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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Right-to-Repair Laws: The Trend Continues

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A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy.Consistent with this, FDA has taken various steps to accelerate the availability of testing, as we have <a href="https://lifesciences.mofo.com/topics/FDA-uses-EUAs-broadly-in-the-fight-against-Covid-19.html" target="_blank" rel="noopener noreferrer">previously reported</a>. Notably, in its <a href="https://www.fda.gov/media/135659/download" target="_blank" rel="noopener noreferrer">Policy for Diagnostic Tests for Coronavirus Disease-2019</a> (last updated May 11), FDA describes circumstances under which CLIA-certified laboratories that develop and validate tests for coronavirus can use the tests before the agency has completed review of the lab’s EUA.Read more on <a href="https://lifesciences.mofo.com/topics/FDA-signals-flexibility-with-COVID-19-tests.html">MoFo Life Sciences</a>.

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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.

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

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FDA Signals Flexibility with COVID-19 Tests

Using Waivers to Curb COVID-19 Legal Exposure

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A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 mil

FDA Signals Flexibility with COVID-19 Tests

Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been studied in outbreaks of other respiratory infections as well, including the 2003 SARS and 2012 MERS epidemics. Recognizing this, FDA updated <a href="https://www.fda.gov/media/136798/download">guidance</a> regarding convalescent plasma on Friday.As serology tests measure the amount of antibodies present in the blood when the body responds to an infection such as COVID-19, they may also help identify individuals who have developed an immune response. Coupled with other data, this could inform employers’ return-to-work strategies, a topic we analyzed <a href="https://elc.mofo.com/topics/eeoc-issues-return-to-work-covid-19-guidelines-for-employers.html?utm_source=linkedin_elevate&utm_medium=social">here</a> (noting that, thus far, EEOC only endorses testing employees to “determine if they have the virus” and has not addressed testing for antibodies to the virus). But despite this <a href="https://directorsblog.nih.gov/2020/05/07/study-finds-nearly-everyone-who-recovers-from-covid-19-makes-coronavirus-antibodies/">early optimism</a> and much press about antibody tests, more scientific evidence is needed. For example, the World Health Organization last month <a href="https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19">released a clear statement</a> on the current state of the science: “[T]here is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ‘immunity passport’ or ‘risk-free certificate.’”During a <a href="https://www.fda.gov/media/135010/download">Public Health Emergency</a> such as the COVID-19 crisis, FDA can use emergency authorities, including EUAs, to accelerate the availability of medical products by allowing unapproved products to reach patients in need when there are no adequate, FDA-approved alternatives, a process we described <a href="https://classdismissed.mofo.com/fda/fda-inspires-modifications-and-quick-authorizations-for-ventilators/">here</a>. These products can include tests to diagnose diseases, drugs to treat or prevent life-threatening conditions, and medical devices otherwise needed in the context of a public health crisis. FDA has maintained a fairly relaxed policy for serology tests in the COVID-19 crisis, since mid-March, permitting commercial antibody tests to be marketed and used without FDA EUA review if the test is labeled clearly that is it not the sole diagnostic for COVID-19, among other things. That policy does not apply to at-home specimen collection or at-home testing because of the added challenges in assuring test accuracy that these pose, as we have <a href="https://classdismissed.mofo.com/fda/covid-19-update-fda-authorizes-first-at-home-collection-kit/">previously reported</a>.Recently, a congressional subcommittee criticized FDA for “fail[ing] to police” the coronavirus serological antibody test market. Although the agency has been actively monitoring the market for fraudulent COVID-19 products, a topic we have analyzed repeatedly, the subcommittee found that “[n]umerous companies appear to be marketing fraudulent tests.”In response, FDA stated in its updated policy on testing:  “FDA’s policy was based on the considerations that serology tests are not meant to diagnose active SARS-CoV-2 infection and that early availability and use of these tests could help answer critical questions about the prevalence of COVID-19 infections in different communities, whether the presence of antibodies conveys immunity, and, if so, for how long. That policy succeeded in encouraging development of serology tests.”By April 7, <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests">over 70 test developers</a> had notified FDA that they had validated serology tests available for use but were not seeking an EUA. However, FDA has <a href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations">authorized a dozen EUAs</a>. At present, FDA policy regarding serological antibody tests has three distinct features:<ol><li>Validating Tests. <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts">FDA announced</a> in late April that it is collaborating with the National Institutes of Health (NIH) to establish a capability at NIH to evaluate serology tests for developers. In short, any serology test seeking an EUA should meet NIH standards for validation and submit its test to NIH for independent verification, which FDA will use in its EUA decision process.