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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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.

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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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

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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

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FDA Warns Against At-Home COVID-19 Testing Kits

Using Waivers to Curb COVID-19 Legal Exposure

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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 healthc

FDA Warns Against At-Home COVID-19 Testing Kits

With nearly half of the United States population being either urged or ordered to stay at home and avoid all non-essential travel in light of the COVID-19 crisis, modern forms of communication such as telephone calls, video chat, and, of course, text messaging, are providing critical connections between business and consumers. Indeed, businesses may be looking for ways to reach consumers with information about inventory, shipment status, and other issues related to an increase in demand for all the things that people need to “shelter-in-place”—from groceries to yoga mats.Businesses by now know that calling or sending text messages to consumers is fraught with risk in light of the Telephone Consumer Protection Act (“TCPA”), which carries stiff statutory penalties and is a favorite tool of the class action plaintiffs’ bar. For the uninitiated, the TCPA regulates:  1) “autodialed, prerecorded, or artificial voice calls” to wireless telephone numbers, including text messages, without the prior express consent of the called party;<a href="#_ftn1" name="_ftnref1">[1]</a> and 2) artificial or prerecorded voice calls to residential telephone numbers without the prior express consent of the called party.<a href="#_ftn2" name="_ftnref2">[2]</a> In reviewing call or text message campaigns for TCPA compliance in light of the COVID-19 crisis, however, eagle-eyed readers may have noticed that the TCPA exempts from liability calls and messages that are made for “emergency purposes.”<a href="#_ftn3" name="_ftnref3">[3] </a>But as the FCC recently clarified in a March 20 Declaratory Ruling, although the TCPA exempts calls made for “emergency purposes,” that exemption is very narrow and applies only in very specific circumstances.<a href="#_ftn4" name="_ftnref4">[4]</a>The FCC’s rules provide that “calls made necessary in any situation affecting the health and safety of consumers” qualify as calls for “emergency purposes.”<a href="#_ftn5" name="_ftnref5">[5]</a> And in its March 20 Declaratory Ruling, the FCC acknowledged that “the current pandemic constitutes such an imminent health risk to the public.”<a href="#_ftn6" name="_ftnref6">[6]</a> But the FCC determined that only “certain callers may lawfully make automated calls and send automated text messages to wireless telephone numbers when such calls are necessary to protect the health and safety of citizens pursuant to the TCPA’s ‘emergency purposes’ exception.”<a href="#_ftn7" name="_ftnref7">[7]</a> Specifically, the FCC ruled that in order for the “emergency purposes” exception to apply, the calls or messages at issue must be:  1) made by hospital, healthcare provider, state or local health official, or other government official; and 2) “solely informational, made necessary because of the COVID-19 outbreak, and directly related to the imminent health or safety risk arising out of the COVID-19 outbreak.”<a href="#_ftn8" name="_ftnref8">[8]</a> Thus, “calls that contain advertising or telemarketing” do not qualify for the exception, even if the goods or services being offered may be critical for consumers who face travel restrictions.<a href="#_ftn9" name="_ftnref9">[9]</a> The FCC specifically stated that calls “advertising a commercial grocery delivery service, or selling or promoting health insurance, cleaning services, or home test kits” are not exempt from the TCPA.<a href="#_ftn10" name="_ftnref10">[10]</a> Accordingly, business should remain vigilant in all aspects of their TCPA compliance programs, despite the national emergency.One final note:  businesses must also be mindful about navigating individual state laws and emergency provisions governing telemarketing in the current environment. For example, last year, New York State passed legislation prohibiting “unsolicited telemarketing sales call to any person in a county, city, town or village under a declared state of emergency.”<a href="#_ftn11" name="_ftnref11">[11]</a> On March 7, 2020, Governor Cuomo declared a state of emergency. So, although New York law permits certain unsolicited telemarketing calls made during specific hours, and with required disclosures,<a href="#_ftn12" name="_ftnref12">[12]</a> while the state of emergency is in effect—currently until September 7, 2020<a href="#_ftn13" name="_ftnref13">[13]</a>— all unsolicited telemarketing calls in New York are prohibited. Companies therefore should remember that telemarketing call compliance does not end with the TCPA; it requires a multistate approach.<a href="#_ftnref1" name="_ftn1">[1]</a> See In the Matter of Rules and Regulations Implementing the Telephone Consumer Protection Act of 1991, DA 20-318 (March 20, 2020) (the “March 20 Declaratory Ruling”); 47 U.S.C. § 227(b)(1)(A).<a href="#_ftnref2" name="_ftn2">[2]</a> 47 U.S.C. § 227(b)(1)(B).<a href="#_ftnref3" name="_ftn3">[3]</a> See 47 U.S.C. § 227(b)(1)(A), (b)(1)(B).<a href="#_ftnref4" name="_ftn4">[4]</a> See March 20 Declaratory Ruling.<a href="#_ftnref5" name="_ftn5">[5]</a> See 47 CFR § 64.1200(f)(4).<a href="#_ftnref6" name="_ftn6">[6]</a> See March 20 Declaratory Ruling.<a href="#_ftnref7" name="_ftn7">[7]</a> Id.<a href="#_ftnref8" name="_ftn8">[8]</a> Id.<a href="#_ftnref9" name="_ftn9">[9]</a> Id.<a href="#_ftnref10" name="_ftn10">[10]</a> Id.<a href="#_ftnref11" name="_ftn11">[11]</a> N.Y. G.B.L. § 399-z(5-a).<a href="#_ftnref12" name="_ftn12">[12]</a> See NY G.B.L. §§ 399-p(2), 399-z(2).<a href="#_ftnref13" name="_ftn13">[13]</a> <a href="https://www.governor.ny.gov/news/no-202-declaring-disaster-emergency-state-new-york">https://www.governor.ny.gov/news/no-202-declaring-disaster-emergency-state-new-york</a>.

