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

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Nine months ago, we discussed several issues that had been raised by COVID-19 face mask-related litigation.[1] Soon after, COVID-19 infection rates spiked to unprecedented levels. But with the emergency use authorization of three COVID-19 vaccines in the United States, the state of the pandemic has drastically changed during the first half of 2021. Vaccines are now widely available for people 12 years of age and older, and infection rates have drastically declined across the United States as a result.With months of real-world data showing the safety and efficacy of the Moderna, Pfizer, and Johnson & Johnson vaccines in hand, the CDC issued Interim Public Health Recommendations for Fully Vaccinated People (“CDC Interim Recommendations”) on May 13, 2021, which has changed the way people are thinking about masks. The CDC Interim Recommendations have also prompted a range of reactions from companies and employers and impacted mask-related disputes in the courts. This post provides an overview of these recent developments, which businesses and employers would be wise to keep in mind.Read our client alert <a href="https://www.mofo.com/resources/insights/210709-a-return-to-normalcy.html?utm_source=publication&utm_medium=email">here</a>.

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Of Counsel

Lloyd W. Aubry, Jr. is a member of our Employment and Labor Group. Lloyd’s practice encompasses all aspects of employment and labor law, including litigation and counseling.

Lloyd Aubry

Lloyd Aubry’s practice encompasses all aspects of employment and labor law, including litigation and counseling. He represents public and private clients in a variety of matters relating to wage and hour law, employment discrimination, wrongful discharge, safety and health issues, and National Labor Relations Act (NLRA) issues. Mr. Aubry represents clients before administrative agencies and in state and federal court. A significant part of his practice involves expert testimony and consulting on issues relating to the Department of Industrial Relations. In this capacity, he has served for both employers and employees.

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Associate

Michael Ahern is an associate in the Litigation Department of Morrison Foerster’s New York office.
Prior to joining Morrison Foerster, Mr. Ahern clerked for the Honorable Eileen Bransten in the Comm

Michael G. Ahern

Michael Ahern

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A Return to Normalcy? Check Your Local Rules – An Update on Mask Litigation and Guidelines

A Return to Normalcy? Check Your Local Rules – An Update on Mask Litigation and Guidelines

gavel and mask

Nine months ago, we discussed several issues that had been raised by COVID-19 face mask-related litigation.[1] Soon after, COVID-19 infection rates spiked to un

