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Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

Supreme Court to Hear Design Defect Preemption Case

Generic drug manufacturers were encouraged on Friday when the Supreme Court granted certiorari in the case of Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit, Bartlett v. Mutual Pham. Co.,...more

Kurns - Anything In It For Us?

A couple of weeks ago – yeah, that’s right, on February 29 – the Supreme Court issued a ruling preempting asbestos product liability claims in Kurns v. Railroad Friction Products Corp., 2012 WL 631857, slip op. (U.S. Feb. 29,...more

Federal Pre-Emption Under The Food, Drug & Cosmetic Act From Medtronic, Inc. V. Lohr; Pliva, Inc. V. Mensing

INTRODUCTION Beginning in 1996, the United States Supreme Court took a series of cases related to Federal preemption of state law claims for products approved by the United States Food and Drug Administration (''FDA'')....more

Mensing and Its Impact on State-Law-Based Claims Against Generic Drug Manufacturers

Following the U.S. Supreme Court’s five–four decision in PLIVA, Inc. v. Mensing,1 it appears doubtful that many state-law-based claims against generic drug manufacturers remain viable. In Mensing, the Supreme Court held that...more

Two More From The Supreme Court

Generic Manufacturers Win Preemption In Mensing The Court decided 5-4 in favor of generic preemption today in Pliva, Inc. v. Mensing, No. 09–993, slip op. (U.S. June 23, 2011). We’d like to talk about Mensing, but it’s a...more

U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers

On June 23, 2011, the U.S. Supreme Court issued a decision in Pliva, Inc. v. Mensing,1 holding that state-law claims against generic drug manufacturers are federally preempted pursuant to the Supremacy Clause of the U.S....more

Federalism And Tort Reform

On Wednesday, we discussed the relevant parts of pending tort reform legislation. Earlier in the month we updated our favorite federalist point, which is that federal courts should not issue expansive interpretations of state...more

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