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.

Social

Search

Editors

park_julie_blog_150x150.png

park_julie_common_640x280.jpg

park_julie_heroretina_2700x1160.jpg

park_julie_mobileretina_750x1040.jpg

park_julie_social_600x600.jpg

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).

preovolos_penelope_blog_150x150.png

preovolos_penelope_common_640x280.jpg

preovolos_penelope_heroretina_2700x1160.jpg

preovolos_penelope_mobileretina_750x1040.jpg

preovolos_penelope_social_600x600.jpg

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.

vetesi_claudia_blog_150x150.png

vetesi_claudia_common_640x280.jpg

vetesi_claudia_heroretina_2700x1160.jpg

vetesi_claudia_mobileretina_750x1040.jpg

vetesi_claudia_social_600x600.jpg

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.

preece_alex_blog_150x150.png

preece_alex_common_640x280.jpg

preece_alex_heroretina_2700x1160.jpg

preece_alex_mobileretina_750x1040.jpg

preece_alex_social_600x600.jpg

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.

hunt_adam_blog_150x150.png

hunt_adam_common_640x280.jpg

hunt_adam_heroretina_2700x1160.jpg

hunt_adam_mobileretina_750x1040.jpg

hunt_adam_social_600x600.jpg

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

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

Morrison Foerster’s Class Dismissed blog provides insights and reports on the latest news, developments, and trends that affect consumer-facing companies. Subscribe to receive the latest updates by attorneys from our nationally recognized Consumer Class Action and Product Liability practices.

Welcome to Class Dismissed

class-dismissed-welcome-image.jpeg

class-dismissed-welcome-image

Morrison Foerster’s Class Dismissed blog provides insights and reports on the latest news, developments, and trends that affect consumer-facing companies. 

Class Action

Blog - Terms of Use

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insight

The latest news and insights from the nationally recognized Consumer Class Action and Product Liability practices of Morrison & Foerster.

Class Dismissed

  Linkedin

MoFo LinkedIN

Class Dismissed Blog - RSS

Stay Connected

By submitting your data to subscribe to this blog, you approved Morrison & Foerster LLP to email you future information about MoFo news and events. You may opt-out at any time by sending a request to <a href="mailto:mofonews@mofo.com">mofonews@mofo.com</a>. To learn more about how Morrison & Foerster LLP uses and protects your personal data, please view our <a href="https://www.mofo.com/about/privacy-policy.html">Privacy Policy</a> at <a href="https://www.mofo.com/">www.mofo.com</a>.

Never miss a post from Class Dismissed. Enter your email below to stay up-to-date.

Subscribe

Class Action and Product Insights for Your Business

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

TCPA

Announcements & Press

Antitrust

Appellate & Supreme Court

Arbitration

Autonomous Vehicles & Robotics

Aviation & Drones

Class Certification

Consumer Products

Coronavirus (COVID-19)

CPSC

Drug & Medical Device

Emergency Use Authorization (EUA)

Environmental Law

False Advertising

FCRA

Food Misbranding

Government Actions

Internet of Things

Mass Torts

Pharmaceutical & Medical Devices

Privacy

Product Liability

Public Readiness and Emergency Preparedness Act (PREP Act)

