Category Archives: Preemption

This Week’s Life Science Headlines

        Litigation

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The Manufacturer Made Me Do It – One Claim By Negligent Surgeon Survives

California certainly breeds interesting cases. In the Chao case, available here, recently decided by a federal judge in the Southern District of California, the plaintiff was not an injured person. He was an orthopedic surgeon found to be negligent in his treatment of a patient by an arbitration panel, which awarded in excess of $2 million to the patient. The surgery was a hip replacement surgery during which the surgeon lacerated the patient’s femoral artery. Following the award, the orthopedic surgeon brought an indemnity action…

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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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Generic Drug Manufacturer Loses Battle on Preemption, But Wins War on Causation

Are state law claims against a generic drug manufacturer preempted where labeling of the generic drug differs from the brand name drug labeling?  In a recent drug liability case decided in the federal district court in Arizona, the court said no and held that the plaintiff’s claims were not preempted.  Nevertheless, the court concluded that the plaintiff’s physicians did not read or rely on the labeling and, therefore, Arizona law required dismissal of the plaintiff’s claim.  The case is Carter v. APP Pharmaceuticals and can…

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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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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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Alabama Supreme Court, Latest to Consider Liability for Generic Drugs

The relationship between brand name and generic drugs on the market continues to fuel litigation battles across the country.  On June 24, we reported that the United States Supreme Court held that state-law tort claims against generic drug manufacturers are preempted under the Hatch-Waxman Amendments to the federal Food, Drug and Cosmetic Act. Our June report is available click here.  In July, we reported that the Eastern District of Kentucky dismissed claims against a brand name manufacturer for warnings contained on generic versions of…

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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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