News & Analysis as of

PLIVA v Mensing Prescription Drugs

Mintz

Massachusetts Supreme Judicial Court Allows Innovator Liability Claims to Proceed Under A Recklessness Standard

Mintz on

Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name...more

Morrison & Foerster LLP - Class Dismissed

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...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

Morrison & Foerster LLP

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...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

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