United States District Court, S.D. New York
November 4, 2014
SUZANNA BOWLING and EDWARD BUCHANNAN, individually and on behalf of all others similarly situated, Plaintiffs, -
- JOHNSON & JOHNSON, McNEIL-PPC, INC., and JOHNSON & JOHNSON HEALTHCARE PRODUCTS, Defendants
For Plaintiffs: Neal J. Deckant, Esq., Bursar & Fisher, P.A., New York, NY; Patrick C. Cooper, Esq., Ward & Wilson, LLC, Birmingham, AL.
For Defendants: Steven A. Zalesin, Esq., Peter A. Nelso, Esq., Patterson, Belknap, Webb & Tyler LLP, New York, NY.
OPINION AND ORDER
Shira A. Scheindlin, United States District Judge.
On May 23, 2014, Suzanna Bowling filed this action on behalf of herself and others
similarly situated, alleging that Johnson & Johnson (" J& J" ) violated (1) numerous state statutes, as well as (2) the Magnuson-Moss Warranty Act (" MMWA" ), when it misbranded Listerine Total Care (" LTC" ), a line of mouthwashes. J& J moved to dismiss on the grounds that the state law claims are preempted by the Food Drug and Cosmetics Act (" FDCA" ), and the MMWA claim is legally deficient. For the reasons set forth below, J& J's motion is GRANTED.
Because plaintiffs' substantive allegations are largely irrelevant to the legal analysis, they will be summarized only briefly. J& J owns the Listerine brand of dental hygiene products. LTC is one line of mouthwashes under the umbrella Listerine brand. The LTC label represents various health benefits, including -- as relevant here -- that LTC products " Restore Enamel." 
According to plaintiffs, " an overwhelming consensus of medical and dental experts concludes that the loss of tooth enamel is permanent," making it " false and misleading" to represent that LTC restores enamel. Put simply, the claim " cannot possibly be true," because restoring enamel " is physically impossible." 
The Food and Drug Administration (" FDA" ) has issued two " monographs" that set out labeling regulations for over-the-counter (" OTC" ) dental hygiene products. First, in 1980, the FDA published a proposed monograph (" 1980 Monograph" ), which found, inter alia, that " [t]he deposition of fluoride in dental enamel has been shown to increase resistance to enamel solubility and therefore dental decay"  -- or in plain English, flouride is good for preserving enamel. Second, in 1995, the FDA published a final monograph (" 1995 Monograph" ), which permits manufacturers of OTC drugs containing sodium fluoride (such as LTC) to market the product as " aid[ing] the prevention of dental... decay,"  along with " other truthful and nonmisleading statements [further] describing [this] use."  In other words, pursuant to the 1995 Monograph, manufacturers of OTC drugs containing sodium fluoride are allowed (1) to represent that such drugs prevent tooth decay and (2) to provide further labeling to explain how decay is prevented.
One way the FDA exercises its regulatory authority is by sending " warning letters" to industry actors. On multiple occasions, the FDA has sent such letters to manufacturers of OTC drugs containing sodium fluoride -- including, but not exclusively, J& J -- to clarify the parameters of the 1995 Monograph (the " Warning Letters" ). In each of these letters, the FDA has objected to certain labeling practices -- for example, the representation that sodium fluoride " fights plaque"  -- but it has expressed no concern about the label " Restores Enamel." 
III. APPLICABLE LAW
A. Federal Preemption Under The FDCA
The FDCA sets out a comprehensive statutory framework for regulating the development and marketing of food, drugs, and cosmetics. The Act defines " food" as " (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article."  " Drugs," by contrast, are defined as
(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.
Under this definition, LTC is a drug. The FDCA prohibits the misbranding of drugs; " [a drug] shall be deemed to be misbranded [if] its labeling is false or misleading in any particular."  The FDA has exclusive regulatory authority over the enforcement of this provision. Under section 379r of the FDCA, state law claims
that depart in any way from FDA regulation -- claims that would impose labeling requirements " different from," " in addition to," or " otherwise not identical with" federal labeling requirements -- are expressly preempted.
B. The MMWA
" The MMWA grants relief to  consumer[s] 'who [are] damaged by the failure of a . . . warrantor . . . to comply with any obligation . . . under a written warranty.'"  By the statute's express terms, " [n]o claim shall be cognizable" under the MMWA " if the amount in controversy of any individual claim is less than the sum or value of $25." 
II. STANDARD OF REVIEW
Motions to dismiss are governed by Rule 12(b)(6) of the Federal Rules of Civil Procedure. The question is whether the moving party's allegations " 'plausibly give rise to an entitlement for relief.'"  In assessing this question, the court must " accept all factual allegations in the complaint as true, and draw all reasonable inferences in the plaintiffs favor." 
