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Media Alerts - Church & Dwight Co., Inc., v. SPD Swiss Precision Diagnostics, GmbH - Second Circuit
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September 16, 2016
  Church & Dwight Co., Inc., v. SPD Swiss Precision Diagnostics, GmbH - Second Circuit
Headline: Second Circuit Affirms False Advertising Ruling Against Maker of Clearblue "Weeks Estimator" Pregnancy Test

Area of Law: Advertising Law

Issue(s) Presented: Whether, given that the Clearblue "Weeks Estimator" pregnancy test used a different measurement metric than the metric used by doctors, its packaging and advertising were implicitly false.

Brief Summary: In 2013, the manufacturer of the Clearblue pregnancy tests launched a new product: the Clearblue Pregnancy Test with Weeks Estimator. This was the first pregnancy test that not only measured whether or not a woman was pregnant (based on the presence of a hormone in her urine), but also indicated how many weeks she had been pregnant (based on the amount of that hormone). However, the way in which the test dated the pregnancy differed from the commonly-used metric used by doctors. The medical profession dates a pregnancy based on the number of weeks since a woman's last menstrual period. The Clearblue Weeks Estimator test, by contrast, dates it based on weeks since ovulation. Accordingly, the Clearblue Weeks Estimator test generally produces a "weeks pregnant" number that is approximately two weeks less than the number a doctor would provide (since ovulation, on average, occurs two weeks after the start of a menstrual period).

The makers of First Response pregnancy tests (Clearblue's main competitor) brought suit in the United States District Court for the Southern District of New York, alleging that the manufacturer of the Clearblue "Weeks Estimator" test had engaged in false advertising because its materials implied that Clearblue was using the same metric as that used by doctors, boosting its sales. The district court found the defendant liable for false advertising, enjoined defendant from distributing the misleading materials and from using specified phrases, and ordered it to take corrective measures. The Second Circuit affirmed, explaining that the product's "Launch Package, TV Commercial, and other advertising all unambiguously implied the false message that the Product provides a measurement of weeks-pregnant that is consistent with the measurement a doctor would provide."

To read the full decision, please visit:
http://www.ca2.uscourts.gov/de...0b7c5cd707e/5/hilite/
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B]Extended Summary: The Second Circuit affirmed a decision of the United States District Court for the Southern District of New York which found Defendant-Appellant liable for false advertising and issued a permanent injunction regarding its advertising and packaging of one of their pregnancy tests.

For historical and practical reasons, doctors have always dated a woman's pregnancy from her last menstrual period. This method - despite the fact that a woman's egg is not actually fertilized until she ovulates approximately two weeks later - is widely used and remains the standard convention for expressing pregnancy duration. In 2013, the manufacturer of Clearblue pregnancy tests launched a product using an alternate pregnancy-dating method. This product, named the "Clearblue Pregnancy Test with Weeks Estimator," measures how many weeks a woman has been pregnant since ovulation. The test calculates this by measuring the amount of hCG (the hormone human chorionic gonadotropin) in a woman's urine; this hormone is released once the fertilized egg implants in the uterine lining.

Plaintiff-Appellee, Church & Dwight Co., Inc., is the manufacturer of a different test, the "First Response Pregnancy Test," which is Clearblue's direct competitor in the home-pregnancy test market. Plaintiff brought a false advertising suit against the defendant, alleging that defendant's product "communicated the false impression that it uses the same metric and gives the same number of weeks of pregnancy as a medical professional would do," and that this false impression boosted the product's sales, at the expense of plaintiff's competing product.

The defendant lost in the district court, and appealed. First, defendant raised the argument that since it had obtained FDA approval on their packaging and satisfied the requirements of the Federal Food, Drug and Cosmetic Act, it should be protected from liability under a false advertising claim based on the Lanham Act.. The Second Circuit, however, explained that the Lanham Act and the FDCA actually complement each other because the Lanham Act's mission is to protect the concerns of a competitor harmed by false advertising while the FDCA protects public health and safety.

On the substance of the false advertising claim, the Second Circuit affirmed the ruling that the advertising and packaging for the "Weeks Estimator" product was impliedly false. The court held that "if an advertising message means something different from what reasonable consumers would understand it to mean, that message can be considered false." Here, the court concluded that reasonable consumers would have assumed from the various advertising materials that the product was not giving a different number than a medical professional would give - when, in fact, it was. The initial launch package "did not indicate in any visible or clear way that the Product provides a different measurement from a doctor's." Even after the defendant revised its original packaging and advertising because the FDA had expressed concerns over the use of "weeks" language, confusion to a reasonable consumer still existed. The revised version of the "Weeks Estimator" test specifically included the language "Weeks Since Ovulation," but that did not resolve confusion, because "many women are not aware that the medical profession measures pregnancy as starting approximately two weeks prior to ovulation and fertilization." The court stated that even if the confusion were attributable to widespread consumer ignorance on how a doctor measures pregnancy, the defendant still should have "adequately communicat[d] that its measurement was not consistent with the metric used by doctors."

Finally, because Defendant's product advertised such a unique characteristic, this misrepresentation influenced consumers' purchasing decisions. This false advertising was found to have a direct causal connection with Plaintiff's lost sales.
The broad injunction entered by the district court was also affirmed by the Second Circuit. The terms of the injunction, among other things, direct the Defendant to remove all current products from points of sale within forty-five days, deliver within seven days to all retailers and distributors a specified written notice with a copy of the injunction, set up and maintain for a year a page on its website with a message about the lawsuit, publish internet advertising prominently displaying its logo and stating that a federal court has determined they engaged in false advertising, among other severe punishments.

To read the full decision, please visit:
http://www.ca2.uscourts.gov/de...0b7c5cd707e/5/hilite/

Panel: Circuit Judges Leval and Wesley; District Judge Sannes, sitting by designation

Argument Date:
03/11/2016

Date of Issued Opinion: 09/09/2016

Docket Number: No. 15-2411

Decided: Affirmed

Case Alert Author: Eve I. Lincoln

Counsel: Paul D. Clement, Bancroft PLLC, for Plaintiff-Appellee and Seth P. Waxman, Wilmer Cutler Pickering Hale and Dorr LLP, for Defendant-Appellant

Author of Opinion: Judge Leval

Circuit: 2nd Circuit

Case Alert Circuit Supervisor:
Professor Emily Gold Waldman

    Posted By: Elyse Diamond @ 09/16/2016 09:39 AM     2nd Circuit  

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