FTC Continues Crack Down on Unfounded COVID Claims

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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The Rule 702 Toolbox: Proposed Amendments Seek to Reset the Application of FRE 702

Litigators! Substantive amendments have been proposed to Federal Rule of Evidence 702. The public comment period closes February 16.

Rule 702 was last amended substantively in 2000, soon after the concluding chapter in the Daubert trilogy, Kumho Tire. Those amendments were intended to reset the Rule based on the post-Daubert experience.

Lower courts had read snippets of language in Daubert through variable lenses, influenced by their level of enthusiasm or reluctance to keep flawed expert opinions from the jury. Though Daubert mandated rigorous gatekeeping, it also included Delphic comments about the “liberal thrust” of the federal rules (compared to the “rigid’ and “austere” Frye rule they replaced) and about the ability of the adversarial process to limit the impact of “shaky but admissible” evidence. Some courts misread these comments to limit the scope and depth of their gatekeeping obligation and adopted standards consistent with this vision.

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FDA Solicits Comments Prior to Regulating 3D Printing of Medical Devices at the Point of Care

Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have occurred within traditional manufacturing facilities. Over the past two years, however, supply chain disruption caused by the COVID-19 pandemic has created medical device shortages that have amplified the use of 3D printing technologies at the point of care. Indeed, healthcare providers have collaborated with 3D printing companies to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts within healthcare facilities. As 3D printing technologies improve and healthcare facilities innovate in the face of economic opportunities and pandemic-related challenges, the industry can expect increasing use of 3D printers within the healthcare setting. In turn, FDA is taking notice and has recently issued a paper to facilitate discussion about potential approaches to regulating 3D printed devices at the point of care.

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Eastern District of Virginia Denies Motion to Certify Class, Sheds Light on Rule 23(b)(3) Predominance and Superiority Requirements for Class Actions

The U.S. District Court for the Eastern District of Virginia analyzed Federal Rule of Civil Procedure 23(b)(3)’s predominance and superiority requirements for class actions in a recent decision denying a motion to certify a purported class of motor vehicle purchasers.  The decision underscores that plaintiffs seeking to certify classes asserting claims that will render the process of identifying class members to be a mere series of individualized inquiries will not pass muster under Rule 23.

The Facts in Dispute

Garcia, et al. v. Volkswagen Group of America, Inc., et al. involved a purported class of plaintiffs residing in multiple states who purchased vehicles manufactured by defendants within the last 14 years.  The plaintiffs sued a group of auto manufacturers alleging damages resulting from defendants’ alleged fraudulent misrepresentations about the vehicles, and asserting claims for violations of the Federal Odometer Act, fraud, breach of contract, and unjust enrichment, in addition to state law claims under the laws of California, Colorado, Florida, Illinois, New Jersey, and Washington.

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Let Me Google That for You: A Recent Central District of Illinois Opinion Highlights the Limits of Googling by Expert Witnesses Under Rule 702 and Daubert

While we all rely on Google or other internet search engines to find and absorb information quickly these days, a recent decision in the Central District of Illinois highlights the problems for expert witnesses relying on internet research as a methodology. See Sherman v. BNSF Railway Co., Case No. 1:17-cv-01192, 2022 WL 138630 (C.D. Ill. Jan. 14, 2022). While Googling is likely a practice that many experts may engage in (though may be loathe to admit it), Google searching alone is a suspect methodology upon which to base expert opinions.

In Sherman, Plaintiff sued Defendant BNSF Railway Co. (BNSF) pursuant to the Federal Employers’ Liability Act, alleging that during her employment with BNSF, she was exposed to toxic substances and carcinogens, including asbestos, that caused her to develop rectal cancer.

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Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care clinics for minor illnesses or simple-to-prescribe medications. The last two years shifted that race into high gear, particularly with new products and platforms being introduced that range from virtual clinic platforms that allow patients—and their programmable implanted medical devices—to connect with their providers from the comfort of their own homes, to passive smart devices that remotely monitor patient vital signs, analyze that data using proprietary algorithms, and evaluate whether a patient is having a medical emergency or needs to schedule an appointment with their provider. These technologies are now so ubiquitous that they are being showcased at the 2022 Consumer Electronics Show.

To be sure, regulatory changes in response to the COVID-19 pandemic made telemedicine more permissible—and reimbursable—than in the past. But that alone is not driving medical device companies forward. Instead, medical device manufacturers are rapidly developing smart or algorithm-driven medical devices that take advantage of the ever-increasing power of those technologies and leveraging telemedicine to make the remote treatment and management of medical conditions less complicated. A recent article in Nature’s npj Digital Medicine confirmed the growth in this area, counting 64 separate smart- or algorithm-driven medical devices currently on the market as of 2020. See Stan Benjamens, et al., The State of Artificial Intelligence-Based FDA-Approved Medical Devices and Algorithms: An Online Database, 3 npj Digital Medicine Article No. 118 (2020). Each of these new devices endeavor to enable physicians to practice more effectively and efficiently than they could before. The future for smart or algorithm-driven medical devices looks promising.

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