United States v. Diapulse Manufacturing Corporation

• Decision Date: 24 May 1967
• Docket Number: No. 4818.,4818.
• Court: U.S. District Court — District of Connecticut
• Parties: UNITED STATES of America v. An Article of Device . . . DIAPULSE MANUFACTURING CORPORATION OF AMERICA.

269 F. Supp. 162

UNITED STATES of America v. An Article of Device . . . DIAPULSE MANUFACTURING CORPORATION OF AMERICA.

No. 4818.

United States District Court D. Connecticut.

May 24, 1967.

COPYRIGHT MATERIAL OMITTED

Jon O. Newman, U. S. Atty., Hartford, Conn., Charles Marr, Department of Health, Ed. & Welfare, Washington, D. C., for plaintiff.

Jason E. Pearl, Nair & Pearl, New Britain, Conn., for claimant, Diapulse Mfg. Corp.

Milton O. Bass, Bass & Friend, New York City, Jacob D. Zeldes, Lawrence W. Kanaga, Bridgeport, Conn., for claimant, C. I. T. Leasing Corp.

RULING ON MOTION FOR JUDGMENT NOTWITHSTANDING THE VERDICT AND FOR A NEW TRIAL

BLUMENFELD, District Judge.

This is an in rem action against a device which the Government alleged was misbranded. Pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 334(a) and (b) (Supp.1965), the Food and Drug Administration seized one "Diapulse" machine, and filed a libel of information against it in the United States District Court for the Northern District of Georgia. The libel alleged that the machine was misbranded, i. e., that the labeling of the device was "false or misleading in any particular." 21 U. S.C. § 352(a) (1964). After the intervention of the Diapulse Corporation as claimant, this action was removed to this district, 21 U.S.C. § 334(b) (Supp. 1965), tried to a jury, and a verdict returned for the libelant, the United States, specifically finding the device to be misbranded. On special interrogatories, the jury found misbranding to be present as to 49 diseases, disorders and conditions, and made no finding as to the remaining 68 diseases, disorders, or conditions claimed by the Government.

In accordance with the verdict of the jury, this court has entered an order declaring the device to be misbranded, and in its discretion, pursuant to 21 U.S. C. § 334(d) (Supp.1965), has given the Diapulse Corporation an opportunity to relabel the device to bring its labeling within the law, rather than ordering the device to be destroyed. E. g., United States v. Allan Drug Corp., 357 F.2d 713 (10th Cir.), cert. denied, 385 U.S. 899, 87 S.Ct. 203, 17 L.Ed.2d 131 (1966); Buticaps, Inc. v. United States, 102 U.S. App.D.C. 253, 252 F.2d 634 (1958); Research Laboratories, Inc. v. United States, 167 F.2d 410 (9th Cir.), cert. denied, 335 U.S. 843, 69 S.Ct. 65, 93 L.Ed. 393 (1948).

The claimant has moved for a judgment notwithstanding the verdict and, in the alternative, for a new trial. Rules 50(b) and 59, Fed.R.Civ.P. Both of these motions will be considered together.

I. Labeling

A device is misbranded "if its labeling is false or misleading in any particular." 21 U.S.C. § 352(a) (1964). The claimant contends that certain materials, particularly medical reprints, which were seized with the device in the office of an Atlanta chiropractor, do not constitute labeling. The Food and Drug Act, 21 U.S.C. § 321(m) (1964), expressly defines labeling as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." (Emphasis added). As far as the machine's operating instructions are involved (Gov.Ex. 1), they were actually pasted on the machine, and obviously constitute labeling. The bulk of the labeling, though, consists of reprints from medical journals, and it is these at which claimant's strongest arguments are leveled.

The purpose of the Food and Drug Act is to protect the consumer; it was not Congress' intent to draw a distinction between groups of spurious claims on the basis of whether or not those claims were physically attached to the product, or whether those claims were sent out at a later date. The word "accompanying" has been given a broad interpretation and comprises any materials which are intended to make claims or refer to a product, regardless of whether they accompanied the product in time or in presence, or in neither. The crucial factor is that the device "and the literature had a common origin and a common destination. * * * The products * * * and the literature were interdependent." Kordel v. United States, 335 U.S. 345, 348, 69 S.Ct. 106, 109, 93 L.Ed. 52 (1948). United States v. Urbuteit, 335 U.S. 355, 69 S.Ct. 112, 93 L.Ed. 61 (1948); United States v. Articles of Drug, 263 F.Supp. 212, 214 (D.Neb.1967); United States v. Seven Jugs, etc., 53 F.Supp. 746, 755 (D.Minn. 1944); accord, United States v. Kaadt, 171 F.2d 600 (7th Cir. 1948).

