U.S. v. LeBeau

• Decision Date: 28 January 1993
• Docket Number: No. 92-2724,92-2724
• Citation: 1993 WL 21970,985 F.2d 563
• Parties: NOTICE: Seventh Circuit Rule 53(b)(2) states unpublished orders shall not be cited or used as precedent except to support a claim of res judicata, collateral estoppel or law of the case in any federal court within the circuit. UNITED STATES of America, Plaintiff-Appellee, v. Conrad E. LEBEAU, an individual, Defendant-Appellant.
• Court: U.S. Court of Appeals — Seventh Circuit

Page 563

985 F.2d 563

NOTICE: Seventh Circuit Rule 53(b)(2) states unpublished orders shall not be cited or used as precedent except to support a claim of res judicata, collateral estoppel or law of the case in any federal court within the circuit.

UNITED STATES of America, Plaintiff-Appellee, v. Conrad E. LEBEAU, an individual, Defendant-Appellant.

No. 92-2724.

United States Court of Appeals, Seventh Circuit.

Argued Dec. 4, 1992.

Decided Jan. 28, 1993.

Before CUMMINGS, and CUDAHY, Circuit Judges, and LAY, Senior Circuit Judge. ^*

ORDER

In April of 1991 the government sought to enjoin the defendants from violating the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. The defendants were Conrad LeBeau, the owner and president of co-defendant Vital Health Products, a Muskego, Wisconsin, corporation, which has not appealed from the adverse judgment of the district court.

The complaint alleged that defendants were violating the Act by manufacturing and introducing into interstate commerce six unapproved new drugs which were also misbranded, in violation of 21 U.S.C. § 331(a) and (d). The drugs in question were 35% Hydrogen Peroxide Solution, 17.5% Hydrogen Peroxide and Glycerine, Peroxy Gel, White Birch Mineral Water, Licorice Root Tea, and Lymph System. The literature accompanying these products and some of their labels showed that they were intended to be used as treatments for cancer, AIDS, emphysema, diabetes, multiple sclerosis, Parkinsonism, Alzheimer's Disease, and arthritis. The complaint alleged that between 1987 and April 1991 defendants were issued two warning letters by the Food and Drug Administration that these products violated the Act. Because the warnings were ignored, the government sought an injunction barring the defendants from violating the Act by, inter alia, distributing Vital Health's products. The government's request for injunctive relief was supported by an affidavit of Dr. Gloria Troendle, a well-qualified expert, to the effect that the six products in question were not safe and effective for their intended uses.

In March 1992, Judge Warren issued a 40-page opinion and order granting a permanent injunction and dismissing LeBeau's counterclaim. This caused LeBeau, but not Vital Health Products, to appeal from the judgment below after his motion to amend the judgment and his motion for reconsideration were denied. For the reasons given in the attached decision and order of the district court, we affirm the grant of injunctive relief and summary judgment in the government's favor. This order merely supplements Judge Warren's opinion.

LeBeau's Fifth and Fourteenth Amendment arguments against the constitutionality of the Act were properly rejected on the basis of well-settled authorities. See, e.g., United States v. Sullivan, 332 U.S. 689, and United States v. Walsh, 331 U.S. 432. While LeBeau also attacks the Act on the ground that it violates the Ninth Amendment, that amendment standing alone has never been considered by the Supreme Court to support an attack on a federal statute. Thornburgh v. American College of Obstetricians & Gynecologists, 476 U.S. 747; Roe v. Wade, 410 U.S. 113; Eisenstadt v. Baird, 405 U.S. 438; see also Griswold v. Connecticut, 381 U.S. 479, 486-499 (Goldberg, J., concurring). In addition, three courts of appeals have rejected litigants' Ninth Amendment privacy right claims in favor of governmental regulation of medication. United States v. Byrzynski Cancer Research Institute, 819 F.2d 1301 (5th Cir.1987), certiorari denied, 484 U.S. 1065; Carnahan v. United States, 616 F.2d 1120 (9th Cir.1980); Rutherford v. United States, 616 F.2d 455 (10th Cir.1980), certiorari denied, 449 U.S. 937. Andrews v. Ballard, 498 F.Supp. 1038 (S.D.Tex.1980), relied on by LeBeau to support a claimed privacy right to freedom of choice in medicine, has been implicitly rejected by the Fifth Circuit's Byrzynski opinion.

LeBeau also asserts that the district court should have considered a March 14, 1992, affidavit of Dr. William Douglass to show that Hydrogen Peroxide therapy is useful to treat "cancer, tumor cells, bacterial, fungal and viral infections, HIV infection [from AIDS], arthritis, candidiasis, chronic fatigue syndrome, emphysema" and other conditions (defendants' app. 48), and therefore shows that Dr. Troendle's contrary affidavit was perjured. However, on September 16, 1991, Judge Warren gave defendants 45 days to respond to the government's summary judgment motion, which was supported by Dr. Troendle's affidavit, and on December 12, 1991, extended that time to January 6, 1992, adding that "Any documents filed after this date shall not be considered by this court * * * [and] there shall be no further extension" (R. 60, 70). Consequently, the district judge was justified in refusing to consider the belated submission of Dr. Douglass's affidavit. Olive Can Co., Inc. v. Martin, 906 F.2d 1147, 1152-1153 (7th Cir.1990).

