Monday, March 22, 2010

Burn notice: dueling sunscreen ads found false

Schering-Plough Healthcare Products, Inc. v. Neutrogena Corp., --- F.Supp.2d ----, 2010 WL 960635 (D. Del.)

Earlier ruling. Plaintiff (Coppertone for convenience) makes Coppertone Sport sunscreen, introduced in 1992, and defendant makes Neutrogena Ultimate Sport sunscreen, introduced in late 2008 and first advertised in 2009. There were false advertising claims and counterclaims; both prevailed in part.

The parties disagreed about whether a sunscreen’s ability to protect against UVA rays is subsumed within the SPF measurement, which definitely measures UVB protection. Another measurement, protection factor A (PFA), can be used to quantify protection against UVA rays.

Coppertone challenged a Neutrogena Ultimate Sport ad, “best line of sport sun protection,” claiming superiority based on “average” combined SPF and UVA scores across the parties’ sport product lines, which compared Neutrogena and Coppertone Sport with the phrase “Best average UVA/UVB protection vs. leading sport lines” next to a chart.

The big problem, in my opinion, was that Coppertone’s line included SPF 15 to SPF 70 products, whereas Neutrogena’s line began at SPF 55, leading to very different averages. The other problems were, Coppertone alleged, that Neutrogena double-counted UVA, since it was already measured by the PFA test, and because Neutrogena’s PFA testing wasn’t sufficient to support the “best line of sun protection” claim.

The court found that the bar graphs constituted an implied establishment claim: a signal that numerical values for UVA and SPF were “derived from some manner of product testing.” Neither party presented the court with enough evidence to analyze Neutrogena’s PFA testing, so the court found that Coppertone hadn’t met its burden to show that the tests were inappropriate/unreliable. Thus, notwithstanding “obvious deficiencies” in Neutrogena’s substantiation, this claim failed. This result is a good reminder that even when an establishment claim is challenged, the plaintiff has the burden of proof on something: to cast sufficient doubt on the quality or relevance of defendant’s studies.

On the motion for preliminary injunction, the court had refused to find literal falsity for the differentials between the combined SPF and UVA bars. Coppertone offers products from SPF 15-SPF 70, average 38.5; Neutrogena offers SPF 55-SPF 70, average 64; and the difference across the lines is 40%. Because the SPF portion of the bars in the ad differed by about 40%, there was no literal falsehood. Likewise, the PFA scores across the entire product lines were approximately correct, showing a near 100% difference in relative heights based on a 30.2 average for Neutrogena and 16.7 for Coppertone.

However, the court found that the bar graph was misleading in other ways. First, using UVA and SPF as separate measures of protection. UVA is a kind of ultraviolet light, not a measurement of skin protection. Neutrogena argued that there was nothing false about using PFA scores to make UVA claims, but Neutrogena didn’t use PFA scores to draw its comparison. Instead, it stacked a UVA value on top of a SPF value. On the motion for preliminary injunction, the court had found that this was an ambiguous message, not unambigously double-counting.

After trial, the court found literal falsity. Due to the predominance of UVB in SPF measurements, SPF is commonly understood to refer to UVB, and the FDA has issued a statement to this effect. But at least 10% of SPF correlates to UVA. The ad is literally false because it provides a separate UVA quantification which is “neither an accurate description of protection nor completely independent of the SPF value.” It conveys, by using different labels, that UVA and SPF are different measurements, and this is “indisputably not so.” Though Coppertone and Neutrogena were both treated the same, the “absence of bias” caused by the double-counting doesn’t eliminate the falsity.

The core of the implied falsity argument was that consumers perceive the ad (which was labeled with brand names, not SPF numbers) to reflect an “apples-to-apples comparison of similarly-labeled sunblocks”—Neutrogena SPF 70k to Coppertone SPF 70k, for example, while in fact the comparison is an average and the number of products compared isn’t disclosed. (I would have been willing to find this message conveyed by necessary implication. It doesn’t make sense to compare one brand’s SPF 35 product to another’s SPF 20—even accepting, as a commenter on my earlier post pointed out, that above a certain level all sunblocks provide the same protection; in fact that position makes the ad even more dubious.)

