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

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Consumer products businesses should know that “right to repair” laws are here to stay. Frustrated with restrictions on repairing consumer electronics, advocacy organizations spearheaded a grassroots “right to repair” movement that is gaining traction. Publicly endorsed by the <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/" target="_blank" dir="ltr">White House</a> and the <a href="https://www.ftc.gov/system/files/documents/reports/nixing-fix-ftc-report-congress-repair-restrictions/nixing_the_fix_report_final_5521_630pm-508_002.pdf" target="_blank">Federal Trade Commission</a>, the “right to repair” movement presses manufacturers to give everyone access to the same repair resources that before had only been available to manufacturers and licensed repair vendors. Thus, affected businesses need to become familiar with new regulatory obligations in a growing number of jurisdictions.BackgroundNew York was the trailblazer in this space, enacting the first “right to repair” law in the U.S.: the <a href="https://www.nysenate.gov/legislation/bills/2023/S1320" target="_blank">New York Digital Fair Repair Act</a>, which was signed into law on March 3, 2023. Next year, the <a href="https://www.revisor.mn.gov/laws/2023/0/Session+Law/Chapter/57/" target="_blank">Minnesota Digital Fair Repair Act</a> will go into effect, and the <a href="https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=202320240SB244&showamends=false" target="_blank">California Right to Repair Act</a> will likely follow suit later in 2024. Several more bills are on the road to enactment, with at least 22 state legislatures currently considering “right to repair” bills.Behind many of these bills is the Repair Association, a trade organization that developed the “<a href="https://www.repair.org/legislation" target="_blank">Right to Repair & Fair Repair Legislative Template</a>” (the Model Act). The Model Act reflects the policy objectives of the “right to repair” movement:<ul><li dir="ltr">Ensure that owners and unaffiliated repair vendors have access to the same resources available to the manufacturer or licensed repair vendors;</li><li dir="ltr">Allow owners to service their products at the repair vendor of their choice;</li><li dir="ltr">Legalize the unlocking, adapting, and modifying of any part (including software); and</li><li dir="ltr">Require implementation of “design for repair” principles in product design practices.</li></ul>Generally, “right to repair” laws require manufacturers to make repair parts, tools, and documentation publicly available if they are also available to the manufacturers and licensed repair vendors. Manufacturers must make these resources available on “fair and reasonable terms” and can do so directly to consumers or through affiliated repair vendors. However, each jurisdiction’s law has its own features and scope. This article compares and contrasts some of each law’s main features and presents key takeaways for affected businesses.Key TermsOriginal Equipment Manufacturers (OEMs): Most often, OEMs are businesses that engage in selling or leasing digital electronic equipment that they manufacture or that is manufactured on their behalf. These are covered entities and individuals.Digital Electronic Equipment (DEE): This refers to covered products, largely targeting personal electronics like cell phones, tablets, and computers. Many consumer products that rely on “embedded digital electronics” may also qualify. Each jurisdiction uniquely exempts or includes certain equipment, although some products like video game consoles are routinely exempted.Authorized Repair Providers (ARPs): These are repair vendors that previously had exclusive access to repair resources. An ARP can be the OEM itself or a repair vendor that is directly affiliated with or licensed by the OEM.Independent Repair Providers (IRPs): This term is used broadly and refers to anyone making repairs that is not considered an ARP. Essentially, an individual or business that conducts repairs on DEE and is not affiliated with or licensed by the OEM.Comparison Chart<table dir="ltr" id="_ftnref5"><colgroup data-width='726'><col style="width:41.32231404958678%"><col style="width:15.013774104683195%"><col style="width:13.911845730027547%"><col style="width:14.18732782369146%"><col style="width:15.564738292011018%"></colgroup><tbody dir="ltr" id="_ftnref5"><tr><td> </td><td>NY</td><td>MN</td><td>CA</td><td>Model</td></tr><tr><td>When does the law go into effect?