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Misbranded is Patterson Belknap’s blog covering false advertising litigation—both consumer class actions and competitor suits—with a particular focus on FDA-regulated products (foods/beverages, pharmaceuticals, cosmetics, and dietary supplements).  Writing from the industry perspective, we provide timely updates on important cases, surveys of litigation trends, and in-depth analyses of “hot” legal issues.  Our firm pioneered the modern practice of false advertising law more than 40 years ago, bringing the first competitor suits under the Lanham Act.  In the decades since, we have continued to practice at the cutting edge, handling many of the field’s most groundbreaking cases on behalf of the nation’s best-known businesses.  Today, led by Steven A. Zalesin, our team advocates creatively, strategically, and efficiently on behalf of our clients at all phases of litigation, from pre-complaint demands to Supreme Court appeals.

Courts Say CBD-Product False Ad Actions Should Mellow During FDA Rulemaking Process

Over the past few months, federal courts throughout the country have stayed litigation challenging the labeling of products infused or made with cannabidiol, better known as CBD.  These courts, acknowledging that labeling and product quality requirements for CBD products remain unclear, have cited the need to permit the U.S. Food and Drug Administration (“FDA”) to promulgate uniform rules or regulations focused on CBD, which the agency has indicated are forthcoming in a series of recent administrative actions and public statements.  Staying these cases affords FDA room to fashion a comprehensive regulatory framework in this still-novel industry, rather than allowing plaintiffs to usurp that role via the judicial process.

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In Butter-Flavored Spray Case, Federal Labeling Preemption Sticks In the End

Federal food-labeling laws preempt state laws that impose requirements different from or in addition to those established by federal law.  In some cases, the FDA has spoken directly to a labeling issue by regulation, and if the food manufacturer is in compliance with that regulation, any state-law liability should be preempted.  Careful plaintiffs often try to draft their allegations to get around a federal regulation that would otherwise preempt their claims.  For instance, in challenging a defendant’s representations concerning honey in a cereal, a plaintiff avoided the defendant’s compliance with the federal labeling regulation on “flavoring” by alleging she was deceived about the relative amount of honey as a sweetener (which is not covered by a specific FDA regulation), rather than the relative amount of honey as a flavoring agent (which is covered).  When courts allow creative pleading to circumvent a preemption defense, defendants are deprived of the protections that Congress intended to provide them under federal labeling law, at least at the outset of the case.  But as a recent decision shows, defendants may be able to renew and succeed on a preemption defense after discovery shows plaintiff’s artful allegations were just that.

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What You Do Know Can’t Hurt You:  Standing and the Illinois Biometric Privacy Act

The Illinois Biometric Information Privacy Act (“BIPA”) protects individuals against the unlawful collection, storage and use of their “biometric” information. Under BIPA, plaintiffs may bring claims against companies for failing to obtain informed consent before collecting biometric identifiers (including fingerprints and face scans) and for not maintaining proper privacy policies and procedures for storage of that information. Because the harm can be nebulous — for example, the economic harm from a violation is not always obvious — these cases often raise issues about what constitutes an actual “injury” sufficient to confer standing. Indeed, a number of recent cases in this area have given rise to an emerging circuit split. As in the false advertising context, some courts have permitted such cases to go forward on mere allegations of “bare procedural violations.”  As these cases proliferate, we’ll be watching closely to see whether courts begin to apply the Article III criteria appropriately rigorously, as they have increasingly done in the false advertising context.

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When Two Wrongs Make a Right: Ninth Circuit Holds Proof of Injury Not Required for Unclean Hands

Our parents and teachers taught us that “two wrongs don’t make a right.”  But in the world of Lanham Act litigation, the opposite is often true.  When defending a Lanham Act claim brought by a competitor, the doctrine of unclean hands—the lawyerly version of “But they did it too!”—can be a case-dispositive argument.  Last month, the Ninth Circuit made it a bit easier to establish this defense, holding that a defendant arguing unclean hands need not prove that the plaintiff’s unclean conduct caused “actual harm.” See Certified Nutraceuticals, Inc. v. Avicenna Nutraceutical, LLC, 2020 U.S. App. LEXIS 22351 (9th Cir. July 27, 2020). 

