayinhealth/testosterone-therapy-overhyped
  3. Healthline, “FDA Investigates the Safety of Testosterone Drugs for ‘Low T,’” http://www.healthline.com/health-news/men-hearts-could-be-at-risk-with-testosterone-therapy-020414
  4. Reuters, “Testosterone therapy for ‘low T’ carries risk: endocrinologists,” http://www.reuters.com/article/2014/02/20/us-health-testosterone-therapy-idUSBREA1J1CG20140220