News & Analysis as of

Statutory Violations Pharmaceutical Industry

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

Troutman Pepper Locke

Illinois and Minnesota AGs Join FTC’s Lawsuit Against Private Equity Firm

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Illinois Attorney General (AG) Kwame Raoul and Minnesota AG Keith Ellison have joined the Federal Trade Commission (FTC) in a lawsuit to block the acquisition of Surmodics Inc. by GTCR BC Holdings LLC, two major manufacturers...more

Polsinelli

Supreme Court Declines to Hear “Willfulness” Case

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On Monday, October 7, 2024, the U.S. Supreme Court declined to consider a petition for certiorari in United States ex rel. Hart v. McKesson Corp., Case No. 23-1293, where relator, Adam Hart (“Relator”), sought review of a...more

Stikeman Elliott LLP

Palmer v. Teva Canada Ltd.: Court of Appeal Confirms No Compensation for Risk “In the Air”

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In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more

The Volkov Law Group

BioTek, its CEO, Chaitanya Gadde, and Physician, Dr. David Tabby, Agreed to Pay $20 Million to Resolve Anti-Kickback Violations

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The reach of the Anti-Kickback Statute and the False Claims Act is broad.  As a result, AKS liability is a real and significant risk for healthcare companies and providers. Healthcare companies and providers have to resolve...more

Troutman Pepper Locke

FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a...

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The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more

Akerman LLP - Health Law Rx

State Attorneys General Flex in a Post-Dobbs world – can complying with federal regulatory guidance constitute racketeering...

Are State Attorneys General expanding their reach in this Post-Dobbs world? On February 1, 2023, twenty state Attorneys General signed letters to both CVS and Walgreens warning the giant retail pharmacies against mailing...more

Quarles & Brady LLP

High Court Rules “State of Mind” Relevant in Prosecuting Prescribers under the Controlled Substance Act

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Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more

Hogan Lovells

First company receives FDA violation notice for ClinicalTrials.gov submission omission

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On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more

Troutman Pepper Locke

Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

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Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more

Bricker Graydon LLP

EHR vendor Practice Fusion agrees to $145 million settlement to resolve criminal and civil kickback violations

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On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more

Seyfarth Shaw LLP

5 Key Trends In Workplace Class Action Litigation For 2019: Trend #2 The Impact Of U.S. Supreme Court Rulings

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Seyfarth Synopsis: The second key trend from our 16th Annual Workplace Class Action Litigation Report involves rulings by the U.S. Supreme Court. Over the past few years, the Supreme Court has issued a number of rulings that...more

The Volkov Law Group

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

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Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more

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