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

 1                          UNITED STATES COURT OF APPEALS
 2                              FOR THE SECOND CIRCUIT
 3
 4                                        August Term, 2015
 5
 6                (Argued: March 11, 2016               Decided: September 9, 2016)
 7
 8                                        Docket No. 15-2411
 9
10
11                            _____________________________________
12
13                                CHURCH & DWIGHT CO., INC.,
14
15                                         Plaintiff-Appellee,
16
17                                                 v.
18
19                      SPD SWISS PRECISION DIAGNOSTICS, GMBH,
20
21                                       Defendant-Appellant.
22                            _____________________________________
23
24   Before:
25
26                LEVAL and WESLEY, Circuit Judges, and SANNES, District Judge.1
27
28          Defendant, a marketer of over-the-counter, home pregnancy tests, appeals from
29   the judgment of the United States District Court for the Southern District of New York
30   (Nathan, J.), which, following a bench trial, found Defendant liable for false advertising
31   in violation of Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and issued a
32   permanent injunction prohibiting Defendant from using certain advertising and packaging
33   and requiring it to issue corrective notices and advertising. The false advertising at issue
34   involves the “Weeks Estimator” feature of Defendant’s product, which informs the user
35   the number of the weeks elapsed since ovulation. The medical profession traditionally
36   measures the advancement of a pregnancy not from the date of ovulation or fertilization,
37   but rather from the date of last menstrual period, which generally occurs approximately
38   two weeks prior to ovulation. Plaintiff alleged, and the district court agreed, that
39   packaging and advertising messages used by Defendant were false because they implied


     1
      The Honorable Brenda K. Sannes, of the United States District Court for the Northern District
     of New York, sitting by designation.



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

 1   that Defendant’s product measures weeks of pregnancy in a manner consistent with the
 2   metric used by doctors.
 3          The Court of Appeals concludes that 1) Plaintiff’s Lanham Act claim is not
 4   precluded by the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; 2) the district
 5   court did not err in finding falsity in Defendant’s original packaging; 3) the district court
 6   did not err in finding the revised packaging impliedly false by reason of consumer
 7   confusion; 4) the district court made no error in ruling that Defendant’s false messages
 8   were material and likely to harm Plaintiff; and 5) the district court was within its
 9   discretion in imposing an injunction requiring changes to Defendant’s packaging and
10   requiring Defendant to issue corrective notices and corrective advertising.
11          AFFIRMED.
12
13
14
15                                              PAUL D. CLEMENT, Bancroft PLLC,
16                                              Washington, DC (Jeffrey M. Harris, Amy O.
17                                              Nyberg, Bancroft PLLC, Washington, DC and
18                                              Richard M. Goldstein, Lawrence T. Weinstein,
19                                              Michael T. Mervis, Baldassare Vinti, Jeffrey H.
20                                              Warshafsky, Q. Jennifer Yang, Proskauer Rose
21                                              LLP, New York, NY, on the brief), for
22                                              Plaintiff-Appellee.
23
24                                              SETH P. WAXMAN, Wilmer Cutler Pickering
25                                              Hale and Dorr LLP, Washington, DC (Thomas
26                                              G. Saunders, Ari J. Savitzky, Wilmer Cutler
27                                              Pickering Hale and Dorr LLP, Washington,
28                                              DC; Hanna A. Baek, Wilmer Cutler Pickering
29                                              Hale and Dorr LLP, New York, NY; and Jeffrey
30                                              G. Knowles, Julia D. Greer, David Mehretu,
31                                              Alice H. Wang, Coblentz Patch Duffy & Bass
32                                              LLP, San Francisco, CA, on the brief), for
33                                              Defendant-Appellant.
34
35
36
37
38
39
40
41
42


                                                   2
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   LEVAL, Circuit Judge:

 2         In an exceptionally well argued case, Defendant SPD Swiss Precision

 3   Diagnostics GmbH, a marketer of over-the-counter pregnancy test kits, appeals

 4   from the judgment of the United States District Court for the Southern District of

 5   New York (Nathan, J.), in favor of Plaintiff Church & Dwight Co. Inc., a leading

 6   competing marketer of over-the-counter pregnancy test kits. After a bench trial, the

 7   district court found Defendant liable for false advertising, in violation of Section

 8   43(a) of the Lanham Act, 15 U.S.C. § 1125(a). The pregnancy tests of both

 9   Plaintiff and Defendant detect pregnancy by the presence in the woman’s urine of

10   the hormone human chorionic gonadotropin (“hCG”), which is produced upon the

11   implantation of a fertilized egg in a woman’s uterus. In August 2013, following a

12   Food and Drug Administration (“FDA”) approval process, Defendant released its

13   new product, the Clearblue Advanced Pregnancy Test with Weeks Estimator (the

14   “Product”). Defendant’s Product, in addition to telling the woman whether she is

15   pregnant, is the first such product to also furnish information as to how long (how

16   many weeks) she has been pregnant, which it does by measuring the amount of

17   hCG in her urine.

18         Plaintiff’s claims focus on how Defendant’s Product packaging

19   characterized the advancement of pregnancy. The information communicated by

20   Defendant’s Product was the number of weeks passed since the woman’s


                                                 3
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   ovulation. (An egg is ripe and capable of fertilization only for twenty-four hours

 2   following ovulation.2 Implantation of the fertilized egg in the uterine lining, which

 3   causes the release of hCG, occurs between six and nine days after ovulation.)

 4          For a number of reasons—partially historical, partially because of the

 5   desirability of conformity—the metric commonly used by the medical profession

 6   to describe how long a woman has been pregnant (notwithstanding its obvious

 7   literal inaccuracy) speaks in terms of the number of weeks elapsed not since

 8   ovulation, fertilization, or implantation of the egg, but since the woman’s last

 9   menstrual period (the “LMP”) . A pregnant woman’s LMP normally occurs

10   approximately two weeks prior to her ovulation. Thus, the medical profession’s

11   conventional formula to describe how many weeks a woman has been pregnant

12   yields a number two weeks higher than the number furnished by the Product,

13   which measures weeks since ovulation. It is an uncontested given in this litigation

14   that, when the Defendant’s Product and the woman’s doctor are in complete

15   agreement in estimating how long the woman has been pregnant, the Product

16   would announce a number of weeks that is about two weeks lower than what the

17   doctor would say.3



     2
      Except when certain in vitro fertilization methods are used.
     3
      For example, if a doctor would tell a woman she is three weeks pregnant, then the Product
     would indicate that the same woman is one week pregnant.



                                                    4
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1         The gist of Plaintiff’s claim is that, in informing the user as to how long her

 2   pregnancy had been in effect, Defendant’s Product communicated the false

 3   impression that it uses the same metric and gives the same number of weeks of

 4   pregnancy as a medical professional would do.

 5         The district court ruled in favor of Plaintiff. It found, among other things,

 6   that Defendant had advertised falsely in its packaging at the time of the Product

 7   launch (the “Launch Package”) and launch advertising, and also in the revised

 8   packaging that Defendant substituted after the FDA had expressed concerns about

 9   the Launch Package (the “Revised Package”). The court relied on different theories

10   as between the messages associated with Launch Package and those accompanying

11   the Revised Package. For the Launch Package and its accompanying advertising,

12   the court found, among other things, that these materials unambiguously implied a

13   false message that the Product gives the duration of a pregnancy in terms that are

14   consistent with the metric used by doctors to estimate weeks-pregnant. For the

15   Revised Package, the court relied on survey evidence to support a finding that

16   Defendant communicated a misleading message.

17         The district court imposed an injunction on Defendant. The court’s order,

18   among other things, prohibited Defendant from distributing the misleading

19   materials and from using specified phrases. The order also required Defendant to




                                                 5
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   issue various corrective notices and advertising acknowledging that it had been

 2   found to have engaged in false advertising.

 3         We affirm the district court’s judgment. We agree with the district court that

 4   Plaintiff’s Lanham Act claim is not precluded by the Food, Drug, and Cosmetic

 5   Act, 21 U.S.C. §§ 301 et seq. (“FDCA”). We find no error in the court’s finding of

 6   falsity in Defendant’s Launch Package and advertising messages associated with it

 7   by reason of their unambiguous implication that Defendant’s Product measures

 8   weeks-pregnant in a manner that is consistent with the measurement used by

 9   doctors. Nor do we find fault in the district court’s finding, based on survey

10   evidence, that the message communicated by the Revised Package was impliedly

11   false. We also find no error in the district court’s findings that the falsity was

12   material and injurious to Plaintiff. Finally, we hold that the court did not abuse its

13   discretion in issuing the injunction.

