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Supreme Court of the United States › Preemption › Pharmaceutical Industry

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 -
Epstein Becker & Green

Another Leak Confirmed and Other Important Decisions and Divisions Issued, but Not Loper or Trump - SCOTUS Today

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The Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more

Epstein Becker & Green

State Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of Oklahoma...

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On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit (the “Tenth Circuit”) issued its decision in Pharmaceutical Care Management Association (PCMA) v. Mulready, one of the first major opinions to further define...more

Foley & Lardner LLP

50 State Map of MAC Laws – Can PBMs No Longer Rely on ERISA Preemption to Avoid Certain State Laws?

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Recent court trends suggest that preemption under the Employee Retirement Income Security Act (ERISA) may not apply to certain state laws that regulate pharmacy benefit managers (PBMs), including state laws governing Maximum...more

Harris Beach PLLC

U.S. Supreme Court Decision Supports State Regulation of Pharmacy Benefit Managers

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The U.S. Supreme Court’s recent unanimous decision clears the way for state regulation of Pharmacy Benefit Managers (“PBMs”). Rutledge v. Pharm. Care Mgmt. Ass’n, 141 S. Ct. 474 (2020). At issue before the High Court was...more

Akerman LLP - Health Law Rx

New Supreme Court Ruling Affirms State Regulation of PBM Reimbursement Pricing

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The U.S. Supreme Court ruled against pharmacy benefit managers (“PBMs”) last month, in a decision that marks a major win for state regulators. (See Rutledge v. Pharmaceutical Care Management Association, 2020 WL 7250098 (U.S....more

Locke Lord LLP

Supreme Court Rules ERISA Does Not Preempt Arkansas’ PBM Regulation

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Recently, the Supreme Court released its decision in Rutledge v. Pharmaceutical Care Management Association. The case considers whether the Employee Retirement Income Security Act of 1974 (“ERISA”) preempts an Arkansas state...more

Mintz - Employment Viewpoints

Supreme Court Holds that ERISA Does Not Preempt Arkansas PBM Law: The Impact on Employer Sponsored Group Health Plans

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In a recently decided case, Rutledge v. Pharmaceutical Care Management Association, the U.S. Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas statute that...more

Groom Law Group, Chartered

The Supreme Court Narrows ERISA Preemption in Rutledge v. PCMA

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In the recently-decided Rutledge v. Pharmaceutical Care Management Association (“PCMA”), the Supreme Court found 8–0 (Justice Barrett did not take part) that ERISA did not preempt an Arkansas state law that established...more

White & Case LLP

Supreme Court Green Lights Arkansas Law Regulating PBM Pricing Practices

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On December 10, 2020, the Supreme Court in Rutledge v. Pharmaceutical Care Management Association held that ERISA does not pre-empt an Arkansas law regulating PBM prescription drug payment rates to pharmacies because it...more

K&L Gates LLP

340B Update: Recent Supreme Court Ruling May Curtail 340B Program Discriminatory Pricing

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The U.S. Supreme Court recently issued a unanimous decision in Rutledge v. Pharmaceutical Care Management Ass’n, which supports the validity of state statutes that regulate reimbursement rates pharmacy benefit managers (PBMs)...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decision Caps Big Week in Litigation for Pharmacy Benefit Managers

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The U.S. Supreme Court handed down a decision on Thursday of last week that will impact state-level regulation of pharmacy benefit managers (PBMs) by holding that an Arkansas law regulating PBMs was not preempted by the...more

Ballard Spahr LLP

Supreme Court Finds ERISA Does Not Preempt State Prescription Drug Pricing Law

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Summary The U.S. Supreme Court unanimously upheld an Arkansas statute that regulates the price that pharmacy benefit managers (PBMs) pay retail pharmacies for prescription drugs.   ...more

Robinson+Cole ERISA Claim Defense Blog

Supreme Court Rules that ERISA Does Not Preempt State Law Regulating PBM Reimbursements

Robinson+Cole ERISA Claim Defense Blog on

In Rutledge v. Pharmaceutical Care Mgt. Assoc., — U.S. –, 2020 WL 7250098 (Dec. 10, 2020), the Supreme Court held that ERISA’s broad express preemption will not reach a state law that focuses on the price of prescription drug...more

BakerHostetler

Supreme Court Gives Nod to States Regulating Pharmacy Benefit Managers Reimbursement

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On Dec. 10, the United States Supreme Court issued its ruling in Rutledge v. Pharmaceutical Care Management Association. The Court reversed the 8th Circuit to uphold a state’s ability to regulate the price at which pharmacy...more

Jackson Lewis P.C.

U.S. Supreme Court: State Law Regulating Pharmacy Benefit Managers Is Not Preempted By ERISA

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An Arkansas law regulating pharmacy benefit managers’ (PBMs) generic drug reimbursement rates, and affecting the cost of prescription drugs provided under ERISA-governed benefit plans and the administration of those plans, is...more

Faegre Drinker Biddle & Reath LLP

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

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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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

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

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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

Foley & Lardner LLP

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

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On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

Mintz

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

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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

McDermott Will & Emery

ANDA Update - October 2015

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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

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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

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