Opinion ID: 599675
Heading Depth: 3
Heading Rank: 1

Heading: united states' action for permanent injunction

Text: 47 Mr. LeBeau has taken issue with one of the plaintiff's most crucial pieces of evidence. He argues that the affidavit of Gloria Troendle, M.D., which contains assertions that Vital Health's products are not recognized as safe and effective for its intended purposes, should be stricken from the record. Dr. Troendle, who has had no formal training in hydrogen peroxide therapy, should not be permitted to give her opinion. 48 Dr. Troendle's affidavit is certainly damaging to the defendants' case, since it contains the following statements: 49 10. ... I do not recognize Vital Health's hydrogen peroxide, even in a diluted form, as safe and effective in preventing, treating, or curing ... any ... disease listed in Vital Health's promotional material. Further, it is my opinion that hydrogen peroxide is not recognized among qualified experts as safe and effective for these conditions or for any of the other conditions for which the product is promoted ... 50 11. ... [I]n my opinion, there is no scientific basis for believing that any product containing hydrogen peroxide is effective to cure, treat, and prevent the diseases for which these products are promoted.... 51 These statements form the basis of the government's motion for summary judgment, since lack of recognition of the safety and effectiveness of drugs is one of the prerequisites for a violation of the Act. 52 Instead of attempting to strike Dr. Troendle's affidavit, the defendants would have fared better had they introduced their own expert affidavits which, presumably, would have contradicted the government's evidence and given rise to a material issue of fact. The defendants have set forth the names and abbreviated qualifications of several experts whom they would have called to testify at trial. However, the Court has no knowledge as to what those experts would have said. 53 The fact that Dr. Troendle has not had any training or experience working with hydrogen peroxide or ozone cannot automatically disqualify her as an expert. When she testifies that the claims made by the defendant are not generally accepted or credible, she is relying upon her experience as a physician. She is familiar with a broad variety of drugs and cures, and knows the quantum of evidence necessary to establish these drugs as new, unapproved, and misbranded. Requiring a physician to be trained in the very field whose legitimacy he questions would be unreasonable. The Court finds that Dr. Troendle is competent, due to her education, training and experience, to render the opinions given in her affidavit. 54 The Court may also rely upon these opinions in ruling upon the government's motion for summary judgment. Because Dr. Troendle is an expert, she is qualified to give her opinion in an affidavit, provided that the opinion is based upon specific facts that are set forth in the affidavit. Mid-State Fertilizer v. Exchange National Bank, 877 F.2d 1333 (7th Cir.1989). In her affidavit, Dr. Troendle testified about the parameters under which she has evaluated the safety and effectiveness of drugs and their labeling. She set forth the requirements for a new drug application. She indicated that anecdotal evidence about the effects of drugs was essentially meaningless when the drugs had not been tested under rigorous scientific conditions. Troendle Aff. at p 6. Finally, she reviewed Vital Health's literature and labels. Based upon this evidence, she reached her conclusions. 55 The defendants have submitted various articles and books written by proponents of hydrogen peroxide therapy, with which they purport to raise issues of fact. However, as the plaintiff has pointed out, these sources are hearsay. Contrary to Vital Health's assertions, Federal Rule of Evidence 803(18) does not render these documents admissible. Rule 803(18) provides that statements contained in learned treatises may be admitted as exceptions to hearsay when the treatise has been established as a reliable authority by the testimony or admission of [a] witness or by other expert testimony or by judicial notice. Moreover, Rule 803(18) applies only to the extent that the treatise is either relied upon by an expert witness during direct examination or is used to impeach the expert during cross examination. The defendants in this case have not shown that these articles and books are considered to be reliable authorities, nor have the sources been used in conjunction with expert affidavits. 3
