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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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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On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC (BMW) concerning the soft-closing automatic doors (SCA) in various BMW models. While many automotive defect claims are brought as pure product liability actions, the plaintiffs in Azoulai sought to “hybridize product liability and consumer fraud doctrines” in pursuit of a more lucrative fraud-based class action damages award. Encouragingly, the court rejected these efforts, finding that slamming doors are a known hazard (that was warned against) and that the consumer fraud doctrine was inapplicable.BackgroundIn 2002, BMW introduced SCA on certain automobile models. The SCA feature “auto-activates and pulls the door of the vehicle to the frame of the automobile and firmly closes it when the door is within 6mm of the closed position.” The Azoulai plaintiffs claimed that the “SCA crushed their fingers while drawing the doors of their vehicles to the closed position.” They contended that the SCA should have included a sensor that halted its operation if it detected small objects (like fingers) between the door and the frame of the vehicle. But rather than focus on their physical injuries, the plaintiffs alleged deception in their lawsuit against BMW. Specifically, they claimed that BMW “wrongfully induced Plaintiffs to purchase and/or lease their vehicles by concealing [the alleged defect], and that Plaintiffs would have paid less for their vehicles or would not have purchased or leased them at all had they known of the defect.”Plaintiffs sued for breaches of warranties, as well as violations of the California Consumer Legal Remedies Act (CLRA) and the California Unfair Competition Act (UCL). Plaintiffs did not bring product liability claims.StandingThe court held that the plaintiffs lacked standing because they did not allege facts showing an injury derived from the legal theories alleged in their pleading. To allege standing for fraud-based claims, a plaintiff must plead facts that establish an economic, as opposed to purely physical, injury. The court found that plaintiffs failed that test. Although their physical injuries might have conferred standing under a traditional product liability theory, plaintiffs “expressly decline[d] to assert [a product liability] claim,” opting instead to pursue fraud-based claims. As the court stated, “[r]ather than seeking to recover for their injuries, Plaintiffs bring this suit grounded in consumer fraud[.]” In short, plaintiffs’ actual injuries and theories of liability didn’t match.The court also concluded that plaintiffs had no basis for their contention that their vehicles “declined in value because the SCA lacked a [safety] sensor.” The court noted that plaintiffs did not allege that an added safety sensor was bargained for or was built in to the purchase price of the vehicles. The court further stated that plaintiffs did not allege that the SCA design received negative attention from the media, thus decreasing the value of their vehicles. Accordingly, the court rejected plaintiffs’ hybridization attempt, holding that they suffered no injury in fact related to BMW’s alleged fraud, and therefore lacked standing.Plaintiffs’ Deficient Claims The court further rejected arguments that BMW overstated the safety of the SCA and concealed a design defect in the technology. Specifically, plaintiffs alleged that BMW misrepresented that the SCA “safely” closes the doors of the vehicles and that BMW actively concealed that the SCA lacked a safety sensor. The court rejected these claims.BMW argued that its marketing statement that the SCA operates “safely” was mere puffery and, therefore, not actionable under the CLRA or UCL, and did not create a warranty. In order to be actionable (and not considered puffery), a statement must be “specific and measureable”—it cannot be generalized, vague, or unspecified.<a href="#_ftn1" name="_ftnref1">[1]</a> The court held that there is nothing “specific and measurable” about the word “safely.” This determination proved fatal to all of plaintiffs’ claims.To allege a concealment or “failure to disclose” claim under the CLRA or UCL, plaintiffs are required to allege that the undisclosed defect posed an unreasonable safety hazard. Plaintiffs’ claims failed for two reasons. First and foremost, they did not adequately allege existence of a defect in the design of the SCA. Second, the court noted that even if plaintiffs had established the existence of a defect, their claims would still fail because they were unable to allege an unreasonable safety risk posed by the SCA. “Humans have been slamming their fingers in doors since doors were invented,” noted the court, and “[s]lamming one’s finger in a car door, while plausibly hazardous, is an anticipated risk of using any door, and is a risk of which BMW expressly warns consumers.”ConclusionAzoulai illustrates the perils of overreaching. Had plaintiffs brought product (or strict) liability claims for the injuries allegedly caused by the SCA, and sought damages to compensate for their medical bills and reasonable related expenses, the outcome might have been different. However, electing to bring fraud-based class action claims with the hope of a larger payoff closed the door on any plaintiff recovery.<a href="#_ftnref1" name="_ftn1">[1]</a> Anunziato v. eMachines, Inc., 402 F. Supp. 2d 1139 (C.D. Cal. 2005).