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In Baking Chips Decision, District Court Holds Consumer Survey Gets “White” Claim Wrong

The past few months have witnessed a veritable sugar rush of decisions dismissing consumer class action complaints alleging that baking chips and candies labeled as “white” falsely imply the presence of actual white chocolate.  See, e.g., Prescott v. Nestle USA, Inc., 2020 WL 3035798 (N.D. Cal. June 4, 2020); Rivas v. Hershey Co., No. 19-CV-3379(KAM)(SJB), 2020WL 4287272 (E.D.N.Y. July 27, 2020); Cheslow v. Ghirardelli Chocolate Co., 2020 WL 4039365 (N.D. Cal. July 17, 2020).  Each of these decisions is noteworthy for holding, at the pleadings stage, that a consumer’s purported interpretation of a labelling claim is unreasonable as a matter of law.  But Cheslow is particularly instructive, as it recognizes that even consumer survey evidence cannot convert an implausible interpretation of a labeling claim into a reasonable one.

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First Circuit Rejects Boundless Consumer-Protection Liability for “Pure Omissions”

Increasingly, consumers base their purchase decisions on facts about a company or its product that have nothing to do with the performance or quality of the product itself.  For example, does the manufacturer treat its workforce fairly?  Is it a responsible steward of the environment?  What are its stances on social issues like abortion or LGBTQ rights?  To which parties or candidates does it (or its officers) donate?  All of these facts—and countless others—are “material” to many consumers in the sense that they affect (or even dictate) purchase decisions.  Indeed, in recent years, ethical, moral, and political concerns like these have led to countless instances of boycotts and other forms of consumer speech—a welcome sign of a healthy body politic and liberal democracy.

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Flushable Wipes, Take Three: The Second Circuit Gets Injunctive Standing Right, But Classwide Damages Models Wrong

As our readers know, we’ve kept a close eye on the “flushable wipes” litigation—known variously as Kurtz v. Costco and Belfiore v. Procter & Gamble—as it has bounced between Judge Weinstein’s courtroom in the Eastern District of New York and the Second Circuit.  The cases raise several issues important to class-action defendants, including the necessity of a rigorous damages model at the class-certification stage; the availability of injunctive relief to customers who are already wise to the alleged deception; and the appropriateness of massively multiplied “statutory damages” in the class context.  We (and others) had hoped that the Second Circuit would use the case to provide clear answers to these questions and to remedy the New York federal courts’ status as a hotbed for questionable class-action complaints.  But with that court’s latest ruling—fortunately, an unpublished and non-precedential one—those hopes may have gone down the tubes.

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Injunction Defunction: The Second Circuit Extinguishes Injunctive Relief as a Remedy for Consumer False Advertising Claims

Last week, the Second Circuit issued an important published decision holding that previously injured consumers who seek to challenge product labeling lack constitutional standing to pursue claims for injunctive relief, and cannot obtain certification of an injunctive relief class under Federal Rule of Civil Procedure 23(b)(2).  See Berni v. Barilla S.P.A., 2020 U.S. App. LEXIS 21167 (2d Cir. July 8, 2020).  Although the Second Circuit’s holding arose in the context of a settlement class, not a litigation class, the court’s reasoning was not dependent on or limited to that specific context; rather, the panel held, in unqualified terms, that “past purchasers of a product . . . are not likely to encounter future harm of the kind that makes injunctive relief appropriate.”  The Berni decision appears to close the door to injunctive relief for consumers asserting mislabeling claims in the Second Circuit.

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Federal Court Wipes Away Challenge to Nivea Lotion on Preemption Grounds

What distinguishes a “cosmetic” from a “drug” under the Federal Food, Drug, and Cosmetic Act (FDCA)?  The FDA has struggled to offer clear guidance on the distinction, but the classification as one or the other (or both) carries significant legal and regulatory consequences for manufacturers: a product that is a “drug” needs pre-market approval from the FDA, while a cosmetic does not.  A cosmetic product that has not received this approval may not represent that, like a drug, it is “intended to affect the structure or any function of the body of man.” 21 U.S.C. § 321(g)(1).  Thus, a product that claims to be capable of changing how part of the body works (e.g., “reduces cellulite” or “regenerates cells”), but has not been subjected to this pre-approval process, is considered mislabeled under the FDCA.

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So Much For “Improved Memory”: Prevagen Class Decertified Post-Trial Due To Lead Plaintiff’s Forgetful Testimony

A California district court recently decertified, after a jury trial, a class of vitamin supplement purchasers in a false advertising case.  As we detailed in a prior post, a federal judge declared a mistrial in the same case earlier this this year after the jury deadlocked.  The case, Racies v. Quincy Bioscience, LLC, 15-cv-00292 (N.D. Cal.) (Gilliam, J.), was already interesting because certified class actions rarely make their way to trial.   And it is rarer still for a district court to decertify a class following a trial.  But setting those procedural quirks aside, the opinion may prove useful for defendants seeking to decertify or defeat putative classes on typicality and predominance grounds. 

