News & Analysis as of

Fraud 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. 
ArentFox Schiff

Investigations Newsletter: DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to...

ArentFox Schiff on

DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more

ArentFox Schiff

Investigations Newsletters: Georgia Laboratory Owner Pleads Guilty to Felony Anti-Kickback Statute Violations

ArentFox Schiff on

Georgia Laboratory Owner Pleads Guilty to Felony Anti-Kickback Statute Violations - On February 28, the US Department of Justice (DOJ) announced the guilty plea of Andrew Maloney, who, along with his clinical laboratory...more

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...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

MoFo Life Sciences

Prevent A Clinical Trial From Turning Into A Criminal Trial

MoFo Life Sciences on

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

Farrell Fritz, P.C.

Herbal COVID Remedy Is Not The Government’s Cup of Tea

Farrell Fritz, P.C. on

Last week, the EDNY and the DOJ Consumer Protection Branch brought a civil enforcement action against defendants who manufacture and sell an herbal tea product called B4B Earth Tea Extra Strength (“Earth Tea”).  Earth Tea...more

Mintz - Health Care Viewpoints

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...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

ArentFox Schiff

Investigations Newsletter: HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute

ArentFox Schiff on

HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute - On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more

ArentFox Schiff

Investigations Newsletter: Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and...

ArentFox Schiff on

Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family - On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...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

Foley Hoag LLP - White Collar Law &...

First Circuit's New England Compounding Center Decisions Illustrate Reach of Federal Criminal Law

In 2012, New England Compounding Center (“NECC”) shipped contaminated anti-pain medication to hospitals and clinics around the country, with devastating consequences. Patients around the country developed fungal meningitis...more

Morrison & Foerster LLP - Class Dismissed

FDA And FTC Send Warning Letters To Companies Marketing Products To Treat Coronavirus; State Attorneys General Follow Suit

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more

Rivkin Radler LLP

FTC and FDA Take Joint Action to Stop COVID-19 Fraud

Rivkin Radler LLP on

On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more

King & Spalding

Eleventh Circuit Rules That the Mere Purchase of Dietary Supplements Allegedly Sold in Violation of the FDCA Is Sufficient, by...

King & Spalding on

A recent Eleventh Circuit decision took a broad view of what type of economic injury is sufficient to confer Article III standing, concluding that two dietary supplement companies’ alleged violations of a federal statute...more

Nutter McClennen & Fish LLP

Product Liability: 2017 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2017. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

Proskauer - Advertising Law

When the Strength of the Facts Cannot be Lifted – SDNY Dismisses Muscle Maker Slack-Fill Class Action

The Southern District of New York recently dismissed a putative class action against Cytosport, the maker of Muscle Milk protein powder. The plaintiff, Orlando Bautista, alleged that he bought a container of Muscle Milk...more

Mintz - Health Care Viewpoints

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

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

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

23 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide