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

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Partner

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

Adam Hunt

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

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

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

Alexandra Barlow

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

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Senior Counsel

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

Penelope A. Preovolos

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

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Associate

Zak Newman

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

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Mitchell Hokanson

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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.

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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

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This week, Acting Chairman Ann Marie Buerkle <a href="https://cpsc.gov/about-cpsc/chairman/ann-marie-buerkle/statements/statement-acting-chairman-ann-marie-buerkle">withdrew</a> her <a href="https://classdismissed.mofo.com/cpsc/buerkle-poised-to-take-her-seat/">nomination</a> to serve as Chairman of the U.S. Consumer Product Safety Commission (CPSC). She will wrap up her tenure as Acting Chairman, a <a href="https://classdismissed.mofo.com/consumer-products/same-enforcement-trend-new-cpsc-leadership/">position she has held</a> since February 2017, on September 30, and will finish her CPSC term on October 27. As we <a href="https://classdismissed.mofo.com/consumer-products/nomination-of-a-new-chairman-at-the-cpsc/">previously reported</a>, Buerkle has guided the CPSC in a more corporate-friendly position, and her 2019 priorities included the Internet of Things, CPSC technology upgrades, and traditional product safety initiatives, such as furniture tipover safety. The White House has yet to indicate whether Republican Commissioner Dana Baiocco or Peter Feldman will be tapped to fill the Chairman role, or if the person selected to fill Buerkle’s CPSC seat will also get the nod for Chairman. You can find more of MoFo’s Class Dismissed articles about Buerkle <a href="https://classdismissed.mofo.com/?s=buerkle">here</a>.

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Co-Chair, Litigation Department

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

Erin M. Bosman

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

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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

Julie Park

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

Change Is in the Air: Buerkle Withdraws Her Nomination to Chair the CPSC

This week, Acting Chairman Ann Marie Buerkle withdrew her nomination to serve as Chairman of the U.S. Consumer Product Safety Commission (CPSC). She will wrap u

