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content/uploads/2014/01/testosterone-side-effects.jpg)A panel
of federal judges has ordered all testosterone product lawsuits
filed in federal courts nationwide to be centralized in the U.S.
District Court for the Northern District of Illinois before one judge
as part of a multidistrict litigation (MDL).
As the testosterone product lawsuits share many common
complaints that the drugs caused the users to suffer strokes,
heart attacks, and other cardiovascular issues, the U.S. Judicial
Panel on Multidistrict Litigation (JPML) decided to centralize the low-t drug lawsuits. This
consolidation helps reduce the chances of duplicative discovery, avoid conflicting rulings from
different judges around the country, and aids expediency for the parties, witnesses and the courts. The
JPML issued an order transferring at least 45 low-T lawsuits to U.S. District Judge Matthew Kennelly to
coordinate handling during pretrial proceedings.
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By Barbara Anderman June 16, 2014
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All Testosterone Product Lawsuits Consolidated
In an order delivered June 6, the panel of federal judges wrote: “We are typically hesitant to centralize
litigation on an industry-wide basis.”
That has been brought up in the proposals on how to manage the MDL. In a May 29 hearing, some
suggested that only AndroGel or T-Gel lawsuits be included in the MDL, while others (particularly
defendants) say all testosterone industry cases should be culled for one proceeding.
After deliberation, the judges decided that industry-wide consolidation was best in this scenario.
“Plaintiffs suggest that related cases will number in the thousands. Significantly, in the actions and
potential tag-along actions already filed, a number of plaintiffs used more than one testosterone
replacement therapy,” the JPML wrote.
Additionally, the JPML believes that common regulatory issues will impact all of the different
testosterone therapies.
Grumpiness, lack of energy, or fatigue are often part of the natural lowering of testosterone levels all
men experience with age. However, those symptoms are also used in marketing to sell “Low-T” drugs.
Drug makers, for many years, have encouraged men to seek testosterone replacement therapies
(TRT), like T-Gel treatment, for any of these symptoms.
However, it’s been alleged that Low-T drugs cause serious medical problems, including life threatening
cardiac events, strokes, and thrombolytic events. A large number of victims say they didn’t receive
adequate warning for these risks, but suffered the consequences. As a result, these individuals have
filed testosterone product lawsuits against the manufacturers. Most of the testosterone lawsuits are
regarding AndroGel, as it is the most commonly sold T-Gel product, but the others like Axiron, Testim,
Foresta, AndroDerm and Depo-Testosterone are not free from litigation.
History of Testosterone and the FDA
The U.S. Food and Drug Administration (FDA) issued a black box warning for testosterone
prescriptions in 2009, but no one really seemed to take notice until the publication of two studies in
2013 and 2014.
In November 2013, the Journal of the American Medical Association (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.
Another study was published in January 2014 in PLOSOne found that low-T treatments could hurt two
groups: men over the age of 65 and younger men with heart disease. In these cases, use of
testosterone replacement therapy could double the risk of heart attack.
In response to the findings, the FDA kickstarted a safety review on Jan. 31, 2014. Media outlets
reporting on the review brought the risks of testosterone replacement therapies to the public, and a
wave of lawsuits into existence.
Going forward, as product liability lawyers review and file new testosterone product lawsuits, it is
estimated that several thousand cases will be included in the low-T drug MDL.
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