News & Analysis as of

Whistleblowers Federal Food Drug and Cosmetic Act (FFDCA)

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

DarrowEverett LLP

The DOJ’s New White-Collar Agenda: Implications for Businesses

DarrowEverett LLP on

On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more

Foley & Lardner LLP

Snackable: Food & Beverage Review

Foley & Lardner LLP on

We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings. The past two years have seen significant changes...more

Skadden, Arps, Slate, Meagher & Flom LLP

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more

ArentFox Schiff

Investigations Newsletter: DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008

ArentFox Schiff on

DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more

Skadden, Arps, Slate, Meagher & Flom LLP

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

Seyfarth Shaw LLP

New Food Safety Whistleblower Regulations: OSHA Bites Off More Than It Can Chew

Seyfarth Shaw LLP on

Seyfarth Synopis: Employers may face liability for retaliation charges from employees who report food safety issues under the Food Safety Modernization Act (FSMA). Employers in the food industry have a new headache to...more

Dorsey & Whitney LLP

Quirky Question #257, Food for thought – whistleblowing claims against agricultural companies

Dorsey & Whitney LLP on

You are right to be concerned. Under the FDA Food Safety Modernization Act (FSMA), employees who work for entities engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or...more

Polsinelli

For Whom the Whistle Blows

Polsinelli on

In This Issue: - Applicability and Protected Activity - Procedure Governing Section 402 Claims - Five Steps to Compliance - For More Information - Excerpt from Applicability and Protected...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

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