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Supreme Court of the United States › Department of Justice (DOJ) › 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 -
Arnall Golden Gregory LLP

HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group

Arnall Golden Gregory LLP on

In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S....more

A&O Shearman

Pharma Company Brings Latest Constitutional Challenge To False Claims Act In Third Circuit

A&O Shearman on

On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation - June 2025

Cozen O'Connor on

Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the most notable...more

Womble Bond Dickinson

For Whom the Bell Tolls? The Impact of Wisconsin Bell v. United States ex rel. Todd Heath and United States v. Regeneron...

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The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). ...more

Lowenstein Sandler LLP

Circuit Split Deepens on Anti-Kickback Statute’s Causation Standard

Lowenstein Sandler LLP on

Introduction: In its recent decision in United States v. Regeneron Pharmaceuticals, Inc., the United States Court of Appeals for the First Circuit deepened an existing federal circuit court split regarding the causation...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

Wiley Rein LLP

Wiley Consumer Protection Download (June 4, 2024)

Wiley Rein LLP on

Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

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Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Sheppard Mullin Richter & Hampton LLP

Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

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For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...more

Mintz - Antitrust Viewpoints

FTC and DOJ Antitrust Memorialize Joint Workshop on the Future of Antitrust Enforcement in the Pharmaceutical Industry

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The Federal Trade Commission, in coordination with the U.S. Department of Justice Antitrust Division, recently released a summary of the Agencies’ June 2022 joint workshop titled “The Future of Pharmaceuticals: Examining the...more

Jenner & Block

Government Contracts Legal Round-Up - May 2023 Issue 8

Jenner & Block on

Notable Headlines - False Claims Act - It used to be rare for the Supreme Court to hear False Claims Act cases. It’s a lot less rare now. On April 18, the Supreme Court heard argument concerning two Seventh Circuit...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter

Morrison & Foerster LLP on

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Oberheiden P.C.

U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals

Oberheiden P.C. on

On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Rules for Physicians in Blow to DOJ

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In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws...more

Fox Rothschild LLP

Enhanced Scrutiny of Opioid Prescriptions Poses Legal Risks for Medical Professionals

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The U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments For June 2020

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In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

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Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

WilmerHale

False Claims Act: 2019 Year-in-Review

WilmerHale on

The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

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On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

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This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

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This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Robins Kaplan LLP

Your Daily Dose of Financial News

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Drugmaker Gilead has kickstarted a largely quiet period for big pharma deals with the announcement that it’s acquiring Kite for about $11.9 billion. Kite Pharma’s best known for its emerging cancer treatments that focus on...more

Cadwalader, Wickersham & Taft LLP

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

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Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

Morrison & Foerster LLP

Top Ten International Anti-Corruption Developments for June 2016

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In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

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