Generic Makers Of Testosterone Drugs Argue For Dismissal

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Some generics makers in the testosterone replacement therapy lawsuits are attempting to use a 2011 Supreme Court ruling to have the claims filed against them dismissed.

Friday, May 1, 2015 - With the number of testosterone replacement therapy lawsuits involved in multidistrict litigation nearing 1,500 cases, a number of manufacturers that made generic versions of the Androgel and AndroDerm drugs are attempting to use a 2011 U.S. Supreme Court ruling to have claims against them currently in multidistrict litigation dismissed. The particular case the pharmaceutical companies are attempting to invoke in their defense is Pliva v. Mensing, the case in which the Supreme Court decided that state drug-labeling laws are preempted by federal laws when investigating common questions of fact. Since the lawsuits against the companies arose from state courts, the companies are attempting to argue that they obeyed the laws pursuant to federal jurisdiction, which would dismiss the standing state claims.

Abbott and AbbVie are the main defendants involved in a large MDL that could reportedly gain more than a thousand more lawsuits in addition to those already filed for the serious side effects caused by the testosterone drugs AndroGel and AndroDerm manufactured by the companies. The side effects included in the allegations are mostly tied to cardiovascular and circulatory issues with heart attacks, pulmonary embolisms and strokes suffered as a result of taking the testosterone drugs.

There are also plaintiffs claiming that the testosterone drugs were intentionally marketed for casual use, which was not recommended according to the warning label attached to the medication. The allegations claimed that a deceiving marketing campaign advertised AndroGel as a drug that could combat low testosterone, libido and energy in men. Plaintiffs have taken issue with this line of advertising as they claim that the symptoms AndroGel relieves are just natural processes the body goes through while aging. They claim the additional messaging negligently caused more patients to prescribe to the testosterone drug and heightened their risk of suffering from one of its debilitating side effects.

The generic makers of the drugs are attempting to use the precedent set in the Pliva v. Mensing ruling to have the warning label claims against them dismissed. The Supreme Court ruled during Pliva v. Mensing that state regulation relating to generic drug manufacturers preempted state tort laws. The law preempted in this case concerns the failure to warn claims levied against the defendants, which is at odds with an FDA requirement for generics to display the same information on their warning labels as the name-brand version of the drug. Generic makers are arguing this law preempts the failure to warn lawsuits filed against the companies as the FDA requirement indicates they are not liable for the content of their warning labels.

Attorneys for the plaintiffs are worried that this preemption will make it difficult for generics makers to be punished for serious side effects caused by their products. There has been action taken by the FDA to allow for generics to modify their own warning labels, although those actions were proposed in 2013 and the period for public comment concerning those proposed changes just passed last week. If passed, this change to the way generic pharmaceuticals are governed could end the use of Pliva v. Mensing by generics manufacturers to dismiss lawsuits involving their drug.

The MDL for these cases began when just 45 lawsuits were transferred in 2014 before U.S. District Judge Matthew Kennelly in the Northern District Court of Illinois. Since then, the number of lawsuits has risen swiftly and continues to balloon. If the MDL proceeds, the first group of bellwether trials will take place between October 2016 and April 2017.