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

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

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

Erin M. Bosman

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

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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

Julie Park

Julie Park | Product Liability Lawyer

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

Prior to the California Legislature’s May 31, 2019 deadline to pass bills out of their chamber of origin, the California Assembly passed six additional bills that would amend the California Consumer Privacy Act (“CCPA” or “Act”). The California Senate now has until September 13, 2019 to consider and potentially pass these bills prior to the conclusion of the Legislature’s 2019 term.

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Recognized as an authority on financial privacy issues, Nathan helps financial institutions and other companies develop practical solutions for complying with privacy and data security laws. In partic

Nathan D. Taylor

Nathan Taylor

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CCPA: California Assembly Passes Additional Bills to Amend the CCPA

California Attorney General Holds Public Hearing in Los Angeles on Draft CCPA Regulations

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Prior to the California Legislature’s May 31, 2019 deadline to pass bills out of their chamber of origin, the California Assembly passed six additional bills th

CCPA: California Assembly Passes Additional Bills to Amend the CCPA

Last week, German regulators decided to no longer accept the widely used “JusProg” software as a sufficient means for online service providers to comply with statutory youth protection requirements. The decision is effective immediately, although it will most likely be challenged in court. If it prevails, it puts video-sharing platforms, distributors of gaming content, and online media services at risk of being held accountable for not properly protecting minors from potentially harmful content. For the affected providers, this is particularly challenging because it will be hard, if not impossible, to implement alternative youth protection tools that will meet the redefined regulatory standards.Our alert provides the legal background for the decision and discusses its implications in more detail. It is relevant to all online service providers that target German users.

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Counsel

Christoph advises national and international clients on a broad range of regulatory questions and has particular industry-specific experience in the areas of technology, media, and telecommunication.


Christoph Nüßing

Christoph Nüßing is a senior associate at Morrison Foerster’s German office in Berlin. He advises German and international clients on a broad range of regulatory questions and has particular industry-specific experience in the areas of technology, media and telecommunication.

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Youth Protection in Germany: Online Age Checks and Daytime Blackouts Ahead?

Youth Protection in Germany: Online Age Checks and Daytime Blackouts Ahead?

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Last week, German regulators decided to no longer accept the widely used “JusProg” software as a sufficient means for online service providers to comply with st

We’re proud to announce that the Daily Journal has named <a href="https://www.mofo.com/people/julie-park.html">Julie Park</a> to its list of 2019 Top Women Lawyers in California. The annual award series recognizes the successes of women lawyers in the court room and at the negotiating table, as well as their advancements in the legal industry.Julie has multiple science degrees researched cancer treatments at Pfizer before pursuing law—a career she loves because of the opportunities she has to solve problems for clients. She recently won a preemption motion in a first-of-its kind order in California, which found that failure-to-warn claims against a drug distributor were preempted.Julie says her training as a violinist also informs her work as a lawyer.“Everything we do is an iterative process, so you’re constantly evaluating what’s good and what can be better, whether that’s in the scientific method or playing a piece of music or solving a legal problem.”Her commitment to excellence and attention to detail are just two of the qualities that have earned Julie a Top Woman Lawyer in California for 2019 title.Congratulations, Julie!

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The Daily Journal Names Julie Park to its list of 2019 Top Women Lawyers in California

The Daily Journal Names Julie Park to its list of 2019 Top Women Lawyers in California

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We’re proud to announce that the Daily Journal has named Julie Park to its list of 2019 Top Women Lawyers in California. The annual award series recognizes the 

In April, a New York federal court denied certification for a purported class alleging that Johnson & Johnson misled customers by placing the words “no trans fat” on labels for its Benecol buttery spreads. See Bowling v. Johnson & Johnson, et al., 1:17-cv-03892, S.D.N.Y. 2017. The court’s order focused on issues highly specific to the lead plaintiff, showing the benefits of carefully investigating the lead plaintiff in class actions.Case BackgroundIn 2017, Suzanna Bowling brought suit against Johnson & Johnson alleging that the labeling for its Benecol buttery spreads was misleading. According to the complaint, the labeling includes text reading “No Trans Fat” and “No Trans Fatty Acids,” some of which is in “all capitalized, bolded letters.” It was these statements that the complaint alleged misled a New York class of customers to purchase, and overpay for, the product.Court Denies Plaintiff’s Motion for Class CertificationThe United States District Judge Alison J. Nathan denied Ms. Bowling’s motion to certify the New York class, finding that Ms. Bowling was not a suitable class representative for a couple of reasons.First, Ms. Bowling had previously settled with Johnson & Johnson, and as a part of that settlement, there was a “covenant not to sue” in place. This covenant, among other aspects of the settlement, could potentially impede the current case were it to proceed. Judge Nathan stated, “It may be that the covenant not to sue is not binding or is inapplicable to Bowling’s claims here, but … the court concludes she will be required to ‘devote considerable time’ to rebutting its applicability.” As a result of this potentially binding covenant, Ms. Bowling was certainly an atypical—and arguably an inadequate—class representative.Second, Ms. Bowling’s credibility suffered “on key issues.” In fact, key allegations in her complaint were demonstrably false. Ms. Bowling stated in the complaint that she purchased Benecol at a particular location and time, but Johnson & Johnson’s internal records showed that Benecol was never sold at that particular location and time. Ms. Bowling also alleged that, after she came to believe that Benecol actually contained trans fats, she immediately wrote Johnson & Johnson requesting a refund. However, Johnson & Johnson’s customer service department found no record of such a refund request.In conclusion, Judge Nathan stated, “Here, defendants have presented unrebutted evidence that Bowling could not have purchased Benecol Light in the manner in which she has testified; she is therefore ‘vulnerable to serious attacks’ on her credibility.” Accordingly, Ms. Bowling’s motion for class certification was denied.TakeawayThis case reinforces that it is imperative for defendants to always carefully investigate the lead plaintiffs, whether by running a background check or asking questions about their prior litigation history during depositions. All too often, as was the case here, the lead plaintiff is an inadequate class representative for personal reasons that are not apparent at first glance. And while the plaintiff’s unsuitability to represent the class may not end the entire litigation, it can certainly stall the proceedings and create leverage for defendants during settlement negotiations.

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