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, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liabi

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Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption | Class Dismissed

Erin M. Bosman

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104 (6th Cir. Dec. 11, 2015). Yates is the first federal appellate authority to recognize “impossibility preemption” of design defect claims against brand-name drug manufacturers.BackgroundThe plaintiff in Yates was a teenager who used the brand-name ORTHO EVRA patch for birth control. She conceded that she was warned of the risk of stroke by her healthcare provider. She further admitted that she would have used the patch even if she had read the warnings regarding the increased risk of stroke and blood clots. One week after she started using the ORTHO EVRA patch, the plaintiff had a stroke.Despite the label’s clear disclosure of the risk of stroke and plaintiff’s awareness of the increased risk from her healthcare provider, plaintiff sued defendants for failure to warn. She also brought claims for manufacturing defect, negligence, and breach of implied and express warranties.The Sixth Circuit affirmed the district court’s grant of summary judgment on all claims. Most importantly, the court affirmed the district court’s ruling regarding the state-law design defect claims and held that “Yates’ state law design defect claims are preempted under Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).”Impossibility PreemptionThe court held that plaintiff’s state-law design defect claims were preempted by federal regulation, regardless of whether the alleged defect occurred pre- or post-FDA approval. In doing so, it became the first ever circuit court of appeals to find that federal law preempts design defect claims against brand-name drug manufacturers.The court began its preemption analysis with a discussion of preemption principles: “State law claims can be preempted expressly in a federal statute or regulation, or impliedly, where congressional intent to preempt state law is inferred.” The court explained that implied preemption exists where “(1) it is impossible for a private party to comply with both state and federal law, and (2) the state law is an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” The court noted, however, that such impossibility preemption “is a demanding defense.”Relying on Wyeth v. Levine, 555 U.S. 555, 571 (2009), the court pointed out that “plaintiffs injured by brand-name prescription drugs retain state-law tort remedies against the manufacturer of those drugs, provided it is not impossible for the drug manufacturer to comply with both state and federal law.”Pre- and Post-Approval Design Defect Claims PreemptedHere, though, impossibility preemption occupied the forefront of the court’s analysis. The court characterized plaintiff’s design defect claim as being of two types: (1) post-approval design defect, whereby the manufacturer should have lowered the dosage after FDA approval; and (2) pre-approval design defect, whereby the manufacturer should have created a different form of the drug in the first place. Both imposed state-law duties that were impossible to comply with while still complying with federal law. Therefore, both were preempted under Bartlett.Post-approval design defect. Plaintiff argued that the manufacturer could have lowered the dosage of the drug to make it safer. Under applicable New York law, a product is defectively designed if it was unreasonably dangerous and a safer design was feasible. But under FDA regulations, once a drug is approved, “the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product . . . .” 21 C.F.R. § 314.70(b)(2)(i). Changing the dosage level clearly constituted a “‘major change’ such that prior FDA approval is necessary.”The court held that, “[b]ased on the plain meaning of the regulation . . . defendants could not have altered the dosage . . . without submission to the FDA and the agency’s approval prior to distribution of the product made using the change.” In short, the manufacturer could not have distributed an altered dosage of the drug without prior FDA approval. Therefore, it would have been impossible for the manufacturer to comply with FDA regulations and still distribute to plaintiff a lower-dosage form of the drug.Pre-approval design defect. Plaintiff argued that the manufacturer should have created a different formulation of the drug in the first place. This argument, the court found, was too attenuated. The court invoked the Supreme Court’s preemption opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011), which rejected the notion that a manufacturer might be required to play a “Mouse-Trap game” with the FDA. A pre-approval duty would require the court to predict the outcome of too long a chain of events: that the manufacturer designed the drug differently, that the FDA would have approved the alternative design, that plaintiff still would have selected that