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

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

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

<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

Zak is an associate in the Litigation Department in Morrison Foerster’s New York office.Zak’s practice focuses on class actions, commercial litigation, white collar defense, government investigations, and antitrust litigation and counseling. He has represented clients before federal and state courts in complex commercial matters, as well as in arbitration tribunals.Zak received his J.D. from New York University School of Law in 2018, where he was inducted into the Order of the Barristers. During law school, Zak also served as the Marden executive editor for the NYU Law Moot Court Board. In 2013, Zak received his B.A. and M.A. in political science from Yale University, receiving honors in his major and the Ellsworth Prize for Best Senior Essay in the Social Sciences.

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Associate

Zak Newman

Mitchell A. Hokanson is an associate in the Litigation Department of Morrison Foerster’s San Diego office.Mitchell’s practice focuses on commercial litigation and consumer class actions. He has extensive experience with civil litigation, including managing day-to-day strategy, propounding and responding to discovery, taking and defending depositions, and engaging in motion practice. He also has experience providing regulatory advice to clients, including pro bono partners and multinational corporations. Mitchell maintains an active pro bono practice.After law school, Mitchell worked as a judicial clerk for Justice Susan M. Carney of the Alaska Supreme Court, where he drafted bench memoranda and opinions on a wide range of state and federal law topics. Prior to joining MoFo, Mitchell worked for another international law firm, where he was a member of the Complex Civil Litigation practice group, in Los Angeles, California.Mitchell received his J.D. from Columbia Law School, where he was honored as a James Kent Scholar and Harlan Fiske Stone Scholar. While in law school he was the senior executive editor of the Columbia Journal of Environmental Law and worked as a judicial intern for Judge Sandra S. Ikuta of the United States Court of Appeals for the Ninth Circuit and Judge George B. Daniels of the United States District Court, Southern District of New York. Prior to that, Mitchell earned his B.A. from Stanford University.

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Mitchell Hokanson

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The FTC’s Final “Click-to-Cancel” Rule Faces Legal and Political Hurdles

Right-to-Repair Laws: The Trend Continues

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

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.

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

Using Waivers to Curb COVID-19 Legal Exposure

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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. Department of Transportation (“DOT”) steered into a new direction that may accelerate the development of self-driving technologies. The DOT’s National Highway Traffic Safety Administration (“NHTSA”), in an effort to modernize Federal Motor Vehicle Safety Standards (“FMVSS”), issued a <a href="https://www.nhtsa.gov/files/occupantprotectionforadsnprmwebsiteversionpdf">notice of proposed rulemaking</a> on Tuesday seeking to ease certain safety requirements for Automated Driving Systems (“ADS”).NHTSA’s Goal to Change Regulations that Hinder InnovationNHTSA’s goals with the proposal were outlined in a <a href="https://www.nhtsa.gov/press-releases/adapt-safety-requirements-ads-vehicles-without-manual-controls">statement </a>from Acting Administrator James Owens. Acting Administrator Owens said, “With more than 90 percent of serious crashes caused by driver error, it’s vital that we remove unnecessary barriers to technology that could help save lives. . . . We do not want regulations enacted long before the development of automated technologies to present unintended and unnecessary barriers against innovation and improved highway safety.”The National Traffic and Motor Vehicle Safety Act prohibits certain regulated entities from manufacturing for sale, selling, offering for sale, introducing or delivering into interstate commerce, or importing any motor vehicle or equipment that does not comply with FMVSS. See 49 U.S.C. § 30101 et seq. As NHTSA’s proposal recognizes, FMVSS “were promulgated long before vehicles equipped with ADS were contemplated, and thus, include a variety of assumptions surrounding who would be driving a vehicle, that the vehicle would have human occupants, and what protections drivers and occupants might need.” For the last few years, NHTSA has engaged with various stakeholders through the rulemaking process, and other public events, to understand the differences between ADS and traditional motor vehicles.How Proposals are Accommodating ADS NHTSA’s new proposal rewrites 11 standards found in the FMVSS’s 200 series of rules that pertain to vehicles and requirements for traditional manual controls. Proposed changes would affect rules related to occupant protection, steering wheels and controls, side-impact protection, roof crush resistance, seating systems, door locks, glazing materials, and child restraint anchorage systems.For example, under the revised rules, certain ADS would no longer be required to have traditional steering wheels and frontal passenger protection requirements would be applied to the traditional driver seat. The rationale put forth in the notice is that an occupant should not need protection from a steering wheel system if none exists in the vehicle. Other small changes would allow passenger seats to be designed to allow passengers to face each other instead of the road.While the proposals are aimed at removing certain barriers, NHTSA notes that the proposed changes mainly accommodate ADS that carry property or goods, not human passengers. As NHTSA’s proposal states, “much of this potential [for ADS] is currently unsubstantiated and the impacts unknown, the agency believes the most prudent path forward is to remove unnecessary barriers to innovation while ensuring that occupants continue to receive the same protection afforded by existing regulations.” Nothing is changing in regards to traditional motor vehicle safety.Takeaways for Moving ForwardThough finalizing the proposal will take some time, now is a critical period for interested stakeholders to get involved in the agency process to shape the development of ADS requirements. Agency regulators will be accepting comments from interested stakeholders for 60 days after the proposed rule is published in the Federal Register. Comments are anticipated from the auto industry, safety groups, and the public at large.Although suggested rule changes mainly accommodate ADS carrying property and goods, it may not be too long before NHTSA introduces proposals for ADS carrying human passengers. Any ADS developments pertaining to property and goods may set the course for future proposals related to ADS designed for human passengers.

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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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 mat

Claudia Vetesi

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

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Steering Ahead: NHTSA Looks to Modernize Rules for Automated Driving Systems

Steering Ahead: NHTSA Looks to Modernize Rules for Automated Driving Systems

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Last week, the U.S. Department of Transportation (“DOT”) steered into a new direction that may accelerate the development of self-driving technologies. The DOT’

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.

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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Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice 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 the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice 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

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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.

Julie Park | Product Liability Lawyer

Julie Y. Park

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