Church & Dwight Co., Inc. v. SPD Swiss Precision Diagnostics, GmbH
843 F.3d 48
2d Cir.2016Background
- Church & Dwight (First Response) sued SPD Swiss Precision Diagnostics (Clearblue) under the Lanham Act after Clearblue launched an over‑the‑counter pregnancy test that, in addition to detecting hCG, displayed an estimated number of weeks since ovulation ("Weeks Estimator").
- Medical convention expresses pregnancy duration in weeks since last menstrual period (LMP), which is ~2 weeks earlier than ovulation; Clearblue’s estimator reports weeks since ovulation and therefore yields numbers ~2 weeks lower than a doctor’s LMP‑based statement.
- FDA cleared the device via the §510(k) process but warned the weeks feature could mislead consumers and required labeling changes (e.g., specifying results as weeks since ovulation and including a conversion chart and Indications for Use statement).
- Clearblue’s Launch Package and advertising prominently used “weeks” language and sample displays (e.g., “Pregnant / 1-2 weeks”) without conspicuous notice that the measure was since ovulation. The FDA objected and Clearblue revised packaging and advertising (Revised Package) to add limited disclosures (e.g., "Estimates Weeks Since Ovulation*" with an asterisk to side text).
- The district court held a bench trial, found both the Launch and Revised materials conveyed a false message (literally or impliedly) that Clearblue estimated weeks in the same way doctors do, found the misrepresentations material and likely to harm Church & Dwight, and entered a permanent injunction requiring corrective notices and restrictive changes to Clearblue’s packaging and advertising.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDCA/FDA clearance precludes a Lanham Act suit | P&G: FDA clearance doesn’t preclude competitor Lanham Act claims; statutes serve distinct purposes | SPD: FDA review/clearance immunizes its labeling from Lanham Act claims | Court: Not precluded; POM Wonderful controls—FDCA/FDA requirements are a floor, not a ceiling |
| Literal falsity of Launch Package/ads | Launch materials unambiguously implied the Product reports weeks the same way doctors do | SPD: Messages are ambiguous; a reasonable consumer could read “weeks” as since ovulation | Court: Launch materials were literally false by necessary implication and also impliedly false |
| Implied falsity of Revised Package (survey evidence) | Plaintiff: Even with "since ovulation" text, consumers (per survey) remained confused; packaging failed to correct widespread ignorance | SPD: Survey flawed — confusion may reflect preexisting consumer ignorance, not packaging | Court: Survey plus evidence SPD knew consumers were ignorant sufficed to show implied falsity of Revised Package |
| Materiality, injury, and scope of injunction | P&G: Weeks feature is an inherent, purchase‑relevant characteristic; false messaging likely caused lost sales; broad corrective relief warranted | SPD: Misrepresentations not shown to influence purchasing; injunction overbroad and punitive | Court: Falsity was material and likely caused injury (competitors in same market); injunction within district court’s discretion |
Key Cases Cited
- POM Wonderful LLC v. Coca‑Cola Co., 134 S. Ct. 2228 (2014) (Lanham Act claims against label are not categorically precluded by FDCA/FDA regulation)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (impossibility preemption where generic manufacturers must match FDA‑approved labeling)
- Merck Eprova AG v. Gnosis S.p.A., 760 F.3d 247 (2d Cir. 2014) (standards for Lanham Act falsity, materiality, and injunction review)
- Time Warner Cable, Inc. v. DIRECTV, Inc., 497 F.3d 144 (2d Cir. 2007) (literal falsity by necessary implication; implied falsity standards)
- Tiffany (NJ) Inc. v. eBay Inc., 600 F.3d 93 (2d Cir. 2010) (relief for literal falsity may be granted without proof of consumer confusion)
- Johnson & Johnson v. Carter‑Wallace, Inc., 631 F.2d 186 (2d Cir. 1980) (materiality and logical causal connection between false advertising and competitor injury)