</td><td>Dec. 28, 2023</td><td>July 1, 2024</td><td>Jan. 1, 2024(Proposed)</td><td>N/A</td></tr><tr><td>What are the penalties?</td><td>Up to $500 per violation.</td><td>Injunctive relief and attorneys’ fees.</td><td>$1k–$4k per day.</td><td>Mirror state’s deceptive trade practices act.</td></tr><tr><td>Is there a written notice requirement for IRPs?</td><td>Yes.</td><td>No.</td><td>Yes.</td><td>No.</td></tr><tr><td>Are there exceptions for security-related features?</td><td>Yes.</td><td>Yes.</td><td>Yes.</td><td>No.</td></tr><tr id="_ftnref1"><td>Can an OEM provide pre-assembled parts instead of individual components?</td><td>Yes.</td><td>Yes.</td><td id="_ftnref1">Likely yes.<a href="#_ftn1" target="_self" id="_ftnref1">[1]</a></td><td>No.</td></tr><tr><td>Do repair resources need to be available for modifying DEE?</td><td>No.</td><td>No.</td><td>Not addressed.</td><td>Not addressed.</td></tr><tr id="_ftnref3"><td>Is an OEM required to divulge any trade secrets?</td><td>No.</td><td id="_ftnref2">No, with limited exceptions.<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a></td><td id="_ftnref3">No, with limited exceptions.<a href="#_ftn3" target="_self" id="_ftnref3">[3]</a></td><td>No.</td></tr><tr id="_ftnref5"><td>Is an OEM required to license any intellectual property?</td><td>No.</td><td id="_ftnref4">No, with limited exceptions.<a href="#_ftn4" target="_self" id="_ftnref4">[4]</a></td><td id="_ftnref5">No, with limited exceptions.<a href="#_ftn5" target="_self" id="_ftnref5">[5]</a></td><td>Not addressed.</td></tr><tr dir="ltr"><td>Is an OEM or ARP liable for damage that occurs due to repairs performed by an IRP?</td><td>No.</td><td>No.</td><td>Not addressed.</td><td dir="ltr">No.</td></tr></tbody></table>Key Takeaways“Right to repair” laws will soon go into effect, expanding quickly into more U.S. jurisdictions. While they share many similarities, these laws can vary significantly in scope. Currently the Model Act is the broadest and offers the fewest exceptions for manufacturers, presenting significant implications for a business’s intellectual property portfolio, trade secrets, and product security features.Businesses should verify whether their products are considered DEE and fall under the scope of these laws, what compliance measures are necessary, and if those compliance measures satisfy requirements in all applicable jurisdictions. The most challenging determination is likely whether individual products are considered covered DEE in each jurisdiction. The statutory definitions are vague, with no available precedent to help determine whether products not explicitly addressed qualify.Overall, taking a proactive approach will help businesses reduce the risk of encountering unexpected “right to repair” enforcement actions. There is still time to develop effective and cost-efficient compliance strategies before these laws go into effect. Morrison Foerster’s products liability team is ready to assist in these efforts and will provide updates as future legislation and enforcement actions develop.Julie Harrison, a summer associate in Morrison Foerster’s San Diego office, contributed to this alert.<a href="#_ftnref1" target="_self" dir="ltr" id="_ftn1">[1]</a> The CA Act is silent on this topic. However, the CA Assembly on Privacy and Consumer Protection’s 06/23/23 Analysis stated that “the bill’s definition of ‘part’ includes an ‘assembly of parts.’ [So] if it would be hazardous for a product owner or repairperson to handle a specific component, the manufacturer can provide the component as part of a safer-to-handle assembly.” Jesse Gabriel, SB-244 Bill Analysis, CA Assembly Committee on Privacy and Consumer Protection (June 21, 2023).<a href="#_ftnref2" target="_self" dir="ltr" id="_ftn2">[2]</a> No, “except as necessary to provide documentation, parts, and tools on fair and reasonable terms.” Minn. Chap. Law 57 Sec. 11 Subd. 5(a) (2023).<a href="#_ftnref3" target="_self" dir="ltr" id="_ftn3">[3]</a> No, “except as necessary to comply with this section.” S.B 244, Leg. 42488.2 (c), 2023-2024 Reg. Sess. (Cal. 2023).<a href="#_ftnref4" target="_self" dir="ltr" id="_ftn4">[4]</a> No, “except as necessary to provide documentation, parts, and tools on fair and reasonable terms.” Minn. Chap. Law 57 Sec. 11 Subd. 5(a) (2023).<a href="#_ftnref5" target="_self" id="_ftn5">[5]</a> No, “except as necessary to comply with this section.” S.B 244, Leg. 42488.2 (c), 2023-2024 Reg. Sess. (Cal. 2023).

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Fitbit

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

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Right to Repair Laws: Coming Soon to a State Near You

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Consumer products businesses should know that “right to repair” laws are here to stay. Frustrated with restrictions on repairing consumer electronics, advocacy organizations spearheaded a grassroots “right to repair” movement that is gaining traction.

Right to Repair Laws: Coming Soon to a State Near You

California lawmakers are considering a bill that would limit confidentiality in cases involving allegations of defective products or environmental harms by placing restrictions on protective orders and confidentiality terms in settlement agreements.Generally, parties litigating cases alleging defective products or environmental conditions may stipulate to a protective order that governs discovery and protects the confidentiality of certain documents. Similarly, settlement agreements almost always require both parties to maintain some level of confidentiality as a condition of settlement. The ability to protect confidential information encourages early resolution, which in turn helps reduce the caseload of overburdened courts.The Public Right to Know Act (SB 1149), however, seeks to limit the parties’ ability to enter into such agreements in product liability and environmental cases in California. SB 1149, which was introduced by California State Senator Connie Leyva (D-Chino) this spring and is jointly sponsored by Consumer Reports and Public Justice, seeks to require public disclosure of factual information about an allegedly defective product or environmental condition that “has caused, or is likely to cause, significant or substantial bodily injury or illness, or death.”<a href="file:///C:/Users/TLW9/AppData/Roaming/OpenText/DM/Temp/SAN_FRANCISCO-%234731187-v10-MOFO_SB_1149_Client_Alert.docx#_ftn1">[1]</a> California would join other states such as Florida and Louisiana that impose similar restrictions by statute.If passed, the bill would:<ul><li>Render provisions in settlement agreements that restrict disclosure of such factual information void and unenforceable;</li><li>Preclude courts or arbitral tribunals from entering any protective order that would seek to maintain the confidentiality of such factual information, with narrow exceptions; and</li><li>Allow any person, including a media member acting on behalf of the public, to challenge these types of confidentiality provisions so long as it is reasonably foreseeable that the restriction would affect the challenger.</li></ul>The bill provides some exceptions. A settlement provision or a protective order could still maintain confidentiality over the following:<ul><li>Settlement amount;</li><li>Medical or personal identifying information;</li><li>Citizenship or immigration status; and</li><li>Proprietary customer lists or trade secrets if the party moves the court or arbitral tribunal in good faith and demonstrates that an overriding confidentiality interest outweighs public interest in disclosure.</li></ul>The legislature recently amended SB 1149 to permit a party, including an intervenor who has become a party or a producing or testifying third party, to move for nondisclosure under the above provisions.The bill’s proponents claim to seek a balance between corporate confidentiality and promoting disclosure of evidence related to public safety. If passed, however, the bill could undermine public policy favoring early resolution and harm parties litigating these kind of cases by restricting the tools available to protect confidentiality. Protecting confidential information incentivizes parties to settle cases early. Settlements help parties avoid costly litigation and lessen burdens on courts. Without this incentive, parties would be more likely to avoid seeking early resolution and to engage in protracted litigation.Furthermore, with protective orders severely limited, discovery disputes would likely intensify, as parties defending against such allegations would seek to protect their confidential information from public inquiries.In addition, SB 1149 would place new obligations on attorneys. If passed, attorneys would have to take this legislation into account when advising clients about the scope of confidentiality permitted in settlements and in discovery. Asserting confidentiality over the underlying facts in a settlement agreement, advising a client to sign an agreement containing such a provision, or moving for a protective order that seeks to protect such information could constitute grounds for bar discipline.This bill’s passage is not a foregone conclusion. Similar legislative proposals have failed in the past, including a recent effort in 2017. If SB 1149 passes, however, parties defending in the areas of products and environmental harms could experience increased litigation costs, drawn out discovery disputes, and greater risk of exposing confidential business information.The Morrison Foerster Class Action & Mass Tort team will continue to monitor the progress of SB 1149 and provide updates as the bill proceeds through the legislature. <a href="file:///C:/Users/TLW9/AppData/Roaming/OpenText/DM/Temp/SAN_FRANCISCO-%234731187-v10-MOFO_SB_1149_Client_Alert.docx#_ftnref1">[1]</a> <a href="https://legiscan.com/CA/text/SB1149/id/2520468/California-2021-SB1149-Introduced.html">SB 1149</a>.