Change Is in the Air: Buerkle Withdraws Her Nomination to Chair the CPSC

Internet of Things

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Consumer Products

CPSC

On June 7, 2019, an en banc Ninth Circuit panel affirmed certification of a nationwide settlement class and held, 8-3, that class certification criteria are applied less strictly in a settlement context.[1]  Hyundai II preserves the ability to certify nationwide settlement classes while maintaining more demanding requirements for litigation classes.  As noted in our earlier post, the prior panel decision,[2] which denied certification, sent class action lawyers into a tizzy, creating concerns about the viability of nationwide class settlements.  Hyundai II reversed course, holding that the predominance requirement differs in a settlement context because there is no need to consider the manageability of individual issues at trial.Case BackgroundAs we discussed in our previous post, a flurry of class actions were filed nationwide after the EPA launched an investigation regarding complaints that Hyundai and Kia had overstated the fuel efficiency of some of their vehicles.  The MDL panel consolidated the cases before Judge Wu in the Central District of California, and Judge Wu granted plaintiffs’ motion for certification of the settlement class.  The three-judge panel in Hyundai I vacated the trial court’s decision, holding that the Rule 23(b)(3) predominance inquiry required a choice-of-law analysis, as well as proof of classwide deception, essentially identical to what is required for certification of a litigation class.On July 27, 2018, the Ninth Circuit granted en banc review of the panel decision.Predominance Analysis  Hyundai II held that Rule 23(b)(3) predominance factors must be considered in light of the reason for which certification is sought—litigation or settlement.  Citing the Supreme Court’s decision in Amchem,[3] the Ninth Circuit held that in the settlement context, manageability problems created by the need to resolve individual issues at trial are not a concern because no trial will occur.  Instead, the focus is on the Rule 23 provisions intended to protect absent class members by blocking “unwarranted or overbroad class definitions.”Individual Issues Regarding Exposure and Reliance Did Not Defeat Predominance for a Settlement ClassIn Hyundai II, the Ninth Circuit concluded that common issues predominated regarding exposure and reliance, because so-called “Monroney stickers” containing the alleged fuel efficiency misrepresentations were present on every new car.  The Objectors-Appellants argued that the class of used-car purchasers may not have seen the “Monroney stickers” because they were not required to be displayed on used cars.  The trial court had rejected this argument on the basis that the alleged misrepresentations were part of a nationwide, concerted marketing effort.  The Hyundai II panel, however, did not decide whether Hyundai’s and Kia’s advertising was substantial enough to support an inference of reliance under the Tobacco II standard in a litigation context.<a name="_ftnref4" href="#4033971-v3-Hyundai_-_Ninth_Circuit_Article.docx">[4]</a>  Rather, the court limited its decision to the settlement context and concluded that the potential individual issues would apply only to a subset of the class and thus did not defeat predominance for the settlement class overall.  Moreover, the potential individual issues would “primarily implicate trial management issues, which we do not consider when conducting a predominance analysis for a settlement class.”Variations in State Law Did Not Defeat Predominance for a Settlement ClassHyundai II rejected the objectors’ argument that, in the settlement context presented, Mazza v. American Honda Motor Co., 666 F.3d 581 (9th Cir. 2012), required the district court to address variations in state law affecting claims by used car purchasers.  While a party litigant could “timely invoke the law of a foreign state,” here, no objector had presented an adequate choice-of-law analysis, or argued that differences between the consumer protection laws of all fifty states precluded certification of a settlement class.  As such, the district court was not obligated to address choice-of-law issues, and the Ninth Circuit would not decertify the class for lack of such an analysis.Moreover, the Ninth Circuit held that Mazza was “readily distinguishable.”  There, unlike in the case before the court, the foreign law proponent had “exhaustively detailed the ways in which California law differs from the laws of the 43 other jurisdictions,” and showed how applying the facts to those disparate state laws made “a difference in this litigation.”  The en banc panel emphasized that:  “Importantly, the Mazza class was certified for litigation purposes.  The prospect of having to apply the separate laws of dozens of jurisdictions presented a significant issue for trial manageability, weighing against a predominance finding.”Finally, Hyundai II concluded that application of California law did not violate due process notwithstanding that, under Virginia law, Virginia residents’ claims might be time-barred if they opted out.  Significantly, the Ninth Circuit held that the Virginia objector was free to opt out, but “could not opt out on behalf of anyone else.”  The decision thus eliminates the threat sometimes made by objectors to opt out an entire subclass.Settlement Approval Was Otherwise ProperUnlike a number of recent Ninth Circuit decisions that have been notably critical of the details of class settlements, the en banc panel in Hyundai II rejected a variety of challenges to the settlement and settlement procedures.  It held that both the long form and short form notices were proper.  The long form notice adequately described the terms of the settlement and informed settlement class members that additional compensation could be received.  The short form notice “was designed to be, as the name suggests, short.”  It satisfied its “primary purpose” of alerting class members to the settlement; it provided a high-level overview of the process (including critical dates), and explained where class members could obtain additional information and claim forms.Hyundai II also rejected the argument that claim forms were not necessary and that the claim forms were overly burdensome.  Although the participation rate of lump sum claimants was only 23 percent, the Ninth Circuit noted that it had approved class action settlements “where less than five percent of class members filed claims.”  Finally, the Ninth Circuit found no evidence of collusion between class counsel and the automakers, noting that there was no “clear sailing” provision, no reversion of unclaimed funds to the defendants, and no disproportionate distribution of settlement funds to class counsel.DissentIn her dissent, Judge Ikuta, who authored the original panel decision, largely adopted the analysis contained in that decision.  The dissent argues that settlement classes are not different, and that the trial court should have done a full choice-of-law analysis, as would have been required for a litigation class.TakeawaysHyundai II reaffirms that, in appropriate cases, nationwide settlement classes can be certified under a less stringent standard than litigation classes.  At the same time, the decision is cabined to the settlement context and preserves intact the far more demanding predominance analysis required for certification of a litigation class.________________________________________________________________[1] In re Hyundai and Kia Fuel Economy Litig., 2019 WL 2376831 (June 6, 2019) (“Hyundai II”).[2] In re Hyundai and Kia Fuel Economy Litig., 897 F.3d 1003 (9th Cir. 2018) (“Hyundai I”).[3] Amchem Products Inc. v. Windsor, 521 U.S. 591 (1997).[4] In re Tobacco II Cases. 46 Cal. 4th 298 (2009).

Energy Drink Manufacturer

Consumer Electronics MDL

Computer Power Management System Litigation

Run Them Sweet, LLC v. CPA Global Limited

Online Billing Practices Class Action

Lipitor Antitrust Litigation

American Booksellers Association v. Barnes &amp; Noble, Inc.


