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Judicial Authority Pharmaceutical Industry Statutory Interpretation

Dinsmore & Shohl LLP

D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models

Dinsmore & Shohl LLP on

Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the...more

McDermott Will & Schulte

No Article III Appellate Standing Under the Sun

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final...more

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

Goodwin

First Circuit Adopts Defense-Friendly “But-For” Causation Standard for AKS-Predicated FCA Claims

Goodwin on

In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott Will & Schulte

Loper Bright and the 340B Statute

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

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