Opinion ID: 599675
Heading Depth: 4
Heading Rank: 1

Heading: Unapproved New Drugs

Text: 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.