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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“Make fine lines and wrinkles disappear!”  “Reduce the visibility of fine lines and wrinkles!”  At first read, these claims sound one in the same.  But for decades, a slight difference in phrasing of cosmetics claims—created as a function of current cosmetics regulations—has been responsible for allegedly confusing customers and complicating regulations.  Lawmakers have tried and failed to reform federal cosmetics regulations in the past and are now gearing up for another attempt.Current FDA Regulation of Cosmetics (or Lack Thereof)The U.S. Food and Drug Administration (FDA) regulates both drugs and cosmetics under the Food, Drug, and Cosmetic Act (FDCA).  The FDCA defines a “cosmetic,” in part, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  21 U.S.C. § 321(i).  The FDCA’s definition of “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . ,” and “articles (other than food) intended to affect the structure or any function of the body of man . . . .”  21 U.S.C. § 321(g)(1).Certain products can meet the definitions of both cosmetics and drugs under the FDCA depending on their intended uses.  The claims made about a certain product are determinative of whether the product is regulated as a cosmetic, drug, or both.  For <a href="https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm">example</a>, a shampoo is a cosmetic because its intended use is to cleanse hair.  An anti-dandruff treatment is a drug because its intended use is to treat dandruff.  An anti-dandruff shampoo is therefore both a cosmetic and a drug, and is regulated by the FDA as both.  Unlike drugs or medical devices, however, cosmetic products and ingredients (with the exception of color additives) currently do not require FDA approval before they go to market.  For this reason, a cosmetic product containing the same ingredients as a drug product can enter the market without premarket oversight as long as the product is not advertised as having therapeutic uses.But drug claims and cosmetic claims can sound indistinguishable to a consumer.  Take anti‑aging products for <a href="https://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm388826.htm" target="_blank" rel="noopener">example</a>.  If a product is intended to make lines and wrinkles less noticeable by moisturizing the skin, it is a cosmetic because moisturizing is a cosmetic claim.  On the other hand, products intended to affect the structure of the skin are drugs even if they affect the appearance.  So a product that is intended to remove wrinkles or increase the skin’s production of collagen is a drug.  And the slight difference in the way these two products are advertised can create large disparities in the level of premarket regulations such as mandatory good manufacturing practices.Further, under present cosmetics regulations, cosmetics companies are not required to report postmarket adverse events.  The lack of premarket oversight and mandatory adverse event reporting has contributed to consumer concerns over the safety of the products they use every day.  For example, the FDA is currently investigating reports of hair loss and rashes linked to the use of WEN by Chaz Dean Cleansing Conditioner products.  By November 15, 2016, the FDA received 1,386 adverse event reports from consumers about these products, the largest number of reports ever associated with any cosmetic hair cleansing product.  However, the FDA also became aware of over 21,000 complaints reported directly to Chaz Dean, Inc. and the product distributor, Guthy Renker, LLC, during inspections of the companies’ facilities.  Had these companies been required to submit these reports to the FDA—as drug companies are—it is almost certain that far fewer customers would have been affected.Due to the fine line between the definitions of drugs and cosmetics, as well as the significant difference in FDA regulations for the two categories of products, stakeholders have been calling on lawmakers to reform cosmetics regulations for many years now.  Some believe this long‑overdue legislation is right around the corner.Two Senate Bills on Cosmetics Regulation ReformIn May 2017, Senator Dianne Feinstein (D-CA) reintroduced the Personal Care Products Safety Act, S. 1113, 115th Cong. § 1 (2017), which was originally introduced to the Senate in April 2015 with co‑sponsor Senator Susan Collins (R-ME).  Later in October 2017, Senator Orrin Hatch (R-UT) introduced the FDA Cosmetic Safety and Modernization Act, S. 2003, 115th Cong. § 1 (2017), to the Senate.  Both proposed bills include the following proposed regulations for cosmetics:Mandatory reporting requirements.  Both bills would require cosmetic manufacturers and distributors to report “serious adverse events” to the FDA within 15 business days of receipt of notice.  As defined by both bills, this would include adverse events associated with the use of a cosmetic product, ranging from disfigurement to death.  