News & Analysis as of

Medical Devices Federal Contractors

Morrison & Foerster LLP

DOJ Releases False Claims Act Statistics for Fiscal Year 2022

On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more

Dorsey & Whitney LLP

Eighth Circuit Analyzes Scope of FCA Liability Under Anti-Kickback Statute

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​​​​​​​On July 26, 2022, the Eighth Circuit Court of Appeals issued an opinion interpreting the standard for the causal link the government must show to establish that a “false or fraudulent” claim under the False Claims Act...more

Console and Associates, P.C.

Final Bellwether 3M Earplug Trial Ends at $77.5 M Verdict.

A federal jury in Florida awarded $77.5 million in damages, including $72.5 million in punitive damages, to a former soldier who filed a claim alleging that his hearing loss resulted from defective 3M Co. earplugs. The case...more

Foley Hoag LLP - White Collar Law &...

Health Care Enforcement – A Look Ahead

This is the first post in this year’s series examining important trends in white collar law and investigations. Join us in the weeks ahead as we provide updates on new developments and emerging trends in a number of white...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 21

Nature of Patents and Patent Rights - When a patent is issued under the seal of the United States Patent and Trademark Office, it is signed by the Director of the USPTO or an Office official. The patent contains a grant...more

Console and Associates, P.C.

3M Earplug Lawsuit Update 2021: $1.7M Award

Jury Awards Veteran With Hearing Loss $1.7 Million in Third Bellwether Trial - A Florida jury’s $1.7 million judgment in favor of the plaintiff on June 18, 2021, handed The 3M Company its second defeat in bellwether trials...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – August 2020 # 11

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In Washington - House Speaker Nancy Pelosi (D-CA) is calling Democrats back from the August recess to vote on legislation that would prohibit operational changes at the U.S. Postal Service that could curtail mail-in...more

McDermott Will & Emery

August 13, 2020, Deadline for Healthcare Providers and Life Sciences Federal Contractors: Ban on Use of Certain Chinese...

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Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more

The Volkov Law Group

Drug and Medical Device Fraud Risks Increase in Pandemic Era

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The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in...more

Fox Rothschild LLP

North Carolina Law Provides Limited Immunity To Certain Businesses Against COVID-19 Contraction Claims

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While it is no silver bullet, North Carolina’s new pandemic aid legislation (Session Law 2020-3) includes helpful liability limitations for certain businesses faced with claims by employees, customers and users of personal...more

Hogan Lovells

Trump invokes Defense Production Act to block exports of Personal Protective Equipment

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With reports of widespread shortages of personal protective equipment (PPE) and ventilators and the COVID-19 pandemic continuing to expand nationwide, the Trump Administration has turned to the Defense Production Act (DPA) –...more

Seyfarth Shaw LLP

Federal Government Adopts New Process for States and Tribes to Request Ventilators from the Limited Federal Supply

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On April 1, 2020, a FEMA advisory issued that announced a new, more formalized process for distributing the limited available supply of ventilators to states and tribes.  The federal government’s supply of available...more

Sheppard Mullin Richter & Hampton LLP

Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths

On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this...more

Pillsbury - Internet & Social Media Law Blog

Keep an Eye on the Bayh-Dole Act in Regard to COVID-19-Relevant Patents

While companies in every industry are working hard to figure out the best response to this global pandemic, those in the pharmaceutical and medical device industries have been faced with some unique challenges related to the...more

Fox Rothschild LLP

Does The Defense Production Act Shield Manufacturers From Patent Infringement Risk?

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An Executive Order from President Trump that referred to the Defense Production Act has some manufacturers asking: are we now shielded from patent infringement liability if we produce otherwise-patented protective equipment...more

Hogan Lovells

To fight COVID-19, emergency Federal contracting tools streamline medical device, drug acquisition

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Government needs are expanding rapidly and we expect they will continue to do so throughout this pandemic. Solicitations for products, services, and research and development efforts can be found at beta.SAM.gov using the...more

Seyfarth Shaw LLP

New Federal Contract Reporting Requirements Aimed at Protecting Supply Chains Through Detection of Counterfeit Parts

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Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more

Stinson - Government Contracting Matters

Final FAR Rule Mandating GIDEP Reporting of Actual or Suspected Counterfeit Parts Issued: More Questions Than Answers

Supply chain risks are on the rise. Protecting the supply chain is a critical aspect of our national security, health and public safety. Whether parts are electronic or not, if they aren’t what they are represented to be,...more

Robins Kaplan LLP

Financial Daily Dose 11.15.2019 | Top Story: New Jersey Targets Uber Over “Independent Contractor” Worker Classification

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Sending a shot across the bow of the gig economy, New Jersey is seeking nearly $650 million from Uber for “years of unpaid employment taxes for its drivers, arguing that the ride-hailing company has misclassified the workers...more

ArentFox Schiff

Investigations Newsletter - Medical Device Exec Sentenced to 42 Months in Prison for $4.6 Million Kickback Scheme, Co-Conspirator...

ArentFox Schiff on

Medical Device Exec Sentenced to 42 Months in Prison for $4.6 Million Kickback Scheme, Co-Conspirator Awaits Sentencing - On August 29, the Department of Justice announced that a Tennessee health care executive, Brenda...more

Obermayer Rebmann Maxwell & Hippel LLP

Supreme Court Punts on False Claims Act Specificity Requirement

Last week the Supreme Court of the United States rejected a petition for a writ of certiorari in Medical Device Business Services, Inc. et al. v. United States ex rel. Nagrol et al. In this case, the petitioner asked the...more

Baker Donelson

Washington, D.C. Update – December 2016

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With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more

King & Spalding

Universal Health Services v. Escobar

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On Thursday of last week, the Supreme Court for the first time addressed the “implied certification” theory of liability under the False Claims Act. The Court ruled unanimously that the theory is valid in certain...more

Carlton Fields

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

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The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

The Volkov Law Group

The FCPA Year in Review: Twist and Shout (Part I of II)

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We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

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