News & Analysis as of

Medical Devices Suppliers

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2023

On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...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

Jackson Lewis P.C.

Indiana Enacts COVID-19 Liability Shield For Hoosier Businesses

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In an effort to stimulate safe reopening of the economy and protect companies acting in good faith, Indiana has enacted a COVID-19 immunity shield. Governor Eric Holcomb signed Indiana Senate Bill 1, “Immunity Related to...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at The Ninth: FCRA Dicta and Medicare Channeling

This week, we examine two decisions confronting novel procedural issues. In the first, the Ninth Circuit sought to promote development of the law by encouraging courts to alter how they address claims under the Fair Credit...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

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On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Morgan Lewis

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

Morgan Lewis on

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Emergency Use Authorization for Ventilators, Tubing Connectors and Accessories

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more

Hogan Lovells

FDA moves to increase ventilator supply

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Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020,...more

Hogan Lovells

NHS medicine and device suppliers urged to carry out supply chain coronavirus risk assessment

Hogan Lovells on

At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

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When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...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

Baker Donelson

OIG Work Plan – October 2019 Update

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The OIG updates its Work Plan monthly to identify audits and evaluations that are underway or proposed by the OIG's Office of Audit Services and Office of Evaluation and Inspections. The October 2019 update identifies new...more

Carlton Fields

Court Refuses to Treat Unopposed Petition to Confirm Arbitration Award as a Motion for Default Judgment, Reviews the Merits of the...

Carlton Fields on

The case involved an AAA arbitration centering on the lack of performance under an exclusive distributorship agreement (EDA) that a medical supplier signed with a product manufacturer. The supplier failed to order sufficient...more

Farrell Fritz, P.C.

EDNY Decision Shows Breadth of Fraud Restitution Recoverable By Hospital For Mold-Contaminated Intravenous Bags

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A hospital victimized by the sale of adulterated and mislabeled drug products successful obtained a Court order imposing restitution of over $825,000 earlier this month. ...more

Bryan Cave Leighton Paisner

EU & Competition Law Update - March 2016

Welcome to March's edition of our EU & Competition Law Bulletin covering recent legal developments impacting upon you and your business: - ..United Kindgdom: Large pay for delay fine imposed by CMA. ..Germany and...more

King & Spalding

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

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The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

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