Morrison Foerster’s Class Dismissed blog provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class actions lawsuits and product liability issues that affect consumer-facing companies. Through Class Dismissed, attorneys from our nationally recognized Consumer Class Action and Products Liability practices offer a real-time assessment of the developments in matters that are shaping the industry. This blog examines the full spectrum of consumer-related class action and product liability lawsuits ranging from false advertising, privacy, consumer product safety, ADA, food misbranding, TCPA, environment, retail, and government actions as well as nationwide and multidistrict litigation class actions.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Partner

Adam Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.

Adam Hunt

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.Alexandra has significant trial experience. She has first-chaired a one-week jury trial and second-chaired a five‑week jury trial, both involving multiple claims and witnesses. She also has extensive experience in alternative dispute resolution, representing clients at mediations, mandatory settlement conferences, and early neutral evaluations.Alexandra enjoys tracking developments and keeping her clients updated on product liability and personal injury claims, frequently writing or presenting on emerging areas such as autonomous vehicles and smart devices. Alexandra’s experience also extends to professional liability, warranty claims, eminent domain, and construction law.Alexandra earned her J.D. from the University of San Diego School of Law. While in law school, the San Diego Law Review published her comment on the recovery of damages by plaintiffs in a persistent vegetative state, and she also served as a comment editor. She received her B.A. from the University of California, Los Angeles, where she majored in Political Science and minored in Spanish. A San Diego native, she attended a Spanish immersion school through the eighth grade. Alexandra is active in the San Diego community, advising students at a local college. She is also a member of several legal organizations in San Diego, including Lawyer’s Club, the Association of Business Trial Lawyers, and Wallace Inn of Court.

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Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra’s litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, automobiles, AI, and robotics. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow

<div class="videoWrapper"><iframe frameborder="0" class="sticky-video" allowfullscreen="1" title="Meet Penny Preovolos, Litigation Partner" src="https://www.youtube-nocookie.com/embed/hv7hYn-Bl7c?rel=0&showinfo=0;vq=hd1080" title="iframe"></iframe></div>Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products. According to Chambers USA, Penelope has a “great reputation for antitrust and product liability work” and is a “superb all-around antitrust lawyer.”Penelope was named the 2019 Antitrust Lawyer of the Year by the Antitrust, UCL, and Privacy Section of the California Lawyers Association. She was co-chair of MoFo’s antitrust practice for 14 years. She has served as chair of the Antitrust and Trade Regulation Section of the State Bar of California and as a member of the Ninth Circuit Advisory Committee on Local Rules and Operations. She is an editor of and frequent contributor to Morrison & Foerster’s <a href="https://classdismissed.mofo.com/">Class Dismissed blog</a>, as well as a frequent speaker about class action and antitrust issues.More About PenelopePenelope clerked for the Honorable Charles M. Merrill, United States Court of Appeals for the Ninth Circuit. She graduated cum laude from Harvard Law School, where she was executive editor of the Harvard Civil Rights – Civil Liberties Law Review. Penelope was a member of Phi Beta Kappa at the University of California, Berkeley. She was awarded the University Medal, the highest undergraduate honor at the university, as well as the English Departmental Citation (awarded to the outstanding graduate in that department).

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Senior Counsel

Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products.

Penelope A. Preovolos

Zak is an associate in the Litigation Department in Morrison Foerster’s New York office.Zak’s practice focuses on class actions, commercial litigation, white collar defense, government investigations, and antitrust litigation and counseling. He has represented clients before federal and state courts in complex commercial matters, as well as in arbitration tribunals.Zak received his J.D. from New York University School of Law in 2018, where he was inducted into the Order of the Barristers. During law school, Zak also served as the Marden executive editor for the NYU Law Moot Court Board. In 2013, Zak received his B.A. and M.A. in political science from Yale University, receiving honors in his major and the Ellsworth Prize for Best Senior Essay in the Social Sciences.

