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Case TitleCareToLive v. The Food and Drug Administration (FDA)
DistrictSouthern District of Ohio
CityColumbus
Case Number2:2008cv00005
Date Filed2008-01-02
Date Closed2009-06-23
JudgeJudge Gregory L Frost
PlaintiffCareToLive A Not For Profit Corporation
DefendantThe Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach
Documents
Docket
Complaint
Opinion/Order [23]
FOIA Project Annotation: A federal court in Ohio has granted the FDA an Open America stay after finding the agency had shown the existence of exceptional circumstances that made it impossible to provide a timely response to CareToLive, an association of cancer patients, families, doctors, and advocates. The group had requested information about the biologic Provenge. Its request was the 8,316th FOIA request received by the agency in 2007. While one office at FDA was able to respond that it had no records, the request was also sent to the Center for Drug Evaluation and Research, which classified it as a complex request and contacted the group to indicate that it would be processed on a first-in/first-out basis. CareToLive then filed suit. Mixing elements from Open America and the EFOIA amendments which are not completely consistent with each other, the court borrowed the concept from Open America that exceptional circumstances occurred when request loads were far in excess of what Congress had anticipated. From the EFOIA amendments, it noted that an agency could justify taking more time if it showed its resources were stretched thin because of other demands from courts or administrative tribunals. While the court recognized that the EFOIA amendments also excluded routine backlogs as a justification for exceptional circumstances, it did not acknowledge that the provision largely undercut Open America's justification pertaining to numbers in excess of Congressional expectations. The court noted that "FDA further shows that the raw numbers of annual FOIA requests fail to reflect their size or complexity" and concluded that CareToLive had failed to rebut the agency's claim that it had a "FOIA request workload that is vastly in excess of Congress' anticipation." The court pointed out that FDA was required to use scarce resources to respond to congressional inquiries and litigation demands. At the same time, the agency had shown reasonable progress in dealing with its backlog, cutting the backlog by 50 percent over five years. The court then observed that "cases subsequent to EFOIA have continued to hold that, where an agency is making good faith efforts and exercising due diligence in processing requests on a first-in, first-out basis, a stay of proceedings is authorized so long as the agency also demonstrates reasonable progress in reducing its backlog." Dismissing the group's claim to expedited processing, the court noted that CareToLive had neither requested expedited processing nor provided the appropriate information to certify a compelling need for the information. The court expressed concern that "the FDA's estimate that it will take 20 months before it can respond to Plaintiff's FOIA request may be inflated to account for the possibility that this Court may grant the stay for less time than requested" and decided to give the agency a 10-month stay instead.
Issues: Delay - Backlog reduction activities
Opinion/Order [40]
FOIA Project Annotation: A federal court in Ohio has ruled that the FDA properly responded to a request from CaretoLive for letters sent to the agency concerning the cancer drug Provenge and that the group failed to show that the agency had not conducted an adequate search. The Center for Biologics responded with some documents on Nov. 6, 2007, but the Center for Drugs did not respond until after CaretoLive had filed suit in January 2008. The Center for Drugs released one document on May 18, 2009. On the same day, the agency filed its motion for summary judgment. CaretoLive responded with a motion for discovery in June. Each component of the agency that received a copy of the requested letter accounted for its receipt of the letter, including Dr. Richard Pazdur, a Supervisory Medical Officer in the Office of Oncology. CaretoLive argued that the agency's search was inadequate because only a single additional document had been located. The group argued that an IT specialist should check Pazdur's computer because Pazdur had indicated that, because the letters did not pertain to an application in which he was involved, he had shredded the hard copy of the letter he received and deleted the email version. The court pointed out that "plaintiff does not dispute that the correspondences that Dr. Pazdur admits were destroyed are duplicates of documents already produced to Plaintiff by the FDA. . . Defendant simply is not required to hire an IT expert to search for a copy of a document that has already been produced." The court declined to allow CaretoLive to conduct discovery, rejecting the group's speculation that other documents must exist. The court noted that "plaintiff concludes that Dr. Pazdur lied about the April 2007 correspondences that he possessed and destroyed because the correspondences could not have been 'sent without some kind of email introduction and comments and/or an acknowledgement.' Again, Plaintiff returns to his arguments that there are documents that 'must' exist. Plaintiff's arguments fall woefully short on showing bad faith and, indeed, are completely at odds with the evidence before this Court."