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Latest Scoop on the “Happy Cows” Lawsuit: Court Dismisses False Advertising Claims Against Ben & Jerry’s

Patrons of Ben & Jerry’s ice cream should be familiar with Woody, the bovine mascot touted by the company as “the most interesting cow in the world.”    Ben & Jerry’s packaging has long featured cartoon illustrations of Woody grazing beneath blue skies in bucolic green pastures.  This past year, however, Woody ambled into the sights of the plaintiffs’ class action bar.  Thankfully, she (and Ben & Jerry’s) emerged unscathed:  the district court (D. Vt.) dismissed the case at the pleadings stage, affirming both the authority of district courts to dismiss implausible consumer protection claims and the requirement that plaintiffs seeking injunctive relief demonstrate a probability of future injury.

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Liability Immunity Under The PREP Act: A Potent New Defense Against COVID-Related False Advertising Claims

Our national response to the COVID-19 pandemic has been made more difficult by a shortage of personal protective equipment and lifesaving drugs and medical devices.  Some evidence suggests that manufacturers’ fear of lawsuits has exacerbated these shortages. Seeking to allay these concerns, in March 2020, the Secretary of the Department of Health and Human Services (HHS) issued a Declaration providing manufacturers, distributors, health professionals, and other “qualified persons” immunity against certain claims relating to COVID-19 “countermeasures.”  See 85 Fed. Reg. 15198 (Mar. 17, 2020).  In mid-April, HHS followed up with an Advisory Opinion clarifying the scope of liability immunity under the Declaration.

Much has been written about the Declaration’s potential as a shield against product liability suits.  But does the Declaration also provide immunity from false advertising suits, including Lanham Act, common-law, and statutory consumer protection claims?  There’s not yet any judicial precedent on this question, but the answer appears to be “yes”—at least in many cases.

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Seventh Circuit Rejects Court Intervention In Light Beer Ad Wars: Is A New Trend Brewing In False Advertising Law?

The last few years have seen a pitched battle for market share among the manufacturers of America’s leading “light” beers—a battle that’s been waged not only in America’s bars and on the airwaves, but in the courtroom. Earlier this month, in Molson Coors v. Anheuser-Busch, Nos. 19-2200, 19-2713, 19-2782, 19-3097 & 19-3116, 2020 WL 2097557 (7th Cir. May 1, 2020), the Seventh Circuit gave Anheuser-Busch, the maker of Bud Light, a major victory in that battle, wiping out an injunction that the district court had entered in favor of Molson Coors, the maker of Miller Lite and Coors Light. That’s newsworthy in itself—but, because of its novel reasoning, the Molson Coors ruling may have broader significance for false-advertising law.

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Mislabeling Allegations Stick to Post’s “Honey Bunches of Oats,” But Not Without Creating a Buzz

The Food, Drug, and Cosmetic Act (FDCA) promotes nationwide uniformity in food labeling by establishing a comprehensive federal labeling scheme and preempting state law that imposes different requirements.  21 U.S.C. § 343-1(a).  Over the years, the FDA has issued regulations directed to specific labeling issues, including representations of a food product’s “primary recognizable flavor.”  21 C.F.R. §§ 101.22(a)(3), 170.3(o)(12).  So long as a label’s representation of a “primary recognizable flavor” complies with the FDA’s flavoring regulation, the label is not misleading, and any state law that supposedly says otherwise is preempted.

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How SCOTUS’ Trademark Profits Ruling in Romag Bears On False Advertising Cases

This post originally appeared on Law360.

In Romag Fasteners Inc. v. Fossil Inc.,[1] the U.S. Supreme Court recently made it easier for Lanham Act plaintiffs to disgorge the ill-gotten profits of trademark infringers.

Naturally, the question arises: Since false advertising suits are also governed by the Lanham Act, does Romag apply to false advertising suits, too? The answer is likely yes — but there are important differences between the two types of suits that may make disgorgement awards more difficult for false advertising plaintiffs to obtain.

