Protect your skin from false claims

Kennedy Industries, Inc. v. Aparo, 2005 WL 3752270 (E.D.Pa.)

Plaintiff sells skin protection and skin cream for wrestlers; its product protects skin from chafing and the FDA has determined that its main ingredient is safe as a skin protectant. Defendant Driving Force (Aparo is its president) sells competing products under the brand “99.”
Plaintiff sued defendant and several distributors for false advertising under the Lanham Act.

At various times, Driving Force has claimed, among other things, that 99 kills 99.99% of harmful bacteria on contact; kills 99.9% of disease-causing germs, including the scary VRE and MRSA; provides up to four hours of protection from the above; is more effective than alcohol-based products; exceeds the U.S. FDA protocols required for classification as a Health Care Personnel Hand Wash and as a First-Aid Antiseptic; rapidly sanitizes skin with a broad-spectrum kill that prevents the development of resistant germs; is safe to use in any environment; maintains skin integrity and cleanses more effectively; is fully FDA compliant; has a two year shelf life; and is specifically designed and developed for the wrestling community.

Driving Force attacked plaintiff directly in comparative advertising, stating “Kill or be Killed” and offering a graphic comparison:

	99	Kennedy Skin Protectant
Kills Ringworm	YES	NO
Kills Impetigo	YES	NO
Kills Staph	YES	NO
Kills Strep	YES	NO
Kills E-Coli	YES	NO
Kills 99.9% of harmful bacteria	YES	NO
Kills Athlete’s Foot	YES	NO
Kills Planter’s [sic] warts	YES	NO
Hours of Kill Power	YES	NO

Plaintiff’s experts, a dermatologist and an organic chemist, opined that all these claims (and more) were false and without scientific basis. The court credited their testimony. For example, there are many strains of bateria, and only a few had been tested with any product containing 99’s active ingredient, benzethonium chloride. Driving Force doesn’t manufacture 99 and never had it tested to determine its exact chemical composition (and doesn’t even know what other ingredients it has!). Thus, it doesn’t know how the other ingredients interact with the active ingredient. Moreover, the tests on which Driving Force relied were mostly in vitro, not in vivo. In sum, no evidence supports Driving Force’s claims.

In addition, the FDA has not approved benzethonium chloride as a skin protectant, but rather lists it as a substance not shown to be safe and effective as a skin protectant and antifungal.

The court appears to be treating most of the claims as necessarily implied establishment claims, which makes sense, as consumers are likely to believe that tests support medical/percentage claims of this sort, and possibly that the FDA has approved such claims. (The "special formulation for wrestlers" claim is not like the others, but that was shown to be false, too, since it was just a general product relabeled for wrestlers.) Alternatively, the court invoked the doctrine of Novartis Consumer Health v. Johnson & Johnson-Merck Consumer Pharm. Co., 290 F.3d 578 (3d Cir.2002), that completely unsubstantiated claims are literally false.

Driving Force "recognized reality" and said that it would discontinue many of these claims, but the court found that it was still making them in its catalogs and other advertising. It sent out new ad materials to distributors but didn't recall old, falsely labeled product or tell its distributors to stop making the false claims, which many of them continued to do. Plaintiff, which had been driven out of the market by its inability to compete with the miracles promised by 99, convinced the court that it would reenter if guaranteed a "level mat." (The opinion has other wrestling references, but I'll omit them out of kindness.) Thus, a permanent injunction was warranted.

Comment: In recent years, “falsity by lack of any evidence” has joined “falsity by necessary implication” as a way of decreasing the burden on plaintiffs challenging shady ad claims. The reckless claims here – which implicate public health – illustrate why courts are attracted to such doctrines.

As of Feb. 14, 2006, at least one site was still advertising that Driving Force’s 99 Antimicrobial Skin Sanitizer “is the only product specifically formulated for grapplers that actually kills harmful bacteria on contact.” The claims Driving Force makes for its 99 line on its site are now substantially more limited:

- Non-greasy
- No Alcohol Formulation - no sting!
- Non-aerosol can; safe for travel
- Non-Flammable
- Dye and Fragrance Free

A far cry from preventing VRE!