Subject: COVID-19

FTC Continues Crack Down on Unfounded COVID Claims

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Last month, the Federal Trade Commission (FTC) announced that it “ordered more than 20 marketers nationwide to immediately stop making baseless claims that their products and supposed therapies can treat or prevent COVID-19.” Like prior rounds of cease-and-desist demands, the letters warned that the alleged violators could be subjected to monetary penalties under the COVID-19 Consumer Protection Act, which Congress passed in 2020. Specifically, the letters warned that businesses engaging in a deceptive act or practice associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19 could be subjected to penalties of up to $43,792 per violation.

As the FTC points out, however, “there’s a key point that differentiates these Demands from the more than 400 letters that preceded them.” Namely, copies of the recent round of letters were also sent to the social media platforms used by the advertisers, including Facebook, Instagram, Twitter, YouTube, Etsy, LinkedIn, Shopify, and TikTok. The FTC found that nearly all of the marketers used social media to convey their claims, with many companies utilizing multiple platforms. A recent FTC analysis on the alleged role of social media platforms in the spread of disinformation related to COVID found that deceptive marketers are able to “extend[] the reach of their deceptive COVID claims by using major social media platforms.” The FTC observed that social media’s design helps scammers amplify their deceptive messages while also identifying users most likely to be receptive to those messages. It cautioned, “[b]ogus claims of miracle cures may be successful in attracting consumers’ eyeballs, but they can have devastating consequences for Americans who forgo needed treatment or part with hard-earned money in pursuit of false cures.”

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Circuits Split on CMS Vaccine Mandate, Highlighting “Great Significance” of Issue as It Heads to Supreme Court

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Three circuit court decisions issued in the past two weeks have considered the CMS vaccine mandate, bringing the issue – and similar vaccine mandate lawsuits – to the Supreme Court in the final weeks of the year. The CMS mandate generally requires that facilities certified to participate in Medicare or Medicaid ensure their staff are fully vaccinated against COVID unless the employee is exempt for medical or religious reasons. CMS issued the vaccine mandate on November 5, 2021. It went into effect immediately, with staff to be fully vaccinated by January 4, 2022.

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Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

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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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Defense “Victory” Against Employee’s Spouse in COVID-19 Exposure Case

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On May 7, a California District Court Judge granted Victory Woodworks, Inc.’s (“Victory”) motion to dismiss all COVID-19 liability claims in plaintiffs Robert and Corby Kuciemba’s amended complaint. Kuciemba et al. v. Victory Woodworks Inc., No. 3:20-cv-09355 (N.D. Cal. 2020). Relying on a novel theory of liability, the Kuciembas alleged that Mr. Kuciemba contracted mild COVID-19 in the course and scope of his employment at Victory, and subsequently passed it on to his wife, who suffered a severe case of COVID-19 with lasting injury. The Kuciembas sought damages from Victory for Mrs. Kuciemba’s injuries related to COVID-19.

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Preparing for In-Person Trials in the PCCP during COVID

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In March 2021, the Philadelphia Court of Common Pleas (“PCCP”) released its Protocols and Guidelines for conducting in-person civil jury trials during the COVID-19 pandemic (the “Protocols”). To curb the spread of COVID-19, the Protocols outline several precautions, including mask requirements, enforced social distancing, reduced capacity, strategically placed Plexiglass, and the use of streaming technology. Now, over two months later, more Americans are fully vaccinated and the Centers for Disease Control and Prevention (“CDC”) recently stated that fully vaccinated individuals may forgo wearing masks indoors and outdoors. However, the Protocols currently remain intact. While the Commonwealth of Pennsylvania often has stated that it would follow the CDC’s most recent masking guidelines, Philadelphia has often been more restrictive than the rest of the state. Regardless, it remains unclear what impact the CDC’s guidelines will have on future civil jury trials in the PCCP. Therefore, when preparing for trial in the PCCP, attorneys must familiarize themselves with the Protocols. Below are highlights from the Protocols which attorneys should consider when preparing for trial in the PCCP.

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FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

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As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food and Drug Administration (FDA) updated its “Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency,” providing specific recommendations for ongoing or upcoming clinic trial activities.

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