56 To prevail on its motion for summary judgment, the plaintiff must first demonstrate that the items mentioned in its complaint, including the hydrogen peroxide solutions, Peroxy Gel, and White Birch, are drugs. Then, it must prove the absence of a material issue of fact as to any of the following issues: (1) that the drugs are not generally recognized among the nation's experts as safe and effective for their intended use; (2) that there is no substantial evidence, as required by 21 U.S.C. § 355(d), showing that controlled studies have determined the drug's safety and effectiveness; or (3) that there is little or no scientific literature confirming an expert consensus as to the efficacy or safety of the drug. United States v. Articles of Drug, 624 F.Supp. 776, 779 (N.D.Ill.1985). A new combination of safe and effective drugs is considered a new drug for the purposes of the Act. United States v. Articles of Food and Drug, etc., 518 F.2d 743 (5th Cir.1975). 57 Mr. LeBeau argues that the government is collaterally estopped from asserting that the 17.5% and 35% solutions are unapproved new drugs based upon the settlement agreement negotiated in his earlier encounter with the FDA. In United States v. 120 Bottles, More or Less ... Peroxy Gel, No. 89-C-136 (E.D.Wis.), when the government seized some of Vital Health's products pursuant to the Act, the parties stipulated to a dismissal of the action. Mr. LeBeau agreed to withdraw a motion he had made against the government in exchange for the deletion of the term unapproved new drugs from the settlement agreement. The agreement merely termed the products misbranded drugs and ordered their destruction. 58 In order to prevail on his defense of collateral estoppel, the defendant must prove that the issue raised by the plaintiff was the same issue raised in earlier litigation, the issue was actually litigated in the earlier case, determination of that issue was necessary to the decision, and the decision was final. Continental Can Co., U.S.A. v. Marshall, 603 F.2d 590, 595-96 (7th Cir.1979). The defendant is unable to meet this legal requirement. In the seizure and forfeiture action, the court's primary purpose was to destroy the offending drugs. To accomplish this, it had two statutory means at its disposal. The drugs could be forfeited if they were misbranded or if they were unapproved new drugs. Because the stipulation admitted that the drugs were misbranded, whether they were unapproved new drugs was an issue whose determination was not necessary to the decision. In addition, there was no evidence presented as to whether the drugs were new and unapproved, nor did the government waive its right to bring this claim again. It merely agreed to modify the language in a document which would have led to the same result had the modification not occurred. Therefore, there has been no conclusive determination as to Peroxy Gel's and the hydrogen peroxide solutions' status as unapproved new drugs; collateral estoppel does not bar this Court from making this determination itself. 59 During the preliminary injunction hearing, Mr. LeBeau conceded that hydrogen peroxide and Peroxy Gel are drugs. Transcript at 37. He claims that the government has not shown any evidence that White Birch, Licorice Root Tea, and Lymph System are drugs. Contrary to his assertion, the government has made a showing that, for the purposes of the Act, these three products are drugs. In literature written by Mr. LeBeau, the products are reported to possess certain curative properties. Vital Health's Objection to the motion for summary judgment provides: 60 Vital Health News reported the claims of two priests and one other citizen that White Birch Mineral Water has been effective in treating arthritis, cancer, and genital warts. Vital Health News reported the claims of Laurence Badgley, M.D. with respect to the usefulness of Licorice Root Tea in treating stomach ulcers, AIDS, cancer, candidiasis, chronic infection, and weakened immune systems. Vital Health News states that Lymph System is to be used for the detoxification and purification of lymphatic system. It states that lymphatic problems occur in HIV+ persons and persons afflicted with candidiasis. 61 Opposition Brief at 2-3. From the defendants' own description, these items are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, 21 U.S.C. § 321(g)(2)(B), and thus must be considered drugs under the Act. 4 The defendants have also admitted that no new drug approval applications have been filed with the FDA for any of their products. 62 Because the Court has concluded that the products at issue in this case are drugs, the burden now rests upon the government to show that they are also unapproved new drugs under the Act. Although the Act provides that a drug is a new drug unless it is generally recognized ... as safe and effective for use under the condition prescribed, 21 U.S.C. § 321(p)(1), it does not define general recognition. The Supreme Court has determined that the statutory scheme and overriding purpose of the 1962 amendments [to the Act] compel the conclusion that the hurdle of 'general recognition' of effectiveness requires at least 'substantial evidence' of effectiveness for [a new drug application's] approval. Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 629 (1973). 