14                                     BACKGROUND

15         I.     Parties

16         Plaintiff and Defendant are leading manufacturers of home, over-the-counter

17   pregnancy tests and direct competitors in the U.S. market. Plaintiff uses the brand

18   name “First Response,” while Defendant uses the “Clearblue” brand. Plaintiff’s

19   First Response products have generally led the home pregnancy test market, and

20   Defendant’s Clearblue products have been Plaintiff’s closest competitor.


                                                 6
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1          II.     Background Biology and Medical Conventions

 2          The issues raised in this case involve the biology of the reproductive cycle

 3   and, relatedly, the medical conventions used by doctors to measure and describe

 4   the duration of pregnancy. The district court described these issues with a clarity

 5   on which we cannot improve. We set forth the district court’s explanation here:

 6          The Reproductive Cycle
 7
 8          ....
 9
10                 The typical menstrual cycle lasts 28 days and is marked by two
11          key events: the menstrual period and ovulation. The latter is the
12          release of a ripe egg (or ovum) from the ovary. The time from [LMP]
13          to ovulation, known as the follicular phase of the menstrual cycle, is
14          generally two weeks, but variance in the length of the follicular phase
15          can be “significant.” The time from ovulation to the next menstrual
16          period, known as the luteal phase of the menstrual cycle, is two weeks
17          and is subject to much less variance than the follicular phase.
18
19                 For a successful pregnancy to proceed, the following steps must
20          take place. First, either through sexual intercourse or assisted
21          reproductive technology, sperm must fertilize an egg within 24 hours
22          of ovulation because a ripe egg can survive outside the ovary for only
23          about 12 to 24 hours.[4] In the case of sexual intercourse, fertilization
24          may occur several days after intercourse, but it will not occur more
25          than one day after ovulation. Second, the fertilized egg, now referred
26          to as a blastocyst, must travel down the fallopian tube to the uterus.
27          Third, the blastocyst must adhere to the endometrium (part of the
28          lining of the uterus), a process called implantation, which occurs
29          approximately six to nine days after ovulation. Once implantation
30          occurs, the blastocyst begins secreting [hCG], a hormone that, among


     4
       In this passage, the district court was not describing certain in vitro fertilization technologies
     that permit preservation of an egg for fertilization at a later date.



                                                        7
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1         other things, signals to a woman’s body that she is pregnant and
 2         prevents menses.
 3
 4               Home pregnancy tests, including [Defendant’s] Clearblue brand
 5         and [Plaintiff’s] First Response brand, determine whether a woman is
 6         pregnant by detecting the presence (or absence) of hCG—the
 7         hormone released following implantation—in urine.
 8
 9         The Multiple Methods Used to Determine Pregnancy Duration
10
11                Prior to advances in modern medicine, doctors had only one
12         way to determine a woman’s estimated date of delivery: the date of
13         her LMP, which occurs, on average, 40 weeks prior to delivery.
14         Before the development of more advanced medical technology, such
15         as ultrasound, a woman’s LMP provided the most readily available
16         and reliable estimate of pregnancy duration, which is also known as
17         gestational age. One of the disadvantages of using LMP for
18         determining pregnancy duration is that it assumes a standard 28-day
19         menstrual cycle and that ovulation occurs on day 14; [however], the
20         follicular phase of the menstrual cycle is prone to vary. In addition,
21         women often have a poor recollection of their LMP. These two
22         shortcomings mean that an estimate based on LMP may provide an
23         inaccurate prediction of the date of delivery.
24
25                Ultrasound technology provides doctors with a more
26         sophisticated way to determine pregnancy duration, and it is now
27         “standard practice to take an ultrasound scan of the developing fetus
28         about 8 to 12 weeks after the reported LMP.” An ultrasound scan is
29         used to measure a fetus’s crown-rump length, which, using a formula,
30         can be converted into an estimate of “embryonic age” (the number of
31         weeks that have passed since fertilization). Because fertilization
32         occurs, on average, two weeks after a woman’s LMP, a woman’s
33         estimated date of delivery is generally 38 weeks after fertilization.
34         Although ultrasound results are more accurate, “the date of the
35         LMP. . . remains the most commonly used method for estimating
36         gestational age and assigning a due date.”
37




                                                 8
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1          . . . .[5]
 2
 3          The Standard Convention for Expressing Pregnancy Duration
 4
 5                  Although there are multiple ways to determine a woman’s
 6          estimated date of delivery, and thus the duration of her pregnancy,
 7          there is a separate issue of how to express it—i.e., what words to use
 8          to describe “how far along” the pregnancy is. And on this point, which
 9          is the point that truly matters for resolution of this case, there is little
10          genuine dispute. Doctors and others use a standard convention to
11          express pregnancy duration. It is stated in terms of the number of
12          weeks since a woman’s LMP. As [Defendant]’s medical expert, Dr.
13          Kurt Barnhart, testified: “While doctors have long known that women
14          are not, and cannot be, pregnant at their LMP because ovulation does
15          not occur, on average, for another two weeks, LMP has continued to
16          be a reference point because, until relatively recently, it was either
17          impossible or impractical to estimate when ovulation occurred.” He
18          further noted that “even after the advent of ultrasound scanning
19          technology, the methods for estimating when ovulation (and hence
20          fertilization) occurred were generally intrusive, expensive, and/or
21          impractical, and obviously could not be self-administered by a woman
22          at home prior to becoming pregnant.” Thus, for both historical and
23          practical reasons, dating a woman’s pregnancy from her LMP has
24          been and remains a widely used method for determining pregnancy
25          duration. But more importantly, it has continued to be the standard—
26          indeed, universal—convention for expressing pregnancy duration.
27
28                  In fact, even when pregnancy duration is determined using
29          other methods, such as ultrasound scans, most medical professionals
30          still convert to the LMP convention when communicating pregnancy
31          duration to patients and other medical providers. Ultrasound machines
32          are even programmed to automatically convert an estimate of
33          embryonic age based on crown-rump length into an estimate of
34          pregnancy duration based on weeks since LMP. . . .
35


     5
       We have not included a passage describing in vitro fertilization that is not pertinent to the
     issues before us.



                                                       9
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1                “[D]octors typically will date the pregnancy according to the
 2         ultrasound results, but they will (by convention) express the duration
 3         of pregnancy in terms of the time since LMP would have been
 4         expected to occur in a normal menstrual cycle.” . . . In short, while
 5         doctors may have multiple ways to arrive at the convention—e.g.,
 6         LMP, ultrasound, date of embryo transfer—they use a standard and
 7         uniform convention for expressing pregnancy duration: weeks since
 8         LMP.
 9
10   S.P.A. 5-9 (footnotes, citations, and original brackets omitted) (original emphases

11   omitted and emphasis added).

12         III.   Defendant’s Product

13                a. The Weeks Estimator

14         Before Defendant’s Product was released, most pregnancy tests were binary,

15   expressing only whether or not a woman is pregnant, which was detected by the

16   presence of hCG in her urine. Defendant’s Product, by measurement of the amount

17   of hCG rather than only its presence, additionally estimates time elapsed since

18   implantation. The number of weeks stated by Defendant’s Product as having

19   passed is the number of weeks since ovulation. Depending on the Product’s hCG

20   measurement, its message to the user reads either “Not Pregnant” or “Pregnant”

21   and “1-2 [weeks]”; “2-3 [weeks]”; or “3+ [weeks].” If the result reads Pregnant, 1-

22   2 weeks, 2-3 weeks, or 3+ weeks, that means that the user is pregnant and that her

23   hCG levels indicate that the stated number of weeks have passed since ovulation.

24




                                                10
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1                b. The FDA Clearance Process

 2         Home pregnancy tests are Class II medical devices and, as such, they are

 3   subject to FDA regulation. Specifically, they are subject to the requirements of

 4   § 510(k) of the FDCA, 21 U.S.C. § 360(k), known as the “§ 510(k) process.” See

 5   Medtronic, Inc. v. Lohr, 518 U.S. 470, 478-79 (1996). Under the § 510(k) process,

 6   a party seeking to market a Class II device must submit a “premarket notification”

 7   to the FDA, which must include a description of the device, a statement of

 8   intended use, the proposed labeling, and any other information necessary for the

 9   FDA to determine if the device is “substantially equivalent” to an existing

10   authorized device. A determination that the new device is substantially equivalent

11   to a preexisting device is essentially a finding that the new device is as safe and

12   effective as the preexisting device, meaning the new device may be marketed

13   without further analysis. Id. Under § 513(i)(1)(E) of the FDCA, the FDA may,

14   notwithstanding a substantial equivalence determination, require changes to the

15   product’s labeling or promotional materials designed to discourage potential off-

16   label use of the product that might cause harm to consumers. 21 U.S.C.

