News & Analysis as of

Fraud Life Sciences

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Morrison & Foerster LLP

DOJ and HHS Announce Formation of False Claims Act Working Group and Results of National Health Care Fraud Takedown

As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more

Skadden, Arps, Slate, Meagher & Flom LLP

Core False Claims Act Theories Top the List of DOJ Criminal Enforcement Priorities

The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New...more

Arnall Golden Gregory LLP

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

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

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Securities Enforcement

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eighth episode of When Your Life Sciences Are on the...more

Skadden, Arps, Slate, Meagher & Flom LLP

First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more

Arnall Golden Gregory LLP

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 9, November 2024

Welcome to our ninth 2024 issue of Decoded - our technology law insights e-newsletter. How are States Using Generative Artificial Intelligence? and Employee AI Adoption Cools Globally - Why this is important: As...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - October 2024

Ninth Circuit Affirms Dismissal of Insider Trading Claims Against Satellite Operator Investors Based on Stock Sales After FCC Chairman Vote - In re Silver Lake Grp., LLC Sec. Litig. (9th Cir. July 24, 2024) What to...more

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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

McDermott Will & Schulte

Rules of Evidence Require Weighing Relevance of Evidence Against Potential Prejudice

The US Court of Appeals for the First Circuit affirmed the exclusion of a drug patent in a medical malpractice case, finding that the highly technical language of the patent would more likely confuse a lay jury than be...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: December 2023

Report on Research Compliance 20, no. 12  (December 2023) Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 139: Adair Boroughs, U.S. Attorney for the District of...

Maynard Nexsen on

This week Matthew and Heather are excited to welcome the U.S. Attorney for the District of South Carolina, Adair Boroughs! With health care fraud and abuse cases receiving increased funding and attention from the government, ...more

Bradley Arant Boult Cummings LLP

Genetic Testing Fraud: A New Wave of Medicine, a New Wave of Enforcement Actions

Genetic testing is a burgeoning area of preventative and predictive medicine. Such testing enables greater insight into a patient's unique genetic makeup and, in turn, more tailored and individualized medical decisions....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

Fox Rothschild LLP

COVID-19 Fraud Enforcement Task Force Cracks Down on Pandemic-Related Fraud

Fox Rothschild LLP on

In May 2021, Attorney General Merrick Garland announced the creation of the COVID-19 Fraud Enforcement Task Force. The Task Force is comprised of more than a dozen federal agencies that are investigating and prosecuting...more

Goodwin

Whistleblower Lawyers Use False Claims Act to Target Private Equity Firms Invested In Healthcare and Life Sciences

Goodwin on

Recent developments demonstrate that sponsor-backed companies in the healthcare and life sciences sectors, and in some instances private equity firms and professionals, have entered a new era of heightened regulatory scrutiny...more

Knobbe Martens

Affordable Healthcare Solutions Pleads Guilty to Dealing in Non-FDA Approved Devices

Knobbe Martens on

The United States Department of Justice announced that Affordable Healthcare Solutions, LLC has pleaded guilty and was sentenced to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

Arnall Golden Gregory LLP

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook

On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more

Fox Rothschild LLP

Key Steps The Pharma And Bioscience Sectors Must Take Ahead Of Federal Scrutiny Of COVID-19 Relief Funding

Fox Rothschild LLP on

An unprecedented explosion of government investigation and enforcement is at hand as federal regulators focus their efforts on ferreting out any fraud or abuse of the $1 trillion in COVID-19 relief funding programs through...more

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