This is similar to the existing mandatory reporting requirement for drugs, see 21 C.F.R. § 314.80(c)(1), but adverse event reporting is currently voluntary for cosmetics.  The Feinstein‑Collins bill also includes an annual report requirement, under which companies would have to submit to the FDA a yearly report summarizing all adverse events for each cosmetic product marketed during that year.Registration of cosmetics facilities.  Both bills would require cosmetics manufacturing facilities to register with the FDA and would also give the FDA the authority to suspend a facility’s registration if its products have a reasonable probability of causing serious adverse health consequences or death.  The Feinstein‑Collins bill includes a registration fee based on a company’s annual gross sales of cosmetics.  By contrast, registration under the current regulatory scheme is voluntary, through a program that the FDA administers to collect information on product ingredient listings and registration of manufacturers, packers, and distributors on a voluntary basis.Submitting ingredients to the FDA.  The Feinstein‑Collins bill would also require companies to submit cosmetic ingredient statements for each cosmetic product to the FDA.  The Hatch bill does not contain an analogous provision.  Under the authority of the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. § 1451 et seq., the FDA already requires a list of ingredients for cosmetics marketed on a retail basis to consumers.  21 C.F.R. § 701.3.  Cosmetics that fail to comply with the FPLA are considered misbranded under the FDCA.  15 U.S.C. § 1456.Ingredient review.  Both bills would require the FDA to review the safety of certain cosmetic ingredients and non-functional constituents (incidental components of the ingredients) through a notice and comment process.  The Feinstein‑Collins bill would require the FDA to review at least five ingredients a year and goes as far as to set out the first five ingredients for review:  (1) Diazolidinyl urea; (2) Lead acetate; (3) Methylene glycol/methanediol/formaldehyde, propyl paraben; and (5) Quaternium-15.  The Hatch bill, on the other hand, would have the FDA, in conjunction with industry and consumer groups, identify ingredients for safety review based on public health concerns.  The Hatch bill also provides for accredited third‑party review of these selected ingredients.Good manufacturing standards.  Under both bills, the FDA would be required to establish mandatory good manufacturing practices, and, under the Hatch bill, a cosmetics manufacturers’ noncompliance would constitute the cosmetics being adulterated.  The FDA’s good manufacturing practices for cosmetics manufacturers are currently voluntary.  Both bills would provide small businesses with additional time to comply with the good manufacturing practices—one year under the Feinstein‑Collins bill and two years under the Hatch bill.Mandatory recall authority.  The Feinstein‑Collins bill would give the FDA the authority to order mandatory recalls, while the Hatch bill does not.  The FDA only has the authority to oversee voluntary recalls at this time.Past Failures on Cosmetics Regulation ReformWhile some are encouraged by the bipartisan support for cosmetics regulation reform, the fact that similar bills have previously died in Congress casts doubt on whether either of the Senate bills have any hope of becoming law.Just earlier this year, Representative Pete Sessions (R‑TX) reintroduced his bill, the Cosmetic Modernization Amendments of 2017, as H.R. 575.  This bill was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015, H.R. 4075.  Before this, similar legislation included the Cosmetic Safety Amendments Act of 2012, introduced by Representative Leonard Lance (R‑NJ), H.R. 4395; the Cosmetics Safety Enhancement Act of 2012, introduced by Representative Frank Pallone (D‑NJ), H.R. 4262; and the Safe Cosmetics Act of 2011, introduced by Representative Jan Schakowsky (D‑IL), H.R. 2359.Not one of these bills has passed.Looking AheadCosmetics companies should consider proactively adopting some of the proposed practices described above regardless of whether either of the currently pending bills becomes law in the near future.  As the two proposed bills indicate, any future FDA regulation of cosmetics would build upon the existing voluntary programs for cosmetics and mandatory reporting schemes for drugs, including the Voluntary Cosmetic Registration Program, existing adverse event reporting system, and Good Manufacturing Practices guidelines.  Efforts to employ these programs therefore would not be in vain.  Early adopters can also develop compliance programs at a predictable pace as opposed to an accelerated or unknown schedule set by future legislation.  Lastly, there is little doubt that consumers are demanding self‑regulation in this space in the absence of government action.  Premarket considerations can effectively minimize costly litigation down the road.

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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Makeup Shake Up: Potential New Federal Cosmetics Regulations

Makeup Shake Up:  Potential New Federal Cosmetics Regulations

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“Make fine lines and wrinkles disappear!”  “Reduce the visibility of fine lines and wrinkles!”  At first read, these claims sound one in the same.  But for deca

In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other manufacturers. The U.S. Food and Drug Administration also recognizes the growing importance of these connected devices and issued final guidance on Sept. 6, 2017, relating to their safety.Interoperable medical devices can provide incredibly valuable data to health care providers and patients. Health information that may have taken several doctors’ visits to gather could literally be at a patient’s fingertips with a tap on their smartphone.At the same time, these devices often have highly sensitive applications, such as pacemakers and blood pressure monitors, that give rise to unique safety risks. The guidance urges safety and transparency in developing and designing interoperable medical devices, and highlights information that manufacturers should include in premarket submissions and device labeling. This final guidance follows a draft guidance issued by the FDA in January 2016.Please see our full article as published on <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt3b19f144a7fc88a1/627310c6b5ad5f2863c59400/171016-fda-guidance-medical-devices.pdf" target="_blank" rel="noopener">Law360</a>.

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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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Understanding FDA Guidance On Connected Medical Devices

Understanding FDA Guidance On Connected Medical Devices

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In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to 