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 pro

Penelope Preovolos

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Ninth Circuit’s En Banc Hyundai Decision: Less Strict Standard For Settlement Classes

Start Your Engines: The U.S. Supreme Court Will Yet Again Review the Constitutional Limits of Personal Jurisdiction in a Pair of Cases Involving Ford Motor Company

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On June 7, 2019, an en banc Ninth Circuit panel affirmed certification of a nationwide settlement class and held, 8-3, that class certification criteria are app

Ninth Circuit’s En Banc Hyundai Decision: Less Strict Standard For Settlement Classes

Appellate & Supreme Court

Class Certification

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

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

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

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

Pharmaceutical & Medical Devices

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 

Announcements & Press

We’re proud to announce that the online platform JD Supra has named Class Dismissed editors and frequent contributors <a href="https://www.mofo.com/people/erin-bosman.html">Erin M. Bosman </a>and<a href="https://www.mofo.com/people/julie-park.html"> Julie Y. Park</a> as recipients of the 2019 Readers’ Choice Awards. They were chosen from among the numerous writers who publish on JD Supra as the <a href="https://spotlight.jdsupra.com/readerschoice/list/51">leading authors of content in the product liability field</a>.In addition to helping the firm reach “Top Firm” status for its product liability content, Erin Bosman and Julie Park were recognized as the <a href="https://spotlight.jdsupra.com/readerschoice/list/75">Top Two Authors for Product Liability</a>, out of a pool of over 700 authors, for 2019.

Erin Bosman and Julie Park Receive “Readers’ Choice” Award

We’re proud to announce that the online platform JD Supra has named Class Dismissed editors and frequent contributors Erin M. Bosman and Julie Y. Park as recipi

Erin Bosman and Julie Park Receive “Readers’ Choice” Award

At a recent product safety conference, Ann Marie Buerkle, Acting Chair of the U.S. Consumer Product Safety Commission (CPSC), announced CPSC’s priorities for 2019. These include technology—both for consumers and within the agency—as well as window coverings and furniture tipover. Buerkle surprised the audience with a stern warning that any clothing storage not complying with ASTM’s F2057-17 standard will be deemed to have a defect that could pose a substantial product hazard.Buerkle’s Address at the Annual ICPHSO MeetingBuerkle addressed the annual meeting of the International Consumer Product Health & Safety Organization (ICPHSO), a nonprofit organization that brings together diverse stakeholders. Attendees included manufacturers, retailers, standards organizations, service providers, government agencies, and consumer advocates. This year, the meeting took place in Washington, D.C., to facilitate attendance by regulators, particularly on the day known as “CPSC Day.” Fittingly, CPSC Day opened with Buerkle’s address outlining CPSC’s priorities.IoTBuerkle opened with a topic at the top of everyone’s minds—the Internet of Things (IoT). CPSC recognizes that IoT is here to stay. Although the agency recognizes the urgency of moving quickly in this area to keep up with technology, CPSC appears to be still evaluating possible IoT policy initiatives. Buerkle reminded the audience about CPSC’s past activity in this space, including its January 2017 report, “<a href="https://www.cpsc.gov/content/potential-hazards-associated-with-emerging-and-future-technologies">Potential Hazards Associated with Emerging and Future Technologies</a>,” and its May 2018 hearings on this topic. She also previewed processes CPSC plans to put in place to address emerging technologies, such as reassigning staff to dedicate their efforts solely on IoT, creating an interagency working group, coordinating with the National Cybersecurity Center of Excellence on IoT and Home Safety, and collaborating with voluntary standards organizations.Technology at CPSCIn addition to addressing technology advances outside the agency, Buerkle announced some technology upgrades within the agency. She spoke of the <a href="https://www.cpsc.gov/content/cpsc-releases-new-recall-app">recall app</a> that CPSC recently rolled out. She proudly congratulated the developers of CPSC’s <a href="https://www.cpsc.gov/Newsroom/News-Releases/2019/robot-reboot-cpsc-launches-upgraded-regulatory-robot-tool-to-help-small-business-community">regulatory robot 2.0</a>, which can help assess the regulatory framework that applies to a particular product. And she welcomed the coming changes to CPSC’s SaferProducts.gov website, born out of the Consumer Product Safety Improvement Act of 2008 and now due for a refresh. Though not addressed by Buerkle, other technology advances discussed at the conference included upgrades to the FOIA process; consumer product safety lawyers breathed a sigh of relief on hearing that CPSC will finally send FOIA correspondence electronically and de-duplicate the often voluminous documents responsive to FOIA requests.Window CoveringsNext, Buerkle turned to more traditional product safety initiatives. First, she discussed the updated ANSI window covering standard released last year, which requires stock window coverings to be cordless or have inaccessible cords.Furniture Tipover SafetyFinally, Buerkle addressed furniture tipover safety, which she noted has been one of her top priorities as acting chair. In a surprising announcement, she told the audience that CPSC had that day sent a <a href="https://www.cpsc.gov/s3fs-public/Clothing%20Storage%20Unit_Letter%20to%20Manufacturers_Importers_Distributors_and_Retailers_2.27.19.pdf">letter</a> to furniture manufacturers about tipover safety. The letter stated that any clothing storage units not compliant with ASTM F2057-17 would be regarded as having a defect that could present a substantial product hazard under Section 15(b) of the Consumer Product Safety Act. Though not explicit, her message was clear: even though CPSC has not gone through the formal rulemaking process, it wants noncompliant furniture products off the market, and companies that fail to report noncompliant units run the risk of swift investigation and penalties for failure to report.Our Product Liability and Counseling attorneys provide guidance on how CPSC’s priorities have shifted over time and how those shifting priorities affect our clients and their products. We will continue to monitor and report on any notable updates from CPSC and how they might impact the consumer product safety landscape.