While the use of masks to combat the spread of COVID-19 has become a politicized issue in the United States, the scientific community largely agrees that wearing face coverings is one of the most effective ways to slow infections.[1] State and local governments have issued orders requiring residents to wear masks in public, with some advising employers to provide their employees with face coverings or reimburse the reasonable cost of obtaining one.[2] Governor Gavin Newsom of California, for example, has issued a number of mandates to slow infections. One of those mandates is that all individuals must wear a mask or face covering in public or common spaces statewide. Federal agencies such as the CDC and OSHA have issued non‑binding guidelines that also advise people to wear masks in public.[3]It might seem that as long as businesses comply with these federal, state, and local requirements and guidelines regarding masks, they can expect to be shielded from lawsuits related to their mask-related policies.[4] A few recently filed putative class action lawsuits, however, show that plaintiffs and their attorneys are nevertheless seeking ways to turn mask issues into litigation.Mask-Related Lawsuits Alleging Violations of the Americans with Disabilities Act (“ADA”)The ADA prohibits discrimination against people with disabilities in employment (Title I)[5] and in places of public accommodation (Title III).[6] In recent months, several plaintiffs alleging disabilities have filed lawsuits claiming that businesses they have frequented violated Title III of the ADA by denying the plaintiffs public accommodations due to the businesses’ mask policies.First, on July 30, 2020, Cali Bunn, who alleges that she suffers from a severe hearing loss, filed a class action complaint against Nike, Inc. in San Francisco County Superior Court.[7] According to Bunn, she relies on lip reading and visual cues to understand speech. Bunn alleges that while she was visiting a Nike store in San Diego, she had difficulty understanding the salesperson because the salesperson wore a face mask. Bunn alleges she felt embarrassed and was deprived of “friendly and personalized customer service” due to her disability.[8]Then, on August 21, 2020, more than 60 plaintiffs filed a complaint against Giant Eagle, Inc. and C&J Grocery Co., LLC (owner and operator of a Giant Eagle store) (“Giant Eagle”) in the Western District of Pennsylvania.[9] The plaintiffs allege they suffer from respiratory limitations, asthma, nervous system issues, and/or post-traumatic stress disorder, among other conditions, which allegedly prevents them from being able to wear masks. The plaintiffs further allege that Giant Eagle employees refused to allow them to shop at the Giant Eagle stores and asked them to leave because they were not wearing masks. Plaintiffs also claim that “there was no significant risk to the health or safety of others if Giant Eagle modified its policies, practices and procedures” by allowing them to shop without masks and noted that the CDC acknowledged “the need for a medical exception to the mask requirement.”[10]These lawsuits show that businesses should give careful thought to balancing the need to comply with applicable federal, state, and local orders and guidelines regarding the use of masks and providing reasonable accommodations for people with disabilities under the ADA. There is no one-size-fits-all approach for striking the right balance between complying with the ADA and efforts to stop the spread of COVID-19. Companies should consider what alternatives for patrons with disabilities are reasonable and economically feasible based on the nature of their public‑facing businesses. Options for customers and other visitors whose disabilities prevent them from wearing masks may include, where feasible, providing expanded curbside, online, or other contactless services.Employee Lawsuits Regarding Face Mask PoliciesCompanies should also consider that the mask-related policies they adopt and enforce for their customers may not be the right fit for their employees. In recent months, employees have filed suit against their employers seeking damages for allegedly dangerous working conditions related to COVID-19. Some of these claims are based on purportedly unsafe mask practices.For example, on May 19, 2020, employees and their family members filed a putative class action lawsuit in Illinois state court against the McDonald’s Corporation and a subsidiary alleging claims for public nuisance and negligence due to the alleged failure of McDonald’s to maintain adequate COVID-19 safety protocols.[11] The employees allege that in some McDonald’s restaurants, workers do not regularly wear masks.