17   § 360c(i)(1)(E).

18         Defendant began the § 510(k) process for the Product in 2008. The FDA

19   issued a “hold letter” in August 2012, expressing a concern that the “weeks

20   indicator feature may provide misleading information to lay population of users.”


                                                11
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   J.A. 7581. The letter noted that “[f]or example, the output of this test is not aligned

 2   with gestational aging done by healthcare professionals (i.e. it will under-estimate

 3   gestational age by an average of 2 weeks).” Id. The letter also expressed concern

 4   that “users [may] misinterpret the weeks results to be a substitution for gestational

 5   age determination or may misinterpret weeks results to mean they are pregnant and

 6   their pregnancy is progressing in a healthy manner.” Id. Among other things, the

 7   hold letter required that Defendant remove the phrase “Also Tells you How Far

 8   Along you Are” from the Product’s box. J.A. 7581-83.

 9         After additional communication between Defendant and the FDA, the FDA

10   issued a final “clearance letter” on December 10, 2012. The clearance letter stated

11   that Defendant could begin marketing the device but also invoked the FDA’s

12   § 513(i)(1)(E) authority to impose limitations on the Product’s advertising and

13   labeling. The clearance letter required, among other things, that Defendant include

14   a specific “conversion chart” explaining how a doctor would date the pregnancy

15   compared to the Product’s results, using language provided by the FDA. It also

16   specified that the Product’s results not be expressed as “weeks pregnant,” but only

17   as the number of weeks since ovulation. J.A. 3368-69.

18         Additionally, the clearance letter required that the Product include the

19   following Indications for Use Statement:




                                                12
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1                The Clearblue Advanced Pregnancy Test with Weeks Estimator
 2         is an over-the-counter urine hCG test which is intended for the
 3         detection of pregnancy. The test detects hCG in some cases from four
 4         days before the expected period (which is 5 days before the day of the
 5         missed period).
 6
 7               This test is only intended for individual use at home. It is not
 8         intended for use in a healthcare setting.
 9
10               This test contains a “Weeks Estimator.” The “Weeks
11         Estimator” is meant solely as an estimate for the consumer and is not
12         intended as a substitute for a doctor’s clinical diagnosis. The “Weeks
13         Estimator” is not intended for multiple pregnancies. The estimate
14         provided by the device may be inaccurate in these cases.
15
16                This test cannot be used to determine the duration of pregnancy
17         or to monitor the progression of pregnancy. Your doctor determines
18         how many weeks pregnant you are based on the first day of your last
19         menstrual period and ultrasound results. This test provides a different
20         estimate that cannot be substituted for a doctor’s determination of
21         gestational age. Only your doctor can provide a reliable estimate of
22         gestational age and only your doctor can monitor pregnancy
23         progression. You should seek qualified prenatal care if you suspect
24         you are pregnant.
25
26   J.A. 3370.

27         The clearance letter stated that the “FDA’s issuance of a substantial

28   equivalence determination does not mean that FDA has made a determination that

29   your device complies with other requirements of the [FDCA] or any Federal

30   statutes and regulations administered by other Federal agencies.” Id. Additionally,

31   the letter reminded Defendant that it must obtain FDA approval before modifying

32   or removing any of the required labeling.



                                                13
     15-2411--cv
     Church & Dwight Co
                      o., Inc. v. SP
                                   PD Swiss Preecision Diaggnostics, Gm
                                                                      mbH

 1                 c. The Launch
                               h Packagee and Adveertising C
                                                           Campaign

 2          Defendant
            D         launched
                      l        th
                                he Productt in Augustt 2013. Thhe Launch P
                                                                         Package

 3   containeed the Prod
                       duct’s nam       blue Advannced Pregnnancy Test with Weeks
                                me—Clearb

 4   Estimattor—in larg
                      ge font, alo
                                 ong with a picture off the Produuct. The Laaunch Packkage

 5   also exh
            hibited fou
                      ur windowss, designed
                                          d to appearr similar to the windoow that apppears

 6   on the Product
            P       itseelf. One window sho
                                          owed the w
                                                   word “Pregnnant” on thhe first linee

 7   and “1-2
            2 weeks” on
                     o the seco
                              ond; the seccond show
                                                  wed the word “Pregnaant” on thee

 8   first linee and “2-3 weeks” on
                                  n the secon
                                            nd; the thirrd showed the word ““Pregnant”” on

 9                       “ weeks”” on the second; and the fourth read “Nott Pregnant.”
     the firstt line and “3+

10   (See im
           mage below
                    w.) The worrd “ovulatiion” did noot appear oon the frontt or back oof

11   the Launch Package to descrribe the Product. Onee side paneel of the Laaunch Packkage

12   containeed the full FDA-requ
                                uired Indicaations for U
                                                       Use Statem
                                                                ment in sm
                                                                         mall font. (S
                                                                                     See

13   image below.)
           b




14




                                                 14
     15-2411--cv
     Church & Dwight Co
                      o., Inc. v. SP
                                   PD Swiss Preecision Diaggnostics, Gm
                                                                      mbH




 1

 2          The
            T Producct launch was
                              w accomp
                                     panied by a marketinng campaiggn. One feaature

 3   of the campaign was
                     w a fifteeen-second television
                                         t          ccommerciaal that ran from Auguust

 4   28, 2013 to Decem                   V Commercial”). Thhe commerrcial showed
                     mber 2, 2013 (the “TV

 5   two wom
           men sitting
                     g at a kitch
                                hen table, engaging
                                           e        inn the follow
                                                                 wing dialoogue:

 6          Woman
            W     1: I’m
                     I pregnaant.

 7          Woman
            W     2: Really?
                     R

 8          Woman
            W     1: Two
                     T week
                          ks.

 9          Woman
            W     2: You
                     Y alread
                            dy went to the doctorr?

10          Woman
            W          1: Not
                          N yet, bu          his new Cleearblue tesst. It’s like two
                                  ut I took th
11          teests in one.
12
13          Woman
            W     2: Oh
                     O my God, I think I’m
                                       I going tto cry!

14          84-85. Durring and affter this diaalogue, thee screen shiifted to exaamples of tthe
     J.A. 338

15   various results thaat can appeear on the device,
                                              d       succh as “Preggnant / 1-2 Weeks.” F
                                                                                        For

16   two seconds of thee commerccial, the wo
                                           ords “ESTIIMATED WEEKS S
                                                                  SINCE

17   OVULA
         ATION” ap
                 ppeared on
                          n the screen
                                     n, and for nnine seconnds the folllowing

18   appeareed at the bo
                       ottom of th
                                 he screen:

19          Word
            W    “weeeks” on dissplay is forr illustratioon only. F
                                                                  For home uuse only.


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

 1         Always consult a doctor if you suspect you are pregnant and to
 2         confirm, date and monitor pregnancy. Not for multiple pregnancies.
 3         Estimates weeks since ovulation up to 3+ weeks. Do not use to
 4         monitor pregnancy progress or duration.
 5
 6   The commercial closed with a voiceover: “The new Clearblue pregnancy test also

 7   estimates how many weeks. Weeks Estimator. Only from Clearblue.” Id.

 8         Defendant maintained a webpage dedicated to promoting the Product. A

 9   banner at the top of the page stated: “The ONLY Pregnancy Test that Estimates

10   Weeks.” A large photo of the Product appeared with the window reading “Pregnant

11   / 1-2 weeks.” The webpage stated that the Product “is the FIRST and ONLY

12   pregnancy test that not only tests you if you are pregnant but also estimates the

13   number of weeks. It’s like 2 tests in 1!” J.A. 3415.

14         Defendant also promoted the Product through product placement in the

15   television program “The Doctors.” Additionally, Defendant marketed the Product

16   in retailer presentations, web banners, retailer circulars and websites, and in-store

17   advertising. For example, one advertisement that appeared in Walgreens stated

18   “How Far Along Am I? Clearblue Advanced Pregnancy Test with Weeks

19   Estimator tells you in words if you are pregnant, and estimates how many weeks

20   by measuring the pregnancy hormone level.” J.A. 3418-19.