Retail

Trials

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

More

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

LinkedIN

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

bosman_erin_blog_150x150.png

bosman_erin_common_640x280.jpg

bosman_erin_heroretina_2700x1160.jpg

bosman_erin_mobileretina_750x1040.jpg

bosman_erin_social_600x600.jpg

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

02_28_elc_blog_600px_v2_thumbnail.jpg

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

Using Waivers to Curb COVID-19 Legal Exposure

02_28_elc_blog_600px_v2_image.jpg

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

Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since former Commissioner Dr. Scott Gottlieb resigned unexpectedly in April and was followed by two temporary acting commissioners. Under a permanent commissioner, we will likely see more consistent and future-oriented policy agendas and programs, but the 2020 presidential election may threaten Hahn’s extended tenure as commissioner—a position nominated by the president with no fixed term. Hahn will most likely be compared to Dr. Gottlieb, the well liked and effective communicator. Hahn’s specific strategies and goals for the agency are not yet clear, but his experience as a researcher, practitioner, and administrator will give him valuable insight to take on the issues currently facing FDA. With a specialization in radiation oncology, he was most recently the Chief Medical Executive at the University of Texas M.D. Anderson Cancer Center, which has over 20,000 employees, runs on an annual budget of over $5 billion, and currently ranks as the top cancer center in the United States. Hahn earned respect as a skilled leader after becoming Chief Operating Officer of M.D. Anderson in 2017. At the time, the medical center was suffering major financial losses, but it became profitable merely months after Hahn stepped into the role. Before that, he was a professor, research director, and chief of the Radiation Oncology Department at the University of Pennsylvania Perelman School of Medicine. Hahn has also treated patients as a clinician. Despite his familiarity with running a large healthcare organization, he has never worked in government and his regulatory philosophy is largely unknown. He also has no notable ties to large pharmaceutical companies—a concern raised during Gottlieb’s confirmation process in 2017.Already on Hahn’s future agenda is teen vaping, which has garnered extensive media and government scrutiny due to a rising number of vaping-related illnesses and deaths. Although e‑cigarette products have been targeted by proposed state and federal legislation, they also fall under FDA’s regulatory authority. During his confirmation hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee, Hahn was questioned extensively about his position on a potential ban of flavored tobacco products. The Trump administration proposed the ban on flavored e‑cigarettes earlier this year, but retreated from implementing it before finally settling on a compromise position of banning some but not all flavored e-cigarette cartridges. Despite calling teen tobacco use an “urgent crisis in this country” and saying that “aggressive action needs to be taken to protect our children,” Hahn was similarly noncommittal to the ban. The cancer doctor’s refusal to take a clear stance on the issue led some committee members to question whether Hahn will remain objective against pressure from President Trump and industry lobbyists.In addition to e‑cigarette use, the HELP Committee expressed concerns about generic drug approval and availability, FDA’s framework for assessing cannabidiol‑based medical products, and ongoing management of the opioid crisis. Hahn’s approach to those issues remains to be seen, but he has promised to use “science and data” to guide his decisions as the next FDA Commissioner. Gottlieb, still a prominent voice in the industry, has continued to criticize the current CBD supplement and beverage industry, outside FDA. We will continue to monitor and report on Commissioner Hahn’s impacts on the regulatory landscape alongside other novel FDA regulation and compliance issues, and expect 2020 to be an exciting year as we all get to know him and understand his approach and priorities.

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

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

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

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

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

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

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

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

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

FDA is tackling cybersecurity threats head-on and expects industry to do the same.  Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices.  Industry should take note, as these developments detail the agency’s current expectations for companies preparing to combat future threats.  As part of FDA’s effort to get in front of these issues before they happen, it launched its first ever <a href="https://protect-us.mimecast.com/s/MDpGCAD9WrH5pVxvf9fqgA">Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook</a> (the “Playbook”).  FDA also announced two memoranda of understanding designed to improve information sharing about cybersecurity risks.  Finally, just last week, FDA released an update to guidance from 2014 concerning premarket expectations for devices susceptible to cybersecurity threats.

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

FDA is tackling cybersecurity threats head-on and expects industry to do the same.  Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a serie

