Generic Defendants’ PA Preemption Battle Gets Potential Boost from NJ Judge

The issue of generic-drug preemption continues to be one of the key battlegrounds in pharmaceutical product liability litigation. Recently – as we discussed here – the FDA released a proposed rule that, if adopted, would eliminate the broad preemption of failure-to-warn claims against generic pharmaceutical manufacturers established two years ago by the U.S. Supreme Court in PLIVA v. Mensing. In the wake of Mensing, multiple courts across the country have taken up efforts by generic pharmaceutical defendants to dismiss failure-to-warn claims, as well…
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Mensing-Preemption Battle Continues in Pennsylvania as Defendants Seek Reargument of Denial of Appeal

The nationwide battle over federal preemption in connection with generic drugs continues, with manufacturers of generic metoclopramide in Pennsylvania seeking to reargue the denial of their appeal challenging the court’s refusal to find the claims against them preempted. Since the 2011 Supreme Court opinion in PLIVA, Inv. v. Mensing, the issue of preemption in tort suits against manufacturers of generic pharmaceuticals has been an important issue. In short, preemption arises under the federal requirement that generic drug labeling must be the same as the…
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Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

A United States District Court Judge, sitting in the Middle District of Florida, has rejected arguments by Novartis Pharmaceutical Corporation (“Novartis”) that federal law would prohibit claims that the company should have added “Black Box” warnings regarding potential side effects of Zometa, including potential bone loss.  As a result, plaintiffs will be allowed to proceed with their claims notwithstanding the company’s arguments (1) that all of the failure-to-warn claims were controlled by the Supreme Court’s 2009 decision in Wyeth vs. Levine; and (2) that…
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New York Federal Court Upholds “Failure to Update” Theory

For those who follow pharmaceutical litigation, the issue of preemption – as discussed primarily by the U.S. Supreme Court in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, as well as in a host of other state and federal court opinions – continues to be an important battleground.  Although most courts have rejected the plaintiffs’ efforts to pursue failure-to-warn claims against generic drug manufacturers, based on the generic drug makers’ federal law “duty of sameness,” under which a warning label for a…
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