21                d. The FDA’s Response

22         After receiving complaints from Plaintiff, the FDA emailed Defendant in



                                                16
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   November 2013 stating, “[i]t has come to our attention that [Defendant] is

 2   marketing the ‘Clearblue Advanced Pregnancy Test with Weeks Estimator’ device

 3   in violation of the limitations in FDA’s clearance letter.” J.A. 2152. During a

 4   November 18, 2013 conference call with Defendant, the FDA related its concerns.

 5   Among other things, the FDA complained that the Launch Package included

 6   display windows with the word “weeks.” It instructed Defendant to remove the

 7   word “weeks” from the windows and replace it with “weeks along” outside the

 8   windows.

 9         After some back and forth with the FDA, Defendant submitted a “mitigation

10   proposal” to address the FDA’s concerns, which ultimately resulted in the Revised

11   Package and advertising.

12                e. The Revised Package and Advertising Campaign

13         The Revised Package, which was launched in February 2014, differed from

14   the Launch Package in several ways. The Revised Package included a gray strip in

15   the top right corner with the phrase “Only Test That Estimates Weeks Since

16   Ovulation*”. The asterisk linked to the Indications for Use Statement on the side

17   panel. The four screens on the front of the package no longer contained the word

18   “weeks”; instead, “weeks along” was printed below the screens, as specified by the

19   FDA. (See image below.)




                                                17
     15-2411--cv
     Church & Dwight Co
                      o., Inc. v. SP
                                   PD Swiss Preecision Diaggnostics, Gm
                                                                      mbH




 1

 2          Defendant
            D         stopped
                      s       airring the TV
                                           V Commerrcial and reeplaced it w
                                                                          with an

 3   Internett-Only Com
                      mmercial. The
                                T Intern
                                       net-Only Coommerciall was simillar to the T
                                                                                 TV

 4   Commeercial, but the
                      t dialogu
                              ue was chaanged to rem
                                                   move the ddiscussion of a doctoor

 5   and Wo
          oman 1’s declaration of how farr along shee was. Defeendant alsoo launchedd a

 6   new weebpage whiich essentiaally made the same cchanges as those madde in the

 7   Revised
           d Package. The first paragraph
                                p         on
                                          o the webbpage was also modiffied to readd:

 8   “Clearb
           blue Advan
                    nced Pregn
                             nancy Test with Weekks Estimatoor is the FIIRST and

 9   ONLY pregnancy
                  y test that not
                              n only tellls you if yyou are preggnant but aalso estimaates

10   the num
           mber of weeeks since ovulation.
                                o          It’s
                                           I like 2 ttests in 1!”” J.A. 31655.

11          IV
             V.    Proceedings Below

12                 a. Prreclusion Argument
                                  A      ts

13          Plaintiff
            P         iniitiated this action by a complainnt filed on January 299, 2014 annd

14   moved for
           f a prelim
                    minary inju                  moved to ddismiss the complaintt.
                              unction. Defendant m



                                                 18
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   Defendant’s main argument on its motion to dismiss was that the FDCA precluded

 2   Plaintiff’s Lanham Act claim. On June 3, 2014, the district court denied

 3   Defendant’s motion to dismiss, finding, among other things, that Plaintiff’s

 4   Lanham Act claim would not usurp the FDA’s role in enforcement of the FDCA

 5   and its associated regulations. The district court also directed that the preliminary

 6   injunction hearing would be consolidated with the bench trial on liability. See Fed.

 7   R. Civ. Proc. 65(a)(2).

 8         Before trial, Defendant submitted a motion in limine renewing its preclusion

 9   argument in light of the Supreme Court’s recent decision in POM Wonderful LLC

10   v. Coca-Cola Co., 134 S. Ct. 2228 (2014). The district court adhered to its position

11   that there was no preclusion, finding that POM Wonderful reinforced, rather than

12   undermined, the district court’s original decision.

13                b. Bench Trial on Liability

14         At the parties’ request, the district court bifurcated trial, as between liability

15   and damages. It then conducted a two-week bench trial on liability in April 2015.

16   The court issued an opinion on July 1, 2015 finding Defendant liable for falsely

17   advertising in the Launch Package and its associated advertising, as well as in the

18   Revised Package. The court also determined that, at least around the time the

19   Launch Package was created, Defendant had deliberately set out to deceive




                                                19
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   consumers into believing that the Product could provide a measure of weeks-

 2   pregnant consistent with what doctors provide.

 3                c. Injunction

 4         The district court concluded that Plaintiff was entitled to an injunction

 5   because, among other things, it had demonstrated irreparable harm—the parties

 6   were clearly competitors and there was a logical causal connection between

 7   Defendant’s false advertising and Plaintiff’s sales.

 8         On August 26, 2015, the district court entered a permanent injunction. The

 9   court’s order: (a) enjoined Defendant from communicating in any advertising that

10   the Product provides an estimate of weeks pregnant that is the same as a doctor’s

11   estimate; (b) enjoined Defendant from distributing or communicating any of the

12   Launch or Revised Packaging or advertising and required Defendant to remove all

13   current products from points of sale within forty-five days; (c) required Defendant

14   to include with the Product a specified forty-one-word statement clarifying the

15   difference in the estimates, in a particular position and font size; (d) prohibited

16   Defendant from using several phrases in its advertising, such as “weeks pregnant,”

17   “weeks along,” or “Weeks Estimator”; (e) required Defendant to deliver within

18   seven days to all retailers and distributors a specified written notice (“Corrective

19   Notice”) with a copy of the injunction; (f) required Defendant, for one year, to

20   make available copies of the Corrective Notice with copies of the injunction in


                                                20
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   prominent locations at all U.S. trade shows and professional meetings attended by

 2   Defendant or any of its representatives; (g) required Defendant within seven days

 3   to set up and maintain for a year a stand-alone page on its website with a specified

 4   messaging about the lawsuit and what the court found to be Defendant’s history of

 5   providing misleading information about the Product; (h) required Defendant to

 6   publish a statement in retailer circulars to the same effect; (i) required Defendant to

 7   publish Internet-banner advertising prominently displaying its logo and stating that

 8   a federal court has determined that Defendant “engaged in false advertising”; (j)

 9   required Defendant to publish in three parenting magazines full-page

10   advertisements including a statement similar to the one on the standalone webpage;

11   and (k) required Defendant to produce a video explaining the difference between

12   the Product’s and medical profession’s pregnancy length estimates and stating that

13   “a federal court found the manufacturer . . . to have engaged in false advertising,”

14   and to make it prominently available on Defendant’s webpages, YouTube

15   channels, and Facebook page. S.P.A. 55-60.

16                                       DISCUSSION

17         On appeal, Defendant raises several challenges to the district court’s

18   conclusions. First, Defendant renews its argument that the Plaintiff’s Lanham Act

19   claim is precluded by the FDCA. Second, Defendant challenges the district court’s

20   finding of Lanham Act liability by arguing that the district court misapplied the


                                                21
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   literal falsity and implied falsity analyses to the Launch Package, TV Commercial,

 2   and other advertising, that the district court erred in relying on flawed survey

 3   evidence to find implied falsity with respect to the Revised Package, and that the

 4   district court erred in finding injury and materiality. Finally, Defendant contends

 5   that the injunction is inappropriately broad in scope and overly punitive.

 6         Defendant’s preclusion argument presents a question of law, which we

 7   review de novo. Cf. Goodspeed Airport LLC v. E. Haddam Inland Wetlands &

 8   Watercourses Comm’n, 634 F.3d 206, 209 n.3 (2d Cir. 2011) (“We review de novo

 9   a district court’s application of preemption principles.”). When reviewing a district

10   court’s judgment following a bench trial, we review the court’s findings of fact for

11   clear error and its conclusions of law de novo. Merck Eprova AG v. Gnosis S.p.A.,

12   760 F.3d 247, 255, 261-62 (2d Cir. 2014); see also Time Warner Cable, Inc. v.

13   DIRECTV, Inc., 497 F.3d 144, 158 (2d Cir. 2007). We review the scope of a

14   permanent injunction for abuse of discretion. Merck Eprova, 760 F.3d at 265.

15         I.     Preclusion

16         Defendant contends that Plaintiff’s Lanham Act claim is precluded by

17   Congress’s provision for intensive regulation of Defendant’s Product by the FDA.

18   Defendant argues that it cannot be held liable for its labeling and promotional

19   materials because those materials were under FDA “control,” having been




                                                22
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   reviewed and approved by the FDA through the FDCA § 510(k) process.

