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




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