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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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

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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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Closing the Door on Hybrid Product Defect/Fraud Claims

Closing the Door on Hybrid Product Defect/Fraud Claims

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On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed 

On April 13, 2017, United States District Judge Beverly Reid O’Connell for the Central District of California granted a motion to dismiss a class action complaint alleging that Hyundai sold cars with an alleged latent paint defect that caused the “self-healing” paint to bubble, peel, and flake.  Resnick et al. v. Hyundai Motor Am., Inc. et al., No. 8:16-cv-00593-BRO (PJWx), Dkt. No. 80.  The court dismissed plaintiffs’ warranty, negligent misrepresentation, fraudulent concealment, and state consumer protection claims without prejudice, with the exception of a Massachusetts Unfair and Deceptive Trade Practice Act claim, which was dismissed with prejudice.Consumers Challenge Alleged Paint Defect Under State Consumer Protection Laws.In March 2016, 15 individuals from 10 different states sued defendants Hyundai Motor America, Inc. and Hyundai Motor Co., Ltd.  Plaintiffs are current owners of 2006-2016 Hyundai Santa Fe, Sonata, and Elantra automobiles manufactured in the United States that have an alleged paint defect that manifests itself over time and causes the paint to bubble, peel, and flake.  Plaintiffs claim that Hyundai fraudulently concealed the alleged paint defect when plaintiffs purchased their vehicles and refused to offer plaintiffs or the putative class any relief.In November 2016, the court granted defendants’ motion to dismiss plaintiffs’ First Amended Complaint.  (Dkt. No. 57.)  Plaintiffs filed a Second Amended Complaint in November 2016, and stipulated to consolidate two cases against defendants in January 2017.  In February 2017, plaintiffs filed a Consolidated Class Action Complaint, alleging fourteen causes of action, including for breach of warranty, negligent misrepresentation, fraudulent concealment, and violations of various state consumer protection laws.Court Dismisses Express and Implied Warranty Claims.For the majority of plaintiffs, the court dismissed without prejudice the breach of express warranty claims because the alleged defect occurred outside Hyundai’s warranty period.  The court rejected plaintiffs’ argument that an exception should apply to hold Hyundai liable for latent defects outside the warranty period.  The court also dismissed plaintiffs’ warranty claims based on representations on Hyundai’s corporate website and advertising campaigns regarding the quality of the paint as outside the warranty period, which the court limited to the express warranty period.  The court granted leave to amend for two plaintiffs who may have experienced the alleged defect during the warranty period, but did not clearly allege those facts.The court dismissed without prejudice claims for breach of implied warranty of merchantability under California’s Song-Beverly Consumer Warranty Act.  The court held that the implied warranty of merchantability requires “something beyond mere aesthetic concerns,” and that plaintiffs only allege that the paint defect affected their vehicles’ aesthetics.  The court rejected plaintiffs’ argument that a breach of implied warranty of merchantability arises whenever a vehicle’s behavior fails to comport with industry standards.Court Dismisses Negligent Misrepresentation Claims Under the Economic Loss Rule.The court dismissed without prejudice plaintiffs’ negligent misrepresentation claims as barred under the economic loss rule.  Plaintiffs alleged that the paint defect caused “out of pocket losses associated with the paint defect, corrosion repairs and diminished value of [their] vehicle[s].”  Under the economic loss rule, the court held that these alleged damages were insufficient to support a negligent misrepresentation claim because they arose from harm to the product itself (i.e., the body of the car).  The court rejected plaintiffs’ argument that the economic loss rule did not apply because of the “special relationship” exception, which does not apply to those who have a direct contractual relationship with the defendants (like plaintiffs).Court Dismisses State Consumer Protection and Fraudulent Concealment Claims. Plaintiffs also brought claims based on fraudulent concealment and violations of California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act based on the allegations that:  (1) defendants made affirmative misrepresentations of fact, and (2) defendants fraudulently concealed their knowledge of the alleged paint defect.  The court dismissed these claims without prejudice based on plaintiffs’ failure to allege facts indicating that defendants knew or should have known of the alleged defect at the time of sale.  Plaintiffs’ general allegations that there were “concerns” regarding the possibility of self-healing paints peeling were insufficient to establish presale knowledge.  Plaintiffs failed to allege “who had these concerns, the substance of the concerns, or whether the concerns were ever communicated to Hyundai.”  The court also found that allegations regarding anonymous online complaints were not sufficient to establish defendants’ knowledge of the alleged defect.  The court further emphasized that, even if plaintiffs’ sufficiently pleaded knowledge, plaintiffs did not adequately plead specific reliance on the alleged affirmative misrepresentations.  The court dismissed plaintiffs’ non-California state consumer protection law claims without prejudice on similar grounds.Hyundai Takeaway.The opinion is quite rigorous in holding plaintiffs to their pleading burden.  As was done here, courts typically allow plaintiffs an opportunity to amend.

