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

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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Alexandra Preece Barlow

Adam J. Hunt

The Future of Section 230: Protection Against Product Liability Claims?

New Wave of PFAS Legislation Aimed at Consumer Products

CPSC Releases Annual Report on Deaths and Injuries Involving Nursery Products

CPSC Proposes New Safety Rules for Infant Rockers

CPSC Commissioners Abstain from Retracting Infant Sleep Product Statements

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Legal 500 US 2021 has recommended Erin Bosman, David Fioccola, and Jessica Grant, and named Julie Park among its “next generation” practitioners. The publication also recognized Morrison & Foerster as a top firm in Product Liability, Mass Tort and Class Action (Defense) for Pharmaceuticals and Medical Devices. See what our clients and peers are saying about MoFo’s Class Actions + Mass Torts Group.<div class="embedded-entry redactor-component block-entry" type="entry" data-sys-entry-uid="blt4fafbbc19c76d8c0" data-sys-entry-locale="en-us" data-sys-content-type-uid="image_content" sys-style-type="block"><div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blta6cc7bd9d3d54bb0/627315e24d9f89297129017b/07_01_legal500-tier3_productliability_infographic_150dpi_v6.jpg?format=auto&amp;quality=60" alt="Product Liability Infographic"></div></div>

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Morrison & Foerster Achieves Top Ranking in Product Liability, Mass Torts and Class Action (Defense) for Pharmaceuticals and Medical Devices

Legal 500 US 2021 has recommended Erin Bosman, David Fioccola, and Jessica Grant, and named Julie Park among its “next generation” practitioners. The publicatio

Morrison & Foerster Achieves Top Ranking in Product Liability, Mass Torts and Class Action (Defense) for Pharmaceuticals and Medical Devices

Legal 500 US 2021 has named Erin Bosman, David Fioccola, Jessica Grant, Julie Park, James Schurz, William Tarantino, and Claudia Vetesi among their top product liability and class action practitioners nationwide. The publication also recognized Morrison & Foerster as a top Tier 1 Firm in Product Liability, Mass Tort, and Class Action (Defense) for Consumer Products.<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltfb9918f1567d3c2f/627315df220ab5285f51903d/210708-legal-500-product-liability.jpg?format=auto&quality=60" class="img-responsive" alt="Legal 500 Infographic" type="asset" sys-style-type="download">

Morrison & Foerster Is Recognized As Tier 1 Firm in Product Liability, Mass Torts, and Class Action for Consumer Products

Legal 500 US 2021 has named Erin Bosman, David Fioccola, Jessica Grant, Julie Park, James Schurz, William Tarantino, and Claudia Vetesi among their top product 

Morrison & Foerster Is Recognized As Tier 1 Firm in Product Liability, Mass Torts, and Class Action for Consumer Products

As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern.  Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating psychiatric disorders in its Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (“the Guidance”).Read more on <a href="https://lifesciences.mofo.com/topics/mental-health-during-COVID-19-FDA-waivers-for-digital-health-devices.html">MoFo Life Sciences</a>.

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A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

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Mental Health During COVID-19: FDA Waivers for Digital Health Devices

Using Waivers to Curb COVID-19 Legal Exposure

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As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern.  Last we

Mental Health During COVID-19: FDA Waivers for Digital Health Devices

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel coronavirus (SARS-CoV-2). On the basis of the February 4, 2020 HHS determination, FDA began exercising its Emergency Use Authorization (EUA) powers.Read more on our <a href="https://lifesciences.mofo.com/topics/FDA-uses-EUAs-broadly-in-the-fight-against-Covid-19.html">MoFo Life Sciences Blog</a>.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Fitbit

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

FDA Uses EUAs Broadly in the Fight Against COVID-19

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmet

FDA Uses EUAs Broadly in the Fight Against COVID-19

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The Act includes many provisions addressing specific needs that have come to light during the COVID-19 pandemic, but some of these provisions have important impacts on the drug and device industry well beyond the current pandemic.  The CARES Act, unsurprisingly, also contains provisions unrelated to the COVID-19 pandemic but that have potentially significant impacts on life science and medical device companies.Read more on our <a href="https://lifesciences.mofo.com/topics/CARES-act-of-2020-guide-for-drug-and-device-companies.html">MoFo Life Sciences Blog</a>.

CARES Act of 2020: Guide for Drug and Device Companies

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate 

CARES Act of 2020: Guide for Drug and Device Companies

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.

Fertility Center Litigation

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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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence 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 chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence 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

FDA Inspires Modifications and Quick Authorizations for Ventilators

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

FDA Inspires Modifications and Quick Authorizations for Ventilators

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.