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a citizen’s petition calling for the same warnings.  Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017).Factual BackgroundPlaintiffs (mother, father, and their child) alleged that the fertility drug Clomid led to the child’s birth defects due to the mother’s use of the drug before becoming pregnant.  They sued under Utah tort claims, including failure to warn, breach of implied warranty, negligent misrepresentation, and fraud.Relying on the doctrine of impossibility preemption, the district court granted the defendant’s motion for summary judgment, holding that, because the FDA “would not have approved the drug warnings that the Cervenys allege are required under Utah law,” it was impossible for Aventis to comply with both FDA regulations and state law.On appeal, the plaintiffs relied on a 1987 proposed FDA warning that “Clomid may cause fetal harm when administered to pregnant women.”  Although Aventis did not adopt the FDA’s proposed warning, and even though it only applied to those who took the drug while pregnant (unlike the plaintiff in this case), the Cervenys contended that (1) the proposed warning demonstrated the FDA’s willingness to approve warnings for women taking Clomid before becoming pregnant, and (2) Ms. Cerveny would not have taken Clomid before her pregnancy if Aventis had used the proposed warning.Impossibility PreemptionThe Cerveny court began with a discussion of basic preemption principles.  The court explained that federal law will preempt a state law when (1) the language of the federal law reveals an express congressional intent to preempt state law (express preemption); (2) federal regulation is so all-encompassing that Congress must have intended to leave no room for a state to supplement it (field preemption); or (3) compliance with both the federal and state laws is a physical impossibility (conflict preemption).  When a state’s regulations for drug labels conflict with the FDA’s, preemption issues arise.Impossibility preemption is at play when state law is preempted because compliance with both the federal and state laws is a physical impossibility – the laws are inapposite such that complying with state law necessarily results in a violation of federal law.  In Cerveny, Aventis made that very argument: it only needed to comply with the FDA regulations and not Utah state law because complying with both would be impossible.In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court established a loose framework for determining when federal law could preempt state law failure-to-warn claims against branded drug manufacturers.  Specifically, the defendant must present “clear evidence” that the FDA would have rejected the desired label change in order to preempt a state law failure-to-warn claim.  Id. at 571.Wyeth did not define “clear evidence,” but instead left the question to the lower courts.  A recent Third Circuit case interpreted Wyeth’s not-so-clear “clear evidence” language.  According to In re Fosamax Alendronate Sodium Prods. Liab. Litig., 852 F.3d 268, 285 (3rd Cir. 2017), the phrase “clear evidence” sets forth a standard of proof synonymous with “clear and convincing evidence” and involves a question of fact rather than a question of law.In order to preempt the state law failure-to-warn claim, a manufacturer needs to convince a factfinder that it was “highly probable” that the FDA would not have approved a change to the drug’s label.  The Cerveny court adopted this interpretation.The Court’s “Clear Evidence” AnalysisAs clear evidence that the FDA would not have approved plaintiffs’ suggested warnings, Aventis pointed to (1) the FDA’s history of approving Clomid for use by women before becoming pregnant, and (2) the FDA’s rejection of a citizen’s petition.Although the court determined that Clomid’s regulatory history did not, in and of itself, constitute clear evidence, the FDA’s rejection of a citizen’s petition did provide the requisite evidence.  In 2007, a citizen petition was filed demanding stronger Clomid warnings regarding the potential risks of fetal harm when a woman takes Clomid prior to becoming pregnant.  The FDA first denied the petition in 2009 and in 2012 declined to reconsider its original denial, reasoning that the original denial had “appropriately applied the standards in the [Federal Food, Drug, and Cosmetic Act] and FDA regulations regarding drug safety, warnings, and potential safety hazards.”The standard used by the FDA in rejecting the citizen’s petition was the same standard the FDA would have applied in evaluating a proposed label change to Clomid.  Because the FDA concluded in evaluating the citizen’s petition that the requested additional warnings were unjustified as to risks related to taking Clomid prior to pregnancy, the court determined that, had Aventis sought FDA approval to include stronger pre-pregnancy warnings, the FDA would have denied the request, just as it did the citizen’s petition.The plaintiffs argued that when the FDA considers proposed label changes, it treats manufacturers more favorably than citizen’s petitions, which “leads the FDA to accord greater deference to changes proposed” by manufacturers than those proposed in citizen petitions.  In rejecting this argument, the court explained that the FDA standard for revising a warning label “does not discriminate” between proposals submitted by manufacturers and proposals submitted by citizens.The Cervenys attempted to use the 1987 FDA proposed label change regarding use during pregnancy to argue that Ms. Cerveny would not have taken Clomid prior to becoming pregnant if Aventis had adopted the 1987 proposed label.  They argued that the proposed label would have warned women more directly about the potential harm to a fetus when a woman takes Clomid during pregnancy.  The district court agreed with Aventis that, even if Aventis accepted the proposed label change, Ms. Cerveny took Clomid prior to her pregnancy and therefore the label would not have applied to her.  Under Utah law, a plaintiff cannot allege as a defect in a label a warning that would not have applied to her.Aventis moved for summary judgment based solely on preemption.  While the Cervenys urged the district court to ignore Aventis’s state-law argument, the district court granted Aventis’ motion for summary judgment without explaining why or how a state law defense fell within the scope of the motion that was based solely on preemption.The appellate court remanded the issue because the district court did not “consider whether it could rest on [state] law when deciding a summary judgment motion that had relied solely on federal preemption.”  This leaves open the possibility that this claim could similarly be rejected based on federal preemption at the district court level.Looking ForwardThis ruling clarifies a defendant’s burden of proof in establishing a preemption defense.  It establishes that the FDA’s denial of a sufficiently similar citizen’s petition satisfies the clear-evidence standard required to successfully preempt a failure-to-warn claim.  Therefore, branded drug manufacturers have an additional evidentiary tool even when no other form of FDA decision-making exists to demonstrate that the FDA would have rejected a label change.Ultimately, if other circuits follow the Tenth Circuit’s lead, pharmaceutical companies may no longer need to demonstrate an attempt to provide the kind of warning allegedly required under state law.  We anticipate that going forward parties will disagree on the issue of how similar a citizen’s petition needs to be in order to have this preemptive effect.  Identical?  Virtually identical?  Substantially similar?  In Cerveny, the Tenth Circuit acknowledged that the citizen’s petition was “virtually identical” to the warnings the Cerveny’s advocated; however, we anticipate that courts may still find a preemptive effect when a citizen’s petition is substantially similar to proposed warnings.  So long as the substance of the proposed warning is the same, as well as its effect on the consuming public, it is unlikely that a decision will turn on semantics.*Co-author Karina Pundeff is a summer associate in our San Diego office.

