Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Bowling v. Johnson & Johnson

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, -
v.
- 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.

Page 372

OPINION AND ORDER

Shira A. Scheindlin, United States District Judge.

I. INTRODUCTION

On May 23, 2014, Suzanna Bowling filed this action on behalf of herself and others

Page 373

similarly situated, alleging that Johnson & Johnson (" J& J" ) violated (1) numerous state statutes,[1] as well as (2) the Magnuson-Moss Warranty Act (" MMWA" ),[2] 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.[3] For the reasons set forth below, J& J's motion is GRANTED.

II. BACKGROUND

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.[4] The LTC label represents various health benefits, including -- as relevant here -- that LTC products " Restore[] Enamel." [5]

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.[6] Put simply, the claim " cannot possibly be true," because restoring enamel " is physically impossible." [7]

The Food and Drug Administration (" FDA" ) has issued two " monographs" that set out labeling regulations for over-the-counter (" OTC" ) dental hygiene products.[8] 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" [9] -- 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," [10] along with " other truthful and nonmisleading statements [further] describing [this] use." [11] 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.

Page 374

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" ).[12] In each of these letters, the FDA has objected to certain labeling practices -- for example, the representation that sodium fluoride " fights ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.