Pain Relief Claims Can be Painful

By Edward F. Glynn Jr.

The centers of the direct response television (DRTV) business are California and the East Coast, but two of the most draconian decisions in cases brought by the Federal Trade Commission (FTC) have emerged from the Federal District Court in Chicago. Most observers in the industry are familiar with the case against Kevin Trudeau (more properly, the several cases) brought by the Commission, which culminated in a sweeping order from a federal judge in the Windy City limiting Trudeau's ability to participate in the DRTV industry. Last month, the Commission won another one in Chicago obtaining a multimillion-dollar judgment against the marketer of the Q-Ray ionized bracelet. At one level, the opinion is not remarkable because it announced few, if any, novel legal principles.

Still, the 135-page decision is worth noting, because it reinforces the applicable rules in an area of increasing importance in the DR industry--claims for pain relief. Moreover, the size of the redress ordered is sufficiently large to make marketers sit up and take notice. The redress ordered includes a minimum of some $22 million, which constituted the amount of profits realized by the marketers of the Q-Ray, and a maximum of some $87 million constituting the net sales to consumers over a three-and-a-half-year period.

As most regular television viewers know, the Q-Ray bracelet is a C-shaped bracelet with screw caps, which comes in various metallic finishes. Starting in September 2000, the marketer promoted the Q-Ray bracelet to the public on television, as well as through the Internet and print media. A principal method of marketing the product was the use of four different television infomercials, which aired over 42,000 times between April 2001 and June 2003. In May 2003, the Commission filed a complaint for injunctive and other relief in federal court in Chicago, and the judge granted the FTC's motion for a temporary restraining order and asset-freeze.

THE CASE UNFOLDS
The essence of the FTC case--and what was found by the court--was that the marketers of the Q-Ray ionized bracelet had conveyed in their advertising the claim that the bracelet provided immediate, significant (or complete) pain relief from various types of pain. The court observed that the claim was obvious and apparent from viewing the infomercials and, under the law, the marketers were required to possess competent and reliable scientific evidence to substantiate the claim. A major issue in the case is what amounts to "competent, reliable scientific evidence" sufficient to support a pain-relief claim. The experts at trial agreed that at least one well-conducted, placebo-controlled, randomized, double-blind (or sham-controlled) clinical trial would be required by qualified experts in the field of pain to support a claim that a product relieves or treats musculo-skeletal pain. This standard has been applied in the past in a variety of cases, including hair-growth and weight-loss claims, and is a familiar test facing marketers seeking to make health-related claims.

The judge noted that the defendants would not be required to have a gold-standard study to substantiate the Q-Ray bracelet if they did not make such a strong medical claim. The choice belonged to the marketers. For example, the marketers could have said, "The Q-Ray bracelet is a stylish bracelet that is fun to wear," or "The Q-Ray bracelet will look cool on your wrist." Barely any substantiation would have been required for those claims. However, when the marketers made an express, health-related claim that the Q-Ray bracelet relieved pain, scientific validity requires a gold-standard study to support such claims.

Well, the Q-Ray defendants did not have, in the opinion of the court, that kind of study and credited the expert testimony of the Commission's witness that there is no scientifically plausible means, besides a process using radioactive particles or vacuums, of maintaining a charge of ionization on a metal bracelet for more than a few minutes regardless of the type of metal used in its construction. Moreover, the court dismissed the marketers' argument that the placebo effect (i.e., people who bought the bracelet and believed that it worked realized some benefit from that belief) was entitled to credence. Relying on another case that discussed the inapplicability of the placebo effect, the court observed that a "kiss from mother on the affected area would serve just as well to relieve pain" if mothers' kisses were marketed as effectively as the product at issue.

THE DEFENDENTS
In addition to the corporate marketer, the FTC sought to establish liability against the owner of the company and his wife, trying to prove that they either participated directly in the deceptive acts or practices, or had authority to control them, or that they knew or should have known about the deceptive practices. The court concluded that Que Te Park (the CEO of the marketer and the sole shareholder) met this test, but that his wife, Jung Joo Park, did not. Notwithstanding her formal titles as secretary of the company and the possessor of signatory authority on most of the corporate bank accounts, Mrs. Park's responsibilities and duties at the company did not include the marketing of the bracelet and focused, instead, in such areas as assembly, shipping and handling, and employee relations. The Commission also failed to prove that she either knew or should have known about the deceptive practices of the corporate marketers.

How much application will this decision have to other marketers of pain-relief products? Ironically, it probably won't apply that much. Most topical pain relief products are creams or ointments and the like (think Ben-Gay and other products available in your local drug store) and are marketed under the FDA's Monograph for Topical Analgesic Products. The Monograph specifies certain active ingredients, which must be included in over-the-counter products for the relief of muscle pain and states that if the products contain active ingredients of the type and at the dosage specified, they are deemed safe and effective. In other words, the FDA supplies your substantiation for you if you follow the conditions of the Monograph.

Now, it is still possible to get into trouble selling a pain-relief topical cream--as Blue Stuff discovered when, according to the FTC, it made claims that went beyond the scope of the Monograph. What made the Q-Ray bracelet different was that it was not covered by the Monograph and thus, was responsible for conducting its own "gold-standard" study--a study the court said it didn't have.

Ed Glynn practices law in the District of Columbia with Venable LLP and can be reached at (202) 344-4805, or via e-mail at efglynn@venable.com.