Misbranded Blog

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.

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

by Joshua Kipnees and Michael D. Schwartz on October 9, 2019

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.

Court Hops Up Injunction, Enjoining Bud Light Packaging

by Terra Hittson and Joshua Kipnees on September 16, 2019

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.

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

by Michael D. Schwartz and Joshua Kipnees on August 20, 2019

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.

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

by Camille L. Fletcher and Joshua Kipnees on August 6, 2019

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.

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

by D. Brandon Trice and Joshua Kipnees on June 26, 2019

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.

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

by Camille L. Fletcher and Joshua Kipnees on June 3, 2019

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.

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

by Kathrina Szymborski and Joshua Kipnees on April 29, 2019

“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?

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

by Michael D. Schwartz, Joshua Kipnees and Jonah M. Knobler on April 4, 2019

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.

Class Damages Models After Comcast: Rigorous Proof or Expert’s Promise?

by D. Brandon Trice, Joshua Kipnees and Jonah M. Knobler on March 4, 2019

In Comcast v. Behrend, 569 U.S. 27 (2013), the Supreme Court held that a plaintiff cannot obtain class certification with an inadequate damages model. In the years since, courts have diverged over how much a plaintiff must do to satisfy this requirement. Often, plaintiffs seek class certification with nothing more than a skeletal proposal to develop and perform an analysis at some future point, using information they do not—and might never—possess. While some courts have found such adumbrative “models” sufficient at the class certification stage, the better decisions require more. As Comcast recognizes, Rule 23 “does not set forth a mere pleading standard.” Rather, a plaintiff “must affirmatively demonstrate” through “evidentiary proof” that damages are measurable on a class-wide basis through a common methodology. Faithful application of that principle obligates plaintiffs and their experts to offer a detailed methodology that is tailored to the facts of the case, and to show that any data that the model requires in fact exists and can be obtained.

Conjoint Analysis: No Silver Bullet for Calculating Class-Wide Damages

by Kade N. Olsen, Jonah M. Knobler and Joshua Kipnees on March 1, 2019

Over the last few years, “conjoint analysis” has become the methodology du jour for false advertising plaintiffs seeking to demonstrate they can calculate class-wide damages. Conjoint analysis is so named because it is used to study the joint effects of multiple product attributes on consumers’ choices. At bottom, conjoint analysis uses survey data to measure the strength of consumers’ preferences for particular product features. Or, put differently, it tries to isolate how much people care about an individual product attribute in a multi-feature product (in a more scientific manner than just asking them directly).