United States v. Evers

• Decision Date: 27 June 1978
• Docket Number: Civ. A. No. 78-93-N.
• Citation: 453 F. Supp. 1141
• Parties: UNITED STATES of America, Plaintiff, v. H. Ray EVERS, M. D., an Individual, doing business as Ra-Mar Clinic, Defendant.
• Court: U.S. District Court — Middle District of Alabama

453 F. Supp. 1141

UNITED STATES of America, Plaintiff, v. H. Ray EVERS, M. D., an Individual, doing business as Ra-Mar Clinic, Defendant.

Civ. A. No. 78-93-N.

United States District Court, M. D. Alabama, N. D.

June 27, 1978.

Barry E. Teague, U. S. Atty., Kenneth E. Vines, Asst. U. S. Atty., Montgomery, Ala., Richard M. Cooper, Chief Counsel, Robert A. Dormer, Associate Chief Counsel, for Enforcement, Food & Drug Administration, Rockville, Md., for plaintiff.

J. Paul Lowery, Montgomery, Ala., for Evers.

Clifford W. Cleveland, Prattville, Ala., for defendants-intervenors.

MEMORANDUM OPINION AND FINDINGS OF FACT AND CONCLUSIONS OF LAW

VARNER, District Judge.

This cause is submitted upon the pleadings, the briefs, and evidence for final judgment. The Plaintiff, the United States of America, spear-headed by the Federal Drug Administration, filed this proceeding against Dr. H. Ray Evers, a licensed physician in the State of Alabama, alleging (1) that Defendant has been engaged in promoting and administering calcium disodium versenate in treatment for arteriosclerosis; (2) that the labeling of the drug, commonly called the package insert,¹ which is prescribed and approved by the Federal Drug Administration, indicates that the drug is recommended for treatment for heavy metal poisons but not for other things here relevant; (3) that patients being treated by the Defendant are subjected to an unwarranted risk of grave physical injury or death as a result of said treatment; and (4) that the promotion and administering of said drug, after having utilized interstate commerce in obtaining the same, amounts to a mislabeling of the drug under the provisions of Title 21, U.S.C. §§ 331(k) and 352(f)(1). The Plaintiff contends that using chelating drugs² in the treatment of arteriosclerosis and other cardiovascular problems creates a use for the drug for which it is not properly labeled, thereby misbranding or mislabeling the drug within the meaning of 21 U.S.C. § 352(f)(1).

The defense is that Defendant is not using the drug for other than treatment of metal poisoning, its recommended use, and that, in any event, the Defendant is a licensed physician in the State of Alabama and that licensed physicians have a right and a duty to use drugs in prescribing for their patients' usage in accordance with their best judgment as physicians and that the Federal Food and Drug Act does not prohibit a licensed physician's using a drug for a disease or weakness in a patient in any manner which is not contraindicated on the package insert.³

It is necessary in considering the issues in this case to have at least a lay conception of what the process of chelation amounts to in treatment of heavy metal poisons⁴ or for arteriosclerosis. Chelation involves intravenous injections in the patient of chemicals which tend to react chemically with the harmful metals which accumulate in and deter passage of blood within the blood vessels. Upon dissolution of these harmful substances by the chemical reaction to the chelating drug, the harmful metals are dissolved and pass out of the body through the kidneys. The danger involved is that too many of such substances may be passed into the kidneys too rapidly and, on occasion, renal poisoning sets in, and kidney failure results in the death of the patient. The danger associated with the harmful metals remaining in the blood vessels is that the blood vessel may become clogged, disallowing free passage of the blood through the blood vessels and cause stroke, diminished ability to reason or remember (senility) because of inadequate blood supply to the brain, gangrene resulting from failure of sufficient blood in the limbs, and various degrees of numbness, dizziness and pain associated with failure of circulation.

The Defendant explains that his method of chelation originally involved the intravenous injection of a chelating drug (disodium EDTA, which he no longer uses) mixed with vitamins and minerals designed to maintain the strength of the patient and the proper mineral balance within the patient's body. He insists that each patient who comes into his clinic is given extensive tests to determine the mineral (good and bad) content of the body and that he mixes the injectables to replace the needed trace minerals and to dissolve the harmful mineral content in the fluids of the body.