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Ninth Circuit: Plaintiff’s Lawyer Can’t “Mint” Money Over Voluntary Label Changes

Earlier this month, in a consumer action challenging alleged slack-fill in boxes of Junior Mints and Sugar Babies, the Ninth Circuit considered the reach of the “catalyst theory” for recovering attorney’s fees under California law. See Gordon v. Tootsie Roll Industries, Inc., No. 18-56315, 2020 WL 1846920 (9th Cir. Apr. 13, 2020). Under this theory—which the U.S. Supreme Court has rejected for federal claims—a litigant may be considered a “successful party” entitled to seek a fee award upon a showing that the litigation impelled the defendant to take corrective action.  Unfortunately for the plaintiff, the panel held that she was not a “successful party” under California law—even though the defendant had changed its marketing practices after the lawsuit was filed—because she had insisted that those changes would not resolve her gripes.

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High Steaks: Second Circuit Nixes Suit Over “Angus” Sandwiches

“Whether reasonable consumers would be deceived by a challenged advertisement is a question of fact that can’t be decided on a motion to dismiss.”  This claim is one of the biggest sacred cows in false advertising litigation.  But as the Second Circuit has made clear twice in the past year, it’s just a load of bull.  Take, for example, Chen v. Dunkin’ Brands, Inc., --- F.3d ----, 2020 WL 1522826, which the Second Circuit decided unanimously earlier this week.  In Chen, the court doubled down on its June 2019 holding that a court can decide at the pleadings stage “whether a reasonable consumer would have been misled by a particular advertisement,”  Geffner v. Coca-Cola Co., 928 F.3d 198, 200 (2d Cir. 2019), affirming the dismissal of a false advertising claim involving the meaning of “steak.” In the process, the court also served up a tasty side dish of personal jurisdiction doctrine.

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Federal Agencies Crack Down on Coronavirus Advertising

As coronavirus (COVID-19) spreads across the country, some companies are advertising their products’ usefulness in preventing or treating the disease.  But federal agencies—including the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC)—are close behind.  Over the past few weeks, they have together sent more than a dozen warning letters to COVID-19 advertisers, insisting that they cease making coronavirus claims.

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Eighth Circuit Serves Another Round of First Amendment Protection for Alcohol Advertising

Food and beverage advertising, like other forms of speech, is usually entitled to First Amendment protection – even if it may not always enjoy the same caliber of protection as, for example, journalism or political speech.  See, e.g., Sorrell v. IMS Health, Inc., 564 U.S. 552, 557 (2011) (“Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”)

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Paradise Lost: Court Dismisses Class Action Alleging Gin “Adulteration”

Grains of paradise (aframomum melegueta), are a peppery, citrusy spice indigenous to West Africa, related to ginger and cardamom.  The name purportedly derives from medieval merchants’ claims that the plant grew only in the Garden of Eden.  Common to West African cuisine, grains of paradise are also one of the botanicals sometimes used to give gin its characteristic flavor.

In Florida, however, an obscure 1868 law makes it a third-degree felony to “adulterate[] … any liquor” with certain specified substances, ranging from grains of paradise and capsicum (chili pepper) to potentially deadly opium and “sugar of lead.”  Fla. Stat. § 562.455.  Some have postulated that this law’s original intent was to prevent consumer deception, as the banned ingredients were once added to liquor to make it taste stronger (more alcoholic) than it actually was.  That same practice spurred an 1816 law of Parliament (56 Geo. III, ch. 58) making it illegal for brewers and dealers in beer to possess grains of paradise.  Unlike merrie olde England, however, the Sunshine State never got around to repealing its law.

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And So It Begins: The Wave of CBD-Related Consumer Actions Has Arrived

It was only a matter of time.  As we anticipated last summer, the plaintiffs’ bar recently filed a slew of false advertising suits against manufacturers of products infused or made with cannabidiol, a/k/a CBD.  This development was a fait accompli, given the combination of a booming CBD market, a murky federal regulatory landscape, and a patchwork of state regulatory efforts at varying degrees of development.  This confluence of factors has paved the way for at least ten consumer lawsuits in the last six months against producers of CBD products.  We expect more suits to follow in the near future as copycat suits are filed, CBD products become increasingly mainstream, and more deep-pocketed players enter the CBD market.