5 In order for a drug to achieve general recognition, there must be a showing that: (1) there is a general agreement among experts that the product is effective; and (2) that the expert consensus is based on substantial evidence. United States v. An Article Of Drug Consisting of 4,680 Pails, 725 F.2d 976, 985 (5th Cir.1984). The substantial evidence standard, which is not as stringent as the preponderant evidence standard, takes into account the frequent differences of opinion that will arise in the area of drug testing and evaluation. To show substantial evidence, a drug's proponent should be able to point to a responsible body of qualified opinion, as well as to studies which are adequate and well-controlled, upon which qualified experts can reasonably conclude that the product is effective for its labeled indications. Id. (citations omitted). 63 From the facts presented, the Court concludes that Mr. LeBeau's products are new drugs. There is no evidence that controlled studies were conducted to determine the products' effects. Mr. LeBeau has testified that he did some experiments with hydrogen peroxide and yogurt, and that he provided the 35% and 17.5% solutions to customers for oral use only after they demanded it. Transcript at 21, 24. Selling these products to customers and relying upon their letters cannot constitute adequate and well-controlled studies. Hydrogen peroxide was not administered to patients under constant and controlled conditions, and the alleged results of the products were not verified by any medical experts. 64 Nor is there evidence that there is a responsible body of qualified opinion about the benefits of oral ingestion of hydrogen peroxide. First of all, the defendants' presentation of evidence to this effect is woefully inadequate. Although the briefs refer to a computer printout with 156 reference to hydrogen peroxide, the printout is nowhere to be found in the record. The Court is unable to independently judge the weight and credibility of the evidence asserted. Mr. LeBeau's references to it are nothing but hearsay. In addition, the defendants' references to a book on hydrogen peroxide which was published in 1904 cannot raise an issue of fact in this case. The book is nearly a century old, and in any case, does not purport to describe theories that are generally recognized. 6 65 In contrast, the government has introduced Dr. Troendle's affidavit. Dr. Troendle is qualified, as an expert, to testify as to her opinions concerning the general recognition of hydrogen peroxide's use as described by Mr. LeBeau. She has given her opinion that it is not recognized as safe and effective in treating many of the conditions listed in Mr. LeBeau's literature, nor is there any scientific basis supporting Mr. LeBeau's conclusions. Her opinions are consistent with the defendants' admissible evidence in the case, including the pleadings. Mr. LeBeau's arguments focus on the facts that his products have been used safely and successfully for many different purposes. These factors are irrelevant under the Act if the products are unapproved new drugs, since isolated case reports, random experience, and reports lacking the details which permit scientific evaluation will not be considered. 21 C.F.R. § 314.126(e). 66 The defendants have not rebutted this affidavit with any competent testimony from their own experts, choosing instead to impeach Dr. Troendle's methods and to rely upon articles written by proponents of hydrogen peroxide therapy. Dr. Troendle has admitted that she has not tested or observed the effects of hydrogen peroxide, has not published articles concerning the drugs at issue, and has not interviewed doctors or patients who have used hydrogen peroxide therapy. However, she had no responsibility to do these studies; she gave her opinion based upon the information made available to her. Since the government has met its initial burden of production, the defendants bear the burden of raising a genuine issue of fact that necessitates a trial through their pleadings, answers to interrogatories, affidavits, and admissions on file. Although they have attempted to impeach Dr. Troendle's expertise, they have not presented a factual basis which raises an question about the accuracy of her conclusions. There are no counter-affidavits from practitioners of hydrogen peroxide therapy or authors of the articles defendants seek to have admitted. The testimonials of Vital Health's customers are not admissible as evidence in a summary judgment motion. Mr. LeBeau's affidavit consists largely of conclusions with no factual basis, which are similarly inadmissible. Those assertions that are admissible do not raise any material issues of fact sufficient to rebut the government's case. Therefore, the Court finds that the 35% and 17.5% hydrogen peroxide solutions, Peroxy Gel, White Birch Mineral Water, Lymph System, and Licorice Root Tea are unapproved new drugs whose production may be enjoined by the FDA.
