# Amicus Curiae Brief — Weinberger v. Hynson, Westcott & Dunning, Inc. > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386414_0169%3A20 ## Record - **Collection:** Supreme Court brief - **Document type:** Amicus Curiae Brief - **Published:** January 1, 1973 - **Citation:** 412 U.S. 609 ## Text > “A 2 SF INDEX Page Isterest OF E. R. Squiss anv Sons, Inc. as Amicus SEE covey coer 0 teewnsenentsbo0s0s seen dnuaocax 1 QuesTION PRESENTED ....................... Srererre 2 SratuToRY Provisions AND REGULATIONS INVOLVED .... 3 GPATEMENT 20... c cc ccc ccc cc ccc ccccccccccccrccecce 4 WOOT onc ccccccodicccocccvccvceccecccvcscosecs 8 I. Introduction ............. 0... cece eee cece ee 8 II. As Applied in This Case, Respondents’ ‘‘Sum- mary Judgment’’ Regulation Violates Both Con- stitutional and Statutory Requirements ....... 10 A. Burden of Proof .................0.00000. 12 (1) Commissioner’s Summary Judgment | Procedure; Failure to Show Absence of Genuine Issue of Fact ................ 17 (2) Commissioner’s Final Order; Failure to Present Adequately Supported Findings 22 CONCLUSION 2.00. ccc cc cc cc cc cr cc cc ccccscccccces 24 CITATIONS CASES: Arndt v. United States, 222 F.2d 484, 488 (C.A.5,1955) 15 Adickes v. S. H. Kress and Co., 398 U.S. 144, 157 ..... 18 8. Buchsbaum & Co. v. F.T.C., 153 F.2d 85 (C.A. 7, TY) pbaudaeee sh yy snd oe4 we 4st au eens beeeness 20 when seeking summary disposition, but instead shifts the burden of coming forward with proof to the party opposing the motion, and provides for the granting of such an order against that party solely because he hag failed to establish the existence of a factual issue. Such an Order, in a license revocation proceeding, clearly violates the APA, section 7(c), 5 U.S.C. § 556(d), due process requirements, and the requirements of the Fed- eral Food, Drug, and Cosmetic Act that the license revocation must be based upon findings of fact and supported by substantial evidence. (§505(e) and (h), 21 U.S.C. 355(e) and (h)). Petitioners appear to speak to this point in footnote 22, on page 32 of their brief, where in discussing SV v. Secretary of Health, Education, and Welfare, 466 F.2d 455 (C.A.D.C., 1972) it is contended that the Commissioner may, ‘‘by adopting the findings of the NAS/NRC panels rightly place upon the holder of NDA’s issued prior to October 10, 1962 (when it was not necessary to submit any proof of effectiveness to receive approval of an NDA) the burden of coming forward with substantial evidence of effectiveness, to avoid withdraw of the approval of that NDA.’’ The short answer to this post hoc argument by counsel in this Court is that the Notice of Opportunity for a Hear- ing in this case (J.A. 12) did not purport to adopt the NAS/NRC findings nor were they even referred to in the ‘‘Findings’’ made in support of the Order.” (J.A. 72-78). They did not because the 130.14 regulations un- der which the Order was issued are not designed for, or limited to, pre-1962 drugs or to situations where 12 Nor, despite the quoted footnote, did the Commissioner “adopt” or even refer to the NAS/NRC review in the Notice, 33 F.R. 9908 (July 10, 1968), or in the Order, 35 F.R. 16332 (October 17, 1970), involved in the USV case. 21 NAS/NRC panels have spoken. The regulations pro- vide for the same shift of the burden of coming forward with proof regardless of the vintage of the drug or the grounds alleged for withdrawal.” The NAS/NRC Panel review did not constitute any part of the Com- missioner’s ‘‘summary judgment’’ procedure under 21 C.F.R. 130.14, in this or any other proceeding.” Petitioners’ argument is therefore both post hoc and purely hypothetical, i.e., had the Commissioner adopted the findings of the NAS/NRC Panels, then he could have shifted the burden of coming forward with proof. Clearly the Order in this case was not based upon the panel reports because the Commissioner intended to 13Tn addition to the grounds alleged in this proceeding, i.e.,— ‘‘new information . . . that there is a lack of substantial evidence _..? of effectiveness, 21 U.S.C. 355(e) provides that a new drug application may be withdrawn if, e.g.,— (1) the drug is ‘‘unsafe’’ : (2) new evidence shows that such drug is not shown to be safe (3) the application contains any untrue statement of material fact (4) the applicant fails to maintain certain records or make re- quired reports (5) on the basis of new information the labeling is false or misleading in any particular. (J.A. 479-480) 4 The claim that the Notice had ‘‘adopted’’ the NAS/NRC find- ings was not briefed by either party in the Court of Appeals. FDA has, in fact, applied these regulations in Notices of Oppor- tunity for Hearing on Proposed Withdrawals of New Drug Appli- cations involving only issues of ‘‘safety,’’ and where there was no NAS/NRC, or any other committee opinion available to rely upon, see e.g., Notice of Opportunity for Hearing; Dienestrol Diacetate, 38 F.R. 3211 (February 2, 1973). In other proceedings, the FDA has applied these regulations where the Order itself admits that the NAS/NRC conclusions were “unclear.’’ Notice Withdrawing Approval of New Drug Applica- tions, 36 F.R. 20543, 20545 (October 23, 1971). a . 22 base this Order (like the other Orders where there was no NAS/NRC review available) upon the far broader base of the procedural regulations which purport to automatically shift the burden of coming forward, with no showing of any kind.” (2) Commissioner's final order; failure to present adequately supported findings The Commissioner’s final order in this proceeding must ‘‘state the findings on which it is based,”’ 21 U.8.0. 305(e), and be ‘‘supported by and be in accordance with the reliable, probative and substantial evidence,” 5 U.S.C. 556(d). The ‘‘burden of proof” of present- ing sufficient probative evidence to support an order must be carried by the Commissioner and the findings must be based upon such evidence. However, under the procedures established by 130.14, no such showing or findings are required, nor were they made in this case." 1 Tf the Court were to consider the argument that the Commis. sioner. had inferentially attempted to adopt the NAS/NRC review as a basis for ‘‘shifting the burden of coming forward’’ we would be faced with the issues of (1) whether HW&D had proper notice of what arguments it was expected to meet on such a ““summary judgment’’ motion, and (2) whether the unsworn, brief summary of views of a committee, which had, according to the summary it- self, considered only two published papers (J.A. 7-10), would be sufficient to support a summary judgment decision. (‘On summary judgment the inferences to be drawn from the underlying facts contained in such material must be viewed in the light most favor- able to the party opposing the motion.’’ United States v. Diebold, Inc., 396 U.S. 654, 655.) However, since the Order does not pur- port to rely upon the Panel reports (nor did the petitioners’ brief make this argument in the court below), this issue is not before this Court. 16 This case was not unique in omitting findings of fact adequate to support either a summary administrative decision or the final order. Among the reported cases, no such findings were made in the orders rendered in Ciba-Geigy Corp v. Richardson, 446 F.2d 466 (C.A. 2, 1971), 35 F.R. 15253 (Sept. 30, 1970) or USV Phar- maceutical Corp. v. Secretary of Health, Education, and Welfare, 466 F.2d 455 (C.A.D.C., 1972), 35 F.R. 16332 (Oct. 17, 1970). 23 That part of the order which dealt with the alleged existence of ‘‘substantial evidence”’ was not and did not purport to be based upon an examination of all the data presented. Rather, the Order specifically recites the Commissioner’s refusal to do so because according to the Commissioner, the ‘‘materials [relied upon by HW&D] are described for the most part in general terms (e.g., data presented in connection with the New Drug Application for Lutrexin tablets * * * Lutrexin bibliography * * * Trexinest bibliography * * * reprints and abstracts * * *).’’? The Commissioner specifically refused to ‘‘research each article and then determine if itis relevant... [b]ecause such a procedure is not con- templated by the regulations... ..”’ (J.A. 77-78). Eleven studies were analyzed for the purpose of show- ing that ‘‘Lutrexin [is a] new drug within the meaning of 21 US.C. 321(p)(1),”’ (J.A. 74-77) and conclusion- ary general comments concerning what the Commis- sioner characterized only as ‘‘the most basic material in the Lutrexin new-drug application’’ were presented. (J.A. 78). It is, however, clear, and the Order does not allege otherwise, that these two categories do not exhaust the listing of information and data presented by HW&D in support of its position regarding the existence of ‘‘substantial evidence.’’ Since this brief is limited to legal procedural issues, we have not attempted to argue whether the findings which were actually made concerning the eleven studies are in fact supported by the record. However, it is apparent that at least certain of the Com- missioner’s alleged reasons for dismissing these eleven studies were based upon evidence and information which is not in, or supported by, the record. For instance, the Commissioner’s criticism (J.A. 75) of the statistical treatment of the Magewski study, ‘‘Statistical Evaluation of the Reduction of the Incidence of Prematurity (1968)’’ criticizes the manner in which the author presented his data concerning ‘‘24 [women] with one previous pregnanecy’’ and suggests an alternative presentation. The author’s presentation £ € 24 The absence of adequate findings of fact ‘‘on consid. eration of the whole record’’ and ‘‘supported by and in accordance with reliable, probative, and substantia] evidence,’’ to support the Commissioner’s conclusions, in statutory language ‘“‘that on the basis of new infor. mation before him with respect to [Lutrexin] evaly. ated together with the evidence available to him when [such] application was approved, there is a lack of substantial evidence that [it] will have the effects it is purported to have . . .’’ violates section 7(c) of the Administrative Procedure Act, 5 U.S.C. 556(d), and the Federal Food, Drug, and Cosmetic Act, 21 U.8.¢. 355(e) and (h), see Universal Camera Corp. v. NIBB, 340 U.S. 474, Labor Board v. Brown, 380 U.S. 278, 291, CONCLUSION The Court of Appeals in this case upheld the validity of the Commissioner’s regulations but reversed the order withdrawing the new drug application without a hearing on the ground that ‘‘the showing of [HW&D] was such that under a reasonable construction of the Commissioner’s own regulations, as well as under (J.A. 110) appears to be for the purpose of evaluating the effee- tiveness of Lutrexin for increasing the likelihood of ‘‘live births” by these 24 women, as compared with their own prior experiences during their own prior pregnancies. The Commissioner’s suggested alternative ‘‘paring’’ would result in a comparison of the “live birth’’ percentage in these 24 women during their second preg- nancies, against the ‘‘live birth’’ percentage in 15 other women during their first and second pregnancies. Which of these com- parisons is more meaningful is, at the very least, a question of fact requiring evidentiary support. Similarly, although the author analyzed the data in the same Table I by the ‘‘chi-square method,” the Commissioner states that it ‘‘does not admit to a statistical eval- uation by the chi-square method since the test is based on the assumption that each number of the columns in Table I is the sum of independent yes or no responses....’’ (J.A. 75) Such a finding also requires, at the very least, a factual basis in expert testimony, subject to cross-examination and rebuttal by HW&D. Se 25 familiar principles of due process and the requirements of the Administrative Procedure Act, it was entitled to an impartial hearing before its NDA was withdrawn.” (J.A. 179) ' The petitioners have, in this case, sought review of that finding. Squibb recognizes that this Court may afirm the decision of the Court below for the reasons stated by the Court of Appeals—i.e., Hynson, Westcott and Dunning’s showing was adequate to require a hearing even under the Commissioner’s regulations— without the need to reach the question of whether the regulations are themselves valid. Indeed, -this course may be preferable since the adequacy of that showing was the ground relied upon in the Court of Appeals. If this is done, however, the fact that the validity of the regulations has not been decided by this Court should be clearly stated so that the important questions of administrative law presented by these regulations, and potentially affecting administrative practices by . all agencies, will not be foreclosed without adequate consideration by this Court. On the other hand, if the Court should find that HW&D’s showing was not adequate under the Commis- sioner’s regulations, it must of necessity reach the issue of the validity of these regulations. On this issue, we submit that these regulations are invalid, and that the judgment of the Court of Appeals should be affirmed on that ground. Respectfully submitted, VINCENT KLEINFELD ALAN H. Kapitan Rosert H. BecKER ‘Kleinfeld, Kaplan and Becker 1200 Seventeenth Street, N.W. Washington, D.C. 20036 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386414_0169%3A20. Public record. Not legal advice.