But because the court saw this message as one conveyed only by implication, Coppertone had to prove consumer reception. Coppertone offered a survey conducted by Gary Ford, who concluded that “consumers perceive that they can get greater protection ... and/or durability from Neutrogena than Coppertone after seeing [the Best line ad].” He found a 24% difference between test and control groups. But his testimony was brief and summary-level, and Coppertone redacted the details, apparently in response to Neutrogena’s pretrial objection; thus the court found that Coppertone hadn’t met its burden to prove actual deception.

The counterclaim dealt with a Coppertone Sport ad showing athletes running in the ocean, applying sunscreen, then running/swimming/biking. The voiceover says, “You give your sport 100%--so should your sunscreen. Coppertone Sport® spray and Neutrogena spray provide the same amount of sun protection. Coppertone Sport® gives you better coverage. Waterproof, sweatproof--Coppertone Sport®--100%.” “Better coverage” accompanies an image in which a Coppertone spray user is depicted covered by blue shading, while a Neutrogena spray user is covered by slightly lighter blue shading. Text at the bottom says, “Simulated coverage study results. Among sprays with comparable SPF.” One version of the ad also had a visual where the Coppertone user was labeled “100% sunscreen formula” and the Neutrogena user “28% chemical propellant,” with a voiceover to the same effect.

The court agreed that “better coverage” was an establishment claim not supported by sufficiently reliable tests. To date, Coppertone hasn’t performed an in vivo coverage study on either spray featured in the ad, though it has tested other non-sport-branded products. In that earlier test, Coppertone Ultra-Guard outperformed Neutrogena Fresh Cooling Mist only in density, and there was testimony that density alone provides better coverage, as well as corroborating in vitro evidence.

The court disapproved of running a head-to-head comparative ad without testing the actual products. Coppertone argued that its in vivo study showed that its method of delivery provided better coverage than Neutrogena’s aerosol, regardless of formulation. The court found this conclusion “too sweeping” to be based on a comparison of just one of each party’s products. Neutrogena’s sport spray has a different formulation and different orifice size for its aerosol can than its Fresh Cooling Mist. A J&J scientist (Neutrogena’s parent company) testified that these specific formulation differences made extrapolation of test results impossible, and a consultant with experience in aerosol design made the same point about ingredients and orifice design.

Though they didn’t detail how these differences affected performance or substantiate the claim with scientific evidence, Coppertone’s witness admitted that they might produce different results in vivo. Coppertone’s director of packaging said that there were “too many other factors” to “categorically” state that a small orifice results in a particular spray. The court found this convincing as comporting with the “generally-accepted scientific principle that compositions of different molecular weights tend to have different properties. In this context, some differences in the formed aerosol droplets and their trajectories appear to be more likely than not.”

Even testing the right products, the in vivo test was insufficiently reliable to support a coverage claim. The test had no specific goals for substantiation; it looked at density, evenness and thoroughness, and Coppertone chose density after the fact when that was where Coppertone prevailed. But density doesn’t equal “coverage.” Ultimately, Coppertone used a non-standard protocol (there is no standard one) with no particular goal in mind, and the analysis “was driven by the results obtained by the tests.” (In a footnote, the court stated that it didn’t want to discourage novel protocols; the issue here was not novelty but overall unreliability, “a portion of which” is attributable to the lack of protocol or cited industry support for Coppertone’s methods.)

Given the differences between the products tested and the products in the ad, there was no “true scientific basis” for attributing the Neutrogena Fresh Cooling Mist data to Neutrogena Ultimate Sport. Coppertone “elected not to test the competitive product at the heart of its advertisement and, instead, superimposed data from an in vivo test of another competitive product into its commercial. This type of unsubstantiated ‘scientific’ claim is precisely what the Lanham Act seeks to prevent.”

The court also addressed the “28% chemical propellant” statement in one version of the ad. The court found that the “ultimate import” of the ad was that the Neutrogena sunscreen “as applied on the athlete” was 28% propellant. This was undisputedly false: though the can is 28% propellant by weight, that primarily evaporates when the aerosol is used. The ad “contrasts two sunscreens, not two cans or delivery methods.” The visual—overlaying the words “Neutrogena” and “28% propellant” on the bare chest of an athlete—reinforces the message that 28% is applied to the body. There was no qualifying statement or other clarifying language. This was a literally false message, unambiguously conveyed by necessary implication.

In conclusion, the court commented that these ads were “essentially meaningless and, therefore, of no help to the consuming public who, finally, is paying attention to the health concerns presented by overexposure to the sun.” The consumer was the real loser.

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