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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
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
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
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
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
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
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
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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