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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

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

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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