Case Detail
| Case Title | CareToLive v. The Food and Drug Administration (FDA) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| District | Southern District of Ohio | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| City | Columbus | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Case Number | 2:2008cv00005 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Filed | 2008-01-02 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Closed | 2009-06-23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Judge | Judge Gregory L Frost | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Plaintiff | CareToLive A Not For Profit Corporation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Defendant | The 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.
Opinion/Order [40]Issues: Delay - Backlog reduction activities 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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