Opinion ID: 599675
Heading Depth: 4
Heading Rank: 3

Heading: Misbranded drugs

Text: 77 Whether a drug is misbranded pursuant to the Act is a question of fact which is best determined at trial. As discussed earlier, a drug is misbranded when its labeling or advertising is misleading. If the government is able to present factual evidence tending to prove that the Vital Health products were misbranded drugs and Mr. LeBeau or Vital Health are unable to dispute this evidence, then the Court may grant summary judgment for the government. 7 78 The first issue is whether the literature distributed by Publications constitutes labeling for the purposes of the Act. The Supreme Court has held that even when literature on a drug's use is sent in a different package than the drug itself, the literature may still be a label. Kordel v. United States, 335 U.S. 345 (1948). In Kordel, the petitioner was convicted under the criminal provisions of the Act for selling misbranded drugs. The pamphlets that he distributed in connection with his drugs were the only source of instruction to consumers. Both the drugs and the pamphlets were held to have had a common origin and a common destination, and the Court held that the pamphlets were labeling. Id. at 348. 79 In order to reach its conclusion that the drugs were misbranded, the Court had to find that the literature accompanied the drugs. It determined that [o]ne article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment ... is necessary. Id. at 350. The fact that the literature was shipped separately was irrelevant, since the literature was clearly intended to be used to distribute and sell the drugs. Id. Finally, it held that the fact that the pamphlets had a selling price was immaterial, because the pamphlets and the drugs were interdependent and both parts of an integrated distribution program. Id. 8 80 Although not parallel, the facts in Kordel and this case are remarkably similar. Both defendants are self-styled authorities of the products they promote. Neither had any formal medical training. Both have sent literature and drugs to customers in separate packages. The customer need not purchase the defendant's drugs in order to buy his literature. 81 The two most notable differences between Kordel and the instant case are that Kordel was a criminal defendant and that he was charged with selling products that had no labeling other than what was contained in the literature. In contrast, Mr. LeBeau is a civil defendant in an action seeking to enjoin him from distributing his products. No criminal penalties have been sought. Furthermore, the products' containers are labeled with instructions for use and warnings of possible side effects. 82 Nevertheless, these distinctions do not negate the message of Kordel. Mr. LeBeau's newsletter and booklet discuss uses to which Peroxy Gel and hydrogen peroxide may be put and these uses do not appear on the packages' labels. For example, the label attached to the Peorxy Gel bottle does not suggest that the solution may be used to treat Downs Syndrome. Yet Hydrogen Peroxide Therapy reports that a child with Downs Syndrome responded favorably after a small about [sic] of [a hydrogen peroxide based] gel was rubbed on the bottom of her feet for 2 months. Plaintiff's Exhibit 2 at 11. The booklet also recommends topically applying one tablespoon of a hydrogen peroxide/aloe vera juice solution to treat cancer. 83 Admittedly, many of the claims made about hydrogen peroxide's healing properties are made not by Mr. LeBeau, but by third parties whose letters and testimonials he cites. However, by including this information in his booklet and newsletters, Mr. LeBeau effectively endorses other potential uses for his products. When he describes a patient who cured her cancer by following a vegetarian diet with lots of yogurt, using TriBalene 4 times a day ... and using 1/2 Tablespoon of a hydrogen peroxide based gel three times a day, it has the same effect as prescribing this treatment for any of his readers. Indeed, many of the letters sent to the Court by Mr. LeBeau's customers indicate that his products were used for ailments other than those listed on the packaging. 84 Apparently, Vital Health and Publications no longer distribute News or Hydrogen Peroxide Therapy. However, on several occasions, Vital Health enclosed a leaflet with products it shipped, informing the purchaser that Hydrogen Peroxide Therapy could be ordered from Nutri Books in Denver, CO. Claflin Aff. at p 5; Plaintiff's Exhibit 12. Although the relationship between the booklet and the actual drugs has become slightly more attenuated, the Court still finds that the core relationship is intact and that the two products are interdependent. Therefore, even though Vital Health technically does not sell Hydrogen Peroxide Therapy, it is still distributing it in conjunction with its other products, which makes the booklet labeling under Kordel. 85 Since the Court has concluded that the booklets and the newsletters constitute labeling, it is now necessary to determine whether the drugs were misbranded. Although this issue was not reached by the Supreme Court in Kordel, the Seventh Circuit did address it in its holding. 86 The Seventh Circuit found that the public would be endangered by Kordel's misleading labeling. Although the products that he promoted were not inherently dangerous or toxic, there was the strong possibility that consumers who used his remedies would rely upon self-diagnosis instead of seeing a physician. United States v. Kordel, 164 F.2d at 916. In addition, the literature encouraged people to experiment with themselves and that meant they were gambling with their health and life. Id. at 915-16. 87 In this case, Mr. LeBeau is promoting at least two products which present a clear danger to his customers. He has acknowledged that excessive ingestion of hydrogen peroxide can cause death, and that a bottle of it in the refrigerator can easily be mistaken for a glass of water. To his credit, his products and literature do contain warnings about excessive consumption and keeping the product out of a child's reach. However, as Dr. Sorrell Schwartz has pointed out, the directions for internal use of hydrogen peroxide are ambiguous. Schwartz Aff. at p 12. For the 35% solution, the label recommends adding 3 to 7 drops to a glass of water. It also suggests that the dose may be repeated several times daily. No formula for diluting the solution is given. The Court finds that the products' instructions, as well as the literature, set forth so many different dosage levels that a consumer is likely to become confused and attempt to construct his own formula. If he takes the claims made in the literature at face value, it would not be difficult for him to reach a conclusion of the more, the better. 88 The remainder of Vital Health's products named in the government's complaint are probably not inherently dangerous. The danger surrounding Peroxy Gel, Lymph System, White Birch Mineral Water, and Licorice Root Tea is the same danger that the Seventh Circuit described in Kordel. Customers may attempt to treat serious ailments themselves rather than seeing a physician. The delay in seeking adequate medical treatment could harm the customer, and major medical consequences could arise from a relatively minor cause that would have been easily curable if the patient had gone to a professional at once. A non-prescription drug that meets the standards of the Act will have undergone a battery of tests and studies to ensure that it does what it purports to do. Mr. LeBeau has not presented scientific evidence showing that his products perform in the manners alleged in his publications. Although his customers have sent letters to him and to the Court that glow with praise, this is not substantial evidence under law; Mr. LeBeau needs to present more than mere anecdotal evidence from lay people that the drugs are not misbranded.