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Seventh Circuit Lets The Air Out Of Another “Slack Fill” Claim

This blog has previously examined the recent spate of so-called “slack-fill” lawsuits, in which consumers claim that a food (or other) product is misleadingly packaged because it contains excess air.  We noted that the growing trend is for courts to reject such suits at the motion-to-dismiss stage, for a variety of reasons.  For example, courts have found slack-fill complaints deficient for failing to allege, beyond conclusory platitudes, that the package’s empty space serves no legitimate function, or for failing to allege with plausibility that a reasonable consumer would actually be deceived.  Late last year, in Benson v. Fannie May Confections Brands, Inc., the U.S. Court of Appeals for the Seventh Circuit issued an important decision affirming the pleadings-stage dismissal of a slack-fill suit, but based on a distinct justification: the failure to plausibly allege any cognizable damages associated with slack-filled packaging.

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Prevagen Maker Avoids Sting of Defeat as Judge Declares Mistrial in Consumer False Advertising Class Action

On January 14, faced with a deadlocked jury, a federal judge in California declared a mistrial in a consumer class action involving the marketing of Prevagen, a popular dietary supplement based on jellyfish-derived proteins that claims to improve brain functioning and memory.  This outcome runs counter to the conventional, but mostly untested, viewpoint that juries tend to favor the plaintiffs in consumer class actions.  The Prevagen trial also underscores that scientific uncertainty about the truth of an advertising claim may present challenges for the defense in the earlier stages of a class action, but become an advantage for a defendant who chooses to fight all the way to trial.  

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FDCA Preclusion: When Can a Manufacturer Defeat a Competitor’s Lawsuit by Complying with FDA Regulations?

As many readers probably know, when a food or beverage manufacturer gets a consumer class action alleging that its labeling violated state law, one of the first things it should do is consider whether the disputed aspect of the labeling is covered by the federal Food, Drug and Cosmetic Act (“FDCA”).  Many provisions of that statute—and, by extension, their implementing regulations—expressly preempt non-identical state-law regulations.  If a putative class of consumers is asking a manufacturer to do something different with its labeling than those provisions do, there is a strong argument that the case is preempted:  federal law (the FDCA) trumps state law (the relevant consumer protection statute).

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Update: Flushable Wipes

A few months ago, we wrote about the Second Circuit’s oral argument in the “flushable” hygienic wipes consumer class action cases.  And now, the septic saga continues.

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Ninth Circuit Endorses RICO Claims For Prescription Pharmaceutical Promotion

Ninth Circuit Endorses RICO Claims For Prescription Pharmaceutical Promotion

The Racketeer Influenced and Corrupt Organizations Act (RICO) was meant to help take down the Mafia.  For years, however, plaintiffs have attempted to contort it into a federal false advertising regime for prescription pharmaceuticals, complete with treble damages and attorney’s fees.  The Ninth Circuit recently gave plaintiffs a boost in that effort, permitting RICO claims to proceed against pharmaceutical companies based on allegedly improper labeling and promotion of their prescription medications. 

Patterson partner and Misbranded contributor Jonah Knobler recently critiqued the Ninth Circuit’s decision—and pharmaceutical RICO suits generally—at Drug and Device Law.  Check out that post here.

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Joining the Trend: D.C. Circuit Latest Court of Appeals to Decline to Certify Class Containing Uninjured Members

A few weeks ago, the U.S. Court of Appeals for the D.C. Circuit weighed in on a recurring question in class action litigation: can a court certify a class where some class members—even if only a small fraction of the class—are uninjured? Joining a string of recent decisions on this subject, the circuit court held in In re Rail Freight Fuel Surcharge Antitrust Litig., 934 F.3d 619 (Aug. 30, 2019), that class certification was properly denied for lack of predominance because twelve percent of the proposed class—constituting thousands of proposed class members—were uninjured by the defendants’ alleged misconduct. This ruling follows a similar determination from the First Circuit last October, covered here. Although both cases involved antitrust allegations, their holdings are readily applicable to consumer product class actions, where there is often evidence—either from the defendants’ files or the plaintiffs’ own experts’ analysis—that a considerable number of proposed class members were uninjured by defendant’s alleged mislabeling.

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Court Hops Up Injunction, Enjoining Bud Light Packaging

In the latest development in the Lanham Act litigation between beer titans MillerCoors and Anheuser-Busch, the district court issued an order enjoining Bud Light from using the “No Corn Syrup” language and icon on product packaging, expanding the existing injunction covering the same claims in print and television advertisements.  MillerCoors v. Anheuser-Busch Cos. (MillerCoors II), No. 19-cv-218-wmc, 2019 U.S. Dist. LEXIS 149954 (W.D. Wis. Sept. 4, 2019).  However, the court permitted Anheuser-Busch to exhaust its existing supply of packaging with the enjoined image and language (assuming it can be done in 270 days, which Anheuser-Busch has signaled it will).  The decision offers an interesting analysis of implied comparative claims and how the defendant’s replacement costs may impact the “irreparable harm” inquiry at the preliminary injunction stage.