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Associate

Zak Newman

Mitchell A. Hokanson is an associate in the Litigation Department of Morrison Foerster’s San Diego office.Mitchell’s practice focuses on commercial litigation and consumer class actions. He has extensive experience with civil litigation, including managing day-to-day strategy, propounding and responding to discovery, taking and defending depositions, and engaging in motion practice. He also has experience providing regulatory advice to clients, including pro bono partners and multinational corporations. Mitchell maintains an active pro bono practice.After law school, Mitchell worked as a judicial clerk for Justice Susan M. Carney of the Alaska Supreme Court, where he drafted bench memoranda and opinions on a wide range of state and federal law topics. Prior to joining MoFo, Mitchell worked for another international law firm, where he was a member of the Complex Civil Litigation practice group, in Los Angeles, California.Mitchell received his J.D. from Columbia Law School, where he was honored as a James Kent Scholar and Harlan Fiske Stone Scholar. While in law school he was the senior executive editor of the Columbia Journal of Environmental Law and worked as a judicial intern for Judge Sandra S. Ikuta of the United States Court of Appeals for the Ninth Circuit and Judge George B. Daniels of the United States District Court, Southern District of New York. Prior to that, Mitchell earned his B.A. from Stanford University.

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Mitchell Hokanson

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Morrison Foerster’s Class Dismissed blog provides insights and reports on the latest news, developments, and trends that affect consumer-facing companies. Subscribe to receive the latest updates by attorneys from our nationally recognized Consumer Class Action and Product Liability practices.

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Software Gains New Status as a Product Under Strict Liability Law

MAHA Commission Publishes Report to Highlight Childhood Chronic Disease Drivers

Tenth Circuit Denies Challenge to CPSC Rule Regulating High-Powered Magnets

Ousted CPSC Democrats Fight Back Against President Trump

Setting Consumer Standards for Lithium-Ion Batteries Act

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How close a connection does there need to be between a lawsuit and the defendant’s in-state activities for specific personal jurisdiction to apply? The Supreme Court issued a decision on that issue today in Ford Motor Co. v. Montana Eighth Judicial District Court and Ford Motor Co. v. Bandemer. The Court held the connection here was close enough: These were product-liability suits in which Ford served the states’ market for the products and the products caused in-state injury to the plaintiffs, who were state residents. That sufficed, the Court held, even if the defendant’s in-state conduct did not cause the plaintiffs’ claims. Justice Kagan wrote the majority opinion for five Justices, while Justice Alito and Justice Gorsuch (the latter joined by Justice Thomas) penned concurrences in the judgment. (Justice Barrett did not participate.)Read our <a href="https://www.mofo.com/resources/insights/210325-specific-personal-jurisdiction.html?utm_source=publication&utm_medium=email">client alert</a>.

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Brian Matsui co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Brian is a go-to appellate advocate for sophisticated clients in complex appeals nationwide. 

Brian R. Matsui

Brian Matsui is a partner in Morrison Foerster’s Appellate and Supreme Court practice. For nearly 20 years, Brian has been a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Clients turn to Brian for his substantial experience in patent appeals in the Federal Circuit. He has argued more than 10 times in that Court, winning appeals from both district courts and the Patent Trial and Appeal Board. Brian excels at applying significant legal principles to complex technologies in a way that distills them for the Court. He has done so for companies in a myriad of industries, including mobile device manufacturers, pharmaceutical companies, medical device companies, memory manufacturers, movie studios, and software companies.

Brian Matsui

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Close Enough: Horseshoes, Hand Grenades, and Specific Personal Jurisdiction

Close Enough: Horseshoes, Hand Grenades, and Specific Personal Jurisdiction

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How close a connection does there need to be between a lawsuit and the defendant’s in-state activities for specific personal jurisdiction to apply? The Supreme 

