News & Analysis as of

Supreme Court of the United States › Preemption › Food and Drug Administration (FDA)

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
Faegre Drinker Biddle & Reath LLP

Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

Faegre Drinker Biddle & Reath LLP on

We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and...more

Faegre Drinker Biddle & Reath LLP

California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal...

Faegre Drinker Biddle & Reath LLP on

Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer,...more

Faegre Drinker Biddle & Reath LLP

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

Faegre Drinker Biddle & Reath LLP on

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

Faegre Drinker Biddle & Reath LLP

Third Circuit Clarifies Next Steps in Fosamax Decision

Faegre Drinker Biddle & Reath LLP on

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 3, 2019

Spilman Thomas & Battle, PLLC on

Welcome to the third 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues.... In This Edition: - Vitamin E Found in Cannabis-Containing Vape Products Linked...more

Epiq

New Supreme Court Decision Offers Guidance for Mass Tort Preemption Defense

Epiq on

After years of limited guidance, the Supreme Court has finally provided direction to lower courts on the issue of preemption when they delivered their opinion in Merck v. Albrecht. “Preemption” is a common defense used by...more

Faegre Drinker Biddle & Reath LLP

Worth the Wait? Some Semi-Mature Thoughts on Albrecht

Faegre Drinker Biddle & Reath LLP on

For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical...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

Morrison & Foerster LLP - Class Dismissed

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

Morrison & Foerster LLP - Class Dismissed on

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption.  In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third...more

Morgan Lewis

Supreme Court Clarifies Judges Must Decide Impossibility Pre-Emption

Morgan Lewis on

The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law. To succeed on a...more

Hogan Lovells

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

Hogan Lovells on

Opinion highlights importance of a "clear" record at FDA - On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a...more

McDermott Will & Emery

US Supreme Court Refines Impossibility Preemption Doctrine, Changes Litigation Dynamics

McDermott Will & Emery on

Following confusion from a 2009 decision, the US Supreme Court on May 20, 2019, decided a significant impossibility preemption case. This new decision will change the dynamics of litigation involving the impossibility...more

Jones Day

Supreme Court Sides with Merck in Unanimous Fosamax® Product-Liability Decision

Jones Day on

The Situation: Name-brand pharmaceutical manufacturers are often sued with claims that they should have strengthened the warnings on their labels, even where (as here) the Food and Drug Administration ("FDA") would not allow...more

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme Corp. v. Albrecht (2019)

McDonnell Boehnen Hulbert & Berghoff LLP on

Last week, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be...more

Husch Blackwell LLP

Supreme Court Reiterates That Federal Law Preemption For Product Warnings Is A Matter For Judge, Not Jury

Husch Blackwell LLP on

On Monday, the United States Supreme Court found that a judge is better suited than a jury to decide if consumers’ tort claims are preempted by federal regulations. In the case, Merck Sharp & Dome, Corp. v. Albreecht, the...more

Troutman Pepper

Supreme Court Clarifies Scope of Implied Preemption in Prescription Drug Cases

Troutman Pepper on

On May 20, the U.S. Supreme Court issued its latest opinion on preemption in cases involving prescription medications, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. May 20, 2019). ...more

Faegre Drinker Biddle & Reath LLP

Judges to Decide Whether Manufacturers Meet “Clear Evidence” Impossibility Preemption Standard, Supreme Court Says

Faegre Drinker Biddle & Reath LLP on

The U.S. Supreme Court issued its potentially most significant preemption decision in several years, Merck Sharp & Dohme Corp. v. Albright, 587 U.S. ____ (2019), reversing what some had dubbed the worst drug and device...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Merck Sharp & Dohme Corp. v. Albrecht

Faegre Drinker Biddle & Reath LLP on

On May 20, 2019, the Supreme Court of the United States decided Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, holding that the judge, not the jury, must decide whether state-law failure-to-warn claims are preempted by...more

Faegre Drinker Biddle & Reath LLP

Labeling Preemption Questions are for the Court, not the Jury, Holds U.S. Supreme Court in Fosamax Decision That Clarifies the...

Faegre Drinker Biddle & Reath LLP on

A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held on Monday, May 20, 2019. The Court also...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Significant Rulings Expected for Ongoing Mass Tort, Consumer Class Action Issues

Skadden, Arps, Slate, Meagher & Flom LLP on

In 2019, significant developments are expected on issues that have been percolating in the mass tort and class action litigation arena for several years. The U.S. Supreme Court is expected to rule on cases relating to...more

Cozen O'Connor

ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims

Cozen O'Connor on

The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question...more

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

McDonnell Boehnen Hulbert & Berghoff LLP on

Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

Goodwin

Amgen v. Sandoz: Sandoz Requests Remand to District Court

Goodwin on

As we have previously reported, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz holding that notice of commercial marketing may be given prior to FDA approval. The Court also held that no...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

The Patent Dance Is Optional

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more

40 Results
 / 
View per page
Page: of 2
Next »

"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