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

In Hadley v. Kellogg Sales Company, Plaintiff Stephen Hadley, who has filed at least two additional lawsuits alleging the mislabeling of breakfast foods, sought certification of four California subclasses of purchasers of Kellogg’s cereal and cereal bar products.  On August 17, 2018, Judge Koh issued an order that carefully dissected Plaintiff’s request.  The court concluded that Plaintiff had established the requirements for class certification for several of his proposed subclasses challenging health claims on the labels of the products at issue.  Significantly, however, Judge Koh rejected Plaintiff’s attempts to certify a subclass challenging a representation made on the back of packaging of cereal bars.  She also concluded that Plaintiff had not established Rule 23(b)(3)’s predominance requirement as to his deceptive omission theory of liability due to his failure to present a viable damages model.Background. Plaintiff alleges that Kellogg’s use of statements containing terms such as “healthy,” “nutritious,” or “wholesome” on its cereal and cereal bar products misled consumers into believing that those products are healthy, when they are not because of the amount of added sugar they contain.  On this basis, Plaintiff alleges violations of the FAL, CLRA, and UCL, and asserts a claim for breach of warranty.  Plaintiff also predicates his consumer-protection claims on his allegations that Kellogg deceptively failed to disclose to consumers the products’ high sugar content, and that certain of the challenged statements violate FDA regulations.Narrowly Defined Subclasses Prevent Predominance Challenge Based on Lack of Exposure, But Back-of-the-Package Statements Do Not. Kellogg argued that many of the allegedly deceptive statements did not appear on the packaging of the cereal products for a substantial portion of the class period, and that this lack of uniform exposure created significant differences regarding the legal viability of class members’ claims.  The court disagreed.  Judge Koh reasoned that Plaintiff sidestepped this potential problem by narrowly defining the subclasses to include only those individuals who purchased products that actually displayed the challenged statements on their packaging.  Nevertheless, the court agreed with Kellogg that it could not infer class-wide exposure to the “wholesome goodness” statement that only appeared on the back panel of cereal bar packaging.  The court therefore declined to certify a subclass of purchasers of the cereal bar because it would have to conduct individualized inquiries to determine which class members saw the challenged statements.Advantage Realized Model Flunks Comcast for Omission Claims.  Comcast Corp. v. Behrend, 569 U.S. 27 (2013), requires a plaintiff to establish a damages model that matches his or her theory of liability and measures damages across the entire class.  Plaintiff claimed that his expert’s proposed “advantage realized model” satisfied the Comcast requirement for his theory that Kellogg deceptively failed to inform consumers about the allegedly high sugar content of its breakfast products.  Under the advantage realized model, Plaintiff’s expert proposed to measure the market advantage that Kellogg obtained by omitting that information.  The court concluded, however, that this model only provided a measure of nonrestitutionary disgorgement (Kellogg’s unjust enrichment), rather than restitutionary disgorgement (Plaintiff’s loss).  The court explained that nonrestitutionary disgorgement is not a permissible class-wide remedy under the FAL, CLRA, or UCL, and therefore Plaintiff’s damages model was not consistent with his omission theory of liability.Takeaway. Judge Koh’s decision in Hadley emphasizes that plaintiffs challenging multiple statements on multiple products in a single action are not excused from establishing the requirements for class certification for each product at issue and each theory of liability.  Even where defendants cannot entirely defeat class certification, they should parse plaintiffs’ broad requests and direct pointed attacks to particular products or theories of liability that are susceptible to challenge on any class certification requirement.  In particular, Judge Koh’s denial of class certification as to back-of-the-package statements and omission-based claims demonstrates that predominance and damages model requirements remain fruitful areas for opposing class certification.

shutterstock_721312936_600px_thumbnail.jpg

Mixed Results on Class Certification for “Cereal” Plaintiff

Mixed Results on Class Certification for “Cereal” Plaintiff

shutterstock_721312936_600px_image.jpg

In Hadley v. Kellogg Sales Company, Plaintiff Stephen Hadley, who has filed at least two additional lawsuits alleging the mislabeling of breakfast foods, sought

In December, the U.S. Food and Drug Administration (FDA) issued guidance on <a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf?utm_campaign=CDRH%20New%202017-12-05&utm_medium=email&utm_source=Eloqua&elqTrackId=0143682DBD922C680E5ECEF5378087CA&elq=3ca3ce2d66164349a31507fefc45ff0c&elqaid=1630&elqat=1&elqCampaignId=1050" target="_blank" rel="noopener">Technical Considerations for Additive Manufactured Medical Devices</a>.  The guidance represents FDA’s efforts to provide regulatory direction about additive manufacturing (AM)—the broad field of 3D printing—of medical devices.  Specifically, AM makes objects by sequentially building 2-dimensional layers and joining each to the layer below.  AM enables diverse design models without the need to retool or create complex manufacturing machines to build components.  The FDA guidance focuses on technical aspects of AM, and is organized into two topics:  (1) design and manufacturing considerations; and (2) device testing considerations.  The guidance notes that FDA “does not comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing” of AM devices.  Instead, FDA recommends testing and characterization for devices that include at least one additively‑manufactured component or additively‑fabricated step.  The guidance also reflects the agency’s current thinking on AM for medical devices.<a href="#_ftn1" name="_ftnref1">[1]</a>AM is a rapidly growing technology with numerous applications in medical devices.  Representing a step toward personalized medicine, AM can facilitate anatomically‑matched devices and surgical instrumentation by using the patient’s own medical imaging (these are referred to as “patient-matched devices”).  AM can create complex geometric structures that would otherwise be impossible to manufacture, or too costly to manufacture under traditional manufacturing approaches.  These technologies can prove life-saving.  For example, in 2012, after receiving emergency clearance from FDA, medical staff at the University of Michigan used AM processes to create a bioresorbable tracheal splint that they used to rescue an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia.<a href="#_ftn2" name="_ftnref2">[2]</a>  The splint was implanted in the infant’s airway, expanding the bronchus and allowing for future proper growth.  Within weeks, the infant was off ventilator support and breathing normally.  AM saved the baby’s life.Recognizing the benefits of AM, FDA is preparing for “a significant wave of new technologies that are nearly certain to transform medical practice.”  The FDA Commissioner does recognize that novel aspects of the AM process lack substantial clinical histories and experimentation.<a href="#_ftn3" name="_ftnref3">[3]</a>  Accordingly, use of AM techniques in sensitive medical contexts poses challenges, and FDA anticipates that manufacturers may struggle in “determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and acceptance methods for these devices.”  So far, FDA has reviewed more than 100 medical devices that were manufactured using AM techniques.  FDA also recently approved a drug for seizures that was 3D-printed to create a more porous matrix than the drug would have had if manufactured using traditional means.  This allowed the drug to dissolve more rapidly in the mouth.  FDA further anticipates that AM can lead to treatments for burn wounds and even artificial replacement organs.<a href="#_ftn4" name="_ftnref4">[4]</a>Design and Manufacturing Process ConsiderationsFDA anticipates that its standard premarket submission process will apply in equal force to AM devices as it does to traditionally-manufactured devices.  Accordingly, for Class II and III devices (and select Class I devices), manufacturers “must establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met per 21 CFR 820.30 Design Controls.”  The FDA further expects manufacturers to “establish procedures including validation of the manufacturing process of AM devices to ensure that the device can perform as intended.”  Especially where the final result of a process cannot be fully verified by subsequent inspection and testing, the process must be “validated with a high degree of assurance and approved according to established procedures.”Because several AM technologies and processing steps can be used in medical devices, the guidance urges manufacturers to “clearly identify each step in the printing process.”  In this vein, FDA recommends use of production flow diagrams coupled with high-level summaries of each critical step to help ensure product quality.  Each described process step should include “a description of the process, and identification of the process parameters and output specifications.”  Delineated, step-by-step descriptions of each process should be well documented to allow the manufacturer to identify and remedy any root causes of failures from manufacturing defects; absent such detailed process instructions, defects can be difficult to pinpoint and correct.  Because AM processes can be quickly modified and adapted to specific use-scenarios, dimensional specifications for the final device or component, as well as manufacturing tolerances of the manufacturing machine, should be properly documented.Additional considerations come with patient-matched devices, which may not have a “standard‑sized template” (since they are contoured to individual patients) and may be modified by clinical staff, the device manufacturer, or third parties in response to clinical inputs.  Because of this customizability, manufacturers “should clearly identify clinically relevant design parameters, the pre-determined range (min/max) for these parameters, and which of these parameters can be modified for patient-matching.”  The guidance specifically recommends, to the extent applicable, that manufacturers address:  (1) effects and necessity of imaging; (2) clinical and patient interactions with design models; (3) maintenance of data integrity of complex design files; and (4) the (cyber)security of personally identifiable information.FDA provides that “AM typically involves interaction between several software packages, often from different manufacturers[.]”  As a result, errors in file conversions and software interactions can negatively impact the quality of the AM process and final device.  For this reason, FDA recommends that manufacturers “verify the critical attributes and performance criteria of [their] final products as part of the software workflow validation to ensure expected performance, especially for patient-matched devices.”Further, once a device design is complete, manufacturers should consider additional preparatory processes, including:<ul><li>placement, orientation, and packing density of devices or components within the build volume;</li><li>use of additional support material or structures for certain design features;</li><li>layer thickness of each “slice” created by the AM machine as related to the layer-by-layer printing process;</li><li>the build path, or path traced by the energy or material delivery system (e.g., laser or extruder);</li><li>required machine parameters and calibrations (e.g., build speed, total energy density, and focal point or nozzle diameter); and</li><li>environmental conditions within the build volume (e.g., temperature, pressure, and atmospheric compositions).