67 Mr. LeBeau next claims that his products are exempt from new drug status under the grandfather provision of 21 U.S.C. § 321(p)(1), which states that a drug is not a new drug if at any time prior to the enactment of [the] Act [enacted June 25, 1938] it was subject to the Food and Drug Act of June 30, 1906 ... and if at such time its labeling contained the same representations concerning the conditions of its use. To be exempt from the Act by virtue of this grandfather clause, the drug must meet four conditions: 68 (A) the drug must have been commercially used or sold in this country before 1962; 69 (B) it must not have been with the definition of a new drug in the 1938 Act; 70 (C) it must not have been covered by an effective new drug application; and 71 (D) it must currently be intended solely for use under conditions prescribed or recommended in its 1962 labeling. 72 United States v. Articles of Drug: 5,906 Boxes, 745 F.2d 105, 108 (1st Cir.1984). Since 1938, the Act has required that experts generally recognize the safety of a drug, while language concerning a drug's effectiveness was not added to the Act until 1962. Therefore, a manufacturer attempting to qualify his drug under the grandfather clause must show that his drug was generally recognized as safe prior to 1962 and need not demonstrate that it was effective. Id. 73 In applying for an exemption under the grandfather clause, the moving party bears the burden of proof as to each element. Moreover, because the clause is an exception to a comprehensive regulatory scheme which protects public safety, it must be strictly construed. 5,906 Boxes, 745 F.2d at 113. Neither of the defendants has offered competent evidence which raises an issue of fact as to all four elements, and therefore, Vital Health's products are not exempt from new drug status. 74 Mr. LeBeau has argued that his products' ingredients, such as hydrogen peroxide, glycerin, and aloe vera, have been used for centuries to cure infections, burns, and dry skin. Once again, however, he offers no admissible evidence to support these conclusions. Even if the Court was to take judicial notice as to the medical properties of these substances, there is still no valid claim for exemption. The defendants have not raised issues of fact about whether their products were used or sold commercially before 1962, whether the products were recognized as safe for their proposed uses, and whether the products are intended for use under the same conditions as they were prior to 1962. Furthermore, there is no evidence that the products were used in the past for the same purposes that Mr. LeBeau has suggested in his advertising and labeling. 75 It appears that many of the ingredients in Vital Health's products may have been used and sold prior to 1962. However, Mr. LeBeau has not presented any evidence that the chemical equivalents of items such as Peroxy Gel, 17.5% hydrogen peroxide solution, and White Birch Mineral Water were commercially used or sold at that time. Even if the individual components of the drugs could have qualified for exemption under the grandfather clause, the defendants have not shown that the combinations are equal to the sum of their parts. Courts have held that a combination of approved drugs is a new drug for the purposes of the Act. United States v. Articles of Food and Drug, Etc., 518 F.2d 743 (5th Cir.1975). Because there is nothing in the record indicating that Vital Health's drug combinations were commercially used or sold before 1962, these combinations are not exempt under the grandfather clause. 76 Insofar as 35% hydrogen peroxide solution is concerned, there is no competent evidence showing that it was commercially used or sold for internal use prior to 1962. The same is true for Lymph System and Licorice Root Tea. Therefore, the Court concludes that these products are subject to the Act as well.
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.
