News & Analysis as of

Prescription Drugs Vacated

Bass, Berry & Sims PLC

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

Bass, Berry & Sims PLC on

On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...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

Robinson+Cole Health Law Diagnosis

Federal Judge Vacates Final Rule on Drug Pricing Transparency in Consumer Advertising

In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...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

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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

Farrell Fritz, P.C.

Second Circuit Vacates Conviction of Pharmaceutical Distributor on Advice-of-Counsel Defense

Farrell Fritz, P.C. on

Last week, in United States v. Scully, the Second Circuit vacated the conviction of a distributor of pharmaceutical products on misbranding charges due to evidentiary issues surrounding his advice-of-counsel defense at trial....more

Carlton Fields

Third Circuit Creates Framework for Analyzing Numerosity

Carlton Fields on

The Third Circuit recently vacated class certification, granted by the Eastern District of Pennsylvania after nearly a decade of litigation, in an antitrust case alleging that a pharmaceutical company entered into agreements...more

Troutman Pepper

Third Circuit Decertifies Class on Numerosity Grounds, Listing Relevant Factors for the First Time

Troutman Pepper on

The Modafinil decision bodes well for defendants and represents another step toward increased scrutiny of the class action device in the Third Circuit. On September 13, a divided panel of the U.S. Court of Appeals for...more

Robins Kaplan LLP

Teva Pharms. USA, Inc., v. Sandoz, Inc.

Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...more

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