United States District Court, S.D. New York
Church & Dwight Co. Inc., Plaintiff,
SPD Swiss Precision Diagnostics, GmbH, et al., Defendants.
OPINION AND ORDER
ALISON J. NATHAN, District Judge.
Plaintiff Church & Dwight ("C&D") has filed a Complaint against Defendant SPD Swiss Precision Diagnostics ("SPD") bringing claims for false advertising under the Lanham Act and New York General Business Law § 349. In connection with this Complaint, C&D also filed a motion for a preliminary injunction. In response, SPD has opposed the preliminary injunction and has moved to dismiss the Complaint, arguing primarily that C&D cannot bring its claims because these are matters more properly resolved by the FDA. For the reasons explained below, the Court denies SPD's motion to dismiss and does not at this juncture reach the arguments raised by the preliminary injunction papers.
I. Legal Standard
When deciding a motion to dismiss for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6), a court must accept as true all well-pleaded facts and draw all reasonable inferences in the light most favorable to the non-moving party. See Kassner v. 2nd Ave. Delicatessen, Inc., 496 F.3d 229, 237 (2d Cir. 2007). Although factual allegations are therefore afforded a presumption of truth, a court is "not bound to accept as true a legal conclusion couched as a factual allegation." Bell All. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Papasan v. Allain, 478 U.S. 265, 286 (1986)). "To survive a motion to dismiss, the plaintiffs pleading must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.' Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 570).
In addition to the allegations in the complaint, a court may consider documents attached as exhibits, incorporated by reference, or relied upon by the plaintiff in bringing suit, as well as any judicially noticeable matters. See Halebian v. Berv, 644 F.3d 122, 131 n.7 (2d Cir. 2011); In re Harbinger Capital Partners Funds Investor Litig., No. 12 Civ. 1244 (AJN), 2013 WL 5441754, at *15 n.6 (S.D.N.Y. Sept. 30, 2013). "If a document relied on in the complaint contradicts allegations in the complaint, the document, not the allegations, control, and the court need not accept the allegations in the complaint as true." TufAmerica, Inc. v. Diamond, 968 F. Supp, 2d 588, 592 (S.D.N.Y. 2013) (quoting Poindexter v. EMI Record Grp. Inc., No. 11 Civ. 559 (LTS), 2012 U.S. Dist. LEXIS 42174, at *6 (S.D.N.Y. Mar. 27, 2012)) (internal quotation marks omitted).
A. C&D's Alleged False Advertising
1, C&D, SPD, and the Weeks Estimator Product
C&D and SPD are competitors in the market for home pregnancy test kits. Compl. ¶¶ 2, 15. Sometime around August 2013, SPD began marketing a new home pregnancy test kit, the "Clearblue Advanced Digital Pregnancy Test with Weeks Estimator" (the "Weeks Estimator"). Compl. ¶¶ 2, 17. Like other home pregnancy test kits, the Weeks Estimator was designed to tell a woman whether or not she is pregnant but also was designed to estimate the number of weeks that had passed since the woman last ovulated. Compl. ¶ 17.
The crux of C&D's claims is that the Weeks Estimator cannot be used to provide an estimate of how long a woman has been pregnant. In particular, according to C&D, the medical profession does not measure pregnancy with reference to the time of ovulation-the time that an egg is released from the ovary-but rather measures it based on the "universally accepted convention" that pregnancy begins at the time of the woman's last menstrual period. Compl. ¶ 18. The last menstrual period occurs, on average, approximately two weeks before ovulation and, as a result, C&D alleges that doctors would determine the length of a woman's pregnancy differently using this standard than they would based on the date of ovulation. Compl. ¶ 18.
