UNITED STATES DISTRICT COURT DISTRICT OF COLUMBIA Civil Action No. 479-688 CONNIE A. MATONIS, R-639, DEVON STRATFORD APARTMENTS, DEVON, PENNSYLVANIA 19333, PLAINTIFF บ. THE FOOD AND DRUG ADMINISTRATION OF THE DEPARTMENT OF HEALTH, EDUCATION AND WELFARE OF THE UNITED STATES OF AMERICA, DEFENDANT STATEMENT OF MATERIAL FACTS AS TO WHICH Set forth below are the material facts as to which defendant contends there are no genuine issues. 1. The Food and Drug Administration of the Department of Health, Education and Welfare received a total of 65,536 pieces of mail during the month of February. (McCarter Affidavit, Par. 4.) Of this total 2003 pieces of mail were received by the Consumer Services Staff of the Food and Drug Administration. (Stahl Affidavit Par. 4). One of the functions of the Consumer Services Staff is to answer general correspondence from the public and an unscientific and nonregulatory nature. This is done by four employees of the Food and Drug Administration. (Stahl Affidavit, Par. 2.) 2. The Food and Drug Administration received plaintiff's identical letters dated February 8, 1968 and February 19, 1968, on February 12 and February 20, 1968, respectively. On February 27, 1968, these letters were referred by the Consumer Services Staff to Miss Dorothy Koegler, Information Center Officer of the Food and Drug Administration, for reply. (Koegler Affidavit, Pars. 1 and 5 and Exhibits "B" and "C" thereto.) 3. Plaintiff's letters which were referred to Miss Koegler for reply requested that the Food and Drug Administration make available records described as follows: (a) "all records of the Food and Drug Administration pertaining to the review of claims of the effectiveness of 'drugs for human use containing rutin, quercetin, hesperidin or bioflavonoid." (b) "a copy of, or in the alternative, access to the report submitted by the National Academy of Sciences ‘on a number of drugs containing rutin, quercetin, and citrus bioflavonoid compound"." (c) "access to the names, addresses, and profession, if any, of the members of the National Academy of Sciences-National Research Council committee or panel which studied and/or reported on the above-mentioned 'drugs' and which [the Commissioner of Food and Drugs] referred to at the January 23, 1968 Drug Efficacy Review Conference, in relation to the NAS-NRC secret panel: 'By agreement, members of the panel shall remain anonymous .'" (Koegler Affidavit, Par. 3 and Exhibits "E" and "C" thereto.) 4. On February 28, 1968, Miss Koegler responded to plaintiff's letters as follows: (a) She enclosed a copy of each of the five reports relating to the "drugs containing rutin, quercetin and citrus bioflavonoid compound." (b) She stated that she could not supply the names, addresses, or professions of the National Academy of Sciences-National Research Council Panel which studied or reported on these drugs because the United States Food and Drug Administration did not have that information. (c) She stated that the demand for "all records" of the United States Food and Drug Administration pertaining to the review of claims of the effectiveness of "drugs for human use containing rutin, quercetin, heaperdin, or bioflavonoid" was too vague and all-inclusive and that the Food and Drug Administration would be glad to consider requests for specific records. (Koegler Affidavit, Par. 6 and Exhibit "D" thereto.) 5. The Food and Drug Administration has branded plaintiff's request for copies of the report submitted by the National Academy of Sciences on drugs containing rutin, quercetin and citrus bioflavonoid compound. The Food and Drug Administration does not have the "... names, addresses, and professions... of the members of the National Academy of Sciences-National Research Council committee or panel which studied and/or reported on [these] . . drugs. . . ." The Food and Drug Administration has neither granted nor denied plaintiff's request for "all records of the Food and Drug Administration pertaining to the review of claims of the effectiveness of 'drugs for human use containing rutin, quercetin, hesperidin or bioflavonoid,'" because this description was too vague and all-inclusive for the Food and Drug Administration to act upon the request. (Koegler Affidavit, Paras. 4 and 6 and Exhibit "D" thereto.) 