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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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

<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

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class action lawsuits. Claudia also regularly counsels clients in the food, cosmetics, retail, and technology industries. She represents companies in false advertising disputes before the National Advertising Division (NAD) of the Council of Better Business Bureaus, Inc.<h5>More about Claudia</h5>Claudia is active in MoFo’s pro bono efforts, and recently traveled to El Paso, Texas, to work with families separated and detained at the border. She is also supervising a pro bono collaboration with Equal Rights Advocates, a nonprofit fighting for gender justice in work places and schools across the country. The initiative will help students who have been victims of sexual assault, attempted assault, or harassment find support and seek justice. Claudia is also a board member of Bay Area Legal Aid and a former board member of Equal Rights Advocates. Claudia is an editor and frequent contributor to MoFo’s <a href="https://classdismissed.mofo.com/">Class Dismissed</a> blog, which provides reports about the latest defense news, developments, and trends in class action lawsuits and product liability issues that affect consumer-facing companies. Her perspectives are also respected in the larger legal community: Claudia has published articles about class action and false advertising issues, and is a co-author of Chapter 7 — “Unfair Competition in California Business Litigation 2016” — of The Recorder. She also regularly speaks at conferences on class action and advertising trends. Claudia is currently serving as a Lawyer Representative for the Northern District of California. She received her J.D. degree in 2004 from Berkeley Law (Boalt Hall School of Law), where she was an associate editor of the Berkeley Technology Law Journal.

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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

Adam J. 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.Mr. Hunt has extensive experience representing consumer products companies, financial institutions, and technology firms in class action cases and complex commercial disputes before state and federal trial courts, as well as in arbitrations. Clients seek Mr. Hunt’s counsel for his creative, strategic thinking in high-stakes, high-profile matters. He has represented clients facing claims under false advertising, antitrust, and privacy laws throughout the country, securing wins at the pleading stage, summary judgment, and trial, in addition to negotiating favorable settlements, often early in the case. Representative experience includes successfully securing rulings dismissing two putative false advertising class action cases against one of the best-known consumer electronics companies in the world; obtaining a complete win on summary judgment for a major shipping and logistics company in a multimillion-dollar commercial dispute; appearing as counsel at trial for a leading financial institution in a $100 million commercial dispute, winning a bench trial verdict; and prevailing on motions to dismiss false advertising class actions against a leading Greek yogurt company.Mr. Hunt is also an editor of the firm’s <a href="https://classdismissed.mofo.com/" target="_self">Class Dismissed blog</a>, which provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class action lawsuits that affect consumer-facing companies.Mr. Hunt maintains an active pro bono practice and is the recipient of the New York State Bar Association’s 2017 President’s Pro Bono Service Award for the First Judicial Department, the 2018 Public Service Award from New York University School of Law, and Morrison Foerster’s Kathi Pugh Award for Pro Bono Services.Mr. Hunt received his B.A. with honors from Swarthmore College and his J.D. cum laude from New York University.

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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

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Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. O

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FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked | Class Dismissed

