Opinion ID: 322373
Heading Depth: 1
Heading Rank: 4

Heading: Refusal to Allow Dr. Robinson to Cross-Examine Dr. Sebrell

Text: 104 Section 701(e)(3) of the Food, Drug and Cosmetic Act is one of the relatively few federal regulatory statutes which require rules 'to be made on the record after opportunity for an agency hearing' within the meaning of 5 U.S.C. 553(c). See United States v. Florida East Coast Ry. Co., 410 U.S. 224, 238, 93 S.Ct. 810, 35 L.Ed.2d 223 (1973). Instead of being governed by the rather lenient standards generally imposed by 553 with respect to rulemaking, such cases are subject to 5 U.S.C. 556, the same section which governs adjudication. Subsection (d) of 556 provides, inter alia, that 105 (a) party is entitled to present his case or defense by oral or documentary evidence, to submit rebuttal evidence, and to conduct such cross-examination as may be required for a full and true disclosure of the facts. 106 During the presentation of the FDA's case, all parties were permitted liberal cross-examination. 44 However, after the opposition began to offer its evidence almost eighteen months after the hearing commenced, the Hearing Examiner, evidently concerned about the length of the proceeding, decided to limit the rights of Participants to cross-examine the witnesses called by other Participants. In an order dated December 24, 1969, the Hearing Examiner 'concluded that said Participants are in opposition to the said Stayed Regulations and that witnesses offered by such Participants would not ordinarily be considered to be hostile to the opposition to the said Stayed Regulations of any other such Participant.' If any Participant wished to cross-examine the witness of another, he was to serve a notice of intention to do so. The notice had to state that the written direct testimony of the witness was adverse to the interest of the Participant, make specific reference to the portion of the testimony considered to be adverse, and state the reasons therefor. The Hearing Examiner would determine whether to grant permission to cross-examine in his discretion. If such permission were granted, the Participant's cross-examination was to be limited to those portions of the witness' written direct testimony specified in the notice. On its face this was fair enough. As the Committee Report on the APA indicated, 'The provision (556(d)) on its face does not confer a right of so-called 'unlimited' cross-examination. Presiding officers will have to make the necessary initial determination whether the cross-examination is pressed to unreasonable lengths.' Sen.Doc.No.248, 79th Cong., 2d Sess. 271 (1946). See also, 2 Davis, Administrative Law Treatise 14.15 (1958); Hamilton, Rulemaking on a Record by the Food and Drug Administration, 50 Texas L.Rev. 1132, 1149 (1972). 45 The problem was created by the Hearing Examiner's application of the order in the case of a particularly important witness, Dr. William H. Sebrell, Jr., who had been Chairman of the Committee on Recommended Dietary Allowances of the Food and Nutrition Board of the National Academy of Sciences-- National Research Council, the body which had prepared the 1968 RDA's whence the U.S. RDA's were drawn. The scientific validity of the RDA's was, of course, a question of central importance to the agency's promulgation of the regulations and to this Court's review of them. 107 Dr. Sebrell's name had been included in the FDA's list of witnesses in support of the proposed regulations. He was not called for the reason, as we were told at argument, that he was unwilling to support all of the FDA's regulatory proposals. 46 However, this change of plan was not made known in advance to the Participants, 47 who had justifiably withheld cross-examination of other FDA witnesses because these witnesses had less personal knowledge of the process by which the RDA's were developed and, in many cases, testified before the final form of the 1968 RDA's were made public. 48 108 One of the principal opponents of the regulations was Dr. Miles H. Robinson, 49 representing the National Health Federation (NHF). He had cross-examined the FDA witnesses persistently, doubtless too persistently. 50 When Dr. Sebrell was ultimately called as a witness by the American Medical Association (AMA), Dr. Robinson served two notices of his desire to cross-examine Dr. Sebrell. It was explained to the Examiner that the interests of the NHF and the AMA were antithetical rather than identical, since the NHF was opposing substantially all the proposals, whereas the AMA was generally favorable, proposing only a few modifications. 51 The Examiner declined to permit Dr. Robinson to cross-examine Dr. Sebrell, although he did allow such examination by Mrs. Janie A. Meeter (one of a group of individual consumer opponents), counsel for pharmaceutical manufacturers and a trade organization, and, of course, the FDA. The Examiner also denied permission to appeal his adverse ruling to the FDA. He later said he was standing by his ruling 'so that we will have a clear-cut issue which can eventually be determined by the courts.' We must gratify his ill-chosen wish. 109 We recognize that a hearing examiner must be allowed, indeed encouraged, to take steps to avoid repetitious or aimless cross-examination, particularly in a rulemaking proceeding which had become so gargantuan as this. As the Administrative Conference has recommended, Recommendations and Reports of the Administrative Conference of the United States, vol. 2, Recommendation 71.7, PD(3), at 46, 110 If several participants with common interests desire to cross-examine a witness, the hearing examiner should encourage the participants to select a lead attorney or attorneys to conduct the cross-examination. In the absence of a showing of prejudice, participants with common interests should be grouped by the hearing examiner, and participants in a group should not be permitted to cross-examine witnesses called by other members of the group. 111 But here the NHF and the AMA clearly did not have 'common interests'; the NHF was substantially as adverse to the AMA as it was to the FDA. Moreover, those who were permitted to cross-examine Dr. Sebrell either did not share common interests with NHF or were ineffective. Mr. Dym, counsel for the Pharmaceutical Manufacturers Association (PMA), cross-examined Dr. Sebrell after counsel for the FDA completed his cross-examinations. 52 As the Hearing Examiner noted, Mr. Dym's interest was limited 'to develop(ing) with Dr. Sebrell aspects of the testimony which affected over-the-counter therapeutic preparations.' Indeed, the interests of NHF and PMA were in many respects adverse. 53 Neither can the Examiner's ruling be defended on the basis that cross-examination by another consumer representative was allowed. Mrs. Meeter, a housewife, lacked the professional skills essential for effective cross-examination of Dr. Sebrell. Whereas Dr. Sebrell's expertise relating to the RDA's was what greatly concerned NHF, 54 Mrs. Meeter concentrated mainly on the problems of excluded nutrients and special individual nutritional needs and even in those areas had a great deal of difficulty in framing questions that could survive the objections of FDA counsel. In 21 pages of transcript she obtained answers to fewer than ten distinct questions; objections were sustained as to at least a dozen more and on four occasions the Examiner had to caution Mrs. Meeter about the drift of her questions. So far as concerned the RDA's she succeeded only in obtaining from Dr. Sebrell general statements that they were up-to-date, that they will be periodically revised, and that they are based upon the best available information. This is in sharp contrast to the skills of Dr. Robinson, whose 'ability to ask scientific questions' was recognized early in the hearings by the Hearing Examiner. Of course the Examiner could have limited the time to be allowed Dr. Robinson for cross-examination or taken other means to control Dr. Robinson's persistence. But one must wonder at the brinksmanship that would imperil a hearing which had already lasted for some eighteen months and was to continue for almost five more by what the Examiner himself recognized to be an exclusionary ruling of dubious validity-- even to the point of denying permission to appeal to the agency itself. 55 112 A court reviewing an agency rule-making determination, even when governed by 5 U.S.C. 556, is naturally disinclined to order a remand for failure to allow cross-examination, particularly on a record as enormous as this. Apart from the point which most trial lawyers have learned, through sad experience, that early dreams of confounding experts by cross-examination usually are dreams indeed, the court wonders how much more there would have been for the agency to learn. But Dr. Sebrell was no ordinary witness. 56 The FDA had presented no other witness who was a member of the Food and Nutrition Board, which adopted the 1968 RDA's, except Dr. Bernard Schweigert, whose direct examination was limited by the FDA to nutrient losses which occur as a result of the processing, transportation, storage, and cooking of foods and to a proposed regulation dealing with food fortification to overcome any such losses. 57 When Dr. Robinson attempted to question Dr. Schweigert about the scientific validity of the RDA tables, the Hearing Examiner sustained the objection of FDA counsel that the question 'is beyond the scope.' 58 In contrast, Dr. Sebrell had been chairman of the committee that had prepared the RDA's and on his own account had made many changes in adapting the RDA's into the U.S. RDA's that were incorporated into the regulations; and his testimony is the sole authority cited in the findings for the validity of these derivations. 59 The only other Board members who testified (except for Dr. Schweigert) were called by other Participants, and were thus as unavailable for cross-examination by Dr. Robinson as was Dr. Sebrell himself. 60 113 The FDA is now fertile with suggestions how Dr. Robinson could have overcome the Examiner's egregious error, e.g., by calling Dr. Sebrell as his own witness. But apart from other problems, we are not to take so lightly the command of Congress, whether wise or not, that in a rulemaking hearing governed by 566 'a party is entitled . . . to conduct such cross-examination as may be required for a full and true disclosure of the facts.' 61 The opponents of the regulations were entitled to probe into such important matters as how the RDA's were prepared, 62 whether those who prepared them had any biases that might affect their judgment, 63 what doubts they entertained, what inconsistencies there were, 64 and how far the formulators intended the RDA's to be applied for the purposes to which they have been put. It is no sufficient answer that this court now has a good deal of such information, particularly on the last point, in the General Observations to the 1974 edition, to which we have referred in Part IV, and has not considered this to require invalidation of the regulations. The question rather is whether there is a significant probability that vigorous cross-examination of Dr. Sebrell might have caused the agency to adopt regulations differing from those that it adopted or have provided a record that would have affected the judgment of a reviewing court on the question of sufficiency. Since we cannot say in good conscience that there is not, 65 we must, therefore, remand the case to the FDA with instructions to reopen the record for the limited purpose of permitting reasonable cross-examination of Dr. Sebrell (or, if he is not available, some other qualified member of the Board) by Dr. Robinson or counsel of some other similarly interested Participants. 66