89 The Ninth Amendment provides that [t]he enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people. In support of their objection to the plaintiff's summary judgment motion, the defendants have argued that the Ninth Amendment gives citizens the right to choose their own medical treatment. 90 Rather than enunciating a particular affirmative right, the Ninth Amendment serves to protect other fundamental rights that are not set forth in the Constitution. Charles v. Brown, 495 F.Supp. 862, 863 (N.D.Ala.1980). Some unenumerated rights may be of Constitutional magnitude, but only by virtue of other amendments, such as the Fifth or Fourteenth Amendment. A person cannot claim a right that exists solely under the Ninth Amendment. Id. at 864. 91 In Anderson v. Ballard, 498 F.Supp. 1038 (S.D.Tex.1980), to which the defendants cite in support of their defense, the district court concluded that the decision to obtain or reject medical treatment ... is both personal and important enough to be encompassed by the right of privacy. Id. at 1048. Therefore, articles and rules that limited the practice of acupuncture in Texas deprived citizens of the right to obtain acupuncture treatment and violated their right to privacy. Id. at 1057. Nevertheless, the Anderson court balanced the individual's right to medical treatment with the State's interest in preserving the health of the patient, and found that the State could have accomplished its goal by less drastic means. Id. 92 In Anderson, the court found that the right to obtain and reject medical treatment was grounded in the liberty aspect of the Fourteenth Amendment, which formed the basis for an individual's right to privacy. Assuming that the defendants in this case had even asserted a Fifth or Fourteenth Amendment defense, which they did not, their right to privacy would still not be implicated by the government's action. There are cases where the government's interest in protecting the health of its citizens often overrides a patient's choice of a particular treatment or medication. Jacob v. Curt, 721 F.Supp. 1536, 1539 (D.R.I.1989). For instance, when cancer patients sought to enjoin the government from interfering with the interstate shipment of Laetrile, the Tenth Circuit noted that the patients' right of privacy could not override the fact that Laetrile might have been a new drug. 93 It is apparent in the context with which we are here concerned that the decision by the patient whether to have a treatment or not is a protected right, but his selection of a particular treatment, or at least a medication, is within the area of governmental interest in protecting public health. 94 Rutherford v. United States, 616 F.2d 455, 457 (10th Cir.1980). Even under the string of Supreme Court cases which have held that individuals have various rights of privacy, Congress still has the authority to limit a patient's choice of medication. Id. 95 Therefore, a claim that American citizens have the freedom to choose whatever medication or treatment they desire is not grounded in the Fifth, Ninth or Fourteenth Amendment. The defendants have asserted only the Ninth Amendment, which is not a source of substantive rights unless it is coupled with the denial of a fundamental right. See e.g., United States v. Choate, 576 F.2d 165, 181 (9th Cir.1978). Because the right to receive any medicine or treatment is not a constitutional right under the Fourteenth Amendment's right to privacy, the defendants' Ninth Amendment defense must be overruled. See Charles v. Brown, 495 F.Supp. at 364 (a ... claim based solely on alleged Ninth Amendment rights must fail because there are no constitutional rights secured by that amendment.). 96 Since the Court has found that Vital Health's products are unapproved new drugs and misbranded drugs, and has rejected the defendants' Ninth Amendment defense, it must determine whether there is a risk that the defendants will continue to manufacture and promote their products in spite of the Act's restrictions. It finds that there is a reasonable chance that the defendants will continue to do so unless they are permanently enjoined. Mr. LeBeau was already the subject of a civil forfeiture action with respect to another substance, Oxygel, which was found to be a misbranded drug. In addition, he has received warning letters from the FDA which apprised him of the government's suspicions that Vital Health's products contravened the Act. The only changes he has made in his behavior were thinly veiled attempts to circumvent the specific language of the Act; in particular, he has argued that his products are not misbranded by virtue of the claims in Hydrogen Peroxide Therapy, because Vital Health and News no longer sell this booklet. While this may be true, Mr. LeBeau is the author of the booklet and advertises it with shipments of Vital Health's products. This type of behavior, as well as his insistence on distributing his products in the face of impending litigation and his misapprehension of his rights under the Ninth Amendment, have led this Court to conclude that a permanent injunction is the only means by which Mr. LeBeau and Vital Health can conform their conduct to that required by the Act. Therefore, the government's motion for summary judgment shall be granted.