6. The regulations of the Departmenet of Health, Education and Welfare governing requests under the Public Information Act for identifiable records provide for review of initial administrative determinations such as Miss Koegler's upon application of the requester. Plaintiff has not applied for administrative review of the determinations of Miss Koegler contained in her letter of February 28, 1968. (Koegler Affidavit, Par. 7 and Exhibits "A" and "E" thereto.) Respectfully submitted. EDWIN L. WEISL, Jr., Assistant Attorney General, United States Attorney, By E. GREY LEWIS, Assistant United States Attorney, IRVIN GOLDBLOOM, JOHN E. SHOCKEY, Attorneys, Department of Justice, Attorneys for Defendant, The Food and Drug Administration. UNITED STATES DISTRICT COURT DISTRICT OF COLUMBIA Civil Action No. 479-68 CONNIE A. MATONIS, R-639, DEVON STRATFORD APARTMENTS, v. THE FOOD AND DRUG ADMINISTRATION OF The DepartmenT OF HEALTH, EDUCATION, AND WELFARE OF THE UNITED STATES OF AMERICA, DEFENDENT DEFENDENT'S MOTION TO DISMISS OR, IN THE ALTERNATIVE, FOR Defendent, by its undersigned attorneys, respectfully moves the Court to dismiss the Complaint filed herein upon the grounds that: 1. The Court lacks jurisdiction over the subject matter. (a) Plaintiff's action is moot insofar as it attempts to compel defendant to make available agency records which have already been made available to plaintiff administratively. (b) Insofar as plaintiff seeks to compel defendant by this action to make available "all records of the Food and Drug Administration pertaining to the review of claims of the effectiveness of 'drugs for human use containing rutin, quercetin, hasperidin, or bioflavenoid,'" plaintiff's action is pre-mature and she has failed to exhaust her administrative remedies. 2. The Complaint fails to state a claim upon which relief can be granted. In the alternative, defendant moves for summary judgment pursuant to Rule 56, F.R.Civ.P., upon the ground that there is no genuine issue of material fact and defendant is entitled to judgment as a matter of law. In support of these motions the Court is repectfully referred to the Complaint and Exhibits attached thereto, to the Affidavits of Dorothy Koegler, Catherine Stahl, and Ernest McCarter which are filed herewith and made a part hereof, to the Statement of Material Facts As To Which There Is No Genuine Issue, and to Defendant's Memorandum in Support of Defendant's Motion to Dismiss Or, in the Alternative, for Summary Judgment and in Opposition to Plaintiff's Motion for Injunction which is filed herewith. Respectfully submitted. EDWIN L. WEISL, Jr., Assistant Attorney General, United States Attorney, By E. GREY LEWIS, Assistant United States Attorney, IRWIN GOLDBLOOM, JOHN E. SHOCKEY, Attorneys, Department of Justice, Attorneys for Defendant, The Food And Drug Administration. UNITED STATES DISTRICT COURT DISTRICT OF COLUMBIA Civil Action No. 479-68 CONNIE A. MATONIS, R-639, DEVON STRATFORD APARTMENTS, DEVON, v. THE FOOD AND DRUG ADMINISTRATION OF THE DEPARTMENT OF HEALTH, EDUCATION AND WELFARE OF THE UNITED STATES OF AMERICA, DEFENDANT MEMORANDUM IN SUPPORT OF DEFENDANT'S MOTION TO DISMISS OR, IN THE ALTERNATIVE, FOR SUMMARY JUDGMENT AND IN OPPOSITION TO PLAINTIFF'S "MOTION FOR INJUNCTION." I STATEMENT OF THE CASE Plaintiff, as a member of the public, seeks to require the defendant, the Food and Drug Administration of the Department of Health, Education and Welfare, to make available to her the records described as follows: 1. Report submitted by the National Academy of Sciences "to the Food and Drug Administration on a number of drugs containing rutin, quercetin, and citrus bioflavonoid compound." (Complaint, Par. 7(2) and Exhibits 1 and 2 thereto; Exhibits "B" and "C" to Koegler Affidavit.) 2. The "... names, addresses, and profession, if any, of the members of the National Academy of Sciences-National Research Council committee or panel which studied and/or reported on the above-mentioned 'drugs' and which [the Commission of Food and Drugs] referred to at the January 23, 1968 Drug Efficacy Review Conference, in relation to the NAS-NRC secret panel: 'By agreement, members of the panel shall remain anonymous (Complaint, Par. 7(3) and Exhibits 1 and 2 thereto; Exhibits "B" and "C" to Koegler Affidavit.) 3. "[A]ll records of the Food and Drug Administration pertaining to the review of claims of the effectiveness of drugs for human use containing rutin, quercetin, hesperidin, or bioflavanoid' .. [referred to in] . . . the Federal Register, Vol. 33, No. 15, January 23, 1968, Page 618." (Complaint, Par. 7(1) and Exhibits 1, 2, and 3 thereto; Exhibits "B", "C", and "D" to Koegler Affidavit.)1 1 In paragraph 4 of the body of her Complaint, plaintiff incorrectly identifies the Volume of the Federal Register to which she refers as Volume 13 rather than Volume 33. See Exhibits 1, 2, and 3 to Complaint and Exhibits "B", "C", and "D" to Koegler Affidavit for correct identification. As is demonstrated by the Affidavit of Dorothy Koegler, Information Officer of the Food and Drug Administration, which is filed herewith, plaintiff has been promptly supplied by the Food and Drug Administration with the reports requested without charge; the names, addresses, and professions of the members of the National Academy of Sciences' committee which studied and reported on drugs are not known by the Food and Drug Administration and therefore cannot be supplied; and plaintiff's request for access to all the records of the defendant pertaining to the review of claims of the effectiveness of these drugs has neither been granted nor denied because plaintiff has not furnished sufficient information to the agency for it to act upon this request. (Koegler Affidavit, Pars. 4 through 6 and Exhibit "D" thereto.) Plaintiff has filed and served along with her complaint a "Motion for Injunction" which has been set down for hearing as a motion for preliminary injunction although it does not ask for preliminary relief but, in effect, asks for the identical and ultimate relief requested in the Complaint. Defendant now opposes plaintiff's "Motion for Injunction" and moves to dismiss or, in the alternative, for summary judgment upon the grounds that plaintiff's action is moot as to all identifiable records properly requested by plaintiff from the Food and Drug Administration and plaintiff's action is pre-mature as to those records which require a more specific description in order for the Food and Drug Administration to further process plaintiff's request. II A. Plaintiff's Action Is Moot As To The Drug Reports Furnished By The National Academy Of Sciences To The Food And Drug Administration And The List Of Names, Addresses, And Professions Of The National Academy Of Sciences' Committee Which Studied And Reported On The Drugs Plaintiff's Complaint attempts to allege a cause of action under the new Section 3 of the Administrative Procedure Act, 5 U.S.C. § 552, effective July 4, 1967. This statute provides that: 66 "... Each agency, on request for identifiable records made in accordance with published rules stating the time, place, fees to the extent authorized by statute, and procedures to be followed, shall make the records promptly available to any person." (Emphasis added.) The statute further provides that on complaint the district courts have jurisdiction to enjoin the agency from withholding agency records covered by the Act and goes on to provide that nine categories of records are exempt from the Act's coverage. A copy of the entire Public Law 90-23 is attached hereto as Appendix "B". Plaintiff seeks to compel the Food and Drug Administration to make available pursuant to the Act three classes of records described as follows: 1. Report submitted by the National Academy of Sciences "to the Food and Drug Administration on a number of drugs containing rutin, quercetin, and citrus bioflavonoid compound." (Complaint, Par. 7(2) and Exhibits 1 and 2 thereto; Exhibits "B" and "C" to Koegler Affidavit.) 2. The "... names, addresses, an professions, if any, of the members of the National Academy of Sciences-National Research Council Committee or panel which studied and/or reported on the above-mentioned 'drugs' and which [the Commission of Food and Drugs] referred to at the January 23, 1968 Drug Efficacy Review Conference, in relation to the NAS-NRC secret panel: 'By agreement, members of the panel shall remain anonymous (Complaint, Par. 7(3) and Exhibits 1 and 2 thereto; Exhibits "B" and "C" to Koegler Affidavit.) 2 Inasmuch as plaintiff's "Motion for Injunction" neither purports upon its face to be a motion for preliminary injunction nor upon reading does it purport to ask for preliminary relief, it should be treated by this Court as a motion for summary judgment which may not properly be filed and served by plaintiff until 20 days after the commencement of the action. Rule 56(a), F.R.Civ.P. In this connection, defendant notes that plaintiff has herself recognized in her memorandum filed in opposition to defendant's motion for continuance March 8. 