Product Liability

Trials

Mass Torts

More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making good on his promise to reverse course from the previous administration’s product safety agenda.So far, we witnessed rare civil penalties against product manufacturers, a flurry of recalls, and the progression of new product safety regulations. We also expect Biden to nominate a new commissioner to the Consumer Product Safety Commission (CPSC), which will shift the agency’s power balance.Enforcement Actions. CPSC recently announced a $7.95 million civil penalty in a settlement with Cybex International, Inc., an exercise equipment manufacturer.[1] CPSC charged Cybex with failing to immediately report a known product safety defect. CPSC learned Cybex had received 85 reports of broken handles on its arm curling machine and 27 reports of injuries on its press machine but never notified CPSC. Cybex recalled the products several years ago but, on February 11, 2021, agreed to pay the civil penalty to resolve CPSC’s charges.In early January 2021, a fire extinguisher manufacturer was ordered to pay a $12 million civil penalty following a rare referral from CPSC to the Department of Justice.[2] The government alleged Kidde failed to immediately report a serious defect in its fire extinguishers, underreported the scope and nature of the defect and associated risk, made misrepresentations to CPSC, and misused a registered safety certification mark.All companies in a product’s distribution chain have a duty to report potential defects that create an unreasonable risk of serious injury to consumers. The civil penalties against Cybex and Kidde should remind consumer product companies to evaluate and refresh their own compliance policies if needed. CPSC’s charges for failure to report underscore the urgency for companies to act fast in determining whether reportable product hazards exist. As a result, it is critical to promptly consult products liability counsel to assess reportability when a potential safety issue arises.Recalls. Since President Biden took office, CPSC has announced 20 product recalls, following 256 total recalls in 2020. The surge comes on the heels of steadily declining recall levels under prior acting chairwoman Ann Marie Buerkle. Recalls in 2019 decreased 7 percent from 2018 levels, which were a decrease of 8 percent from 2017 levels.[3] However, once Robert Adler, the current acting chairman, took over in October 2019, recall levels in 2020 jumped 6 percent from the previous year. This trend is likely to continue.Regulations. We expect the Biden Administration’s preference to shift to mandatory standards over the previous administration’s deference toward voluntary standards. Children and baby products represent a key area of CPSC’s current focus. The agency seeks to finalize a mandatory standard for crib mattresses that incorporates ASTM F2933-19 with modifications to make the standard more stringent. The proposed rule will also add “crib mattresses” as defined in the standard to the regulatory definition of “durable infant or toddler product.” In addition, CPSC issued a direct final rule to update its regulation of infant swings to the newly revised version of the standard, ASTM-F2088-20, which takes effect April 3, 2021. Businesses should keep an eye out as new proposed regulations come down the pipeline.CPSC’s Leadership. Biden has three opportunities to reshape the Commission. Acting Chairman Adler’s term ends in October 2021, prompting the anticipated announcement of his replacement in the next few months. Commissioner Elliot Kaye, whose term ended in October 2020 and is being held over for a year, is also due for a replacement while a fifth seat remains vacant. With the chance to fill three seats, Biden can return CPSC to full strength and secure a Democratic majority to pursue his agenda.One hurdle persists – the stalled nomination of Nancy Beck. President Trump nominated Beck to fill the vacant chairman position but she encountered opposition in the Senate. Even if the Senate confirms, Biden can simply remove her and nominate a new candidate. With a slim Democratic Senate majority, Beck’s nomination appears doomed, paving the way for a Biden nominee to replace Acting Chairman Adler. A Democrat-led Commission would likely drive increased compliance activities across industries and push for new mandatory safety regulations – a more aggressive approach lobbied for by consumer product safety advocates.Be on the lookout for more Client Alerts from Morrison & Foerster’s products liability and counseling group to stay apprised of the latest consumer product safety developments.[1] <a href="https://cpsc.gov/Newsroom/News-Releases/2021/Cybex-Agrees-to-Pay-7-95-Million-Civil-Penalty-for-Failure-to-Report-Serious-Injuries-Involving-its-Exercise-Equipment">https://cpsc.gov/Newsroom/News-Releases/2021/Cybex-Agrees-to-Pay-7-95-Million-Civil-Penalty-for-Failure-to-Report-Serious-Injuries-Involving-its-Exercise-Equipment</a>[2] <a href="https://www.justice.gov/opa/pr/fire-extinguisher-manufacturer-ordered-pay-12-million-penalty-delay-and-misrepresentations">https://www.justice.gov/opa/pr/fire-extinguisher-manufacturer-ordered-pay-12-million-penalty-delay-and-misrepresentations</a>[3] <a href="https://www.washingtonpost.com/business/2020/01/13/product-recalls-under-trump-fall-lowest-level-16-years-new-signs-emerge-tougher-regulator/">https://www.washingtonpost.com/business/2020/01/13/product-recalls-under-trump-fall-lowest-level-16-years-new-signs-emerge-tougher-regulator/</a>