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Court Dismisses Peeling Paint Class Action Against Hyundai, But Grants Third Opportunity to Amend

Court Dismisses Peeling Paint Class Action Against Hyundai, But Grants Third Opportunity to Amend

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On April 13, 2017, United States District Judge Beverly Reid O’Connell for the Central District of California granted a motion to dismiss a class action complai

California’s innovative Safer Consumer Products regulations, also known as the Green Chemistry Initiative, are ready for another step forward with the proposed inclusion of Spray Polyurethane Foam (SPF) Systems containing Unreacted Methylene Diphenyl Diisocyanates (MDI) as a Priority Product. These SPF systems are used for insulation, roofing, or sealants and raise safety concerns because of their widespread use by both professional contractors and “do-it-yourself” users for home repairs. This is the second Priority Product proposed for listing, following the inclusion of children’s foam-padded sleeping products with fire retardants.

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California Adds New Priority Consumer Product for Green Chemistry Regulation

California Proposes Next Group of Priority Products Under Its Green Chemistry Initiative

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California’s innovative Safer Consumer Products regulations, also known as the Green Chemistry Initiative, are ready for another step forward with the proposed 

California Adds New Priority Consumer Product for Green Chemistry Regulation

Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th Cir. Feb. 21, 2017). This defense decision is another step toward limiting liability for manufacturers that could not prevent these types of claims even if they endeavored to.Please see our full article as published on <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltd2eccee2c43452d8/62731588b5ad5f2863c59560/170403-preemption-case-law.pdf">Law360</a>.

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Another Step Toward Reasonable Preemption Case Law

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Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v.

Another Step Toward Reasonable Preemption Case Law

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule.  The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of their abbreviated new drug application (ANDA) labels, allowing them to make changes that differ from the product’s reference listed drug label and without obtaining prior FDA approval.  While proponents of the rule argue that it promotes patient health and safety, those in the industry have strongly opposed the rule, recognizing that it would result in conflicting labels, thereby likely opening the floodgates to failure to warn litigation based on conflicting labels.The proposed rule, which has received enormous pushback and delay, appears even less likely to survive in light of Trump’s nominee for FDA commissioner, Scott Gottlieb.  Gottlieb previously served as a deputy commissioner at the FDA and has been vocal in opposing the proposed labeling rule.  He argues that the rule would increase healthcare costs and expose generic drug manufacturers to failure to warn lawsuits.  The rule has faced numerous delays since it was first proposed in 2013, and is unlikely to be finalized in April as currently scheduled.  If confirmed by the Senate, Gottlieb will almost certainly attempt to halt the rule.

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Associate

Brittany Scheinok is an associate in the Litigation Department of the firm’s San Diego office.