</li></ul>FDA recommends that materials used in AM processes should be well documented and chosen based on the AM technology used, the intended use of the final medical product, and any other information available.  Reuse of certain materials (something possible when using AM technologies) is allowed but should be scrupulously documented.  Evidence should be provided that reuse will not adversely affect the final device.  Any post-processing steps of AM (manufacturing steps occurring after the printing process) that may affect device performance and material properties should also be well documented and include analysis of any effects such steps may have.As noted above, when a final result of a process cannot be fully verified by subsequent inspection and testing, the process must be validated with a high degree of assurance.  For such validation processes, monitoring and control methods of data must be documented.  Such methods may include monitoring and documenting parameters such as:<ul><li>temperature at the beam focus;</li><li>melt pool data;</li><li>build-space environmental conditions;</li><li>location in the build volume where a device or component was built; and</li><li>power of the energy delivery system.</li></ul>These same methods may also be helpful for processes that are not required to be validated.Device Testing ConsiderationsGenerally, FDA advises that AM product performance testing should be implemented in the same manner as if the device were manufactured using traditional manufacturing methods.  Depending on the device type, these testing methods may include: “material property testing such as modulus, yield strength, ultimate strength, creep/viscoelasticity, fatigue, or abrasive wear.”  Further, performance testing should be conducted on all finished devices following post-processing, cleaning, and sterilization steps.  Manufacturers should also conduct tests targeting the “worst-case combinations” of dimensions, features, orientations of the materials, and locations in the build space to ensure adequate product performance.  These tests should include a discussion of how the combinations were selected and why each test was conducted.  Manufacturers should create and maintain “test coupons” (a representative test sample of the device or component) when evaluating AM products.Recognizing that AM processes may lead to a wider variance in end products than traditional manufacturing methods, FDA recommends that manufacturers specify and adhere to pre-set dimensional tolerances by measuring representative product samples.  Manufacturers should address any variability due to orientation and build location if studies show variance based on these parameters.  In order to maintain consistency, product measurements should be made on samples from multiple build cycles and manufacturers are expected to provide justification for the sampling scheme used.  Finally, process validation information may help demonstrate negligible variability between products in different build cycles or batches.Because of the iterative nature of AM, starting materials may be exposed to partial re-melting and solidifications multiple times.  This may result in unexpected or undesired material compositions.  Because many AM medical devices will be used in sensitive medical contexts (often surgically implanted into a patient), manufacturers should conduct biocompatibility testing and incorporate guidance proffered in “<a href="https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf" target="_blank" rel="noopener">Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’</a>” if necessary.  Specific testing (e.g., in vitro degradation testing) may be necessary if the AM device uses an absorbable material.One of the greatest advantages of AM devices is the ability to make highly complex components and end products.  With that advantage comes an inherent disadvantage—AM devices may be exceptionally hard to clean and sterilize.  AM also allows porous structures to be produced earlier in the manufacturing process than traditional methods, which may result in greater soiling by subsequent exposure to other AM materials.  Accordingly, manufacturers should create work-flows and be able to validate that any remaining material residue will not adversely affect the device’s quality.  A summary of this information should be included in premarket submissions to the agency.  Additionally, the guidance warns that many end-use facilities will not have access to the equipment or materials needed to implement on-site cleaning procedures designed to remove residual manufacturing materials.  Accordingly, only devices that are sufficiently cleaned should be provided to the end user.LabelingFinally, the guidance provides that AM device labeling “should be developed in accordance with applicable regulations, device-specific guidance documents, and consensus standards.”  Additional labeling is recommended for AM devices that are patient-matched.  FDA recommends that such labeling identify (1) the patient; (2) the products used (e.g., left distal femoral surgical guide); and (3) final design iteration or version used to produce the device.  Expiration dates for patient-matched devices should also be included.  Because it is possible that a patient may experience an event between imaging and surgery, FDA also recommends that manufacturers include a precaution in their labeling that the patient should be evaluated for potential anatomical changes prior to the procedure.ConclusionThough not binding, manufacturers should consider adopting the recommendations included in the FDA’s guidance on AM.  As with other FDA guidance documents, future regulations are likely to incorporate and expand on these existing guidelines.<a href="#_ftnref1" name="_ftn1">[1]</a>  The FDA categorized this document as “leap-frog” guidance because “it helps bridge where we are today with innovations of tomorrow.”<a href="#_ftnref2" name="_ftn2">[2]</a> Moore, Nicole, 3D Printed Splint Saves the Life of a Baby, Michigan Engineer News Center (May 22, 2013).<a href="#_ftnref3" name="_ftn3">[3]</a> Statement of FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products (Dec. 4, 2017), <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587547.htm" target="_blank" rel="noopener">https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587547.htm</a>.<a href="#_ftnref4" name="_ftn4">[4]</a> Id.

3dprintingdna_shutterstock_361057199_600px_thumbnail.jpg

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

3D Printing Meets Medical Devices:  FDA Weighs In On Additive Manufacturing

3dprintingdna_shutterstock_361057199_600px_image.jpg

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.  The guidance re

“Make fine lines and wrinkles disappear!”  “Reduce the visibility of fine lines and wrinkles!”  At first read, these claims sound one in the same.  But for decades, a slight difference in phrasing of cosmetics claims—created as a function of current cosmetics regulations—has been responsible for allegedly confusing customers and complicating regulations.  Lawmakers have tried and failed to reform federal cosmetics regulations in the past and are now gearing up for another attempt.Current FDA Regulation of Cosmetics (or Lack Thereof)The U.S. Food and Drug Administration (FDA) regulates both drugs and cosmetics under the Food, Drug, and Cosmetic Act (FDCA).  The FDCA defines a “cosmetic,” in part, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  21 U.S.C. § 321(i).  The FDCA’s definition of “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . ,” and “articles (other than food) intended to affect the structure or any function of the body of man . . . .”  21 U.S.C. § 321(g)(1).Certain products can meet the definitions of both cosmetics and drugs under the FDCA depending on their intended uses.  The claims made about a certain product are determinative of whether the product is regulated as a cosmetic, drug, or both.  For <a href="https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm">example</a>, a shampoo is a cosmetic because its intended use is to cleanse hair.  An anti-dandruff treatment is a drug because its intended use is to treat dandruff.  An anti-dandruff shampoo is therefore both a cosmetic and a drug, and is regulated by the FDA as both.  Unlike drugs or medical devices, however, cosmetic products and ingredients (with the exception of color additives) currently do not require FDA approval before they go to market.  For this reason, a cosmetic product containing the same ingredients as a drug product can enter the market without premarket oversight as long as the product is not advertised as having therapeutic uses.But drug claims and cosmetic claims can sound indistinguishable to a consumer.  Take anti‑aging products for <a href="https://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm388826.htm" target="_blank" rel="noopener">example</a>.  If a product is intended to make lines and wrinkles less noticeable by moisturizing the skin, it is a cosmetic because moisturizing is a cosmetic claim.  On the other hand, products intended to affect the structure of the skin are drugs even if they affect the appearance.  So a product that is intended to remove wrinkles or increase the skin’s production of collagen is a drug.  And the slight difference in the way these two products are advertised can create large disparities in the level of premarket regulations such as mandatory good manufacturing practices.Further, under present cosmetics regulations, cosmetics companies are not required to report postmarket adverse events.  The lack of premarket oversight and mandatory adverse event reporting has contributed to consumer concerns over the safety of the products they use every day.  For example, the FDA is currently investigating reports of hair loss and rashes linked to the use of WEN by Chaz Dean Cleansing Conditioner products.  By November 15, 2016, the FDA received 1,386 adverse event reports from consumers about these products, the largest number of reports ever associated with any cosmetic hair cleansing product.  However, the FDA also became aware of over 21,000 complaints reported directly to Chaz Dean, Inc. and the product distributor, Guthy Renker, LLC, during inspections of the companies’ facilities.  Had these companies been required to submit these reports to the FDA—as drug companies are—it is almost certain that far fewer customers would have been affected.Due to the fine line between the definitions of drugs and cosmetics, as well as the significant difference in FDA regulations for the two categories of products, stakeholders have been calling on lawmakers to reform cosmetics regulations for many years now.  Some believe this long‑overdue legislation is right around the corner.Two Senate Bills on Cosmetics Regulation ReformIn May 2017, Senator Dianne Feinstein (D-CA) reintroduced the Personal Care Products Safety Act, S. 1113, 115th Cong. § 1 (2017), which was originally introduced to the Senate in April 2015 with co‑sponsor Senator Susan Collins (R-ME).  Later in October 2017, Senator Orrin Hatch (R-UT) introduced the FDA Cosmetic Safety and Modernization Act, S. 2003, 115th Cong. § 1 (2017), to the Senate.  Both proposed bills include the following proposed regulations for cosmetics:Mandatory reporting requirements.  Both bills would require cosmetic manufacturers and distributors to report “serious adverse events” to the FDA within 15 business days of receipt of notice.  As defined by both bills, this would include adverse events associated with the use of a cosmetic product, ranging from disfigurement to death.  This is similar to the existing mandatory reporting requirement for drugs, see 21 C.F.R. § 314.80(c)(1), but adverse event reporting is currently voluntary for cosmetics.  The Feinstein‑Collins bill also includes an annual report requirement, under which companies would have to submit to the FDA a yearly report summarizing all adverse events for each cosmetic product marketed during that year.Registration of cosmetics facilities.  Both bills would require cosmetics manufacturing facilities to register with the FDA and would also give the FDA the authority to suspend a facility’s registration if its products have a reasonable probability of causing serious adverse health consequences or death.  The Feinstein‑Collins bill includes a registration fee based on a company’s annual gross sales of cosmetics.  By contrast, registration under the current regulatory scheme is voluntary, through a program that the FDA administers to collect information on product ingredient listings and registration of manufacturers, packers, and distributors on a voluntary basis.Submitting ingredients to the FDA.  The Feinstein‑Collins bill would also require companies to submit cosmetic ingredient statements for each cosmetic product to the FDA.  The Hatch bill does not contain an analogous provision.  Under the authority of the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. § 1451 et seq., the FDA already requires a list of ingredients for cosmetics marketed on a retail basis to consumers.  21 C.F.R. § 701.3.  Cosmetics that fail to comply with the FPLA are considered misbranded under the FDCA.  15 U.S.C. § 1456.Ingredient review.  Both bills would require the FDA to review the safety of certain cosmetic ingredients and non-functional constituents (incidental components of the ingredients) through a notice and comment process.  The Feinstein‑Collins bill would require the FDA to review at least five ingredients a year and goes as far as to set out the first five ingredients for review:  (1) Diazolidinyl urea; (2) Lead acetate; (3) Methylene glycol/methanediol/formaldehyde, propyl paraben; and (5) Quaternium-15.  The Hatch bill, on the other hand, would have the FDA, in conjunction with industry and consumer groups, identify ingredients for safety review based on public health concerns.  The Hatch bill also provides for accredited third‑party review of these selected ingredients.Good manufacturing standards.  Under both bills, the FDA would be required to establish mandatory good manufacturing practices, and, under the Hatch bill, a cosmetics manufacturers’ noncompliance would constitute the cosmetics being adulterated.  The FDA’s good manufacturing practices for cosmetics manufacturers are currently voluntary.  Both bills would provide small businesses with additional time to comply with the good manufacturing practices—one year under the Feinstein‑Collins bill and two years under the Hatch bill.Mandatory recall authority.  The Feinstein‑Collins bill would give the FDA the authority to order mandatory recalls, while the Hatch bill does not.  The FDA only has the authority to oversee voluntary recalls at this time.Past Failures on Cosmetics Regulation ReformWhile some are encouraged by the bipartisan support for cosmetics regulation reform, the fact that similar bills have previously died in Congress casts doubt on whether either of the Senate bills have any hope of becoming law.Just earlier this year, Representative Pete Sessions (R‑TX) reintroduced his bill, the Cosmetic Modernization Amendments of 2017, as H.R. 575.  This bill was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015, H.R. 4075.  Before this, similar legislation included the Cosmetic Safety Amendments Act of 2012, introduced by Representative Leonard Lance (R‑NJ), H.R. 4395; the Cosmetics Safety Enhancement Act of 2012, introduced by Representative Frank Pallone (D‑NJ), H.R. 4262; and the Safe Cosmetics Act of 2011, introduced by Representative Jan Schakowsky (D‑IL), H.R. 2359.Not one of these bills has passed.Looking AheadCosmetics companies should consider proactively adopting some of the proposed practices described above regardless of whether either of the currently pending bills becomes law in the near future.  As the two proposed bills indicate, any future FDA regulation of cosmetics would build upon the existing voluntary programs for cosmetics and mandatory reporting schemes for drugs, including the Voluntary Cosmetic Registration Program, existing adverse event reporting system, and Good Manufacturing Practices guidelines.  Efforts to employ these programs therefore would not be in vain.  Early adopters can also develop compliance programs at a predictable pace as opposed to an accelerated or unknown schedule set by future legislation.  Lastly, there is little doubt that consumers are demanding self‑regulation in this space in the absence of government action.  Premarket considerations can effectively minimize costly litigation down the road.

makeup-gettyimages-648954620-600px_thumbnail.jpg

Makeup Shake Up: Potential New Federal Cosmetics Regulations

Makeup Shake Up:  Potential New Federal Cosmetics Regulations