Rutherford v. United States

• Decision Date: 10 October 1975
• Docket Number: No. CIV-75-0218-B.,CIV-75-0218-B.
• Citation: 399 F. Supp. 1208
• Parties: Glen L. RUTHERFORD, Plaintiff, Intervenor, and Jimmie Stowe and Gene Schneider, Individually and on behalf of a class composed of cancer victims and their spouses, who are responsible for the costs of treatment, Original Plaintiffs, v. UNITED STATES of America and Caspar Weinberger, Secretary of Health, Education and Welfare, Defendants.
• Court: U.S. District Court — Western District of Oklahoma

399 F. Supp. 1208

Glen L. RUTHERFORD, Plaintiff, Intervenor, and Jimmie Stowe and Gene Schneider, Individually and on behalf of a class composed of cancer victims and their spouses, who are responsible for the costs of treatment, Original Plaintiffs, v. UNITED STATES of America and Caspar Weinberger, Secretary of Health, Education and Welfare, Defendants.

No. CIV-75-0218-B.

United States District Court, W. D. Oklahoma.

August 14, 1975.

As Amended October 10, 1975.

Clyde J. Watts of Watts, Looney, Nichols, Johnson & Hayes, Oklahoma City, Okl., for plaintiffs.

J. H. Geller, Associate Chief Counsel for Enforcement, Food and Drug Administration, Los Angeles, Cal., and William R. Burkett, U. S. Atty., by William S. Price, Asst. U. S. Atty., Oklahoma City, Okl., for defendants.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

BOHANON, District Judge.

The case was called and the parties announced ready for trial on plaintiff's Amended Complaint insofar as it pertains to a temporary injunction, plaintiff praying that this Court order and direct the Secretary of Health, Education and Welfare (HEW), of which the Federal Drug Administration (FDA) is a branch, to desist from precluding the administration of Vitamin B17 or laetrile to patients in the United States suffering from cancer.

The plaintiffs seek relief under the Fifth Amendment to the Constitution of the United States from the provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 1-392 alleging that by reason of the arbitrary and capricious acts of the Secretary the rights of the plaintiffs, under the Constitution of the United States and under the statutes herein involved, have been violated wherein plaintiffs are entitled to judicial relief and are entitled to maintain this action as a class action under Rule 23 Federal Rules of Civil Procedure.

Plaintiff Glen L. Rutherford testified that he became ill with cancer in the summer and fall of 1971 and that he was examined by local medical doctors who concluded that he was suffering from cancer. Thereafter he was sent to J. Walker Butin, M.D. of the Wichita Clinic, Wichita, Kansas, for examination and diagnosis.

A number of letters were written by the doctors treating Mr. Rutherford, none of which letters were written in contemplation of this legal action. Such letters which comprise Plaintiffs' Exhibit 1 are in pertinent part as follows:

On November 30, 1971, J. Walker Butin, M.D., of the Wichita Clinic, wrote to Eugene C. McCormick, M.D. of Wellington, Kansas, regarding plaintiff Rutherford:

"Dear Dr. McCormick:

. . . We found the source of his bleeding on sigmoidoscopy. A large polyp is present at 15 cm. from the anal sphincter. It prolapses down and fills the lumen at this point. I was able to biopsy it and the specimen was sent to the Associated Laboratories; we should have a report in two or three days.

My proposal is that he be seen by Dr. Bartlett here with a sigmoidoscopy to see if it might be possible to remove this polyp from below by fulguration. At the moment I think it probably is too large for anything but surgical removal, but if it is okay with you and the patient, we will schedule him to see Dr. Bartlett for his opinion.

* * * * * *

At the moment the arrangement is that he will call us back for the biopsy report in 72 hours, and we will arrange follow-up with Dr. Bartlett and will get his polyp out in the near future."

Dr. Butin again wrote on December 4, 1971:

"Dear Dr. McCormick:

Here is the latest followup on Mr. Rutherford.

He was seen by Dr. Bartlett yesterday, December 3, and was advised that, because of the biopsy showing an invasive adenocarcinoma in the polyp, he should have open operation.

Consequently, he is scheduled to enter Wesley Medical Center on December 10, 1971, for preoperative colon prep and apparently will have surgery several days later, possibly on Tuesday, December 14. The lesion is at about 15 centimeters which is an area where abdominoperineal resection is sometimes necessary. However, it is our hope that he can have an anterior resection with reformation of the normal bowel continuity possible."

On February 28, 1972, Dr. Butin wrote to Dr. Price of Wellington, Kansas:

"Dear Dr. Price:

Mr. Rutherford reported to the Wichita Clinic on November 1, 1971, with a history of aching in the left upper quadrant and bloody stools. On examination, he was rather tender in the middle and left upper abdomen, but there were no specific findings of mass or palpable organs.