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

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

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

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical device companies to increase production of existing products currently in short supply, and to develop new innovative COVID-19 therapies and treatments by limiting tort liability for the goods.Medical companies typically spend years of development and testing in cooperation with the U.S. Food and Drug Administration (FDA) before a new product reaches consumers. While there are economic and reputational incentives for a company to quickly develop these products, there is one looming concern that risks chilling product manufacturers’ race to bring products to market: product liability litigation.In order to limit exposure to private litigation when companies respond to public health emergencies, Congress enacted the Public Readiness and Emergency Preparedness (PREP) Act in 2005. The PREP Act allows the Department of Health and Human Services (HHS) to provide defined liability immunity for recommended activities regarding covered countermeasures for particular public health emergencies.The current pandemic is exactly the type of emergency that the PREP Act contemplates. In response to COVID-19, the HHS Secretary issued a PREP Act declaration. The declaration was published in the Federal Register on March 17, 2020, but was backdated to February 4, 2020. It will remain in effect until October 2024. Now, firms at any stage of the product life cycle can continue development and marketing knowing these additional protections will apply when their COVID-19 therapies reach consumers.The PREP Act confers immunity from suit and liability under state and federal law for any claims caused by, arising out of, relating to, or resulting from the administration or use of certain medical products. 42 U.S.C. § 247d-6d. While injured parties cannot maintain private lawsuits, they may be able to recover from the Countermeasures Injury Compensation Program (<a href="https://www.hrsa.gov/cicp/index.html">CICP</a>), a fund designed to compensate individuals for injuries sustained by PREP Act-protected products. The declaration defines the following parameters:<ul><li>Covered Persons: The United States, manufacturers, distributors, program planners, qualified persons, and their officials, agents, and employees.</li><li>Recommended Activities: Manufacture, testing, development, distribution, administration, or use of approved countermeasures. Willful misconduct is not protected by a PREP Act declaration.</li><li>Covered Countermeasures: Any antiviral, drug, biologic, diagnostic, device, or vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19 or its transmission. This includes any device used to administer such a product. Covered countermeasures must be: <ul><li>A qualified pandemic or epidemic product, which includes specific drugs, biologics, or devices that require FDA review by definition;</li><li>A security countermeasure, which is either a drug or device as defined by the Food, Drug, and Cosmetics Act (FDCA), or a biological product as defined by the Public Health Service Act; or</li><li>A drug, biological product, or device authorized for emergency use under the Food, Drug, and Cosmetics Act.</li></ul></li></ul>The PREP Act has been invoked several times in the past, most notably during outbreaks of Ebola, Zika, and other diseases, and for potential biological warfare emergencies presented by anthrax and certain nerve agents. While the PREP Act is not a novel protection, the COVID-19 pandemic has ushered in other unprecedented measures to bring medical products to market. This week, FDA announced <a href="https://lifesciences.mofo.com/topics/FDAs-New-Guidance-Novel-Coronavirus-COVID19-Diagnostic-Tests.html">a new policy</a> whereby states are responsible for authorizing test kits and laboratories, manufacturers can distribute test kits before obtaining emergency use authorization from FDA, and companies can distribute serological tests without FDA review. These measures follow FDA’s cooperation with manufacturers like Abbott Laboratories, Roche, and Thermo Fisher Scientific to rapidly review and issue emergency use authorizations for testing kits. FDA also issued <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials">guidance</a> with recommendations for product developers dealing with disruptions to clinical trials.This declaration will also encourage firms to increase production of existing preventative products that are in short supply. For example, certain products like N95 respirators were initially not covered by this PREP Act declaration because they are regulated by the National Institute for Occupational Safety and Health (NIOSH), not FDA. But Congress <a href="https://www.law360.com/productliability/articles/1253313/covid-19-relief-bill-includes-protections-for-face-masks?nl_pk=e2e6a684-d4a3-4f8d-8490-29768a3c4854&utm_source=newsletter&utm_medium=email&utm_campaign=productliability">extended PREP Act protection</a> to those respirators this week in the Families First Coronavirus Response Act.Products for treating and preventing COVID-19 are in critical demand. These measures should incentivize manufacturers to spend more resources on those products. Product manufacturers should expect federal agencies and Congress to continue supporting and encouraging companies to bring products to market swiftly and to keep them stocked once they do hit store shelves. But companies and the public should not interpret these steps as a trade-off on product safety. As we have reported, FDA and the Federal Trade Commission are still taking <a href="https://classdismissed.mofo.com/consumer-products/fda-and-ftc-send-warning-letters-to-companies-marketing-products-to-treat-coronavirus-state-attorneys-general-follow-suit/">enforcement measures</a> against companies making unsupported or misleading claims. And companies can still face liability for willful misconduct even if the PREP Act otherwise applies to their activities.We also advise manufacturers to remain informed and stay flexible. Continued policy changes, guidance, and incentives are sure to come as the COVID-19 pandemic progresses. We will continue to provide updates on these developments as they arise.

PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vacci

PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published 20 years of reports submitted through the ASR Program that had not previously been disclosed to the public, leaving manufacturers with potentially massive amounts of data to sort through regarding their products.Read our <a href="https://protect-us.mimecast.com/s/AEKyCyPJ7zfZWVJRFQzirL">client alert</a>.

