News & Analysis as of

Preemption Pharmaceutical Industry

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

Locke Lord LLP

Oklahoma PBM Law’s Uncertain Appeal to the Supreme Court

Locke Lord LLP on

On January 2, 2024, the United States Court of Appeals for the Tenth Circuit (“Tenth Circuit”) denied the State of Oklahoma’s motion for a stay pending appeal to the United States Supreme Court and one week later transferred...more

Proskauer - Minding Your Business

Ozempic Gains Popularity, Its Maker Loses First Legal Fight

With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Quarles & Brady LLP

Oklahoma Patient's Right to Pharmacy Choice Act Preempted by ERISA

Quarles & Brady LLP on

On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more

Bass, Berry & Sims PLC

Tenth Circuit Rules ERISA Preempts Oklahoma PBM-Reform Law

Bass, Berry & Sims PLC on

In a win for self-funded (i.e., self-insured) health plans subject to the Employee Retirement Income Security Act of 1974, as amended (ERISA), the Tenth Circuit recently ruled that ERISA preempts provisions of an Oklahoma law...more

Troutman Pepper

State AGs Choose Products Liability Case as Battleground for State Sovereignty

Troutman Pepper on

A bipartisan coalition of 23 state attorney generals led by Virginia AG Jason Miyares recently went up in arms about a products liability ruling they believe will threaten state consumer protection laws. On May 30, the...more

Shook, Hardy & Bacon L.L.P.

Goldberg, Gramling & O’Rourke: A Prescription for Pharmaceutical Preemption

The U.S. Supreme Court has issued several consequential decisions over the past 15 years setting guidelines for when federal regulations over prescription drug warnings preempt state failure-to-warn claims. Shook Partners...more

McDermott Will & Emery

ERISA Preemption Developments in Managed Care

McDermott Will & Emery on

For plans governed by the Employee Retirement Income Security Act of 1974, 29 U.S.C. §§ 1001-1461 (ERISA), the doctrine of federal ERISA preemption over state statutes, regulations or administrative schemes has been a central...more

Foley & Lardner LLP

Ninth Circuit Holds that Implied Preemption Bars State Law Claims Based on a Violation of the FDCA

Foley & Lardner LLP on

In Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040, 1041 (9th Cir. 2022), the Ninth Circuit recently held that the implied preemption doctrine barred state law claims because they were...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Implied FDCA Preemption

This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Hogan Lovells

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more

Holland & Knight LLP

Proposed FDA Rules Could Be Game Changers for the Pharmaceutical Supply Chain

Holland & Knight LLP on

New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2021

Harris Beach PLLC on

From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Holland & Knight LLP

Medical Manufacturer Prevails in Massachusetts Product Liability Suit

Holland & Knight LLP on

When someone is deciding whether to undergo a medical procedure, they think about a lot of things: How much does the procedure cost? What are the risks? What are the benefits? They probably don't consider whether their...more

Harris Beach PLLC

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

Harris Beach PLLC on

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

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

Locke Lord LLP on

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

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

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

White & Case LLP on

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

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