Brittany Scheinok

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Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

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President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s pr

The Big Picture:  On Tuesday, Judge Koh granted Kellogg’s Motion to Dismiss in its entirety in Hadley v. Kellogg Sales Company, No. 5:16-cv-04955-LHK (N.D. Cal.).  Hadley is one of three cases<a href="#_ftn1" name="_ftnref1">[1]</a> against well-known cereal makers pending in the Northern District of California.  All three actions challenge various factually true “health” representations on the cereal packaging as misleading due to the amount of “added sugars” in the products.  FDA requires the total amount of sugars to be included on the Nutrition Facts Panel but does not yet require the amount of “added sugars” be broken out of the sugar category.<a href="#_ftn2" name="_ftnref2">[2]</a>While Judge Koh granted the motion in its entirety, she did not address several key arguments (e.g. preemption) and gave plaintiff leave to amend on several causes of action.  Thus, before we can play the funeral march for these “added sugars” cases, we need to see how one more round of pleadings shakes out and whether Judges Orrick and White follow Judge Koh’s lead.Key Holdings:<ul><li>“Added Sugars”—Plaintiff’s claims as to the amount of “added sugars” were dismissed with leave to amend for failing to satisfy 9(b).  Plaintiff did not plausibly allege that the various health claims were misleading because he failed to allege the amount of added sugar versus the total amount of sugar in each product and whether the amount of added sugar exceeded plaintiff’s own alleged “healthy” threshold.</li><li>Trans Fats—Plaintiff’s label challenges based on the fact that some products contained trans fats were dismissed with prejudice.  It was simply not plausible that the inclusion of trans fats made the factually true (and seemly unrelated) phrase “MADE WITH Real Fruit” misleading.</li><li>Miscellaneous Violations of FDA Regulations<a href="#_ftn3" name="_ftnref3">[3]</a>—Plaintiff’s claims based on alleged violations of FDA regulations were dismissed because plaintiff failed to plausibly plead that consumers would have been misled by the violations.  While the court generally granted leave to amend on these claims, a few were dismissed with prejudice based on futility or waiver.</li><li>Warranty Claims—Plaintiff’s express and implied warranty claims were dismissed with leave to amend because plaintiff provided a litany of statements but did not match them to the respective products.</li><li>Injunctive relief—The court found that while a willingness to consider repurchasing the product was likely sufficient to establish standing, here plaintiff’s willingness to repurchase was dependent on the products being “appropriately” priced.  Since any injunctive relief would not affect the price of the product, plaintiff lacked standing to seek such relief.</li></ul><a href="#_ftnref1" name="_ftn1">[1]</a> The other two cases are Krommenhock v. Post Foods, LLC, No. 3:16-cv-04958 (N.D. Cal. Filed Aug. 29, 2016); Truxel v. Gen. Mills Sales, Inc., No. 4:16-cv-04957 (N.D. Cal. Filed Aug. 29, 2016).<a href="#_ftnref2" name="_ftn2">[2]</a> On May 27, 2016, FDA issued a final rule on how “added sugars” should be listed on the Nutrition Facts Panel (“NFP Final Rule”).   Food Labeling: Revision of the Nutrition and Supplement Facts Panel, 81 Fed. Reg. 33,741 (May 27, 2016).  The NFP Final Rule revises the Nutrition Facts label by, among other things, “requiring the declaration of the gram amount of ‘added sugars’ in a serving of a product, establishing a Daily Reference Value (DRV), and requiring the percent Daily Value (DV) declaration for added sugars.”  Id. at 33,744.  The NFP Rule, which went into effect on July 26, 2016, does not require manufacturer compliance with the new labeling requirements until July 26, 2018.<a href="#_ftnref3" name="_ftn3">[3]</a> 21 C.F.R. §§ 101.13(e) (prohibition on the use of “free” or “low” unless product contains an altered amount of nutrient), (f) (type size of nutrient content claim), (i) (misleading nutrient content claim), 101.14(d) (limits on intervening material between health claims and required disclosures), 101.60 (calorie content claims), and 1.21 (material omissions)

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