IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

 

__________________________________________

                                                                                   

JUDICIAL WATCH, INC.,                                                              

                                                                                   

                                    Plaintiff,                                   

v.                                                                                             Civil Action No.

                                                                                                00-2973 (RJL)

FOOD AND DRUG ADMINISTRATION, et al   

                                                                                   

                                    Defendants.                            

__________________________________________

 

PLAINTIFF’S OPPOSITION TO DEFENDANT’S

MOTION FOR SUMMARY JUDGMENT

 

Plaintiff, Judicial Watch, Inc., by counsel, respectfully submits this Opposition to the Defendant Food & Drug Administration’s Motion for Summary Judgment.

MEMORANDUM OF LAW

 

I.            INTRODUCTION.

 

            Plaintiff, Judicial Watch, Inc., is a non-profit, non-partisan, tax-exempt 501(c)(3) corporation dedicated to deterring, monitoring, uncovering, and addressing corruption in government.  Judicial Watch was organized to improve the ethical and legal standards of government, accountability of government officials to the rule of law, and public understanding of government operations.  To accomplish these goals, Judicial Watch often requests information and documentation from federal agencies through the Freedom of Information Act (“FOIA”).

            In accordance with 5 U.S.C. §552(a), et seq., Plaintiff pursues the goal of FOIA which is “openness in government essential to [government] accountability.”  President's Memorandum for Heads of Departments and Agencies Regarding the Freedom of Information Act, 29 Weekly Comp. Pres. Doc. 1999 (Oct. 4, 1993), reprinted in FOIA Update, Vol. XIV, No. 3, at 3.  In the case at hand, Plaintiff sent a FOIA request to the Defendant, Food & Drug Administration (“FDA”) on October 13, 2000.  The FOIA requested all documents regarding the drug mifepristone (a.k.a. “RU-486”) and the FDA’s approval of mifepristone.  After an unsatisfactory response by the FDA, Plaintiff filed suit on December 12, 2000.  On July 18, 2001 Defendant’s Motion for Stay was granted and this Court ordered Defendant FDA to produce all responsive documents by October 15, 2001.

            On October 15, 2001 Defendant FDA served Plaintiff with a CD-ROM containing the responsive documents.  The CD-ROM consisted of approximately 9,300 pages of information and was subsequently made available on the FDA website.  On December 17, 2001, Defendant FDA served Plaintiff with a Vaughn Index (“the Index”) containing all of the documents withheld either partially or in their entirety.  The Index was three volumes and 1,500 pages in length and contained over 6,000 withholdings.  Several months later, the Population Council, Inc. (“Council”)[1] and Danco Laboratories, LLC (“Danco”)[2] intervened as defendants.  On June 14, 2002, Defendant FDA filed its Motion For Summary Judgment.

            Defendant FDA’s motion for summary judgment is based on three arguments: (1) that the FDA performed an adequate search; (2) that the FDA produced a sufficiently detailed Vaughn Index; and (3) that the FDA correctly and properly applied Exemptions 3, 4, 5 and 6 in withholding documents or portions of documents from Plaintiff.  However, each of Defendant FDA’s arguments is incorrect and lacking in legal authority.  First, Defendant FDA did not perform an adequate search.  The search performed by FDA was not reasonable as is confirmed by a conclusory, vague declaration.  Additionally, Defendant FDA’s search was not reasonable based on the fact that the search did not yield some essential documents.  Second, Defendant FDA did not produce a sufficiently detailed Vaughn Index.  The Index is composed of a conclusory laundry list of vague descriptions of withheld documents and even vaguer descriptions of the bases of the claimed exemptions.  Lastly, Defendant FDA improperly withheld information pursuant to Exemptions 3, 4, 5 and 6 of FOIA.  In addition to the extremely vague descriptions in the Index and the declaration, it is still apparent that the arguments used by Defendant FDA lack legal authority. 

            Because Defendant FDA has not carried its burden of an adequate search and a proper Vaughn Index, its Motion For Summary Judgment should be denied.  Additionally, Defendant FDA’s Motion should be denied because it improperly withheld documents under the FOIA exemptions.

II.            ARGUMENT.

 

A.        FDA has not performed an adequate search and therefore, has not

met its burden.

 

            When an agency receives a FOIA request, its first requirement is to perform an adequate search.  Defendant FDA defined the phrase “adequate search” in its motion as a search that is reasonable.  Memorandum of Points And Authorities In Support of Defendant’s Motion For Summary Judgment (“Defendant’s Memo”) at 7.  Plaintiff does not dispute this reasonableness standard.  Whether a search is reasonable can be proven through sworn affidavits of agency officials who are familiar with the search process.  As stated by the FDA in its motion, the affidavits must be “relatively detailed, non-conclusory and submitted in good faith.”  Defendant’s Memo at 7 (citing Miller v. Department of State, 779 F.2d 1378, 1383 (8th Cir. 1985)).  Plaintiff argues that Defendant FDA did not meet this burden.

            With its motion and memorandum, Defendant FDA submitted the Declaration of Andrea C. Masciale (“Declaration”) as evidence of the reasonableness of the search. The Declaration is detailed about the general process of collecting FOIA documents in response to a FOIA request, but it does not give a detailed account of how the responsive documents for this request were collected.  Only paragraph 13 speaks to collecting documents for this specific request.  Declaration at 5.  The extent of the detail in paragraph 13 is that the Director of the Office of Regulatory Policy, the Office of Regulatory Affairs and FDA’s main office issued emails requesting responses to Plaintiff’s request.  Id.  The next mention of Plaintiff’s request is in paragraph 18, which states that Defendant gathered all of the documents.  Id. at 7.  The Declaration does not contain any information on how the responsive documents were located by the various recipients of the email or who was responsible for locating and arranging them. The lack of this type of information leaves the Declaration lacking in adequate detail and conclusory.  Without a relatively detailed and non-conclusory affidavit, Defendant FDA’s search cannot be deemed reasonable and is therefore, not adequate.

            Additionally, Defendant FDA’s search cannot be deemed reasonable because the search failed to yield documents that are essential to the approval process.  Declaration of Donna J. Harrison,(“Harrison Declaration”),(Exhibit 1).[3]  Plaintiff acknowledges that Defendant FDA’s search is not required to be “perfect” but the search must still be considered reasonable.  Plaintiff contends that the FDA’s search was not reasonable because a reasonable search would have located documents essential to the approval of mifepristone.  Certain guidelines have been established that Defendant FDA must follow in regards to the approval procedure for new drugs.  21 C.F.R. §314.126, et seq.; See also Harrison Declaration, ¶ 3.  Without these related documents, Defendant FDA cannot establish that it followed these guidelines and therefore, cannot prove the approval of mifepristone was legal.

            For example, Defendant FDA’s inadequate search failed to locate documents relating to the two required blinded comparator controlled trials.  Harrison Declaration, ¶ 4(a).  These trials are mandatory in the approval process and their documentation should be easily accessible to the Defendant.  Defendant FDA’s failure to include this documentation does not amount to a requirement of perfection, but a requirement of reasonableness.  It is entirely reasonable that information that was required for the FDA’s approval would be located in an adequately performed search. 

            Also inexplicably missing is any documentation on the “off-label” use of misprostol, the second drug needed to complete a chemical abortion.  Harrison Declaration, ¶ 4(l).  Only approved uses of a drug can be marketed. The FDA must give the required approval. However, Plaintiff has received no documentation of the Defendant FDA’s approval of misoprostol for the purpose of chemical abortion.  In conjunction with this, Plaintiff has received no documentation of a supplemental new drug application (“NDA”) submitted by the sponsor of Cytotec, the trade name for misoprostol, to change the approved use of the drug for chemical abortion.[4]  According to statute, a drug previously approved by the FDA must receive a request in the form of a supplemental NDA when the sponsor wants to use the drug for a new purpose.[5] 21 C.F.R.§314.70.

