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Supreme Court of the United States › Preemption › Generic Drugs

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

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

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

Mintz - Health Care Viewpoints

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

Mintz - Health Care Viewpoints on

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...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

K&L Gates LLP

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

K&L Gates LLP on

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Haight Brown & Bonesteel LLP

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

Haight Brown & Bonesteel LLP on

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

Foley Hoag LLP

Product Liability Update - July 2013

Foley Hoag LLP on

Included in this Issue: ..United States Supreme Court Reverses First Circuit and Holds Federal Food Drug & Cosmetic Act Preempts Design Defect Claims against Generic Pharmaceutical Manufacturers ..United States...more

Sheppard Mullin Richter & Hampton LLP

A Short-Lived Victory for Generic Drug Manufacturers?

Sheppard Mullin Richter & Hampton LLP on

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

Cozen O'Connor

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company

Cozen O'Connor on

On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more

Ballard Spahr LLP

Supreme Court Rejects ‘Stop-Selling’ Argument in Conflict Preemption Cases

Ballard Spahr LLP on

In a 5-4 decision, the U.S. Supreme Court rejected the notion that a manufacturer’s option to stop selling its product resolves preemption concerns raised by conflicting state and federal laws....more

Baker Donelson

U.S. Supreme Court Bartlett Decision in Favor of Generic Drug Manufacturers

Baker Donelson on

In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more

Morrison & Foerster LLP

Mutual v. Bartlett Further Shields Generic Drug Manufacturers from Liability

Morrison & Foerster LLP on

Yesterday, the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Supreme Court’s Bartlett Decision Reaffirms Broad Scope of Generic Drug Preemption"

Skadden, Arps, Slate, Meagher & Flom LLP on

In a significant victory for generic drug companies, the Supreme Court today issued its decision in Mutual Pharmaceutical Co. v. Bartlett, reversing the decision of the First Circuit, which had affirmed a multimillion dollar...more

Morrison & Foerster LLP

A Narrow Exception To The Mensing Preemption Defense

Morrison & Foerster LLP on

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Morrison & Foerster LLP

Breaking Down The Bartlett Oral Argument

Morrison & Foerster LLP on

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Morrison & Foerster LLP

Driving on Both Sides of the Road: Supreme Court Hears Bartlett Oral Argument

Morrison & Foerster LLP on

The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

Skadden, Arps, Slate, Meagher & Flom LLP on

Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more

Morrison & Foerster LLP

Supreme Court to Hear Design Defect Preemption Case

Morrison & Foerster LLP on

Generic drug manufacturers were encouraged on Friday when the Supreme Court granted certiorari in the case of Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit, Bartlett v. Mutual Pham. Co.,...more

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