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Tough Nut to Crack: First Circuit Panel Splits on Reasonable Interpretation of Flavored Coffee Packaging

We have written previously about application of the “reasonable consumer” standard when labeling statements are claimed to be false or misleading, despite the presence of clarifying information elsewhere on the product label.  We’ve observed the inconsistent standards courts apply in ruling on a motion to dismiss, particularly as to whether a “reasonable consumer” views the alleged misstatement in the context of the entire product packaging and ingredient list.

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“Born in the U.S.A.”? Proceeding with Caution on USA Origin and other Location-Based Claims

Many companies take pride in the geographic origin of their products (e.g., cars that are “Made in the USA”), or in their products’ capacity to evoke a certain region (e.g., “Hawaiian style” pizza).  Claims about the origin or provenance of products seem to pose a relatively low risk of consumer deception:  these typically do not implicate health or safety, nor do they convey anything concrete about the products’ qualities.  Nevertheless, these “origin” and “provenance” claims have drawn scrutiny from the Federal Trade Commission, state regulators, and – most recently – class action plaintiffs’ lawyers.   Below, we’ve highlighted some guidance from regulators and the courts that may be helpful to manufacturers when they consider highlighting their geographic origins in their product branding. 

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CBD: The Next Cure-All—and the Next Frontier for False Advertising Litigation?

Cannabidiol—better known as “CBD,” a cannabis-derived compound—is one of the latest crazes in the consumer packaged goods industry. CBD sales are expected to top $5 billion in 2019—a 700% increase from 2018—and reach $24 billion in sales by 2023.  Manufacturers have flooded the market with CBD-infused food, dietary supplements, cosmetics, pet food, and other animal health products.  CBD is being touted as a miracle chemical compound capable of treating a host of diseases and ailments in both humans and animals, such as anxiety, depression, joint issues, digestive issues, chronic pain, ADHD, Alzheimer’s disease, cancer, and heart disease.  CBD products are largely unregulated, but the days of unfettered marketing may be coming to an end:  The FDA has recently taken a keen interest in CBD products, and a slew of consumer protection actions may not be far behind.

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Misbranded Editors Present Webinar On “Hot Topics in Consumer False Advertising Litigation”

Last month, Misbranded co-editors Josh Kipnees, Jonah Knobler, and Jane Metcalf presented a live-streamed webinar via Bloomberg Law titled “Hot Topics in Consumer False Advertising Litigation.”  The free hour-long webinar, now available on demand, covers the following subjects, some of which should be familiar to regular readers of this blog:

  • “Natural” / “no artificial ingredients” claims

  • “No preservatives” claims

  • Ingredient claims (“made with [X]”)

  • Geographic origin claims (e.g., “Made in the USA”)

  • Slack-fill claims

  • Claims involving nondisclosure of morally troubling/offensive facts

  • What’s next in consumer false advertising litigation?

We encourage you to check it out (and obtain some CLE credit in the process).

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Breaking: Supreme Court To Decide Whether Willfulness Is Required To Disgorge Profits Under Lanham Act

Today, in its final orders list of the Term, the Supreme Court granted cert in Romag Fasteners, Inc. v. Fossil Inc. (No. 18-1233), to resolve a deep circuit split regarding Lanham Act remedies.  The specific question in Romag is “[w]hether … willful [wrongdoing] is a prerequisite for an award of [the defendant’s] profits.”  (All agree that an award of the plaintiff’s actual damages, as opposed to disgorgement of the defendant’s profits, is available irrespective of the defendant’s mens rea—but actual damages are often difficult to prove.)  Romag presents this question in the context of a trademark infringement claim, but the outcome should also control in federal false advertising cases, which are likewise governed by the Lanham Act.

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Court Finds No “Support” for Certification of Full-Refund Class Involving Biotin Supplement

A frequent target of consumer class actions are “structure/function” claims made in connection with dietary supplements.  These claims describe a nutrient or dietary ingredient and its role in the body’s structure or function: for example, “glucosamine promotes healthy joints.”  Plaintiffs may allege that a product’s labeling is misleading because the typical consumer already receives enough of the nutrient or ingredient from her diet.  At the same time, those plaintiffs will seek a refund on behalf of everyone who bought the product—even if many in the class have received a benefit.  A recent decision out of the Southern District of California, Alvarez v. NBTY, Inc., 2019 U.S. Dist. LEXIS 87420 (May 22, 2019), suggests that this disconnect between the proposed class and the plaintiffs’ theory of liability and damages may no longer be tolerated at the class-certification stage.