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FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

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The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about 

*This is an update to a previous post on the Class Dismissed blog, seen <a href="http://classdismissed.mofo.com/consumer-products/the-revival-of-ecj-lawsuits-sweet-tooth-for-plaintiffs-or-toothless-claims/" target="_blank" rel="noopener noreferrer">here</a>.On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because she failed to provide specifics about her own Sports Beans purchase.  The court held that the Complaint was implausible because it only provides a cursory and formulaic recitation that Ms. Gomez purchased the Product relying on Jelly Belly’s representations regarding the ingredients of the Product, and that but for those representations, she would not have purchased or paid as much for the Product.  See Gomez v. Jelly Belly Candy Company et al., No. EDCV 17-00575-CJC(FFMx) (C.D. Cal. June 8, 2017) (Dkt. No. 17) (order granting motion to dismiss with leave to amend).  The Judge noted that “[a]bsent from the complaint are any factual allegations concerning the circumstances of Gomez’s purchase of the product, how she intended to use the product, whether she in fact expected a sugar-free product, whether she thought ‘evaporated cane juice’ was juice as opposed to sugar, and whether she consumed the product.”  Id.Judge Carney also struck Ms. Gomez’s prayer for injunctive relief, finding that it is impossible for her to be deceived in the future by Jelly Belly’s use of the term ECJ, because she now knows that it really means “sugar.”  Judge Carney accordingly joins the list of district court judges who have refused to allow plaintiffs to pursue claims for injunctive relief given their awareness of the misrepresentations alleged in their complaints.The court granted leave to amend and Ms. Gomez filed an Amended Complaint on June 22, 2017.  The Amended Complaint provides more details regarding the circumstances surrounding Ms. Gomez’s purchase and consumption of the Sports Beans; it is unclear whether these allegations will survive another motion to dismiss should Jelly Belly renew its challenge.

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UPDATE: The Revival of ECJ Lawsuits*

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*This is an update to a previous post on the Class Dismissed blog, seen here. On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because

UPDATE: The Revival of ECJ Lawsuits*

Introduction.  On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”) for allegedly misleading consumers by listing “evaporated cane juice” (ECJ) instead of “sugar” in the ingredient list of its “Sports Beans” candy.  The Gomez matter suggests that ECJ claims, previously dormant pending FDA’s issuance of final ECJ guidance, are now being filed and litigated since FDA issued its final guidance in May 2016. It remains to be seen, however, whether courts will dismiss these claims at the pleadings or summary judgment stage.Background on  FDA’s ECJ Guidance.  In 2009, FDA issued draft guidance stating that the term ECJ is false and misleading under Section 403(a)(1) of the FDCA because ECJ “does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups, as required by 21 CFR 102.5.).”  In other words, FDA suggested that ECJ could mislead consumers into believing that a product did not include sugar.  Instead of finalizing its Draft Guidance, FDA reopened the comment period on March 4, 2014.  In the meantime, ­­several lawsuits in the Northern and Central Districts of California were stayed pending FDA’s issuance of its Final Guidance.  (See e.g., <a href="http://classdismissed.mofo.com/fda/judge-seeks-answers-from-fda-on-ecj-draft-guidance/">The (Not So) Sweet Sound of FDA’s Silence:  Judge Seeks Answers From FDA on ECJ Draft Guidance.</a>)  On May 25, 2016, FDA issued its <a href="https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm502680.htm">2016 ECJ Final Guidance</a> (“2016 Final Guidance”), upholding its previous finding that the use of ECJ is false and misleading and further stating that “sweeteners derived from sugar cane should not be listed in the ingredient declaration by names such as ‘evaporated cane juice,’ which suggest that the ingredients are made from or contain fruit or vegetable ‘juice’ as defined in 21 CFR 120.1.”  After FDA issued the 2016 Final Guidance, stays were lifted in multiple cases, and new complaints have been filed alleging that the use of ECJ, instead of sugar, on an ingredient list violates the FDCA and California’s corresponding Sherman Act.The Gomez case.  One of these new ECJ lawsuits was filed by Ms. Gomez in February 2017 against Jelly Belly in San Bernadino Superior Court.  Plaintiff alleged that she, and others similarly situated, were misled by Sports Beans’ ingredient list because it lists ECJ rather than sugar.  Plaintiff further alleges that she was harmed because she would not have purchased the Sports Beans, or paid as much for them, had she known that they contained sugar.  She brings claims for violations of California’s CLRA, FAL, UCL, and for negligent misrepresentation under common law.  The lawsuit was removed in March to the Central District of California and assigned to Judge Carney.Jelly Belly’s Defense:  FDA’s Guidance is Not Binding Law.  Jelly Belly filed a motion to dismiss on April 21, 2017, arguing that Ms. Gomez failed to allege facts sufficient to show that the label was misleading to consumers or that it was material to their decision to purchase the Sports Beans.  In moving to dismiss Plaintiff’s claims, Jelly Belly contends that FDA’s Final Guidance is not binding law.  Indeed, FDA explicitly states that its “guidance documents, including this guidance, do not establish legally enforceable responsibilities,” but instead “describe [FDA’s] current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”Plaintiff’s Reliance on FDA’s Guidance.  In response, Ms. Gomez does not dispute that FDA’s 2016 Final Guidance is not binding law.  Instead, she contends that it does not matter, because “the law was settled long ago by the relevant statutes and regulations.”  The FDA’s 2016 Final Guidance simply clarified FDA’s position that the use of ECJ instead of sugar is false and misleading under 21 U.S.C. §343(a)(1) and its accompanying regulations.<a href="#_ftn1" name="_ftnref1">[1]</a>  Therefore, Plaintiff argues that Jelly Belly’s use of the term ECJ instead of sugar on Sports Beans’ label violates these regulations and §343(a)(1).  FDA’s 2016 Final Guidance was simply underscoring the alleged violation.Takeaway.  We have <a href="http://classdismissed.mofo.com/?s=ECJ+Guidance">written</a> about courts issuing stays on ECJ claims pending FDA’s issuance of the 2016 Final Guidance.  Now that the guidance is finalized, these claims have been revived and, as indicated by Gomez, are still being filed.  Yet it remains to be seen whether ECJ claims can survive motions to dismiss and/or motions for summary judgment.  Indeed, none of the 17 cases filed in the Northern District of California have advanced beyond the pleadings.  In fact, Judge Chen recently dismissed in its entirety the ECJ claim in Swearingen v. Healthy Beverage, LLC because the label of the product at issue included a link to the product’s website, which “specifically states that ‘cane juice is natural sugar.’”<a href="#_ftn2" name="_ftnref2">[2]</a>  Similarly in Gomez, Jelly Belly argues that ECJ is listed right below the product’s sugar content on the Nutrition Facts Panel, so purchasers of the Sports Beans who read the label would know that it contains sugar.Although Judge Chen’s holding does not address Ms. Gomez’s argument regarding the FDA’s 2016 Final Guidance, it does suggest that plaintiffs who raise ECJ claims may be required to show that there is no other way for them to know that the product at issue contains sugar.We will provide updates with relevant developments.<a href="#_ftnref1" name="_ftn1">[1]</a> These regulations include the following: (1) 21 C.F.R. § 184.1854 (FDA’s definition of “Sucrose” as “a substance obtained by crystallization from sugar cane or sugar beet juice that has been extracted by pressing or diffusion, then clarified or evaporated”), (2) 21 C.F.R. 104(b)(20) (the common name for “sucrose” is “sugar”), (3) 21 C.F.R. 101.4(a)(1) (ingredients must be referred to by their common or usual name on food labels), (4) 21 C.F.R. 102.5(d) (the common or usual name of an ingredient is the name established by common usage or regulation), and (5) 21 C.F.R. 102(a) (the common or usual name of an ingredient must accurately describe the basic nature of the food or its characterizing properties).<a href="#_ftnref2" name="_ftn2">[2]</a> Swearingen v. Healthy Beverage, LLC, et al.,  No. 13-cv-04385-EMC (N.D. Cal. May 2, 2017) (Dkt. No. 92) (order granting motion to dismiss).

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

Introduction.  On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not

The Revival of ECJ Lawsuits:  Sweet Tooth For Plaintiffs, or Toothless Claims?

