News & Analysis as of

Pharmaceutical Industry › Preemption › FDA Approval

McDermott Will & Schulte

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

McDermott Will & Schulte on

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Implied FDCA Preemption

Morrison & Foerster LLP - Left Coast Appeals on

This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...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

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

Nutter McClennen & Fish LLP on

Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Mintz

Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA

Mintz on

On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act...more

Morrison & Foerster LLP

Liability for Brand Drug Manufacturers All But Clear

Morrison & Foerster LLP on

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

Morrison & Foerster LLP

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Morrison & Foerster LLP on

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104...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

8 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide