722 CASE PRINTOUTS TO ACCOMPANY BUSINESS LAW
cycle specific to each individual wearer” so that only the bracelet’s original wearer can experience pain relief is designed to increase sales by
eliminating the second-hand market and “explaining” the otherwise–embarrassing fact that the buyer’s friends and neighbors can’t perceive
any effect.
• Even statements about the bracelet’s physical composition are false. It is sold in “gold” and “silver” varieties but is made of brass.
The magistrate judge did not commit a clear error, or abuse his discretion, in concluding that the defendants set out to bilk unsophisticated
persons who found themselves in pain from arthritis and other chronic conditions.
[1] Defendants maintain that the magistrate judge subjected their statements to an excessively rigorous standard of proof. Some passages in
the opinion could be read to imply that any statement about a product’s therapeutic effects must be deemed false unless the claim has been
verified in a placebo-controlled, double-blind study: that is, a study in which some persons are given the product whose effects are being
investigated while others are given a placebo (with the allocation made at random), and neither the person who distributes the product nor
the person who measures the effects knows which received the real product. Such studies are expensive, not only because of the need for
placebos and keeping the experimenters in the dark, but also because they require large numbers of participants to achieve statistically
significant results. Defendants observe that requiring vendors to bear such heavy costs may keep useful products off the market (this has been
a problem for drugs that are subject to the FDA’s testing protocols) and prevent vendors from making truthful statements that will help
consumers locate products that will do them good.
[2] Nothing in the Federal Trade Commission Act, the foundation of this litigation, requires placebo-controlled, double-blind studies. The Act
forbids false and misleading statements, and a statement that is plausible but has not been tested in the most reliable way cannot be
condemned out of hand. The burden is on the Commission to prove that the statements are false. (This is one way in which the Federal Trade
Commission Act differs from the Food and Drug Act.) Think about the seller of an adhesive bandage treated with a disinfectant such as iodine.
The seller does not need to conduct tests before asserting that this product reduces the risk of infection from cuts. The bandage keeps foreign
materials out of the cuts and kills some bacteria. It may be debatable how much the risk of infection falls, but the direction of the effect would
be known, and the claim could not be condemned as false. Placebo-controlled, double-blind testing is not a legal requirement for consumer
products.
[3] To this defendants respond that one study shows that the Q-Ray Ionized Bracelet does reduce pain. This study, which the district court’s
opinion describes in detail, compared the effects of “active” and “inactive” bracelets (defendants told the experimenter which was which),
with the “inactive” bracelet serving as a control. The study found that both “active” and “inactive” bracelets had a modest-and identical-effect
on patients’ reported levels of pain. In other words, the Q-Ray Ionized Bracelet exhibits the placebo effect. Like a sugar pill, it alleviates
symptoms even though there is no apparent medical reason. The placebo effect is well established. See, e.g., Anne Harrington, The Placebo
Effect: An Interdisciplinary Exploration (1999); Asbjorn Hrobjartsson & Peter C. Gotzsche, Is the Placebo Powerless? An Analysis of Clinical
Trials Comparing Placebo with No Treatment, 344 New England J. Medicine 1594 (2001); Ted Kaptchuk, Intentional Ignorance: A History of
Blind Assessment and Placebo Controls in Medicine, 72 Bulletin of the History of Medicine 389 (1998). Defendants insist that the placebo
effect vindicates their claims, even though they are false-indeed, especially because they are false, as the placebo effect depends on deceit.
Tell the patient that the pill contains nothing but sugar, and there is no pain relief; tell him (falsely) that it contains a powerful analgesic, and
the perceived level of pain falls. A product that confers this benefit cannot be excluded from the market, defendants insist, just because they
told the lies necessary to bring the effect about.