Case Detail

FOIA Project Annotation: Judge Ricardo Urbina has ruled that the Campaign for Responsible Transplantation did not substantially prevail under the Buckhannon standard and is not entitled to attorney's fees. The Campaign made a request for records concerning xenotransplantation, which involves the use of animal tissues transplanted into humans to treat human diseases. The FDA regulates these products as investigational new drugs. After the request was narrowed to cover 19 INDs, Urbina allowed the agency to produce a Vaughn index and make exemption claims on one IND that would be considered representative of all 19 files. Urbina found the agency's original Vaughn inadequate and ordered further revisions. During those revisions, the FDA released some records it did not plan to withhold. After it submitted the revised Vaughn, Urbina ruled in favor of the agency's exemption claims and ordered non-exempt records in the other 18 INDs released. When the agency had not done so after a matter of months, the Campaign asked Urbina to enforce his order. Urbina declined to do so, suggesting that better communications between the parties could resolve the issue. Ruling against the Campaign on the issue of attorney's fees, Urbina rejected each claim the plaintiffs had made. On the voluntary release of documents by the FDA, he noted that "under the Buckhannon rule, the FDA's voluntary release of the requested documents ends the court's inquiry. Although CRT may have partially achieved a desired result when the FDA voluntarily releases some responsive documents, the plaintiff is not considered a prevailing party because the court did not order this relief." As to his requirement that the agency revise its Vaughn, Urbina pointed out that "an interim order that is procedural, rather than substantive, does not alter the legal relationship between the parties" as required by Buckhannon. He also found that his instruction to the agency to disclose non-exempt records from the other INDs based on his rulings on the sample Vaughn did not provide relief to CRT. He observed that "because the court permitted the defendant to continue withholding contested documents related to the sample IND, the court also permitted the FDA to continue withholding similar documents related to the other eighteen INDs. Likewise, because the defendant voluntarily released responsive, non-exempt documents related to the sample IND, the court's 2004 memorandum opinion signaled to the defendant that it should begin releasing uncontested responsive documents related to the other eighteen INDs."
Issues: Litigation - Attorney's fees - Prevailing party

FOIA Project Annotation: Judge Ricardo Urbina has granted the Campaign for Responsible Transplantation attorney's fees for its suit that forced the FDA to release all non-exempt documents relating to investigational new drugs pertaining to xenotransplantation, a cellular treatment therapy. Urbina had previously ruled that CRT was not eligible for fees because it had not substantially prevailed. However, that ruling was overturned by the D.C. Circuit, which sent the case back for further determination of whether CRT was entitled to fees. The agency argued that CRT had not been awarded any contested documents. But Urbina pointed out that the argument "does not undermine the public benefit of the request for and subsequent disclosure of documents showing 'numerous side-effects and tumors in patients who had undergone xenotransplantation.' Indeed, it was the disclosure of the uncontested, non-exempt documents that rendered the plaintiff a prevailing party." He also rejected the claim that CRT's bias against xenotransplantation lessened its public interest claim. He noted that "it is beyond peradventure that CRT is a nonprofit, public interest group designed to alert the public of issues associated with the risks of xenotransplantation, CRT designed its document request in furtherance of this mission, and the documents released after the plaintiff initiated this lawsuit furthered this mission." In a novel approach to what constituted commercial interest, the agency argued that some members of CRT might benefit commercially if xenotransplantation was banned. Urbina observed that "the FDA does not argue that the plaintiff, a nonprofit organization, was seeking the information to benefit commercially, but rather that the membership would receive a derivative commercial benefit if the documents led to a ban on xenotransplantation or if trade secrets were disclosed. Assuming that it is appropriate for the court to inquire into such derivative benefits, this argument is too attenuated to be of great import." The agency also argued that its actions were reasonable since the court upheld all its exemption claims. But Urbina indicated that "the FDA incorrectly focuses on the contested documents that it lawfully withheld under the appropriate FOIA exemptions and ignores the nonexempt documents that it delayed disclosing, despite eventually acknowledging that the documents were nonexempt." He added that "the parties reached no agreement for, at a minimum, the eight months between the plaintiff's FOIA request and the filing of this lawsuit." He concluded that "because the FDA has not demonstrated a reasonable basis in law for withholding nonexempt documents beyond the twenty days deadline set forth in FOIA, this factor favors the plaintiff, and the court concludes that the plaintiff is entitled to attorneys' fees."
Issues: Litigation - Attorney's fees - Entitlement - Reasonable Basis for Withholding

Date Filed	Doc #	Docket Text
2000-11-27	1	COMPLAINT filed by plaintiff CAMPAIGN/RESPONSIBLE (bm) (Entered: 12/13/2000)
2000-11-27		SUMMONS (3) issued to federal party federal defendant FDA , and non-parties: U.S. Attorney and U.S. Attorney General. (bm) (Entered: 12/13/2000)
2000-11-27	2	LCvR 26.1 Certificate of disclosure of corporate affiliations and financial interests by plaintiff CAMPAIGN/RESPONSIBLE (bm) (Entered: 12/13/2000)
2000-11-29	3	MOTION filed by plaintiff CAMPAIGN/RESPONSIBLE for relief from Local Civil Rule 11.1. (aet) (Entered: 12/17/2000)
2000-12-08	4	ORDER by Judge Ricardo M. Urbina : granting motion for relief from Local Civil Rule 11.1. [3-1] by CAMPAIGN/RESPONSIBLE; and that plaintiff is permitted to use a post office box address in the caption of plaintiff's complaint. (N) (ks) (Entered: 01/08/2001)
2000-12-15	5	MOTION filed by federal defendant FDA to extend time to 1/26/01 to answer complaint [1-1] (aet) Modified on 01/08/2001 (Entered: 12/18/2000)
2000-12-15	6	ATTORNEY APPEARANCE for federal defendant FDA by Brian J. Sonfield (cjp) Modified on 01/08/2001 (Entered: 12/18/2000)
2000-12-19	7	RESPONSE IN OPPOSITION by plaintiff CAMPAIGN/RESPONSIBLE to motion to extend time to 1/26/01 to answer complaint [1-1] [4-1] by FDA (aet) Modified on 01/08/2001 (Entered: 01/01/2001)
2000-12-21	8	ORDER by Judge Ricardo M. Urbina : denying motion to extend time to 1/26/01 to answer complaint [1-1] [4-1] by FDA; defendant motion for 30-day extension denied. (N) (jwd) Modified on 01/08/2001 (Entered: 12/21/2000)
2000-12-27	9	ANSWER TO COMPLAINT [1-1] by federal defendant FDA . (aet) Modified on 01/08/2001 (Entered: 01/01/2001)
2001-01-02	10	AMENDED ANSWER [1-1] filed by federal defendant FDA (hsj) Modified on 01/08/2001 (Entered: 01/04/2001)
2001-01-10	11	RETURN OF SERVICE/AFFIDAVIT of summons and complaint executed upon U.S. Attorney General on 11/27/00 (td) (Entered: 01/11/2001)
2001-01-10	12	MOTION filed by plaintiff CAMPAIGN/RESPONSIBLE for Amy R. Atwood to appear pro hac vice ( Meyer & Glitzenstein 1601 Connecticut Ave. Ste 700, NW, Washington, DC 20009, 202-588-5206) (aet) (Entered: 01/11/2001)
2001-01-12	13	ORDER by Judge Ricardo M. Urbina : granting motion for Amy R. Atwood to appear pro hac vice ( Meyer & Glitzenstein 1601 Connecticut Ave. Ste 700, NW, Washington, DC 20009, 202-588-5206) [12-1] by CAMPAIGN/RESPONSIBLE (N) (jwd) (Entered: 01/12/2001)
2001-01-12	14	MOTION filed for CIRCE BIOMEDICAL, IN to intervene ; EXHIBITS (ANSWER OF PROPOSED INTEVENOR) (aet) (Entered: 01/17/2001)
2001-01-16	15	MOTION filed for NEXTRAN, INC. to intervene ; EXHIBITS (ANSWER; RULE 26.1 DISCLOSURE) (aet) (Entered: 01/17/2001)
2001-01-24	16	MOTION filed for DIACRIN/GENZYME LLC to intervene ; EXHIBITS (26.1 CERTIFICATE OF DIACRIN, INC.; 26.1 CERTIFICATE OF DIACRIN/GENZYME LLC; PROPOSED ANSWER OF DIACRIN/GENZYME LLC AND DIACRIN, INC.) (aet) (Entered: 01/26/2001)
2001-02-07	17	MOTION filed for GENZYME CORPORATION to intervene as a defendant ; EXHIBITS (Answer and LCvR 26.1) (td) (Entered: 02/08/2001)
2001-02-12	18	MOTION filed for NOVARTIS PHARMACEUT to intervene as a defendant ; EXHIBIT (Answer and Certificate LCvR 26.1) (td) (Entered: 02/13/2001)
2001-03-01	19	ORDER by Judge Ricardo M. Urbina : granting motion for GENZYME CORPORATION to intervene as a defendant [17-1] (N) (jwd) (Entered: 03/01/2001)
2001-03-01	20	ORDER by Judge Ricardo M. Urbina : granting motion for NEXTRAN, INC. to intervene [15-1] (N) (jwd) (Entered: 03/01/2001)
2001-03-01	21	ORDER by Judge Ricardo M. Urbina : granting motion for CIRCE BIOMEDICAL, IN to intervene [14-1] (N) (jwd) (Entered: 03/01/2001)
2001-03-01	22	ORDER by Judge Ricardo M. Urbina : granting motion for NOVARTIS PHARMACEUT to intervene as a defendant [18-1] (N) (jwd) (Entered: 03/01/2001)
2001-03-01	23	ORDER by Judge Ricardo M. Urbina : granting motion for DIACRIN/GENZYME LLC to intervene [16-1] (N) (jwd) (Entered: 03/01/2001)
2001-03-01	29	ANSWER TO COMPLAINT [1-1] by intervenor-defendant NOVARTIS PHARMACEUT . (td) (Entered: 06/13/2001)
2001-03-01	30	RULE 26(a)(1) DISCLOSURE STATEMENT filed by intervenor-defendant NOVARTIS PHARMACEUT (td) (Entered: 06/13/2001)
2001-03-01	32	RULE 26(a)(1) DISCLOSURE STATEMENT filed by intervenor-defendant DIACRIN/GENZYME LLC (td) (Entered: 06/13/2001)
2001-03-01	33	ANSWER TO COMPLAINT [1-1] by intervenor-defendant DIACRIN/GENZYME LLC . (td) (Entered: 06/13/2001)
2001-03-01	34	RULE 26(a)(1) DISCLOSURE STATEMENT filed by intervenor-defendant DIACRIN INC (td) (Entered: 06/13/2001)
2001-03-01	35	RULE 26(a)(1) DISCLOSURE STATEMENT filed by intervenor-defendant GENZYME CORPORATION (td) (Entered: 06/13/2001)
2001-03-01	43	LCvR 26.1 Certificate of disclosure of corporate affiliations and financial interests by movant NEXTRAN, INC. (jf) (Entered: 07/16/2001)
2001-03-01	44	ANSWER TO COMPLAINT [1-1] by intervenor-defendant NEXTRAN, INC. . (jf) (Entered: 07/16/2001)
2001-03-01	45	ANSWER TO COMPLAINT [1-1] by intervenor-defendant CIRCE BIOMEDICAL, IN . (jf) (Entered: 07/16/2001)
2001-03-12	24	ANSWER TO COMPLAINT [1-1] by intervenor-defendant GENZYME CORPORATION . (aet) (Entered: 03/26/2001)
2001-03-12	25	ANSWER TO COMPLAINT [1-1] by intervenor-defendant DIACRIN/GENZYME LLC . (aet) (Entered: 03/26/2001)
2001-05-29	26	MOTION filed by plaintiff CAMPAIGN/RESPONSIBLE for Vaughn Index ; exhibits (A-I) (aet) (Entered: 05/31/2001)
2001-06-08	27	STATEMENT filed by intervenor-defendant DIACRIN/GENZYME LLC of non-opposition of plaintiff's motion for a limited vaughn index. (td) (Entered: 06/12/2001)
2001-06-08	28	STATEMENT filed by intervenor-defendant GENZYME CORPORATION of non-opposition to plaintiff's motion for a limited vaughn index. (td) (Entered: 06/12/2001)
2001-06-11	31	RESPONSE by intervenor-defendant NOVARTIS PHARMACEUT to plaintiff's motion for Vaughn Index [26-1]; exhibit (1) (td) (Entered: 06/13/2001)
2001-06-12	36	CROSS MOTIONS by federal defendant FDA for to permit a sample Vaughn Index ; exhibits (7) (td) (Entered: 06/14/2001)
2001-06-12	37	RESPONSE by intervenor-defendant CIRCE BIOMEDICAL, IN to motion for Vaughn Index [26-1] by CAMPAIGN/RESPONSIBLE (td) (Entered: 06/14/2001)
2001-06-26	38	RESPONSE by intervenor-defendant NOVARTIS PHARMACEUT to cross motion for to permit a sample Vaughn Index [36-1] by FDA (td) (Entered: 06/27/2001)
2001-06-29	39	REPLY by plaintiff CAMPAIGN/RESPONSIBLE in support of motion for Vaughn Index [26-1] by CAMPAIGN/RESPONSIBLE; exhibit (J) (aet) (Entered: 07/03/2001)
2001-07-03	40	MOTION filed by plaintiff CAMPAIGN/RESPONSIBLE for leave to file memorandum out of time. (td) (Entered: 07/05/2001)
2001-07-09	41	ORDER by Judge Ricardo M. Urbina : granting motion for leave to file memorandum out of time reply memorandum in support of its motion requesting a vaughn index and in opposition to defendant's cross motion to permit a sample vaughn index [40-1] by CAMPAIGN/RESPONSIBLE (N) (adc) (Entered: 07/09/2001)
2001-07-12	42	REPLY by federal defendant FDA in support of its cross motion for to permit a sample Vaughn Index [36-1] by FDA (td) (Entered: 07/13/2001)
2001-07-23	46	MEMORANDUM OPINION by Judge Ricardo M. Urbina (N) (bm) (Entered: 07/23/2001)
2001-07-23	47	ORDER by Judge Ricardo M. Urbina : denying motion for Vaughn Index [26-1] by CAMPAIGN/RESPONSIBLE; granting cross motion for to permit a sample Vaughn Index [36-1] by FDA; directing within fourteen (14) days the plaintiff shall select one representative new drug application (IND) to use as a sample with the exception of any Novartis IND; directing within 30 days of mutual agreement as to a representative IND, the defendant shall provide the plaintiff with a Vaughn index of FDA generated documents contained in one representative IND and FDA-generated documents concerning xenotransplantation clinical trials in general; directing the parties within 30 days of the defendant's filing of the Vaughn index to discuss, and to report to the Court, the necessity of further litigation and the filing of summary judgment briefs. (N) (bm) (Entered: 07/23/2001)
2001-08-31	48	NOTICE OF FILING by federal defendant FDA of second declaration of Lesia M. Banks (aet) (Entered: 09/04/2001)
2001-10-04	49	STATUS REPORT by federal defendant, intervenor-defendants (td) (Entered: 10/10/2001)
2001-11-14	50	ORDER by Judge Ricardo M. Urbina: scheduling a status hearing set for 10:00 12/4/01; directing that defendant and defendant-intervenors provide further recommendations, with jusitificatios, regarding a scheduling order no later than 11/29/01. (N) (jwd) (Entered: 11/14/2001)
2001-11-21	51	STATEMENT filed by federal defendant FDA to the Court concerning mail service at United States Attorney's Office (bm) (Entered: 11/26/2001)
2001-11-29	52	STATUS REPORT by intervenor-defendant NOVARTIS PHARMACEUT of Further Recommendations, with Justification, for a scheduling order. (ag) (Entered: 11/30/2001)
2001-11-29	53	STATUS REPORT by federal defendants FDA, intervenor-defendants CIRCE BIOMEDICAL, IN, NEXTRAN, INC., DIACRIN/GENZYME LLC, GENZYME CORPORATION, and DIACRIN INC regarding further recommendations and proposed scheduling order. (ag) (Entered: 11/30/2001)
2001-12-04		STATUS HEARING before Judge Ricardo M. Urbina: see scheduling order entry for scheduled events; Reporter: William D. McAllister (jwd) (Entered: 12/04/2001)
2001-12-04	54	SCHEDULING ORDER by Judge Ricardo M. Urbina setting forth certain directives to counseli; defendant's release of documents related to the sample Vaughn Index is due 12/17/01; defendant-intervenor Novartis'dispositive motions due (limited to its treshold issue) 1/4/02; oppositions to Norvartis'dispositive motions due 2/4/02; replies to oppostions to Norvartis' dispositive motions due 2/15/02; interim status hearing set for 11:00 2/14/02; plaintiff's motion for summary judgment due 1/15/02; oppositions/cross-motions for summary judgment, if any, due 3/15/02; replies to oppositions to cross-motions for summary judgment due 4/15/02; replies to cross-motions, if any, due 5/15/02; settlement conference set 10:00 8/2/02 ; finalstatus hearing set for 10:00 8/20/02 (N) (jwd) (Entered: 12/04/2001)
2001-12-04	55	ATTORNEY APPEARANCE for intervenor-defendant CIRCE BIOMEDICAL, IN by Jalena Garee Specht (dam) (Entered: 12/06/2001)
2001-12-06	56	TRANSCRIPT filed for date(s) of 12/4/01. Reporter: William D. Mc Allister (td) (Entered: 12/07/2001)
2001-12-20	57	JOINT STIPULATION AND ORDER by Judge Ricardo M. Urbina: regarding Norvartis application for approval to condust xenotransplantation clinical trial involving the cells, tissue, an/or organs of pigs and/or non-human primates. (see stipulation and order for further details) (N) (jwd) (Entered: 12/20/2001)
2002-01-15	58	MOTION filed by plaintiff CAMPAIGN/RESPONSIBLE for summary judgment ; attachments (68) (td) (Entered: 01/17/2002)
2002-02-14		STATUS HEARING before Judge Ricardo M. Urbina: (held in Jury Room) federal defendant oral request to modify the briefing scheduled, heard and granted; federal defendant indicated they plan to file a Vaugn Index by 3/15/02; parties will be given an additional two (2) weeks after the filing of a Vaughn Index to file any motions for summary judgment; counselfor federal defendant to submit a scheduling order as the modification of Court's scheduling order entered 12/4/01; all aspects of the scheduling order entered on 12/4/01 remains in effect; the final status hearing is set for 8/20/02 at 10:00 a.m. Reporter: Not Reported (jwd) (Entered: 02/14/2002)
2002-02-25	59	ORDER by Judge Ricardo M. Urbina : directing that supplemental Vaughn index due on or before 3/15/02; any oppositions/cross-motion to plaintiff's motion for summary judgment shall be due 3/29/02; plaintiff's replies/oppositions to cross-motion, if any, shall be due on or before 4/29/02; any replies by defendant and/or intervenors shall be due on or before 5/29/02 (N) (jwd) (Entered: 02/25/2002)
2002-03-15	60	NOTICE OF FILING by federal defendant FDA of third declaration of Lesia M. Banks. (td) (Entered: 03/25/2002)
2002-03-29	61	MEMORANDUM by intervenor-defendant CIRCE BIOMEDICAL, IN, intervenor-defendant NEXTRAN, INC., intervenor-defendant DIACRIN/GENZYME LLC, intervenor-defendant GENZYME CORPORATION, intervenor-defendant DIACRIN INC in opposition to plaintiff's motion for summary judgment [58-1]; exhibits (7) (td) (Entered: 04/02/2002)
2002-03-29	62	CROSS MOTIONS by federal defendant FDA for summary judgment ; attachments (14); declarations (2) (td) (Entered: 04/02/2002)
2002-03-29	63	RESPONSE by intervenor-defendant NOVARTIS PHARMACEUT to motion for summary judgment [58-1] by CAMPAIGN/RESPONSIBLE (td) (Entered: 04/02/2002)
2002-04-23	65	MOTION (unopposed) filed by plaintiff CAMPAIGN/RESPONSIBLE to extend time to 5/8/02 reply memoranda in support of motion for summary judgment. (td) (Entered: 04/26/2002)
2002-04-23	66	RESPONSE (OPPOSITIONS) by plaintiff CAMPAIGN/RESPONSIBLE to defendant's cross motion for summary judgment [62-1]. (td) (Entered: 04/26/2002)
2002-04-23	67	RESPONSE by plaintiff CAMPAIGN/RESPONSIBLE to intervenors' memorandum in opposition [61-1] by DIACRIN INC, GENZYME CORPORATION, DIACRIN/GENZYME LLC, NEXTRAN, INC., CIRCE BIOMEDICAL, IN (td) (Entered: 04/26/2002)
2002-04-25	64	ORDER by Judge Ricardo M. Urbina plaintiff's reply memoranda in support of motin for summary judgment, in opposition to defendant's cross-mnotion for summary judgment, and in response to defendant-intervenors' memorandum in opposition due 5/8/02; defendant U. S. Food and Drug Administration's reply memorandum, if any will be due 6/10/02; vacating status conference set for 8/20/02 and rescheduling status conference for 1:30 9/12/02 (N) (jwd) (Entered: 04/26/2002)
2002-05-08	68	REPLY by plaintiff CAMPAIGN/RESPONSIBLE to defendant intervenors' opposition to motion for summary judgment [58-1] by CAMPAIGN/RESPONSIBLE (td) (Entered: 05/09/2002)
2002-05-08	69	REPLY by plaintiff CAMPAIGN/RESPONSIBLE in support of motion for summary judgment [58-1]; exhibits (10) (td) (Entered: 05/10/2002)
2002-05-08	70	RESPONSE by plaintiff CAMPAIGN/RESPONSIBLE in opposition to governments cross motion for summary judgment [62-1]; exhibits (10) (td) (Entered: 05/10/2002)
2002-06-10	71	REPLY by federal defendant FDA in support of cross motion for summary judgment [62-1] by FDA; exhibits (1) (aet) Modified on 06/11/2002 (Entered: 06/11/2002)
2002-06-10	72	MOTION filed by intervenor-defendant CIRCE BIOMEDICAL, IN, intervenor-defendant NEXTRAN, INC., intervenor-defendant DIACRIN/GENZYME LLC for leave to file reply memorandum in support of the FDA's cross motion for summary judgment ; EXHIBIT (REPLY MEMO) (aet) (Entered: 06/12/2002)
2002-06-12	73	ORDER by Judge Ricardo M. Urbina : granting motion for leave to file reply memorandum in support of the FDA's cross motion for summary judgment [72-1] by DIACRIN/GENZYME LLC, NEXTRAN, INC., CIRCE BIOMEDICAL, IN (N) (jwd) (Entered: 06/12/2002)
2002-06-12	74	REPLY by intervenor-defendant CIRCE BIOMEDICAL, IN, intervenor-defendant NEXTRAN, INC., intervenor-defendant DIACRIN/GENZYME LLC, intervenor-defendant GENZYME CORPORATION in support of cross motion for summary judgment [62-1] by FDA; declaration (1) (aet) (Entered: 07/12/2002)
2002-08-09	75	NOTICE OF SUPPLEMENTAL AUTHORITY by plaintiff CAMPAIGN/RESPONSIBLE (aet) (Entered: 08/20/2002)
2002-09-03	76	MEMORANDUM OPINION by Judge Ricardo M. Urbina granting in part and denying in part the plaintiff's and defendant's motions for summary judgment (N) (jwd) (Entered: 09/03/2002)
2002-09-03	77	ORDER by Judge Ricardo M. Urbina : granting in part, denying in part cross motion for summary judgment [62-1], granting in part, denying in part motion for summary judgment [58-1]; directing that defendant file new Vaughn indices (each index shall be contained in one document) that are consistent with the attached Memorandum Opinion no later than 11/10/02; referring case to U. S. Magistrate Judge Kay for settlement discussions to begin no later than 9/20/02; granting Novartis' unopposed request for a ruling that, because none exist, no agency-generated records concerning Novartis shall be produced in response to the modified FOIA request. (N) (jwd) (Entered: 09/03/2002)
2002-09-12		CASE REFERRED to Magistrate Judge Alan Kay for settlement discussions (cp) (Entered: 09/13/2002)
2002-09-16	79	NOTICE OF FILING by plaintiff CAMPAIGN/RESPONSIBLE this it is submitting a proposed order that allows plaintiff to defer any motion that plaintiff is entitled to file for attorneys' fees and costs. (bm) (Entered: 09/18/2002)
2002-09-16	80	MOTION filed by intervenor-defendant NOVARTIS PHARMACEUT to be dropped from the case (bm) (Entered: 09/18/2002)
2002-09-17	78	ORDER by Judge Ricardo M. Urbina: directing that plaintiff defer it motions pursuant to Rule 54(d)(2) until thirty (30) days after it receives the government's new Vaughn Indices, as ordered on 9/3/02. (N) (jwd) (Entered: 09/17/2002)
2002-09-19	81	RESPONSE by plaintiff CAMPAIGN/RESPONSIBLE in opposition to motion to be dropped from the case [80-1] by NOVARTIS PHARMACEUT . (mpt) (Entered: 09/24/2002)
2002-09-24	82	REPLY by intervenor-defendant NOVARTIS PHARMACEUT in support of motion to be dropped from the case [80-1] by NOVARTIS PHARMACEUT; exhibits (1) (cdw) (Entered: 09/26/2002)
2002-10-02	83	NOTICE OF FILING by plaintiff CAMPAIGN/RESPONSIBLE; Memorandum of Understanding (aet) (Entered: 10/07/2002)
2002-10-02	84	JOINT MOTION by plaintiff CAMPAIGN/RESPONSIBLE, federal defendant FDA to extend time to 12/20/02 to file Vaughn indices (aet) (Entered: 10/07/2002)
2002-10-07	85	ORDER by Judge Ricardo M. Urbina : granting joint motion to extend time to 12/20/02 to file Vaughn indices [84-1] by FDA, CAMPAIGN/RESPONSIBLE; directing that the partiesfile a joint status report, limited to three pages, by 1/17/03; scheduling a final status hearing for 2:30 1/23/03 (N) (jwd) (Entered: 10/07/2002)
2002-10-16	86	TRANSCRIPT filed for date(s) of 9/12/02. Reporter: William McAllister (aet) (Entered: 10/17/2002)
2002-12-11	87	SUBSTITUTION OF COUNSEL for intervenor-defendant CIRCE BIOMEDICAL, IN , substituting Richard A. Merrill for attorney Jalena Garee Specht for CIRCE BIOMEDICAL, IN, attorney Bruce Neil Kuhlik for CIRCE BIOMEDICAL, IN (aet) (Entered: 12/12/2002)
2002-12-20	88	VAUGHN INDEX by federal defendant FDA (aet) (Entered: 12/30/2002)
2003-01-13	89	NOTICE OF CHANGE OF ADDRESS by John Michael Engel III representing intervenor-defendant NOVARTIS PHARMACEUT . New address: ENGEL & NOVITT, LLP 750 17th Street, NW, Suite 1100; Washington DC 20006 (202) 778-2321, (FAX) (202) 331-0168. (bm) (Entered: 01/15/2003)
2003-01-16	90	JOINT STATUS REPORT by plaintiffs , federal defendant, intervenor-defendants pursuant to 10/7/02 order (aet) (Entered: 01/21/2003)
2003-01-21	91	ORDER by Judge Ricardo M. Urbina : granting motion to be dropped from the case [80-1] by NOVARTIS PHARMACEUTl directing that Novartis is hereby dropped as an Intervenor-Defendant in this action with leave to interevene should Novartis' records, or Agency generated records concerning Novartis' Records, be put at issue in any future proceedings in this case. (N) (jwd) (Entered: 01/21/2003)
2003-01-21	92	ORDER by Judge Ricardo M. Urbina: vacating final status conference set for 1/23/03 and rescheduling final status hearing for 1:45 4/10/03; directing the parties to file a joint status report no later than 3/24/03. (N) (jwd) (Entered: 01/21/2003)
2003-01-31	93	NOTICE OF FILING by federal defendant FDA; errata to defendant's new sample vaughn index (bm) (Entered: 02/04/2003)
2003-01-31	94	NOTICE OF FILING by federal defendant FDA; errata to defendant's new sample vaughn index (bm) (Entered: 02/04/2003)
2003-03-24	95	JOINT STATUS REPORT by plaintiff, federal defendant, and intervenor-defendants (bm) (Entered: 03/27/2003)
2003-04-10		STATUS HEARING before Judge Ricardo M. Urbina: oral motion of plaintif for FDA to provide additional Vaughn index, heard and deniedl see scheduling order for scheduled events Reporter: William D. McAllister (jwd) Modified on 04/10/2003 (Entered: 04/10/2003)
2003-04-10	96	ORDER by Judge Ricardo M. Urbina: defendants motions for summary judgment due 6/9/03; plaintiff's consolidated oppositin and motion for summary judgment due 7/9/03; defendants' replies and oppositions to plaintiff's motion due 8/11/03; plaintiff's consolidated reply due 8/29/03; defendants' motions for summary judgment are eache limited to 20 pages; plaintiff's consolidated opposition and motion for summary judgmnent is limited to 25 pages; defendants' replies and oppositions to the plaintiff's motion are limited to 20 pages; plaintiff's consolidated reply is limited to 15 pages.(N) (jwd) (Entered: 04/10/2003)
2003-05-16	97	TRANSCRIPT filed for date of 4/10/03 Final Status Hearing. Reporter: William D. McAllister (bm) (Entered: 05/21/2003)
2003-06-05	98	MOTION filed by federal defendant FDA for summary judgment attachments (12) BULKY PLEADING (bm) (Entered: 06/06/2003)
2003-06-08	99	MEMORANDUM by intervenor-defendant DIACRIN/GENZYME LLC in support of motion for summary judgment [98-1] by FDA and notice of filing declarations; attachments (2) (bm) (Entered: 06/11/2003)
2003-07-09	100	CROSS MOTIONS by plaintiff CAMPAIGN/RESPONSIBLE for summary judgment ; attachments (45) BULKY PLEADING (bm) (Entered: 07/10/2003)
2003-07-09	101	MEMORANDUM by plaintiff CAMPAIGN/RESPONSIBLE in support of cross motion for summary judgment [100-1] by CAMPAIGN/RESPONSIBLE BULKY PLEADING (bm) (Entered: 07/10/2003)
2003-07-09	102	RESPONSE by plaintiff CAMPAIGN/RESPONSIBLE in opposition to motion for summary judgment [98-1] by FDA BULKY PLEADING (bm) (Entered: 07/10/2003)
2003-07-21	103	ERRATA by plaintiff CAMPAIGN/RESPONSIBLE to cross motion for summary judgment of exhibit 29. (jf) (Entered: 07/24/2003)
2003-08-08	104	REPLY MEMORANDUM by federal defendant FDA in support of renewed motion for summary judgment [98-1] by FDA; exhbits (5) (bjsp) (Entered: 08/13/2003)
2003-08-08	105	RESPONSE by federal defendant FDA in opposition to cross motion for summary judgment [100-1] by CAMPAIGN/RESPONSIBLE . (bjsp) (Entered: 08/13/2003)
2003-08-28	106	REPLY by plaintiff CAMPAIGN/RESPONSIBLE in support of cross motion for summary judgment [100-1] by CAMPAIGN/RESPONSIBLE; exhibits (6) (mpt) (Entered: 08/29/2003)
2003-09-09	107	MOTION filed by federal defendant FDA for leave to file sur-reply ; EXHIBIT (sur reply) (bjsp) (Entered: 09/12/2003)
2003-09-17	108	JOINT STATUS REPORT by plaintiff and federal defendant (bjsp) (Entered: 09/24/2003)
2003-09-24	109	RESPONSE by plaintiff CAMPAIGN/RESPONSIBLE in opposition to motion for leave to file sur-reply [107-1] by FDA . (bjsp) (Entered: 09/25/2003)
2003-12-02	110	ORDER striking 98 the defendant's motion for summary judgment; striking 100 the plaintiff's cross-motion for summary judgment; granting leave to file new dispositive motions; and denying 107 the defendant's motion for leave to file a sur-reply. Signed by Judge Ricardo M. Urbina on 12/2/03. (Entered: 12/02/2003)
2004-01-05	111	MOTION for Summary Judgment (Renewed) by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Abbreviated Vaughn Index)(Sonfield, Brian) (Entered: 01/05/2004)
2004-01-05	112	MOTION for Summary Judgment by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Exhibit Records At Issue# 2 Exhibit Defendant's 2nd Abbreviated New Sample Vaughn Index)(Lovvorn, Jonathan) (Entered: 01/05/2004)
2004-01-20	113	NOTICE of Appearance by Alan Burch on behalf of FOOD & DRUG ADMINISTRATION (Burch, Alan) (Entered: 01/20/2004)
2004-02-05	114	Memorandum in opposition to motion re 111 filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Meyer, Katherine) (Entered: 02/05/2004)
2004-02-05	115	Memorandum in opposition to motion re 112 and response to plaintiff's statement of material facts filed by FOOD & DRUG ADMINISTRATION. (Burch, Alan) (Entered: 02/05/2004)
2004-02-19	116	REPLY in support of motion re 112 for summary judgment filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Meyer, Katherine) (Entered: 02/19/2004)
2004-02-19	117	REPLY in support of motion re 111 for summary judgment (renewed) filed by FOOD & DRUG ADMINISTRATION. (Burch, Alan) (Entered: 02/19/2004)
2004-09-24	118	ORDER granting 111 Defendants' Motion for Summary Judgment, denying 112 Plaintiff's Motion for Summary Judgment. Signed by Judge Ricardo M. Urbina on 9/24/04. (Entered: 09/24/2004)
2004-09-24	119	MEMORANDUM OPINION. Signed by Judge Ricardo M. Urbina on 9/24/04. (Entered: 09/24/2004)
2004-10-04	120	Unopposed MOTION for Extension of Time to File Motion Under Rule 54 by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Meyer, Katherine) (Entered: 10/04/2004)
2004-10-05		MINUTE ORDER granting 120 Unopposed Motion for Extension of Time. The deadline for the plaintiff to file any motion for fees and costs under the Freedom of Information Act shall be extended to December 7, 2004. Signed by Judge Ricardo M. Urbina on 10/05/04. (Entered: 10/05/2004)
2004-10-05		Set/Reset Deadlines: Plaintiff to file any Motion for fees and costs under the Freedom of Information Act shall be extended to 12/7/2004. (jwd) (Entered: 10/05/2004)
2004-12-06	121	Unopposed MOTION to Stay the Time For Filing A Motion Under Rule 54 by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Text of Proposed Order)(Meyer, Katherine) (Entered: 12/06/2004)
2004-12-06		MINUTE ORDER granting 121 Unopposed Motion to Stay. The deadline for the plaintiff to file any motion for fees and costs under the Freedom of Information Act shall be stayed until 30 days after the defendants complete the disclosure ordered by the court in its September 24, 2004 Memorandum Opinion and Order, or the court resolves any remaining disputes about the defendants' compliance with that order. Signed by Judge Ricardo M. Urbina on 12/6/04. (Entered: 12/06/2004)
2005-04-01	122	NOTICE of Appearance by Howard M. Crystal on behalf of CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION (Crystal, Howard) (Entered: 04/01/2005)
2005-04-01	123	MOTION to Enforce This Court's September 24, 2004 Order and Memorandum in Support by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Attachment 1# 2 Attachment 2# 3 Text of Proposed Order)(Crystal, Howard) (Entered: 04/01/2005)
2005-04-01		MINUTE ORDER: Defendant FDA shall respond to the plaintiff's motion to enforce by April 7, 2005. Signed by Judge Ricardo M. Urbina on 4/1/05. (Entered: 04/01/2005)
2005-04-07	124	Memorandum in opposition to motion re 123 to Enforce filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Exhibit Brockner Ryan Dec.# 2 Exhibit Warren Dec.# 3 Exhibit Egan Dec.# 4 Text of Proposed Order)(Burch, Alan) (Entered: 04/07/2005)
2005-04-18	125	REPLY to opposition to motion re 123 to Enforce filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Text of Proposed Order)(Crystal, Howard) (Entered: 04/18/2005)
2005-04-20	126	MOTION for Leave to File Sur-Reply in Opposition to Plaintiff's Motion to Enforce 123 by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order # 2 Sur-Reply# 3 Exhibit 1 to Sur-Reply)(Burch, Alan) (Entered: 04/20/2005)
2005-04-21		MINUTE ORDER granting 126 Motion for Leave to File Sur-reply. The Clerk of the Court shall enter the defendant's sur-reply on the docket. Signed by Judge Ricardo M. Urbina on 4/20/05. (Entered: 04/21/2005)
2005-04-21	127	SURREPLY in opposition to plaintiff's expedited 123 MOTION to Enforce This Court's September 24, 2004 Order filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Exhibit 1)(jf, ) (Entered: 04/25/2005)
2005-05-03	128	ORDER denying 123 Motion to Enforce. Signed by Judge Ricardo M. Urbina on 5/3/05. (Entered: 05/03/2005)
2005-05-03		Set Deadlines/Hearings: Parties shall submit a joint status report and proposed scheduling order setting forth a document production scheduled by 5/24/2005. (jwd) (Entered: 05/03/2005)
2005-05-24	129	STATUS REPORT by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION, FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Burch, Alan) (Entered: 05/24/2005)
2005-10-20	130	Unopposed MOTION for Extension of Time to File Motion for Fees And Costs Under Rule 54 by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Text of Proposed Order)(Crystal, Howard) (Entered: 10/20/2005)
2005-10-26		MINUTE ORDER granting 130 Motion for Extension of Time to File Rule 54 Motion. The Rule 54 motion is due on or before December 20, 2005. Signed by Judge Ricardo M. Urbina on 10/26/05. (md) (Entered: 10/26/2005)
2005-10-26		Set Deadlines/Hearings: Rule 54 Motions due by 12/20/2005. (jwd) (Entered: 10/26/2005)
2005-12-15	131	Consent MOTION for Extension of Time to File Motion Concerning Entitlement To Attorneys' Fees And Costs by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Text of Proposed Order)(Crystal, Howard) (Entered: 12/15/2005)
2005-12-16		MINUTE ORDER granting 131 the parties' consent motion for a schedule to resolve the plaintiff's entitlement to fees and costs. The plaintiff shall file its brief on or before February 3, 2006; the defendants shall file their opposition brief on or before February 24, 2006; and the plaintill shall file its reply brief on or before March 10, 2006. Signed by Judge Ricardo M. Urbina on 12/16/2005. (md) (Entered: 12/16/2005)
2005-12-19		Set Deadlines/Hearings: Plaintiff's Brief due by 2/3/2006. Defendants's due by 2/24/2006. Plaintiff's Reply due by 3/10/2006. (jwd) (Entered: 12/19/2005)
2006-02-03	132	MOTION for Attorney Fees And Costs by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Exhibit A# 2 Exhibit B# 3 Exhibit C)(Meyer, Katherine) (Entered: 02/03/2006)
2006-02-23	133	Memorandum in opposition to re 132 for attorneys' fees and costs filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Burch, Alan) (Entered: 02/23/2006)
2006-03-09	134	REPLY to opposition to motion re 132 MOTION for Attorney Fees And Costs filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Meyer, Katherine) (Entered: 03/09/2006)
2006-07-19	135	NOTICE Of Filing by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION re 132 MOTION for Attorney Fees And Costs (Attachments: # 1 Supplement Supplemental Authority)(Meyer, Katherine) (Entered: 07/19/2006)