            Since misoprostol had not been approved for use in chemical abortion, the FDA would have required a supplemental NDA before misoprostol could legally be used with mifepristone for the purpose of inducing chemical abortions.  Like the missing documentation of the blinded controlled studies, this missing “off-label” approval documentation should have been located in an adequately performed search.  It is widely known that the approval of mifepristone alone would not result in the desired result of a chemical abortion.  Only with the use of misoprotol can that result be achieved.  Therefore, it is absolutely essential that misoprostol be FDA approved for use in chemical abortions.  However, that documentation has not been provided to Plaintiff.  As such, Defendant FDA’s search was not adequate.[6]

            Because Defendant had not performed an adequate search, Plaintiff is entitled to discovery.  Discovery as to the adequacy of an agency’s search for responsive documents is crucial to a FOIA plaintiff and the proper juridical administration of FOIA.  Founding Church of Scientology of Washington v. NSA, 610 F.2d 824, 836-37 (D.C. Cir. 1979); see also Weisberg v. Department of Justice, 543 F.2d 309, 311 (D.C. Cir. 1976); Shaffer v. Kissinger, 505 F.2d 389, 391 (D.C. Cir. 1974); Phillippi v. CIA, 546 F.2d 1009, 1014 & n. 12 (D.C. Cir. 1976).  Where the agency’s description of its search is conclusory, or the record raises doubts as to the completeness of the agency’s search, or there is evidence of agency bad faith, summary judgment for the government based on affidavits alone is inappropriate.  Perry v. Block, 684 Ff.2d 121, 126 (D.C. Cir 1982); see also Krikorian v. Department of State, 984 F.2d 461, 468 (D.C. Cir. 1993) (plaintiff need not prove bad faith, however); Exxon Corp. v. Federal Trade Commission, 466 F. Supp. 1088, 1094 (D.D.C. 1978).  In such cases, the plaintiff is entitled to discovery to ascertain the nature and scope of the search undertaken by the agency.  Neugent v. Dep’t of Interior, 640 F.2d 386, 389-90 (D.C. Cir. 1981); Weisberg, 543 F.2d at 311; Founding Church of Scientology, 610 F.2d at 836-37.  Moreover, when the adequacy of an agency’s search is challenged, the facts concerning the adequacy of the search should be construed in the light most favorable to the requestor.  Zemansky v. EPA, 767 F.2d 569, 571 (9th Cir. 1985).

In the instant case, allegations of procedural flaws have been brought forward in the Declaration of Donna Harrison.  (Exhibit 1).  In particular, Dr. Harrison has detailed some of the essential documents that should have been located in a reasonably performed search.  It is clear that Plaintiff is entitled to discovery on all three bases – conclusory description, incompleteness or bad faith – set forth by the D.C. Circuit in Perry, 684 F.2d at 126.

            First, as stated earlier, the Declaration submitted by Defendant FDA lacks adequate detail and is conclusory.  The Declaration’s detail is relegated mostly to a description of FOIA searches in general.  The Declaration completely lacks any detail as to the particular search in response to Plaintiff’s request.  As such, Plaintiff should be granted discovery to gain an adequate understanding of how this search was performed.

Second, Dr. Harrison’s Declaration certainly raises doubts about the completeness of the agency’s search.  For instance, the Declaration sets forth evidence establishing the requirements of a good clinical study, an absolute requirement for FDA approval.  Harrison Declaration, ¶ 4.  If the FDA was following the law, these documents must exist.  As they have not been produced, Defendant FDA’s search cannot be deemed adequate and Plaintiff is entitled to discovery.

Since these documents must exist, the only other possible explanation for its missing from the released documents, is that the documents are being withheld unlawfully.  This would clearly be evidence agency bad faith.  Either explanation satisfies the bases for this Court to grant Plaintiff discovery.

            Given:  (1) the fact that the Declaration submitted by Defendant FDA is vague and conclusory; (2) the fact that there are essential documents missing as are outlined in Dr. Harrison’s Declaration; and (3) that reasonable allegations of incompleteness and/or misconduct in the search exist, Plaintiff should be allowed to conduct discovery into the scope and details of the agency’s search and its procedures for classifying documents as responsive or unresponsive and as exempt or non-exempt.

B.        FDA has not provided a sufficiently detailed Vaughn Index and

therefore, has not met its burden.

 

            In Vaughn v. Rosen, 484 F.2d 820, 824, 827 (D.C. Cir. 1973), cert. denied, 415U.S. 977 (1974), the court held that because the nature of FOIA “seriously distorts the traditional adversary nature of our legal system’s form of dispute resolution” the agency must give the requester of information “adequate specificity…to assuring proper justification by the governmental agency.”  Vaughn marked the beginning of the agency requirement to provide an index containing the information that was being claimed as exempt and the exemption under which it was claimed.  The court would later add that the Vaughn index required “a relatively detailed justification, specifically identifying the reasons why a particular exemption is relevant and correlating those claims with the particular part of the withheld document to which they apply.”  Mead Data Center v. U.S. Department of the Air Force, 566 F.2d 242, 251 (D.C. Cir. 1977).  See also Dellums v. Powell, 642 F.2d 1351, 1361 (D.C. Cir. 1980).  Defendant FDA has failed to submit such an Index.

            The Defendant claims in its memorandum that “an examination of the index, filed separately with this Court, reveals that it provides a detailed description of the documents withheld in whole or in part; the date of the record; the author and intended recipient of the document (if known); the number of pages of the entire document, including attachments; the number of pages withheld; and the claimed relevant exemptions, along with an explanation of the basis for the claim.”  Defendant’s Memo at 15.  The memorandum then points the reader to paragraph 20 of the Declaration which states that “information that was exempt from disclosure under FOIA, as well as other relevant statutes, was redacted from the documents.  A total of approximately 1916 records were released with redactions and 4243 records were withheld in their entirety.  These documents and the bases for their respective withholdings are more fully described in the Vaughn Index attached to this declaration and incorporated herein.”  Declaration at 8.  No further description or detail is found in either Defendant’s Memo or the Declaration.  Therefore, the required detail must be present in the Index itself in order for it to be considered adequate. 

            The Index submitted by Defendant FDA is completely devoid of detail.  The “requester and the trial judge must ‘be able to derive from the index a clear explanation of why each document or portion of a document withheld is putatively exempt from disclosure.’”  Campaign For Responsible Transplantation v. FDA, 180 F.Supp.2d 29, 32 (D.D.C. 2001) (quoting Hinton v. Department of Justice, 844 F.2d 126, 129 (3rd Cir. 1988)).  In 1,500 pages of Index, there is not a single entry by the FDA from which the Plaintiff or this Court can derive a clear explanation.  For example Documents 1 through 108, 113 through 164 and 185 through 228 are all described as a “congressional letter”.[7]  All are partially withheld for the reason of “personal privacy.”  This is the extent of the description.  Defendant FDA’s Index does not allow this Court or Plaintiff to derive a clear explanation of what was withheld as a matter of private privacy or how the exemption properly authorizes the withholding.

            Documents 1839 and 5982 are similarly vague.  The subject of the withheld documents is “handwritten notes.”  This is hardly an adequate description of what information Documents 1839 and 5982 contain.  The documents are withheld in full under the (b)(4), (b)(5) and (b)(6) exemptions. Plaintiff has no way of discerning what part of Document 1839 has been withheld under the (b)(6) exemption and what part of the information is a trade secret under (b)(4) and/or 18 U.S. C. §1905.  Equally unclear is what part of Document 5982 has been withheld under (b)(5) and what part under (b)(6).  Plaintiff cannot know whether the withheld information was indeed a trade secret or deliberative or an unwarranted invasion of privacy without first knowing what was withheld.[8]

            Another example is Document 545, described as a “letter re: manufacturer w/ attach.”  The document is 44 pages long and has been withheld in full.  Defendant FDA simply claims that Document 545 is exempt under (b)(4), 18 U.S.C. § 1905 and (b)(6).  Plaintiff is informed that the document contains “confidential commercial information” and “personal privacy.”  The Index does not describe what specifically has been withheld and under which exemption.  The FDA simply blankets the entire document with the general exemption numbers.  Plaintiff has no way of knowing what was withheld under Exemption 4 and § 1905 and what was withheld under Exemption 6.  In Vaughn, the court stated that, “it was preposterous to contend that all of the information is equally exempt under all of the alleged exemptions.”  Vaughn, 484 F.2d. at 827-28.  The court held that the agency was required to use the Index to itemize and index which segment of the document fit under each exemption.  Id.  By blanketing entire documents under several exemptions without explanation, Defendant FDA has failed to comply with the requirements of  Vaughn.