2, Allegedly False Advertising
C&D alleges that SPD has made false statements about the Weeks Estimator in a variety of different media.
a. The Weeks Estimator Box
First, C&D objects to the box containing the Weeks Estimator. In particular, C&D points to the product name-"Advanced Pregnancy Test With Weeks Estimator"-which is prominently displayed on the box, as well as rectangular graphics (representing the product's display window) on the box in which the words "Pregnant 1-2 Weeks, " "Pregnant 2-3 Weeks, " and "Pregnant 3 Weeks" appear. Compl. ¶ 27. C&D also alleges that "Mil violation of the FDA's directives, the indications for use statement does not appear in close proximity to the trade name or in similar font size or in bold font." Compl. ¶ 27. According to C&D "[t]he literal communication (or, at the very least, the necessary implication) of the Product packaging is that the Weeks Estimator can tell a woman how many weeks she has been pregnant - specifically that she is 1-2 weeks pregnant, 2-3 weeks pregnant, or 3 weeks pregnant." Compl. ¶ 29.
b. The Television Commercial
C&D also objects to a television commercial promoting the Weeks Estimator as promoting the same message: "that the Product can tell a woman how long she has been pregnant." Compl. ¶ 30. A woman tells a friend that she is pregnant, to which her friend exclaims "Really?!" Compl. ¶ 31. The woman holds up two fingers and says "two weeks." Compl. ¶ 31. After her friend asks whether she has already seen a doctor, the woman responds "Not yet, " holds up the pregnancy test stick, and says "but I just took this new Clearblue test." Compl. ¶ 31. The scene moves to a close up of the test stick, with the Clearblue logo, and a display window with the word "Pregnant" and "1-2 Weeks" immediately below that word. Compl. ¶ 31. The pregnant woman then is heard to say "It's like two tests in one!" Compl. ¶ 31. The scene then changes to a graphic reflecting the three display windows noted above, while an announcer states "the new Clearblue pregnancy test also estimates how many weeks." Compl. ¶33. At the end of the commercial, the announcer concludes "Weeks Estimator. Only from Clearblue." Compl. ¶ 33.
c. SPD's Website
SPD also maintains a webpage promoting the Weeks Estimator product. Compl. ¶ 35. According to C&D, until its recent alteration that page referred to the Weeks Estimator as "the ONLY Pregnancy test that Estimates Weeks" next to a graphic of a test stick with "Pregnant 1-2 weeks" in the display window, with similar statements repeated farther down on the page. Compl. ¶ 36. The page also suggests that the Weeks Estimator "estimates the number of weeks, " is "Like 2 Tests in I, " and notes that 78% of women surveyed believe it is important to know "how far along they are." Compl. ¶ 36.
Farther down, the page notes that the Weeks Estimator "estimate[s] how many weeks based on time since ovulation"-a phrase C&D claims is deceptive because time since ovulation is not the standard used to measure pregnancy. Compl. ¶ 37. At the bottom of the page, SPD includes the FDA's indications for use statement, including the required language quoted above. Compl. ¶ 38 & Ex. D.
d. Point of Purchase and Retail Advertising
C&D makes similar allegations that the point-of-purchase displays in which the Weeks Estimator is sold by retailers also are deceptive, in that each tray bears either the claim "First pregnancy test to estimate weeks" or "How far along are you?" Compl. ¶ 39. The trays do not contain the FDA's indications for use statement or disclose that the product measures time since ovulation. Compl. ¶ 40. C&D also challenges a web advertisement for the Weeks Estimator which states "Clearblue Advanced Digital Pregnancy Test with Weeks Estimator. Is there a baby on board? How far along? Find out!" and other similar advertisements. Compl. ¶ 41.
e. The Press Release
Finally, C&D also raises a different challenge to the Weeks Estimator based on a press release announcing the launch of the product. Specifically, that press release claimed that the product was "approximately 93 percent accurate in estimating the number of weeks based on time since ovulation." Compl. ¶ 44. According to C&D, this statement is false because SPD's own package insert states that "Agreement of Weeks Estimator results with clinical findings ranged widely from 45%-99%." Compl. ¶ 45,
B. The FDA Process
In response to the preliminary injunction motion, SPD submits significant documentary evidence of its discussions of the Weeks Estimator product with the FDA, and urges the Court to take judicial notice of its communications with the FDA in resolving the motion to dismiss. C&D does not contest this evidence as to the preliminary injunction but contends the Court may not consider it for purposes of the motion to dismiss. To provide context for this evidence, the Court will first briefly turn to the scheme under which the FDA regulates medical ...