Case Detail

FOIA Project Annotation: In finding that the FDA had improperly classified a number of records as non-responsive to a voluminous request from the Judge Rotenberng Educational Center pertaining to electrical simulation devices JRC used to treat aggressive behavior, Judge Beryl Howell has identified serious problems with the developing interpretation of what constitutes a record in the aftermath of the D.C. Circuit's decision in American Immigration Lawyers Association v. Executive Office for Immigration Review (AILA), 830 F.3d 667 (D.C. Cir. 2016), in which the D.C. Circuit ruled that agencies could not withhold records based on their conclusion that they were non-responsive to the request, but instead had to cite an applicable exemption. But because the AILA ruling came in the context of the agency's redactions of personally-identifying information about immigration judges based on its conclusion that even though not exempt, some records were not specifically responsive to the parameters of AILA's request, the D.C. Circuit suggested ways in which records could be recategorized so that non-responsive records would not need to be reviewed in the first place. JRC's four FOIA requests were prompted by the 2016 decision by the FDA to propose a ban of the Graduated Electronic Decelerator, an electrical stimulation device used by JRC. The agency searched four components â€" the Office of the Chief Counsel, the New England District Office, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs. The FDA's FOI Division disclosed roughly 10,000 pages of redacted records. OCC independently disclosed 2,800 pages with redactions, the New England District Office disclosed 10,205 redacted pages, and ORA disclosed 382 redacted pages. Two other components of the Department of Health and Human Services outside the FDA disclosed redacted records as well. The Office of the Secretary provided 756 pages, while the Administration for Community Services disclosed an additional 485 pages with redactions. In total, HHS and FDA, excluding CDRH, produced 24,241 pages. Of those pages, approximately 12,642 pages were redacted in full and another 1,340 pages were redacted in part. Although CDRH had located 60,000 responsive records, it had not yet processed any of them for disclosure. The FDA ultimately provided a 1,979-page Vaughn index explaining its withholding claims made under Exemption 5 (privileges), Exemption 6 (invasion of privacy), and Exemption 7(C) (invasion of privacy concerning law enforcement records). Because of the AILA holding, the agency had recast 51 documents as being non-responsive because they were distinct enough to constitute a separate record. Howell noted that "the defendants' shift â€" now claiming to have withheld only non-responsive records â€" puts a spotlight on a variation of the question of what constitutes an 'agency record' under FOIA that has become particularly relevant since AILA: when must information be grouped into a single 'agency record' and when can information be separated into multiple 'agency records'?" Howell explained that "in practice, agencies 'define a "record" when they undertake the process of identifying records that are responsive to a request,' since defining the universe of responsive records is the first step an agency should take in response to a FOIA request." She pointed out that the Justice Department's Office of Information Policy had instructed agencies to use the definition of a record from the Privacy Act, noting that "thus, each 'item, collection, or grouping of information' on the topic of the request can be considered a distinct 'record.'" But here, Howell observed, "the defendants' withholding of non-responsive information in this case suffers a more fundamental problem: midway through litigation the defendants reclassified collections of information that had been treated as one agency record as multiple agency records." She pointed out that "although the question here is not whether information qualifies as an agency record in the first place, but rather about where one record ends and another begins, the admonition against record manipulation is no less applicable. Allowing the defendants to re-define the contours of a given record midway through litigation would invert the ordinary process of responding to a FOIA request, in which the first step is identifying the responsive records, just because the agency realized that, without the change, certain information would be subject to disclosure. That is precisely the sort of manipulation that undermines the purpose of FOIA." Howell found the agency's recharacterization of records troubling. She particularly faulted the agency for splitting emails from their attachments on the basis that they were now separate records. She pointed out that "while emails and their attachments are not per se a single record, at minimum 'attachments should reasonably be considered part and parcel of the email by which they were sent' when the email 'makes explicit reference to, or includes discussion of, the missing attachments.'" She observed that "ubiquitous email practices suggest that agencies will struggle to justify separating an email and its attachments into multiple records. Of course, from time to time emails are sent with the wrong attachment, but in the ordinary course an attachment is included with the email because it relates to the body of the email. Though not a per se rule, ordinary practice leaves very little wiggle room in generally requiring an email with attachments to be kept together as a single record." She concluded that "defendants need not be given the chance to explain why some emails and attachments should be considered as distinct records because reclassifying records midway through litigation is improper." Howell found the agency's deliberative process privilege claims often lacked any explanation as to why records were predecisional. She pointed out that "the defendants' effort to define the deliberate process so broadly is rejected because the withheld records may in fact pertain to a litany of subsidiary decisions that defendants fail to acknowledge." She added that "without the defendants acknowledging these subsidiary decisions or tying records to those specific decisionmaking processes, the Court cannot be sure that a record related to 'agency action' or 'agency work on particular topics' is in fact predecisional." The agency also claimed it was too burdensome to identify individuals in the decisionmaking process. But Howell observed that "marking, for example, a document as from a subordinate to a superior, from a superior to a subordinate, or as from peer to peer would communicate the needed information about the respective position in the chain of command." However, she agreed with the agency that drafts did not lose their predecisional nature if they were never adopted as agency policy. Turning to Exemption 6, Howell found that the agency had failed to take into account the effect of public statements made by some JRC patients suggesting that their personal privacy interests had been diminished to some extent and that the public interest in disclosure of personally-identifying information of such individuals was increased somewhat as well. She pointed out that "the public interest in the identity of those people, given their role in the Proposed Ban, might be stronger than the interest in the identity of another JRC patient. While the Court is sensitive to the defendants' burden, this is what the law requires."