Fertility Center Litigation

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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

Erin M. Bosman

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

Erin Bosman

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Confidentiality at Risk: California Legislature Considers Bill That Would Limit Scope of Confidentiality in Product Liability and Environmental Cases and Settlements

Confidentiality at Risk: California Legislature Considers Bill That Would Limit Scope of Confidentiality in Product Liability and Environmental Cases and Settlements

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California lawmakers are considering a bill that would limit confidentiality in cases involving allegations of defective products or environmental harms by plac

In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM), 2022 WL 788669 (D. Conn., Mar. 15, 2022). This ruling shows that plaintiffs making vague allegations of injury will not satisfy Iqbal and Twombly.BackgroundApproved by the Food and Drug Administration (“FDA”) in 2006, Merck’s Gardasil vaccine helps protect individuals against human papillomavirus infection, a viral infection associated with cervical cancer. With her mother’s consent, the plaintiff in Herlth received the first two doses of the vaccine at the age of 15. The plaintiff allegedly experienced side effects. She was diagnosed with various disorders, including chronic fatigue syndrome and postural orthostatic tachycardia syndrome, a condition that affects the body’s ability to adjust the heart rate and regulate blood flow. The plaintiff filed a petition for compensation in the “Vaccine Court” (i.e., the Office of the Special Masters of the U.S. Court of Federal Claims)—a prerequisite for bringing a civil action. Only after receiving an unfavorable outcome at the Vaccine Court may an individual sue the manufacturer. Here, the Vaccine Court dismissed the plaintiff’s claim for insufficient proof. The plaintiff then sued in federal court, alleging state law failure to warn, manufacturing defect, negligence, and common law fraud claims. The crux of the plaintiff’s complaint was her failure to warn claim. She alleged that her mother believed the vaccine was safe based on Gardasil television advertisements and other marketing material.The District Court’s DecisionIn granting Merck’s motion to dismiss, the court concluded that all claims were either preempted or inadequately pled. Federal law preempted the failure to warn claim, the plaintiff failed to plausibly plead a manufacturing defect, the plaintiff failed to plead fraud with particularity, and federal law preempted the fraud on the FDA claim.With respect to the failure to warn claim, the court held that the Food, Drug, and Cosmetic Act (“FDCA”) preempts a state law failure to warn claim against a drug manufacturer. FDA approves the text of vaccine labels. Manufacturers may change the label only with FDA approval, unless the changes reflect “newly acquired information” about warnings or adverse reactions, among other things. 21 CFR §601.12(f)(2)(i). A unilateral label change requires reasonable evidence of a causal link between the newly acquired information and the adverse reaction at issue. 21 CFR §201.57(c)(6)(i). Under this standard, the plaintiff had to sufficiently plead that Merck had newly acquired information (i.e., information received after the FDA’s approval of Gardasil) related to the plaintiff’s alleged injuries that justified a label change.Here, the plaintiff failed to meet her burden. She relied on conclusory allegations about risks of Gardasil that bore no concrete relationship to her alleged injuries. Her complaint also referred to scientific studies and news articles linking Gardasil to her alleged injuries without explaining how the studies supported her allegations. Even worse, many of the studies were published well after the plaintiff received her vaccine. Merck could not have relied on them to effect a label change before the plaintiff was allegedly injured.The court also rejected the plaintiff’s argument that drug labeling preemption principles apply only to design defect claims and not failure to warn claims. The plaintiff based this argument on the Vaccine Act’s express preemption of state law design defect claims against vaccine manufacturers. In rejecting this argument, the court reasoned that Congress did not intend to make it more difficult to bring design defect claims, while also, opening the “floodgates” for failure to warn claims. The court thus found that the Vaccine Act preempts both state law design defect and failure to warn claims.As to the manufacturing defect claim, the court found that the design defect claim was in fact a “dressed up” manufacturing defect claim; the plaintiff did not allege a mistake or flaw in the manufacturing process.The rest of the plaintiff’s claims failed for similar reasons. Under her negligence claim, the plaintiff lumped together various disparate theories that sounded in fraud, which requires a heightened pleading standard. The plaintiff failed to meet her burden. For instance, the plaintiff’s references to Merck’s advertisements merely described the advertisements. She did not point to specific statements in the advertisements made with knowing falsity.Finally, even if the plaintiff could have satisfied pleading standards for her fraud on the FDA claim, Buckman preemption applied, barring state law claims alleging fraud on the FDA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). As the court noted, the Second Circuit further clarified that the FDCA preempts state tort law claims only when the cause of action assigns liability “solely on the basis” of fraud against the FDA. Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006). Since the plaintiff sought to assign liability “solely on the basis” of purported fraud against the FDA, the FDCA preempted her fraud on the FDA claim.TakeawaysThis ruling is one of the first major vaccine preemption decisions since FDA authorized the COVID-19 vaccines, which spurred much public attention and discussion around vaccines. Herlth makes clear that there is a high bar for successfully pleading vaccine products liability claims. Under Twombly and Iqbal, showing that a vaccine manufacturer acquired new information regarding possible side effects requires more than vague and conclusory allegations.

