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Legal Review: Legal Advice Clinically Proven to Reduce Lawsuits by Up to 36%

1 Jun, 2011 By: Gregory J. Sater Response

Your results may vary. It is possible that as a result of reading this column, lawsuits filed against you may go up by 93%. Have a nice day.

You’ve seen the ads. They say that their product has been "proven," "demonstrated," or "shown" to do "X." Some may not use those words, but instead present statistics or percentages that, perhaps, convey essentially the same thing, i.e., that rigorous scientific testing was done. Think: "This product reduces that problem by up to 36 percent."

Recent class action cases, competitor-vs.-competitor lawsuits and Federal Trade Commission (FTC) enforcement actions serve as a reminder that such claims — known as "establishment claims" because they convey that the claimed product benefit has been "established" by competent and reliable scientific testing — require great care.

Consider recent ad campaigns for "toning shoes" and the class actions they’ve spawned. Reebok advertised its toning shoe as "proven to tone your hamstrings, calves and butt up to 28-percent more." It was sued in multiple states in multiple class actions. New Balance advertised that its shoe could produce "16-percent more activation to the gluteus and hamstring muscles, 14-percent more activation to the calves, and 10-percent greater calorie burning." It was sued too.

Want an example from the world of competitor-vs.-competitor litigation? There’s a case now pending between Hanson, which sells Monster energy drink, and a competitor, VPX, which sells a drink called "Redline Power Rush! 7-Hour Energy Boost." Hanson alleges that by using "7-Hour" in its name, VPX is making an establishment claim by conveying that its boost is proven to last that long. (So far, the judge has ruled that using the figure "7-Hour" does not rise to the level of making an establishment claim because VPX hasn’t used the word "proven" or the like.)

Why such a battle over whether a claim is an "establishment claim"? Because it can make a huge difference in court! If the "7-Hour" claim is not an establishment claim then, as the challenger, Hanson has the burden of proof to present affirmative evidence to prove VPX’s claim isn’t true. If it is an establishment claim, then all that Hanson needs to do is effectively attack the testing that was done by VPX and prove that the marketer’s testing wasn’t scientific enough. As one federal court has noted: "(P)roving the falsity of a fact asserted in an advertising claim may be more difficult than merely proving that a test asserted to validate the claim is not sufficiently reliable to do so." (C.B. Fleet Co. v. SmithKline Beecham, 1997).

The FTC is active in this area, too. Recently, the FTC has gone after POM Wonderful for establishment claims made for its pomegranate drinks including, "backed by $25 million in medical research" "30-percent decrease in arterial plaque" and "17-percent improved blood flow" and against Dannon for establishment claims made for its yogurt and dairy drinks, for the regulation of the human digestive system, including claims of "clinically proven."

You need a "reasonable basis" for any kind of advertising claim; but if in your ad you’re going to convey that you have a particular level of substantiation, or you’re going to say or imply that certain results have been "shown," you are well advised to make sure you have at least that level of substantiation and, with regard to any testing, that you have experts in the relevant scientific field who agree with you that the testing you’ve got is competent and reliable.

The FTC defines "competent and reliable scientific evidence" as being a test or study that is based on the expertise of professionals in the relevant area, conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. Depending on what’s being tested, under FTC standards that may mean having a placebo or control group, rather than just a test group, and it may mean having a "double-blind" format where both the scientists directly involved with the study subjects and the study subjects themselves are unaware of which is the test product and which is the placebo. It also usually means that the sample size has to be big enough to provide results that have both statistical power and statistical significance.

Consultation with a competent attorney and, as appropriate, a competent scientific expert is always a good idea if you’re planning on making an establishment claim in your advertising because they’re a lightning rod for litigation. Trust me, it’s been proven.


Gregory J. Sater is a partner at Los Angeles-based Rutter Hobbs & Davidoff. He can be reached at ( or (310) 286-1700.

About the Author: Gregory J. Sater

Gregory J. Sater

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