Sigmoidoscopy of 15 cm revealed a large prolapsing polyp which appeared pedunculated. This was biopsied and the path report described invasive, well differentiated adenocarcinoma.

He saw Dr. Bartlett on December 3, 1971, and was scheduled to enter Wesley on December 10 for surgery. He was told that removal of the rectum might be necessary but that it would be saved, if possible. As you are well aware, he has not reported for this surgery.

* * * * * *

We would certainly urge Mr. Rutherford not to delay any longer than the three months, which have already been lost, in the treatment of his polyp. This should be an entirely curable lesion, if removal is performed without delay."

The plaintiff Glen L. Rutherford testified that he was tremendously upset and concerned about the prospects of surgery and the results thereof and that he went to Centro Medico Del Mar in Tijuana, Mexico, for examination and treatment shortly after the report from Dr. Butin was made to him. He stated that at Centro Medico Del Mar he was treated with Vitamin B17 or laetrile for a period of weeks and that through this treatment his condition was cured; that he has returned to his home and has been working at all times since, averaging 10 to 12 hours per day. Mr. Rutherford stated that he has no ill effect of the cancer. However, he feels that without the continued use of laetrile as diagnosed by Dr. Carlos Lopez he faces the prospect of escalation of the lethal cancer cells and thus is seeking relief in this Court for the privilege of buying laetrile for his own use and not for sale or barter to others.

Carlos Lopez, M.D., of the Centro Medico Del Mar, Tijuana, Mexico, wrote on August 8, 1974:

"Re: Glen L. Rutherford

This 57 year old white male came to us for a checkup on June 27, 1974. His past history revealed rectal bleeding in the summer of 1969. Saw a doctor at this time and was told it was diverticulitis. He was referred to Dr. Butin in November 1971. After a sigmoidoscopy they found a large polyp and a biopsy was performed. This showed invasive adenocarcinoma. Scheduled for surgery December 10, 1971, but did not show up.

Came first time to our hospital on December 21, 1971. After treatment here the bleeding had quit and we cauterized the remaining polyp. The treatment was Amygdalin i.v. (3 grams) plus proteolytic enzymes. He took home oral Bly and Wobe-Mugos enzymes.

Now he has come again for a checkup. Physical examination unremarkable . . . .

Chest X-Rays show a doubtful nodule in the left lung in the R.M.L. portion (lingula). The rest of the studies were negative. Barium enema did not show any tumors in the rectum, but showed a diverticulitis inflamation of some of them and others with fecal matter.

We asked him to continue on same dosage of B17 2 pills (500 mg each) a day and 3 Wobe-Mugos enzymes a day."

The Court is compelled to find from the testimony and the exhibits that plaintiff Glen L. Rutherford was in late 1971 suffering from invasive adenocarcinoma and that by the use of laetrile, B17 or amygdalin (all being the same drug) his condition was cured, as there is no evidence to the contrary.

The Court finds that plaintiff's Exhibit 2 is a letter from Mr. Rutherford's supplier of B17 or laetrile stating plaintiff's last order of laetrile was seized. It states that the carrier is in jail facing a $10,000 fine and five years in prison for his efforts to furnish Mr. Rutherford his 1975 supply of laetrile. The writer says that the clinic cannot be responsible and that therefore there will be no more mail orders of laetrile in the future.

The Court finds that the plaintiff Rutherford is not free to have shipped to him, nor is he free to directly purchase and bring back to the United States from Mexico quantities of laetrile for preventative treatment of his cancer. To do so would violate the law and would subject him to criminal prosecution.

21 U.S.C. § 355 provides:

"(a) No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) of this section is effective with respect to such drug."

In this connection the Court finds that laetrile has been in use for a number of years in Mexico and other nations around the world; that the FDA has by its regulations made it impossible for the common man to have an application processed through FDA so that said agency would either approve or disapprove the drug known as laetrile. The Court finds that Congress intended by 21 U.S.C. § 355 that the FDA would on its own initiative and in good faith approve or disapprove the use of laetrile, thereby allowing the courts jurisdiction of the subject matter.

The Court finds that the FDA has abdicated its duty to make a clear determination of whether the drug laetrile should or should not be placed in commerce though the drug has been in use for many years and thousands of persons have been treated with it.

The Court finds from the record, testimony and exhibits that laetrile is not lethal in any sense of the word. It is not harmful to the human body and when used in proper amounts under proper control and supervision can effect relief from cancer disease to the satisfaction of many who are privileged to use the same.

The Court further finds from the record that the plaintiff Rutherford herein and those similarly situated have been denied this right of choice in using B17 or laetrile without just cause on the part of the...