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False Advertising Medical Devices

King & Spalding

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

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On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

King & Spalding

2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

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In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices.  A summary of the noteworthy...more

Foley Hoag LLP

Product Liability Update - February 2021

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MASSACHUSETTS - Massachusetts Supreme Judicial Court Holds State Law Claims Against Manufacturer Of FDA-Approved Medical Device “Parallel” Federal Law Requirements And Hence Are Not Preempted Despite Failure To Identify...more

Cozen O'Connor

1st Amendment Win For Credit Card Surcharges| Texas Sues Over Electricity Bills | Dodgy COVID Fees

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2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more

Patterson Belknap Webb & Tyler LLP

In False Ad Dispute Between Inhaler Companies, Court Grants PI Enjoining Unsupportable Clinical Superiority Claims

In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a...more

Smart & Biggar

Summary of various COVID-19 measures instituted by Health Canada

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Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more

BakerHostetler

AD-ttorneys@law – July 2020 #1

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FTC (Not) Blinded by the Light - In a first, Commission goes after low-level light therapy device makers - Chic-Light -The Willow Curve is an attractive device with all the hallmarks of contemporary design. ...more

BCLP

FTC Deceptive Advertising Health Claims Settlement – Scientific Proof Required

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“Treats Chronic Pain… Clinically Proven… Smart Device… Approved by the FDA…” These are all claims the Federal Trade Commission (FTC) says defendants made advertising the Willow Curve, a low-level light therapy device  (LLLT),...more

Smart & Biggar

Canada cracks down on COVID-19 related product advertising claims

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COVID-19 has resulted in the launch of numerous new products, as well as numerous new claims about existing products. Products can be classified as drugs (including natural health products and hard surface disinfectants) or...more

Butler Snow LLP

Development of the Food & Drug Administration

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The Food & Drug Administration is perhaps the most important, ubiquitous agency in the daily lives of modern American consumers. Consumers rely on the FDA to verify the safety and effectiveness of $2.6 trillion in food,...more

Patterson Belknap Webb & Tyler LLP

Liability Immunity Under The PREP Act: A Potent New Defense Against COVID-Related False Advertising Claims

Our national response to the COVID-19 pandemic has been made more difficult by a shortage of personal protective equipment and lifesaving drugs and medical devices. Some evidence suggests that manufacturers’ fear of lawsuits...more

World Law Group

[Webinar] International Regulatory Initiatives Directing to Improving the Delivery of Healthcare in the Fight Against COVID-19 -...

World Law Group on

WLG has collaborated with members to present a series of meetings and workshops to connect and educate members during the month of May. The Life Sciences Group will host a webinar "International Regulatory Initiatives to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

Robins Kaplan LLP

Financial Daily Dose 1.31.2020 | Top Story: IBM CEO Ginni Rometty is Out After Eight Years at the Helm

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In a week that’s already seen plenty of C-suite shakeups, we’ve learned that Ginni Rometty is stepping down from her role as CEO at IBM. The company’s cloud computing chief, Arvind Krishna, will take over for her, though...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Holland & Knight LLP

Healthcare Law Update: October 2019

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In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - September 2019 #3

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Many cities in the United States utilize a self-pay portal for residents to pay bills online, known as Click2Gov. Click2Gov was compromised in 2017 and 2018, when hackers were able to access over 300,000 payment cards and...more

Jones Day

Italian Supreme Court Upholds Class Action Ruling on Misleading Advertising

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The Situation: On January 31, 2018, the Italian Supreme Court ruled on the first Italian product-related class action promoted by a consumers' association. The Result: The Court upheld the consumer's class action claim...more

Mintz - Health Care Viewpoints

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Mintz - Health Care Viewpoints

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Hogan Lovells

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

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The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Kramer Levin Naftalis & Frankel LLP

Advertising Litigation Report: Vol. 2, No. 2 - Lanham Act False Advertising

Summary Judgment Affirmed for Defendant in Lanham Act Challenge to Statements Concerning Popularity of Advertiser’s Product, Scarcity of Challenger’s Product: Verisign, Inc. v. XYZ.COM LLC, 848 F.3d 292 (4th Cir. 2017)...more

Proskauer - Advertising Law

Michigan District Court Won’t Hear Lanham Act Claim Against Tinnitus Treatment Certifier

Last week, we covered a summary judgment decision holding that posts on the “Science-Based Medicine” blog were not “commercial speech” under the Lanham Act, and therefore the defendant in that case was not liable for false...more

Holland & Knight LLP

Healthcare Law Update: December 2016

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Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Dorsey & Whitney LLP

In What Way is False Advertising False and Why it Makes a Difference

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What is the difference between an advertisement that is literally false by necessary implication and one that is impliedly false? It may seem like a fine (and somewhat opaque) distinction, but determining the particular way...more

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