            Document 653 is another example.  Document 653 is a “letter re: amendment 64 w/ attach.”  The letter is one page and the attachment is 46 pages long.  The document is listed as partially released, but the entire attachment has been withheld.  The Index entry does not list the subject matter of the attachment and yet, it is the attachment that has been withheld in its entirety.  This document does not simply lack a detailed description, it lacks a description all together.  Documents 671 and 4602 are similarly vague.  Document 671 is a 1 page “sending package insert” with a 50 page mysterious attachment.  Defendant FDA withheld the entire 50 page attachment without so much as a general description of what that attachment pertains to.  Document 4602 is described as a letter “re: amendment #39 w/attach.”  The attachment is 48 pages long and has been withheld in full.  Even if the FDA explained what amendment #39 was, which it did not, there is no indication of what the attachment concerns.

            As this Court held in Animal Legal Defense Fund, Inc. v. Department of the Air Force, 44 F.Supp.2d 295, 303 (D.D.C. 1999) summary judgment will be denied if the agency’s declaration “failed to provide a description of the documents to permit the [requester] or [the] Court to test the accuracy of that claim.”  Using the examples of the vague descriptions above, it is clear that neither this Court nor the Plaintiff has the ability to test the accuracy of any of these claims.  As such, Defendant FDA’s motion for summary judgment should be denied.

C.        FDA has improperly withheld information pursuant to Exemptions 3,

4, 5, and 6 of FOIA and therefore, has not met its burden.

 

The Defendant FDA outlines four FOIA exemptions it relies on to withhold

information from Plaintiff’s FOIA request.  Each exemption will be dealt with separately.  However, all suffer from the inadequately detailed Vaughn index.

1.             FDA improperly withheld documents under Exemption 3.

 

Exemption 3 of FOIA concerns records that are:

 

 

class=Section2>

specifically exempted from disclosure by statute (other than section 552b of this title), provided that such statute (A) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (B) establishes particular criteria for withholding or refers to particular types of matters to be withheld.

 

 

class=Section3>

5 U.S.C. § 552(b)(3).  To establish that Exemption 3 has been properly invoked, FDA must demonstrate in a “nonconclusory and detailed fashion” that the withheld record comes within the identified statute.  Goland v. CIA, 607 F.2d 339, 351 (D.C. Cir. 1978) cert. denied, 445 U.S. 927 (1980).  In the instant case, the FDA has failed to make the requisite nonconclusory and detailed showing.

 

class=Section4>

 Defendant FDA claims that Ethics in Government Act (“Ethics Act”), 5 U.S.C. App. § 107, as a withholding statute, prohibits disclosure of confidential financial information required by voting advisory members.   Defendant’s Memo at 16-17.  Pursuant to the Ethics Act, Defendant FDA withheld seven documents in their entirety.  Id. at 16.  In order for the FDA to properly withhold these seven documents under Exemption 3, Defendant FDA must demonstrate in a nonconclusory and detailed fashion that the seven documents come within the purview of the Ethics Act. 

The Ethics Act prohibits disclosure of the “confidential financial disclosure reports” required by “each supervising ethics office.”  5 U.S.C. App. §107(a)(1), (2).  The Ethics Act then, is very narrow in its prohibition.  Presumably, to be exempt from disclosure, the information must be in the form of a confidential financial disclosure report and must have been required by the supervising ethics office.  No where in the Index, or in the Declaration, does Defendant FDA clarify whether these conditions are met.  The declaration submitted by Defendant FDA simply restates the information in the memorandum. Declaration at 10. In fact, the declaration contains no new information or additional details.  Id.  As such, the declaration is conclusory and lacks adequate detail.

Defendant FDA’s Index does not offer any assistance either.  For example, Documents numbered 811 to 816 are all being withheld under the Ethics Act.  Each document is described simply as “fax re: advisory committee.”  Each is withheld in its entirety.  No additional information is given.  Documents 811 to 816 are essentially a mystery.  The FDA does not describe what they are in the declaration or in the memorandum.  The FDA does not demonstrate that it is only confidential financial disclosure reports that are being withheld.  Additionally, the FDA does not show that a supervising ethics committee required the information.  Without showing that the Ethics Act requirements have been fulfilled, Defendant FDA has improperly withheld Documents 811-816.  In short, Defendant FDA has failed to provide the Court and the Plaintiff with a nonconclusory, detailed description of how Documents 811-816 fall within the Ethics Act.  Because Defendant FDA has failed to carry its burden, its Motion should be denied

 

2. FDA improperly withheld documents under Exemption 4, 18 U.S.C. § 1905 and 21 U.S.C. § 331(j).

 

Defendant FDA has withheld 4,225 documents under Exemption 4 of

FOIA, 18 U.S.C. §1905 (the “Trade Secrets Act”) and 21 U.S.C. § 331(j) (the “Federal Food, Drug and Cosmetic Act”).  While each statute differs slightly, all deal with trade secrets and confidential commercial and financial information.

                        a.            Exemption 4

Exemption 4 of FOIA exempts “trade secrets and commercial or financial

information obtained from a person and privileged or confidential.”  5 U.S.C. § 552(b)(4).  To sustain an Exemption 4 withholding, each of these elements (i.e., that the information is commercial or financial, that it is obtained from a person and that it is privileged or confidential) must be demonstrated.  Defendant FDA’s use of Exemption 4 is incorrect in two ways.  First, the FDA includes information which is not, in the ordinary meaning of the words, trade secrets or confidential commercial or financial information.  Second, the FDA includes many documents that cannot be ascertained as being confidential from the lack of description in the Index.

                        First, to claim a (b)(4) exemption, the information sought to be exempt must be a trade secret or confidential commercial or financial information.  In Center For Auto Safety v. NHTSA, 244 F.3d 144, 151 (D.C. Cir. 2001), the court defined “trade secret” as “a secret, commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort.”  The terms “commercial” or “financial” information are a bit less clearly defined.  The courts seem to agree that the terms should be given their ordinary meanings.  This Circuit holds that records are commercial “so long as the submitter has a commercial interest in them.”  Public Citizen Health Research Group v. FDA, 704 F.2d 1280, 1290 (D.C. Cir. 1983) (internal quotation omitted). 

            In its motion, Defendant FDA uses Exemption 4 to withhold the names and addresses of contract manufacturers. Defendant’s Memo at 24.  The FDA contends that the possibility of threats of violence against those who manufacture mifepristone is a proper purpose for withholding information under Exemption 4 and that disclosure would likely cause substantial competitive harm.[9] Id  at 25.  Defendant FDA does not explain how the names and addresses of the contract manufacturer is a trade secret or confidential commercial or financial information.[10]  Names and addresses do not fit into the ordinary meaning of the words and there is also no legal authority to suggest that names and addresses are included in an Exemption 4 withholding.  Withholding names and addresses is not a proper function of Exemption 4.  This type of information is more appropriately placed under Exemption 6.  Because these documents are not trade secrets or confidential commercial or financial information, Defendant FDA improperly withheld them.

            Nor is the alleged potential for violence a sufficient reason to withhold essential information about the approval process of a drug.  The FDA smears all those concerned about the approval process as potential terrorists.  Defendant FDA, as well as Council and Danco, are concerned, more likely, about legitimate public speech in the finest traditions of the First Amendment than about violence.  Bad publicity, not violence caused Hoechst, the parent company of Roussel Uclaf, a French pharmaceutical company, to refuse to act as sponsor or distributor of mifepristone in the U.S.[11] Additionally, the original company Danco contracted with to manufacture mifepristone, Gideon Richter, a Hungarian pharmaceutical company, also backed out of its deal to be associated with the manufacturing and distribution of mifepristone in the U.S.[12] Companies simply do not want to be publicly associated with abortion.  Corporate PR should not take precedence over the public’s “right to know” under FOIA and, more importantly, the public’s health which is advanced by scrutiny available through FOIA.

            Unfortunately, Plaintiff has no way of knowing which documents included in the Index have been withheld under this misapplication of Exemption 4.  The extremely vague nature of the FDA’s Index does not allow Plaintiff or this Court to ascertain which Exemption 4 claims are have been made to withhold the name and address of the contract manufacturer, and which Exemption 4 claims have been withheld for information that may truly fit under the category of trade secrets and confidential commercial and financial information. Without differentiating these, all of Defendant FDA’s Exemption 4 claims should be denied.

            The last element of (b)(4), confidentiality, also has certain factors that must be met.  In Critical Mass Energy Project v. Nuclear Regulatory Commission,(“Critical Mass I”), 830 F.2d 278, 281-82 (D.C. Cir. 1987), vacated by Critical Mass Energy Project v. Nuclear Regulatory Commission, (“Critical Mass II”), 975 F.2d 871 (D.C. Cir. 1992), the Court held that in order for a commercial document to be considered confidential, it must be shown that “disclosure of the information is likely…either…(1) to impair the Government’s ability to obtain necessary information in the future; or (2) to cause substantial harm to the competitive position of the person from whom the information was obtained.”  Critical Mass I at 282.  The agency withholding the information was required to bear the burden of persuading “the reviewing court that ‘the impairment is significant enough to justify withholding the information.’”  Id. at 286 (quoting Washington Post Co. v. HHS, 690 F.2d 252, 268, n.51, (D.D.C. 1982)).  

            Several years after Critical Mass I the same court vacated it’s original holding.  In Critical Mass II, the court made an exception for cases in which the commercial or financial information was given voluntarily to the agency.  In these instances “when a FOIA request is made for information that is furnished on a voluntary basis, however, we have identified a different aspect of the governmental interest in securing confidential information.”  Critical Mass II at 878.  The Critical Mass II court held that “financial or commercial information provided to the Government on a voluntary basis is ‘confidential’ for the purpose of Exemption 4 if it is of a kind that would customarily not be released to the public by the person from whom it was obtained.”  Id. at 879.  Critical Mass II did not change the confidentiality test set forth in Critical Mass I in regards to compulsory commercial and financial information.  

            Defendant FDA properly asserts that the information was compulsory and not voluntary.  This means that in order to withhold documents under Exemption 4, the FDA must show that the information is either likely to impair the Government’s ability to obtain necessary information in the future or the information is likely to cause substantial competitive harm to the submitter.  In its memorandum, Defendant FDA claims that release of the information “provided by the drug manufactures to FDA would cause these third-parties substantial competitive harm.”  Defendant’s Memo at 19. 

            In Gulf & Western Industries, Inc. v. U.S., 615 F.2d 527, 530 (D.C. Cir. 1979), the court stated that in order to demonstrate the required element of substantial competitive harm, the agency needed to show “actual competition and the likelihood of substantial competitive injury.”  In its memorandum, Defendant FDA uses only one example of potential competitive harm: “information about the manufacturing process and formulation of the drug.”  Defendant’s Memo at 23.  The FDA claims that release of such information would “likely assist other companies in developing, manufacturing, and marketing their own designs.”  Id.  However, Defendant FDA does not show actual competition.  The FDA surmises what might happen or what could potentially happen, but the argument lacks the “actual” and “likelihood” elements that make the withholding proper.  Therefore, Defendant FDA’s Exemption 4 withholdings lack legal authority.

b.                  The Trade Secrets Act and the Federal Food, Drug and

            Cosmetic Act.

 

                        The Trade Secrets Act (“TSA”) prohibits disclosure of “trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data.”  18 U.S.C. § 1905.  Defendant FDA argues that the TSA protects trade secrets and confidential commercial or financial information from disclosure.[13]  Defendant’s Memo at 20.  While it is true that the TSA protects certain types of information from disclosure, the TSA is not an independent source of exemption in a FOIA case.  In other words, there is no binding legal authority that holds that information not exempt under Exemption 4 is exempt under the TSA.  See CNA Financial Corporation v. Donovan, 830 F.2d 1132, 1151-52, (D.C. Cir. 1987), cert. denied, 485 U.S. 977 (1988) (holding that the TSA was co-extensive with Exemption 4); See also 9 to 5 Organization For Women Workers v. Board of Governors, 721 F.2d 1, 12 (1st Cir. 1983) (“Consequently, if the government cannot prove that the requested documents are within FOIA exemption 4, their disclosure will not violate section 1905.”). 

                        Therefore, if Defendant FDA fails to carry its burden of proving that the documents are exempt under Exemption 4, the TSA will not operate as a back-up.  Since the FDA has failed to carry its Exemption 4 burden of showing actual competition and a likelihood of substantial competitive harm, the TSA cannot keep the information from being disclosed.

                        Similar to the TSA, the Federal Food, Drug and Cosmetic Act (“FDC”) does not operate as an independent source of exemption.  The FDC prohibits “the using by any person to his own advantage or revealing any information acquired under authority of section…355 [new drugs]…, concerning any method or process which as a trade secret is entitled to protection.”  21 U.S.C. § 331(j).  Like Exemption 4, FDC exemptions must be entitled to protection.  There is no indication that the FDC provides additional authority to withhold.  Rather, the FDA like the TSA, is co-extensive with Exemption 4.  See Anderson v. Department of Health and Human Services, 907 F.2d 936, 951 (10th Cir. 1990) (“In summary, we hold that neither 18 U.S.C. § 1905, 21 U.S.C. § 360(j) nor 21 U.S.C. §331 are broader than Exemption 4’s protection of ‘trade secrets.’”).  Defendant FDA’s inability to sustain the Exemption 4 burden bars the FDA from withholding the documents under the FDC as well

c.                   Inadequate Exemption 4, TSA and FDC descriptions in FDA’s

            Vaughn Index.

 

            As argued above, Defendant FDA’s Index is too vague for the Plaintiff to have a meaningful opportunity to challenge the exemptions.  FDA fails to describe the documents in a manner that would allow Plaintiff or this Court, to challenge the FDA’s contention that the withheld information contains trade secrets or confidential commercial or financial information. 

An example of the inadequacy of Defendant FDA’s Index is Document 707.  The document is described as “cover pages w/ attach.”  The attachment is 25 pages long and the entire attachment is withheld under (b)(4) and 18 U.S.C. §1905.  Defendant FDA claims the reason Document 707 is exempt is because it contains confidential commercial information.  Nowhere in the Index entry for Document 707 does the FDA explain the subject matter of the cover page or the attachment.  These 26 pages could be absolutely anything.  What part of “cover pages with attachment” is confidential commercial information or a trade secret?  Plaintiff has absolutely no way of knowing.

Document 1792 is another example of the inadequacy of Defendant FDA’s Index.  The subject of the withheld Document 1792 is “event reports.”  That is the extent of the FDA’s description.  All of Document 1792’s 40 pages are withheld and for the stated reason of “confidential commercial information.”  What events are reported on in these 40 pages is left up to the imagination of this Court and the Plaintiff.  The need to use one’s imagination is not, however, an element of proper withholding under Exemption 4 of FOIA or 18 U.S.C. §1905.

A particularly disturbing example is Document 2269.  Document 2269 is 839 pages long and described as an “ind submission.”  There is no date on the document and no indication to whom the document was submitted.  All 838 pages of Document 2269 have been withheld under the authority of (b)(4), 18 U.S.C. §1905, 21 U.S.C. §331(j) and (b)(6).  Defendant FDA includes no explanation of what the submission is or what it contains.  There is no mention of what part of the 838 pages is exempt as a trade secret and what part of the 838 pages is exempt as an unwarranted invasion of privacy.  Both this Court and Plaintiff are kept in the dark as to what this 838 pages is and why Defendant FDA claims them as properly withheld.

Many of the documents withheld under Exemption 4 and/or 18 U.S.C. §1905 are so inadequately described that there is no way either this Court or the Plaintiff can even ascertain what the withheld document is.  Documents 526, 527 and 528 are examples. Each document is simply described as a “study summary data” or “combined study summary data.”  Each has been withheld in full and each exceed 100 pages.[14]  The documents have been withheld under (b)(4), the TSA and the FDC.  No other information is given.  Plaintiff cannot meaningfully challenge such exemptions.  Another similar example is Document 4297, described as “data tables.”  The withheld document is 263 pages and has been withheld in full.  There is no indication that these 263 pages of data tables include trade secrets or confidential commercial information.  Document 4297 is simply withheld.

Additionally, there are many withheld documents that are identified by a coding system.  Neither this Court, nor the Plaintiff has been made aware as to what the codes mean.  For example, Document 3880 is described as “study reprints 1987-1988.”  The document is 503 pages and withheld in its entirety.  The description means absolutely nothing to Plaintiff and Defendant FDA does not include a decoder with the Index to which Plaintiff and this Court can refer to find the meaning of “study reprints 1987-1988.” [15]  Other examples of this unidentifiable labeling are vague descriptions like Document 3740’s “study ff/87/486/12” and Document 4398’s “appendix protocol 166a.”  Because the documents have been withheld in full, Plaintiff has no recourse in discovering what the subject of the study or the appendix is.[16]

            This small sampling of documents withheld under Exemption 4, the TSA and the FDC demonstrate that the FDA’s Index in inadequate.  Plaintiff has no way to challenge the propriety of any of the Exemption 4, TSA or FDC withholdings because the Index descriptions are so vague.  Because Defendant FDA has failed to properly invoke Exemption 4, the TSA and the FDC, all documents withheld under these exemptions should be released and Defendant FDA’s motion for summary judgment should be denied.

3. FDA improperly withheld documents under Exemption 5.

 

Exemption 5 of FOIA concerns records that are:  “inter-agency or intra-

agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency ....”  5 U.S.C. § 552(b)(5).  This provision exempts from disclosure those records normally privileged in the civil discovery context.  While this statutory language has been interpreted broadly to incorporate “all civil discovery rules into FOIA [Exemption 5]” (Martin v. Office of Special Counsel, 819 F.2d 1181, 1185 (D.C. Cir. 1987)), each discovery rule or privilege asserted by an agency in any particular case must be construed narrowly to effect FOIA’s overall purpose of liberal disclosure.  As the Supreme Court has noted:

Since virtually any document not privileged may be discovered by

the appropriate litigant, if it is relevant to his litigation, and since

the Act clearly intended to give any member of the public as much

right to disclosure as one with a special interest therein, it is

reasonable to construe Exemption 5 to exempt those documents,

and only those documents, normally privileged in the civil

discovery context.

 

NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 148-49 (1975) (emphasis added) (citations omitted); see also Mapother v. Dep’t of Justice, 3 F.3d 1533, 1537 (D.C. Cir. 1993) (“[Exemption 5], like all FOIA exemptions, must ‘be construed as narrowly as consistent with efficient government operation.’”).  The Supreme Court has recognized three primary privileges/protections covered by this exemption: (1) the deliberative process privilege; (2) the attorney-client privilege; and (3) the attorney work-product doctrine.  Id.

                        The FDA has withheld records under the deliberative process and attorney/client privileges.  Plaintiff will address each basis for withholding responsive records separately.

a. Deliberative Process Privilege.

 

            The deliberative process privilege protects the “decision making processes of government agencies.”  Id. In order to invoke the deliberative process privilege properly, an agency must demonstrate that a record is:  (1) pre-decisional (i.e., prepared prior to the adoption of agency policy); and (2) deliberative in nature (i.e., made in the course of “making recommendations or express[ing] opinions on legal or policy matters”).  Vaughn, 523 F.2d  at 1144.  The agency bears the burden of demonstrating that the record satisfies both requirements.  Coastal States Gas Corp. v. Dep’t of Energy, 617 F.2d 854, 866 (D.C. Cir. 1980).

            In deciding whether recommendations are pre-decisional, an agency must establish “what deliberative process is involved and the role played by the documents in issue in the course of that process . . ..”  Id. at 868.  By contrast, the exemption does not apply to records which merely implement the policy (Brinton v. Department of State, 636 F.2d 600, 605 (D.C. Cir. 1980), cert. denied, 452 U.S. 905 (1981); Nissei Sangyo America, Ltd. v. IRS, No. 95-1019, 1997 U.S. Dist. LEXIS 22473, at **23-24 (D.D.C. May 8, 1997)), or which are intended to explain the action the agency has taken.  Sears, 421 U.S. at 153-54; Judicial Watch, Inc. v. HHS, 27 F. Supp. 2d 240, 245 (D.D.C. 1998) (“deliberative process privilege does not protect documents that merely state or explain agency decisions”).

            In determining whether a document is “deliberative,” the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”)  has held that the exemption covers “recommendations, draft documents, proposals, suggestions, and other subjective documents which reflect the personal opinions of the writer rather than the policy of the agency.”  Coastal States Gas Corp., 617 F.2d at 866.  More recently, however, the D.C. Circuit narrowed its interpretation of this exemption by adopting a standard which focuses on whether there is a genuine likelihood that disclosure will cause harm to the decision making process.  Petroleum Information Corp. v. United States Dep’t of the Interior, 976 F.2d 1429 (D.C. Cir. 1992). 

            In Petroleum Information Corp., the Court identified the “key question” in Exemption 5 cases as “whether  disclosure would tend to diminish candor within the agency” and indicated that this question must be answered by “[i]nquiring whether the requested materials can reasonably be said to embody an agency’s policy-informed or -informing judgmental process . . ..”  Id. at 1435.  The Court emphasized that inquiring “whether the agency has plausibly demonstrated the involvement of a policy judgment in the decisional process relevant to the requested documents serves a further, complementary purpose; it enables us to contain Exemption 5 within its proper scope.”  Id. at 1436.  Thus, records involving more routine decisions “over which the agency has no significant discretion” do not fall within the protections of the privilege.  Id.  Rather, to qualify for protection under the deliberative process exemption, “the kind and scope of discretion involved must be of such significance that disclosure genuinely could be thought likely to diminish the candor of agency deliberations in the future.”  Id. at 1436 n.8.

            As with its other claims of exemption, the FDA has provided only general and conclusory descriptions of the withheld documents which do not provide sufficient specificity to allow an “adequate adversary testing” of the claimed exemptions by the Plaintiff.  Vaughn, 484 F.2d at 828.  In addition, the FDA has consistently failed to demonstrate that the records at issue are pre-decisional or deliberative by failing to identify the decisions to which they pertain or the role the records played in the course of any decision-making process.  Coastal States Gas Corp., 617 F.2d at 868.  Finally, the FDA has also failed to carry its burden of showing that disclosure of the records would actually harm “the process by which policy is formulated.”  Petroleum Information Corp., 976 F.2d at 1435 (emphasis in original).

            An example of this is Document 371, which is described as “advisory committee.”  This entry contains no information on whom the communication is from or to whom it was sent.  The document was withheld in its entirety under the authority of (b)(5) deliberative process.  Neither the Court nor the Plaintiff has any way of ascertaining what decision-making process was involved or how the release of this information will harm agency candor.  The requester is left to assume Document 371 pertains to the decision to approve mifepristone.  However, even with that assumption, Defendant FDA includes no information on how Document 371’s release would demonstrate the process of the FDA’s formulated their approval.  There is no indication that Document 371 involved a policy judgment at all.

            Two other examples are Documents 837 and 839.  Document 837 is described as a “letter re: briefing of meeting w/ attach” and Document 839 is described as a “letter re: briefing w/ attach.”  Both documents have been withheld in their entirety, 41 pages and 15 pages respectively.  The Index lists “deliberative process” as the reason for withholding and the authority as (b)(5).  No further information is given in the Index.  Plaintiff cannot challenge whether these two documents were deliberative or part of a decision-making process because Plaintiff cannot ascertain what these two documents are.  Simply stating that these two documents are letters is not enough to give Plaintiff an opportunity to challenge the withholding.  Defendant FDA does not state what the subject of the meeting was or what the attachment concerns.  The FDA just states that the documents are exempt.

                        Defendant FDA had also included several documents described as “calendar manager appointment with notes” in its Index.[17]  In each of these entries, the document is withheld in full for the stated reason of “deliberative process.”[18]  From this scant description, it is impossible to ascertain how each of these documents is part of a policy-making decision or how each is detrimental to agency candor.  These withholdings do not provide Plaintiff with an adequate opportunity to test their exempt status.

                        Given the FDA’s woefully inadequate descriptions of the records at issue, it clearly failed to meet its burden of demonstrating that the deliberative process privilege applies.  A such, all documents withheld under (b)(5) deliberative process should be released and Defendant FDA’s motion for summary judgment denied.

b. Attorney-Client Privilege.

 

                        “It is settled law that the party claiming the privilege bears the burden of proving that the communications are protected.”   In re Lindsey, 148 F.3d 1100, 1106 (D.C. Cir. 1998), cert. denied, 525 U.S. 996 (1998).  “The ‘attorney-client privilege must be ‘strictly confined within the narrowest possible limits consistent with the logic of its principle,’’” In re Lindsey,148 F.3d at 1108, quoting, In re Sealed Case, 676 F.2d 793, 807, n.44 (D.C. Cir. 1982).  “A blanket assertion of the privilege will not suffice.  Rather, ‘the proponent must conclusively prove each element of the privilege.’” In re Lindsey, 148 F.3d at 1106, quoting, Securities and Exchange Commission v. Gulf & Western Indus., 518 F. Supp. 675, 682 (D.D.C. 1981).   The attorney-client privilege applies only if:

(1) the asserted holder of the privilege is or sought to become a

client; (2) the person to whom the communication was made (a) is

a member of the bar or a court or his subordinate and (b) in

connection with this communication is acting as a lawyer; (3) the

communication relates to a fact of which the attorney was

informed (a) by his client (b) without the presence of strangers (c)

for the purpose of securing primarily either (I) an opinion on law

or (ii) legal services or (iii) assistance in some legal proceeding,

and not (d) for the purpose of committing a crime or tort; and (4)

the privilege has been (a) claimed and (b) not waived by the client.

 

In re Sealed Case, 737 F.2d 94, 99 (D.C. Cir. 1984).  Business and personal advice are not covered by the privilege, even when given by an attorney.  Gulf & Western Indus., Inc., 518 F. Supp. at 681.  In addition, the substance of communications from attorney to client are shielded only if they rest on confidential information obtained from the client.  Mead, 566 F.2d at 254.  “When an attorney conveys to his client facts acquired from other persons or sources, those facts are not privileged.”  Brinton, 636 F.2d at 604, cert. denied, 452 U.S. 905, 101 S. Ct. 3030, 69 L.Ed.2d 405 (1981).  Any voluntary disclosures by a client to a third party breaches the confidentiality of the attorney-client relationship and therefore waives the privilege, not only as to the specific communication disclosed, but often as to all other communications relating to the same subject matter.  In re Sealed Case, 676 F.2d at 809. 

            As with the deliberative process privilege, the FDA failed to meet its burden of demonstrating the applicability of the attorney-client privilege. The lack of any meaningful description leaves the Index devoid of evidence of whether the claimed attorney-client privilege is legitimate.  For instance, from reading the Index it is impossible to discern if the person seeking advice is a client of the attorney; if the person is seeking legal advice; if there was anyone else present who would have destroyed the privilege or if the privilege was waived.  Defendant FDA simply claims the privilege exists.  For example, Document 110 is described as “memorandum re: abortion pill.”  It is from a Department of Justice employee to an FDA employee and has been withheld in full.  Among the reasons for withholding, the Defendant FDA listed attorney-client privilege with (b)(5) as the authority.  From this scant description, Plaintiff cannot even ascertain that an attorney was involved in this communication.  There is certainly no way of qualifying the other requirements of a (b)(5) attorney-client privilege exemption.

            Another example is Document 660 which is an 8 page document described as a “fax re: manufacturers.”  The fax purports to be from outside counsel to an FDA employee.  However, there is no evidence in the Index that the FDA employee went to outside counsel to seek legal advice or that it was legal advice that is the subject of the Document 660.  Plaintiff cannot properly challenge the claimed attorney-client privilege with so little information.

            An additional example is Document 787 that is described as “minutes of meeting.”  The document is from a Searle employee to an FDA employee and it has been withheld in its entirety because of a (b)(5) attorney-client exemption.  Like Document 110, Document 787 has been withheld in full and for the reason of the (b)(5) attorney-client privilege.  However, this entry provides no evidence in the Index of attorney involvement or if that communication was for the purpose of legal advice.

            Defendant FDA has improperly withheld documents pursuant to (b)(5) attorney-client privilege.  Because Defendant FDA has failed to sustain its burden, all documents withheld under (b)(5) attorney-client privilege should be released and Defendant’s motion for summary judgment should be denied.

4.            FDA improperly withheld documents under Exemption 6.

 

Exemption 6 of FOIA exempts “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.”  5 U.S.C. § 522(b)(6).  To properly invoke Exemption 6, the information being withheld must be “personnel and medical files and similar files.”  5 U.S.C. §522(b)(6).  The courts have been fairly liberal in defining the types of information this Exemption includes.  While “personnel and medical file” are sufficiently clear, the term “similar files” has been a point of contention in the courts.  The phrase “similar files” has been defined by courts as information that is personal in nature.  See U.S. Department of State v. Washington Post, 456 U.S. 595 (1982); See also New York Times v. NASA, 920 F.2d 1002 (D.C. Cir. 1990).  In Hemenway v. Hughes, 601 F.Supp. 1002, 1005 (D.D.C. 1985), this Court held that to survive the “initial inquiry the agency need only establish that the records in question apply to a ‘particular individual.” 

            It is impossible to ascertain from the Index, whether the claimed exemptions are records that pertain to a particular individual.  Documents 1738, 1739, 1740, 1741, 1742, 1744, 1745 and 1746 could very well be patient files that would clearly be medical files and would therefore qualify as a (b)(6) exemption.  However, the lack of description in the Index does not enable Plaintiff or this Court to make that conclusion.  Each of these documents is described only as “exhibit – pregnancy test.”  Each document is withheld in full.  Document 1743 is described as “exhibit – subject records.”  This too could be patient’s medical files.  Plaintiff is not however, given enough information in the Index to know.  Documents 1901 through 1924 are referred to as “subject records.”[19]  The “subjects” could be patients.  However, due to a complete lack of adequate description, the exact nature of the subject records are remains a mystery.  If this Court and the Plaintiff cannot ascertain whether these types of withheld documents are indeed medical files, the documents should be released since the preference of the courts is disclosure.

Seemingly different from the documents above, Documents such as 417, 418, 419 and 420 do not appear to be related to patients at all.  Document 417 is a six-page “order for supplies and services.”  Document 418 is a two-page “conflict of interest letter.”  Document 419 is a two-page “exec. secretary: notice of meeting.”  Document 420 is a one-page “notice of meeting.”  All of these documents have been withheld in their entirety for the reason of “personal privacy.”  Defendant FDA includes no more detail than that.  A “notice of meeting” wouldn’t ordinarily be considered a medical or personnel file, nor would an “order for supplies and services.”  The problem is, Plaintiff has no way of knowing what those documents are.  With such little detail, there is no way for Plaintiff to know whether this information is a medical, personnel or similar file.  Without first knowing whether the withheld document is a medical, personnel or similar file, weighing the public interest is virtually impossible.

Many of the documents claimed by Defendant FDA as exempt under (b)(6) do not look like privacy issues at all.  For example, Document 2848 is described as “chemistry and clinical information.”  Document 2848 is 110 pages in length and has been withheld for both confidential commercial information and personal privacy reasons.  The Index entry does not state what it is that is being claimed as a matter of personal privacy.  There is no indication that the “chemistry and clinical information” is from a medical, personnel or similar file.  This information, whether the information is truly personal, is essential to proper withholding under (b)(6).

In addition to an inadequately descriptive Index, in its memorandum, the FDA claimed Exemption 6 for “names of agency personnel and government employees…names of various HHS employees…names and employment addresses of various private individuals” all of whom were associated with the approval of mifepristone.  Defendant’s Memo at 33.  This is not a proper application of Exemption 6.  While the names the FDA seeks to exempt are personal to the individual, the records from which the name was excised is not a “detailed government record on an individual.”  Department of State v. Washington Post Co., 456 U.S. 595, 602 (1982) (emphasis added).  The records Defendant FDA presumably seeks to exempt are not files about agency personnel or government employees.[20]  Rather, the files are medical studies and correspondence regarding the approval of a new drug in which the name of an agency or government employee appears.  

            Association with a trade, or project is not an Exemption 6 function.  In Board of Trade of the City of Chicago v. Commodity Futures Trading Commission, 627 F.2d 392, 399-400 (D.C. Cir. 1980) the court held that the “withheld information associates these individuals with business of the Board, and not with any aspect of their personal lives.  The interest in non-disclosure thus asserted is not in continued privacy of personal matters, but in anonymity of criticism on purely commercial matters.”  Like Board of Trade, the information Defendant FDA seeks to withhold is information in relation to an individual’s association with the mifepristone approval.  It is not the type of personal information the courts exempt under Exemption 6.

Even if this Court finds that the information is a “similar file,” Exemption 6 is tempered by the fact that even information decidedly personal can be released if the public interest sufficiently outweighs the individual’s privacy.  See United States Department of Justice v. Reporters Committee, 489 U.S. 749 (1989).  A drug with the potential to be deadly to the patient qualifies as public interest.  Public health and well-being is historically a proper reason to make public information that overlaps into areas of personal privacy.  The available information regarding the testing of mifepristone reveals that the approval was granted without taking into account many important considerations. 

For example, there is no indication that Defendant FDA tested mifepristone on women with pre-existing medical conditions and the question of drug interactions remains largely unanswered. See Citizen Petition re: Request for Stay and Repeal of the Approval of Mifeprex (mifepristone) for the Medical Termination of Intrauterine Pregnancy through 49 Days’ Gestation, 30-36 (August 2002).  Also, the FDA approval did not require the use of ultrasound testing prior to the administration of mifepristone.  Id. at 57-61. However, the women used in the study trials were all given ultrasound tests to determine the age of the fetus and whether an ectopic pregnancy existed.  Defendant FDA has admitted that mifepristone does not terminate an ectopic pregnancy.  This leaves the women in serious physical jeopardy if the ectopic pregnancy goes undetected.  Id. at 60-61.  Therefore, any and all information pertaining to these health risks and other health risks not specifically named here, must be made public.  The public interest here far outweighs any privacy interests.

In addition to the potential side effects, the various studies done and released by Defendant FDA did little to dispel the potential side effects of mifepristone use.  Id. at 87.  For example, there is no information on how repeated use or long-term use of mifepristone will affect the reproductive health of women.  Id.  These facts are of public interest and any privacy interest involved is outweighed by the public importance.

Additionally, the emotional well-being of women who take mifepristone is a matter of great public interest.  The FDA approval of mifepristone includes the use of misoprostol, the drug that causes contractions and causes the women to expel the dead fetus.  Defendant FDA approved the use of misoprostol at home.  Id. at 72-73.  Essentially, the woman receives the misoprostol to take home and administer herself 48 hours after receiving the mifepristone from the doctor.  Chances are the woman will contract and deliver her dead fetus alone.  Making the full impact of this act public is of such great public interest that even if the information withheld does properly fall within (b)(6), it should be made available to the public. 

Whether the approval of mifepristone side-stepped necessary medical investigations that would have substantiated safety restrictions is of pubic interest.  By waiving the Pediatric Rule, the FDA approved mifepristone without knowing how it will affect women under the age of 18.  Id. at 66, 76-83.  Yet, the approval was granted without a restriction on prescribing mifepristone to women under 18.    Also, Defendant FDA relied heavily on trials already performed in France. Id. at 25-27, 35, 40-41. These trials had serious flaws and incorporated elements in the testing that the FDA did not in turn require for approval in this country.  Id. at 75-76.  Any information pertaining to the FDA’s use of flawed, incomplete or inconsistent tests should be made public regardless of personal privacy concerns.  The use of these tests underscores the safety and effectiveness of the product the FDA approved and released for public use.  Any information that sheds light on potential health and safety risks is of public interest and should be released.

Lastly, whether the FDA pushed through the approval of mifepristone because of political pressure is certainly of high public interest.  The fact that Defendant FDA went looking for a sponsor for mifepristone is unprecedented.  The parties involved in this, from the Clinton-Gore White House to the drug companies, should be made public.  Id. at 8.  The personal privacy interest in this information is outweighed by the great public interest in fostering openness in government, the very purpose of FOIA.  The fact that Defendant FDA approved mifepristone under the Accelerated Approval Regulations is an indication that politics played a part in the approval process.  Id. at 18-73.  Mifepristone is clearly not a drug prescribed for a life-threatening disease or condition.  All other drugs approved under the Accelerated Approval Regulations, have been for life-threatening diseases or conditions.  (See Exhibit 4).  Even the sponsor of mifepristone, Danco, objected to the use of the Accelerated Approval. In the end Danco acquiesced to its use to gain approval. (See Exhibit 5). 

The reason Defendant FDA, over overt objections from the drug’s sponsor, utilized an inappropriate approval statute, is of intense public interest.  In short, the documents Defendant FDA seeks to withhold under Exemption 6 are of such high public interest that even if they are considered “similar files,” the public interest outweighs the individual’s personal privacy.[21]  In other words, the disclosure of this information is not an unwarranted invasion of privacy.

Defendant FDA claims that the information should be withheld because of the “risk that individuals associated with the development, marketing, and distribution of mifepristone could become the targets of threats and acts of violence.”  Defendant’s Memo at 35.  Defendant relies on Hudson v. Department of the Army, 1987 U.S. Dist. LEXIS 16736 (D.D.C. Jan. 29, 1978) as its legal authority.  Hudson is so factually different than this case, that it should be disregarded.

In Hudson, the plaintiff requested a computer tape that included the names, ranks, military organizations and mailing addresses for all of the active duty military personnel who had a registered vehicle.  Id. at *2.  The court held that the information was exempt because releasing it put the military personnel overseas at serious risk of terrorist threats.  Id. at *4.  The court acknowledged that the FOIA statute required it to construe the exemption narrowly, but that the well-documented “recent terrorist activity, including increased intelligence gathering by terrorists of information similar to that requested here” was enough to tilt the balancing test toward a privacy exemption.  Id. at *5.  The court also held that “the public interest in disclosure is minimal and is not sufficient to override the serious privacy concerns raised here.  Releasing the name, rank, and unit of overseas military personnel does not foster governmental accountability or other public purposes…”  Id. at *10.

This case is not like Hudson for three reasons.  First, despite the claims of the Defendant, the facts of this case are significantly different.  In the FDA’s declaration, it claims that a few isolated incidents of violence qualify to withhold the names and identities of those associated with the approval of mifepristone.  By using Hudson, the Defendant tries to convince this Court that these isolated instances are the same as the terrorist threats overseas military personnel face.  They are not the same.  The areas of the world that the Hudson plaintiff sought the information included areas like the Middle East that are constantly involved in a state of war and unrest.  That is not the case here.  There is no state of war or unrest here and the isolated acts of violence that occur should be and will be prosecuted under the laws of this country.  It is simply too much of a stretch to say that this case is the same as one involving international terrorism.

Second, Defendant FDA’s reliance on Hudson is misplaced because of the FDA’s focus on effects.  In Arieff v. U.S. Department of Navy, 712 F.2d 1462, 1468 (D.C. Cir. 1983), the court held that “the test of the Exemption [6] does not apply to an invasion of privacy produced as a secondary effect of the release.  According to the statute, it is the very ‘production’ of the documents which must ‘constitute a clearly unwarranted invasion of personal privacy.’”  (emphasis in original).  The FDA has relied too heavily on the potential effects of the release of the information and not on the actual production itself.  As such, Defendant FDA’s reliance on Hudson is misplaced.

Lastly, the FDA’s explanation of Hudson overlooks a significant point.  The court in Hudson carefully considered the balancing test between personal privacy and public interest.  Even with the clear threat of overseas terrorism, the court still deliberated the balancing test.  Hudson at *10.  Additionally, as stated earlier, the idea that anyone with a legitimate concern for the safety and well-being for the health of women is a terrorist is ridiculous.  What Defendant FDA is attempting to avoid is not violence, but public scrutiny.  However, Defendant FDA has not provided a legitimate reason explaining why only this process, the approval of mifepristone, should be immune from public scrutiny. In the end, the public interest did not outweigh the privacy interests involved.  Id.  As argued above, the public interest in this case does outweigh any privacy interests.

III.                 CONCLUSION.I.INTRODUCTION.

            Defendant FDA has failed to meet its burden of demonstrating that it is entitled to summary judgment because it has not satisfied the requirements of performing an adequate search or submitting a proper Vaughn Index. Wherefore, for all of the foregoing reasons, this Court should deny Defendant FDA’s motion for summary judgment.

Respectfully submitted,

                                                                        JUDICIAL WATCH, INC.

 

                                                                        ________________________________

                                                                        Larry Klayman, Esq.

                                                                        D.C. Bar No. 334581

                                                                        Paul Orfanedes, Esq.

                                                                        D.C. Bar No. 429716

                                                                        501 School Street, S.W.

                                                                        Suite 725

                                                                        Washington, D.C.  20024

                                                                        (202) 646-5172

 

 

 

CERTIFICATION

 

            I hereby certify that on October 11, 2002 a true copy of the foregoing PLAINTIFF’S OPPOSITION TO DEFENDANT’S MOTION FOR SUMARY JUDGMENT was served by first-class mail, postage prepaid, on the following:

 

Attorneys for Defendant FDA:

 

                                                Edith Shine, Esq.

                                                Assistant U.S. Attorney

                                                FOOD AND DRUG ADMINISTRATION

                                                Judiciary Center Building

                                                555 Fourth Street, NW

                                                Washington, D.C.  20001

 

Attorney for Defendants-Intervenors The Population Council, Inc., and Danco Laboratories, LLC:

 

                                                Nancy L. Buc, Esq.

                                                Kate C. Beardsley, Esq.

                                                BUC & BEARDSLEY

                                                919 Eighteenth Street, NW

                                                Washington, D.C.  20006

 

                       

 

 

 

                                                ________________________

                                                Meredith Cavallo

 

 


            [1]Population Council was the sponsor of mifepristone.  It also owns the trademark “Mifeprex” which is the official trade name for mifepristone.

                [2]Danco Laboratories is the distributor of mifepristone in the United States.

[3] Dr. Harrison relies primarily on Guidance for Industry, E6 Good Clinical Consolidated Guidance, U.S. Department of Heath & Human Services, Center For Drug Evaluation and Research, April 1996.  A copy of this has been attached as Exhibit 2.

[4] Searle was the sponsor of misoprostol in the FDA approval process and owns the trademark “Cytotec.”

[5] Subpart H Final Rule, 57 Fed. Reg. At 58, 953.

[6] For a more complete look at the missing documentation, Plaintiff has attached the Declaration of Donna J. Harrison, M.D., F.A.C.O.G.  This Declaration cites twelve areas of documentation that should have been located in an adequately performed search.

[7] This does not include Documents numbered 13, 42, 43, 52, 91, 96, 99, 104, 122, 160, 186 or 220.

[8] Other extreme examples of a complete lack of description are Documents 1787 and 1788 (“table, main lab temp”), Document 1950 (“organization chart”), Document 1951 (“map”), Documents 2166, 2169 and 2175 (“operational checklist”), Documents 2167, 2168 and 2183 (“batch record”), Document 2372 (“study ste-196-A-03-1”), Document 2377 (“fda form w/ attach”), Document 2420 (“report on 2 studies w/ attach”), Document 2539 (“study f/82/486/01”), Document 2544 (report re: articles/study reports”), Document 2572 (“articles”), Document 2573 (“report re: additional information”), Document 2676 (“fda form: handwritten”), Documents 2937 and 2938 (“annual reports”), Documents 3058, 3060, 3061, 3062, 3064, 3067, 3068, 3071, 3074, 3075, 3077, 3081, 3082, 3084, 3090, 3091, 3092, 3095, 3096, 3097, 3098, 3099, 3100, 3101, 3102, 3104, 3105, 3106, 3107, 3109 - 3116, 3118, 3119, 3120, 3121, 3122, and 3123 (“meeting minutes”); Document 3078 and 3086 (“outstanding issues”), Document 3222 (“fax re: listing w/ attach”), Document 3331 (“references 89/11450gn”),Document 4280 (“memo to file”),  Documents 6033 and 6036 (“fax transmission sheet”) and Document 6035 (“fax cover page”).  This is not a complete list of documents with inadequate descriptions.

[9] The FDA states that it relied on the findings of FDA Commissioner Jane Henney and Acting Principal Deputy Commissioner Bernard Schwetz.  Defendant’s Memo at 24.  In turn, both of these individuals relied on attorneys in the Civil Rights Division at the Department of Justice.  The attorneys who prognosticated that the manufacturer of mifepristone would be a target for threats and acts of violence serve on the National Task Force on Violence Against Reproductive Health Care Providers.  The potential for bias in the foundation of this “authority” is very likely.

[10] Interestingly, the name of the contract manufacturer is much less of a secret than Defendant FDA makes it out to be in its Memorandum.  In fact, the name of the manufacturer, the Chinese pharmaceutical company in Shangai, Hua Lian Pharmaceutical Company, appears both in the Vaughn Index (Documents 1719 and 1977 for example) and in the Documents released on the FDA website (MIF 005082 for exaple).  Hua Lian’s identity as the manufacturer of mifespristol has also been the subject of several articles in national publications.  (Exhibit 3).  Therefore, as a practical matter, the need for secrecy does not exist.

[11] See Andre Ulmann, M.D.., “The Development of Mifepristone: A Pharmaceutical Drama in Three Acts,” Journal of the American Medical Women’s Association 55 (Supplement 2000): 1177-20, at 119.

[12] See “RU-486: U.S. Partners Sue European Manufacturer,” Kaiser Daily Reproductive Health Report (June 12, 1997).

[13] In its Memorandum, the FDA cites 18 U.S.C. § 1906 as its authority for the Trade Secrets Act.  Reading the context of the brief, Plaintiff assumes this is a typo.  Also, the FDA uses § 1905 in the Vaughn Inex as its authority.

[14] Document 526 is 108 pages.  Document 527 is 177 pages and Document 528 is 290 pages.

[15] Documents 3878, 3879, 3881 - 3888, 4124 and 4219 are all “study reprints” with different years.  They vary in length, but have all been withheld in their entireties.

[16] Other examples with unidentifiable labeling are Documents 3707, 3713, 3716, 3719, 3722, 3725, 3728, 3731, 3734, 3737, 3741, 3744, 3747, 3751, 3758, 3762, 3765, 3768, 3771, 4238 and 4243  (all described as “study protocol” with specific numbering); Documents 3952, 3954, 3955, 3956, 3958, 3724, 3727, 3730, 3733, 3736, 3743, 3746, 3750, 3756, 3757, 3761, 3764, 3767, 3770, 4049, 4179 and 4180 - 4191 (all described as “report study” or “study report” followed by specific numbering); Documents 2850, 2851, 2852, 2853, 2855, 2856, 2858, 2859, 3009, 3011 -  3042, 3665, 3666, 3667, 3668, 3670, 3671, 3672, 3673, 3674, 3675, 3705, 3706, 3715, 3717, 3718, 3720, 3721, 3723, 3726, 3729, 3732, 3735,  3740, 3742, 3745, 3748, 3752, 3753, 3754, 3755, 3759, 3768, 3766, 3769, 3772, 3965, 4048,  4051 -  4058, 4061, 4062, 4063, 4199, 4200 - 4206, 4226, 4227, 4228, 4229, 4232, 4237, 4239, 4240, 4241, 4242, 4244, 4245, 4246 and 4247 (all described as “study”, “full report of study” or “continuation of study” with specific referencing numbers after); Documents 4070 – 4098 (all described as “clinical study summary” followed by specific numbering); Documents 4399, 4400 -  4408, 4414 – 4426 (all described as “protocol 166a and 166b”).   All of these documents have been withheld in their entireties and many are hundreds of pages long.  This is a sampling of these types of unidentifiable documents.  It is not a complete listing.

[17] For example, Documents 3059, 3065, 3066, 3072, 3073, 3076, 3079, 3088, 3089, 3103 and 3108.  Document 8083 is described as “calendar manager appointment w/ attach” and is not claimed as exempt under (b)(5) deliberative process.

[18] These documents were also claimed exempt under (b)(6),(b)(4) and 18 U.S.C. §1905.  Defendant FDA does not distinguish which part of each document is exempt under (b)(5) deliberative process.

[19] Documents 1902 – 1924 have all been withheld in full.  These documents are not uniform in length.  A few are as long as 6 or 7 pages while some are as short as 2 pages in length.  This would suggest that these documents are not standard medical forms.

[20] Plaintiff says presumably because the Index does not give an adequate description of the documents claimed under Exemption 6.

[21] It has been estimated that since it’s approval in 2000, there have been over 100,000 RU-486 abortions performed in the U.S. alone.  This effectively means that 100,000 women used a drug without adequate information as to how it affects their physical and emotional well-being.  (See Exhibit 6).