</li><li style="margin-top: 1rem;">Requiring EUA for Commercial Manufacturers. FDA revised its <a href="https://www.fda.gov/media/135659/download">Policy for COVID‑19 Tests during the Public Health Emergency</a> (first issued in February and revised in March) this week. FDA reversed course and now requires that commercial manufacturers of antibody tests submit EUA requests along with their validation data within 10 business days from the date they notified FDA of their validation testing or from the date of this policy revision, whichever is later. The prior list of antibody tests that had submitted notification to FDA of validation (but which were not seeking an EUA) has been removed from the FDA website and is no longer available. It is our understanding that all commercial manufacturers of serology tests that had provided such notice to FDA must submit an EUA to FDA by May 20, or those serology tests will be considered unauthorized products. This is presumably why the list of “notified” serology tests has now been removed from the public FDA website.</li><li style="list-style-type: none;margin-top: 1rem;">Laboratories certified by CLIA to perform high complexity tests may continue to develop and use antibody tests without an EUA from FDA, but FDA does encourage even labs to consider submitting an EUA.</li></ol> <ol start="3"><li style="margin-top: 1rem;">Including Warning Labels. Last month, <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests">FDA warned</a> that some firms were falsely claiming their serology tests were approved by FDA. The agency advised that it will take appropriate action against firms making false claims, which could include removing products from the market or referring them to criminal investigators. It repeated this admonition Monday.</li></ol>Ultimately, FDA is requiring commercial manufacturers to submit EUA requests for their serology tests, as an EUA will assure laboratories and providers that FDA has reviewed that test. The agency is working around the clock to review EUA submissions and ensure this process is streamlined and efficient. In fact, it recently created EUA Templates for <a href="https://www.fda.gov/media/135659/download#page=21">test kit manufacturers</a> and <a href="https://www.fda.gov/media/135659/download#page=33">laboratories</a> to facilitate submission of an EUA for a serology test. But as an added measure, it has begun providing performance <a href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance">threshold recommendations</a> for specificity and sensitivity to the serology tests it has authorized.The FDA guidance outlined above works in tandem with the Public Readiness and Emergency Preparedness (PREP) Act—<a href="https://www.federalregister.gov/documents/2020/04/15/2020-08040/amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical">as expanded</a> by the Coronavirus Aid, Relief, and Economic Security (CARES) Act—and corresponding guidance from the U.S. Department of Health & Human Services (HHS) and Office of the Assistant Secretary for Health (OASH), an agency within it. HHS issued an <a href="https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf">omnibus advisory opinion</a> regarding PREP Act immunity, which we summarized <a href="https://classdismissed.mofo.com/fda/hhs-guidance-broadens-prep-act-immunity-tightens-focus-on-public-private-cooperation/">here</a>. As an Authority Having Jurisdiction under the PREP Act, OASH then extended this immunity to <a href="https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf">licensed pharmacists</a>, authorizing them to order and administer serology tests that FDA has “authorized.” By doing so, such pharmacists will qualify as “covered persons” under the PREP Act and may receive immunity with respect to claims for loss caused by, arising out of, relating to, or resulting from the use of such tests.Although OASH included a footnote to FDA’s Emergency Use Authorizations, it did not state whether Prep Act immunity was premised on obtaining an EUA. We would argue it was not. At that time, FDA policy specifically allowed serology tests to be marketed and used if the test developers provided notice of validation to FDA. Before the policy reversal, “authorized” serology tests could have included those tests listed on FDA’s website as having submitted notice of validation, whether or not they were submitting EUA requests. Further, when OASH issued its guidance on April 8, FDA had only granted one EUA; therefore, this guidance could not “rapidly expand[] COVID-19 testing across America” if it was referring to a single test. Still, FDA’s revised policy requiring EUAs for all serology tests creates uncertainty, and neither HHS nor OASH appear to have issued new guidance regarding serology tests since FDA reversed course. We encourage anyone evaluating potential PREP Act immunity to consult legal counsel. In addition, the Morrison & Foerster COVID-19 Task Force will continue to provide updates to consumer-facing product manufacturers as agencies issue new guidance.Follow Morrison & Foerster’s <a href="https://lifesciences.mofo.com/">Life Sciences</a> blog to stay informed as we continue to report on FDA’s evolving role and its impact on the medical product industry.