1968, that her action is not one for temporary restraining order or preliminary injunction. A copy of plaintiff's memorandum is attached hereto as Appendix "A" for the convenience of the Court. 3 Public Law 90-23, 81 Stat. 54, repealing Public Law 89-487, 80 Stat. 250. 3. "[A]ll records of the Food and Drug Administration pertaining to the review of claims of the effectiveness of 'drugs for human use containing rutin, quercetin, hesperidin, or bioflavonoid' . . [referred to in] . . . the Federal Register, Vol. 33, No. 15, January 23, 1968, Page 813." (Complaint, Par. 7(1) and Exhibits 1, 2, and 3 thereto; Exhibits "B", "C", and "D" to Koegler Affidavit.) As the Affidavit of Dorothy Koegler, Information Officer, Food and Drug Administration, which is filed herewith demonstrates, plaintiff has been furnished without charge the five reports prepared by the National Academy of Sciences. (Koegler Affidavit, Par. 4 and Exhibit "D" thereto.) Miss Koegler's Affidavit states: "3. In this action, plaintiff demands the production of: "(b) ‘a copy of, or in the alternative, access to the report submitted by the National Academy of Sciences "on a number of drugs containing rutin, quercetin, and citrus bioflavonoid compound”.'” "4. In my capacity as Information Center Officer, United States Food and Drug Administration, I have granted the request referred to in paragraph 3 (b), . . .” "5. The United States Food and Drug Administration received plaintiff's identical letters dated February 8, 1968, and February 19, 1968, on February 12 and February 20, 1968, respectively. Copies of those letters are attached as Exhibits B and C. On February 27, 1968, these letters were located in the Consumer Services Staff office and referred to me for reply. “6. On February 28, 1968, I responded to plaintiff by letter, as follows: “(a) I enclosed a copy of each of the five reports relating to the 'drugs containing rutin, quercetin, and citrus bioflavonoid compound.'" As to the list of names and addresses, Miss Koegler's Affidavit explains: cannot either grant or deny the request . . . because the Food and Drug Administration does not have this information." [Par. 4.] "On February 28, 1968, I responded to plaintiff by letter . . . [stating that] I could not supply the names, addresses or professions of the members of the National Academy of Sciences-National Research Council panel which studied or reported on such drugs because the United States Food and Drug Administration did not have that information . . ." [Par. 6] Clearly, the list of names requested is not an "agency record" possessed by the Food and Drug Administration and, therefore, cannot be made available to plaintiff. Under these circumstances, plaintiff's action is obviously moot as to the first two classes of records described. B. Insofar As Plaintiff Seeks To Compel Defendant By This Action To Make Available "All Records Of The Food And Drug Administration Pertaining To The Review Of Claims Of The Effectiveness Of 'Drugs For Human Use Containing Rutin, Quercetin, Hesperidin, Or Bioflavonoid," Plaintiff's Action Is Pre-Mature And She Has Failed To Exhaust Her Administrative Remedies. The third class of records which plaintiff seeks to compel the Food and Drug Administration to make available is described in plaintiff's letters to the Commission as ". . . all records of the Food and Drug Administration pertaining to the review of claims of the effectiveness of 'drugs for human use containing rutin, quercetin, hesperidin, or bioflavonoid'. (Complaint, Pars. 4 and 7 and Exhibits 1 and 2 thereto; Koegler Affidavit, Par. 3(a) and Exhibits "B" and "C" thereto.) In response to this reference in plaintiff's letter, Miss Koegler replied as follows: "We cannot comply with your third demand, which is that "all records" of the Food and Drug Administration pertaining to the review of claims of the effectiveness of 'drugs for human use containing rutin, quercetin, hesperidin or bioflavonoid' be made available to you or to your attorney. This request is too vague and all-inclusive. We shall be glad to consider requests for specific records." [Exhibit "D" to Koegler Affidavit.] |