News & Analysis as of

PLIVA v Mensing Preemption

Faegre Drinker Biddle & Reath LLP

Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more

Butler Snow LLP

No Way Around It: The Need for Federal "Permission and Assistance" Can Preempt a State Tort Duty

Butler Snow LLP on

In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more

Sheppard Mullin Richter & Hampton LLP

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

Latham & Watkins LLP

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

Latham & Watkins LLP on

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

K&L Gates LLP

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

K&L Gates LLP on

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Carlton Fields

A Double Play For Prescription Drug Manufacturers In The Eleventh Circuit

Carlton Fields on

Consistent with the U.S. Supreme Court’s opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Eleventh Circuit recently held that generic prescription drug manufacturers cannot be held liable under state-law failure...more

Sheppard Mullin Richter & Hampton LLP

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

Morrison & Foerster LLP

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Morrison & Foerster LLP

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more

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