Opinion
Civil Action: 2:12-cv-00264 AJS
07-23-2012
RAE SCHIFF, Plaintiff v. DENNIS J. HURWITZ, M.D.; HURWITZ CENTER FOR PLASTIC SURGERY, P.C,; INVASIX, Ltd.; ESSEX INSTITUTIONAL REVIEW BOARD, Inc. , and an UNKNOWN ENTITY, agent for INVASIX, Ltd. Defendants.
ORDER
Upon consideration of Plaintiff's Supplemental Motion to Compel Discovery , defendant, Invasix, Ltd, ("Invasix"), shell within five (5) days of the date of this Order produce all "Documents" and "Communications" as those terms are defined in Plaintiff's First Request for Production of Documents with respect to the following whether or not such documents were prepared or dated on or after March 3, 2010
a)All Documents and Communications between Invasix and the Federal Food andDrug Administration(FDA) Without limiting foregoing, Invasix shallallcorrespondence, emails, meeting minutes, memos to record, notes, writings and deficiency memoranda concerning Invasix's FDA §510(k) filings at K083696 & K100482, any supplements to those filings, any additional §510(k) filings that Invasix may have submitted to the FDA and all IDE or pre-IDE filings including those at 1100693 and 1090523
b)Counsel for Invasix is to forward a draft of a proposed confidentiality order to plaintiff's counsel within five (5) days of the date of this Order and is to produce all documents subject to the terms of the confidentiality order that this Court may enter of such order.
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United States District Judge