Treatment Action Grp. and Global Health Justice P'ship v. FDA, No. 15-976, 2016 WL 5171987 (D. Conn. Sept. 20, 2016) (Bolden, J.)

Treatment Action Grp. and Global Health Justice P'ship v. FDA, No. 15-976, 2016 WL 5171987 (D. Conn. Sept. 20, 2016) (Bolden, J.)

Re: Request for records concerning clinical trial data and communications regarding clinical trial design and FDA approval process relating to two Hepatitis C virus drugs

Disposition: Denying defendant's motion to stay; denying plaintiff's motion for summary judgment regarding entitlement to expedited processing; granting defendant's motion for summary judgment regarding entitlement to expedited processing

• Litigation Considerations, Mootness and Other Grounds for Dismissal: The court finds that, "[b]ecause Plaintiffs remain unsatisfied with Defendants' proposed schedule of production and seek additional relief from the Court, in addition to an order that Defendants' immediately begin processing their FOIA requests, the motion for stay and the motions for summary judgment regarding expedited processing are not moot." The court relates that defendant argues that because "[p]laintiffs' FOIA request has reached the top of the queue and . . . [defendant] has already begun processing the request, . . . the pending motions in this case are now moot." The court finds that "precedent . . . suggests that a plaintiff's request for expedited processing cannot be moot until all records have been produced."
   
• Procedural Requirements, Expedited Processing: The court grants defendant's motion for summary judgment regarding plaintiff's entitlement to expedited processing. First, the court finds "that no reasonable jury could find that Plaintiffs can show the need for expedited processing on the grounds of imminent threat to the life or safety of an individual." The court relates that "[p]laintiffs can only potentially support a case for expedited processing on the grounds of urgent need to inform the public." "Their briefs also do not contain any allegations regarding specific types of medical problems, whether side effects or drug interactions, caused or exacerbated by [the two drugs] and that could result in harm to specific subsets of patients or be immediately solved by access to the requested information." Second, the court finds that there is no urgency to inform the public. The court finds that, "[b]ased on the information in the agency record, neither [plaintiff] qualif[ies] as organizations primarily engaged in disseminating information[]" because neither can demonstrate that they are "'primarily, and not just incidentally, engaged in information dissemination.'" The court then finds that "[t]he record before the agency does not support a reasonable showing that the clinical trial data and other information surrounding the approval of [the two drugs] is a matter of exigency to the American public[]" because there is no showing that this issue "involve[s] a breaking news story that is the subject of intense media interest."
   
• Litigation Considerations, "Open America" Stays of Proceedings: The court denies defendant's request for a stay. The court first finds that "FDA cannot . . . show that it faces a volume of requests unanticipated by Congress, one that significantly exceeds the 'predictable agency workload' for the FDA[]" and that FDA's "showing is insufficient to establish that all or most . . . FOIA requests 'have become increasingly or unexpectedly more complex as of late.'" The court then finds that defendant "has had the benefit of an increased number of full-time employees." The court finds that, "[a]s the Defendants cannot show the first two factors required to obtain a stay, there is no need for the Court to reach the issue of whether the agency has shown due diligence in processing its FOIA requests." However, "[t]he Court does not believe that ordering Defendants to produce all documents by a certain date is warranted." "Instead, the Court orders the FDA to immediately produce all responsive records gathered so far and report back to the Court[.]"