News & Analysis as of

Preemption Food and Drug Administration (FDA) Warning Labels

Nutter McClennen & Fish LLP

Product Liability 2023 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

Conn Kavanaugh

Defining the Boundaries for Pre-emption of Drug Labeling Claims

Conn Kavanaugh on

Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the...more

Nutter McClennen & Fish LLP

Product Liability 2019 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Faegre Drinker Biddle & Reath LLP

Third Circuit Clarifies Next Steps in Fosamax Decision

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

Epiq

New Supreme Court Decision Offers Guidance for Mass Tort Preemption Defense

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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

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

Morrison & Foerster LLP - Class Dismissed

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

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

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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)

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

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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

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

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...

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

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Hogan Lovells

California Appeals Court Reverses Decision Requiring Proposition 65 Warnings on Cereals for Acrylamide

Hogan Lovells on

A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning...more

Downey Brand LLP

Court Determines Breakfast Cereal Currently Does Not Require Prop 65 Warnings

Downey Brand LLP on

A recent appellate decision from the Second District Court of Appeal in Los Angeles has determined that breakfast cereals do not require a Proposition 65 warning for acrylamide. Post Foods, LLC v. Superior Court of Los...more

Perkins Coie

Precedent-Setting Proposition 65 Pre-emption Decision Involving Breakfast Cereal

Perkins Coie on

Last week, the California Court of Appeal held that a plaintiff’s suit seeking to require Proposition 65 acrylamide based cancer warnings on 59 popular breakfast cereals was preempted by federal nutrition policies aimed at...more

Foley Hoag LLP

Product Liability Update: October 2017

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Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Shook, Hardy & Bacon L.L.P.

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Holland & Knight LLP

Healthcare Law Update: June 2017

Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

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