 2   Appellant’s Br. 23.

 3         We hold that Plaintiff’s Lanham Act claim is not precluded.

 4   Notwithstanding certain differences, the Supreme Court case of POM Wonderful

 5   LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014) presents similar facts, and the

 6   Court’s ruling is instructive. POM Wonderful concerned a Lanham Act challenge

 7   between two marketers of fruit juice. The plaintiff alleged that the defendant’s

 8   practice of calling its juice blend “pomegranate blueberry,” when it only contained

 9   0.3% pomegranate juice and 0.2% blueberry juice, was deceptive. The defendant

10   argued that a Lanham Act suit regarding the labeling of its product was precluded

11   by the FDCA, which regulates the labeling of food products to protect the public

12   against false labeling. 21 U.S.C. §§ 331, 343.

13         The Supreme Court addressed the interaction between the Lanham Act’s

14   unfair competition provisions and the FDCA. The Court concluded that the

15   Lanham Act claim was not precluded. POM Wonderful, 134 S. Ct. at 2238-39.

16   Applying principles of statutory interpretation, the Court found, among other

17   things, that the Lanham Act and the FDCA complement one another because “each

18   [statute] has its own scope and purpose.” Id. at 2238. The Lanham Act “protects

19   commercial interests against unfair competition, while the FDCA protects public

20   health and safety.” Id. The Court noted that Congress’s intent in maintaining the


                                                23
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   distinction between these goals can be further seen in the fact that the FDCA’s

 2   enforcement is by the FDA, which does not have a mission to protect the concerns

 3   of a competitor harmed by the regulated entity’s misleading advertising or

 4   labeling. Id.

 5         The Court also rejected an alternative position, proposed by the government

 6   as amicus curiae, that Lanham Act claims are not precluded by the mere fact that

 7   the FDCA covers a product generally, but are precluded in situations when the

 8   FDCA or the FDA, through its regulations, have “specifically require[d] or

 9   authorize[d]” a challenged aspect of a label. Id. at 2240. The Court rejected the

10   proposition that the FDCA’s or FDA’s regulation of a label creates a “ceiling” that

11   precludes any further challenges to that label under other statutes. Id. The Court

12   concluded that even the government’s limited preclusion theory would distort

13   Congress’s intent to allow the Lanham Act and the FDCA to exist in tandem to

14   serve the distinct interests each statute protects. Id. at 2240-41.

15         We agree with the district court that POM Wonderful is controlling here. We

16   see no reason why the subjugation of Defendant’s Product labeling to FDA

17   regulation through the § 510(k) process should categorically immunize it from

18   Lanham Act claims by competitors regarding the regulated labeling. As the POM

19   Wonderful opinion noted, regardless of the fact that the FDCA and Lanham Act

20   sometimes overlap in scope and effect, each statute nonetheless has a distinct


                                                24
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   purpose, and in carrying out its FDCA duties, the FDA is not charged with

 2   protecting the interests of its subject’s competitors. Id. at 2238-39.

 3           The fact that the FDA has satisfied itself that a product’s labeling is

 4   sufficiently accurate to secure FDA approval gives no assurance that the

 5   intervention of a competitor would not reveal problematic misleading messaging

 6   that is harmful to the competitor’s interests, which the federal agency either

 7   overlooked or failed to appreciate as important. POM Wonderful is clear: FDA

 8   approval is no substitute for the intervention of a competitor, which by dint of its

 9   “market expertise” is uniquely qualified to “provide incentives for manufacturers

10   to behave well.” Id. FDA approval of the accuracy of a subject’s representations

11   does not create a ceiling that bars still better protections against the capacity of the

12   representations to mislead. Indeed, the FDA explicitly warned Defendant in its

13   clearance letter that its approval “does not mean that FDA has made a

14   determination that your device complies with other requirements of the [FDCA] or

15   any Federal statutes and regulations administered by other Federal agencies.” J.A.

16   3370.

17           Notwithstanding that the FDA’s regulation of Defendant’s labeling

18   addressed the same issue as raised by Plaintiff in its Lanham Act suit—the risk that

19   consumers will misunderstand Defendant’s messages as implying that the Product

20   utilizes the same metric for pregnancy duration as used by medical professionals—


                                                25
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   there is no reason to assume that Congress would see the FDCA’s precautions as

 2   undermined by a court’s decision, upon a competitor’s suit, that protection of the

 3   competitor against unfair competition through false advertising requires still

 4   greater protection against consumer miscomprehension than was mandated by the

 5   FDA.

 6          We see no merit in Defendant’s efforts to distinguish POM Wonderful.

 7   Although the FDA did not preapprove the juice labels at issue in POM Wonderful,

 8   as it did here pursuant to its more proactive, extensive, and focused role in drug

 9   regulation, the Supreme Court explicitly rejected the government’s argument that a

10   Lanham Act claim is precluded to the extent that the FDCA or FDA regulations

11   “specifically require or authorize” aspects of a label that are then challenged under

12   the Lanham Act, noting that the FDA’s requirements are a floor, not a ceiling. 134

13   S. Ct. at 2235.

14          Defendant’s reliance on PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) is also

15   misplaced. At first glance, PLIVA appears to share much in common with this case.

16   PLIVA involved consumer lawsuits against generic drug manufacturers under state

17   tort laws requiring drug manufacturers to label their drugs so as to reveal to

18   consumers the dangers posed by the drugs. Id. at 608-09. The defendant generic

19   drug manufacturers asserted that the state law tort claims were preempted by FDA

20   regulations, which require generic drug labels to be the same as their brand-name


                                                26
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   equivalents. Id. at 613. The Supreme Court agreed, reasoning that it would be

 2   “impossibl[e]” for the defendants to comply with the FDA’s rules and also provide

 3   the more robust warning that state law required. Id. at 618. The Court found

 4   impossibility even though the defendants could have requested permission from

 5   the FDA to change their labels so as to comply with the state laws. The Court held

 6   that when a party must affirmatively seek permission from the federal agency in

 7   order to comply with a state law requirement, the state law is preempted. Id. at

 8   620-24.

 9         It is true that Defendant here, like the defendants in PLIVA, could have

10   marketed the Product under a label that differed from the label approved by the

11   FDA only by obtaining permission of the FDA. This was required by the FDA’s

12   clearance letter and the § 510(k) process generally. Nonetheless, we conclude that

13   PLIVA is not controlling here because this dispute does not involve the question

14   whether a state law is preempted by a federal agency’s regulation; rather, this

15   dispute involves the question whether the application of a federal agency’s

16   regulation, promulgated under one federal statute, precludes a private action under

17   another federal statute. While federal law-state law preemption principles can be

18   “instructive” in the federal law-federal law preclusion context, “the Court’s

19   [preemption] precedent does not govern preclusion analysis.” POM Wonderful,

20   134 S. Ct. at 2236. In a preemption case, concerns about the primacy of federal law


                                                27
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   and the “state-federal balance . . . frame the inquiry,” but that is not so in a

 2   preclusion case. Id. The uniformity concerns that drive preemption doctrine are not

 3   necessarily applicable when two federal statutes overlap. Our analysis must be

 4   governed by POM Wonderful, which establishes that a Lanham Act claim is not

 5   precluded by FDA regulation under the FDCA because the two statutes serve

 6   distinct and complementary purposes.6

 7          II.     Lanham Act Liability

 8                  a. Falsity

 9          Defendant contends that the district court erred in finding falsity in its

10   packaging and advertising. To prevail on a Lanham Act false advertising claim, a

11   plaintiff must establish that the challenged message is (1) either literally or

12   impliedly false, (2) material, (3) placed in interstate commerce, and (4) the cause

13   of actual or likely injury to the plaintiff. Merck Eprova AG v. Gnosis S.p.A., 760

14   F.3d 247, 255-56 (2d Cir. 2014).7

15          A plaintiff may establish falsity in two different ways. To establish literal

16   falsity, a plaintiff must show that the advertisement either makes an express

     6
       Defendant further argues that, at minimum, the district court’s injunction is precluded because
     Defendant cannot comply with it without violating the FDA’s instructions. Defendant notes that,
     for example, the district court enjoined Defendant from using the words “Weeks Estimator” in
     the Product’s name unless it is modified to refer to ovulation, even though Defendant cannot
     change the Product’s name without the FDA’s approval. This argument fails as a preclusion
     argument for the reasons explained above.
     7
       As the parties do not dispute that Defendant has placed the Product in interstate commerce, we
     do not address that issue.



                                                    28
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   statement that is false or a statement that is “false by necessary implication,”

 2   meaning that the advertisement’s “words or images, considered in context,

 3   necessarily and unambiguously imply a false message.” Time Warner Cable, Inc.

