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15-2411-cv 

Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH 

UNITED STATES COURT OF APPEALS 

FOR THE SECOND CIRCUIT 

 At a stated term of the United States Court of Appeals for the Second Circuit, held at 

the Thurgood Marshall United States Courthouse, 40 Foley Square, in the City of New 

York, on the 5th day of December, two thousand sixteen. 

PRESENT: PIERRE N. LEVAL,

RICHARD C. WESLEY, 

Circuit Judges, 

 BRENDA K. SANNES, 

 District Judge.*

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CHURCH & DWIGHT CO., INC., 

Plaintiff-Appellee,

v. No. 15-2411-cv 

SPD SWISS PRECISION DIAGNOSTICS, GMBH, 

 Defendant-Appellant. 

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

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

follows. 

 Following the conclusion of the sentence (at page 41, line 4) reading “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 United States District Court for the Northern 

District of New York, sitting by designation.
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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 arguments, and find them to be without merit,” a footnote is 

hereby added, reading as follows: 

Defendant contends, in a petition for 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 between 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 advertisement us[ing] information 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 consideration of the claim was assumed. 

The issue was whether aspects of the defendant’s advertising incorporating 

FDA-approved factual assertions about pharmacological 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 fact 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 FDCA 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 that 
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“Lanham act liability might arise . . . [in cases where] the advertisement [is] 

literally or implicitly false.” Id. at 64 n.10. 

Finally, the Lanham Act claims in the two cases relate to significantly 

different aspects of the FDA’s competence. The inquiry here does not relate 

to the truth or falsity of an FDA-approved factual assertion about the effects 

of a medical product, but rather to the question of whether the phrasing of 

advertising messages might be misunderstood by consumers. The contention 

in Apotex was that a fact about the pharmacological effects of a drug, which 

the FDA had determined to be true, should nonetheless be found by the court 

to be false. We ruled against the claim, noting that the FDA, as the agency 

responsible for approving the truthfulness of the content of the label, had 

expertise in the matter and had devoted 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 issue 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 which its competence vastly exceeds that of courts. 

For these reasons, we have concluded that there is no inconsistency 

between our holding and Apotex, and have denied Defendant’s petition for 

rehearing. 

FOR THE COURT: 

Catherine O’Hagan Wolfe, Clerk of Court