527 F.2d 1008

UNITED STATES of America, Plaintiff-Appellant, v. ARTICLES OF DEVICE CONSISTING OF THREE DEVICES . . . "DIAPULSE,” Defendant-Appellee, and Dr. Rovelle C. Choate, Claimant-Appellee.

No. 75-1317.

United States Court of Appeals, Sixth Circuit.

Argued Oct. 9, 1975.

Decided Jan. 12, 1976.

Rehearing Denied March 5, 1976.

See 532 F.2d 1056.

*1009Thomas E. Kauper, Asst. Atty. Gen., Carl D. Lawson, Samuel R. Simon, Antitrust Div., Dept, of Justice, Washington, D. C., Stuart M. Pape, Food & Drug Div., Dept, of Health, Education and Welfare, Rockville, Md., for plaintiff-appellant.

Joseph J. Leary, Frankfort, Ky., Edward H. Stopher, Boehl, Stopher, Graves & Deindoerfer, Louisville, Ky., for appellees.

Before MILLER, LIVELY and EN-GEL, Circuit Judges.

MILLER, Circuit Judge.

This action was brought in the district court, Eastern District of Kentucky, to condemn three devices known as Diapulse machines,1 on the ground that they were misbranded within the meaning of 21 U.S.C. § 352(f)(1), or more specifically, that their labeling failed to bear adequate instructions for use.

On September 20, 1972, the government filed a claim in the district court for forfeiture of the devices. Subsequently, the United States Marshal seized the items pursuant to 21 U.S.C. § 334.2 No claim having been filed to the devices, the district court entered a default decree of condemnation on January 31, 1973, directing that the devices be destroyed. The default decree, however, was later set aside, and on the ground of excusable neglect, claimant was allowed to file a verified claim to the devices in which it was alleged that he was entitled to possession of the property. Claimant then filed his answer and intervening claim together with written interrogatories directed to the plaintiff, which were later answered. In his answer and intervening claim, claimant admitted that the devices do not bear adequate directions for use within *1010the meaning of 21 U.S.C. § 352(f)(1).3 Nevertheless, claimant alleged that the devices are exempt from th.e labeling requirement under the provisions of 21 C.F.R. § 1.106(d).4

On May 24, 1974, the parties agreed to the following order:

It is hereby agreed to by and between the attorney for the plaintiff and the attorney for the defendant, as evidenced by their signatures hereto, that this cause of action be submitted on the record for final determination, and it is
Ordered that this cause of action be submitted for final determination as presently constituted subject to the answers supplied by the plaintiff to the interrogatories propounded by the intervenor-claimant, and subject to any further orders of the court concerning this matter.

In August 1974, the parties filed cross-motions for summary judgment. The court entered its opinion and order on November 18, 1974, granting claimant’s motion for summary judgment and denying the government’s motion. In its opinion, the court stated:

*1011Turning to the issues raised on the motions for summary judgment, it is noted at the outset that there is no genuine issue as to any material fact, [footnote omitted].

In a footnote, the court stated, inter alia:

The question for resolution herein is whether, on the undisputed facts of record, the machines are in violation of the statute and if the exemption provided for in 21 CFR 1.106(d) is applicable.

The government argues that the court misconceived its function in considering the cross-motions for summary judgment as shown by the following statements of the court:

libelant [the government] must establish its contention by a fair preponderance of the evidence.
I find that the government has failed to prove by a fair preponderance of the evidence that the Diapulse devices are not in compliance with 21 CFR 1.106(d)(3), (4) [footnote omitted] and (5). •

In response, claimant argues that the “agreed order” of May 24, 1974, convérted the cross-motions for summary judgment into motions for judgment on an agreed submission, entitling the court to make findings of fact on any disputed factual questions.

We believe that claimant’s contention is without merit. The parties expressly referred to Rule 56 in their respective motions for summary judgment. Neither referred to the order of May 24. Thus it appears that the parties in effect waived or abandoned the stipulation contained in the May 24 order and elected to invoke summary judgment procedure.

The function of a motion for summary judgment is not to permit the court to decide issues of fact, but solely to determine whether there is an issue of fact to be tried. Aetna Ins. Co. v. Cooper Wells & Co., 234 F.2d 342 (6th Cir. 1956); Nyhus v. Travel Management Corp., 151 U.S.App.D.C. 269, 466 F.2d 440 (D.C.Cir. 1972); United States v. Bissett-Berman Corp., 481 F.2d 764 (9th Cir. 1973). “[Preponderance of the evidence is not the test in a summary judgment proceeding; rather the test is whether a genuine issue of material fact remains after examination of pleadings, depositions, answers to interrogatories, and admissions . on file, together with affidavits.” Ransburg Electro-Coating Corp. v. Lansdale Finishers, Inc., 484 F.2d 1037, 1039 (3d Cir. 1973). It follows that the district court’s consideration of the preponderance of the evidence in ruling on the cross-motions for summary judgment was erroneous.

Instead, the district court should have required the party moving for summary judgment to bear the burden of clearly establishing the non-existence of any genuine issue of fact material to a judgment in his favor. Berry v. Michigan Bell Telephone Co., 319 F.Supp. 401 (E.D.Mich.1967). The evidence should have been construed in the light most favorable to the party opposing the motion. Bohn Aluminum & Brass Corp. v. Storm King Corp., 303 F.2d 425 (6th Cir. 1962).

Claimant concedes that the critical issue centers around the proviso to the third condition for the exemption:

(3) ... Provided, however, that such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.

In support of its motion for summary judgment, the government presented the affidavits of two physicians, both of whom stated that the directions for use of the devices “are not commonly known [by] practitioners who are licensed by law to use the devices.” In considering these affidavits, the district court stated:

*1012I am unable to accept as a certainty, on the basis of the affidavits herein, that the seized articles are devices for which hazards, warnings and other information are not commonly known to practitioners licensed by law to use them. The court is not bound to accept the opinion of expert witnesses as conclusive.

We are aware that courts are not generally required to accept, without more, the bare opinions of expert witnesses. In the present case, the affidavits of the two physicians, when read in their entirety, are not merely bald assertions of opinions but rather are statements of the witnesses relevant to the factual issue of whether directions for use and warnings as to the hazards involved are commonly known among practitioners licensed to use the devices. Although the physicians did give their opinions, the opinions were accompanied by statements of the physicians’ qualifications and other facts on which the opinions were based.5

On the other hand, claimant made no showing that directions for use of the devices were commonly known to practitioners licensed to use them.6 Instead, claimant presented affidavits showing at best that claimant had used the devices to administer 125,000 treatments over a long period of years without any adverse side-effects. On appeal, claimant insists that his use of the device for a long period without any adverse effects is sufficient to satisfy the exemption provisions of the regulations because the purpose of the statute is to exempt labeling which “is not necessary for the protection of the public health.” 21 U.S.C. § 352(f).

Assuming that claimant' has used the device for a long period without adverse effects, this assumption alone in no way suggests that the information for use of the device is commonly known by practitioners licensed for its use. We are not free to disregard the plain meaning of the regulation or the undisputed affidavits of the government that information for use of the device is not commonly known by practitioners licensed to use it.

We have considered other contentions raised on appeal and find them to be without merit.

The judgment of the district court is therefore reversed, and the action is remanded to that court for entry of judgment overruling the claimant’s motion for summary judgment and granting the government’s motion.

United States v. Articles of Device Consisting of Three Devices . . . "Diapulse''
527 F.2d 1008

Case Details

Name
United States v. Articles of Device Consisting of Three Devices . . . "Diapulse''
Decision Date
Jan 12, 1976
Citations

527 F.2d 1008

Jurisdiction
United States

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