 4   v. DIRECTV, Inc., 497 F.3d 144, 158 (2d Cir. 2007). A message can only be

 5   literally false if it is unambiguous. Id. If an advertising message is literally false,

 6   the “court may enjoin the use of the message without reference to the

 7   advertisement’s impact on the buying public.” Tiffany (NJ) Inc. v. eBay Inc., 600

 8   F.3d 93, 112 (2d Cir. 2010) (quoting McNeil–P.C.C., Inc. v. Bristol–Myers Squibb

 9   Co., 938 F.2d 1544, 1549 (2d Cir. 1991)).

10         If a message is not literally false, a plaintiff may nonetheless demonstrate

11   that it is impliedly false if the message leaves “an impression on the listener or

12   viewer that conflicts with reality.” Time Warner Cable, 497 F.3d at 153 (quoting

13   Schering Corp. v. Pfizer Inc., 189 F.3d 218, 229 (2d Cir. 1999), as amended on

14   reh’g (Sept. 29, 1999) (brackets omitted)). Courts have, at times, required a claim

15   of implied falsity to be supported by extrinsic evidence of consumer confusion. Id.

16   Alternatively, courts have allowed implied falsity to be supported by evidence that

17   the defendant intended to deceive the public through “deliberate conduct” of an

18   “egregious nature,” in which case a rebuttable presumption of consumer confusion

19   arises. Merck Eprova, 760 F.3d at 255-56.




                                                 29
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1         The district court engaged in separate falsity analyses as between the Launch

 2   Package, together with its associated TV Commercial and additional advertising,

 3   and the Revised Package. As the district court relied on the same theories with

 4   respect to the Launch Package, TV Commercial, and additional advertising, we

 5   address those together before turning to the Revised Package.

 6                        i. The Launch Package, Television Commercial, and Other
 7                           Advertising
 8
 9         The district court found that the Launch Package, TV Commercial, and other

10   associated advertising were literally false by necessary implication, as well as

11   impliedly false. The court found that although none of these materials expressly

12   stated that the Product estimates weeks-pregnant using a metric consistent with the

13   metric doctors would use, these materials included statements and images, which,

14   when considered in context, unambiguously implied that false message.

15         Defendant primarily argues that the district court erred in finding literal

16   falsity because these materials were “susceptible to more than one reasonable

17   interpretation” and thus not unambiguous. Appellant’s Br. at 45 (quoting Time

18   Warner Cable, 497 F.3d at 158). Defendant argues that a reasonable ordinary

19   person in the market for a home pregnancy test could understand Defendant’s

20   advertising regarding the Product’s ability to measure “weeks” as weeks-since-

21   ovulation/fertilization without forming a belief about whether that measure is the



                                                30
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   same or different from the convention used by doctors.

 2         This argument is not persuasive. The issue is not whether Defendant’s

 3   measure of weeks could have been understood to measure from LMP versus from

 4   ovulation/fertilization. The issue is whether Defendant’s measurement of weeks

 5   would be understood by reasonable consumers to measure by a different metric

 6   than used by the medical profession. If an advertising message means something

 7   different from what reasonable consumers would understand it to mean, that

 8   message can be considered false. Time Warner Cable, 497 F.3d at 158 (citing

 9   Novartis Consumer Health, Inc. v. Johnson & Johnson–Merck Pharm. Co., 290

10   F.3d 578, 586-87 (3d Cir. 2002) (“A ‘literally false’ message may be either explicit

11   or ‘conveyed by necessary implication when, considering the advertisement in its

12   entirety, the audience would recognize the claim as readily as if it had been

13   explicitly stated.’ ”)). The district court found that the medical profession has a

14   “standard—indeed universal—convention for expressing pregnancy duration.”

15   S.P.A. 8. It was undisputed that Defendant’s Product does not utilize the medical

16   profession’s standard, universal convention. The crucial point is that a reasonable

17   consumer would have assumed from the text of the Launch Package, TV

18   Commercial, and other associated advertising that the Product was not giving a

19   different number than a medical professional would give. The district court

20   concluded that message was false. We can see no error in the court’s reasoning.


                                                31
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1         The Launch Package did not indicate in any visible or clear way that the

 2   Product provides a different measurement from a doctor’s. The packaging referred

 3   to the Product as a “Weeks Estimator” and included sample windows listing

 4   possible results such as “Pregnant / 2-3 Weeks.” No reference to ovulation was

 5   included on the front of the packaging. The only mention of ovulation and of the

 6   difference in dating conventions was contained in the small Indications for Use

 7   Statement on the side of the box, which, the district court found, was too wordy

 8   and “minuscule” to render ambiguous the Launch Package’s message that the

 9   Product provides an estimate of weeks-pregnant that is consistent with the

10   measurement provided by doctors. S.P.A. 31.

11         Similarly, the TV Commercial unambiguously implied the false message

12   that the Product provides a measurement of weeks-pregnant that is consistent with

13   the metric used by medical professionals. Like the Launch Package, the

14   commercial discussed the Product’s ability to estimate “weeks” without clarifying

15   that it measures weeks since ovulation—and, more importantly, without clarifying

16   that it measures weeks differently from how a doctor would measure. A voiceover

17   in the commercial states, “The new Clearblue pregnancy test also estimates how

18   many weeks.” J.A. 3384-85. The commercial also includes shots of the misleading

19   digital screens from the Launch Package. Its references to ovulation in the

20   disclaimers were too fleeting and small to affect a consumer’s understanding, and,


                                                32
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   furthermore, made no reference to the fact that the Product uses a different metric

 2   from the medical profession’s universal standard.

 3          Finally, the additional associated advertising—including, among other

 4   things, the website, web banners, and in-store advertising—utilized the same

 5   misleading “weeks” language as the Launch Package and TV Commercial without

 6   revealing in any meaningful way that the number of weeks differs from the number

 7   a doctor would provide.

 8          As the Launch Package, TV Commercial, and other advertising all

 9   unambiguously implied the false message that the Product provides a measurement

10   of weeks-pregnant that is consistent with the measurement a doctor would provide,

11   we find no error in the district court’s findings of literal falsity.

12          It makes no difference, however, whether the Defendant’s messages were

13   literally false, because the district court also correctly found the messages to be

14   impliedly false.8 The court’s finding of implied falsity was supported by actual

15   evidence of consumer confusion (to the effect that consumers understood from the


     8
       Implied falsity should not be confused with literal falsity by necessary implication. A court may
     find a statement literally false by necessary implication, without considering extrinsic evidence,
     when the advertisement’s “words or images, considered in context, necessarily and
     unambiguously imply a false message.” Time Warner Cable, 497 F.3d at 158. A message—even
     a message that is ambiguous—is impliedly false if it leaves “an impression on the listener or
     viewer that conflicts with reality.” Id. at 153. Implied falsity is often demonstrated through
     extrinsic evidence of consumer confusion, id., or though evidence of the defendant’s deliberate
     deception, which creates a rebuttable presumption of consumer confusion. Merck Eprova, 760
     F.3d at 255-56.



                                                     33
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   Defendant’s messaging that the Product gives the same number of weeks as a

 2   doctor would give), and by evidence of Defendant’s intent to deceive, which the

 3   court found sufficient to give rise to a presumption of consumer confusion. The

 4   court found that Defendant engaged in intentional deception because Defendant’s

 5   “staff recognized and understood that the Weeks Estimator’s result did not align

 6   with how doctors express pregnancy duration and that this misalignment could

 7   confuse consumers.” S.P.A. 19. The court cited to extensive evidence in the record

 8   supporting this conclusion. We briefly highlight some of the more significant

 9   evidence credited by the district court.

10         Some of this evidence showed that Defendant was clearly aware that LMP is

11   the metric used by doctors. Dr. Sarah Johnson, Defendant’s Head of Clinical and

12   Medical Affairs, stated in a peer-reviewed article that pregnancy was historically

13   dated in reference to LMP. Several studies and documents that Defendant

14   submitted to the FDA stated that this was the traditional or conventional practice.