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

Julie Park

Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

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Consumer Product Safety Enforcement To Heat Up Under Biden Administration

Consumer Product Safety Enforcement To Heat Up Under Biden Administration

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More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making 

Consumer Products

CPSC

Court Rules the Federal Officer Removal Statute May Provide “Critical Infrastructure” Companies Additional Pathway to Litigate COVID-19 Claims in Federal CourtThe Eastern District of Texas ruled last week that Tyson, a “critical infrastructure” company, properly removed a COVID-19-related case to federal court under the federal officer removal statute, 28 U.S.C. § 1442.[1] In light of the COVID-19 pandemic, the federal government designated certain industries and sectors as “critical infrastructure” under the Patriot Act to maintain production of essential goods and services. The court’s ruling provides these companies an additional pathway to litigate COVID-19-related claims in federal court when they have a plausible federal defense, even in the absence of traditional grounds for federal jurisdiction.Federal Officer Removal StatuteOrdinarily, the basis for federal subject matter jurisdiction to remove a case to federal court must arise from the plaintiff’s complaint; a defense based on federal law is insufficient to create federal question jurisdiction. The federal officer removal statute provides an exception to this general rule for officers of the United States and persons “acting under” an officer “for any act under color of such office.” 28 U.S.C. § 1442(a)(1).To remove under this statute, the defendant must prove: “(1) it is a person for purposes of the statute; (2) it was ‘acting under’ a federal officer’s directions; (3) there was a connection or association between those directions and the plaintiff's claims; and (4) it can assert a colorable federal defense.”[2]Fields v. BrownFormer Tyson meatpacking plant employees who were exposed to and contracted COVID-19 sued the company in Texas state court for negligence and gross negligence, alleging Tyson failed to provide “adequate precautions or protections” from the virus.[3] Tyson removed the case to federal court, and plaintiffs moved to remand. The court denied plaintiffs’ motion to remand, finding that federal jurisdiction existed under the federal officer removal statute.[4] Plaintiffs did not challenge that Tyson constituted a “person” under the statute, and the court found the three remaining elements of the statute were present.[5] In doing so, the court followed precedent of broadly applying the statute.[6]First, the court found Tyson was “acting under” the directions of an officer because Tyson “exhibited ‘an effort to help assist, or carry out, the duties and tasks’” of the federal government.[7] After the federal government designated meatpacking facilities as “critical infrastructure,” Tyson communicated regularly with multiple federal agencies, coordinated with FEMA to obtain personal protective equipment for its employees, and permitted the Food Safety and Inspection Service (FSIS) to staff employees at the Tyson facility to ensure production continued.[8] Although complying with regulations in itself would not suffice to constitute “acting under” a federal officer, the court found that Tyson went beyond compliance and actively worked with multiple government agencies.[9]Second, the court held that the federal decision to designate meatpacking facilities as “critical infrastructure” was sufficiently connected to plaintiffs’ claims against Tyson.[10] Mandating food production facilities to remain open “naturally” connected to what safety precautions those facilities put in place to continue operation in light of COVID-19.[11]Finally, the court found that Tyson raised a “colorable federal defense” under the Poultry Products Inspection Act’s (PPIA) express preemption provisions.[12] Plaintiffs argued that the PPIA does not apply, but the court emphasized that Tyson met its burden by presenting sufficient support to show its asserted federal defense is plausible.[13] Any decision on the merits of the defense would be premature.[14]TakeawayFields provides precedent for “critical infrastructure” companies to remove COVID-19-related personal injury cases to federal court. The court’s decision illustrates that many COVID-19-related claims against companies that operated under the direction of, or in coordination with, the federal government in response to COVID-19 will likely be litigated in federal court so long as the company can present a plausible federal defense. [1] Fields v. Brown, No. 6:20-cv-00475, 2021 WL 510620 at *1 (E.D. Tex. 2021).[2] Id. at *2.[3] Id. at *1.[4] Id. at *5.[5] Id. at *2.[6] Id. (citing Willingham v. Morgan, 395 U.S. 402, 407 (1969)).[7] Id. at *3 (citing Watson v. Phillip Morris, 551 U.S. 142, 152 (2007)).[8] Id.[9] Id.[10] Id. at *4.[11] Id.[12] Id. at *5.[13] Id. at *4 (citing Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286, 297 (5th Cir. 2020)).[14] Id.