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, autom

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Pleading and Preemption: Immunization Against Vaccine Products Liability Claims

Pleading and Preemption: Immunization Against Vaccine Products Liability Claims

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In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gard

Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount of protein in the food products. Read the full article below. Since spring 2020, food manufacturers have been hit with a wave of protein-labeling lawsuits all making the same core allegation: that their products' front-label protein content statements violate U.S. Food and Drug Administration regulations, and mislead consumers, by overstating the amount of protein in the food products. While the plaintiffs admit that the FDA regulations are explicitly applicable to back-label claims, they allege that these same regulations do not apply to the same statements being made on front labels. The defendants argue otherwise, claiming that the plaintiffs' proffered theory would result in the illogical result of having different protein statements on the front and back labels. And indeed, the U.S. District Court for the Northern District of California, in a February ruling in Nacarino v. Kashi Co., described the applicable regulatory scheme as "convoluted."[1] That was true — until recently. Earlier this year, the FDA released new guidance clarifying labeling requirements concerning protein claims, undermining the foundation of the labeling plaintiffs' claims. And the Northern District of California has since dismissed these protein lawsuits with prejudice. These decisions highlight the dispositive impact of preemption arguments. But in two cases, plaintiffs have since appealed the district courts' orders dismissing their claims, bringing the regulatory scheme back into question. District Courts' Distaste for Protein Suits On Feb. 10, in Nacarino v. Kashi Co., Judge Vince Chhabria dismissed with prejudice the plaintiff's claims that Kashi mislabels its food products by miscalculating their protein content.[2] The Nacarino court found that Kashi's use of the nitrogen method for calculating protein is appropriate under FDA regulations, and any claims brought by individuals based on the use of this method were preempted by the Federal Food, Drug, and Cosmetic Act.[3] In making its ruling, the Nacarino court relied heavily on the FDA's newly issued guidance on its website clarifying appropriate methods for calculating front-label protein statements. Less than a week after the Nacarino decision, another court in the Northern District of California followed suit, dismissing with prejudice the allegations of the plaintiff in Chong v. Kind LLC that Kind's front-label protein claims were deceptive and unlawful.[4] In Chong, the court declined to follow its own earlier decision in what it admitted was a "nearly identical" lawsuit from 2020, Minor v. Baker Mills, which had permitted protein-labeling claims to proceed past a motion to dismiss.[5] The Chong court acknowledged that "it has now become apparent ... that Minor was incorrectly decided."[6] Referencing Nacarino, the Chong court held that the plaintiff's claims were preempted because federal regulations establish "that producers may state grams of protein even outside the Nutrition Facts panel calculated by the nitrogen method, and without adjustment for digestibility."[7] Furthermore, the court rejected plaintiff's claims based on Kind's failure to include a percentage of the daily value of protein on the back label, in violation of FDA regulations. The court found that, because they were entirely dependent on violations of the FDCA, the plaintiff's claims under California's Sherman Law were impliedly preempted under the U.S. Supreme Court's 2001 ruling in Buckman v. Plaintiffs' Legal Committee.[8] The plaintiffs in both Nacarino and Chong have since appealed the courts' decisions dismissing their claims with prejudice.[9] Opening briefs are due in June, which will provide additional insight into the plaintiffs' basis for challenging the courts' conclusions that FDA guidance on protein claims is definitive. FDA Regulations and New Guidance Under FDA regulations, food manufacturers may calculate protein content for front-label protein claims at least two different ways: (1) calculating the amino acid content of the food directly, or (2) using the nitrogen method, which requires manufacturers to multiply the nitrogen content of the food by a factor of 6.25.[10] When food manufacturers calculate the percentage daily value of protein on the product's back label, federal regulations require that the percentage be adjusted for digestibility using a "protein digestibility-corrected amino acid score."[11] Because plant-based proteins are not fully digestible by the human body, the amount of protein calculated under the nitrogen method may differ from the amount of protein as adjusted for digestibility and as used for calculating the percentage of daily value on the back label. Plaintiffs have seized on these nuances in the federal regulations to argue that front-label protein claims overstate the amount of protein by failing to account for protein digestibility. In essence, plaintiffs claim that, despite manufacturers calculating protein claims in accordance with FDA regulations for back-label protein statements, using this same calculation for front-label claims is misleading. But no requirement to calculate protein digestibility exists for front-label claims. In its Jan. 11 guidance, the FDA made it clear that, contrary to plaintiffs' claims, food manufacturers are not required to use only an amino acid content method for calculating front-label protein statements, nor are they required to adjust the front-label content claims for digestibility. Indeed, the FDA approves of the use of the nitrogen method for front-label protein claims, and does not require that manufacturers adjust protein content for digestibility when making such claims. Looking Ahead Where plaintiffs' claims rest on an interpretation of the federal regulatory scheme that the FDA recently rejected, decisions from the Northern District of California suggest that preemption arguments may present a viable defense — at least for now. As the U.S. Court of Appeals for the Ninth Circuit grapples with Chong and Nacarino, manufacturers can expect some reprieve from the barrage of these protein case filings. Even if they are named in new filings, manufacturers have additional ammunition in their pockets, and should consider and give great weight to asserting preemption arguments and requesting a stay of their proceedings. This article is for general information purposes and is not intended to be and should not be taken as legal advice. [1] <a href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2023409&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2023409&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&" target="_blank">Nacarino v. Kashi Co. </a>, No. 21-cv-07036-VC, 2022 WL 390815, at *1 (N.D. Cal. Feb. 9, 2022). [2] Id. [3] Id. at *5. [4] <a href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2027438&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2027438&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&" target="_blank">Chong v. Kind LLC </a>, No. 21-cv-04528-RS, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022). [5] Id. at *1; <a href="https://advance.lexis.com/api/search?q=2020%20U.S.%20Dist.%20LEXIS%20258880&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2020%20U.S.%20Dist.%20LEXIS%20258880&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&" target="_blank">Minor v. Baker Mills Inc. </a>, No. 20-cv-02901-RS, 2020 WL 11564643 (N.D. Cal. Nov. 12, 2020). [6] Chong, 2022 WL 464149, at *1. [7] Id. at *3. [8] Id. at *4. [9] Nacarino v. Kashi Co., No. 22-15377 (9th Cir.) (appeal filed March 14, 2022); Chong v. Kind LLC, No. 22-15368 (9th Cir.) (appeal filed March 11, 2022). [10] See 21 C.F.R. § 101.9(c)(7). [11] Id.

