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Case TitleKREMERS URBAN PHARMACEUTICALS INC. v. UNITED STATES FOOD AND DRUG ADMINISTRATION
DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2017cv00050
Date Filed2017-01-10
Date Closed2020-03-20
JudgeJudge Royce C. Lamberth
PlaintiffKREMERS URBAN PHARMACEUTICALS INC.
Case DescriptionKremers Urban Pharmaceuticals submitted two FOIA requests to the FDA for records concerning the reason the agency decided to reject a new drug application from Kremers. The agency acknowledged receipt of both requests, but after hearing nothing further from the agency, Kremers Urban Pharmaceuticals filed suit.
Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees

DefendantUNITED STATES FOOD AND DRUG ADMINISTRATION
Documents
Docket
Complaint
Complaint attachment 1
Complaint attachment 2
Complaint attachment 3
Complaint attachment 4
Complaint attachment 5
Complaint attachment 6
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2017-01-101COMPLAINT against UNITED STATES FOOD AND DRUG ADMINISTRATION ( Filing fee $ 400 receipt number 0090-4801096) filed by KREMERS URBAN PHARMACEUTICALS INC.. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Civil Cover Sheet, # 4 Summons, # 5 Summons, # 6 Summons)(Boone, Brian) (Entered: 01/10/2017)
2017-01-102LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by KREMERS URBAN PHARMACEUTICALS INC. (Boone, Brian) (Entered: 01/10/2017)
2017-01-103NOTICE of Appearance by Brian D. Boone on behalf of KREMERS URBAN PHARMACEUTICALS INC. (Boone, Brian) (Entered: 01/10/2017)
2017-01-11Case Assigned to Judge Royce C. Lamberth. (zsb) (Entered: 01/11/2017)
2017-01-114SUMMONS (3) Issued Electronically as to UNITED STATES FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachment: # 1 Consent Form)(zsb) (Entered: 01/11/2017)
2017-01-135RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 1/12/2017. Answer due for ALL FEDERAL DEFENDANTS by 2/11/2017. (Boone, Brian) (Entered: 01/13/2017)
2017-01-136RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. UNITED STATES FOOD AND DRUG ADMINISTRATION served on 1/12/2017 (Boone, Brian) (Entered: 01/13/2017)
2017-01-137RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 1/12/2017. (Boone, Brian) (Entered: 01/13/2017)
2017-01-178NOTICE of Appearance by Damon William Taaffe on behalf of UNITED STATES FOOD AND DRUG ADMINISTRATION (Taaffe, Damon) (Entered: 01/17/2017)
2017-02-139ANSWER to Complaint by UNITED STATES FOOD AND DRUG ADMINISTRATION.(Taaffe, Damon) (Entered: 02/13/2017)
2017-03-0210ORDER regarding dispositive motions. Signed by Judge Royce C. Lamberth on 2/28/2017. (lcrcl2) (Entered: 03/02/2017)
2017-03-1011Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Taaffe, Damon) (Entered: 03/10/2017)
2017-03-1312NOTICE of filing Joint Status Report with Exhibit by UNITED STATES FOOD AND DRUG ADMINISTRATION re 11 Status Report (Attachments: # 1 Exhibit Joint Status Report with Exhibit)(Taaffe, Damon) (Entered: 03/13/2017)
2017-03-1613ORDERED Defendant shall produce documents responsive to plaintiff's FOIA requests on a rolling basis. ORDERED parties shall file a joint status report every 90 days.. Signed by Judge Royce C. Lamberth on 3/14/17. (lcrcl1, ) (Entered: 03/16/2017)
2017-06-1414Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Taaffe, Damon) (Entered: 06/14/2017)
2017-09-1215Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Taaffe, Damon) (Entered: 09/12/2017)
2017-09-2816NOTICE OF RELATED CASE by KREMERS URBAN PHARMACEUTICALS INC.. Case related to Case No. 1:17-cv-1998. (Boone, Brian) (Entered: 09/28/2017)
2017-12-1117STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Taaffe, Damon) (Entered: 12/11/2017)
2017-12-1218STATUS REPORT by KREMERS URBAN PHARMACEUTICALS INC.. (Attachments: # 1 Exhibit)(Boone, Brian) (Entered: 12/12/2017)