CPSC Acting Chair Buerkle’s Priorities Include IoT and Furniture Safety

At a recent product safety conference, Ann Marie Buerkle, Acting Chair of the U.S. Consumer Product Safety Commission (CPSC), announced CPSC’s priorities for 20

CPSC Acting Chair Buerkle’s Priorities Include IoT and Furniture Safety

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

On Friday, October 12, 2018, California’s Second Appellate District Court stayed the trial that was set to begin on Monday, October 15, 2018, in Los Angeles Superior Court, regarding whether cancer warnings are required for sales of coffee in California. The trial in Council for Education and Research on Toxics v. Starbucks Corporation et al. (Los Angeles Superior Court Case No. BC435759/BC461182) is stayed pending further order of the Appellate Court.The plaintiff in the eight-year-old Starbucks matter alleges under California’s Proposition 65 that coffee companies must warn consumers of the presence of the chemical acrylamide in coffee. Acrylamide, listed under Proposition 65 as a chemical “known to the state to cause cancer,” is formed when green coffee beans are roasted. Today’s Appellate Court order responds to the request of the 50+ coffee company defendants set to appear at trial that the case be stayed pending adoption of a new regulatory rule by California’s Office of Environmental Health Hazard Assessment (OEHHA) that is intended to be dispositive of the Starbucks action.OEHHA’s proposed rulemaking, announced June 15, 2018, would adopt a regulation providing that exposure to Proposition 65-listed chemicals in coffee, when produced as a result of the roasting and brewing of coffee, does not pose a significant risk of cancer. OEHHA has found that Proposition 65 and its existing regulations do not require Proposition 65 warnings on coffee and has proposed this regulation to clarify that fact.In granting the stay, the Appellate Court has ordered the coffee companies to provide a written status update by January 15, 2019.Morrison & Foerster LLP represents the petitioner coffee companies in the above-mentioned case, along with Daniel Kolkey of Gibson, Dunn & Crutcher LLP.

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BREAKING: Appellate Court Halts Trial on Coffee

BREAKING: Appellate Court Halts Trial on Coffee

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On Friday, October 12, 2018, California’s Second Appellate District Court stayed the trial that was set to begin on Monday, October 15, 2018, in Los Angeles Sup

Environmental Law

Updating and building on guidance issued one year ago, the U.S. Department of Transportation published a new federal guidance document entitled Preparing for the Future of Transportation: Automated Vehicles 3.0 (“AV 3.0”).AV 3.0, released on October 4, 2018, incorporates extensive stakeholder feedback to provide updated voluntary guidance and policy considerations regarding safety standards and federal agencies’ roles in the development process of automated vehicles. DOT hopes this guidance will bring some clarity to a murky regulatory space and in turn will shepherd developers, manufacturers, and state and local governments in implementing autonomous vehicle technology in a safe, consistent, and organized way.

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U.S. DOT Revamps Federal Guidance on Automated Vehicle Development and Rollout

U.S. DOT Revamps Federal Guidance on Automated Vehicle Development and Rollout

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Updating and building on guidance issued one year ago, the U.S. Department of Transportation published a new federal guidance document entitled Preparing for th