[12] The employees further allege that they each were provided with only one mask, which became dirty after multiple uses. The court granted in part plaintiffs’ emergency motion for a preliminary injunction. The court found that although a McDonald’s subsidiary provided employees with a sufficient number of masks, the subsidiary was not enforcing its mask policy or complying with the Illinois Governor’s mask requirements. The court ordered the McDonald’s subsidiary to train employees on social distancing in a manner consistent with the Governor’s executive order and enforce mask wearing policies when employees are not six feet apart.COVID-19 presents a new safety concern for employers. Consulting with counsel can help determine what safeguards can and should be implemented in the workplace. Depending on the nature of the work and workplace, issues employers may want to consider could include remote work options, flexible return-to-work plans, appropriate and feasible return-to-work logistics, and reasonable accommodations for vulnerable groups.Key TakeawaysWith so many constituents, businesses may feel as if they are caught between a rock and a hard place. On one hand, customers are suing businesses for requiring them to wear masks. On the other hand, employees are suing them for not enforcing mask-related policies and guidelines. In developing their COVID-19 protocols, businesses must simultaneously consider their obligations as public accommodations to customers and other visitors and their obligations as employers. Doing so requires not only knowledge of applicable rules and guidance but also an eye toward flexibility.Morrison & Foerster’s <a href="https://www.mofo.com/capabilities/class-actions-mass-torts.html">Class Action + Mass Torts Group</a>, <a href="https://www.mofo.com/capabilities/employment-labor.html">Employment + Labor Group</a>, and Coronavirus Task Force have advised and represented many clients on developing COVID-19 protocols and emerging claims related to COVID-19. To stay a step ahead, our team continuously analyzes newly filed lawsuits as well as COVID-19 government orders, guidance, and trends. [1] “Use of Masks to Help Slow the Spread of COVID-19.” Centers for Disease Control and Prevention. Accessed September 16, 2020. [2] “Industry Guidance to Reduce Risk.” Coronavirus COVID-19 Response. California, State Government. Accessed September 16, 2020. <a href="https://covid19.ca.gov/industry-guidance/">https://covid19.ca.gov/industry-guidance/</a>.[3] “Use Masks to Help Slow Spread.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention. Accessed September 16, 2020. See also United States Department of Labor. COVID-19 Frequently Asked Questions, Occupational Safety and Health Administration. Accessed September 16, 2020. [4] The HEALS Act, the Senate’s July proposed stimulus package, included the SAFE TO WORK Act, which, if enacted, would create a broad liability shield for employers and businesses faced with coronavirus exposure claims as well as certain other specified coronavirus-related claims. Safeguarding America’s Frontline Employees to Offer Work Opportunities Required to Kickstart the Economy Act (“SAFE TO WORK ACT”), S.4317, 116th Cong. (2020); see also “The SAFE TO WORK Act: An In-Depth Guide for Employers to the Senate’s Proposed Coronavirus Liability Shield.” Morrison & Foerster LLP. Accessed September 17, 2020. <a href="https://www.mofo.com/resources/insights/200811-safe-to-work-act.html">https://www.mofo.com/resources/insights/200811-safe-to-work-act.html</a>. With the House and Senate unable to agree on a stimulus package, the SAFE TO WORK Act has thus far not progressed past its assignment to the Senate Judiciary Committee on July 27, 2020. In the meantime, several states (not including California) have enacted legislation shielding businesses from civil liability for COVID-19-related injuries, losses, or deaths. [See, e.g. COVID-19 Liab. Safe Harbor, 2020 N.C. ALS 89, 2020 N.C. Sess. Laws 89, 2020 N.C. Ch. 89, 2019 N.C. HB 118, enacted, July 2, 2020; Georgia COVID-19 Pandemic Business Safety Act, 2020 Ga. ALS 588, 2020 Ga. Laws 588, 2020 Ga. Act 588, 2020 Ga. SB 359, enacted August 5, 2020; and 2020 Bill Text NV S.B. 4B, enacted August 11, 2020.][5] 42 U.S.C. §§ 12111-12117.[6] 42 U.S.C. § 12182(a).[7] Cali Bunn v. Nike, Inc., (S.F.Super.Ct., Jul. 30, 2020, No. CGC-20-585683) 2020 WL 4383483.[8] See Bunn Compl. ¶ 11.[9] Second Amended Consolidated Complaint, Pletcher v. Giant Eagle, Inc., No. 2:20-cv-754 NBF (W.D. Pa. Aug. 21, 2020), ECF No. 32.[10] See Pletcher SACC ¶ 290.[11] Massey v. McDonald’s Corp. et al., No. 20 CH 4247, 2020 Ill. Cir. LEXIS 465 (Ill. Cir. Ct. June 24, 2020).[12] See Complaint, Massey v. McDonald’s Corp. et al., No. 20 CH 4247 at ¶ 81 (Ill. Cir. Ct. June 24, 2020).

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Michelle Sosa-Acosta is an associate in the  Securities Litigation, Securities Enforcement, and Investigations + White Collar Defense Groups in Morrison Foerster’s San Francisco office. 

Michelle Sosa-Acosta

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Are You Covered? Warnings From Recent Face Mask Litigation

Using Waivers to Curb COVID-19 Legal Exposure

While the use of masks to combat the spread of COVID-19 has become a politicized issue in the United States, the scientific community largely agrees that wearin

Are You Covered? Warnings From Recent Face Mask Litigation

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.

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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

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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.

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

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

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