Issues: Adequacy - Search
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2008-01-021Civil Cover Sheet. (pes) (Entered: 01/02/2008)
2008-01-022COMPLAINT against The Food and Drug Administration (FDA), filed by CareToLive. (pes) (Entered: 01/02/2008)
2008-01-02Filing fee: $ 350, receipt number COL1093 (pes) (Entered: 01/02/2008)
2008-01-023CERTIFICATE of Clerk - certified mailing of summons and complaint via the Clerk's Office. (pes) (Entered: 01/02/2008)
2008-01-044ORDER REASSIGNING CASE re: related case 2:07cv729: We agree that the cases are related and that the subject case should be transferred to the docket of Judge Frost. Case reassigned to Judge Gregory L Frost for all further proceedings. Judge Michael H. Watson no longer assigned to case. Signed by Judge Gregory L Frost on 1/4/08. (pes) (Entered: 01/04/2008)
2008-01-04Judge Norah McCann King added per NMK. Judge Terence P Kemp no longer assigned to case. (pes) (Entered: 01/04/2008)
2008-01-075SUMMONS Returned Executed: US Attorney c/o The Food and Drug Administration (FDA) served on 1/4/2007, answer due 3/5/2007. (rew ) (Entered: 01/08/2008)
2008-01-146SUMMONS Returned Executed: The Food and Drug Administration (FDA) served on 1/9/2007, answer due 3/10/2007. (Attachments: # 1 Certified Mail Receipt Return) (pes) (Entered: 01/14/2008)
2008-01-147SUMMONS Returned Executed: US Dept of Justice c/o The Food and Drug Administration (FDA) served on 1/8/2008, answer due 3/10/2008. (rew, ) (Entered: 01/14/2008)
2008-02-048ANSWER to 2 Complaint by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 02/04/2008)
2008-02-059NOTICE of Hearing: Pretrial Conference set for 3/5/2008 @ 03:30 PM in chambers before Norah McCann King. (jm1, ) (Entered: 02/05/2008)
2008-02-1810MOTION to Stay Proceedings by Defendant The Food and Drug Administration (FDA). (Attachments: # 1 Exhibit A, Declaration of Frederick Sadler, # 2 Exhibit B, Declaration of Nancy Sager) (Stark, John) (Entered: 02/18/2008)
2008-02-1911MOTION to Continue Preliminary Pretrial Conference by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 02/19/2008)
2008-02-1912ORDER re 10 MOTION to Stay Proceedings filed by The Food and Drug Administration (FDA); Non-oral hearing on said motion set for 4/4/2008. Signed by Gregory L Frost on 2/19/08. (sem1, ) (Entered: 02/19/2008)
2008-02-2013ORDER granting # 11 Motion to Continue. The preliminary pretrial conference will be rescheduled if otherwise appropriate, following resolution of the motion to stay. Signed by Norah McCann King on 2/20/08. (rew ) (Entered: 02/20/2008)
2008-02-2014ORDER granting # 11 MOTION to Continue Preliminary Pretrial Conference. Signed by Norah McCann King on 2/20/08. (rew ) (Entered: 02/20/2008)
2008-03-0315AMENDED ANSWER to 2 Complaint by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 03/03/2008)
2008-03-0516RESPONSE to Motion re 10 MOTION to Stay Proceedings filed by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 03/05/2008)
2008-03-0617ORDER granting # 16 filed as a response to Defendant's Motion, is a Motion for an Extension of Time to Respond. Plaintiff may have until 3/14/08 to respond to Defendant's Motion to Stay. Signed by Norah McCann King on 3/06/08. (rew ) Modified on 3/10/2008 (sem1, ). (Entered: 03/07/2008)
2008-03-1118RESPONSE in Opposition re 10 MOTION to Stay Proceedings filed by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 03/11/2008)
2008-03-2519REPLY to Response to 10 MOTION to Stay Proceedings filed by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 03/25/2008)
2008-03-2520First MOTION for Leave to File Twenty Requests for Admissions by Plaintiff CareToLive. (Donahue, Kerry) Modified on 3/26/2008 to correct text (kk2). (Entered: 03/25/2008)
2008-04-0321RESPONSE in Opposition re 20 First MOTION for Leave to File Request for Admissions filed by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 04/03/2008)
2008-04-1222REPLY to Response to Motion re 20 First MOTION for Leave to File Request for Admissions filed by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 04/12/2008)
2008-05-2223ORDER granting 10 Defendant's Motion to Stay this action until 12/1/08. Signed by Gregory L Frost on 5/22/08. (sem1, ) (Entered: 05/22/2008)
2008-05-2224ORDER denying # 20 Motion for leave to file, without prejudice to renewal should the stay be vacated. Signed by Norah McCann King on 5/22/08. (rew ) (Entered: 05/23/2008)