COVID-19 Alert: FDA Updates Antibody Test Policy

Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the bloo

COVID-19 Alert: FDA Updates Antibody Test Policy

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers.”Still, as we <a href="https://classdismissed.mofo.com/fda/fda-warns-against-at-home-covid-19-testing-kits/">previously reported</a>, no diagnostic test had been authorized for at-home collection by Americans. But <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection">that changed last Tuesday</a> when FDA authorized the first diagnostic test with an at-home collection option for COVID-19. Specifically, the agency re-issued an EUA for the Laboratory Corporation of America’s (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home.Importantly, the EUA is not a general authorization for at-home tests fully conducted at home. Instead, the EUA permits at-home collection using LabCorp’s designated self-collection kit, which contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make these kits available to consumers in most states (with a doctor’s order) within the coming weeks.FDA worked with LabCorp to ensure that at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. FDA encourages developers to discuss their validation of home use or self-collection tests with the agency early in their development process.To that end, while the LabCorp self-collection kit includes a specific nasal swab and may not be used with other cotton swabs at the present time, FDA is working with test developers to determine whether or not Q-tip-style cotton swabs can be used safely and effectively with other tests.The Morrison & Foerster COVID-19 Task Force will continue to provide updates as FDA issues guidance for consumer-facing product manufacturers.

COVID-19 Update: FDA Authorizes First At-Home Collection Kit

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to F

COVID-19 Update: FDA Authorizes First At-Home Collection Kit

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>.

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Associate

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

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

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>.

