News & Analysis as of

Fraud Food and Drug Administration (FDA)

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

NAVEX

A Look at the Whistleblowers Who Made Lasting Impacts

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As seen in the previous article, whistleblowing cases regularly make the news headlines. And while some of the names of the reporters or the cases are well known, it’s worthwhile to take a closer look at the people behind the...more

American Conference Institute (ACI)

[Event] 12th Annual Forum on Dietary Supplements - June 25th - 26th, New York, NY

ACI and CRN are excited to welcome you back to New York City this Spring for our 12th Legal, Regulatory & Compliance Forum on Dietary Supplements. Network and collaborate with over 150 industry stakeholders to explore how...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Dechert LLP

Dechert Re:Torts - Issue 14

Dechert LLP on

A Prescription for Liability: Michigan Repeals Flagship Drug Immunity Law - Michigan’s recent repeal of immunity provisions under its Product Liability Act has potentially significant implications for pharmaceutical...more

Dechert LLP

Developments in Securities Fraud Class Actions Against U.S. Life Sciences Companies

Dechert LLP on

Last year marked an increase in federal securities class action filings, with plaintiffs filing 212 cases in 2023, up from 197 in 2022 and ending an overall decline in filings since 2019. Life sciences companies remained...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Knobbe Martens

FDA Issues Warning about Fraudulent and Unreliable Laboratory Data

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The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more

ArentFox Schiff

Investigations Newsletter: Ultragenyx to Pay $6 Million To Settle False Claims Act Case

ArentFox Schiff on

Ultragenyx to Pay $6 Million To Settle False Claims Act Case - Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). Ultragenyx manufactures a...more

ArentFox Schiff

Investigations Newsletter: Two Individuals Indicted for Operating $25 Million Crypto-Fraud

ArentFox Schiff on

Two Individuals Indicted for Operating $25 Million Crypto-Fraud - On December 11, a federal court in California unsealed a superseding indictment, which charged two men with operating a $25 million cryptocurrency fraud...more

Foley & Lardner LLP

Remote Patient Monitoring: OIG Issues Consumer Alert

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On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public about a fraud scheme involving monthly billing for remote...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 11

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A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more

American Conference Institute (ACI)

[Event] 11th Legal, Regulatory & Compliance Forum on Dietary Supplements - June 28th - 29th, New York, NY

ACI and CRN are excited to welcome you back to New York City this Spring for the 11th Legal, Regulatory & Compliance Forum on Dietary Supplements. Since last year, there have been numerous important developments...more

Perkins Coie

Weekly Notable Ruling Roundup - June 2023

Perkins Coie on

Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. - Felix Bermudez et al. v. Colgate-Palmolive Company, No. 1:21-cv-10988-JLR (S.D.N.Y. – March...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

BakerHostetler

Note of Caution to Compounding Pharmacies

BakerHostetler on

Key Takeaways: ..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012. ..Individuals face criminal liability for misrepresentations made to FDA. ...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

Gardner Law

Anti-Fraud & Sunshine Update

Gardner Law on

Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more

ArentFox Schiff

Investigations Newsletter: DOJ Indicts 47 Individuals in Largest COVID-19 Fraud Scheme To Date

ArentFox Schiff on

DOJ Indicts 47 Individuals in Largest COVID-19 Fraud Scheme To Date - On September 20, 2022, the US Department of Justice (“DOJ”) announced federal criminal charges against 47 defendants from the nonprofit, Feeding Our...more

Benesch

Dialysis & Nephrology Digest - August 2022

Benesch on

DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more

Snell & Wilmer

Supreme Court Clarifies That Medical Providers Cannot Be Convicted Of Illegal Drug Distribution If Prosecutors Do Not Prove the...

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In Justice Breyer’s final opinion from the bench in a 9-0 decision, the United States Supreme Court clarified that for a physician to be criminally convicted of distributing a controlled substance, the Department of Justice...more

King & Spalding

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

King & Spalding on

On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

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