2008-12-0125NOTICE by Defendant The Food and Drug Administration (FDA) (Defendant United States Food and Drug Administration's Notice of Filing Supplemental Declaration) (Attachments: # 1 Exhibit A) (Stark, John) (Entered: 12/01/2008)
2008-12-0126First MOTION Leave to serve 20 interrogatories by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 12/01/2008)
2008-12-0127First MOTION Deny further Stay or require more specificity by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 12/01/2008)
2008-12-0128ORDER denying without prejudice 26 Plaintiff's Discovery Motion and denying 27 Plaintiff's Motion to Deny a Continued Stay in this matter. This case shall remain STAYED and ADMININISTRATIVELY CLOSED until Defendant responds to FOIA request on or before 5/18/09. Defendant is ORDERED to notify this Court upon responding to the FOIA request. Signed by Gregory L Frost on 12/1/08. (sem1, ) (Entered: 12/01/2008)
2009-05-1829MOTION for Summary Judgment by Defendant The Food and Drug Administration (FDA). Responses due by 6/11/2009 (Attachments: # 1 Exhibit A, Declaration of Frederick J. Sadler, # 2 Exhibit B, Declaration of Beth Brockner-Ryan, # 3 Exhibit C, Declaration of Nancy B. Sager, # 4 Exhibit D, Declaration of Dr. Richard Pazdur) (Stark, John) (Entered: 05/18/2009)
2009-05-2030NOTICE of Hearing: Preliminary Pretrial Conference set for 7/15/2009 @ 02:15 PM in chambers before Magistrate Judge Norah McCann King. (jm1, ) (Entered: 05/20/2009)
2009-05-2031ORDER re 29 MOTION for Summary Judgment filed by The Food and Drug Administration (FDA); Non-oral hearing on said motion set for 7/10/2009. Signed by Judge Gregory L Frost on 5/20/09. (sem1, ) (Entered: 05/20/2009)
2009-05-2032MOTION to Continue Preliminary Pretrial Conference by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 05/20/2009)
2009-06-0133ORDER vacating 32 Motion to Continue. The preliminary pretrial conference on 07/15/2009 will be rescheduled. Signed by Magistrate Judge Norah McCann King on 06/01/2009. (sr1) (Entered: 06/01/2009)
2009-06-0634First MOTION 56(f) and leave by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 06/06/2009)
2009-06-0835ORDER re 34 MOTION for Leave to Conduct Complete Discovery under Rule 56(f) filed by CareToLive; Defendant shall have until 6/12/09 to file its Memorandum in Opposition; Plaintiff shall have until 6/16/09 to file their Reply; Non-oral hearing on said motion set for 6/17/2009. Signed by Judge Gregory L Frost on 6/8/09. (sem1, ) (Entered: 06/08/2009)
2009-06-0836MOTION to Amend/Correct by Plaintiff CareToLive. (Donahue, Kerry) (Entered: 06/08/2009)
2009-06-0937ORDER granting 36 Plaintiff's Motion to Amend/Correct their 6/6/09 Motion for Leave to Conduct Complete Discovery under Rule 56 (f). Signed by Judge Gregory L Frost on 6/9/09. (sem1, ) Modified on 6/10/2009 (sem1, ). (Entered: 06/09/2009)
2009-06-1238RESPONSE in Opposition re 34 First MOTION 56(f) and leave filed by Defendant The Food and Drug Administration (FDA). (Stark, John) (Entered: 06/12/2009)
2009-06-1639RESPONSE in Support re 34 First MOTION 56(f) and leave filed by Plaintiff CareToLive. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C) (Donahue, Kerry) (Entered: 06/16/2009)
2009-06-2340ORDER denying 34 Plaintiff's Motion for Discovery and granting 29 Defendant's Motion for Summary Judgment. Signed by Judge Gregory L Frost on 6/23/09. (sem1, ) (Entered: 06/23/2009)
2009-06-2341JUDGMENT entered pursuant to the Opinion and Order signed by Judge Gregory L Frost on 6/23/09. (sem1, ) (Entered: 06/23/2009)
2009-08-1442NOTICE OF APPEAL as to 41 Judgment, 40 Order on Motion for Miscellaneous Relief, Order on Motion for Summary Judgment by Plaintiff CareToLive. Filing fee $ 455. (Donahue, Kerry) (Entered: 08/14/2009)
2009-08-14Notice of Appeal Filing fee: $ 455, receipt number 200COL008968 (sr) (Entered: 08/14/2009)
2009-09-03USCA Case Number 09-4084 for 42 Notice of Appeal filed by CareToLive. (er1 ) (Entered: 09/03/2009)
2011-01-1143OPINION and JUDGMENT of USCA as to 42 Notice of Appeal: The judgment of the District Court is AFFIRMED. (er1) (Entered: 01/11/2011)
2011-03-0144MANDATE of USCA as to 42 Notice of Appeal filed by CareToLive (jcw1) (Entered: 03/01/2011)
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by FOIA Project Staff
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