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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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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Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. The court found tha

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Federal Preemption Claims: Clear Evidence and an Unclear Standard

Federal Preemption Claims: Clear Evidence and an Unclear Standard | Class Dismissed

Erin M. Bosman

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption.BackgroundPlaintiff Victoria Cerveny was prescribed and used Clomid in 1992. Following her Clomid use, Mrs. Cerveny became pregnant and gave birth to a son, who was missing two fingers and had a congenital dislocation of the left radial head on his left elbow. The Cervenys alleged that the defects were caused by the residual Clomid in Mrs. Cerveny’s body during conception and organogenesis, and that Aventis breached its duty to warn of potential birth defects associated with Clomid use before pregnancy.Aventis moved for summary judgment on the basis of conflict preemption, arguing that it was impossible for Aventis to comply with federal and state requirements for labeling because the FDA would not have permitted Aventis to include the exact warnings the Cervenys demanded should be added to the label. Specifically, Aventis relied on evidence that the FDA had previously considered Plaintiff’s argument and determined that using Clomid before pregnancy posed no heightened risk of future birth defects. In sum, the Cervenys argued that Aventis should have changed the label and Aventis responded that its hands were tied by the FDA—even if Aventis had sought the requested change, the FDA would not have approved it.Changing a Drug LabelThe central dispute was Aventis’s ability to add the warnings that the Cervenys sought. In general, manufacturers bear responsibility for the content of drug warning labels, but cannot change the labeling of a drug without seeking prior approval from the FDA.  See 21 C.F.R. § 314.70(b). In limited circumstances, however, a drug manufacturer can strengthen warnings without prior approval through a changes being effected (CBE) supplement, but the FDA retains authority to reject those changes.The FDA also has a process whereby interested parties may submit “citizen petitions” seeking modifications to a drug’s labeling. Parties may submit these petitions accompanied by scientific and other evidence of potential health risks associated with a drug’s use. Although a causal relationship is not required, FDA standards mandate that if there is “reasonable evidence of an association of a serious hazard with a drug,” the drug’s label should be revised to include a warning. 21 C.F.R. § 201.80(e). Sometimes, “newly acquired information” (i.e., testing performed subsequent to a drug label’s approval or reports of negative drug reactions) is included in these reports and leads the FDA to require stronger warnings.In 2007 and again in 2009, the FDA received citizen petitions about Clomid and its association with birth defects. Both petitions embodied the exact failure-to-warn theories presented by the Cervenys and included supplemental scientific research, seeking the same additional warnings that the Cervenys sought.  Ultimately, the FDA rejected both petitions. Importantly, both of these petitions came many years after Mrs. Cerveny’s Clomid use.Clear EvidenceTo demonstrate conflict preemption, a defendant must present “clear evidence” of a conflict between federal and state law. The “clear evidence” standard was first enunciated in Wyeth v. Levine, 555 U.S. 555 (2009) but was not defined.  Ever since, courts have grappled with this legal standard, which remains anything but clear.The Cerveny court shed welcome new light on this “clear evidence” standard. Specifically, Judge Benson found that Aventis met its burden with evidence that the FDA had denied the two previous requests for strengthened warnings in the form of citizen petitions, “based on the same theories and substance on which Plaintiff’s case relies.” In fact, “every piece of scientific literature cited in the Plaintiffs’ Amended Complaint was presented to the FDA” in the 2007 citizen petition.The court found additional “clear evidence” of the FDA’s position because the FDA “consistently approved Clomid labeling that includes affirmative rejections of the Plaintiffs’ theories.” Specifically, since 1994, Clomid’s FDA-approved label stated that “Clomid exposure prior to pregnancy does not cause birth defects at a rate greater than that observed in the general population.” Thus, not only did the FDA previously consider Plaintiff’s argument, but it also determined that drug ingestion before pregnancy raised no additional risk of future birth defects. This determination was clear from the FDA’s prior approval of Clomid labeling.The court’s ruling represents a step in the right direction for pharmaceutical defendants, especially in light of the recent Dolin decision muddying the “clear evidence” burden of proof on defendant manufacturers arguing for preemption. Defendant manufacturers should also note that this court found that both the rejection of the citizen petitions and the FDA’s consistent approval of Clomid’s labels operated as independent sources of clear evidence to support conflict preemption. This is a clear departure from the Dolin court’s ruling, which seems to require an actual denial by FDA of a label change. As courts continue to analyze what “clear evidence” is without concrete guidance, the Cerveny ruling sets a favorable precedent and provides new guideposts to follow.