Morrison Foerster’s Class Dismissed blog provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class actions lawsuits and product liability issues that affect consumer-facing companies. Through Class Dismissed, attorneys from our nationally recognized Consumer Class Action and Products Liability practices offer a real-time assessment of the developments in matters that are shaping the industry. This blog examines the full spectrum of consumer-related class action and product liability lawsuits ranging from false advertising, privacy, consumer product safety, ADA, food misbranding, TCPA, environment, retail, and government actions as well as nationwide and multidistrict litigation class actions.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Partner

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

<div class="videoWrapper"><iframe frameborder="0" class="sticky-video" allowfullscreen="1" title="Meet Penny Preovolos, Litigation Partner" src="https://www.youtube-nocookie.com/embed/hv7hYn-Bl7c?rel=0&showinfo=0;vq=hd1080" title="iframe"></iframe></div>Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products. According to Chambers USA, Penelope has a “great reputation for antitrust and product liability work” and is a “superb all-around antitrust lawyer.”Penelope was named the 2019 Antitrust Lawyer of the Year by the Antitrust, UCL, and Privacy Section of the California Lawyers Association. She was co-chair of MoFo’s antitrust practice for 14 years. She has served as chair of the Antitrust and Trade Regulation Section of the State Bar of California and as a member of the Ninth Circuit Advisory Committee on Local Rules and Operations. She is an editor of and frequent contributor to Morrison & Foerster’s <a href="https://classdismissed.mofo.com/">Class Dismissed blog</a>, as well as a frequent speaker about class action and antitrust issues.More About PenelopePenelope clerked for the Honorable Charles M. Merrill, United States Court of Appeals for the Ninth Circuit. She graduated cum laude from Harvard Law School, where she was executive editor of the Harvard Civil Rights – Civil Liberties Law Review. Penelope was a member of Phi Beta Kappa at the University of California, Berkeley. She was awarded the University Medal, the highest undergraduate honor at the university, as well as the English Departmental Citation (awarded to the outstanding graduate in that department).

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Senior Counsel

Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products.

Penelope A. Preovolos

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class action lawsuits. Claudia also regularly counsels clients in the food, cosmetics, retail, and technology industries. She represents companies in false advertising disputes before the National Advertising Division (NAD) of the Council of Better Business Bureaus, Inc.<h5>More about Claudia</h5>Claudia is active in MoFo’s pro bono efforts, and recently traveled to El Paso, Texas, to work with families separated and detained at the border. She is also supervising a pro bono collaboration with Equal Rights Advocates, a nonprofit fighting for gender justice in work places and schools across the country. The initiative will help students who have been victims of sexual assault, attempted assault, or harassment find support and seek justice. Claudia is also a board member of Bay Area Legal Aid and a former board member of Equal Rights Advocates. Claudia is an editor and frequent contributor to MoFo’s <a href="https://classdismissed.mofo.com/">Class Dismissed</a> blog, which provides reports about the latest defense news, developments, and trends in class action lawsuits and product liability issues that affect consumer-facing companies. Her perspectives are also respected in the larger legal community: Claudia has published articles about class action and false advertising issues, and is a co-author of Chapter 7 — “Unfair Competition in California Business Litigation 2016” — of The Recorder. She also regularly speaks at conferences on class action and advertising trends. Claudia is currently serving as a Lawyer Representative for the Northern District of California. She received her J.D. degree in 2004 from Berkeley Law (Boalt Hall School of Law), where she was an associate editor of the Berkeley Technology Law Journal.

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.Alexandra has significant trial experience. She has first-chaired a one-week jury trial and second-chaired a five‑week jury trial, both involving multiple claims and witnesses. She also has extensive experience in alternative dispute resolution, representing clients at mediations, mandatory settlement conferences, and early neutral evaluations.Alexandra enjoys tracking developments and keeping her clients updated on product liability and personal injury claims, frequently writing or presenting on emerging areas such as autonomous vehicles and smart devices. Alexandra’s experience also extends to professional liability, warranty claims, eminent domain, and construction law.Alexandra earned her J.D. from the University of San Diego School of Law. While in law school, the San Diego Law Review published her comment on the recovery of damages by plaintiffs in a persistent vegetative state, and she also served as a comment editor. She received her B.A. from the University of California, Los Angeles, where she majored in Political Science and minored in Spanish. A San Diego native, she attended a Spanish immersion school through the eighth grade. Alexandra is active in the San Diego community, advising students at a local college. She is also a member of several legal organizations in San Diego, including Lawyer’s Club, the Association of Business Trial Lawyers, and Wallace Inn of Court.

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Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra’s litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, automobiles, AI, and robotics. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow

Adam J. Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.Mr. Hunt has extensive experience representing consumer products companies, financial institutions, and technology firms in class action cases and complex commercial disputes before state and federal trial courts, as well as in arbitrations. Clients seek Mr. Hunt’s counsel for his creative, strategic thinking in high-stakes, high-profile matters. He has represented clients facing claims under false advertising, antitrust, and privacy laws throughout the country, securing wins at the pleading stage, summary judgment, and trial, in addition to negotiating favorable settlements, often early in the case. Representative experience includes successfully securing rulings dismissing two putative false advertising class action cases against one of the best-known consumer electronics companies in the world; obtaining a complete win on summary judgment for a major shipping and logistics company in a multimillion-dollar commercial dispute; appearing as counsel at trial for a leading financial institution in a $100 million commercial dispute, winning a bench trial verdict; and prevailing on motions to dismiss false advertising class actions against a leading Greek yogurt company.Mr. Hunt is also an editor of the firm’s <a href="https://classdismissed.mofo.com/" target="_self">Class Dismissed blog</a>, which provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class action lawsuits that affect consumer-facing companies.Mr. Hunt maintains an active pro bono practice and is the recipient of the New York State Bar Association’s 2017 President’s Pro Bono Service Award for the First Judicial Department, the 2018 Public Service Award from New York University School of Law, and Morrison Foerster’s Kathi Pugh Award for Pro Bono Services.Mr. Hunt received his B.A. with honors from Swarthmore College and his J.D. cum laude from New York University.

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Adam Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.

Adam Hunt

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Alexandra Preece Barlow

Adam J. Hunt

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

New Wave of PFAS Legislation Aimed at Consumer Products

CPSC Releases Annual Report on Deaths and Injuries Involving Nursery Products

CPSC Proposes New Safety Rules for Infant Rockers

CPSC Commissioners Abstain from Retracting Infant Sleep Product Statements

On February 12, 2016, the Ninth Circuit affirmed the district court’s decision barring the California Attorney General’s efforts to enforce nonfunctional slack fill provisions against Del Real LLC, a producer of Mexican heat-and-serve meat and poultry products.  Del Real LLC v. Kamala D. Harris et al., No. 13-16893.  The district court had issued a permanent injunction barring the AG’s enforcement on the basis that the claims were preempted by the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).   Del Real LLC v. Kamala D. Harris, 966 F. Supp. 2d 1047 (E.D. Cal. 2013).The Ninth Circuit affirmed the preemption ruling, finding that California’s nonfunctional slack fill provisions are in “in addition to, or different than” the federal statutes’ general prohibitions against containers “filled as to be misleading.”  The court articulated two reasons why it would be impermissible to allow the California provisions to be applied to meat and poultry products: (1) the legislative history of the FMIA and PPIA shows a clear intent to create a uniform national labeling standard, counseling against allowing the states to develop variant standards; and (2) Congress intended to allow meat and poultry packaging to be subject to less specific regulation than other types of products.  The court reasoned that both of these intentions suggest it is unlikely that Congress intended for the states to be allowed to develop and apply more specific standards to slack fill for meat and poultry products.The court noted, however, that nothing in its decision should be read to prevent California from addressing misleading packaging of meat and poultry products in accordance with its concurrent authority under the FMIA and PPIA.

Ninth Circuit Affirms Bar on California AG’s Efforts to Enforce Slack Fill Provisions Against Del Real in Meat and Poultry Case

On February 12, 2016, the Ninth Circuit affirmed the district court’s decision barring the California Attorney General’s efforts to enforce nonfunctional slack 

Ninth Circuit Affirms Bar on California AG’s Efforts to Enforce Slack Fill Provisions Against Del Real in Meat and Poultry Case

Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the Health Insurance Portability and Accountability Act (HIPAA) that, among other things, broadened the definition of a “Business Associate,” many technology companies found themselves wondering whether they were, or were not, subject to HIPAA. Health and Human Services (HHS) recently issued some guidance, Health App Use Scenarios & HIPAA, that attempts to provide some clarity on these issues for app developers.

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

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

Julie Park

Julie Park | Product Liability Lawyer

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HIPAA and Health Care Apps: Is Your App Covered?

HIPAA and Health Care Apps: Is Your App Covered?

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Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the H

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Welcome to Class Dismissed

The Internet of Things (IoT) is booming. Smart cars, wearable health trackers, connected medical devices, drones—entrepreneurs and evolving industry are connecting to the world in ways only science fiction writers imagined. In 2008, the number of connected devices surpassed the number of people on earth. By 2020, conservative estimates predict the IoT market will grow to $7.1 trillion (up from $1.9 trillion in 2013). Its massive scale and expected future growth belies the simple truth that IoT is still in its infancy. In fact, you were probably born before IoT was; the market didn’t even have a name until 1999.As with any profitable and developing market, legal questions abound. IoT is no different, especially for designers and manufacturers of novel devices. What happens if your product injures a customer? What kind of data should your product collect? Do you have a duty to review and understand all the information your product provides? What happens when your connected device gets hacked? How much control should customers have over connected devices? Is a recall necessary when a product’s connection to the Internet fails but the product still works? These questions all share a common thread: there is not yet a developed body of case law with the answers.Because of companies’ abilities to capture, analyze, and capitalize on information gathered from connected devices, one of the most important questions for IoT companies concerns data ownership and governance. Who “owns” all of the data that’s being collected by these billions of devices? Again, the courts have not weighed in on this yet. But we have some ideas that may help companies stay out of trouble in courtrooms.Figure It Out Early. Where ownership of data hasn’t been properly appropriated, we expect significant disputes between all interested parties. This means companies may be unwittingly signing up for prolonged litigation down the road when they haven’t made clear (1) what data it plans to collect; (2) what it plans to do with that data; and (3) how much say the consumer has in limiting the amount or kind of data collected. Much of what a company can, or should, do with information collected depends on (1) the type and source of the data; (2) the specific ways in which the data will be used; (3) the scope of disclosure or consent given by the data subject; (4) contractual restrictions on data usage; and (5) regulatory authority over the use of data. These complicated and often intertwined factors require serious analysis and foresight when bringing novel products to market.Take for example, a “smart” thermostat. This cool device provides the manufacturer with advanced metrics about consumer usage and preferences. In turn, the company can use this information to implement firmware updates designed to reduce overall energy use or to provide personalized settings for individual users. The company could also analyze aggregate data and use patterns from all of its customers to tailor its marketing and design for future models. The company may further capitalize on this data by selling it to third parties for research or analysis purposes. But what if a customer objects (or sues!) saying it didn’t agree to the company using or selling data collected from his or her home? Or more concerning, what if a third party breaks into the company’s database and can ascertain when a customer has turned off his or her smart thermostat and is, therefore, not home? When the hacker then robs the customer’s house and the customer sues the manufacturer for failing to keep his or her information safe, who’s to blame? Although they may not provide an answer to every disagreement down the road, clearly delineated user agreements and disclaimers can go a long way in providing customers’ expectations of what their data will or will not be used for.With great data comes great possibilities. We are here to remind you that these possibilities can also lead to great risks. Check back for more tips and insights on IoT!

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Internet of Things: Whose Data Is It Anyway?

Digital Single Market Update: Technology Standardization in the EU

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The Internet of Things (IoT) is booming. Smart cars, wearable health trackers, connected medical devices, drones—entrepreneurs and evolving industry are connect

Internet of Things: Whose Data Is It Anyway?

Chobani recently suffered a major setback in its battle with Dannon over the advertising of low-calorie Greek yogurt. Judge David Hurd of the Northern District of New York issued a preliminary injunction on January 29, 2016, barring Chobani from continuing its “Simply 100” campaign—a compendium of television, print, and online ads touting Chobani’s Simply 100 Greek yogurt as containing no artificial sweeteners or preservatives as compared to Dannon’s Light & Fit Greek yogurt. See Chobani, LLC v. Dannon Co., No. 3:16-CV-30, 2016 WL 369364, at *8 (N.D.N.Y. Jan. 29, 2016).Chobani’s Ads. Chobani’s ads attack Dannon for adding sucralose, an artificial ingredient made by adding chlorine compounds to sucrose molecules to form a chloride, to its yogurts. A Chobani television commercial features a woman sitting by a pool, inspecting the ingredients of Dannon’s Light & Fit Greek yogurt, with a voiceover exclaiming that the product contains artificial sweeteners like sucralose, which contains added chlorine. The woman discards the Dannon product and instead chooses Simply 100 Greek yogurt, with a voiceover claiming that Chobani is “the only 100 calorie light yogurt sweetened naturally.” The scene cuts back to the pool with the final shot, which includes the hashtag “#NOBADSTUFF.” Chobani’s print and electronic ads include similar messages and images. The Litigation. Chobani extended its attack to the courtroom, seeking a declaratory judgment that its “Simply 100” campaign was not false, misleading, disparaging, or deceptive under the Lanham Act, 15 U.S.C. § 1125(a). Dannon struck back, asserting Lanham Act and related state law false advertising counterclaims. It also moved for a preliminary injunction to prevent Chobani from continuing its “Simply 100” campaign pending a trial on the merits.Chobani’s Defense. Chobani contended that the statement that sucralose contains added chlorine is literally true and that the remainder of its messages were mere “puffery”: expressions of Chobani’s own opinion that its products are superior. The Court’s Decision. The court disagreed. It concluded that Chobani’s “Simply 100” campaign conveys the literally false message that sucralose in Dannon’s Light & Fit Greek yogurt contains added chlorine, rendering the product unsafe to eat. However, the FDA has determined that sucralose is safe; the chloride compound created to manufacture sucralose is found throughout nature and in numerous natural food sources. By contrast, pool chlorine is a powerful bleach and disinfectant that is harmful if added to foods or ingested. The language and images (such as the pool scene) in Chobani’s ads conveyed the false impression that the chlorine in sucralose is harmful and unsafe.The court concluded that Chobani’s direct attacks against its competitor’s products were more than mere “exaggeration[s] or overstatement[s] expressed in broad, vague, and commendatory language.” 2016 WL 369364, at *8 (citation omitted). And even if the statement that chlorine was added to sucralose were literally true, “the message conveyed by the advertisement may still be ‘literally false’ if its clear meaning, considered in context, is false.” Id. (emphasis added). Here, a consumer could readily conclude that the entire context of the “Simply 100” campaign “unambiguously convey[s] the literally false message that Dannon’s product contains sucralose and is therefore unsafe to consume.” Id. at *9. Dannon thus had met the requirements for a preliminary injunction: (1) it was likely to prevail on its Lanham Act claim; (2) it was likely to suffer irreparable harm if Chobani continued its campaign; and (3) the balance of hardships and public interest weighed in Dannon’s favor. Key Takeaways. As Chobani demonstrates, a puffery defense typically is not effective against Lanham Act and related state law false advertising claims if the ads at issue directly attack a competitor. The decision also demonstrates the importance of analyzing an allegedly false claim in context. While Dannon used this argument offensively, relying on the full context of an advertisement can also be a successful defense to false advertising claims if the defendant can show that the advertisement as a whole clarifies any ambiguities or allegedly misleading statements. Chobani is a reminder to advertisers to consider the full context of their ads, and not to assume that “puffery” offers an easy way out of alleged falsity.

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Chobani Suffers Setback in Greek Yogurt Wars

Chobani Suffers Setback in Greek Yogurt Wars

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Chobani recently suffered a major setback in its battle with Dannon over the advertising of low-calorie Greek yogurt. Judge David Hurd of the Northern District 

On February 2, 2016, the FTC settled claims against Sale Slash LLC regarding the marketing of its weight loss pills, including Premium Green Coffee, Pure Garcinia Cambogia, Premium White Kidney Bean Extract, Pure Forskolin Extract, and Pure Caralluma Fimbriata Extract. FTC v. Sale Slash, Case No. CV15-03107 PA (AJWx). The FTC alleged that Sale Slash misrepresented the effectiveness of its “bogus” weight loss pills, improperly used spam emails, and used fake celebrity endorsements to market its products.As part of the stipulation for a permanent injunction and monetary penalties, Sale Slash agreed to pay $43 million in equitable monetary relief to settle the claims. In addition, the stipulation bars Sale Slash from (1) sending emails that fail to identify the sender, that include misleading subject headings, and/or that lack a proper opt-out option for recipients; (2) using fake celebrity endorsements; and (3) making weight loss or health-related claims unless Sale Slash can substantiate the claims with competent and reliable scientific evidence.

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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

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Diet Pill Company Sale Slash to Pay $43 Million in Settlement with FTC Over Spam Email and Fake Celebrity Endorsements

Diet Pill Company Sale Slash to Pay $43 Million in Settlement with FTC Over Spam Email and Fake Celebrity Endorsements

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On February 2, 2016, the FTC settled claims against Sale Slash LLC regarding the marketing of its weight loss pills, including Premium Green Coffee, Pure Garcin

The FDA’s recently issued draft guidance on “<a href="http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm482022.pdf" target="_blank">Postmarket Management of Cybersecurity in Medical Devices</a>” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about postmarket cybersecurity standards related to medical devices. Because the consequences of cybersecurity breaches related to medical devices can be serious, manufacturers, health care facilities, and providers should take precautions to ensure that cybersecurity policies and protocols are thorough and up-to-date. It should be noted that this draft guidance is still in draft form and not to be implemented yet.Imagine this scenario: A rogue agent gains access to the serial number on the Vice President’s pacemaker. The agent sends the number to an associate who remotely hacks his way through the device’s security framework and accelerates the Vice President’s heart rate, inducing a heart attack. Sound familiar? Fortunately, this was not a news report; rather, it was a plot line during the second season of Showtime’s television series Homeland. But like many science fiction predictions, this one has already found roots in reality. With the rapidly expanding Internet of Things, and with millions of medical devices now connected to the Internet, hackers have more devices to target every day. Many of these devices, like the pacemaker in Homeland, are essential to a customer’s health, and as a result security breaches should not be taken lightly.BackgroundIn February 2013, President Obama issued <a href="https://www.whitehouse.gov/the-press-office/2013/02/12/executive-order-improving-critical-infrastructure-cybersecurity" target="_blank">Executive Order 13636</a>, which stated that cyber threats to national security are among the most serious our nation faces. Additionally, <a href="https://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil" target="_blank">Presidential Policy Directive – 21</a> tasks Federal agencies to strengthen the security and resilience of critical infrastructure against physical and cyber threats. The FDA’s draft guidance borrows principles from these directives and represents the FDA’s current efforts to help strengthen cybersecurity in the rapidly-growing medical device market. Moreover, the FDA encourages manufacturers to apply the voluntary National Institute of Standards and Technology (“NIST”) framework in the development and implementation of their cybersecurity controls. Although the NIST framework only applies to critical infrastructure, the FDA encourages applying its principles broader than critical infrastructure and offers guideposts for companies to improve their cybersecurity posture.Although the FDA’s guidance does not establish legally enforceable responsibilities, it does paint a picture of the FDA’s “current thinking” on this topic, though it should be noted that the draft guidance does not establish any rights for any person, and it is not binding on the public or the FDA, and medical device manufacturers retain the ability to use alternative approaches.Focusing primarily on patient safety, the FDA recommends that medical device manufacturers monitor, identify, and respond to cybersecurity vulnerabilities and exploits during the postmarket management of their devices. The draft document also provides some guidance concerning reporting duties related to cybersecurity breaches.General Principles Concerning Postmarket RegulationThe FDA states that its position is that medical device cybersecurity is a shared responsibility that implicates not just the manufacturer of medical devices, but also health care facilities, patients, and providers, though manufacturers are likely to be on the front line of any litigation.The FDA stated its view that due to the continuing evolution of cybersecurity risks associated with medical devices, it is not possible to eliminate risks through premarket controls alone. Accordingly, manufacturers should[1] increase their postmarket cybersecurity risk management measures. The draft guidance suggests that medical device manufacturers focus on certain aspects, including:<ol><li>Identify problem areas in cybersecurity framework. This can be achieved through analysis of complaints, returned products, service records, and other sources of data that may help identify existing and potential cybersecurity risks. Many medical devices now contain or share internal records, statistics, and incident reports related to their performance. These metrics can be crucial for manufacturers to identify potential weaknesses in their cybersecurity armor before they are exploited.</li><li>Characterize and assess the identified vulnerabilities with regards to exploitability and potential severity of impact to health. This includes establishing and communicating the process for receiving and managing vulnerability reports. The FDA guidance provides additional detail and recommends using a cybersecurity vulnerability assessment tool or similar scoring system in this process.</li><li>Clearly define “essential clinical performance” of the medical device at issue in order to develop safeguards that protect, respond, and recover from the cybersecurity risk. Essential clinical performance is defined as “performance that is necessary to achieve freedom from unacceptable clinical risk.” In turn, an unacceptable clinical risk is one with high exploitability potential that poses a severe impact to health. The FDA admits that risk assessment may be difficult (i.e. manufacturers may struggle to categorize a risk as acceptable or unacceptable). Even so, the FDA recommends that manufacturers “make a binary determination that a vulnerability is either controlled or uncontrolled using an established process that is tailored to the product, its essential clinical performance, and the situation.”</li><li>Adopt a coordinated vulnerability disclosure policy and practice. Clearly defining user expectations and allocating risks appropriately can save manufacturers time and money in the long run.</li><li>Deploying mitigations that address cybersecurity risk early and prior to exploitation. If possible, risks should be addressed before they are exploited. Not only will early action protect customers, it may also limit potential damage claims down the road. The FDA notes that “acceptable mitigations will vary according to the device’s essential clinical performance”—i.e., manufacturers should apply a sliding scale analysis. For example, the FDA notes that more significant mitigation may be necessary for a vulnerability affecting an insulin pump than one affecting a thermometer.</li></ol>The FDA recognizes that even in the most sophisticated cybersecurity programs, vulnerabilities may arise and complete security is impossible. The FDA’s guidance focuses only on those vulnerabilities that may affect safety. Manufacturers should be cognizant that other issues beyond the scope of the draft guidance could become the focus of other regulating bodies and/or plaintiffs’ attorneys.ReportingThe FDA document also provides some guidance to manufacturers with regard to reporting cybersecurity vulnerabilities and breaches to the FDA. Generally, the FDA does not plan to require premarket review or approval of “cybersecurity routine updates and patches” to medical device software.Additionally, the FDA does not plan on requiring reporting when changes to a device are made to address vulnerabilities associated with controlled risks. Controlled risks are those that present “sufficiently low residual risk that the device’s essential clinical performance could be compromised by the vulnerability.” Reporting is also not necessary when these changes are implemented “solely to strengthen cybersecurity.” However, the FDA suggests that companies report newly acquired information about cybersecurity vulnerabilities and device changes made as part of a cybersecurity routine update or patch in an annual report when they concern a premarket approval (or Class III) medical device (one that supports or sustains human life).The draft guidance provides a relevant example where manufacturers may not have to report an action to mitigate a controlled risk. In this example, a manufacturer becomes aware of an “open communication port” on its device. However, a design feature prevents unauthorized remote firmware from being downloaded onto the device. This requirement for physical access to the device substantially mitigates the threat; therefore, the risk is considered by the FDA to be controlled and acceptable. The manufacturer then enhances the device’s security by closing the open communication port and notifying users. These actions would be considered a cybersecurity routine update or patch and may not require reporting under federal standards. However, if this were a Class III device, the manufacturer would need to report the changes to the FDA in its annual report.On the other hand, when manufacturers implement risk control measures to account for uncontrolled risks to essential clinical performance, the FDA’s view is different, and reporting might be necessary. However, the FDA does not intend to enforce these reporting requirements when:  (1) there are no known serious adverse events or deaths associated with the vulnerability; (2) within 30 days, the manufacturer identifies and implements device changes and/or compensating controls to bring the residual risk to an acceptable level and notifies users; and (3) the manufacturer is a participating member of an Information Sharing Analysis Organization (“ISAO”)[2], such as the National Health Information Sharing & Analysis Center.The FDA’s drafters may have been Homeland fans as the guidance contains a familiar example where reporting may be necessary:  a manufacturer becomes aware of a vulnerability in a Class III medical device (i.e. a pacemaker) that allows it to be reprogrammed by an unauthorized user. The manufacturer performs a risk assessment and concludes that the vulnerability is moderately exploitable and the risk to the device’s essential clinical performance is uncontrolled. The manufacturer notifies the relevant stakeholders and distributes an emergency patch to mitigate the risk. The manufacturer is not a member of an ISAO. Even if the manufacturer is unaware of any incidents, because this vulnerability could result in severe injury or death, reporting may be necessary.ConclusionEven in light of the FDA’s guidance, manufacturers will likely struggle to categorize risks associated with cybersecurity vulnerabilities. Consequently, determining reporting requirements (contingent on whether a risk is uncontrolled or controlled) may also present challenges unique to each medical device at issue. Manufacturers will be well served by factoring in the FDA guidance into their existing cybersecurity plans. [1] The use of the word should in Agency guidance means that something is suggested or recommended, but not required.[2] An “ISAO” is a group created to gather, analyze, and disseminate critical infrastructure information. See <a href="https://www.whitehouse.gov/the-press-office/2015/02/13/executive-order-promoting-private-sector-cybersecurity-information-shari" target="_blank">Exec. Order No. 13691 (Feb. 13, 2015)</a>.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that me

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

On January 29, 2016, NAD recommended that Church & Dwight, the maker of OxiClean White Revive, modify or discontinue various advertising claims conveying the message that chlorine bleach is damaging or “scary” if used on white garments. Church & Dwight Co., Inc. v. OxiClean White Revive, Case No. 5919 (Jan. 29, 2016). The NAD challenge was filed by competitor The Clorox Company, whose rival product is Clorox Regular Bleach. Clorox challenged several advertising claims, including:<ul><li>Bleach is “scary.”</li><li>“We read the care labels on thousands of white garments and we were surprised they had this warning symbol which means do not use chlorine bleach.”</li><li>“Get the tough stains out without the worry of chlorine bleach.”</li><li>“Do not use Chlorine bleach.”</li><li>“Try OxiClean White Revive. The way clothes love to be whitened.”</li></ul>Advertisements at Issue. Two television commercials were at issue in the NAD challenge. The first is the “Test Lab” commercial, in which an announcer in a white lab coat in the “OxiClean White Revive Stain Remover Laundry Lab” states, “We read the care labels on thousands of white garments” and “were surprised they had this warning symbol, which means do not use chlorine bleach.” A large amount of white clothes fall on the floor from the ceiling into a pile. The announcer then says that OxiClean White Revive is the clear choice, and concludes: “Get the tough stains out without the worry of chlorine bleach.”The second challenged advertisement, the “Scary Bleach” commercial, begins by asking “Why is bleach so scary to clothes?” It shows a white shirt clutching the back of its owner. The commercial then states, “It’s right on the tag, don’t use chlorine bleach.” It then concludes, “Try OxiClean White Revive. The way clothes love to be whitened.”Clorox argued that the message conveyed by these commercials is that chlorine bleach is both dangerous and not efficacious. NAD’s Decision. NAD agreed with Clorox, and found that if Church & Dwight’s advertising conveys that bleach is “damaging or scary to white garments,” it must have a reasonable basis for the claims based on reliable testing demonstrating that chlorine bleach is damaging to the kinds of white garments depicted in the advertising. Since Church & Dwight did not have this evidence, NAD recommended that Church & Dwight discontinue the “Scary Bleach” commercial. NAD further recommended that Church & Dwight modify its “Test Lab” commercial to remove words like “worry” and “warning” when referring to the care labels on garments and to avoid conveying a message that chlorine bleach is damaging to white garments.

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NAD Recommends Church & Dwight Discontinue OxiClean “Scary Bleach” Advertising Claims

Full Disclosure: New Labeling for Cleaning Products

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On January 29, 2016, NAD recommended that Church & Dwight, the maker of OxiClean White Revive, modify or discontinue various advertising claims conveying the me

NAD Recommends Church & Dwight Discontinue OxiClean “Scary Bleach”  Advertising Claims