Church & Dwight Co. v. SPD Swiss Precision Diagnostics

104 F. Supp. 3d 348, 2015 WL 2359467, 2015 U.S. Dist. LEXIS 67187
CourtDistrict Court, S.D. New York
DecidedMarch 24, 2015
DocketNo. 14-CV-585 (AJN)
StatusPublished
Cited by5 cases

This text of 104 F. Supp. 3d 348 (Church & Dwight Co. v. SPD Swiss Precision Diagnostics) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Church & Dwight Co. v. SPD Swiss Precision Diagnostics, 104 F. Supp. 3d 348, 2015 WL 2359467, 2015 U.S. Dist. LEXIS 67187 (S.D.N.Y. 2015).

Opinion

MEMORANDUM AND ORDER

ALISON J. NATHAN, District Judge:

The present motion in limine asks the Court to decide whether the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360c, bars certain false advertising claims brought under the Lanham Act, 15 U.S.C. § 1125(a). More accurately, the question is whether the FDCA bars Lan-ham Act false advertising claims relating to medical devices if the Food and Drug Administration (“FDA”) pre-approved the medical device’s labeling. The Court answered this question in the negative at the motion to dismiss stage, but it indicated that a different result might be reached on a more fully developed record and after the Supreme Court’s anticipated decision in POM Wonderful LLC v. Coca-Cola Co., — U.S. —, 134 S.Ct. 2228, 189 L.Ed.2d 141 (2014). See Church & Dwight Co. Inc. v. SPD Swiss Precision Diagnostics, GmbH, No. 14 Civ. 00585(AJN), 2014 WL 2526965, at *8-15, 2014 U.S. Dist. LEXIS 76752, at *21-43 (S.D.N.Y. June 3, 2014) (“Church & Dwight I ”). Shortly thereafter, the Supreme Court rendered a decision in POM Wonderful, which only strengthens the Court’s earlier analysis on this point. Therefore, Defendant Swiss Precision Diagnostics, GmbH (“SPD”)’s motion in limine to bar Plaintiff Church & Dwight Co. Inc. (“C & D”)’s Lanham Act claim is DENIED.

I. LEGAL STANDARD

Generally, “‘[t]he purpose of a motion in limine is to allow the trial court [350]*350to rule in advance of trial on the admissibility and relevance of certain forecasted evidence.’ ” Great Earth Int’l Franchising Corp. v. Milks Dev., 311 F.Supp.2d 419, 424 (S.D.N.Y.2004) (quoting United States v. Paredes, 176 F.Supp.2d 192, 193 (S.D.N.Y.2001)). And “[w]hile ‘dismissing claims is not the prototypical purpose of a motion in limine,’ such motions have sometimes been addressed on the merits and have sometimes ‘been construed as or converted into motions to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure or motions for summary judgment under Rulé 66.’ ” Id. (quoting Fournier v. McCann Erickson, 242 F.Supp.2d 318, 334-335 (S.D.N.Y.2003)).

As noted, the issue raised in this motion in limine was first raised at the motion to dismiss stage, which coincided with a motion for a preliminary injunction that the Court consolidated with, an expedited bench trial op liability. Although the, motion to dismiss was denied, the Court informed the parties that it was prepared to reconsider its ruling on a more fully developed record. At a subsequent conference with the parties, SPD requested permission to raise the FDCA preclusion issue as a pre-trial motion and contended that briefing could be done on the basis of the record as it then existed. Status Conf. Tr. 12:10-19, Aug. 12, 2014. The Court made clear that it discouraged summary judgment motion practice in bench trials and, because it wished to avoid a “duplication of effort, coupled with the fact that [the Court was] not persuaded [the preclusion analysis] could be done fairly in advance of the close of discovery,” Status Conf. Tr. 13:25 — 14:2, it would only permit SPD to brief the FDCA preclusion issue once the record on the issue was fully developed. The parties agreed. Hence, because the record on this issue is now fully developed and because any issues of fact are to be tried before the Court rather than a jury, the Court will address the merits of SPD’s motion, rather than treat it as a motion to dismiss under Rule 12(b)(6) or for summary judgment under Rule 56. Accord Fournier, 242 F.Supp.2d at 335 (deciding, “for purposes of efficiency,” to address a motion in limine on the merits rather than as a motion to dismiss or for summary judgment).

II. BACKGROUND

The Court assumes familiarity with its Opinion and Order dated June 3, 2014, Church & Dwight I, 2014 WL 2526965, 2014 U.S. Dist. LEXIS 76752, but the Court will briefly summarize portions of that decision that are relevant to the present motion.

C & D and SPD are competitors in the global market for home pregnancy test kits. Around August 2013, SPD began producing and marketing a new home pregnancy test kit called the “Clearblue Advanced Digital Pregnancy Test with Weeks Estimator” (the “Weeks Estimator”). The Weeks Estimator is designed to tell a woman if she is pregnant, but it has the added feature of also estimating the number of weeks that have passed since the woman last ovulated. As the Court earlier explained, “[t]he 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,” Church & Dwight I, 2014 WL 2526965, at *2, 2014 U.S. Dist. LEXIS 76752, at *4. This is because, “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.” Id. (quoting Compl. ¶ 18). Based on this distinction, C & D alleges that SPD made a number of false statements in its advertís-[351]*351ing campaign for the Weeks Estimator, which included, inter alia, the Weeks Estimator’s product packaging, the Weeks Estimator’s television commercial, SPD’s website, point-of-purchase displays, and an SPD press release.1 In short, C & D contends that SPD’s advertising for the Weeks Estimator — indeed, the very name of the product itself — conveys the message that the Weeks Estimator can tell a woman how many weeks she has been pregnant and that this message is false or misleading.

SPD moved to dismiss C & D’s Complaint and opposed C & D’s motion for a preliminary injunction primarily by asserting a preclusion defense. That is, SPD argued that the FDCA precludes C & D’s Lanham Act claim because the FDA subjected the Weeks Estimator’s labeling to a rigorous pre-approval process before the product was launched. In support of its FDCA preclusion argument, SPD submitted documentary evidence of its discussions with the FDA regarding the Weeks Estimator. The Court declined to take judicial notice of most of these documents with respect to the motion to dismiss, and, because the ‘ preliminary injunction was consolidated with an expedited bench trial on liability, the Court did not consider the documents in reaching its earlier decision.2

A. The Court’s Motion to Dismiss Opinion

FDCA preclusion is premised on the FDA’s “authority to regulate medical devices under the Medical Devices Amendments Act.” Church & Dwight I, 2014 WL 2526965, at *4, 2014 U.S. Dist. LEXIS 76752, at *8-9 (citing Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71, 74 (2d Cir.2006)). That statute establishes three tiers, or classes, of devices, each subject to an increasingly stringent level of regulatory control to ensure safety and. effectiveness. Id.; see also 21 U.S.C. § 360e(a).

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104 F. Supp. 3d 348, 2015 WL 2359467, 2015 U.S. Dist. LEXIS 67187, Counsel Stack Legal Research, https://law.counselstack.com/opinion/church-dwight-co-v-spd-swiss-precision-diagnostics-nysd-2015.