1 15-2411-cv Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

UNITED STATES COURT OF APPEALS FOR THE SECO ND CIRCUIT

At a stated term of the United States Cour t of Appeals for the Se cond Circuit, held at the Thurgood Marshall United Stat es Courthouse, 40 Foley Sq uare, in the City of New York, on the 5 th day of December, two thousand sixteen.

PRESENT: PIERRE N. LEVAL, RICHARD C. WESLEY, Circuit Judges, BRENDA K. SANNES, District Judge.*

---------------------------- ---------------------------- ------------------ CHURCH & DWIGHT CO., INC., Plaintiff-Appellee

,

v. No. 15-2411-cv

SPD SWISS PRECISION DIAGNOSTICS, GMBH, Defendant-Appellant

.

---------------------------- ---------------------------- ------------------

IT IS HEREBY ORDERED that (1) Defendant-Appellant’s petition for panel

rehearing is DENIED and (2) the opinion i ssued on September 9, 2016 is amended as

follows.

Following the conclusion of the sentence (at page 41, line 4) readin g “Although the

essential elements of the materiality standard . . . we need not resolve the issue now,” a

footnote is hereby added, reading as follows:

* The Honorable Brenda K. Sannes, of the Un ited States District C ourt for the Northern District of New York, sitting by designation.2 Apotex Inc. v. Acorda Therapeutics, Inc. , 823 F.3d 51 (2d Cir. 2016), recently settled the materiality standard in this Circuit, explaining that the standard is whether the deception is “likely to influence purchasing decisions.” Id . at 63; See also id . at 67. Consideration of the Apotex decision has no effect on our determination, as our analysis above assumes that the standard is exactly as Apotex decided.

Following the conclusion of the sentence (at page 46, line 14) reading “We have

considered Defendant’s other ar guments, and find them to be without merit,” a footnote is

hereby added, reading as follows:

Defendant contends, in a petition fo r rehearing, that our decision cannot be reconciled with Apotex Inc. v. Acorda Therapeutics, Inc. , 823 F.3d 51 (2d Cir. 2016). We disagree. If there is some tension be tween our decision and Apotex , it is only a tension of emphasis, not content. There are at least three reasons why our decision is not incompatible with Apotex

. First, Apotex ’s holding does not purport to exclude all claims of falsity in an FDA-approved message. The decision indeed stated that “representations commensurate with information in an FDA label generally ” will not be actionable under the Lanham Act, id . at 64 (emphasis added), but went on to acknowledge (in a footnote following this sentence) that “Lanham Act liability might arise if an advertis ement us[ing] inform ation contained in an FDA-approved label. . . [is] literally or implicitly false,” id . at 64 n.10. That is the circumstance we have here. Second, this case and Apotex involve different questions of law. In Apotex , the propriety of the court’s consid eration of the claim was assumed. The issue was whether aspects of the defendant’s advertising incorporating FDA-approved factual assertions ab out pharmacologica l effects of its product were nonetheless false. Here, in contrast, the question is whether the court may even entertain a claim of falsity relating to FDA-approved messaging, or whether such a claim is legally precluded , so that a court may not even consider the claim but must dismiss it without consideration of whether the advertising or labeling in fa ct misleads. As explained above, the question was answered by the Supreme Court in POM Wonderful , which clearly held that a Lanham Act claim is not precluded by FDA approval because the Lanham Act and the FD CA serve distinct purposes. The Apotex decision contained no suggestion that a court is precluded by law from entertaining such a claim of falsity. Indeed, it explicitly acknowledged that3 “Lanham act liability might arise . . . [i n cases where] the advertisement [is] literally or implicitly false.” Id . at 64 n.10. Finally, the Lanham Act cl aims in the two cases relate to significantly different aspects of the FDA’s competen ce. The inquiry here does not relate to the truth or falsity of an FDA-appr oved factual assertion about the effects of a medical product, but rather to the question of whether the phrasing of advertising messages might be misunder stood by consumers. The contention in Apotex was that a fact about the pharmac ological effects of a drug, which the FDA had determined to be true, should nonethele ss be found by the court to be false. We ruled against the clai m, noting that the FD A, as the agency responsible for approving the truthfulne ss of the content of the label, had expertise in the matter and had devote d exhaustive process to the inquiry, which justified court deference to its determination of truthfulness. Id . at 64. Here, in contrast, there is no claim that any fact relating to the effects of a medical product found by the FDA to be true should nonetheless be found by the court to be false. What is at issu e is whether messages that the FDA has concluded are not misleading are nonetheless susceptible to being misunderstood by the consuming public . We have not second-guessed the FDA on matters as to wh ich its competence vastly exceeds that of courts. For these reasons, we have conclude d that there is no inconsistency between our holding and Apotex , and have denied De fendant’s petition for rehearing.

FOR THE COURT: Catherine O’Hagan Wolfe, Clerk of Court