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Cognitive Claims Draw FTC’s Focus

The promise of improved cognitive capability or memory appeals to almost everyone.  So it’s no surprise that the market for such enhancements is broad, ranging from “brain training” apps for your phone to dietary supplements promising memory boosts.

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Another One Bytes the Dust: Court Dismisses Flash Drive False Advertising Suit Based On Back-Of-Package Clarifying Disclosures

A few months ago, we wrote about courts’ inconsistent application of the “reasonable consumer” standard when labeling statements are claimed to be false or misleading, despite clarifying information elsewhere on the product label.  In Williams v. Gerber Products Co., 552 F.3d 934 (9th Cir. 2008), the Ninth Circuit (in)famously held that a “reasonable consumer” should not be “expected to look beyond misleading representations on the front of the box to discover the truth … on the side of the box.”  Id. at 939-40.  As we explained in our prior post, Williams is in tension with longstanding authority that “reasonable consumers” are expected to read the entire advertisement, including disclaimers and clarifying language.  We observed that numerous lower-court decisions, recognizing Williams’ shaky foundation, have sought to distinguish it and narrow it to its facts.

Add to this list Dinan v. SanDisk LLC, No. 5:18-cv-5420 (BLF), 2019 U.S. Dist. LEXIS 91633 (N.D. Cal. May 31, 2019), a recent decision out of the Northern District of California.  While Dinan was not a food, drug, or cosmetic case, its discussion of Williams and the “reasonable consumer” test bears directly on such cases, and should help manufacturers dispatch some false advertising claims at the pleadings stage when their packages include proper clarifying disclosures.

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Court Partially Bars Advertisements Depicting Corn Syrup in Beer

A recent decision, MillerCoors v. Anheuser-Busch Cos., LLC, No. 19-cv-218-wmc, 2019 U.S. Dist. LEXIS 88259 (W.D. Wis. May 24, 2019), denied and granted in part a preliminary injunction enjoining a series of advertisements and commercials depicting corn syrup in MillerCoors’s beer.

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How Much Is Too Much Deference to FDA Warning Letters in Consumer Class Actions?

Consumer class actions involving goods regulated by the Food and Drug Administration (“FDA”) coexist in parallel with FDA enforcement efforts.  Consumers have no private right of action to enforce the Food, Drug, and Cosmetics Act—the statute the FDA is charged with implementing—and attempts to use state consumer protection laws that interfere with the FDA’s regulatory regime are preempted.  Even so, private litigants often invoke FDA guidance, rules, and statements regarding labeling practices as evidence that a manufacturer’s marketing claims are—or are not—susceptible to challenge as deceptive advertising under state law.

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Interlocutory Appeal in “Flushable Wipes” Cases Goes Down The Drain

Last month, the Second Circuit heard oral argument in what had seemed like the most consequential consumer class-action appeal in that court in years: three consolidated cases involving “flushable” hygienic wipes.  Both sides of the class-action bar were at the edge of their seat waiting for the Second Circuit’s guidance on several controversial issues of class-action law, including the appropriate standard for reviewing damages models at the class-certification stage.  Earlier this week, however, the Second Circuit essentially punted, sending the cases back to the district court for “further factual development.”  This is a frustrating result, but reading between the lines, class-action defendants may have reasons for cautious optimism.

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Extreme Pro-Plaintiff Changes Proposed To New York’s Consumer-Protection Law

It’s hard to argue that New York’s consumer-protection laws (Gen. Bus. Law §§ 349350) are being underutilized by private plaintiffs.  But, on that claimed basis, the state’s Legislature is considering a multifaceted amendment that would make those laws vastly more plaintiff-friendly—and business-unfriendly—than they already are.  It’s hard to understate the impact these changes would have on the business community.  We’re not sure what the bill’s odds of passage are, but given the extremity of the amendments, we’re a bit surprised they haven’t attracted more public attention.

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Lanham Act Dispute Brewing over Corn Syrup in Beer

While the New England Patriots were besting the Rams in the 2019 Super Bowl, Anheuser-Busch tried to get the upper hand on MillerCoors in a series of ads highlighting the “use of” corn syrup in Miller Lite and Coors Light. 

