Pasadena Research Laboratories v. United States

• Decision Date: 25 October 1948
• Docket Number: No. 11690.,11690.
• Citation: 169 F.2d 375
• Parties: PASADENA RESEARCH LABORATORIES, Inc., et al. v. UNITED STATES.
• Court: U.S. Court of Appeals — Ninth Circuit

169 F.2d 375 (1948)

PASADENA RESEARCH LABORATORIES, Inc., et al. v. UNITED STATES.

No. 11690.

Circuit Court of Appeals. Ninth Circuit.

July 16, 1948.

Writ of Certiorari Denied October 25, 1948.

COPYRIGHT MATERIAL OMITTED

John C. Stick, R. Welton Whann, and Robert M. McManigal, all of Los Angeles, Cal., for appellants.

James M. Carter, U. S. Atty., Ernest A. Tolin, Chief Asst., and Norman W. Neukom, Asst. U. S. Atty., all of Los Angeles, Cal. (Arthur A. Dickerman, Atty., Federal Security Agency, of Washington, D. C. of counsel), for appellee.

Before GARRECHT, MATHEWS and HEALY, Circuit Judges.

Writ of Certiorari Denied October 25, 1948. See 69 S.Ct. 83.

GARRECHT, Circuit Judge.

The appellants were found guilty on five counts of an information charging violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq., hereinafter referred to as the Act, in that they "did * * * unlawfully cause to be introduced * * * into interstate commerce" adulterated and misbranded drugs. The corporate appellant was fined $3,000, and the appellant Bavouset was placed on five years' probation, imposition of sentence upon him having been suspended.

The trial was without a jury, a jury trial and special findings of fact having been specifically waived in writing.

1. The Facts

(a) "Indoform"

It was stipulated as to Counts I and II that a number of vials of "Indoform" were shipped by the appellants on or about September 17, 1945, from Pasadena, California, to Dr. Joseph C. Bunten, Cheyenne, Wyoming. One vial was picked up as a sample by Ralph M. Davidson, a Federal Food and Drug Inspector, on or about January 24, 1946, from Dr. Bunten, and was sealed and mailed to the Food and Drug Administration at Washington, D. C., hereinafter referred to as the Administration.

The vials carried labels announcing that each cubic centimeter of the drug contained three International Units of posterior pituitary and one grain of "thyroid substance."

On February 18, 1946, Arnold E. Mason, at that time employed by the Administration as pharmacologist and analyst, examined the contents of the sample vial. He testified that he "found practically no posterior pituitary in that product, an almost immeasurable quantity." After conducting the test, Mason replaced the bottle into a locked refrigerator until the next day, when he wrapped it and put a seal on it. The vial was sent to San Francisco, according to his testimony.

Mason was asked hypothetical questions, objected to by the appellant, as to whether the drug had contained three international units on the date of shipment, September 17, 1945. The questions assumed that the product had not been exposed to the "destructive temperature" of 212 degrees, had been handled in "a normal and careful manner," and had been tested as Mason had already stated on the stand. Mason answered that it was his opinion that on the date in question "there was a quantity of posterior pituitary which was not measurable by the standard methods of measuring it, or there was none."

On March 27, 1946, Andrew G. Buell, a chemist for the Administration, stationed at San Francisco, broke Mason's seal on the paper wrapper around the vial and examined the product for "thyroid content." He testified that "There was no thyroid present whatsoever." After he made his examination, he "immediately" put his seal on the bottle. The seal was dated March 28, the day after he examined the contents.

(b) The Deficient Pluri-B

As stipulated, a number of vials that form the basis of Counts III and IV were shipped by the appellants to Dr. Clement Swaim, Reno, Nevada, on July 16, 1945. Inspector Frank A. Griebling, of the Administration, picked up two of these vials, which contained Pluri-B, from Dr. Swaim, on August 30, 1945.

The inspector sealed the vials and contents with official seals, and forwarded them by mail to the Vitamin Division of the Administration at Washington.

Hubert H. Capps, a chemist of the Administration, examined one of the vials on September 24, 1945. Although the label on the vial sets forth that this "Sterile Solution of Pluri-B" contains 50 milligrams of Thiamine Hydrochloride, per cubic centimeter, Capps testified that he found it contained approximately only 33 milligrams per cc.

The Government chemist also stated that at the time he received the vial, it had the same cap that it had at the time when he was testifying, "or one very similar to it," adding that "since this does not appear to be broken, I think that it did have that identical cap." He also said, however, that he did not make any examination of the cap to determine whether or not it was punctured in any way, "other than just looking at it."

During the direct examination of Capps, he was asked the following hypothetical question, which the appellants contend was improper because it assumed facts none of which "are supported by any evidence whatever":

"Now, assuming that the product received ordinary and reasonable care, and was not exposed to excessive heats, such as heats any more than would be normal from shipping and the weather, and basing upon what you found on September 24, 1945, the amount of the B-1 or thiamine chloride that you found, have you an opinion as to what percentage or what amount that product, substance, or solution had on or about July 16, 1945, the date it was originally shipped?"

Capps replied that he believed that it did not contain more than 33 milligrams of thiamine hydrochloride per cubic centimeter.

(c) The Contaminated Pluri-B

According to the stipulation, a number of vials with labels, which form the subject-matter of Count VII, were shipped by the appellants on June 18, 1946, to Dr. P. M. Ryerson, Phoenix, Arizona. The vials contained "Pluri-B," and, according to the labels, the contents were "for intramuscular or intravenous use."

On or about July 12, 1946, Maurice P. Kerr, an inspector for the Administration, collected a sample consisting of six vials and their contents, each at random from different boxes of the shipment in Dr. Ryerson's possession. The inspector marked the labels, sealed the vials with official seals, and forwarded them by express to the Administration at Washington.

Dr. Frank H. Wiley, chief of the chemical section of the medical division of the Administration, holding a doctor's degree in biochemistry, testified that he received the sample on July 23, 1946. He put the vials up to a light and found "with the naked eye" that all six of them "were very badly contaminated with undissolved material."

Dr. Wiley was asked the following hypothetical question, which the appellants assert was "bad and improper because it did not include a sufficient factual basis to support an opinion":

"Q. * * * Dr. Wiley, taking the two vials, * * * which I understand you examined about six weeks after the shipment in question here, from your knowledge of sterile solutions and from your observation of sterile solutions, your experience, are you able to express an opinion to this court as to whether or not the contents of those two vials, * * * did contain the undissolved particles you noticed there then as of the date they were shipped, namely, on or about June 18, 1946? Your answer is yes or no. A. Yes.

* * * * * *

"Q. * * * Will you please relate your opinion?"

The appellants object that in the foregoing questions "no mention whatever was made of the conditions to which the drug had been subjected after shipment by appellants."

Dr. Wiley's answer to the question was as follows:

"A. From experience with these materials and from general information of so-called supersaturated solutions, of which this is an example, I would say that this undissolved material was undoubtedly present on June 18th when the material was shipped. There is only one external factor of which I know that would hasten or increase the crystallization of this material, and that would be refrigeration. I doubt very much if the mail bag in which this material was transmitted to Washington was in a refrigerator car."

The appellants comment that "even if the question was proper Wiley's opinion given in response thereto is not entitled to any weight whatever."

Other evidence relating to the drugs in question will be referred to in appropriate places in the discussion that follows.

2. The Canon of Construction

The Act is remedial, and should be liberally construed so as to carry out its beneficent purposes.

In United States v. Dotterweich, 320 U. S. 277, 280, 64 S.Ct. 134, 136, 88 L.Ed. 48, the Court said of this statute:

"The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words. Cases cited"

As we will point out hereafter, we are here being asked to accept defensive refinements that we believe are as gossamer-like as the traditional "shadow of a shade" of the ancient legal commentators. We have recently had occasion to construe this same statute and have endeavored to do so in the liberal spirit commanded by the Supreme Court. Research Laboratories, Inc., v. United States, 9 Cir., 167 F.2d 410, 421. In the instant case, we do not feel disposed to depart from that same generous norm of interpretation, which we believe accords with public policy and with the spirit of the law itself.

3. The Government's Burden and the Appellate Function

The appellants seem to be laboring under a fundamental misconception regarding (1) the degree of proof required from the appellee and (2) the duty of this court in the evaluation of the evidence. Because these misapprehensions are basic, we will endeavor to clear them away at the outset.

(a) "Reasonable" versus "Possible" Doubt

While the appellants professedly recognize the...