Food and Drug Administration regulations do not prevent Church & Dwight Co. from bringing a false advertising suit against SPD Swiss Precision Diagnostics GmbH in connection with the company’s Clearblue home pregnancy tests, a federal court judge in New York recently held.

In 2013, SPD launched a new line of Clearblue pregnancy tests with a “Weeks Estimator.” In addition to informing a woman if she was pregnant, the test was designed to estimate the number of weeks that had passed since she last ovulated. According to Church & Dwight, the name of the product line itself – “Advanced Pregnancy Test With Weeks Estimator” – was deceptive, as were the graphics that informed a user “Pregnant 1-2 Weeks,” “Pregnant 2-3 Weeks,” or “Pregnant 3+ Weeks.” Also deceptive were statements in television ads like “It’s like two tests in one!” and similar representations made by SPD on its Web site, in point of purchase and retail advertising, and in a press release announcing the product.

According to C&D, the claims communicated to women that the Weeks Estimator can inform them how many weeks they have been pregnant, based on their last day of ovulation. But the medical profession does not measure pregnancy by reference to the time of ovulation, C&D argued. Instead, the measurement is based on the “universally accepted convention” that pregnancy begins at the time of the woman’s last menstrual period, typically two weeks prior to ovulation. In addition to the factual falsity, C&D said SPD overstated in its press release the accuracy of its product as “approximately 93 percent accurate” when the package insert pegged the range between 45 to 99 percent.

SPD moved to dismiss the suit on preemption grounds, pointing to FDA regulations, the Food, Drug, and Cosmetic Act, and the FDA’s Clearance Letter for the product line, which demanded certain requirements of the product packaging and labeling.

But U.S. District Court Judge Alison J. Nathan said “a close reading” of the complaint did not involve the direct application of the FDA’s regulation.

She concluded that C&D asked the court to decide whether the Weeks Estimator marketing conveyed to consumers a misleading message about the duration of pregnancy, a task that does not require the court “to interpret, apply, or enforce the FDCA, the FDA’s regulations, or the Clearance Letter.”

“On this view of C&D’s complaint, its claims are directed at the simple factual falsity of SPD’s marketing of the Weeks Estimator,” the court wrote. “In that case, the court’s task in adjudicating C&D’s claims would be essentially two-fold: determine the message conveyed to consumers by SPD’s marketing and then determine whether that message is either literally false or likely to mislead and confuse consumers.”

The fact that the FDA regulates in an area does not inevitably lead to preclusion, Judge Nathan noted. “[T]he mere facts that C&D’s complaint cites actions taken by the FDA and that the FDA has some authority to act in this area do not counsel in favor of applying preclusion.”

Assessing the potential consumer confusion fell squarely within its jurisdiction, the court concluded.

To read the opinion in Church & Dwight Co. Inc. v. SPD Swiss Precision Diagnostics, click here.

Why it matters: The decision indicates that pre-emption may not always serve as a defense in matters that the FDA has promulgated regulations. The court engaged in a detailed analysis of FDCA preclusion as well as the doctrine of primary jurisdiction, finding that neither applied to C&D’s claims against SPD. Judge Nathan recognized that the preemption issue “does not lend itself to a simple application,” and noted that while dismissal was inappropriate, the questions raised by the preclusion analysis “are often fact-intensive, and are frequently resolved after the pleading stage,” so that SPD might be able “to re-raise this argument at a later stage, if appropriate given the development of the proceedings.”