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Matt is an associate in the Litigation Department in MoFo’s San Diego office. Matt’s practice focuses on the product lifecycle, from early product development to litigation to end-of-life advisement. He counsels clients through complex consumer product safety regulatory landscapes and product recalls.











Matt Robinson

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Ex-Tyson Employees’ COVID-19 Suit to Be Litigated in Federal Court

Ex-Tyson Employees’ COVID-19 Suit to Be Litigated in Federal Court

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Court Rules the Federal Officer Removal Statute May Provide “Critical Infrastructure” Companies Additional Pathway to Litigate COVID-19 Claims in Federal Court


Coronavirus (COVID-19)

AI and machine-learning advances have made it possible to produce fake videos and photos that seem real, commonly known as “deepfakes.” Deepfake content is exploding in popularity. In this article, we explore deepfake technology and the legal risks it presents to companies while providing practical tips to manage these risks.  Read our <a href="https://www.mofo.com/resources/insights/210210-ai-machine-learning-manipulation.html">client alert</a>.

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Deepfake Litigation Risks: The Collision of AI’s Machine Learning and Manipulation

Digital Single Market Update: Technology Standardization in the EU

AI and machine-learning advances have made it possible to produce fake videos and photos that seem real, commonly known as “deepfakes.” Deepfake content is expl

Deepfake Litigation Risks: The Collision of AI’s Machine Learning and Manipulation

Privacy

Erin Bosman, Julie Park, and Alexandra Preece authored an article for Law360 discussing how product liability regulation and litigation changed in 2020 due to the impact of the COVID-19 pandemic, as well as upcoming trends.“In a year dominated by the pandemic and political gridlock in Washington, D.C., it comes as no surprise that we saw no major product safety laws or regulations in 2020,” the authors wrote.“In fact, the U.S. Consumer Product Safety Commission did not issue a single civil penalty last year, although it did recently refer a case to the U.S. Department of Justice. We expect an uptick in regulatory activity this year, as consumer product safety advocates urge the incoming Biden administration to take a more aggressive approach to product safety.”

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.
Alexandra litigates product liability matters involving medical devices, pharmaceuticals, autom

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How 2020 Changed Product Liability — And What's Next

Using Waivers to Curb COVID-19 Legal Exposure

Erin Bosman, Julie Park, and Alexandra Preece authored an article for Law360 discussing how product liability regulation and litigation changed in 2020 due to t

How 2020 Changed Product Liability — And What's Next

Autonomous Vehicles & Robotics

Public Readiness and Emergency Preparedness Act (PREP Act)

Emergency Use Authorization (EUA)

