News & Analysis as of

Medical Devices Appeals Manufacturers

Rivkin Radler LLP

Seventh Circuit Rejects Extension of AKS to Marketing Companies Without Evidence of Intent to Induce Referrals

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The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more

Morgan Lewis

Seventh Circuit Overturns AKS Conviction in DME Marketing Case

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The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more

King & Spalding

Seventh Circuit Reverses AKS Conviction Involving Payments to Marketers and DME Manufacturer

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On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

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The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

Foley Hoag LLP

Product Liability Update - January 2023

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MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more

Nutter McClennen & Fish LLP

Product Liability 2021 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Harris Beach Murtha PLLC

Circumstantial Evidence Ruled Not Enough in Case Against Medical Device Manufacturer

Frederick (Rick) Fern and the New York City Harris Beach Life Science Practice Group were successful in securing a summary judgment for medical device manufacturers Curlin Medical Inc., Moog Inc., and distributor B. Braun...more

Cozen O'Connor

Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices

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The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are...more

Knobbe Martens

Medical Device Manufacturers’ Duty to Warn Expands

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The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more

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