The alternative treatment for arteriosclerosis is by-pass surgery and one danger associated with Defendant's treatment, according to Plaintiff, is that persons will be delayed beyond the point of no return to surgery by first resorting to Defendant's treatment.

The relief sought by the Plaintiff is that this court grant an injunction restraining (1) The receipt or possession of disodium edetate, calcium disodium edetate, or any other drug possessing chelating action by the Defendant; (2) The continuance of administration of chelating therapy by the Defendant; and (3) The allowance of regular inspection of Defendant's clinic by the Federal Drug Administration.

It must be borne in mind that there are a number of things which this suit is not. This is not a suit for malpractice by the Defendant nor a proceeding to enjoin false advertising. It is not a proceeding to cancel the license to practice medicine of the Defendant nor is this court authorized to invoke such a remedy. It is also not a suit challenging the Defendant for failure to use an obvious cure for a known disease or weakness. This is also not an attempt to enjoin Dr. Evers from administering intravenous injections of vitamins and minerals to his cardiovascular or other patients. While the government suggests that this treatment for cardiovascular patients is without value and could be harmful, these concerns are not within the purview of this lawsuit. This court derives its power from the clause of the Constitution granting the United States authority over interstate commerce and jurisdiction of this court is so limited.

The legal issues presented by this cause, in the opinion of this court, place squarely before this court the question of whether a licensed physician may be enjoined from prescribing for his patients a drug of which the package insert is silent as to whether the drug is indicated or contraindicated for the patient's illness.

Several recognized factors which the court should keep in mind is that the decision making power of a physician may involve a consideration of the possible curative value of not notifying a patient of all of the risks associated with the use of a drug or indicated on the package insert on the drug prescribed for that patient. In the opinion of this court, that decision must be a professional one made by the physician himself. This court finds from the evidence that Dr. Evers, before using EDTA, did not always inform his patients of the risks shown on the package insert to have been associated with the use of calcium EDTA as a chelating agent. The Court will also keep in mind the well-known medical fact proved by several physicians in testimony in this proceeding that, of all patients treated by physicians, a large majority would recover no matter what treatment is provided therefor. However, this majority is obviously not applicable to those suffering from advanced arteriosclerosis wherein the patient may expect an early disabling resulting from stroke, hypertension, heart failure, or other related diseases or cardiovascular problems.

A part of the defense of Dr. Evers is that no scientific person would attempt to chelate for arteriosclerosis with calcium EDTA. The well-supported theory is that calcium is an element which tends to accumulate in the blood vessels and that the calcium in the calcium EDTA would not tend to chemically react with the calcium in the blood vessels materially so as to achieve dissolution of the deposits within the blood vessels commensurate with action by other chelating agents not having high calcium content. However, Dr. Evers admits that, in treating for a metal toxicity, such as lead, patients who also have arteriosclerosis, he has found that chelation with calcium EDTA has proven effective to aid, not only the heavy metal poison but also, the arteriosclerosis. He explains that the metal content of the blockage in the arteries is neutralized by the chelating agent and passes out of the blood and that the calcium deposit remaining in the blood vessels, having lost its mineral structural balance, tends to disintegrate and pass out through the kidneys along with other undesirable elements. He compares it with the failure of a structural building once the metal supports therein have been removed. It is therefore clear that, while Dr. Evers preferred another chelating agent for arteriosclerosis, he admits a large degree of success in treating arteriosclerosis victims with calcium EDTA. He is now of the opinion that no chelating agent is necessary for arteriosclerosis as the treatment may be accomplished through intravenous injections of minerals and vitamins without a chelating agent. This suit poses no threat to such treatments for arteriosclerosis or other disease.

It is well-established by the evidence in this case and by the package insert that the danger associated with the use of chelating drugs is kidney failure resulting in death. It is therefore not surprising that no former patient of the subject physician survives to testify against his use of chelating drugs. It is also well-established that there have been no controlled scientific tests in this country which have demonstrated that chelation therapy with calcium EDTA has been successful in treatment of cardiovascular disease. However, the favorable lay support of chelating drugs from former patients relieved by the Evers system of the obvious symptoms of arteriosclerosis, together with testimony from a few doctors and osteopaths who have used the treatment, cannot be ignored. Irrespective of the strong medical school of thought...