Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering food to taking the bus to work could be achieved and tracked through a simple app. During the pandemic, the reliance on electronic mediums went from preferable to necessary, as many businesses shut down and transitioned to a remote or online-only presence.

The escalation of the digital age has led some manufacturers to consider electronic warnings for their products, through the manufacturer’s website, by providing a QR code, or by recommending (or requiring) the consumer to download an app. Even the American National Standards Institute (ANSI) has bought into digital warnings. ANSI’s Z535 standards provide guidance for product manufacturers related to the size, content, and location of warnings. Recently, ANSI created a subcommittee on warnings in electronic media and is in the process of developing a new standard, ANSI Z535.7, for safety information in electronic media. This new standard is expected to be published by December 2022. The FDA has also recently utilized electronic means to communicate information regarding the COVID-19 vaccines. In October 2021, the FDA published three Consumer Fact Sheets for the three currently authorized vaccines on its website and included a QR Code linked to the “most recent” COVID-19 Vaccine Fact Sheets.

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Challenging Price Premium Allegations Can Pay Off for Defendants

Motions to dismiss in consumer fraud cases often focus on the element of deception—whether a reasonable consumer would be deceived by the statement or practice at issue. But there is another element of statutory consumer fraud claims that deserves closer scrutiny at the pleading stage—injury. Where plaintiffs claim that they were injured because they paid a “price premium” but do not allege facts to support that claim, defendants should consider moving to dismiss for failure to adequately plead injury.

State consumer protection statutes typically include injury as a required element for a private cause of action. New York General Business Law Sections 349 and 350, for example, require a plaintiff to establish that she purchased a product because of the allegedly deceptive business practice and did not receive the full value of the purchase. Similarly, plaintiffs suing under California’s Unfair Competition Law, False Advertising Law, or Consumer Legal Remedies Act must establish that they suffered an “economic injury” caused by the practice or advertising at issue.

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New Jersey Ethics Committee: Beware Marketers that “Lead” to Ethics Violations

Increasingly popular online “lead generation” services offering to connect attorneys with potential mass tort plaintiffs may expose counsel to ethics violations, the New Jersey Advisory Committee on Professional Conduct cautioned in two recent advisory opinions.

New Jersey attorneys are charged with the affirmative responsibility to “question whether the marketing company is improperly labeling its services,” the committee stated in a June 21, 2021 joint opinion with the Committee on Attorney Advertising.  On the same date, the Advisory Committee issued another joint opinion with the Committee on the Unauthorized Practice of Law offering further insight on the circumstances in which a permissible client lead becomes an improper for-profit referral.

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New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

Overview

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction to block the FDA from withdrawing a longstanding enforcement policy regarding homeopathic drug products.

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Cosmetics Companies: Beware of PFAS

It’s no secret that the regulatory landscape of cosmetics and personal care products as we know it is changing. Over the last few years, Congress, along with industry and consumer groups, have made a combined effort to push for heightened regulation of these products. The latest effort, introduced in Congress on June 15, 2021, seeks to ban the addition of per- and polyfluoroalkyl substances (generally known as “PFAS”) in cosmetics and personal care products.

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Summary of HB1125: Deceptive Lead Generation

Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous.  Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading as “medical alerts.”  Some estimates have total spending on legal advertisements at around $1 billion annually.  As a result, state legislatures are beginning to take action to combat deceptive advertising and come up with solutions, including in Indiana, which recently passed House Bill 1125.  House Bill 1125 places several limitations on the practice of lead generation – the use of commercial communications to initiate consumer interest or inquiry into legal services intended to redress an alleged injury from a medical device or legend drug – and provides a private right of action for manufacturers and sellers of medical devices and legend drugs against deceptive lead generators.

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