News & Analysis as of

Deferred Prosecution Agreements Qui Tam

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

The Volkov Law Group

Raytheon’s False Claims Act Settlement (Part IV of IV)

The Volkov Law Group on

The Justice Department’s global settlement included a significant False Claims Act resolution, resulting in a second deferred prosecution agreement (“DPA”) for a three-year term. A criminal information was filed in the...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: Investment Bank To Pay Over $130 Million To Resolve Foreign Corrupt Practices Act and Fraud Allegations

ArentFox Schiff on

Deutsche Bank to Pay Over $130 Million to Resolve Foreign Corrupt Practices Act and Fraud Allegations - Deutsche Bank Aktiengesellschaft (Deutsche Bank) has agreed to pay more than $130 million to resolve the government’s...more

ArentFox Schiff

Investigations Newsletter: Health Information Technology Developer to Pay $145 Million to Resolve Kickback Allegations

ArentFox Schiff on

In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Mintz - Health Care Viewpoints

Insys Bankruptcy Filing Immediately After Global Settlement Triggers Powerful Remedies

Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more

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