News & Analysis as of

Fraud Pharmaceutical Industry Prescription Drugs

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Cozen O'Connor

Weighty Penalty for Bootleg GLP-1 Drug Sales

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Connecticut AG William Tong announced a settlement with Triggered Brand following allegations that the company unlawfully advertised and sold counterfeit GLP-1 weight loss drugs in violation of state consumer protection laws....more

Cozen O'Connor

The State AG Report – 07.17.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more

Husch Blackwell LLP

False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement

Husch Blackwell LLP on

Host Jonathan Porter welcomes back to the show Husch Blackwell attorney Abe Souza to discuss False Claims Act (FCA) enforcement in the pharmacy context. Pharmacies face multiple pressures, from disruptive online enterprises...more

Troutman Pepper Locke

Connecticut AG Pursuing Companies for Allegedly Selling Unlawful Weight Loss Drugs

Troutman Pepper Locke on

Connecticut Attorney General (AG) William Tong has taken legal action against two online distributors, Triggered Brand and Made In China, for allegedly selling research-grade GLP-1 weight loss drugs directly to Connecticut...more

Arnall Golden Gregory LLP

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

Polsinelli on

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Quarles & Brady LLP

“It’s Okay, These Products Aren’t Paid for by Medicare” – Think Again

Quarles & Brady LLP on

A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Polsinelli

SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

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On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding...more

Bradley Arant Boult Cummings LLP

SuperValu: Supreme Court Clarifies FCA’s State-of-Mind Requirement

On June 1, 2023, in U.S. ex rel. Schutte v. SuperValu Inc., the Supreme Court clarified the state-of-mind (or “scienter”) standard under the False Claims Act (FCA), holding that a defendant’s subjective belief that a claim...more

McDermott Will & Schulte

SuperValu: It’s Not Super Bad! A Practical Look at the Supreme Court’s Recent FCA Scienter Ruling

Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the pharmacies could defeat these...more

Skadden, Arps, Slate, Meagher & Flom LLP

Supreme Court Clarifies False Claims Act Scienter Element in Schutte

On June 1, 2023, the U.S. Supreme Court issued its highly anticipated decision in the consolidated cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc., Nos. 21-1326 &...more

Patterson Belknap Webb & Tyler LLP

Supreme Court Rejects Objective Standard for Scienter for False Claims Act

On June 1, 2023, the United States Supreme Court decided two consolidated cases, United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, 589 U.S. ___ (2023), holding that a defendant’s...more

Venable LLP

Yes, Contractors and Providers, What You Think Matters - U.S. Supreme Court Unanimously Holds That Defendants' Subjective Beliefs...

Venable LLP on

On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in United States ex rel. Schutte v. SuperValu Inc. reversing a pair of False Claims Act (FCA) cases on review from the Seventh Circuit Court of Appeals. In...more

Foley Hoag LLP - White Collar Law &...

Supreme Court Rejects “Objectively Reasonable” Defense to False Claims Act Liability

The SuperValu case arose from separate lawsuits against two companies that operate retail drug pharmacies across the country: SuperValu Inc. and Safeway, Inc. In each case, a whistleblower – on behalf of the federal...more

Perkins Coie

US Supreme Court Clarifies Knowledge Requirement in False Claims Act Cases—Raising New Interpretive Issues

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A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more

Zuckerman Spaeder LLP

Part III | SCOTUS Ruling: “Knowing” Violations of Unknowable Rules: Is the Supreme Court Poised to Alter the FCA Enforcement...

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For background on this case, please refer to Part I. For updates from the Supreme Court oral arguments on April 18, please refer to Part II. On Thursday, June 1, the Supreme Court issued its opinion in United States et al....more

ArentFox Schiff

Supreme Court FCA Scienter Ruling Revives Fraud Lawsuits Against Safeway and SuperValu

ArentFox Schiff on

Supreme Court FCA Scienter Ruling Revives Fraud Lawsuits Against Safeway and SuperValu On Thursday, the US Supreme Court issued its highly anticipated ruling regarding the threshold of liability under the False Claims Act...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Clarifies that Subjective (Not Objective) Knowledge of Falsity of Claim Dictates False Claims Act Liability

On June 1, 2023, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway....more

Zuckerman Spaeder LLP

Part II - April 18 Oral Argument: “Knowing” Violations of Unknowable Rules: Is the Supreme Court Poised to Alter the FCA...

Zuckerman Spaeder LLP on

On April 18, 2023, the Supreme Court heard oral arguments in United States ex rel. Schutte v. Supervalu Inc., 9 F.4th 455, 459 (7th Cir. 2021) and United States ex rel. Proctor v. Safeway, Inc., 30 F.4th 649 (7th Cir. 2022)...more

Polsinelli

SCOTUS Appears Poised To Reject Defense-Friendly Safeco Scienter Standard In FCA Cases

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On April 18, 2023, the Supreme Court of the United States (SCOTUS) heard oral arguments in a pair of monumental False Claims Act (FCA) cases to decide whether and when a defendant’s subjective understanding of an objectively...more

Rivkin Radler LLP

Fraud Week: Unlucky Pharmacist

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Rivkin Rounds’ first annual Fraud Week kicks off with kickbacks. The U.S. Department of Justice (DOJ) recently announced that the owner of Boerne Drug in Boerne, Texas was indicted on conspiracy charges for his role in an...more

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