method of birth control, and that she still would have suffered a stroke.Simply put, “[i]n contending that defendants’ pre-approval duty would have resulted in a birth control patch with a different formulation, [plaintiff] essentially argues that defendants should have never sold the FDA-approved formulation . . . in the first place.”The court rejected plaintiff’s “never-start-selling” rationale just as the Supreme Court in Bartlett rejected the argument that a manufacturer must stop selling a drug if doing so is the only way to comply with state and federal regulation. If a drug manufacturer complies with federal law, it should not be compelled to stop selling or never to sell in the first place to comply with state law.Adequacy of WarningThe court also found that plaintiff failed to meet her burden on the failure-to-warn claim. She argued that (1) defendants’ warnings were inadequate because they failed to convey the level of risk of stroke, and (2) defendants had a duty to warn plaintiff directly pursuant to FDA regulations. Ultimately these claims failed, because the label clearly disclosed the risk of stroke and plaintiff conceded she was in turn warned by her healthcare provider.On the adequacy of the warnings, plaintiff argued that the warnings failed to convey the “degree of risk.” She essentially claimed that the label “should have stated that the risk of stroke was higher than other methods of birth control, namely birth control pills.” The court easily disposed of this argument, relying on DiBartolo v. Abbott Laboratories, 914 F Supp. 2d 601 (S.D.N.Y. 2012). As the DiBartolo court made clear, the requirement of identifying comparative risks “extends to patients with different underlying risk factors, not to different drugs treating the same ailment.”Notably, the court also rejected plaintiff’s argument that “a subsequent improvement to the label, even a change that is required by the FDA, is probative evidence of the label’s previous failure to warn.” Adopting the defendants’ reasoning, the court noted that “[w]arnings can always be made ‘better,’ but ‘better’ is not the standard New York law requires—adequacy is.” Here, the warnings in place at the time were adequate. As a result, the subsequent changes to the label were irrelevant.The court also found that defendants had no duty to warn plaintiff directly under the learned-intermediary doctrine. It is well established that, “[e]xcept where FDA regulations otherwise provide, the manufacturer’s duty is to warn the doctor, not the patient.” The record was clear that plaintiff’s healthcare provider was well aware of the risk of stroke, “and plaintiff admitted to being counseled about the risk of stroke associated with ORTHO EVRA.” Accordingly, the court granted summary judgment on the failure-to-warn claim.Manufacturing Defect, Negligence, and Breach of WarrantyThe court granted summary judgment on the remaining claims. Plaintiff could not sustain a claim for manufacturing defect, because there was no evidence that the patches she received differed from “either the manufacturing specifications or from other identical units.” Her negligence claim was preempted because, under New York law, claims of negligence are preempted per se when the article in question is regulated by federal law. Here, FDA regulations govern. Finally, plaintiff’s warranty claims failed because defendants adequately warned her prescribing physician of the risks, those risks were communicated to her, and there were no other representations to plaintiff of the drug’s safety or efficacy.ConclusionYates marks a key development in the evolution of case law regarding a branded drug manufacturer’s federal and state law liability. Bartlett made clear that certain design defect claims were preempted against generic manufacturers due to their inability to deviate from the brand manufacturer’s design, including warnings. Here, the Sixth Circuit has made clear that federal regulation controls the safety and adequacy of the actual composition and design of the drug itself.Brand-name drug manufacturers cannot be expected to comply with state law when doing so would require them to design a drug that is different from the one the FDA has approved for distribution and sale. Likewise, they cannot be required to alter the suggested dosage or administration of the drug subsequent to approval to comply with state law when doing so would violate the FDA regulation governing post-approval alterations to the drug’s formulation.After Levine, liability for brand-name drug manufacturers was fraught with “what-ifs,” as manufacturers struggled to predict which FDA-approved labels might be deemed inadequate under state law. Even after Bartlett, the question of design defect remained open for brand-name drug manufacturers. The Yates decision finally offers some certainty that seeking and obtaining FDA approval can cut off certain avenues of liability. We continue to monitor these important preemption cases, as they signal meaningful changes to future liability.