Erin M. Bosman

Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based hand sanitizers. Recognizing the significant supply disruptions for hand sanitizers, and that compounders and manufacturers are better equipped than ordinary consumers to formulate safe and effective hand sanitizer products, FDA is providing flexibility in manufacturing such products during the COVID-19 public health emergency.Guidance for CompoundersThe first of the two guidance documents—Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency—is specifically directed at pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities (referred to collectively as “compounders”). This guidance covers the formulation of hand sanitizer for both consumer and healthcare professional use, replacing a previous version initially released on March 14 that only covered a formulation for consumer use.The guidance explains that FDA will exercise enforcement discretion for compounders that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs for the duration of the public health emergency, as long as the following specific requirements are followed:<ol><li>The hand sanitizer contains the following USP grade ingredients, consistent with WHO recommendations, and no additional active or inactive ingredients: <ol type="a"><li>Alcohol, which may be either ethanol (80% v/v) in an aqueous solution denatured according to the Alcohol and Tobacco Tax and Trade Bureau regulations (27 CFR part 20) or isopropyl alcohol (75% v/v) in an aqueous solution</li><li>Glycerol (1.45% v/v for ethanol, but for isopropyl alcohol, 0.725% may be more effective)</li><li>Hydrogen peroxide (0.125% v/v)</li><li>Sterile distilled water or boiled cold water</li></ol></li><li>Extra caution is exercised to ensure that the active ingredient is correct, and that the correct amount of the active ingredient is used</li><li>The hand sanitizer is prepared under the same conditions as similar nonsterile drugs compounded by the compounder, including current Good Manufacturing Practices or USP &lt;795&gt; (as applicable) and proper sanitary conditions</li><li>The hand sanitizer is labeled according to one of the four appendices provided in the guidance: <ol type="a"><li>Appendix A (Labeling for Ethyl Alcohol Formulation Consumer Use)</li><li>Appendix B (Labeling for Isopropyl Alcohol Formulation Consumer Use)</li><li>Appendix C (Labeling for Ethyl Alcohol Formulation Health Care Personnel Handrub Use)</li><li>Appendix D (Labeling for Isopropyl Alcohol Formulation Health Care Personnel Handrub Use)</li></ol></li></ol>Additionally, the hand sanitizers must not make pathogen-specific disease claims or include false or misleading advertising and promotion.Guidance for Entities Not Currently Licensed as Drug ManufacturersFDA set forth those same formulation and labeling requirements for firms that are not licensed drug manufacturers in a second guidance, Temporary Policy for Preparation of Certain Alcohol‑Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). The guidance provides that FDA will not take enforcement action against entities that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs for the duration of the public health emergency. In addition to the requirements set forth for compounding pharmacists, these firms must also:<ul><li>Document the controls and steps taken to assure consistency with the prescribed formula;</li><li>Test samples to ensure that the alcohol content of the finished product is verified prior to distribution; and</li><li>Register their facility and list their hand sanitizer products in FDA’s Drug Registration and Listing System (DRLS). Firms may begin manufacturing hand sanitizer immediately after receiving the automatic registration confirmation from FDA.</li></ul>Like the compounded hand sanitizers, the manufactured hand sanitizers must not make pathogen-specific disease claims or include false or misleading advertising and promotion.FDA has slightly modified the requirements for firms that are not licensed drug manufacturers and therefore may not be familiar with drug manufacturing protocols. For example, those firms may use either U.S. Pharmacopeia (USP)-grade or Food Chemical Codex-grade ethanol, whereas compounding pharmacists must use USP-grade ethanol. Also, non-drug manufacturers must merely manufacture the product under sanitary conditions and ensure their equipment is fit for that purpose, while compounders must comply with FDA’s current good manufacturing practices or USP chapter 795’s standard for compounding nonsterile preparations. With these compromises come additional oversight: unlike compounders, firms must develop a process for accepting adverse event reports related to the products they manufacture and must submit those reports to FDA.Industry TakeawaysThis is yet another FDA move to bolster the medical product supply chain to meet public need and soaring demand, consistent with the Administration’s recent focus on essential prevention products like N95 respirators and test kits. Last week, FDA announced that it would allow states to approve their own COVID-19 test kits and testing laboratories and allowed some of those kits to be marketed before an emergency use application was expressly approved. The Department of Health and Human Services also rallied drug and device manufacturers to develop coronavirus vaccines and therapies by issuing a <a href="https://classdismissed.mofo.com/product-liability/prep-act-declaration-emboldens-drug-and-device-industry-to-innovate-in-the-face-of-a-growing-crisis/">PREP Act declaration</a>, waiving tort liability for those novel products.With store shelves empty, various how-tos and instructions for DIY hand sanitizer are circulating the Internet, encouraging average consumers to concoct their own hand sanitizer products. To ensure safety and efficacy, allowing pharmacists to compound and sell their own sanitizing solutions makes sense. But even more significant is the effort to enlist new participants to the medical drug and device market. The new guidance will encourage firms with existing relevant capability to retool their production lines for hand sanitizers. This is a huge opportunity for certain industries. Cosmetics companies and alcohol breweries and distilleries—whose usual businesses will be hit hard by the recent stay-home and business closure orders around the country—are particularly suited for the task.Producers should note that this move is consistent with FDA’s recent policy to decentralize and defer regulatory scrutiny in the interest of getting low-risk, prevention-focused products into consumer hands. While it may be relaxing traditional pre-market requirements that can be costly and time consuming, FDA is still keeping watch over these goods. It has provided pharmacists and manufacturers with a formula for the disinfectant, some quality control guidelines, and the precise labeling that should accompany the sanitizers. Deviations from these terms will likely result in FDA intervention.The Administration is keeping an even closer eye on non-medical firms that decide to manufacture sanitizer products. Unlike compounding pharmacists, these firms must register their facilities with FDA, list their sanitizing products, and implement additional quality control measures. They must also set up adverse event reporting: a post-market safety measure commonly used in the drug and device industry to ensure that products are safe even after obtaining FDA approval.We will continue to monitor and report on further FDA guidance and implications for the product industry.