News & Analysis as of

Fraud › Medical Devices › Federal Food Drug and Cosmetic Act (FFDCA)

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

ArentFox Schiff

Investigations Newsletter: Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations

ArentFox Schiff on

Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations - On January 4, 2023, a criminal information was filed in the Southern District of Illinois, in which Jet Medical Inc. (Jet), a medical device...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

King & Spalding

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

King & Spalding on

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

Haug Partners LLP

Clarifying the Scope of the Parallel Claim Exception to Federal Regulatory Preemption of Medical Devices

Haug Partners LLP on

Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the...more

Mintz - Health Care Viewpoints

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Mintz - Health Care Viewpoints on

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

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