15   Defendant’s witnesses at trial, including Dr. Joanna Pike, Defendant’s Senior

16   Global Pregnancy Product Manager, and Mark Gittens, Defendant’s Chief

17   Compliance Officer, acknowledged the LMP convention. Some evidence also

18   indicated that Defendant was aware that consumers would likely become confused

19   if the distinction between the Product’s ovulation metric and the conventional LMP

20   metric was not made explicit. For example, Dr. Pike stated in an email: “I think


                                                34
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   FDA would NOT approve if we used ‘Weeks Pregnant’ in any materials and we

 2   are very likely to also confuse consumers and might end up with

 3   challenge/complaint.” J.A. 4384. Similarly, one of Defendant’s board members

 4   raised concerns at a board meeting about the digital display, and expressed that the

 5   Defendant “[n]eed[ed] to be clearer what this means i.e. from time of conception

 6   NOT LMP, we are Not saying what we are doing.” J.A. 6215.

 7         The district court also found that statements by Kristen Suarez, Clearblue’s

 8   Brand Manager, “suggest a deliberate attempt both to evade FDA limitations and

 9   convey a false message about the [P]roduct.” S.P.A. 24. For example, when

10   discussing promotional materials for CVS, Suarez stated that “we can’t actually

11   link together the weeks and pregnant in the way it was on the last couple. What

12   you can say is the only test that estimates weeks, or the only test that also estimates

13   weeks, then the consumer will see Pregnant 1-2 Weeks in the windows and put it

14   together.” J.A. 8554. In another email, in response to a suggestion that an

15   advertisement say “Find out how far along you are,” Suarez stated, “This is a

16   tricky one, but the FDA doesn’t actually want us to say that. I think it can be

17   phrased as a question . . . , or we need to use the ‘estimate weeks’ language.” J.A.

18   8989-90.

19         This evidence, together with other evidence noted by the district court,

20   S.P.A. 19-27, supports the district court’s finding that the Defendant, at least at the


                                                35
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   time the Launch Package, TV Commercial, and additional associated advertising

 2   were under development, intended to deceive the public into believing that the

 3   Product provides a measurement of weeks-pregnant consistent with the metric used

 4   by doctors. This evidence was sufficient to support a presumption of consumer

 5   confusion supporting a finding of implied falsity.

 6                       ii. The Revised Package

 7          Defendant also challenges the district court’s finding that the Revised

 8   Package was impliedly false. In the Revised Package, Defendant set forth more

 9   clearly that the Product measures weeks since ovulation. Among other things, the

10   Revised Package added the phrase “Only Test That Estimates Weeks Since

11   Ovulation*” (with the asterisk directing to the Indications for Use Statement on the

12   side) at the corner.9 The package also replaced the windows that said “Pregnant”

13   and “1-2 weeks,” “2-3 weeks,” or “3+ weeks” with windows that said “Pregnant”

14   and “1-2,” “2-3,” or “3+,” with the phrase “Weeks Along” placed below the

15   windows.

16          To support its finding of implied falsity, the district court relied, in part, on

17   the consumer surveys of Plaintiff’s expert witness, Hal Poret. With respect to the

18   Revised Package, “Poret concluded that 16.0% or 17.3% of participants. . .

     9
      The Indications for Use Statement on the side of the Revised Package (as well as the Launch
     Package) included an acknowledgement that doctors measure pregnancy from LMP, but did so in
     an inconspicuous manner, making it “unlikely to be noticed by consumers.” S.P.A. 31-32.



                                                 36
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   answered both that the [P]roduct estimates the number of weeks a woman is

 2   pregnant and that the [P]roduct’s estimate of weeks is the same as a doctor’s

 3   estimate of weeks-pregnant.” S.P.A. 36-37. The district court found this to be

 4   sufficient evidence of consumer confusion to support finding the Revised Package

 5   impliedly false.

 6         Defendant’s most forceful argument is that the Poret survey was flawed

 7   because the main survey questions at issue failed to test whether survey

 8   respondents were confused into thinking that the Product’s measurements were the

 9   same as a doctor’s because of the Product’s packaging or because of the survey

10   respondents’ preexisting erroneous beliefs about the way pregnancy is measured.

11         We agree that the consumer confusion revealed by the survey could have

12   been attributable to preexisting consumer ignorance about the conventional

13   medical practice of dating the beginning of pregnancy from LMP. Poret derived his

14   16.0% or 17.3% deception rate by looking at the number of survey respondents

15   who expressed the belief that the Product measures the number of weeks a woman

16   is pregnant and also answered that “the [P]roduct’s estimate of weeks is telling you

17   . . . [t]he same thing as when a doctor gives you an estimate of weeks.” J.A. 6680

18   (emphases omitted); see also J.A. 1576. A survey respondent might have given this

19   answer not because the Revised Package confused her into believing that the

20   Product provides the same measurement as provided by a doctor, but because she


                                                37
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   was already under the preexisting mistaken belief that a doctor measures

 2   pregnancy from the date of ovulation, rather than LMP, and, therefore, any product

 3   that purports to “Estimate[] Weeks Since Ovulation” would provide the same

 4   estimate as a doctor.

 5         However, in light of the ample evidence that Defendant was aware of this

 6   widespread consumer ignorance and took no effective steps to guard against

 7   misunderstanding of Defendant’s messages attributable to that ignorance, we find

 8   no error in the court’s use of the Poret survey. Considering the counterintuitive

 9   nature of the LMP pregnancy measurement used by doctors (which includes about

10   two weeks prior to ovulation, during which it is biologically impossible for a

11   woman to be pregnant), it must have been obvious to Defendant, a seasoned

12   manufacturer of home pregnancy tests, that many women are not aware that the

13   medical profession measures pregnancy as starting approximately two weeks prior

14   to ovulation and fertilization. The record demonstrates furthermore that Defendant

15   was in fact aware that most consumers do not understand the nature of ovulation

16   and its relation to pregnancy duration. For example, in an email exchange, Brand

17   Manager Suarez stated that “American women just aren’t that in tune” with the

18   concept of ovulation, that the concept “doesn’t really make sense to them,” and

19   that American women “don’t have a knowledge of the right days, poor

20   understanding of the details, etc. and it’s not common vernacular of how we would


                                                38
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   talk [sic] anything.” J.A. 4709-10. Similarly, a document summarizing a meeting

 2   involving Dr. Johnson, notes as an “[a]dditional discussion point[]” that the

 3   “[o]verall lack of consumers’ understanding of ovulation may cause confusion”

 4   and points to the “[n]eed to address the reason why [doctor]s use [a] different

 5   method.” J.A. 4506.

 6         Defendant misses the point in its argument that the court should not have

 7   relied on Poret’s survey because the survey failed to test for whether consumer

 8   confusion resulted from preexisting ignorance, rather than Defendant’s message.

 9   Widespread consumer ignorance as to how the medical profession measures the

10   advancement of a pregnancy was the fact—a fact that was known by the

11   Defendant. In the face of consumer ignorance as to how the medical profession

12   measures the advancement of a pregnancy, Defendant’s message that the Product

13   estimates weeks since ovulation did nothing to tell ignorant consumers that weeks

14   since ovulation is a different measurement from that used by doctors. It makes no

15   difference whether the widespread consumer ignorance predated the Defendant’s

16   Revised Package or was caused by it. The message of the Revised Package—that

17   the Product tells you the degree of advancement of your pregnancy in terms of

18   “weeks since ovulation”—implies a message that this is how the advancement of a

19   pregnancy is measured by medical professionals. The Revised Package did not

20   adequately communicate that its measurement was not consistent with the metric


                                                39
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   used by doctors. We therefore conclude that the evidence, including the Poret

 2   Survey, amply supported the district court’s finding of falsity.

 3                   b. Materiality and Injury

 4          Defendant contends the district court failed to make findings necessary to

 5   support the court’s conclusion that Defendant’s misrepresentations were material

 6   to Plaintiff’s claim. Defendant also contends that the district court failed to find a

 7   logical causal connection between any falsity in Defendant’s messages and injury

 8   to Plaintiff.

 9          Plaintiff and Defendant disagree about what exactly is required to satisfy the

10   materiality requirement for a Lanham Act false advertising claim. They agree that

11   for a false message to be material, the defendant must have at least

12   “misrepresented an inherent quality or characteristic of the product.” Merck

13   Eprova, 760 F.3d at 255. Defendant argues, however, that, according to our

14   precedents, there is an additional requirement that the deception be “likely to

15   influence [consumer] purchasing decisions,” citing NBA v. Motorola, Inc., 105

16   F.3d 841, 855 (2d Cir. 1997). Appellant’s Br. 52-53. The district court expressly

17   found that “[t]he Weeks Estimator’s ability to estimate weeks is, as the [P]roduct’s

18   name conveys, an inherent quality or characteristic of the [P]roduct as it is the key

19   feature that differentiates it from the many other home pregnancy tests on the

20   market.” S.P.A. 40. Defendant points out, however, that, in its discussion of the


                                                 40
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   materiality element, the court made no express finding that Defendant’s

 2   misrepresentation was likely to influence purchasing decisions.