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption.  In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries.  Merck Sharp & Dohme Corp. v. Albrecht et al., No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”).  However, those who had criticized the Third Circuit’s opinion were left wanting more—the limited holding does not reach the issue of whether plaintiffs’ claims against the manufacturer were preempted.BackgroundOver 500 patients sued Merck alleging they suffered atypical femoral fractures, a rare type of stress fracture affecting the thigh bone, after using Merck’s Fosamax drug.  They claimed that Merck failed to disclose these risks on the drug label.  Merck countered that FDA had rejected or would have rejected its proposed addition to the drug label.  As a result, Merck said it could not comply with both federal drug labeling requirements and its duty to warn under state law.  In these circumstances, Merck argued, the federal law and regulations preempt the patients’ state‑law claims such that Merck should not be held liable for failing to disclose the stress fracture risks to consumers.Merck based its argument on years of back-and-forth discussions with FDA about whether Fosamax could cause these types of stress fractures.  In 1995, when FDA first approved Fosamax, the label did not include the fracture warning because—at that time—the risk was still theoretical.  After more than a decade of post-market surveillance, Merck sought preapproval to add these risks to its Fosamax label in 2008.  FDA rejected Merck’s proposed change.  Not until 2011 did FDA agree to add language to the Fosamax label disclosing the risks of atypical femoral fractures.Beginning in 2010, hundreds of patients filed lawsuits that were eventually consolidated in a multidistrict litigation in the District of New Jersey.  The district court granted Merck’s summary judgment motion on the ground that the patients’ state-law failure to warn claims were preempted by federal law.  The Third Circuit reversed, finding that the preemption question involved factual disputes the jury should have resolved and that Merck needed more evidence to meet the “clear evidence” standard set forth in Wyeth v. Levine to establish its preemption defense.Defining Wyeth’s “Clear Evidence” StandardIn 2009, the Supreme Court issued the first of several important pharmaceutical preemption decisions in Wyeth v. Levine, 555 U.S. 555 (2009).  There, a Vermont jury found that Wyeth failed to provide an adequate warning that direct injection of its Phenergan drug created a significant risk of harm to patients.  The Vermont Supreme Court agreed, finding no preemption.The U.S. Supreme Court affirmed.  In doing so, the Court explained that unless a drug manufacturer can show “clear evidence” that FDA would not have approved a change to its drug label, a court cannot conclude that it was impossible for the drug manufacturer to comply with both federal drug labeling requirements and state-law duty to warn requirements.  In other words, to succeed on this type of impossibility preemption defense, a drug manufacturer has to provide clear evidence that FDA considered the risk and made an affirmative decision to either (a) not change the label or (b) prohibit the manufacturer from strengthening its warning.However, what constituted “clear evidence” under Wyeth remained unclear until now.  Post-Wyeth, courts have struggled to apply the undefined clear evidence standard to determine if the FDA would have rejected a proposed warning change that was never submitted.In Albrecht, Merck had sought preapproval from FDA to strengthen Fosamax’s warnings, but that proposal was rejected.  When Fosamax users brought state-law failure-to-warn claims, Merck argued that the claims were preempted by federal law because the FDA had rejected Merck’s proposed changes to the Fosamax label.The Court clarified that “clear evidence” means “evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.”  This definition dispels the notion that the “clear evidence” standard is an evidentiary standard, as some district courts had interpreted it to be.But whether the FDA’s action in Albrecht satisfies the standard is left open.  The Court did not actually reach the preemption question.Preemption Questions Must Be Decided by the JudgeNext, the Court held that judges, not juries, must decide the question of whether state-law failure-to-warn claims are preempted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations.  This includes whether there is clear evidence that FDA would not have approved the warning that state law requires.  The Court reasoned that resolving questions of agency disapproval often requires legal skills to understand an agency decision within the applicable regulatory framework.  The Court acknowledged that the preemption issue typically involves factual disputes but that these factual questions are “subsumed within an already tightly circumscribed legal analysis.”Key Takeaways<ul><li>Justice Thomas joined the opinion but wrote separately to say that Merck’s preemption defense failed. Why?  Because Merck relied on FDA response letters as evidence that Merck could not have strengthened its warning.  According to Justice Thomas, an FDA response letter cannot have preemptive effect because it is “not a final agency action with the force of law.”  His concurrence is surprising given that he wrote the majority opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), holding that certain generic pharmaceutical failure-to-warn claims are preempted.</li><li>Justice Alito, joined by Justices Roberts and Kavanaugh, also wrote separately. He would have found preemption here and suggested that the Third Circuit should find “clear evidence” that the FDA would not have approved Merck’s label.  Justice Alito cited the record showing that FDA was deeply involved in the stress fracture issue for years, and that the agency has a statutory duty to require label changes upon learning new evidence warranting a change.  Under these circumstances, Justices Alito, Roberts, and Kavanaugh would have found preemption.</li><li>Defendants should welcome this clarity on the “clear evidence” standard, which relieves them of the confusing pseudo-evidentiary burden that some lower courts had applied.</li><li>Although the opinion may disappoint by not reaching the preemption question, Justice Alito’s concurrence provides drug manufacturers a roadmap for satisfying the “clear evidence” standard.</li><li>Given the favorable—albeit limited—holding, defendants should feel emboldened to assert a federal preemption defense in other areas beyond pharmaceuticals.</li></ul>

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption.  In its much-anticipated opinion deli

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer