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

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

Partner

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

Adam Hunt

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

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

<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

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

newman_zak_blog_150x150.png

newman_zak_common_640x280.jpg

newman_zak_heroretina_2700x1160.jpg

newman_zak_mobileretina_750x1040.jpg

newman_zak_social_600x600.jpg

Associate

Zak Newman

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

hokanson_mitchell_blog_150x150.png

hokanson_mitchell_common_640x280.jpg

hokanson_mitchell_heroretina_2700x1160.jpg

hokanson_mitchell_mobileretina_750x1040.jpg

hokanson_mitchell_social_600x600.jpg

Mitchell Hokanson

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

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Adam J. Hunt

More

Alexandra Preece Barlow

Mitchell A. Hokanson

Software Gains New Status as a Product Under Strict Liability Law

MAHA Commission Publishes Report to Highlight Childhood Chronic Disease Drivers

Tenth Circuit Denies Challenge to CPSC Rule Regulating High-Powered Magnets

Ousted CPSC Democrats Fight Back Against President Trump

Setting Consumer Standards for Lithium-Ion Batteries Act

LinkedIN

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>

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

Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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

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

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

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

Appellate & Supreme Court

Product Liability

Pharmaceutical & 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 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

Privacy

Drug & Medical Device

Consumer Products

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

Class Certification

Food Misbranding

Retail

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

makeup-gettyimages-648954620-600px_image.jpg

“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 deca

In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other manufacturers. The U.S. Food and Drug Administration also recognizes the growing importance of these connected devices and issued final guidance on Sept. 6, 2017, relating to their safety.Interoperable medical devices can provide incredibly valuable data to health care providers and patients. Health information that may have taken several doctors’ visits to gather could literally be at a patient’s fingertips with a tap on their smartphone.At the same time, these devices often have highly sensitive applications, such as pacemakers and blood pressure monitors, that give rise to unique safety risks. The guidance urges safety and transparency in developing and designing interoperable medical devices, and highlights information that manufacturers should include in premarket submissions and device labeling. This final guidance follows a draft guidance issued by the FDA in January 2016.Please see our full article as published on <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt3b19f144a7fc88a1/627310c6b5ad5f2863c59400/171016-fda-guidance-medical-devices.pdf" target="_blank" rel="noopener">Law360</a>.

scheinok_brittany_blog_150x150.png

scheinok_brittany_common_640x280.jpg

scheinok_brittany_heroretina_2700x1160.jpg

scheinok_brittany_mobileretina_750x1040.jpg

scheinok_brittany_social_600x600.jpg

Brittany Scheinok is a partner in the Litigation Department of the firm’s San Diego office.

Brittany Scheinok

gettyimages-682158022_small_thumbnail.jpg

Understanding FDA Guidance On Connected Medical Devices

Understanding FDA Guidance On Connected Medical Devices

gettyimages-682158022_small_image.jpg

In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to 

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a citizen’s petition calling for the same warnings.  Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017).Factual BackgroundPlaintiffs (mother, father, and their child) alleged that the fertility drug Clomid led to the child’s birth defects due to the mother’s use of the drug before becoming pregnant.  They sued under Utah tort claims, including failure to warn, breach of implied warranty, negligent misrepresentation, and fraud.Relying on the doctrine of impossibility preemption, the district court granted the defendant’s motion for summary judgment, holding that, because the FDA “would not have approved the drug warnings that the Cervenys allege are required under Utah law,” it was impossible for Aventis to comply with both FDA regulations and state law.On appeal, the plaintiffs relied on a 1987 proposed FDA warning that “Clomid may cause fetal harm when administered to pregnant women.”  Although Aventis did not adopt the FDA’s proposed warning, and even though it only applied to those who took the drug while pregnant (unlike the plaintiff in this case), the Cervenys contended that (1) the proposed warning demonstrated the FDA’s willingness to approve warnings for women taking Clomid before becoming pregnant, and (2) Ms. Cerveny would not have taken Clomid before her pregnancy if Aventis had used the proposed warning.Impossibility PreemptionThe Cerveny court began with a discussion of basic preemption principles.  The court explained that federal law will preempt a state law when (1) the language of the federal law reveals an express congressional intent to preempt state law (express preemption); (2) federal regulation is so all-encompassing that Congress must have intended to leave no room for a state to supplement it (field preemption); or (3) compliance with both the federal and state laws is a physical impossibility (conflict preemption).  When a state’s regulations for drug labels conflict with the FDA’s, preemption issues arise.Impossibility preemption is at play when state law is preempted because compliance with both the federal and state laws is a physical impossibility – the laws are inapposite such that complying with state law necessarily results in a violation of federal law.  In Cerveny, Aventis made that very argument: it only needed to comply with the FDA regulations and not Utah state law because complying with both would be impossible.In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court established a loose framework for determining when federal law could preempt state law failure-to-warn claims against branded drug manufacturers.  Specifically, the defendant must present “clear evidence” that the FDA would have rejected the desired label change in order to preempt a state law failure-to-warn claim.  Id. at 571.Wyeth did not define “clear evidence,” but instead left the question to the lower courts.  A recent Third Circuit case interpreted Wyeth’s not-so-clear “clear evidence” language.  According to In re Fosamax Alendronate Sodium Prods. Liab. Litig., 852 F.3d 268, 285 (3rd Cir. 2017), the phrase “clear evidence” sets forth a standard of proof synonymous with “clear and convincing evidence” and involves a question of fact rather than a question of law.In order to preempt the state law failure-to-warn claim, a manufacturer needs to convince a factfinder that it was “highly probable” that the FDA would not have approved a change to the drug’s label.  The Cerveny court adopted this interpretation.The Court’s “Clear Evidence” AnalysisAs clear evidence that the FDA would not have approved plaintiffs’ suggested warnings, Aventis pointed to (1) the FDA’s history of approving Clomid for use by women before becoming pregnant, and (2) the FDA’s rejection of a citizen’s petition.Although the court determined that Clomid’s regulatory history did not, in and of itself, constitute clear evidence, the FDA’s rejection of a citizen’s petition did provide the requisite evidence.  In 2007, a citizen petition was filed demanding stronger Clomid warnings regarding the potential risks of fetal harm when a woman takes Clomid prior to becoming pregnant.  The FDA first denied the petition in 2009 and in 2012 declined to reconsider its original denial, reasoning that the original denial had “appropriately applied the standards in the [Federal Food, Drug, and Cosmetic Act] and FDA regulations regarding drug safety, warnings, and potential safety hazards.”The standard used by the FDA in rejecting the citizen’s petition was the same standard the FDA would have applied in evaluating a proposed label change to Clomid.  Because the FDA concluded in evaluating the citizen’s petition that the requested additional warnings were unjustified as to risks related to taking Clomid prior to pregnancy, the court determined that, had Aventis sought FDA approval to include stronger pre-pregnancy warnings, the FDA would have denied the request, just as it did the citizen’s petition.The plaintiffs argued that when the FDA considers proposed label changes, it treats manufacturers more favorably than citizen’s petitions, which “leads the FDA to accord greater deference to changes proposed” by manufacturers than those proposed in citizen petitions.  In rejecting this argument, the court explained that the FDA standard for revising a warning label “does not discriminate” between proposals submitted by manufacturers and proposals submitted by citizens.The Cervenys attempted to use the 1987 FDA proposed label change regarding use during pregnancy to argue that Ms. Cerveny would not have taken Clomid prior to becoming pregnant if Aventis had adopted the 1987 proposed label.  They argued that the proposed label would have warned women more directly about the potential harm to a fetus when a woman takes Clomid during pregnancy.  The district court agreed with Aventis that, even if Aventis accepted the proposed label change, Ms. Cerveny took Clomid prior to her pregnancy and therefore the label would not have applied to her.  Under Utah law, a plaintiff cannot allege as a defect in a label a warning that would not have applied to her.Aventis moved for summary judgment based solely on preemption.  While the Cervenys urged the district court to ignore Aventis’s state-law argument, the district court granted Aventis’ motion for summary judgment without explaining why or how a state law defense fell within the scope of the motion that was based solely on preemption.The appellate court remanded the issue because the district court did not “consider whether it could rest on [state] law when deciding a summary judgment motion that had relied solely on federal preemption.”  This leaves open the possibility that this claim could similarly be rejected based on federal preemption at the district court level.Looking ForwardThis ruling clarifies a defendant’s burden of proof in establishing a preemption defense.  It establishes that the FDA’s denial of a sufficiently similar citizen’s petition satisfies the clear-evidence standard required to successfully preempt a failure-to-warn claim.  Therefore, branded drug manufacturers have an additional evidentiary tool even when no other form of FDA decision-making exists to demonstrate that the FDA would have rejected a label change.Ultimately, if other circuits follow the Tenth Circuit’s lead, pharmaceutical companies may no longer need to demonstrate an attempt to provide the kind of warning allegedly required under state law.  We anticipate that going forward parties will disagree on the issue of how similar a citizen’s petition needs to be in order to have this preemptive effect.  Identical?  Virtually identical?  Substantially similar?  In Cerveny, the Tenth Circuit acknowledged that the citizen’s petition was “virtually identical” to the warnings the Cerveny’s advocated; however, we anticipate that courts may still find a preemptive effect when a citizen’s petition is substantially similar to proposed warnings.  So long as the substance of the proposed warning is the same, as well as its effect on the consuming public, it is unlikely that a decision will turn on semantics.*Co-author Karina Pundeff is a summer associate in our San Diego office.

gettyimages-172748011_small_thumbnail.jpg

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

gettyimages-172748011_small_image.jpg

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about 

*This is an update to a previous post on the Class Dismissed blog, seen <a href="http://classdismissed.mofo.com/consumer-products/the-revival-of-ecj-lawsuits-sweet-tooth-for-plaintiffs-or-toothless-claims/" target="_blank" rel="noopener noreferrer">here</a>.On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because she failed to provide specifics about her own Sports Beans purchase.  The court held that the Complaint was implausible because it only provides a cursory and formulaic recitation that Ms. Gomez purchased the Product relying on Jelly Belly’s representations regarding the ingredients of the Product, and that but for those representations, she would not have purchased or paid as much for the Product.  See Gomez v. Jelly Belly Candy Company et al., No. EDCV 17-00575-CJC(FFMx) (C.D. Cal. June 8, 2017) (Dkt. No. 17) (order granting motion to dismiss with leave to amend).  The Judge noted that “[a]bsent from the complaint are any factual allegations concerning the circumstances of Gomez’s purchase of the product, how she intended to use the product, whether she in fact expected a sugar-free product, whether she thought ‘evaporated cane juice’ was juice as opposed to sugar, and whether she consumed the product.”  Id.Judge Carney also struck Ms. Gomez’s prayer for injunctive relief, finding that it is impossible for her to be deceived in the future by Jelly Belly’s use of the term ECJ, because she now knows that it really means “sugar.”  Judge Carney accordingly joins the list of district court judges who have refused to allow plaintiffs to pursue claims for injunctive relief given their awareness of the misrepresentations alleged in their complaints.The court granted leave to amend and Ms. Gomez filed an Amended Complaint on June 22, 2017.  The Amended Complaint provides more details regarding the circumstances surrounding Ms. Gomez’s purchase and consumption of the Sports Beans; it is unclear whether these allegations will survive another motion to dismiss should Jelly Belly renew its challenge.

jellybeans-shutterstock_291088268-600px_thumbnail.jpg

UPDATE: The Revival of ECJ Lawsuits*

jellybeans-shutterstock_291088268-600px_image.jpg

*This is an update to a previous post on the Class Dismissed blog, seen here. On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because

UPDATE: The Revival of ECJ Lawsuits*

False Advertising

Introduction.  On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”) for allegedly misleading consumers by listing “evaporated cane juice” (ECJ) instead of “sugar” in the ingredient list of its “Sports Beans” candy.  The Gomez matter suggests that ECJ claims, previously dormant pending FDA’s issuance of final ECJ guidance, are now being filed and litigated since FDA issued its final guidance in May 2016. It remains to be seen, however, whether courts will dismiss these claims at the pleadings or summary judgment stage.Background on  FDA’s ECJ Guidance.  In 2009, FDA issued draft guidance stating that the term ECJ is false and misleading under Section 403(a)(1) of the FDCA because ECJ “does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups, as required by 21 CFR 102.5.).”  In other words, FDA suggested that ECJ could mislead consumers into believing that a product did not include sugar.  Instead of finalizing its Draft Guidance, FDA reopened the comment period on March 4, 2014.  In the meantime, ­­several lawsuits in the Northern and Central Districts of California were stayed pending FDA’s issuance of its Final Guidance.  (See e.g., <a href="http://classdismissed.mofo.com/fda/judge-seeks-answers-from-fda-on-ecj-draft-guidance/">The (Not So) Sweet Sound of FDA’s Silence:  Judge Seeks Answers From FDA on ECJ Draft Guidance.</a>)  On May 25, 2016, FDA issued its <a href="https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm502680.htm">2016 ECJ Final Guidance</a> (“2016 Final Guidance”), upholding its previous finding that the use of ECJ is false and misleading and further stating that “sweeteners derived from sugar cane should not be listed in the ingredient declaration by names such as ‘evaporated cane juice,’ which suggest that the ingredients are made from or contain fruit or vegetable ‘juice’ as defined in 21 CFR 120.1.”  After FDA issued the 2016 Final Guidance, stays were lifted in multiple cases, and new complaints have been filed alleging that the use of ECJ, instead of sugar, on an ingredient list violates the FDCA and California’s corresponding Sherman Act.The Gomez case.  One of these new ECJ lawsuits was filed by Ms. Gomez in February 2017 against Jelly Belly in San Bernadino Superior Court.  Plaintiff alleged that she, and others similarly situated, were misled by Sports Beans’ ingredient list because it lists ECJ rather than sugar.  Plaintiff further alleges that she was harmed because she would not have purchased the Sports Beans, or paid as much for them, had she known that they contained sugar.  She brings claims for violations of California’s CLRA, FAL, UCL, and for negligent misrepresentation under common law.  The lawsuit was removed in March to the Central District of California and assigned to Judge Carney.Jelly Belly’s Defense:  FDA’s Guidance is Not Binding Law.  Jelly Belly filed a motion to dismiss on April 21, 2017, arguing that Ms. Gomez failed to allege facts sufficient to show that the label was misleading to consumers or that it was material to their decision to purchase the Sports Beans.  In moving to dismiss Plaintiff’s claims, Jelly Belly contends that FDA’s Final Guidance is not binding law.  Indeed, FDA explicitly states that its “guidance documents, including this guidance, do not establish legally enforceable responsibilities,” but instead “describe [FDA’s] current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”Plaintiff’s Reliance on FDA’s Guidance.  In response, Ms. Gomez does not dispute that FDA’s 2016 Final Guidance is not binding law.  Instead, she contends that it does not matter, because “the law was settled long ago by the relevant statutes and regulations.”  The FDA’s 2016 Final Guidance simply clarified FDA’s position that the use of ECJ instead of sugar is false and misleading under 21 U.S.C. §343(a)(1) and its accompanying regulations.<a href="#_ftn1" name="_ftnref1">[1]</a>  Therefore, Plaintiff argues that Jelly Belly’s use of the term ECJ instead of sugar on Sports Beans’ label violates these regulations and §343(a)(1).  FDA’s 2016 Final Guidance was simply underscoring the alleged violation.Takeaway.  We have <a href="http://classdismissed.mofo.com/?s=ECJ+Guidance">written</a> about courts issuing stays on ECJ claims pending FDA’s issuance of the 2016 Final Guidance.  Now that the guidance is finalized, these claims have been revived and, as indicated by Gomez, are still being filed.  Yet it remains to be seen whether ECJ claims can survive motions to dismiss and/or motions for summary judgment.  Indeed, none of the 17 cases filed in the Northern District of California have advanced beyond the pleadings.  In fact, Judge Chen recently dismissed in its entirety the ECJ claim in Swearingen v. Healthy Beverage, LLC because the label of the product at issue included a link to the product’s website, which “specifically states that ‘cane juice is natural sugar.’”<a href="#_ftn2" name="_ftnref2">[2]</a>  Similarly in Gomez, Jelly Belly argues that ECJ is listed right below the product’s sugar content on the Nutrition Facts Panel, so purchasers of the Sports Beans who read the label would know that it contains sugar.Although Judge Chen’s holding does not address Ms. Gomez’s argument regarding the FDA’s 2016 Final Guidance, it does suggest that plaintiffs who raise ECJ claims may be required to show that there is no other way for them to know that the product at issue contains sugar.We will provide updates with relevant developments.<a href="#_ftnref1" name="_ftn1">[1]</a> These regulations include the following: (1) 21 C.F.R. § 184.1854 (FDA’s definition of “Sucrose” as “a substance obtained by crystallization from sugar cane or sugar beet juice that has been extracted by pressing or diffusion, then clarified or evaporated”), (2) 21 C.F.R. 104(b)(20) (the common name for “sucrose” is “sugar”), (3) 21 C.F.R. 101.4(a)(1) (ingredients must be referred to by their common or usual name on food labels), (4) 21 C.F.R. 102.5(d) (the common or usual name of an ingredient is the name established by common usage or regulation), and (5) 21 C.F.R. 102(a) (the common or usual name of an ingredient must accurately describe the basic nature of the food or its characterizing properties).<a href="#_ftnref2" name="_ftn2">[2]</a> Swearingen v. Healthy Beverage, LLC, et al.,  No. 13-cv-04385-EMC (N.D. Cal. May 2, 2017) (Dkt. No. 92) (order granting motion to dismiss).

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

Introduction.  On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not

The Revival of ECJ Lawsuits:  Sweet Tooth For Plaintiffs, or Toothless Claims?