 3          Although the essential elements of the materiality standard indeed appear to

 4   be somewhat unsettled in our circuit,10 we need not resolve the issue now. We

 5   assume for purposes of this ruling that a defendant’s false advertising is not

 6   material to a plaintiff’s Lanham Act claim unless that falsity had the capacity to

 7   adversely affect the plaintiff’s business by influencing consumer purchasing

 8   decisions. While the materiality of the falsity and the likelihood of injury to the

 9   plaintiff resulting from the defendant’s falsity are separate essential elements, in

10   many cases the evidence and the findings by the court that a plaintiff has been

11   injured or is likely to suffer injury will satisfy the materiality standard—especially

12   where the defendant and plaintiff are competitors in the same market and the

13   falsity of the defendant’s advertising is likely to lead consumers to prefer the

14   defendant’s product over the plaintiff’s. See Johnson & Johnson v. Carter-

15   Wallace, Inc., 631 F.2d 186, 190 (2d Cir. 1980) (In Lanham Act claims, the injury

16   “standard is whether it is likely that [defendant]’s advertising has caused or will

     10
        In NBA, we defined “material” as “an inherent quality or characteristic of the product.” 105
     F.3d at 855 (internal quotation marks omitted). In so doing, we cited three other circuits and a
     treatise, and included parentheticals for each citation that defined “material” as “likely to
     influence purchasing decisions.” Id. However, our post-NBA cases do not mention this “likely to
     influence purchasing decision” feature of the standard; they focus instead on the “inherent
     quality or characteristic” descriptor. See, e.g., Merck Eprova, 760 F.3d at 255; Time Warner
     Cable., 497 F.3d at 153 n.3; S.C. Johnson & Son, Inc. v. Clorox Co., 241 F.3d 232, 238 (2d Cir.
     2001).



                                                    41
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   cause a loss of [plaintiff’s] sales,” which can be established when defendant and

 2   plaintiff “are competitors in a relevant market” and plaintiff demonstrates a

 3   “logical causal connection between the alleged false advertising and its own sales

 4   position.”). In discussing the essential element of likelihood of harm to Plaintiff’s

 5   business resulting from Defendant’s false advertising, the district court expressly

 6   found that Plaintiff “lost sales on account of [Defendant’s] false advertising.”

 7   S.P.A. 45. The court concluded its discussion of likelihood of injury stating,

 8   “[Plaintiff] established a logical causal connection between [Defendant]’s false

 9   advertising and its market harm that is sufficient to establish [Defendant]’s liability

10   for false advertising under the Lanham Act.” Id.

11         In our view, the district court’s conclusion, although uttered in connection

12   with the element of likely injury, also constituted a finding that Defendant’s

13   misrepresentations were likely to influence purchasing decisions and were

14   therefore material to Plaintiff’s claim. If consumers, faced with the choice to

15   purchase either the plaintiff’s product or the defendant’s, are likely to prefer the

16   defendant’s product by reason of the defendant’s false advertising, the falsity of the

17   defendant’s advertising is material to the plaintiff’s Lanham Act claim.

18         The evidence furthermore amply supported the conclusion that the falsity of

19   Defendant’s advertising was both material and likely to cause injury to Plaintiff. It

20   is entirely reasonable to expect that, for a significant number of women interested


                                                42
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   in learning whether they are pregnant—especially those who have not previously

 2   been pregnant or are otherwise ignorant of the details of the reproductive cycle—

 3   the information that Defendant’s Product will tell them something different from

 4   what a doctor would provide would make them less likely to trust Defendant’s

 5   Product, and more likely to purchase from Plaintiff, Defendant’s closest

 6   competitor. The district court’s finding is further supported by the evidence that

 7   this was precisely the risk that motivated Defendant to avoid making clear to

 8   consumers that its Weeks Estimator gave information different from what a doctor

 9   would give.

10         We conclude that both the evidence and the district court’s findings, to the

11   effect that Plaintiff likely suffered a loss of sales by reason of Defendant’s false

12   advertising, adequately supported both the materiality element and the likely injury

13   element. With respect to the injury element, Defendant argues that the district

14   court’s reasoning was fallacious because the court relied in part on statistics

15   showing that Plaintiff’s share of the market decreased, while the Defendant’s share

16   increased upon Defendant’s introduction of the Product. Defendant argues that this

17   redistribution of consumer preference was attributable to the important new feature

18   Defendant was offering, and that there is no reason to attribute any diminution in

19   Plaintiff’s market share to the falsity of Defendant’s advertising. Even assuming,

20   however, that Defendant is correct in discrediting an aspect of the district court’s


                                                43
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1   reasoning, the district court’s finding that Plaintiff likely lost market share to

 2   Defendant attributable to the falsity of Defendant’s concealment was amply

 3   supported by the evidence, as explained above.11 Furthermore, as the trial was

 4   bifurcated, the district court went only so far as to find liability. The trial

 5   conducted did not encompass the issue of damages awardable to Plaintiff. At the

 6   liability stage, the Lanham Act “demands only proof providing a reasonable basis

 7   for the belief that the plaintiff is likely to be damaged as a result of the false

 8   advertising.” Johnson & Johnson, 631 F.2d at 190 (emphases added). We find no

 9   fault in the district court’s conclusion that Plaintiff suffered a likelihood of loss of

10   sales of its product, attributable to Defendant’s false concealment that its Product

11   gave information about the advancement of a pregnancy that was inconsistent with

12   the information that the medical profession would give.

13          Accordingly, we reject Defendant’s contention that the district court erred in

14   finding either the materiality of Defendant’s false advertising or the likelihood of

15   injury to Plaintiff’s sales resulting from Defendant’s false advertising.

16

17
     11
       Furthermore, “where . . . a plaintiff has met its burden of proving deliberate deception in the
     context of a two-player market, it is appropriate to utilize a presumption of injury.” Merck
     Eprova, 760 F.3d at 259. Defendant and Plaintiff are direct competitors in a sparsely populated
     market. Plaintiff has been the market leader, followed closely by Defendant. Other home
     pregnancy test brands (which are manufactured by a co-owner of Defendant) represent only a
     small portion of the market.



                                                     44
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1         III.   The Injunction

 2         Finally, Defendant contends the district court abused its discretion in

 3   fashioning an injunction that is excessively broad and unreasonably punitive.

 4         “It is axiomatic that the contours of an injunction are shaped by the sound

 5   discretion of the trial judge and, barring an abuse of that discretion, they will not be

 6   altered on appeal.” Merck Eprova, 760 F.3d at 265. At the same time, injunctive

 7   relief should be “no broader than necessary to cure the effects of the harm caused

 8   by the violation,” Forschner Group, Inc. v. Arrow Trading Co., 124 F.3d 402, 406

 9   (2d Cir. 1997), and “should not impose unnecessary burdens on lawful activity,”

10   Patsy’s Brand, Inc. v. I.O.B. Realty, Inc., 317 F.3d 209, 220 (2d Cir. 2003).

11         Defendant argues first that the injunction’s prohibition of further use of the

12   advertising Defendant devised for the Revised Package was abusive because the

13   court’s findings never explicitly focused on the contents of this advertising, finding

14   it to be false. We reject the contention. Even if the district court did not explicitly

15   focus on the wording of this advertising in its express findings of falsity, the

16   advertising had the same capacity to mislead as the Revised Package materials that

17   the district court extensively discussed. There is no doubt the district court

18   intended its discussion of the misleading aspects of the Revised Package to refer to

19   the associated advertising as well.




                                                45
     15-2411-cv
     Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH

 1         Defendant contends further that the injunction terms were excessively harsh

 2   in that they require Defendant to distribute corrective notices that expressly

 3   acknowledge that the court found Defendant to have engaged in false and

 4   misleading advertising. We disagree. Especially in view of the district court’s

 5   findings that Defendant was intentionally deceptive in its advertising, we cannot

 6   say that the relief ordered by the district court went beyond curing the effects of the

 7   harm caused by Defendant’s falsity.

 8         Finally, Defendant contends that the court abused its discretion in the

 9   sweeping scope of the relief it ordered, especially in view of such factors as the

10   relatively brief time the public was exposed to the deceptive materials and the time

11   passed since their withdrawal. Although Defendant’s argument is not

12   unreasonable, and less intrusive requirements might well have sufficed, we cannot

13   say the court’s orders constituted an abuse of the court’s wide discretion to fashion

14   the terms of injunctive relief.

15         We have considered Defendant’s other arguments, and find them to be

16   without merit.

17                                      CONCLUSION

18         The judgment of the district court is hereby AFFIRMED.




                                                46
