United States v. Lanpar Company

• Decision Date: 25 October 1968
• Docket Number: Civ. A. No. 3-2647-B.
• Parties: UNITED STATES of America, Plaintiff, v. LANPAR COMPANY et al., Defendants.
• Court: U.S. District Court — Northern District of Texas

293 F. Supp. 147

UNITED STATES of America, Plaintiff, v. LANPAR COMPANY et al., Defendants.

Civ. A. No. 3-2647-B.

United States District Court N. D. Texas, Dallas Division.

September 13, 1968.

As Amended October 25, 1968.

Melvin M. Diggs, U. S. Atty., Kenneth J. Mighell, Asst. U. S. Atty. Northern District of Texas, Dallas, Tex., for plaintiff.

William P. Fonville, Dallas, Tex., for defendants.

FINDINGS OF FACT, AS AMENDED

HUGHES, District Judge.

I.

Lanpar Company, defendant, is a corporation organized and existing under the laws of the State of Texas and doing business at 2727 Mockingbird Lane, Dallas, Texas. Oren Parmeter, defendant, is Chairman of the Board and a Director of Lanpar Company and resides in Dallas, Texas. Carroll D. Brown, defendant, is President and a Director of Lanpar Company and resides in Dallas, Texas. Robert Bennett, defendant, is Vice-President and a Director of Lanpar Company and resides in Dallas, Texas.

II.

Lanpar has been and is now engaged in Dallas, Texas in manufacturing, processing, packing, labeling, promoting, selling and distributing in interstate commerce products denominated Thyalis, parloid, digitalis, ethinyl estradiol, Thy-Odone, Ethimens, Progest-L, testosterone, Parmone, testradol, Thyrac, Racs, Trep-En-Ol, ammonium chloride, potassium chloride, phenobarbital, amobarbital, Phe-Bel, Cal-Trol, Bar-It, desoxyephedrine, Cellobese, Encholezyme, Glutain, Pepadain, As-Ma-Pa, Heplan, R. J., R.J-Nia, Cal-D, Biflav-C, Nia, Tein, Par-Li-Cin, Par-Up, Partein Powder, Partein Wafers, Par-Tab and Par-Amino.

III.

A number of the products described in Paragraph II, when shipped in interstate commerce by the defendants are accompanied by package inserts and are labeled.

IV.

Persons receiving the products described in Paragraph II from the defendants in interstate commerce also receive from the defendants, both initially and monthly, written, printed, or graphic material including Lanpar Clinical Reviews, Lanpar Technical Reports, Parmae Laboratory Reports and Bulletins, various leaflets, booklets and charts, as set out in Paragraph V of plaintiff's Complaint for Injunction. This written, printed or graphic material supplements and explains the use of the defendants' products in the treatment of obesity. In addition, such persons may receive tape recordings of symposia sponsored by the Lanpar Company which furnished information about intended uses of defendants' products. At these symposia physicians discuss use of thyroid, digitalis and other products made by defendants in the treatment of obesity.

V.

On January 31, 1966, the defendant, Lanpar Company, and the defendants, Oren Parmeter and Carroll D. Brown, entered pleas of guilty to two counts of a criminal Information charging them with shipping drugs which were adulterated in violation of 21 U.S.C. § 331(a) in that the methods used in and the facilities and controls used for their manufacturing, processing, packing and holding did not conform to and were not operated and administered in conformity with current good manufacturing practices as required by 21 U.S.C. § 351(a) (2) (B).

VI.

Various inspections of the Lanpar Company plant at 2727 Mockingbird Lane, Dallas, Texas, were made by Inspectors of the Food & Drug Administration. The last inspection took place during the period February 9 through February 14, 1968. This inspection disclosed that the methods, facilities, and controls used by Lanpar Company for the manufacturing, processing, packing, labeling, and distribution of said drugs were inadequate in the following respects:

a. The compression room was dusty and inadequate to minimize mixups between different drugs.

b. Plastic bags used in packaging were reused. c. Samples for assays were taken only at the beginning of a tablet compression run rather than throughout the run.

d. There were instances of long periods of time between packaging and release for shipment.

e. Assays were not performed for vitamin D in Cal-D nor for belladonna in phebel.

f. Two batches of Cal-Trol were shipped when the records of Lanpar showed that disintegration of individual tablets did not take place within the time provided by company guide lines.

g. Notations on a batch record of Cal-D were not initialed and dated and the weight record was not in file.

h. In the record of a batch of Trep-En-Ol an ingredient was stricken and another inserted with no explanation for the change. Tablets were shipped with labels containing the original ingredients. Doctors receiving such drugs were not instructed to return them, but one year later were sent different labels to put on the bottles.

i. The pyrogen testing room was considered inadequate for proper testing because of a lack of humidity and temperature control.

j. There were instances of records showing actual yield being as much as 30% below theoretical yield.

k. The packaging operation was inadequate in that different products similar in appearance were packaged on four packing machines in close proximity to one another and not separated by physical partitions.

l. A sample of potassium chloride, collected from open stock failed to meet the standard established in the United States Pharmacopia for tablet disintegration.

m. A sample of Thyalis from open stock was found to contain an odd tablet of different size and color from other tablets in the package.

VII.

After the inspection of February 1968 by the Food & Drug Administration and prior to the time of trial steps have been taken by Lanpar to improve procedures in its Dallas plant including the following:

a. Additional equipment has been installed and improvements made in the building.

b. Plastic bags are not reused in packaging.

c. Assays on two batches of Cal-Trol for belladonna have been made and instructions have been given that assays for belladonna must be made.

d. Complete partitions now separate each tablet compressing machine to prevent mixups of different drugs.

e. Packaging machines are now separated.

f. Batch packaging records have been redesigned to prevent errors.

g. Cal-D is now being sent to a biological laboratory for checking for vitamin D potency.

h. A program of representative stability tests is now being set up.

i. The storage area has been completed and additional lighting has been placed in the area.

VIII.

Samples of Cal-D, Par-Tab, digitalis, cellobese, Sp Rx 2099, Trep-En-Ol. Cal-Trol, Sodium Liothyronine and Sp Rx 2123, which had been shipped in interstate commerce by Lanpar Company were tested and their strength was found to fall below that which they were purported to possess.

IX.

The active ingredients of all of the products manufactured by the defendants except for oyster shells and a small proportion of the thyroid glands employed are received by the defendants at Dallas, Texas, from sources outside of the State of Texas.

X.

The Lanpar Company sells the articles manufactured by it to licensed physicians and pharmacies.

XI.

The Lanpar Clinical Reviews recommend and suggest the use of all of the defendants' products except Sp Rx 2099, Trep-En-Ol, and Sodium Liothyronine in the Lanpar program for obesity.

The Clinical reviews and the transcript of the New York Symposium of July, 1965 show this program to provide for the patients' medical history to be recorded on forms supplied by the Lanpar Company, for the patient to be weighed and measured, and for his blood pressure and pulse to be determined at the time of his initial visit. Further laboratory tests such as electrocardiograms, blood tests, including red and white cell counts, and hematocrit determinations, and urinalyses are sometimes suggested. No rigid diet or exercise routine is recommended. An initial regimen of medication is dispensed which provides for patients to receive from 2 to 10 grains of thyroid a day with a median dose of 3 grains a day and from zero to 2 grains of digitalis a day with a median dose of ¾ of a grain a day. In practically all cases a fixed dosage combination of thyroid and digitalis, thyalis, which contains 3 grains of thyroid and ¾ of a grain of digitalis is recommended for use.

Return visits are usually scheduled every 28 days although sometimes drugs are mailed to patients. On visits after the first visit, measurements of weight, blood pressure, pulse rate, and size of bust, waist and hips are recorded. Additional laboratory tests may be done. The daily dose levels of thyroid and digitalis are generally increased. After six months of Lanpar treatment the daily thyroid dose ranges from 3 to 14 grains with a median of 9 grains a day and the daily digitalis dose ranges from zero to 2 grains a day with a median of 1¼ grains per day. Recommended daily dose levels of thyroid reach 22 grains a day and that of digitalis reach 4 grains a day. Defendants also recommend addition of each of the drugs listed in Paragraph II of these findings in various combinations at various times throughout treatment pursuant to the Lanpar program for treatment of obesity. Further, on occasion, defendants also recommend use of thiazide diuretics in combination with their products.

Digitalis is used in the Lanpar program for obesity to cause loss of appetite. Users are told to treat digitalis as a safe drug and that dosage should be regulated according to the size of patients. Belladonna is intended to counter the side effects of digitalis. Thyroid is used to accelerate metabolism and burn off fat. Users are told that doses of thyroid ranging up to 30 grains a day may be given and that in patients with the heart pain of angina, thyroid can be given up to the point of precipitating an attack of heart pain.

Users are told not to inquire further into the way a patient on the program feels if he says he feels fine. They are advised to use double talk to avoid disclosing to patients, or to their physicians, what drugs such patients are being given pursuant to the program.

XII.

The written, printed, and graphic matter referred to in ...