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA enforcement and let companies know what to expect if they do become the target of enforcement action. To do just that, MoFo’s product regulatory team has tracked and analyzed these enforcement efforts against COVID-19 products to bring you this year‑end guide.Triggering FDA EnforcementThe COVID-19 pandemic has not significantly changed the scope of FDA’s regulatory authority. The agency regulates drugs and medical devices: instruments or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease or condition. Any product that makes these drug or device claims is subject to FDA’s regulatory authority.Indeed, product manufacturers most commonly trigger FDA scrutiny by making an unauthorized COVID-19 claim in product advertising or labeling. For example, FDA has taken enforcement action against products claiming to:<ul><li>Provide any type of COVID-19 testing;</li><li>“Treat” or “fight” COVID-19 or “inhibit” the virus;</li><li>“Prevent” or “reduce the risk” of contracting COVID-19; or</li><li>Treat or reverse bodily symptoms caused by COVID-19.</li></ul>Even suggesting these claims, such as using a “#coronavirus” hashtag on social media for a disinfectant spray, can trigger enforcement.Common Enforcement ActionsFDA generally uses one of two regulatory devices to remove dangerous or unauthorized COVID-19 products from the market.Warning LettersIn most circumstances, FDA takes enforcement action by issuing a warning letter to the manufacturer detailing violations of the Food, Drug, and Cosmetics Act. To date, FDA has issued over 140 warning letters to manufacturers of products like test kits, homeopathic drug products, disinfectant sprays, and various devices that claim to test for or treat COVID-19. FDA publishes these letters and maintains them in a list of “fraudulent” COVID-19 products. The Federal Trade Commission may also sign onto these letters because claiming that a product can prevent, treat, or cure disease without competent and reliable scientific evidence also violates the FTC Act.Warning letters may require that a manufacturer remove impermissible product claims or take an unapproved product off the market altogether. FDA also demands expedited corrective action for COVID-19 products. Whereas general warning letter recipients typically have 15 business days to respond, COVID-19 product manufacturers have only 48 hours to describe the corrective steps they have taken to correct violations.Failure to comply with a warning letter can lead to swift judicial intervention. In April, FDA and FTC issued a warning letter to a seller of “Miracle Mineral Solution,” a dangerous chlorine dioxide product touted as a COVID-19 cure. The seller refused to remove the product from the market. Within 10 days of the warning letter, a federal court issued a temporary restraining order against the seller, and later a permanent injunction against selling or distributing the misbranded products. The individual defendants have been charged with conspiracy to defraud the United States, conspiracy to violate the FDCA, and criminal contempt.Product RecallsWhen a defective or potentially harmful product has already been sold to consumers and patients, FDA may ask a manufacturer to recall the product. A great example of this is FDA’s activity on hand sanitizers. Since shortages began early in 2020, hand sanitizer products have flooded the market to keep up with soaring demand. Some of these products include dangerous, prohibited ingredients like methanol and 1‑propanol instead of or in addition to the generally permitted ethanol or isopropyl alcohol. FDA has been working extensively to test the many sanitizers on the market and remove those that pose harm to consumers.FDA has identified over 220 products on a do-not-use list of hand sanitizers, but has faced difficulty getting manufacturers to comply with its efforts to recall these products. While it has authority to issue mandatory recalls for dangerous biologics and medical devices, FDA does not have authority to forcibly recall over-the-counter drugs like hand sanitizer. Newly proposed legislation would vest FDA with that power so it would not need to rely on manufacturer cooperation to get dangerous drugs off store shelves.FDA is currently able to prevent some these products, many of which are imported from Mexico, from entering the country by issuing an import alert for certain brands of sanitizers. Products on this list imported from abroad cannot pass through customs into the U.S., a restriction that serves as a reminder of FDA’s leverage over manufacturers that import goods from abroad.ConclusionWe have reported on FDA’s unique abbreviated approval pathways for various COVID-19 products designed to encourage production and decrease time-to-market. In contrast to the innovative solutions the agency has deployed in product review and approval, the agency has continued to use its tried‑and‑true methods on the enforcement side. Warning letters and product recalls remain the primary weapons in FDA’s arsenal for unapproved treatment claims for COVID-19, but FDA is enforcing its policies more aggressively in relation to COVID‑19. Companies must take swifter compliance measures, and FDA will turn to more drastic actions like judicial intervention and import detention if those measures are inadequate.

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FDA’s COVID-19 Product Regulation Enforcement Roadmap

FDA’s COVID-19 Product Regulation Enforcement Roadmap

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Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic