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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Indiana Appellate Court Holds Negligence Action Involving Medtronic Defibrillator Not Preempted by Federal Law

An Indiana appellate court decided that oral representations by a medical device manufacturer during a surgery about the function of device are not preempted by federal law.  Could this be a significant exception to the U.S. Supreme Court’s seminal decision in Riegel vs. Medtronic? In 1997, David Malander received an implanted Medtronic defibrillator and right ventricular lead (“Lead”), which remained in place until he began experiencing problems several years later.  The Lead was a Class III medical device subject to premarket approval by the…
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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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A Rock and a Hard Place: Court Rejects Drug Manufacturer’s Defense that Changes to the Label Required FDA Approval and Were Preempted

This week, a Florida federal court denied a drug manufacturer’s motion in limine to preclude a plaintiff’s alternative warning theory on the basis that any changes to the label required FDA approval and were preempted. Dopson-Trout v. Novartis Pharma. Corp., 2013 U.S. Dist. LEXIS 135834 (M.D.Fla. Sept. 23, 2013). During her treatment for breast cancer that had metastasized to her bones, the plaintiff was infused with Aredia and then Zometa. She then had her tooth extracted, after which she began experiencing jaw pain caused…
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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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Banana Boat High SPF Sunscreen Class Action Survives Challenge

A California plaintiff survived a challenge to her consumer fraud complaint against Playtex Products and other makers of Banana Boat sunscreens with SPF [sun protection factor] of 85 to 110.  The critical allegation is the claim that that scientific studies show that sunscreen with SPF over 50 provides no clinically-significant benefit over the use of SPF 50 products.  Plaintiff claims the marketing of the Banana Boat products is misleading because the advertising campaign combined extreme SPF values with unproven claims of greater sun protection than…
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Litigation Concerns Rise as FDA Proposes Reclassification of Tanning Beds

The Food and Drug Administration (FDA) issued a press release regarding its proposed order to reclassify sunlamp products from a Class I medical device (low risk) to a Class II medical device (moderate risk).  Additionally, the FDA is now recommending that persons under the age of 18 be warned to not use these products at all. The FDA press release notes that “[a]ccording to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin…
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Preemption Defense Not Completely Dead for Branded Drugs

As all who follow drug and device law know full-well, the 2009 decision from the United States Supreme Court in Wyeth v. Levine represented a significant setback for brand-name drug manufacturers seeking to defend failure-to-warn claims on preemption grounds.  In Levine, the court held that state law failure-to-warn claims involving brand-name drugs are not preempted, unless there is “clear evidence” that the Food and Drug Administration (FDA)  would not have approved whatever labeling change forms the basis for the failure-to-warn claim.  Such a standard…
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Preemption Wars Over Class III Medical Devices Continue

Preemption wars over Class III medical devices continue unabated.  The plaintiff’s bar is vigilant, creative and undeterred in their efforts to limit the effects of the Buckman case.  In some cases, their efforts are rewarded.  An example is a case decided just this week.  The issue was addressed in a device manufacturer’s 12(b)(6) motion to dismiss a lawsuit against a Class III device on federal preemption grounds.  According to the court’s opinion, a previous preemption motion to dismiss was granted with leave to re-plead.  The…
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