CCPA and Data Breach Class Action for Leading Software Company

BIPA Class Action Against Gaming and Hospitality Company

TCPA and Other Class Actions for Major Technology Company

Data Breach Class Action for Technology Company

Wiretap Act action against a Major Consumer Electronics Manufacturer

TCPA Class Action Against National Chain

In re Pharmaceutical Industry Average Wholesale Price Litigation

In re Verizon Wireless Data Charges Litigation

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Clients seek out Tiffany for her successful track record in defending class action claims on behalf of clients in a broad range of industries, including technology, healthcare, and consumer product companies. She represents numerous Fortune 500 companies in high-stakes litigation involving privacy and marketing claims in courts throughout the United States.

Tiffany Cheung

Clients seek out Tiffany for her successful track record in defending class action claims on behalf of clients in a broad range of industries, including technology, healthcare, and consumer product companies. She represents numerous Fortune 500 companies in high-stakes litigation involving privacy and marketing claims in courts throughout the United States.

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.

Text Messaging in a Time of COVID-19: FCC Guidance on “Emergency Messages” and Restrictions on Telemarketing in New York

With nearly half of the United States population being either urged or ordered to stay at home and avoid all non-essential travel in light of the COVID-19 crisi

Text Messaging in a Time of COVID-19: FCC Guidance on “Emergency Messages” and Restrictions on Telemarketing in New York

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

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of joint warning letters to several companies claiming their products—teas, essential oils, tinctures, and colloidal silver—could prevent or treat COVID-19.Warning Letters to Seven Companies The warning letters were sent to Vital Silver, Quinessence Aromatherapy, Xephyr, GuruNanda, Vivify Holistic Clinic, Herbal Amy, and The Jim Bakker Show on March 6, 2020. The joint letters and separate, corresponding press releases are available <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or">here</a> (FDA) and <a href="https://www.ftc.gov/news-events/press-releases/2020/03/ftc-fda-send-warning-letters-seven-companies-about-unsupported">here</a> (FTC).The companies claimed their products could be curative or healing, claims that were both directly and indirectly targeting coronavirus. For example, Quinessence Aromatherapy marketed “eucalyptus radiate,” an essential oil, as having “a powerful antibacterial, antifungal and anti-infectious action, which makes it extremely useful for all types of infection.” Quinessence Aromatherapy also alluded to COVID-19 in other marketing materials, including claims that it had the “most powerful anti-virus essential oils to provide defence against coronavirus.”The agencies also addressed products that more directly claimed to treat coronavirus, too. Herbal Amy, which sells teas and tinctures, was targeted by the agencies for the following claims about its product:“Corona virus treatment . . . All the herbs are specific in one way or another for this virus. A number of the herbs are strongly antiviral for corona viruses . . . . The formulations are preventative as well as specific for acute infections . . . .”In the jointly issued warning letters, the agencies ordered each company to cease selling products claiming to prevent or treat COVID-19, noting that the products lack competent and reliable scientific evidence, much less regulatory approval, supporting the companies’ claims. FDA stressed that these letters were part of its broader campaign requiring urgent measures to protect consumers from products that claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.FTC stated that, according to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent COVID-19.Numerous state attorneys general are also taking action against unauthorized and unsupported product claims. For example, Missouri Attorney General Eric Schmitt sued The Jim Bakker Show for selling “Silver Solution,” a dietary supplement, as a “coronavirus cure,” and New York Attorney General Letitia <a href="https://ag.ny.gov/sites/default/files/bakker_cease_and_desist_letter_notification.pdf">James issued</a> a “cease and desist” order to Bakker for the same. Washington Attorney General Bob <a href="https://www.atg.wa.gov/news/news-releases/ag-ferguson-statement-price-gouging-public-health-emergency">Ferguson announced</a> that his office “is investigating price gouging in the wake of the COVID-19 public health emergency.”Takeaways for Consumer-Facing Product Manufacturers <ul><li>Avoid sales of unapproved products. Avoid selling products that claim to prevent or treat COVID-19 without approval, clearance, and/or authorization under the FD&C Act. The warning letters covered diverse products including teas, essential oils, tinctures, and colloidal silver. In its corresponding press release, FDA also warned consumers that fraudulent COVID-19 products could include dietary supplements and other foods, as well as products purporting to be drugs, medical devices, or vaccines.</li><li>Avoid making claims without evidence. Avoid claiming that products can prevent or treat COVID-19 without competent and reliable scientific evidence under the FTC Act. FTC may consider a “misbranded” product unlawful. While there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of development and have not completed testing for safety or effectiveness.</li><li>Be proactive. Review marketing statements contained on websites, social media, and other sales channels. An FDA cross-agency task force was established to closely monitor for fraudulent products related to COVID-19, and it has already worked with major retailers and online marketplaces to remove more than three dozen product listings.</li><li>Assess potential exposure. With respect to FDA, failure to correct the FD&C Act violations may result in an injunction and seizure. On the other hand, failure to correct the FTC violations may result in an injunction and order to pay back money to consumers. Further, agency warning letters can often spawn consumer lawsuits, adding to companies’ potential legal exposure for unsupported claims.</li><li>Follow agency guidance. FDA and FTC are motivated to halt production of products with unapproved or unsupported claims because they can cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. Companies should continue to closely track agency-issued guidance.</li></ul>Conclusion In the coming days and weeks, we can expect more of these types of warning letters from FDA and FTC relating to COVID-19, as well as from state attorneys general. We will continue to provide updates as the federal agencies and state offices issue more guidance in the face of this rapidly evolving health crisis.

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit