IN THE UNITED STATES DISTRICT COURT

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 SURREPLY IN SUPPORT OF ITS OPPOSITION TO DEFENDANT’S MOTION FOR SUMMARY JUDGMENT

Plaintiff, Judicial Watch, Inc., by counsel, respectfully submits this surreply in support of its opposition to Defendant’s motion for summary judgment.

MEMORANDUM OF LAW

On October 13, 2000 Plaintiff served a Freedom of Information Act (“FOIA”) request on FDA regarding the FDA’s approval of the drug mifepristone (a.k.a. “RU-486"), the drug that chemically induces abortion. After an unsatisfactory response, Plaintiff filed suit on December 12, 2000. FDA served Plaintiff with a CD-Rom containing approximately 9,300 pages of responsive documents on October 15, 2001 and later served Plaintiff with a Vaughn Index containing over 6,000 withheld documents. On November 2, 2001, The Population Council, Inc. and Danco Laboratories, LLC intervened. Defendants filed motions for summary judgment on June 14, 2002.

FDA’s motion for summary judgment focused on three claims: (1) FDA performed an adequate search; (2) FDA released all responsive records; and (3) FDA validly withheld documents listed in its Vaughn Index. Council and Danco’s motion for summary judgment presented no new or different arguments and focused on the FDA properly withholding information under FOIA exemptions. See Statement of Points and Authorities in Support of Motion of The Population Council, Inc. and Danco Laboratories, LLC For Summary Judgment (“Council’s Motion”) at 10.

Plaintiff submitted its opposition to the motions for summary judgment on October 11, 2002. Plaintiff’s opposition countered all arguments made by Defendants and demonstrated that: (1) FDA had not performed an adequate search; (2) FDA had not submitted an adequately detailed Vaughn Index; and (3) FDA improperly withheld information pursuant to Exemptions 3, 4, 5 and 6 of FOIA. With regard to this last argument in particular, Plaintiff clearly countered all arguments made by Defendants regarding the withheld documents.

On December 20, 2002, Defendants submitted their reply briefs. In their reply briefs Defendants made several incorrect assertions and misstatements. First, Defendants incorrectly alleged that Plaintiff failed to oppose Council and Danco’s motion for summary judgment and that they are therefore entitled to summary judgment. Second, Defendants made several misstatements regarding case law and specific holdings and regarding the Vaughn Index FDA submitted as well as individual exemptions. Plaintiff’s surreply focuses on clarifying these false allegations and misstatements.

ARGUMENT

I. Plaintiff’s Opposition Clearly and Convincingly Countered All of Defendants’ Arguments, Therefore, Defendants Are Not Entitled to Summary Judgment.

Council and Danco’s motion for summary judgment did not present any new or different claims from those presented by FDA. It was nothing more than a “me too” motion. Council and Danco’s motion centered on the claim that FDA properly withheld documents from Plaintiff. Council’s Motion at 10. Defendants claimed that the FDA properly withheld the documents because the information was either a trade secret, confidential commercial information and/or an unwarranted invasion of personal privacy. Id. Each one of these claims was included in FDA’s motion for summary judgment. Memorandum of Points and Authorities in Support of Defendant’s Motion For Summary Judgment (“FDA’s Motion”) at 17-25, 32-37. Plaintiff countered each of these arguments in its opposition. Plaintiff’s Opposition to Defendant’s Motion For Summary Judgment (“Opposition”) at 14-20, 30-39. Therefore, every claim made by Defendants in their motions for summary judgment was countered by Plaintiff in its opposition.

II. Defendants’ Reply Briefs Contain Many Misstatements and Incorrect Applications of Law.

In their reply briefs, Defendants misstate and misuse several cases. This misuse ranges from cases being inapplicable because the holding pertains to a very specific factual scenario, to cases that do not contain the proposition Defendants claim. See e.g., Westinghouse Electric Corp. v. Brown, 443 F.Supp. 1225 (E.D. Va. 1977); Nadler v. FDIC, 92 F.3d 93 (2^nd Cir. 1996). Additionally, Defendants’ reply briefs contain misstatements about the adequacy of the Vaughn Index as well as the individual exemptions.

A. Defendants Misuse and Misstate Several Cases and Holdings

In its reply, FDA cites Gulf & Western Industries, Inc. U.S, 615 F.2d 527 (D.C. Cir. 1979) to demonstrate that actual competitive harm is not necessary to properly withhold information under Exemption 4 and suggest that Plaintiff’s opposition is incorrect. FDA’s Reply at 26. However, Defendants fail to acknowledge, or simply ignore the fact that Plaintiff itself cited to Gulf and in fact quoted the exact same portion of the case. Opposition at 18. “[A]ctual competition and the likelihood of substantial competitive injury is all that is needed.” Id. at 530. Plaintiff’s opposition never claimed that Defendants were required to prove actual competitive harm. Rather, Plaintiff pointed out that the holding of Gulf required Defendants to prove actual competition. Proof of actual competition is still lacking in the Defendants’ reply briefs and, as such, Defendants have not satisfied the Exemption 4 standard set in Gulf.

In addition to misusing Gulf, FDA also misuses Department of State v. Washington Post Co., 456 U.S. 595 (1982). In its reply, FDA suggests that Plaintiff has “not done its homework” regarding what constitutes “similar files” in relation to FOIA Exemption 6. FDA claims that Washington Post holds that any information applying to a particular individual meets the “threshold requirement for Exemption 6 protection.” FDA’s Reply at 37. However, FDA takes the Washington Post quote out of context. The actual wording of Washington Post holds,

“‘[T]he exemption [was] intended to cover detailed Government records on an individual which can be identified as applying to that individual.’ When disclosure of information which applies to a particular individual is sought from Government records, courts must determine whether release of the information would constitute a clearly unwarranted invasion of that person’s privacy.”

Washington Post, 456 U.S. at 602 (quoting H.R. Rep. No. 1497).

Defendants have not demonstrated in either their initial motions for summary judgment or in their reply briefs that the information withheld under Exemption 6 consist of records about particular individuals. Defendants have withheld the “names of agency personnel and government employees...names of various HHS employees...names and employment addresses of various private individuals.” FDA’s Motion at 33. These individuals are people associated with the approval of mifepristone, not the subject of the files. Withholding the names of agency personnel and government employees in files that do not pertain personally to those employees is improper under the Washington Post holding.

Council and Danco also misstate and misuse several cases in their reply brief. Council and Danco claim in their reply that three cases support their proposition that “courts have consistently upheld the application of Exemption 4 to the withholding of names of individuals and corporations.” Defendant-Intervenors’ Reply Memorandum to Plaintiff’s Opposition to Defendant’s Motion For Summary Judgment (“Council’s Reply”) at 9. Defendants cite to Nadler v. FDIC, 92 F.3d 93 (2^nd Cir. 1996), Public Citizen Health Research Group v. FDA, 2000 U.S. Dist. LEXIS 4108 (D.D.C. 2000) and Westinghouse Electric Corp. v. Brown, 443 F.Supp. 1225 (E.D. Va. 1977) as evidence of this proposition. However, none of these cases support Defendants broad statement that courts have consistently upheld the application of Exemption 4 to the withholding of names of individuals and corporations.

In Nadler, the Second Circuit held that the FDIC could withhold disclosure of confidential information pursuant to Exemption 4. Nadler, 92 F.3d at 93. The information FDIC sought to withhold did not, however, include names of agency personnel or government employees. The redacted information consisted of:

detailed commercial and financial terms and conditions of the rights and obligations running between [Amore] and [Brewran], as set forth in the joint venture agreement. The information withheld, without limitation, is as follows: property...; statements of ownership percentages for various aspects of the commercial venture as agreed to between the joint venture partners...; budgets and cost estimates...; terms of agreements for cost-sharing of the payment of expenses...; estimate values...; [and] options provisions and terms governing the parties [sic] rights to elect other courses of action for project development...

Id at 95.

Nowhere in the description of the redacted information was employee names or addresses mentioned. Council and Danco claim that Nadler stands for the proposition that the “release of name of company would work a competitive harm under Exemption 4.” Council’s Reply at 9. However, Defendants do not supply a page in the opinion to find that proposition. The only logical explanation for this omission is that Defendants’ proposition does not exist in Nadler. Defendants misstated and misused Nadler.

Very similar to Defendants’ misuse of Nadler, Public Citizen is also misstated and misused. In Public Citizen, the Court held that the investigator names and article titles could be withheld because release of the information would cause substantial harm to the intervenor. Public Citizen, 2000 U.S. Dist. LEXIS at 1. The intervenor explained that the release of the investigator names would cause substantial harm because:

researchers retain knowledge of the test procedures used, the test results, and other significant factors in the drug development process, such as competitor of Searle could retain the same persons to conduct its own studies on another COX-s Inhibitor drug...[and] thereby could improve the scientific accuracy and accelerate the pace of its own drug development efforts....

Id. at 11. The names were found to be exempt from release under Exemption 4 because of the confidential commercial information the investigators retained and the possibility of those investigators being wooed by a competitor, thereby accessing the confidential commercial information. The exemption was not for the mere association with a particular project or drug, and the holding did not provide a blanket exemption for names of individuals under Exemption 4.

Council and Danco also misused Westinghouse. In Westinghouse, the Court held that the information, which contained names, salaries, Social Security numbers and other personal information of employees, could be withheld under Exemptions 4 and 6 of FOIA. Westinghouse, 443 F.Supp. at 1228. The Court held that the names were exempt because the release of the names would cause a substantial harm to Westinghouse’s competitive position. Id. at 1228-29. This competitive harm was based on the fact that Westinghouse did business with “several highly competitive industries and the competition to hire female and minority research and development employees to meet affirmative action goals is intense.” Id. at 1229. Because Westinghouse provided evidence of “raiding – the hiring away by a competitor of valuable employees”, the Court was satisfied that the warranted Exemption 4 protection. Id.

As with Public Citizen, the Westinghouse court found that the names were directly related to a confidential commercial interest. The names were not exempt from disclosure per se, and mere association was not at issue. Defendants in this case have not provided any such evidence or claimed that the name of agency personnel and government employees or Danco’s employees are exempt from release because they fear these individuals will divulge confidential commercial information and cause a competitive harm. Additionally, Westinghouse does not hold that names and addresses are consistently withheld under Exemption 4. The holding of Westinghouse, like the holding in Public Citizen pertains to a specific set of facts which Defendants cannot duplicate.

In addition to misstating and misusing cases for Exemption 4, Council and Danco also misstated and misused cases in regard to Exemption 6. Defendants claim that “privacy interests of individuals are cognizable under Exemption 6 even though their names and addresses are associated with a business transaction or relationship.” Council’s Reply at 12. Defendants cite Campaign for Family Farms v. Glickman, 200 F.3d 1180, 1188-89 (8^th Cir. 2000) as evidence of their claim. However, it is a basic legal tenet that cases outside the ruling jurisdiction are at most persuasive and are certainly not binding. Defendants cite to an Eighth Circuit case and do not demonstrate that this Court has either accepted the Glickman holding as precedent or that this Court routinely follows the Eighth Circuit in matters it has yet to decide for itself. Defendants use of Glickman is an attempt by Defendants to demonstrate support for a claim that has not been accepted by this Court or in this Circuit.

Additionally, Council and Danco claim that the “association principle” they have concocted is “particularly true when the disclosure of information will associate the individual with a group that is targeted by violent extremists and disclosure dramatically increases the risk of violence.” Council’s Reply at 12. Defendants cite to three cases as evidence of this claim: Hudson v. Department of Army, 1987 U.S. Dist. LEXIS 16736, *7 (D.D.C. Jan. 29, 1987), Falzone v. Department of Navy, 1986 U.S. Dist. LEXIS 17349, *3-4, (D.D.C. Nov. 21, 1986) and Hemenway v. Hughes, 601 F. Supp. 1002, 1007-8 (D.D.C. 1985). Defendants use of these three cases is completely misplaced. In each of the cases used by Council and Danco the subject of the fear of disclosure is international terrorists and the fear that location information for overseas military personnel or overseas journalists would cause a physical threat. Nowhere in Hudson, Flazone or Hemenway did the Court suggest that the holding should be extended to any other factual situations. Defendants simply state that Plaintiff’s distinction between domestic and international terrorism should be rejected. Council’s Reply at 12. However, Defendants do not demonstrate why a distinction should not be made in light of the narrow holdings of Hudson, Flazone and Hemenway. As the moving party it is Defendants burden to carry.

Defendants’ misstatement and misuse of these cases does not support their summary judgment position. Rather, these cases further highlight the fact that Defendants have not provided this Court or Plaintiff with the necessary burden of proof to sustain a motion for summary judgment.

B. Defendants Misrepresent the Adequacy of the Vaughn Index and Exemptions.

Defendants suggest that the Vaughn Index is adequate and the few errors pointed out by Plaintiff are the exception and not the rule. FDA’s Reply at 33. This is simply not true. The obligation of the withholding agency in a FOIA request is to submit a Vaughn Index which allows the trial court and requestor to “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 Transplantaion v. FDA, 180 F.Supp.2d 29, 32 (D.D.C. 2001) (quoting Hinton v. Department of Justice, 844 F.2d 126, 129 (3^rd Cir. 1988)). The Court did not hold that the agency’s obligation was satisfied if it required either the Court or the requestor to retain experts, consult extraneous government documents or do additional research. The obligation stands alone and is not discharged simply because the answer is “out there somewhere” and available to the Court and the requestor. In Founding Church of Scientology of Washington, D.C. v. Bell, 603 F.2d 945 (D.C. Cir. 1979), this Court held that one of the three “indispensable elements of a Vaughn Index” was that the index be “contained in one document, complete in itself.” Id. at 949.

The Vaughn Index needs to provide a “reasonably 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). FDA did not provide such an Index and the vagueness of the Index is pervasive.

In addition to misstating the adequacy of the Vaughn Index as a whole, Defendants also make several misstatements about the individual exemptions. For example, Defendants claim that Plaintiff failed to refute Council and Danco’s summary judgment claim that the names and addresses of employees and manufacturers are considered confidential commercial information. FDA’s Reply at 24-25, Council’s Reply at 2-3. However, Defendants fail to acknowledge the Gulf holding that requires proof of actual competition to invoke Exemption 4 protection.^[1] While FDA cites and indeed quotes from Gulf, Defendants continue to insist that despite any evidence of actual competition, the names and addresses of employees and manufacturers are exempt under FOIA Exemption 4. Surely Defendants are not suggesting that the individuals they purport to fear are competitors in the abortion industry. According to precedent, proof of actual competition is necessary to claim Exemption 4 protection. None of the Defendants, including Council and Danco, have provided evidence of actual competition in the use of mifepristone for chemical abortion. As such, the names and addresses withheld by FDA under Exemption 4 have been withheld improperly.

In the FDA’s reply it claims that Plaintiff’s assertion that the Exemption 4 withholdings listed in the Vaughn Index are inadequate in incorrect. FDA claims that because Plaintiff has retained a medical expert, it should have understood its Vaughn Index. FDA’s Reply at 29. Once again, Defendant’s claims are without merit. First, Dr. Harrison, who submitted a declaration as an exhibit to Plaintiff’s opposition, is not a retained medical expert. As set forth in her declaration, Dr. Harrison is a board certified OB/GYN and worked on the Citizens’ Petition submitted by the American Association of Pro Life Obstetricians and Gynecologists, the Christian Medical Association and Concerned Women of America in August 2002. Declaration of Donna J. Harrison, (Opposition Exhibit 1) ¶1. In her declaration, Dr. Harrison described her familiarity with the drug approval process and the basis for that familiarity and highlighted for this Court what specific information was missing from the mifespristone approval process. Id. at ¶¶ 2-4. The fact that Plaintiff submitted a declaration from a medical professional familiar with the drug approval process does not relieve the FDA from its obligation to provide a clear and accurate Vaughn Index. Founding, 603 F.2d at 949. Neither the requestor nor the Court should be required to retain medical experts to interpret a Vaughn Index in any event. The FDA’s Vaughn Index is insufficient regardless of whether Plaintiff or the Court has access to expert witnesses and the availability of medical professionals does not change that fact.

Additionally, FDA also claims Plaintiff inappropriately referred only to the subject line of the Vaughn Index. FDA’s Reply at 30. FDA’s complaint that Plaintiff referred only to the subject line is without merit. FDA’s Vaughn Index gives neither this Court nor Plaintiff much else but the subject line to which to refer. FDA takes issue with documents that Plaintiff refers to in its opposition. FDA claims that two documents, Documents 2269 and 3880, are clearly explained in the Vaughn and attached declaration^[2]. This is simply not true. Despite being aware that “IND” referred to “investigational new drug”, the Vaughn Index simply described Document 2269 as an “ind submission.” Vaughn at 568. Defendants do not describe what type of IND submission Document 2269 is.^[3] The document is simply described as a submission. Plaintiff certainly could guess at what Document 2269 consists of, but the point is that Defendants’ obligation is to provide enough detail so that such guesswork is not necessary. See Founding, 603 F.2d at 949. (reviewing court should not need to speculate).

The same can be said about Document 3880. Described only as “study reprints 1987-1988", Defendants fail to even define what a “study reprint” is. Defendants withheld many other documents listed simply as “study reprints” but never defines the term. See Vaughn Index at 970-972.^[4] If Plaintiff indeed has tunnel vision, as FDA suggests, it is because Plaintiff has only been provided a tunnel. FDA’s Reply at 31.

Defendants also claim that Plaintiff incorrectly applied the confidentiality test for confidential commercial information to the documents Defendants withheld pursuant to Exemption 4. Council’s Reply at 7. Council and Danco claim that the information withheld under Exemption 4 constitutes trade secrets, not confidential commercial information, and does not require a showing confidentiality. Id. However, in its motion for summary judgment FDA simply stated that the “withheld records constitute trade secrets and/or ‘commercial or financial’ information....” FDA’s Motion at 19. (emphasis added). FDA did not claim that all of the information withheld under Exemption 4 was trade secrets.

In her first Declaration, Andrea Masciale states that “disclosure of the withheld documents would discourage the frank exchange of opinions and recommendations among such individuals. Disclosure, therefore, would be harmful to the deliberative process within the FDA.” Masciale Decl.I, ¶ 39. This general statement of harm is not enough and does not discharge FDA’s FOIA duty. The general description provided by FDA consists only of a recitation of a legal standard and a conclusory statement that it will harm the FDA’s deliberative process. This does not satisfy FOIA requirements or the precedent of this Court. See e.g., Campaign, 219 F.Supp.2d at 112.

Second, even those documents typically exempt under FOIA Exemption 5, like drafts and internal memorandum, can be released if the information is factual in nature and not advisory, or if the subject matter of the document is adopted by the agency. Founding, 630 F.2d at 953. Defendants’ Exemption 5 entries are not described well enough to allow the Court or the Plaintiff to ascertain whether the documents are advisory or contain information that was ultimately adopted by FDA. For example, in FDA’s Reply it describes Document 5140 as a document “properly described in the index as ‘e-mail re: draft response re: supply of product w/attach.” It is listed from and to an ‘fda employee.’ The date of the document listed as April 5, 1999, makes clear that it is predecisional because mifepristone was not (sic) approved by FDA on September 29, 2000.” FDA’s Reply at 35. From this scant description it is impossible to ascertain whether the information contained in Document 5140 is factual or advisory in nature or whether the information was ultimately adopted by FDA. Without this pertinent information the Exemption 5 Vaughn entries are inadequate.

Lastly, Defendants make misstatements concerning Exemption 6 in their reply briefs. In both reply briefs Defendants claim that the public’s interest in the disclosure of mifepristone information is at best outweighed by privacy issues and at worst “non-existent.” FDA’s Reply at 38; Council’s Reply at 12. Interestingly, neither of the Defendants’ reply briefs address the issue of public interest laid out in Plaintiff’s opposition. Opposition at 34-37. Additionally, Defendants attempt to downplay the public interest in mifepristone, its approval process, and who was involved in the approval, by ignoring the obvious - - that mifepristone has already caused a number of deaths and other medical problems. See Exhibit 1. The public’s right to know about the approval of mifepristone is as basic as the public’s right to not be subjected to dangerous and life-threatening substances. This right to life and health far outweighs Defendants alleged right to privacy.

CONCLUSION

Plaintiff’s opposition clearly and convincingly countered each of Defendants’ claims and has demonstrated that Defendants failed to meet their summary judgment burden. For the foregoing reasons, and for the reasons set forth in Plaintiff’s opposition, this Court should deny Defendants’ motions 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, DC 20024

(202) 646-5172

Attorneys for Plaintiff

CERTIFICATION OF SERVICE

I hereby certify that on March 13, 2003, a true copy of the foregoing PLAINTIFF’S SURREPLY IN SUPPORT OF ITS OPPOSITION TO DEFENDANT’S MOTION FOR SUMMARY JUDGMENT was served by first-class mail, postage prepaid, on the following:

Attorney for Defendant FDA:

Edith Shine, Esq.

Assistant U.S. Attorney

FOOD AND DRUG ADMINISTRATION

Judiciary Center Building

555 Fourth Street, N.W.

Washington, D.C. 20001

Attorneys for Defendant The Population Council, Inc. and Danco Laboratories, LLC

Nancy L. Buc, Esq.

Kate C. Beardsley, Esq.

BUC & BEARDSLEY

919 Eighteenth Street, N.W.

Washington, D.C. 20006

_______________________

Meredith Cavallo

^[1]In the Declaration of Executive 1, Defendants describe various uses of mifepristone and alternative methods of chemical abortion. Declaration of Executive 1, ¶ However, Defendants fail to demonstrate that they face actual competition regarding mifepristone use in chemical abortion - the subject matter of the IND and NDA.

^[2]FDA’s reply only responds to Documents 2269 and 3880 within the Exemption 4 section of Plaintiff’s opposition. Plaintiff opposition specifically referred to well over one hundred and fifty examples of inadequate Exemption 4 entries. Defendants simply do not respond to these other documents.

^[3]FDA never defines what an “ind” submission contains. Council and Danco defined an “initial IND submission” in the Declaration of Sandra P. Arnold. Declaration of Sandra P. Arnold (“Arnold Declaration”), ¶13. However, the Vaughn entry does not indicate whether Document 2269 is the initial IND submission. Additionally, this constant cross-referencing violates the holding of Founding that the index be “one document, complete in itself.” 603 F.3d at 949.

^[4]These entries alone amount to more than 4,000 pages and are never described as anything more than “study reprints.”

^[5]None of the Vaughn Index entries claiming both trade secret and confidential commercial information as the reason for withholding differentiate between what part of the document is a trade secret and what part is confidential commercial information. See Documents 524, 525, 529, 530, 532, 533, 600, 603, 633, 678-771, 841, 1704, 1705, 1707, 1708, 1712, 1716, 1749, 1754, 1758-1782, 1785, 1786, 1789, 1790, 1795, 1796, 1798, 1799, 1806, 1817, 1818, 2023-2025, 2027-2029, 2131, 2132, 2137, 2144, 2146-2153, 2156, 2166-2194, 2196-2199, 2201-2209, 2251, 2268, 2269, 2295, 2312, 2372, 2513, 2515, 2522, 2690, 2819, 2844, 2873, 2981, 2995, 2996, 3099, 3162, 3169, 3243, 3244, 3267, 3275, 3288, 3291-3293, 3488, 3490, 3547, 3554, 3787-3795, 3798, 3799, 3802, 3815-3817, 3821-3823, 4299, 4456-4683, 4728, 4729, 4731,-4734, 4737, 4762, 4763, 4774, 4775, 4199, 4200, 4203, 4206, 4239, 4262-4264, 4303-4305, 4323, 4327, 4329, 4330, 4338, 4342, 4345, 4347, 4349, 4350, 4407, 4425, 4453, 4454, 4462-4466, 4471, 4472, 4475, 4497, 4498, 4500-4504, 4519, 4523, 4536, 4539-4541, 4549, 4551, 4555-4557, 4565, 4566, 4572-4574, 4582, 4583, 4596-4601, 4607-4618, 4620, 4622-4627, 4629, 4630, 4632, 4633, 4655, 4656, 4658, 4659, 4664, 4667, 4679, 4684, 4691, 4705, 4706, 4777-4779, 5314, 6065, 6077and 6088.

^[6]FDA also fails to address 12 other documents Plaintiff pointed out in its opposition. Opposition at 26-30. Defendants claim that the 6 entries containing “clerical errors” are isolated instances of inadequacy is simply incredulous when reviewing the Vaughn Index. FDA Reply at 33. Even focusing only on the first 500 pages of the Vaughn and only on documents withheld in full, it is clear that the inadequacy of the entries permeates the Index. See Vaughn Documents: 168 (“fda memo”); 169 (“fda memo”); 183 (“fda memo w/attach”); 367 (“e-mail re: mifepristone”); 518 (“memorandum for the record”); 519 (“letter re: notification of commitment”); 630 (“letter re: clinical investigators”); 683 (“call back message”); 810 (“fax re: advisory committee meeting”); 818 (“letter re: advisory committee”); 846 (“form re: important alert”); 847 (“routing and transmittal slip”); 862-686 (“e-mail re: supplement”); 871 (“letter re: labeling w/attach”); 872 (“email re” cytotec and mifepristone”); 873 (“e-mail re: supplement”); 876 (“e-mail re: cytotec and mifepristone”); 880 (“e-mail re: call w/attach”); 897 (“notes re: meeting”); 898-899(“e-mail re:call”), 900 (“e-mail re: telephone call”); 905 (“e-mail re: telephone call”); 906 (“e-mail re: approvable letter mifepristone”); 909 (“e-mail re: update and inquiries”); 945 (“e-mail re: new assignment”); 947 (“e-mail re: talking points”), 951 (“e-mail re: telephone call”); 953-954 (e-mail re: new assignment”); 1001-1002 (“e-mail re: final footnote on cy grid line listing”); 1007 (“e-mail re: sending of new e-mail”); 1025 (“e-mail re: follow up letter”); 1062 (“e-mail re: rollout plan”); 1165 (“e-mail re: population council meeting 9/14/00"); 1174 (“e-mail re: spitz article”); 1187 (“e-mail re: meeting 9/12/00"); 1203 (“e-mail re: more on medguide”); 1241 (“e-mail re: information request letter”); 1243 (“e-mail re: exhibit e comments”); 1267 (“e-mail re: inds in division”); 1268 (“e-mail re: ins in different divisions”); 1290 (“e-mail re: revised table”); 1299 (“e-mail re: registration/listing info”); 1364 (“e-mail re: surgical abortion”); 1392 (“e-mail re: referral of question to division”); 1413-1414 (“e-mail re: loa question”); 1421 (“e-mail re: revisions of letter w/attach”); 1458 (“e-mail re: distribution plan”); 1459 (“e-mail re: registry”); 1521 (“e-mail re: timeline”); 1522 (“e-mail re: supply of drug for ind w/attach”); 1523 (“e-mail re: supply of drug for ind”); 1548 (“e-mail re: meeting and letter response”); 1574 (“e-mail re: see attached for microsoft outlook users”); 1598 (“e-mail re: off ‘cc’ list w/attach”); 1611 (“e-mail re: letter”); 1638 (“e-mail re: review issues”); 1645-1646 (“e-mail re: ind and supply”); 1647 (“e-mail re: tablets use”); 1657 (“e-mail re: action on 2/18"); 1658 (“e-mail re: update and fda press inquiries”); 1663 (“e-mail re: reviews”); 1664 (“e-mail re: distribution system”); 1665 (“e-mail re: information received”); 1671 (monitoring visits assessment list”); 1679-1680 (“operation procedures”); 1690 (“establishment inspection report endorsement”); 1691 (email regarding record search”); 1692 (ru-486 records search”); 1696 (“letter re: corrective action to 483 observations w/attach”); 1867 (email re: establishment evaluation system pending alert”); 1965 (“email re: request for documentation”).