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

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Associate

Lena is an associate in the Litigation Department in Morrison Foerster’s San Francisco office. Lena’s practice focuses on commercial and class actions litigation, with an emphasis on false advertising, unfair competition, and antitrust. Lena regularly counsels clients in the food and beverage, dietary supplement, cosmetics, retail, and technology sectors.











Lena Gankin

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Rulings, FDA Guidance May Help Food Cos. In Protein Suits

Rulings, FDA Guidance May Help Food Cos. In Protein Suits

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Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food m

Erin Bosman has been named “Product Liability Lawyer of the Year.”  This award recognizes high achieving female lawyers and progressive law firms who best support women in law.Co-Chair of MoFo’s Class Actions and Mass Torts Group, Erin defends clients in high-stakes mass tort litigation and navigates them through complex, company-threatening product liability crises. Clients count on her to protect their brands and turn to her as their trusted advisor. Erin has long championed women in the legal profession and serves as mentor, sponsor, and advisor to countless women both within and outside the firm.Morrison & Foerster has also been recognized for the “Gender Diversity International Law Firm” award and was named “Firm of the Year for the U.S. – Northeast Area,” demonstrating MoFo’s commitment to advancing gender diversity in the law.

Erin Bosman Named Product Liability Lawyer of the Year by Euromoney in Americas Women in Business Law Awards

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Erin Bosman Named Product Liability Lawyer of the Year by Euromoney in Americas Women in Business Law Awards

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Erin Bosman has been named “Product Liability Lawyer of the Year.”  This award recognizes high achieving female lawyers and progressive law firms who best suppo