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Medical Devices › False Statements

Arnall Golden Gregory LLP

This is a Land of Confusion: FDA Issues Q&A Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

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In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more

Foley Hoag LLP

Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

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Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

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On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Vinson & Elkins LLP

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

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In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

Stradling Yocca Carlson & Rauth

Ninth Circuit Decision Makes it Harder for Plaintiffs to Plead Securities Fraud Claims Against Drug & Medical Device Companies

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On June 10, 2020, the Ninth Circuit, in Vicky Nguyen v. Endologix, Inc., et al., affirmed in a published decision the district court’s dismissal with prejudice of a putative securities fraud class action because plaintiff...more

Skadden, Arps, Slate, Meagher & Flom LLP

Hong Kong Regulatory Update - July 2020

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This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

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ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Dorsey & Whitney LLP

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

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Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims...more

Dorsey & Whitney LLP

DOJ Files FCA Complaint Against Recipient of Grant Funding

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The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

Knobbe Martens

Medtronic Settles Federal Lawsuit for $4.41 Million

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On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over...more

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