Generic Testosterone Defendants To Seek Dismissal of Claims on Pre-Emption Grounds
The impact of a 2011 U.S. Supreme Court Decision governing generic drug injury cases could soon be felt by some plaintiffs pursuing testosterone treatment lawsuits in the federal litigation underway in U.S. District Court, Northern District of Illinois. According to a Joint Status Report filed with the Court on April 16th, a number of generic drug defendants will soon seek to have claims involving their products dismissed.
The Joint Status Report notes that testosterone lawyers representing plaintiffs and defendants are currently conferring on a proposed schedule for the submission of briefs pertaining to the possible dismissal for the generic drug cases. They’ve also asked the Court for guidance regarding a hearing date for oral arguments on the matter.
Generic Drug Lawsuits and FDA Regulation
Most of the testosterone lawsuits currently pending in the Northern District of Illinois involve name-brand drugs like AndroGel, but a certain number of cases were filed on behalf of men who were allegedly injured by generic brands. Unfortunately for plaintiffs, a 2011 U.S. Supreme Court decision in a case called Pliva vs. Mensing barred consumers from bringing state law failure-to-warn claims against generic drug manufacturers. In doing so, the Court’s majority reasoned that such claims were preempted because generic drug makers had no control over their products’ labels.
Generic medications are required to bear labels identical to their name-brand counterparts. As it stands now, FDA rules do not allow generic manufacturers to initiate changes to their drug’s labels, even if they become aware of new risks or side effects associated with the products. Instead, the makers of generic medications must wait until the FDA orders a label modification before any such updates can be made to those drugs.
In 2013, the FDA proposed new regulations that would allow generic manufacturers to alter their labels whenever new safety information becomes available, a change that could finally eliminate the current pre-emption on failure-to-warn claims. However, The New York Times reports that the industry is pushing back aggressively against the proposal. The final date for public comment on the matter is April 27th.
Contact a Testosterone Lawyer Today
Bernstein Liebhard LLP represents men who have allegedly experienced heart attacks, strokes and other life-threatening cardiovascular events due to their use of testosterone replacement therapy. To learn more about filing a testosterone treatment lawsuit, please call 1-877-779-1414 to arrange for a free, no-obligation case review.