Court Opinion

ID: 7838637
Source: CourtListenerOpinion
Date Created: 2022-09-08 16:54:03.747079+00
Date Added: 2024-06-11T15:56:15.968018
License: Public Domain

McGOWAN, Circuit Judge,
concurring and dissenting:
Judge Bazelon’s opinion is a careful analysis of an area fraught with both substanfive and procedural complexities, and I find myself in agreement with a very large part of it. In particular, I join in Parts I and II, and generally as well in Part III. It is the remedy discussed and provided in Part IV that gives me difficulty.
The relief afforded by the majority is to leave the grant of summary judgment undisturbed but to remand the record for further proceedings from which it is hoped there will emerge an adequate basis for this court to decide whether that grant shall stand or fall. Part IV in terms assumes that those proceedings will necessitate the production of evidence by both sides, but it expressly abjures any prescription as to just how that will be done. It appears to envisage something that approaches the familiar evidentiary hearing for adjudicatory purposes, but does not go that far, as it could not, of course, without compromising the majority’s avowed goal of retaining the benefits of the streamlined summary judgment procedure.
Since the expedition ordinarily assumed to be characteristic of summary judgment disposition is the majority’s objective, I wonder whether it will in fact be realized. I suspect the parties will have substantial difficulties in accommodating their views on the precise nature of the hearing to be held on remand; and I can foresee this court once more required to wrestle with conflicting contentions on this score. More substantively, I am apprehensive that, in *231view of the nature of the problem identified in Part III, anything short of the statutory hearing identified by the Supreme Court in Hynson as the alternative to summary judgment will be inadequate to accomplish a satisfactory resolution of these problems, either by the agency in the first instance or by this court upon further review. Weinberger v. Hynson, Wescott & Dunning, 412 U.S. 609, 621, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973).
On the one hand, if the applicant’s burden on remand — having been charged by FDA with failing to meet one of the agency’s “imprecise” testing requirements — -is simply to put in the record some factual or logical “support for [its] view” that the requirement is indeed met, Maj.Op. at 228 of 190 U. S. App. D.C., at 1125 of 587 F.2d, it is hard to imagine that an applicant, whose submissions to FDA do not appear to us at this stage to be conclusively insufficient on their face, could not almost automatically comply on remand. Hence, the result of remand and review in this court almost inevitably would be to require a statutory hearing anyway, with only further delay on the road to the merits. On the other hand, if the applicant’s burden of production is more stringent — and thus is inconsistent with any recognizable notion of “summary judgment” — it is difficult to see how the more or less informal remand proceeding contemplated will place FDA or us in a better position than we now are in to resolve the “complicated questions in scientific methodology” referred to by the majority. Maj.Op. at 221 of 190 U.S.App. D.C., 1118 of 587 F.2d. In either case, considerations of expedition cannot be overlooked, especially in a proceeding which has been going on as long as this one has; and it may well be — indeed, it seems probable to me — that, in light of the problems raised by the majority opinion, abandonment at this point of summary judgment is the shorter— rather than the longer — route to final termination of the matter.
The Supreme Court labored mightily in Hynson to include the weapon of summary judgment in the FDA’s procedural arsenal. But, in doing so, it was at pains to recognize that there are “imprecise” as well as “precise regulations, and that summary judgment may not lend itself comfortably to the former. 412 U.S. at 621 n.17, 93 S.Ct. 2479. This is the situation here, as the majority appears to recognize, and as is perhaps most eloquently testified to by the three years it took for FDA to conclude that summary judgment was justified, and by the lengthy period of time consumed in a judicial review which hás had to conclude that FDA’s justification for so doing is not so apparent as to dispense with a further agency hearing of “some kind.” Wolff v. McDonnell, 418 U.S. 539, 557-58, 94 S.Ct. 2963, 41 L.Ed.2d 935 (1974); and see Friendly, “Some Kind of Hearing,” 123 U.Pa.L.Rev. 1267 (1975).
In my view, accordingly, summary judgment should not be sustained where, as here, the applicant is charged merely with a failure to meet an “imprecise” testing requirement established by FDA, but where its failure to conform to the scientific norm underlying that requirement is not conclusively apparent on the face of the application. Under these circumstances, FDA should be required to utilize the statutory hearing procedure for determining whether the application is sufficient, and, if so, whether it should be approved.