2018-02-0519ORDER setting a deadline for the Defendant to file its Dispositive Motions by 2/19/2018. Signed by Judge Royce C. Lamberth on 2/2/18. (lsj) (Entered: 02/05/2018)
2018-02-1220Consent MOTION to Stay Briefing Schedule by UNITED STATES FOOD AND DRUG ADMINISTRATION (Taaffe, Damon) (Entered: 02/12/2018)
2018-02-2121NOTICE of Appearance by Joshua M. Kolsky on behalf of UNITED STATES FOOD AND DRUG ADMINISTRATION (Kolsky, Joshua) (Entered: 02/21/2018)
2018-02-2822Joint STATUS REPORT and Motion to Stay Scheduling Order by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Kolsky, Joshua) (Entered: 02/28/2018)
2018-02-2823MOTION to Stay Scheduling Order and Joint Status Report by UNITED STATES FOOD AND DRUG ADMINISTRATION (Kolsky, Joshua) (Entered: 02/28/2018)
2018-03-2324ORDER granting 20 Motion to Stay for 30 days, nunc pro tunc. Signed by Judge Royce C. Lamberth on 3/22/18. (lsj) (Entered: 03/23/2018)
2018-03-2325ORDER granting 23 Motion to Stay Scheduling Order. Signed by Judge Royce C. Lamberth on 3/22/18. (lsj) (Entered: 03/26/2018)
2018-05-0726NOTICE OF WITHDRAWAL OF APPEARANCE as to UNITED STATES FOOD AND DRUG ADMINISTRATION. Attorney Damon William Taaffe terminated. (Taaffe, Damon) (Entered: 05/07/2018)
2018-12-2027NOTICE OF SUBSTITUTION OF COUNSEL by Paul Cirino on behalf of UNITED STATES FOOD AND DRUG ADMINISTRATION Substituting for attorney Joshua M. Kolsky (Cirino, Paul) (Entered: 12/20/2018)
2019-01-3028ORDER requiring the parties to meet and confer. Signed by Judge Royce C. Lamberth on 1/30/2019. (lcrcl2) (Entered: 01/30/2019)
2019-02-2729NOTICE of Proposed Order by UNITED STATES FOOD AND DRUG ADMINISTRATION (Cirino, Paul) (Entered: 02/27/2019)
2019-04-1230ORDER entered, nunc pro tunc. Signed by Judge Royce C. Lamberth on 4/11/2019. (lcrcl1) Modified on 4/15/2019 (zlsj). (Entered: 04/12/2019)
2019-04-1731Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Cirino, Paul) (Entered: 04/17/2019)
2019-04-18MINUTE ORDER: Upon consideration of the April 17, 2019, Joint Status Report 31 , a further Joint Status Report shall be filed on or before May 31, 2019. Signed by Judge Royce C. Lamberth on 4/18/2019. (lcrcl1) (Entered: 04/18/2019)
2019-04-25Set/Reset Deadlines: Joint Status Report due by 5/31/2019 (lsj) (Entered: 04/25/2019)
2019-05-3132Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Cirino, Paul) (Entered: 05/31/2019)
2019-10-2933Joint MOTION to Modify Briefing Schedule by UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Cirino, Paul) (Entered: 10/29/2019)
2019-10-3034ORDER granting 33 Motion to Modify Briefing Schedule. Plaintiff will complete its review and present Defendant with a proposal to narrowthe issues in dispute by December 18, 2019. Defendant will file any motion for summary judgment on February 5, 2020. Plaintiff will file any cross-motion for summary judgment and opposition to Defendant's motion on March 20, 2020. Defendant will file any opposition to Plaintiff's cross-motion and reply in support of its motion on April 21, 2020. Plaintiff will file any reply supporting its cross-motion on May 8, 2020. Signed by Judge Royce C. Lamberth on 10/30/2019. (lcrcl2) (Entered: 10/30/2019)
2019-10-31Set/Reset Deadlines: Summary Judgment motions due by 2/5/2020. Response to Motion for Summary Judgment due by 3/20/2020. Reply to Motion for Summary Judgment due by 4/21/2020. Replies due by 5/8/2020. (lsj) (Entered: 10/31/2019)
2020-02-0535STIPULATION of Dismissal by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Cirino, Paul) (Entered: 02/05/2020)
2020-02-0736ORDER dismissing the case with prejudice, except for plaintiff's claim for the recovery of attorneys' fees. Signed by Judge Royce C. Lamberth on 02/06/2020. (lcrcl2) (Entered: 02/07/2020)
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by FOIA Project Staff
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