Clearblue Test Maker Must Change Advertising

     (CN) — The maker of an over-the-counter pregnancy test must change advertisements that falsely claim its method for determining length of pregnancy comports with generally accepted science, the Second Circuit ruled on Friday.
     SPD Swiss Precision Diagnostics GmbH began selling its Clearblue Advanced with Weeks Estimator pregnancy test in 2013.
     Like other pregnancy tests, the FDA-approved product determines pregnancy by detecting the presence of chorionic gonadotropin in the test taker’s urine.
     Chorionic gonadotropin is a hormone that is created when a fertilized egg is implanted in a woman’s uterus.
     But unlike most pregnancy tests, Clearblue determines the number of weeks a woman is into her pregnancy based on the date of her most recent ovulation not on her last menstrual period, the medical industry standard.
     Despite the difference, SPD maintained Clearblue uses the metric relied on by doctors to estimate weeks-pregnant.
     Church & Dwight Co. Inc., manufacturer of the competing First Response pregnancy test, challenged SPD’s claims in Manhattan Federal Court.
     The court ruled in Church & Dwight’s favor, and enjoined SPD from advertising that Clearblue gives doctors’ estimates of how many “weeks pregnant” a woman is, and ordered it to include a statement in its packaging, advertisements, YouTube videos, and on its website, clarifying the difference.
     SPD appealed, but the Second Circuit affirmed the lower court ruling, holding that it rightly concluded the language used in the company’s Clearblue marketing materials was false.
     “The district court found that the medical profession has a ‘standard — indeed universal — convention for expressing pregnancy duration,'” Judge Pierre Leval wrote for the three-judge panel. “It was undisputed that defendant’s product does not utilize the medical profession’s standard, universal convention.”
     The panel found that the “crucial point is that a reasonable consumer would have assumed from the text of the launch package, TV commercial, and other associated advertising that the product was not giving a different number than a medical professional would give. The district court concluded that message was false. We can see no error in the court’s reasoning.”
     The same goes for the revised packaging, according to the ruling.
     “Widespread consumer ignorance as to how the medical profession measures the advancement of a pregnancy was the fact—a fact that was known by the defendant,” Leval wrote. “In the face of consumer ignorance as to how the medical profession measures the advancement of a pregnancy, defendant’s message that the product estimates weeks since ovulation did nothing to tell ignorant consumers that weeks since ovulation is a different measurement from that used by doctors.”
     Indeed, “it makes no difference whether the widespread consumer ignorance predated the defendant’s revised package or was caused by it,” the ruling continues. “The message of the revised package—that the product tells you the degree of advancement of your pregnancy in terms of ‘weeks since ovulation’—implies a message that this is how the advancement of a pregnancy is measured by medical professionals. The revised package did not adequately communicate that its measurement was not consistent with the metric used by doctors.”
     Attorneys for SPD Swiss with Goodwin Procter in Boston, Kramer Levin Naftalis & Frankel in New York, and Coblentz Patch Duffy & Bass in San Francisco did not respond to requests for comment over the weekend.
     Nor did Church & Dwight’s attorneys with Proskauer Rose in New York.

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