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United States v. an Article of Device... Diapulse


decided: June 10, 1981.


Appeal and Cross-Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. Nos. 73 C 157 and 75 C 343 -- Hubert L. Will. Judge .

Before Cummings, Circuit Judge, Gibson, Senior Circuit Judge,*fn* and Cudahy, Circuit Judge.

Author: Cummings

These appeals arose from two civil seizures under Section 304(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 334(a)) to condemn two identical medical devices known as "Diapulse" devices.*fn1 The Government, on behalf of the Food and Drug Administration (FDA), alleged that the devices were misbranded within the meaning of 21 U.S.C. §§ 352(a) and 352(f)(1) in that they were ineffective for the claims contained in their labeling and failed to bear adequate directions for their use. At the outset of the trial in December 1977,*fn2 the claimant, Dr. Henry Niemeyer, stated that he would not defend the claims presented in the labeling and instead sought to have the devices brought into compliance with the law through relabeling.

The district court ruled that the Government was entitled to partial summary judgment, but, over the Government's objection, declined to condemn the devices and instead conducted a trial to determine the validity of the claims in the relabeling proposal. On May 1, 1980, in accordance with findings of fact and conclusions of law issued on March 28, 1980, the district court entered a judgment directing that the devices be returned to claimant provided that they be relabeled solely for use "as adjunct treatment of soft tissue inflammation, sprains or strains" (Govt.App.29). The Government appeals in Nos. 80-1904 and 1905, contending that the district court erred in (1) conducting a trial de novo to determine the validity of claimant's relabeling claims rather than condemning the devices and requiring claimant to submit a compliance proposal to the FDA; (2) finding that the Diapulse is effective for treatment of tissue inflammation, sprains and strains; and (3) granting claimant's pre-trial motion to release the second seized device for use pending trial. In No. 80-1939, claimant cross-appeals, contending that the district court erred in finding the Diapulse ineffective in the healing of wounds and bone fractures. We agree with the Government's first argument. It disposes of the controversy so that we need not reach the other issues raised in the appeals.

A device is misbranded if any portion of its labeling is "false or misleading in any particular." 21 U.S.C. § 352(a); Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 459 (4th Cir. 1960); United States v. Six Dozen Bottles, 158 F.2d 667 (7th Cir. 1947). Once a device is found to be misbranded, it must be condemned pursuant to 21 U.S.C. § 334(a).*fn3 United States v. 76,552 Pounds of Frog Legs, 423 F. Supp. 329 (S.D.Tex.1976); United States v. Diapulse Manufacturing Corporation of America, 269 F. Supp. 162, 169 (D.Conn.1967), affirmed, 389 F.2d 612 (2d Cir. 1968). After entering a condemnation decree, a district court may in its discretion order the condemned article to be destroyed, sold or returned to the owner "to be destroyed or brought into compliance with the provisions of (the Act) under the supervision of an officer or employee duly designated by the Secretary (of Health, Education and Welfare)." 21 U.S.C. § 334(d)(1).*fn4

Thus, as the statutory language makes plain, where a claimant seeks to bring a misbranded device into compliance through relabeling, "the initial determination of the legality of the new labeling is for the administrative body." United States v. Diapulse Manufacturing Corporation of America, 389 F.2d 612 (2d Cir. 1968), certiorari denied, 392 U.S. 907, 88 S. Ct. 2059, 20 L. Ed. 2d 1365.*fn5 This statutory scheme is "sensible and proper" because courts are "not expert on the medical and scientific issues which must be explored in order to produce accurate labeling." United States v. Diapulse Corporation of America, 457 F.2d 25, 29 (2d Cir. 1972). If the claimant is unable to obtain FDA approval of its claims, then it may of course seek judicial resolution of the dispute. However, we agree with the Tenth and Ninth Circuits that

"the supervisory powers committed to the Secretary (of Health, Education and Welfare under Section 334(d)(1)) undoubtedly carry broad authority to determine whether and in what manner the labeling may be brought within compliance with the act. The judicial function is concerned with the end product of the labeling process. While the final decision lies with the courts, great weight must be given to the administrative decision." United States v. Allan Drug Corp., 357 F.2d 713, 719 (10th Cir. 1966), certiorari denied, 385 U.S. 899, 87 S. Ct. 203, 17 L. Ed. 2d 131.

See also United States v. 1,638 Cases of Adulterated Alcoholic Beverages, 624 F.2d 900, 902 (9th Cir. 1980) (quoting and following Allan Drug, supra); United States v. 1,322 Cans * * * Black Raspberry Puree, 68 F. Supp. 881, 881 (N.D.Ohio 1946).

Here the district court undertook to make an independent de novo determination of the validity of claimant's relabeling without first condemning the devices as required by 21 U.S.C. § 334(a) and directing claimant to submit his proposal to the FDA as required by 21 U.S.C. § 334(d)(1).*fn6 Consequently, the judgments appealed from must be reversed and the consolidated cases remanded for further proceedings consistent with this opinion. If the district court finds that, as the claimant argues, remand to the agency would at this point be pointless, then it may proceed to a determination of whether the agency's refusal to accept relabeling is sustainable under an appropriate standard of judicial review of administrative action.

In both appeals (Nos. 80-1904 and 1905) and in the cross-appeal (No. 80-1939), reversed and remanded, costs to be borne by the respective parties.*fn7

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