Bruton v. Gerber, No. 15-15174.  The district court had dismissed Plaintiff’s unjust enrichment claim, denied class certification for lack of an “ascertainable class,” and granted summary judgment to Gerber because Plaintiff lacked evidence of deception.  The Ninth Circuit reversed the rulings and remanded the case.Background of the Case.  Plaintiff alleged that the labels on certain Gerber baby food products included claims about nutrient and sugar content that violated FDA’s regulations as incorporated into California law.  Plaintiff sued over 69 different Gerber products, with 66 labeled both with and without challenged labels during the class period.  Plaintiff brought claims under California’s consumer protection laws, as well as for unjust enrichment/quasi-contract.Unjust Enrichment/Quasi-Contract.  The Ninth Circuit first found that the district court erred in dismissing Plaintiff’s unjust enrichment/quasi-contract claim at the motion to dismiss stage.  While acknowledging that it was uncertain whether unjust enrichment was a standalone cause of action under California law at the time of the district court’s order, it held that the California Supreme Court had since clarified that an independent claim for unjust enrichment could proceed.  As such, it reversed the dismissal and remanded for the district court’s consideration of whether there are other grounds on which Plaintiff has failed to state a claim for unjust enrichment.Class Certification.  The Court of Appeals next addressed class certification.  It held that the district court erred in holding that the class could not be certified because it was not “ascertainable.”  It clarified that, again, the district court’s ruling contravened a later Ninth Circuit decision:  Briseno v. ConAgra Foods, Inc., 844 F.3d 1121 (9th Cir. 2017).  In Briseno, the Ninth Circuit used different terminology for what the district court called “ascertainability” and held that there was no separate “administrative feasibility” requirement for class certification.  Because the district court’s decision ran contrary to Briseno, the Court reversed and remanded for further consideration regarding whether class certification is appropriate.Summary Judgment.  Finally, the Ninth Circuit reversed the lower court’s ruling on summary judgment.  First, it held that the district court erred in holding that there was no genuine dispute of material fact on Plaintiff’s claims that Gerber’s labels were deceptive under California consumer deception laws.Second, the Court confirmed that Plaintiff presented a viable theory of deception:  the combination of (a) claims on Gerber’s products in violation of FDA regulations and (b) the lack of such claims on competitors’ products made Gerber’s labels likely to mislead the public into thinking that Gerber’s products were of a higher quality than competitor products.Third, the Court held that Plaintiff had submitted sufficient evidence to create a genuine issue of material fact:  (a) Gerber’s and competitors’ labels, (b) Plaintiff’s deposition testimony that she was misled, and (c) two FDA warning letters on the claims.  The key evidence, the Court confirmed, is the labels:  “[a] reasonable jury observing Gerber’s labels and comparing them to those of its competitors could rationally conclude that Gerber’s labels were likely to deceive members of the public.”Finally, the Court held that the district court erred in granted summary judgment to Gerber on Plaintiff’s “unlawful” prong under the UCL.  It found that Plaintiff’s allegations that Gerber “misbranded” its products were sufficient to defeat summary judgment and that the “reasonable consumer test” did not apply to Plaintiffs’ unlawful claims.Takeaways.  Although an unpublished decision, Bruton v. Gerber answers some open questions in the consumer class action litigation field while leaving others unanswered.As for ascertainability, Bruton solidifies the Ninth Circuit’s position that there is no “administrative feasibility” requirement for class certification, but it does not address whether a class is ascertainable where consumers cannot reliably determine whether they are eligible to join the class due to label variations on products during the class period.  This issue has also been briefed in the Jones v. ConAgra appeal, which is pending the U.S. Supreme Court’s decision in Baker v. Microsoft.  (Read our prior blog post on Baker <a href="http://classdismissed.mofo.com/class-certification/class-dismissed-but-not-quite-supreme-court-to-review-appealability-of-class-certification-denials-when-plaintiffs-voluntarily-dismiss-case/">here</a>.)  It remains to be seen whether the Ninth Circuit will address this aspect of “ascertainability” as part of its ruling in the Jones case.As for deception, Bruton arguably lowers the bar for evidence that a plaintiff must submit to get past summary judgment.  Labels, the Court suggests, are enough.  It remains to be seen whether this decision holds and how Bruton will impact consumer class action litigation.

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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Ninth Circuit Revives Gerber Baby Food Class Action

Ninth Circuit Revives Gerber Baby Food Class Action