False Advertising Claim Not Precluded by FFDCA
The 2nd Circuit Court of Appeals has ruled that a Lanham Act false advertising claim brought by Church & Dwight against Swiss Precision Diagnostics (SPD) over its Clearblue Advanced Pregnancy Test with Weeks Estimator is not precluded by the Federal Food, Drug, and Cosmetic Act (FFDCA). Church & Dwight claimed that the packaging and advertising for Clearblue communicated the false message that the product used the same metric and gave information about the same number of weeks of pregnancy as would be provided by a medical professional, according to a blog post by attorney Sandra Edelman (Dorsey & Whitney).
The court ruled that SPD deliberately intended to deceive consumers into believing that the Clearblue products would provide a measure of weeks pregnant consistent with what doctors provide, and held the company liable for false advertising under several different theories.
The first issue the appeals court addressed, Edelman says, was whether the Supreme Court 2014 decision in POM Wonderful applied to a home pregnancy test that is classified as a Class 2 medical device by FDA. That decision held that Lanham Act false advertising claims asserted against juice beverage products were not precluded by the FFDCA because the two federal laws were complementary.
The appeals court said that the POM Wonderful decision was controlling in this instance even though there are material differences in the way FDA regulates beverages and home pregnancy tests. FDA granted the SPD test 510(k) clearance after the company changed the product’s labeling to resolve FDA concern that the “weeks” indicator feature could provide misleading information to users.
SPD argued in its appeal that POM Wonderful should not apply because of the more intensive premarket approval regulatory process applicable to home pregnancy tests and because FDA had cleared its product with specific instructions on how it should be marketed. But the court said that “the fact that FDA has satisfied itself that a product’s labeling is sufficiently accurate to secure FDA approval gives no assurance that the intervention of a competitor would not reveal problematic misleading messaging that is harmful to the competitor’s interest, which the federal agency either overlooked or failed to appreciate as important.”