"One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant." Kordel v. United States, supra, 335 U.S. at 350, 69 S.Ct. at 109.

The only other objection to this labeling would rest on the claim that the reprints were not authored by the Diapulse Corporation, but merely sent out by it. There is no basis in law for such a distinction, for the dispenser of literature is as responsible for its contents as if he had been its author. E. g., V. E. Irons, Inc. v. United States, 244 F.2d 34, 40, n. 6 (1st Cir.), cert. denied, 354 U.S. 923, 77 S.Ct. 1383, 1 L.Ed.2d 1437 (1957). Accord, United States v. John J. Fulton Co., 33 F.2d 506 (9th Cir. 1929); Moretrench Corp. v. FTC, 127 F.2d 792, 795 (2d Cir. 1942).

II. Failure to Reveal Differences of Opinion

Claimant states that the court was in error in charging the jury that if it found a material difference in scientific opinion as to the merits of the device, and if it further found that claimant failed to reveal this difference of opinion, then this failure could be employed by the jury as a method of reaching a finding of misleading labeling.

21 C.F.R. § 1.3 (1967) states without equivocation:

"The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation."

To the same effect, see the Food and Drug Act, 21 U.S.C. § 321(n) (1964).

Claimant states, though, that even if this is the law, it was prejudiced by not being apprised in advance of such a claim. It states, "if such an issue had been raised, the libelant would have been required, in pre-trial discovery, to specify precisely what it is claimed that claimant has omitted from its labelling." But, by operation of the statute, the allegation of false and misleading labeling puts this in issue. There was nothing to stop claimant from specifically asking this question in its interrogatories, although it is hard to determine how libelant's answers could have been different than they were. Claimant makes no claim—nor can it—that it was taken by surprise by the existence of reports adverse to Diapulse, for those reports were always at the heart of the trial. Rather, its claim seems to be that it was taken by surprise by the use to which these reports were put, as a theory of proof. The jury was free to believe, or not to believe, that the claimant had knowledge of adverse reports. Even more to the point, the charge on this issue related especially to evidence elicited on cross examination by the Government of claimant's own witnesses, to the effect that the claimant did not fully or accurately publish the results of its own tests, all this being information peculiarly within the knowledge of the claimant and not discoverable from the Food and Drug Administration. Considering the generally gross and flagrant abuse by counsel on both sides during the pre-trial discovery process— an abuse so pronounced that the Chief Judge of this district requested the United States Attorney to intercede for the purpose of enforcing more proper behavior during pre-trial process ¹—it ill behooves the claimant to complain that this particular issue was not framed clearly enough by the interrogatories.

III. Difference of Opinion Among Experts

As is usual in a trial which hinges on effectiveness of certain treatments or cures, each side produced expert witnesses; and, as is to be expected, the witnesses disagreed with each other as to the effectiveness of the device. According to claimant, this constituted a bona fide difference of opinion and precluded a finding of mislabeling, since proof of falsity of statements must be found as a fact, and a difference of opinion precludes a factual determination.

Claimant, however, has confused the present action which requires the Government to prove that certain statements are false or misleading with an action for fraud, which requires an intent to deceive. Whether the device was capable of performing that which was claimed for it is the ultimate question for the jury, and the only way in which it could make this determination was to weigh the expert testimony. This testimony consisted not only of the personal observations of the witnesses, but also the witnesses' opinions as to the consensus in the scientific community. As 21 C. F.R. § 1.3, supra, makes clear, the existence of a consensus of medical opinion is a fact and is provable as such. United States v. Wood, 226 F.2d 924 (4th Cir. 1955); United States v. Kaadt, supra, 171 F.2d 600, 603-604; see United States v. Dr. David Roberts Veterinary Co., 104 F.2d 785 (7th Cir. 1939). At one time, it is true, the Supreme Court indicated that honest differences of opinion as to the curative effect of a product would rescue a statement from being adjudged falsely or fraudulently advertised. American School of Magnetic Healing v. McAnnulty, 187 U.S. 94, 103-107, 23 S.Ct. 33, 47 L.Ed. 90 (1902). But shortly after a similar decision, United States v. Johnson, 221 U.S. 488, 31 S.Ct. 627, 55 L.Ed. 823 (1911), Congress amended the Food and Drug statute to forbid "false and fraudulent"...