News & Analysis as of September 10, 2025

Food and Drug Administration (FDA)

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Seventh Circuit Affirms Dismissal of FCA Retaliation Suit Against AbbVie for Alleged Off-Label Promotion

ArentFox Schiff on 9/9/2025

The Seventh Circuit affirmed the dismissal of a False Claims Act (FCA) retaliation suit against AbbVie Inc. (formerly Allergan) brought by former sales representative Jeffrey Lewis. In the complaint, Lewis alleged he was...more

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

Orrick, Herrington & Sutcliffe LLP on 4/27/2022

In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Skadden, Arps, Slate, Meagher & Flom LLP on 9/9/2021

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

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

Skadden, Arps, Slate, Meagher & Flom LLP on 9/28/2017

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

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Whistleblowers › Deferred Prosecution Agreements › Food and Drug Administration (FDA)

Seventh Circuit Affirms Dismissal of FCA Retaliation Suit Against AbbVie for Alleged Off-Label Promotion

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

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

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