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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As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Adm

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FDA Inspires Modifications and Quick Authorizations for Ventilators

FDA Inspires Modifications and Quick Authorizations for Ventilators | Class Dismissed

Erin M. Bosman

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators.Ventilator Modification Enforcement PolicyOn March 22, 2020, FDA issued a new guidance document, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance indicates that FDA will not object to limited, low‑risk modifications of certain ventilator devices, including anesthesia gas machines and other respiratory devices, and their accessories. These modifications can include:<ul><li>Hardware changes, such as motors, batteries, and electrical components.</li><li>Modifications to the FDA‑cleared indications, claims, or functionality of ventilators. For example, FDA may allow healthcare facility use of ventilators designed for at-home use, or the use of sleep apnea devices to treat patients with respiratory insufficiency, so long as the proper mitigations are in place.</li><li>Software changes, such as modifying ventilation parameters and implementing the availability of remote monitoring and operation through wireless capability.</li><li>Extension of shelf life. The use of ventilators and gas machine circuit devices beyond their indicated shelf life is also permitted under the new guidance.</li></ul>FDA requires that modifications based on this guidance follow applicable recognized safety standards, and be described in labeling to help users understand the device’s new indications, functions, and risks. Lastly, the guidance lays out FDA’s intended approach for an Emergency Use Authorization (EUA) of ventilator support devices, encouraging manufacturers with capabilities to increase the supply of these devices to contact FDA to determine if an EUA for such devices can be issued.By allowing these modifications, FDA seeks to help manufacturers increase manufacturing capacity and supply without prior submission of a premarket notification. An important consequence is that medical facilities will not have to worry about making modifications to complex machinery themselves, but will have some technical and instructional support from manufacturers. This will make it easier and safer for facilities to make the most of machinery that, with a few tweaks, can be pumping oxygen for COVID-19 patients. The guidance emphasizes, however, that healthcare facilities should still continue to use FDA-cleared ventilators, or a device subject to an EUA, whenever possible.Emergency Use AuthorizationsOn March 24, 2020, the Secretary of HHS released the <a href="https://www.fda.gov/media/136421/download">declaration</a> necessary for FDA to issue EUAs for ventilators. The declaration states that “circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak.” That same day, FDA kept the promise it made in its March 22 guidance to work with manufacturers of ventilators through the EUA process by issuing an <a href="https://www.fda.gov/media/136423/download">EUA</a> covering ventilators, ventilator tubing connectors, and accessories not currently marketed in the U.S., or for which a modification to the device would typically require submitting a new premarket notification to FDA.An EUA is essentially an abbreviated approval pathway, available to certain goods only once an authorization is issued for that product category. In order to be included in the list of authorized products in FDA’s ventilator EUA, the sponsor must demonstrate that the product meets the stated criteria for safety, performance, and labeling. Those criteria, set forth throughout the EUA and Appendix A to the EUA, are no breeze. They require the manufacturer to submit:<ul><li>Declarations of conformity with various International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), and other safety standards as applicable;</li><li>Product specification and instruction information;</li><li>Shelf-life information and reprocessing information for reusable products;</li><li>Manufacturing facility requirements;</li><li>Labeling information, which includes instructions for use and fact sheets for both healthcare providers and patients, which describe benefits, risks, and available alternatives to the device.</li></ul>Additional engineering, manufacturing, and labeling considerations apply for ventilator adapters allowing one ventilator to treat multiple patients simultaneously.FDA will add products to the list after confirming that the applicable safety, performance, and labeling criteria have been met. Once a specific product is authorized, it can be manufactured and distributed without meeting the typical product approval requirements. Authorized products also do not need to comply with current good manufacturing practices for design, manufacture, labeling, storage, and distribution. Nor do sponsors need to follow typical registration and listing requirements for the product. But sponsors do need to maintain records of where they send their devices, notify FDA of their distributors, and report adverse events.In many ways, these recent actions are consistent with FDA’s COVID-19 strategy to date, which is marked by relaxing typical premarket requirements, capitalizing on existing industry capabilities, and maintaining vigilance on post-market product performance. This allows products to be marketed faster, lets producers retool their manufacturing abilities toward necessary products, and keeps FDA well informed about device performance. On the other hand, the new steps indicate that FDA has shifted its attention to different types of countermeasures. FDA’s production-focused policies to date have mainly addressed low-risk, preventative products like <a href="https://classdismissed.mofo.com/fda/fda-calls-all-hands-on-deck-to-keep-hand-sanitizer-stocked/">hand sanitizer</a>, N95 respirators, and in-vitro diagnostic products. Ventilators, which are typically viewed as higher risk devices and are often necessary to keep critical patients alive, play a very different role in the battle against COVID-19.Follow Morrison & Foerster’s <a href="https://classdismissed.mofo.com">Products Liability</a> and <a href="https://lifesciences.mofo.com">Life Sciences</a> blogs to stay informed as we continue to report on FDA’s evolving role and its impact on the medical product industry.