U.S. Supreme Court Denies Certiorari in Generic Pharmaceutical Preemption Case

The United States Supreme Court today issued an order declining a generic pharmaceutical manufacturer’s petition for a writ of certiorari. The drug manufacturer had sought to challenge a ruling from the Iowa Supreme Court. In that state court ruling, the Iowa Supreme Court found that the U.S. Supreme Court’s preemption decision in Mensing did not necessarily prohibit failure to update claims. The U.S. Supreme Court’s decision in Mensing held that failure to warn claims brought against generic drug manufactures were preempted. The plaintiffs’ attorneys have…
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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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Pennsylvania Court Rejects Bid to Reargue Mensing Denial

Last month, we reported on the attempt by several generic manufacturers of metoclopramide to seek reargument before the Pennsylvania Superior Court on the issue of whether the claims against them are preempted under the jurisprudence of the United States Supreme Court’s opinion in PLIVA, Inc. v. Mensing and its progeny. The generic manufacturers’ bid for reargument was rejected by the Pennsylvania Superior Court last week, meaning that the Superior Court’s prior divided decision that upheld the trial court’s refusal to dismiss the claims as preempted…
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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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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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HHS Proposes to Undo the Supreme Court Rulings in Pliva and Bartlett by Regulation Changes

In 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which affected “75 percent of all prescription drugs dispensed in this country.”  The court held that because the FDA requires generic drug manufacturers to use the same labels and warnings as those of the name-brand manufacturer, state law claims against generic companies regarding labeling and warnings are pre-empted. Put another way, because generic drug manufacturers cannot change their labels or warnings, even if they later learn of additional risks associated…
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New Jersey Court Backs Mensing Preemption

Several weeks ago, we discussed the issue of Mensing generic drug preemption and the anticipated decision from Judge Carol Higbee, who is presiding over the consolidated Reglan and metoclopramide litigation pending in Atlantic County.  As readers may recall, generic preemption is a battleground issue now in pharmaceutical litigation, as generic pharmaceutical defendants seek to take full advantage of the U.S. Supreme Court’s favorable ruling last year in Mensing, and plaintiffs’ attorneys try creatively to limit and narrow the scope of Mensing preemption. Judge Higbee…
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Mensing Update

Recently, we posted about the awaited decision from Judge Carol Higbee in response to the generic defendants’ motion to dismiss the plaintiffs’ claims in the consolidated litigation involving metoclopramide on the basis of the U.S. Supreme Court’s ruling last year in Pliva v. Mensing.  While courts across the country continue to take up and decide this issue – including a very favorable opinion from Judge Danny Reeves in the multi-district litigation involving propoxyphene – generic pharmaceutical manufacturers continue to await a ruling from Judge Higbee. …
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Mensing Generic Preemption Decision Awaited in New Jersey

In 2011, the US Supreme Court’s landmark decision in PLIVA v. Mensing altered the world of pharmaceutical product liability litigation, holding that claims challenging the adequacy of warnings provided by generic drug makers were preempted.  The basic underpinning of the Supreme Court’s opinion was that, under federal law, a generic pharmaceutical had to be the same — and provide the same warnings — as the branded drug, and that any deviation by a generic manufacturer would run afoul of federal law.  Mensing involved claims against…
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