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

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19.The PREP Act grants tort liability immunity to manufacturers, developers, sellers, and prescribers of certain medical countermeasures during a public health emergency. In response to the COVID-19 pandemic, the Secretary of HHS <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/">issued a PREP Act declaration</a> last month. The Act immunizes “covered persons,” with respect to all claims for loss arising out of the use or administration of a “covered countermeasure.” But the complexity of these defined terms makes it difficult for entities to determine whether they are protected. The new guidance clarifies the countermeasures, entities, and activities that are covered by the PREP Act declaration and expands protections in a way that encourages cooperation between private parties and public health agencies.Covered CountermeasuresUnder the PREP Act, a covered countermeasure is a qualified pandemic or epidemic product, a security countermeasure, or a product authorized under a Food and Drug Administration (FDA) emergency use authorization (EUA). A recent amendment also includes respiratory protective devices approved by the National Institute of Occupational Safety and Health (NIOSH) as covered countermeasures.Most COVID-19 products would seek to qualify as pandemic or epidemic products. The new HHS guidance states that any product used for COVID-19 that is approved, licensed, or cleared by FDA, authorized under an EUA, described in Center for Disease and Control and Prevention (CDC) Emergency Use Instructions, or being researched under investigational provisions is covered as a qualified pandemic product. Additionally, the CARES Act amended the PREP Act to add  certain NIOSH-approved respiratory protective devices to the definition of “covered countermeasures..”Covered PersonThe guidance explains many of the terms related to “covered person” in the PREP Act. A covered person is a manufacturer, distributor, or program planner of covered countermeasures, a qualified person who prescribes or administers such a countermeasure, or any agent or employee of one of these entities. A program planner is a person who supervises or administers a program to dispense certain countermeasures, including those who offer advice or guidance regarding such a program. And a qualified person is a licensed health professional who is authorized to prescribe countermeasures.A qualified person also includes anyone authorized to prescribe or administer countermeasures in accordance with the public health and emergency response of an Authority Having Jurisdiction. That means that any such Authority—which is a public agency or its delegate with legal responsibility and authority for responding to the COVID-19 emergency—can extend PREP Act immunity to a person or entity by authorizing them to administer covered countermeasures.Strict Compliance Not RequiredIn the spirit of encouraging the development and manufacture of medical products, PREP Act applicability will not be interpreted strictly. The advisory guidance acknowledges that the Act’s definitions may be difficult to parse, and that this uncertainty may chill the market participation that the Act is meant to encourage. As such, the new guidance provides that entities will not be held to a strict-liability standard regarding whether a product is a covered countermeasure or whether a person is a covered person.In other words, persons who in good faith believed that a product was a covered countermeasure will enjoy immunity, even if it turns out the product was not. Likewise, an entity that reasonably believes it is a covered person will be treated as such and will not lose PREP Act immunity, even if it does not meet the statutory definition. As long as the entity otherwise meets the PREP Act requirements and reasonably could have believed that the product or person was covered, they will be protected. For example, if a distributor obtains COVID-19 products that claim and appear to be covered by an EUA but are actually counterfeit, the distributor will still enjoy immunity, even though the goods are not technically covered countermeasures under the statute.Entities should still perform due diligence to ensure operation within the parameters of PREP Act protection. But they should not fear major tort exposure because of an accidental failure to strictly comply with the statute so long as they take reasonable steps to confirm that products fall within the PREP Act’s definition of covered countermeasures.Reasonable PrecautionsAside from remaining open to enforcement actions by government agencies, a covered person will only be liable for willful misconduct that proximately caused a serious injury or death once PREP Act immunity applies. But the guidance clarifies that there is no willful misconduct if a program planner or qualified person acted consistently with the Secretary’s countermeasure use recommendations, so long as the entity notifies the Secretary or a local health authority of any serious injury caused by a product within seven days. Likewise, there is no willful misconduct if neither the Secretary nor the Attorney General initiates enforcement actions, or if an action is terminated or resolved without remedy.The guidance nevertheless encourages covered persons to document the reasonable precautions they have taken to safely use the covered countermeasures. This transparency allows downstream users to make more informed sourcing decisions.Industry TakeawaysThis guidance continues the trend of expanding incentives for companies to bring COVID-19 products to market. The expansion of covered persons and countermeasures, with the addition of “reasonably-could-have-believed” exceptions, aligns with earlier FDA and HHS policies, making it cheaper, faster, and less risky to bring these goods to market. Likewise, the additional encouragement to document precautions and notify local health authorities of injuries caused by countermeasures is consistent with FDA’s recent policy of keeping close post-market surveillance on COVID-19 products, which are developed on an expedited timeline.But a new development in the federal COVID-19 response is the emphasis on public/private cooperation for administering medical countermeasures. The guidance clarifies the discretion of public health agencies to confer PREP Act immunity. It also encourages parties to follow HHS guidelines and to report adverse events to HHS or even local health authorities. This reporting will likely inform those agencies’ policies and guidelines, thus representing a different kind of oversight from the traditional adverse event reporting to FDA, a body that is intended primarily to ensure the safety and efficacy of medical products. These developments add a dynamic element to PREP Act protection by rewarding cooperation between private companies and public agencies. While manufacturers are essential to produce goods, health agencies play the key role in directing how those precious resources will be spent. This guidance reflects that the two must work together during the next step in the battle against COVID-19.We will continue to report updates from public health agencies regarding PREP Act liability immunity as they arise.

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to 

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

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.

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

A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included:  Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell, a company that offers food sensitivity and various other home health tests, and Nurx, an app that delivers prescriptions and STI testing kits.But the U.S. Food and Drug Administration (FDA) quickly responded, demonstrating that it is actively and aggressively monitoring the market for products with fraudulent COVID-19 claims, as we previously reported <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/">here</a>.In its <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits">March 20 statement</a>, FDA directly warned consumers—and indirectly warned the startups—that it “has not authorized any test that is available to purchase for testing yourself at home for COVID-19.” In other words, it “is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.” FDA suggested that the public health value of expanded COVID-19 testing is predicated on testing that is “safe and accurate.”FDA also clarified its Policy for Diagnostic Tests for Coronavirus Disease-2019. The policy was <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics">published on February 29</a>, and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency">updated on March 16</a>, to expedite the availability of diagnostic tests. The policy describes the circumstances under which laboratories that develop and validate tests for coronavirus can use the tests before FDA has completed review of their Emergency Use Authorization (EUA). The policy only applies to laboratories that are certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments (CLIA).However, in an <a href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#offerhometest">FAQ section</a>, FDA clarified that it is not blessing at-home COVID-19 testing kits—even if they are developed by a CLIA-certified lab. Instead, FDA “encourage[d] developers to discuss their validation of home use and/or self-collection tests with [the agency] early in their development process.” Test developers and laboratories who have questions about the EUA process can contact FDA’s 24-hour toll-free phone line.The Morrison & Foerster COVID-19 Task Force will continue to provide updates as the FDA issues guidance for consumer-facing product manufacturers.