Webb v. Department of Health and Human Services

• Decision Date: 14 December 1982
• Docket Number: No. 81-2345,81-2345
• Citation: 225 U.S.App.D.C. 19,696 F.2d 101
• Parties: N. Conant WEBB, M.D., Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 101

696 F.2d 101

225 U.S.App.D.C. 19

N. Conant WEBB, M.D., Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.

No. 81-2345.

United States Court of Appeals, District of Columbia Circuit.

Argued Oct. 22, 1982.

Decided Dec. 14, 1982.

Frederick Townsend, with whom Alan B. Morrison and David C. Vladeck, Washington, D.C., were on the brief, for appellant.

Patricia J. Kenney, Asst. U.S. Atty., with whom Stanley S. Harris, U.S. Atty., Royce C. Lamberth, R. Craig Lawrence and Michael J. Ryan, Asst. U.S. Attys., Thomas Scarlett, Chief Counsel, Food and Drug Administration, Washington, D.C., were on the brief, for appellees, Department of Health and Human Services, et al.

Joel E. Hoffman, with whom Patricia R. Sharin and Bruce J. Brennan, Washington, D.C., were on the brief, for appellee, Pharmaceutical Manufacturers Association.

Before WILKEY and GINSBURG, Circuit Judges and BAZELON, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge WILKEY.

WILKEY, Circuit Judge:

Appellant, a medical doctor seeking to obtain information from the Food and Drug Administration under the Freedom of Information Act, appeals from the district court's dismissal of his suit. Because we agree with the district court that appellant's attack on the validity of an FDA regulation is not justiciable in the present form, we affirm its decision to dismiss.

I. BACKGROUND

A. Regulatory Scheme

Before a manufacturer can legally market a new drug ¹ in interstate commerce, the Food and Drug Administration (FDA) must approve a New Drug Application (NDA) for that drug. ² An NDA must contain extensive data concerning the drug and its intended use, including full reports of pre-clinical and clinical investigations, adverse reaction reports, and published articles on the use or effectiveness of the drug. ³ After evaluating an NDA, the FDA either approves it, rejects it, or requests supplemental information from the submitter.

Every manufacturer of a new drug must obtain a separately approved NDA. Thus a drug manufacturer which has submitted an NDA has a competitive interest in seeing that the information contained in its NDA is not prematurely released to the public. If a manufacturer's competitor could obtain all the data in the manufacturer's NDA, it could utilize them in its own NDA without incurring the time, labor, risk, and expense involved in developing them independently. Premature disclosure of NDA data is further discouraged by the existence of criminal sanctions for FDA officials who release trade secrets without the submitter's consent. These sanctions are contained in both the Food, Drug, and Cosmetic Act ⁴ and the Trade Secrets Act. ⁵

In an effort to balance the need to prevent premature disclosure of NDA data against the policy of open disclosure embodied in the Freedom of Information Act (FOIA), ⁶ the FDA promulgated 21 C.F.R. Sec. 314.14, the regulation presently being challenged. ⁷ Under section 314.14 the amount of material to be disclosed in response to a FOIA request depends on the stage of agency review to which the NDA has progressed and the extent to which the information has already been made available to the public. If the NDA is pending and its existence has not been publicly disclosed or acknowledged, no data or information in the NDA file will be disclosed. ⁸ If the NDA is pending, but its existence has been publicly disclosed, the agency may release summaries of selected portions. ⁹ If the NDA has been approved, more information is made available. ¹⁰ Finally, if the NDA is abandoned or denied, all information not previously disclosed may be obtained. ¹¹

When the FDA denies a FOIA request, the requester is entitled to de novo review of the agency's decision in a federal district court. ¹² If the FDA has denied the request on the grounds that the information sought is confidential and thus covered by Exemption 4 of FOIA, ¹³ the agency requires the drug manufacturer to defend, presuming that a failure to defend constitutes a waiver of the confidentiality defense. ¹⁴ From that point on, the manufacturer bears the burden of proving that the information is covered by Exemption 4.

B. The Present Litigation

Dr. N. Conant Webb filed a FOIA request with the FDA in July, 1980, seeking disclosure of the safety and effectiveness data ¹⁵ contained in Ciba-Geigy's pending NDA for the drug Anturane. ¹⁶ Webb sought the information because of his interest in evaluating and assessing clinical investigations of new drugs, a subject on which he has lectured in the past. Because the Anturane NDA was pending, FDA denied the request, relying on FOIA Exemption 4, the Food, Drug, and Cosmetic Act, the Trade Secrets Act, and various regulations, including section 314.14. ¹⁷ Webb's administrative appeal was denied for the same reasons.

On 22 January 1981 Webb filed the present suit in federal district court, naming the Department of Health and Human Services, the FDA, and Ciba-Geigy as defendants. The relief sought was twofold. First, Webb sought to compel disclosure of the safety and effectiveness data in the Anturane NDA file. Second, he asked the court to invalidate section 314.14, claiming that the regulation violated FOIA because it permitted the agency to deny his request without a document-by-document review of the file. ¹⁸ Ciba-Geigy initially indicated that it intended to defend the suit on the merits, but less than five months later it released the requested information pursuant to an agreement with Webb. ¹⁹ Webb then filed a motion for summary judgment on the issue of the validity of section 314.14. The federal appellees, joined by intervenor, the Pharmaceutical Manufacturers Association (PMA), opposed the motion, and asked the court to dismiss the suit because it no longer involved a live case or controversy.

On 24 September 1981 the district court granted appellees' motion to dismiss, ruling that the case was both moot and not ripe. The court held that insofar as the challenge to the regulation rested on Webb's request for information in the Anturane NDA it was moot since that information was already available to him. The court then concluded that it could not properly rule on the validity of the regulation in the absence of an actual denial of information, holding that such a challenge was premature. Finally, the court held that it was not necessary to find the regulation valid in order to rule on Webb's request for attorneys' fees, noting that it was only required to find that the FDA had a reasonable basis for denying Webb's FOIA request. After the district court amended its order to clarify that Webb's dismissal did not prevent him from making a request for attorneys' fees, Webb appealed to this court.

II. TIMELINESS OF THE APPEAL

At the outset appellees assert that Webb's appeal should be dismissed because it was not filed in a timely manner. Rule 4 of the Federal Rules of Appellate Procedure provides that the notice of appeal must be filed within 60 days after the judgment is entered. ²⁰ The district court below entered its judgment on 24 September 1981, yet the notice of appeal was not filed until 14 December 1981, more than 80 days later. Webb argues that the filing deadline was stayed for 20 days because he filed a motion to amend the judgment, a motion on which the court did not rule until 15 October 1981. Appellees counter by contending that while a Rule 59(e) motion to amend the judgment does stay the time for filing an appeal, ²¹ Webb's motion did not come under that rule because it was a motion for attorneys' fees. They point out that the Supreme Court has recently held that a motion for attorneys' fees is not governed by Rule 59(e). ²² Therefore, appellees argue, Webb's motion did not stay the time for filing an appeal and his notice was filed after the 60 day period expired. Although appellees' argument is technically correct, an examination of the circumstances of this case prompts us to hold that Webb should be allowed to proceed.

The district court's 24 September judgment contained language indicating that Webb would not be entitled to attorneys' fees. ²³ At the time, the law with respect to motions for attorneys' fees was in great flux. Two circuits ²⁴ had held that a motion for attorneys' fees was governed by Rule 59(e) and that, accordingly, it had to be filed within 10 days of the judgment. ²⁵ Four circuits had held to the contrary. ²⁶ Wishing to preserve his right to obtain attorneys' fees, Webb filed a "motion to amend the judgment," asking the court to clarify its position on attorneys' fees. Appellees consented to the order amending the judgment, referring to Rule 59(e). More importantly, the court, without comment, granted the motion and amended the order to permit Webb to move for attorneys' fees, apparently treating it as a motion to amend the judgment under Rule 59(e). Subsequently, the Supreme Court resolved the conflict concerning the applicability of Rule 59(e) to a motion for attorneys' fees by holding that such a motion did not have to be filed within the 10 day period imposed by Rule 59(e). ²⁷ Thus, although appellees are technically correct that Webb's "motion to amend the judgment" was not a Rule 59(e) motion that stayed the filing deadline, we find that this case comes within the narrow exception to Rule 4 recognized by the Supreme Court in Harris Lines, Inc. v. Cherry Meat Packers, Inc., ²⁸ and Thompson v. Immigration and Naturalization Service. ²⁹

In Harris Lines, appellant's counsel sought and obtained from the district court an extension of the filing date for appeal on the grounds of excusable neglect. The court of appeals dismissed the appeal as untimely because it disagreed with the district court's ruling on excusable neglect. The Supreme Court reversed, stressing that it would be unfair to penalize the appellant for relying on the trial judge's ruling. "Whatever the proper result as an initial matter on the facts here, the record contains a...