The medical profession may yet change its view of purveyors like Mr. LeBeau, who urge the benefits of herbal or homeopathic cures. Recently the National Institute of Health established an Office of Alternative Medicine, which will "seek[ ] proposals from researchers who want to explore the merits of therapies outside mainstream healing." Natalie Angier, U.S. Opens the Door Just A Crack to Alternative Forms of Medicine, N.Y. Times, Jan. 10, 1993, at p. 1. One also wonders whether the government would pursue an herbal remedies boutique or a New Age lecturer urging the curative power of crystals as vigorously as it did LeBeau. Their customers are no more or less in need of protection from medical chicanery than rural Wisconsinites. Such observations do not aid LeBeau's present case, however, and summary judgment in favor of the United States is AFFIRMED.

ATTACHMENT

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF WISCONSIN

UNITED STATES OF AMERICA, Plaintiff,

v.

VITAL HEALTH PRODUCTS, LTD., a corporation, and CONRAD E.

LeBEAU, an individual, Defendants.

Case No.: 91-C-363.

Mar. 10, 1992.

Before the Court are the plaintiff's motions for summary judgment and dismissal of the defendant's counterclaim, as well as a host of non-dispositive motions brought by the defendant. Since the non-dispositive motions will become moot once the summary judgment motions are resolved, the Court shall not address them.

I. BACKGROUND

A. VITAL HEALTH AND ITS PRODUCTS

Defendant Conrad LeBeau is a Wisconsin citizen who is engaged in the business of promoting hydrogen peroxide and other "natural remedies" as curative substances. He conducts his business as defendant Vital Health Products, Ltd. ("Vital Health"), a corporation over which he has complete control and is president. Vital Health sells and distributes 35% Hydrogen Peroxide, 17.5% Hydrogen Peroxide and Glycerin, Peroxy Gel, White Birch Mineral Water, Licorice Root Tea, and Lymph System, among other products. In addition, Mr. LeBeau is the author of a newsletter entitled "Vital Health News" ("News"), which is distributed by Vital Health Publications. News calls itself "a publication issued periodically to provide news and new developments in a wide range of health related areas including freedom of choice in medicine, holistic regimens, new health products and new uses for existing health supplements." News, Vol. 2, No. 1 at 2. It contains a warning that "[p]ersons with serious illness should seek the help of a medical professional and should not attempt self treatment solely on the basis of information contained in this newsletter." Id.

"35% Hydrogen Peroxide Solution" and "17.5% H202 and Glycerine" are liquid forms of hydrogen peroxide sold by Vital Health for ingestion. News describes the 35% solution as able to kill intestinal germs and bacteria on contact. The user is instructed to add 3 to 7 drops of the hydrogen peroxide to a glass of water and drink it on an empty stomach, and is warned that if excessive quantities are swallowed, blood sugar levels may be lowered, resulting in coma or death. News suggests keeping the 35% solution in the freezer, out of the reach of children. The label on the 4 ounce bottle has similar instructions and warnings, and instructs the user that the water/peroxide mixture may be taken every three hours. If intestinal gas occurs, the user is instructed to discontinue treatment. First aid procedures are listed for skin and eye contact as well as ingestion. ¹

News' paragraph on the 17.5% solution is shorter and merely describes it as a "no nausea formula," because it does not have an aftertaste or cause an upset stomach. The addition of glycerine slows the absorption of hydrogen peroxide into the bloodstream. Adults are instructed, by the labeling on the 4 ounce bottle, to add 7 to 14 drops of the solution to a glass of water and to take it on an empty stomach once a day. The warnings on the bottle are identical to those on the 35% solution, with one exception. The 17.5% solution's label warns, "Do not use for more than 10 days, except as directed by a doctor."

"Peroxy Gel" is a solution containing hydrogen peroxide, aloe vera, and glycerine, and is distributed for topical application. News endorses Peroxy Gel's healing powers by printing testimonials of parties who have used it to treat various ailments successfully. For example:

Several people claim to have had complete relief from the pain of arthritis and rheumatism. It is effective when used on sore muscles, aching joints, fungal infections, athlete's foot, insect bites, burns and bruises. It has been reported effective against Lyme's disease. Recently, the owner of a health food store in Sonora, CA reportedly shrunk a large tumor with adhesions by applying Peroxy Gel directly on the tumor. The tumor, which was "the size of a hen's egg" shrunk to a "half-dollar" and "all the pain is gone." Also, in Scottsdale, AZ, a registered nurse who was told eight months ago by her doctor that she had terminal cancer of the pancreas...