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Speak of the Devil… Class Certified in “Slack-Fill” Case for the First Time

Speak of the Devil and he doth appear. Today, it’s just a figure of speech.  In medieval England, by contrast, people meant it literally—as a warning that uttering the Prince of Darkness’s name would conjure his evil presence.  Maybe those Anglo-Saxons had a point.  A few weeks ago, we wrote a post about a remarkable string of defense victories in “slack-fill” cases—i.e., lawsuits complaining of too much empty space in product packaging.  In particular, we noted that “every slack-fill case to reach the class-certification stage ha[d] flunked Rule 23’s rigorous test for certification,” and we wondered aloud “how a slack-fill class could ever be certified.”  Well, speak of the Devil: just four days later, a California court certified a class in a slack-fill case for the first time ever.  We apologize for any causal role we may have had in this truly diabolical development.  The good news is that the decision may not stick—and even if it does, it’s likely to remain an outlier.

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Two Big Reasons Courts Dismiss Suits Alleging the Presence of Harmful Ingredients

“Contains detectable levels of the weed-killer chemical glyphosate.”

“Contains limonene, which causes kidney toxicity and tumors, and linalool, a cockroach insecticide.”

“Contains a potent biocide and endocrine disruptor, with detrimental health effects that are still becoming known.”

These are the sorts of headline-grabbing allegations the plaintiffs’ bar has recently relied upon in claiming that products advertised or positioned as “natural” are deceptively marketed.  At first blush, the presence of allegedly dangerous ingredients in foods, cosmetics, and other consumer products might seem like the basis of a strong false advertising case—especially when those substances are undisclosed.  How could a company so deceive the public by promising a “good-for-you” product that contains such “bad” ingredients?

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Proving Retail Sales Figures In Consumer Class Actions: Different Approaches Lead To Very Different Results

To prove damages in a consumer class action, the named plaintiff must show—among other things—how many units of the defendant’s product were purchased by consumers in the relevant state (or states).  This is easier said than done.  Manufacturers generally keep records of their own wholesale transactions—i.e., how much product they shipped to distributors or large retail chains.  But they generally don’t have direct visibility into sales at the retail level, since they aren’t a party to those transactions.  If not all of the product sold at wholesale ends up being purchased by consumers, manufacturers’ records may not reflect this.  Likewise, if the product that a manufacturer ships to an address in State A (e.g., a regional distribution center) ends up being moved to State B before reaching store shelves, manufacturers’ records will not reflect this either.  What, then, is a class-action plaintiff to do?

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Court Certifies Class Action Over Gerber “Good Start Gentle” Baby Formula, Citing Consumers’ General Exposure to Ad Campaign

A recent decision from the Eastern District of New York, Hoth v. Gerber Prods. Co., 15-cv-2995 (E.D.N.Y.), granted class certification to purchasers of Gerber baby formula in Florida and New York who claimed to have been misled by representations that the formula reduced infants’ risk of developing allergies. The certified class is unusual, however, in that not all of its members actually purchased the product labeled with the alleged misrepresentation. Many courts have concluded that this lack of uniform exposure defeats certification by precluding a showing of classwide injury, but the Hoth court credited evidence that the general “advertising and labeling practice [regarding allergy prevention] allowed a price premium to be charged across the entire line of [challenged] products.” Op. at 41 (emphasis in original).

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“Lack of Substantiation” Claims: A Substantively Lacking Liability Theory

As astronomer Carl Sagan famously said, “absence of evidence is not evidence of absence.”  Plaintiffs have not gotten the message.  They often allege that a defendant’s marketing or labeling statements are false and misleading on the sole basis that there is purportedly no evidence (or insufficient evidence) proving their truth.  These so-called “lack of substantiation” claims are easy to plead because a plaintiff does not need to conduct an investigation to identify evidence that the challenged statement is false.  Rather, she alleges only an absence of supporting evidence for the statement—and generally, in a conclusory manner.

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“Slack-Fill” Cases Coming Up Empty

Unless you were born yesterday, you know that packaged goods usually contain some empty space in the box, bottle, or bag.  This has been true for as long as there have been packaged goods.  What is relatively new is that consumers—or, rather, a small cadre of specialized plaintiff’s lawyers—are suing over it.  But as Newton said, for every action, there is an equal and opposite reaction.  And the more that lawyers have inundated courts with these suits, the more aggressively courts have responded to shut the silliness down. This post examines the regulatory underpinnings of these so-called “slack-fill” suits and the many bases that courts have found for letting the air out of them.

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