2006-08-23	136	NOTIFICATION OF SUPPLEMENTAL AUTHORITY by FOOD & DRUG ADMINISTRATION (Attachments: # 1 Exhibit Davis v. DOJ (D.C. Cir. Aug. 22, 2006))(Burch, Alan) (Entered: 08/23/2006)
2006-09-05	137	ORDER denying 132 the plaintiffs' motion for attorney fees. Signed by Judge Ricardo M. Urbina on 9/5/2006. (md) (Entered: 09/05/2006)
2006-09-05	138	MEMORANDUM OPINION. Signed by Judge Ricardo M. Urbina on 9/5/2006. (md) (Entered: 09/05/2006)
2006-10-18	139	NOTICE OF APPEAL by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. Filing fee $ 455, receipt number 1031317. Fee Status: Fee Paid. Parties have been notified. (Meyer, Katherine) (Entered: 10/18/2006)
2006-10-19		Transmission of Notice of Appeal and Docket Sheet to US Court of Appeals re 139 Notice of Appeal (jf, ) (Entered: 10/19/2006)
2006-10-24		USCA Case Number 06-5333 for 139 Notice of Appeal filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION,. (jf, ) (Entered: 10/25/2006)
2008-04-08	140	MANDATE of USCA (certified copy) as to 139 Notice of Appeal filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION reversing and remanding the case. (jeb, ) (Entered: 04/18/2008)
2008-04-18		MINUTE ORDER directing the parties to submit a Joint Status Report on or before Friday, May 2, 2008 addressing the impact of the D.C. Circuit's December 28, 2007 opinion on further proceedings before this court. Include a proposed schedule for any further motions, should they be deemed necessary. SO ORDERED. Signed by Judge Ricardo M. Urbina on 4/18/08. (lcrmu2) (Entered: 04/18/2008)
2008-04-18		Set/Reset Deadlines/Hearings: parties to submit a Joint Status Report on or before Friday, May 2, 2008 addressing the impact of the D.C. Circuit's December 28, 2007 opinion on further proceedings before this court. Include a proposed schedule for any further motions, should they be deemed necessary (jwd) (Entered: 04/18/2008)
2008-05-01	141	NOTICE OF WITHDRAWAL OF APPEARANCE as to CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. Attorney Amy R. Atwood and Jonathan Russell Lovvorn terminated. (Crystal, Howard) (Entered: 05/01/2008)
2008-05-01	142	STATUS REPORT Pursuant To April 18, 2008 Order by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Crystal, Howard) (Entered: 05/01/2008)
2008-05-01		MINUTE ORDER: It is hereby ordered that CRT's fee motion is due on or before May 22, 2008; the FDA's opposition is due on or before June 12, 2008; and CRT's reply is due on or before June 26, 2008. Signed by Judge Ricardo M. Urbina on 5/1/08. (lcrmu2) (Entered: 05/01/2008)
2008-05-01		Set/Reset Deadlines/Hearings: CRT's fee motion is due on or before May 22, 2008; the FDA's opposition is due on or before June 12, 2008; and CRT's reply is due on or before June 26, 2008 (jwd) (Entered: 05/01/2008)
2008-05-22	143	MOTION for Attorney Fees and Costs and Supporting Memorandum by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION (Attachments: # 1 Declaration of Howard M.Crystal, # 2 Declaration of Alix Fano, # 3 Declaration of Stephen Braga, # 4 Text of Proposed Order)(Crystal, Howard) (Entered: 05/22/2008)
2008-06-12	144	Memorandum in opposition to re 143 MOTION for Attorney Fees and Costs and Supporting Memorandum filed by FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Burch, Alan) (Entered: 06/12/2008)
2008-06-25	145	REPLY to opposition to motion re 143 MOTION for Attorney Fees and Costs and Supporting Memorandum filed by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION. (Attachments: # 1 Second Crystal Declaration, # 2 Text of Proposed Order)(Crystal, Howard) (Entered: 06/25/2008)
2008-12-23	146	NOTICE OF SUPPLEMENTAL AUTHORITY by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION (Attachments: # 1 Attachment)(Crystal, Howard) (Entered: 12/23/2008)
2009-01-07	147	RESPONSE re 146 NOTICE OF SUPPLEMENTAL AUTHORITY regarding Davy decision filed by FOOD & DRUG ADMINISTRATION. (Burch, Alan) (Entered: 01/07/2009)
2009-01-22	148	ORDER granting 143 the plaintiff's Motion for Attorney Fees. It is further ordered that the case be referred to Magistrate Judge Facciola for calculating attorneys' fees and costs. Signed by Judge Ricardo M. Urbina on 1/22/09. (lcrmu2) (Entered: 01/22/2009)
2009-01-22	149	MEMORANDUM OPINION. Signed by Judge Ricardo M. Urbina on 1/22/09. (lcrmu2) (Entered: 01/22/2009)
2009-01-22	150	CASE REFERRED to Magistrate Judge John M. Facciola to calculate attorneys' fees and costs. (jeb, ) (Entered: 01/26/2009)
2009-02-02	151	ORDER re referral to Judge Facciola for attorneys' fees and costs. Signed by Magistrate Judge John M. Facciola on 2/2/09. (SP, ) (Entered: 02/02/2009)
2009-02-26	152	STIPULATION of Dismissal and Settlement by CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION, FOOD & DRUG ADMINISTRATION. (Burch, Alan) (Entered: 02/26/2009)
2009-02-26	153	STIPULATION AND ORDER signed by Judge Ricardo M. Urbina on February 26, 2009, of settlement and dismissal of case with prejudice. (jwd, ) (Entered: 02/26/2009)
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