A. Plaintiffs' State Law Claims Are Preempted by the FDCA
In the context of OTC drugs, the FDCA expressly preempts state law labeling requirements that are " different from," " addition[al] to," or " otherwise not identical with" federal labeling requirements. Under this standard, preemption is certainly appropriate when a state law prohibits labeling that is permitted under federal law. But it is also appropriate when a state law prohibits labeling that is not prohibited under federal law. The standard, in other words, is not whether a state law actively undermines federal law. It is whether state law diverges from federal law at all. In settings " [w]here federal requirements address the subject matter that is being challenged through state law claims"  -- as is true of the 1995 Monograph -- the " state requirements are not permitted unless they are identical to federal standards." 
J& J argues that the text of the 1995 Monograph, in tandem with the FDA's silence as to the " Restores Enamel" label in its Warning Letters, leads to the conclusion that " the FDA . . . has reviewed and permitted labels featur[ing] enamel restoration claims."  Plaintiffs view this interpretation as " disingenuous," because no inference of permission should be drawn from the FDA's decision " not to prosecute claims regarding the representation 'Restores Enamel.'"  After all, " [t]here are all kinds of reasons why the
FDA [might choose] not to prosecute [certain] claims." 
But even if they are correct that no inference of permission can be drawn from the FDA's silence, plaintiffs have misunderstood their legal burden. For plaintiffs to establish that their state law claims are not preempted, it is insufficient to show that the FDA has not permitted the label " Restores Enamel." Rather, plaintiffs would need to plead facts suggesting that the FDA has affirmatively prohibited the label. Otherwise, plaintiffs' state law causes of action would be, in effect, imposing a labeling requirement that is " not identical with" labeling requirements under federal law.
Plaintiffs cannot meet this burden. If the FDA had prohibited the " Restores Enamel" label, there would be a regulation saying so. But there is no such regulation. This case might be different if the FDA had issued no guidance as to dental hygiene products, making it possible to conclude that LTC falls beyond the scope of federal regulation entirely. As it stands, however, the FDA has issued a monograph directly on point but declined, in spite of that, to indicate -- either in the monograph itself or in advisory interpretations of the monograph -- that " Restores Enamel" is misleading. If successful, this litigation would do exactly what Congress, in passing section 379r of the FDCA, sought to forbid: using state law causes of action to bootstrap labeling requirements that are " not identical with" federal regulation.
In the alternative, plaintiffs argue that even if the state law causes of action are preempted, their misbranding claim can proceed because it arises independently under federal law. For support, plaintiffs point to the " misbranding" provision of the FDCA, which provides that " '[a drug] shall be deemed to be misbranded [if] its labeling is false or misleading in any particular.'"  According to plaintiffs, if their central allegation is correct -- that " the loss of  enamel is permanent"  -- it follows that the label " Restores Enamel" is " false or misleading."  Therefore, plaintiffs conclude that they have a private cause of action under the FDCA.
This argument rests on a mistaken premise. The FDCA does not authorize
private causes of action. With respect to the labeling of OTC drugs, the whole point of section 379r is that it is not up to private litigants -- or judges -- to decide what is " false or misleading." It is up to the FDA. Plaintiffs' claim under the FDCA is foreclosed for substantively the same reason that their state law claims are foreclosed: both seek to supercede the FDA's regulatory authority.
B. This Court Lacks Subject Matter Jurisdiction Over Plaintiffs' MMWA Claim
Finally, plaintiffs advance a claim under the MMWA. They allege that J& J " issued a written warranty . . . that [LTC] would 'Restore Enamel,"  and because " the product does not, in fact, restore enamel," J& J violated that warranty.
J& J offers three arguments why the MMWA claim should be dismissed. First, it argues that MMWA claims are preempted -- in a manner analogous to the preemption of state law claims -- when they clash with the FDCA. Second, J& J argues that the " Restores Enamel" label is not a " warranty" within the meaning of the statute because it does not " guarantee performance over a 'specific period of time.'"  Third, J& J argues that plaintiffs have failed to meet the MMWA's amount-in-controversy requirement.
Because I agree with the second argument, there is no need to address the other two. The MMWA defines a " warranty"
as a " written affirmation" that a consumer product will be " defect free or will meet a specified level of performance over a specified period of time."  Defendants maintain that the label " Restores Enamel" explains how LTC works; it " does not guarantee enamel restoration over any period of time."  In response, plaintiffs argue that the temporal requirement is satisfied by the " Best Buy" date on LTC bottles -- " purchasers of LTC were promised that," as long as they respected the " Best Buy" date, " the product would 'Restore Enamel.'" 
Plaintiffs' argument proves too much. If the existence of a " Best Buy" date were enough to transform all labels into warranties, virtually any grievance about a consumer product -- food or drug -- would be actionable under the MMWA. That is not how the statute was meant to work. A recent case from the Eastern District of New York -- In re Frito-Lay -- is instructive. There, Judge Rosalyn Mauskopf held that Frito-Lay's " All Natural" label was not a warranty within the meaning of the MMWA because it did not " promise that the product 'will meet a specified level of performance over a specified period of time.'"  Rather, the label was, " at most," a " product description."  The same logic applies here. " Restores Enamel" is a product description, not a promise of performance over time. The MMWA claim fails as a matter of law.
For the foregoing reasons, J& J's motion to dismiss is GRANTED. The Clerk of the Court is directed to close this motion and this case.