Issues: Agency Record, Exemption 5 - Privileges - Deliberative process privilege - Deliberative, Exemption 5 - Privileges - Deliberative process privilege - Predecisional, Exemption 6 - Invasion of privacy

Date Filed	Doc #	Docket Text
2017-10-10	1	COMPLAINT against U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION ( Filing fee $ 400 receipt number 0090-5151524) filed by The Judge Rotenberg Educational Center, Inc., Paul E. Peterson, PH.D., The J.R.C. Parents and Friends Association, Inc.. (Attachments: # 1 Exhibit A-1, # 2 Exhibit A-2, # 3 Exhibit A-3, # 4 Exhibit A-4, # 5 Exhibit A-5, # 6 Exhibit A-6, # 7 Exhibit B, # 8 Exhibit C, # 9 Exhibit D, # 10 Exhibit E, # 11 Exhibit F, # 12 Exhibit G, # 13 Exhibit H, # 14 Exhibit I, # 15 Exhibit J, # 16 Exhibit K, # 17 Exhibit L, # 18 Exhibit M, # 19 Exhibit N, # 20 Exhibit O, # 21 Exhibit P, # 22 Exhibit Q, # 23 Exhibit R, # 24 Civil Cover Sheet, # 25 Summons, # 26 Summons, # 27 Summons, # 28 Summons)(Longosz, Edward) (Entered: 10/10/2017)
2017-10-10	2	Corporate Disclosure Statement by The Judge Rotenberg Educational Center, Inc.. (Longosz, Edward) (Main Document 2 replaced on 10/11/2017) (zsth). (Entered: 10/10/2017)
2017-10-10		Case Assigned to Chief Judge Beryl A. Howell. (sth) (Entered: 10/11/2017)
2017-10-11	3	SUMMONS (4) Issued Electronically as to U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachments: # 1 Notice and Consent)(sth) (Entered: 10/11/2017)
2017-10-12	4	ERRATA by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON 1 Complaint,,, filed by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., PAUL E. PETERSON, JUDGE ROTENBERG EDUCATIONAL CENTER, INC.. (Longosz, Edward) (Entered: 10/12/2017)
2017-10-13	5	Corporate Disclosure Statement by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC.. (Longosz, Edward) (Entered: 10/13/2017)
2017-10-16	6	STANDING ORDER. Signed by Chief Judge Beryl A. Howell on October 16, 2017. (lcbah1) (Entered: 10/16/2017)
2017-11-14	7	NOTICE of Appearance by William Mark Nebeker on behalf of U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Nebeker, William) (Entered: 11/14/2017)
2017-11-20	8	ANSWER to 1 Complaint by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION.(Nebeker, William) Modified to add link on 11/21/2017 (znmw). (Entered: 11/20/2017)
2017-12-04	9	MEET AND CONFER STATEMENT. (Nebeker, William) (Entered: 12/04/2017)
2017-12-06		MINUTE ORDER (paperless) DIRECTING, upon consideration of the parties' 9 Joint Meet and Confer Report, the parties to file, by January 12, 2018, a further Joint Status Report proposing a schedule to govern further proceedings in this matter. Signed by Chief Judge Beryl A. Howell on December 6, 2017. (lcbah4) (Entered: 12/06/2017)
2017-12-06		Set/Reset Deadlines: Joint Status Report due by 1/12/2018. (tg) (Entered: 12/06/2017)
2017-12-06	10	MEET AND CONFER STATEMENT. (Longosz, Edward) (Entered: 12/06/2017)
2017-12-07		MINUTE ORDER (paperless) DIRECTING, in consideration of the parties' 10 Joint Meet and Confer Report, the parties to submit, by January 12, 2018, an additional Meet and Confer Report and propose a briefing schedule. Signed by Chief Judge Beryl A. Howell on December 7, 2017. (lcbah1) (Entered: 12/07/2017)
2017-12-08		Set/Reset Deadlines: Joint Meet & Confer Report due by 1/12/2018. (tg) (Entered: 12/08/2017)
2017-12-12	11	Unopposed MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Max D. Stern, :Firm- Todd & Weld LLP, :Address- 1 Federal Street, Boston, MA 02110. Phone No. - 617-624-4712. Fax No. - 617-227-5777 Filing fee $ 100, receipt number 0090-5243797. Fee Status: Fee Paid. by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Exhibit A, # 2 Text of Proposed Order)(Longosz, Edward) (Entered: 12/12/2017)
2017-12-12	12	Unopposed MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Michael P. Flammia, :Firm- Eckert Seamans Cherin & Mellott, LLC, :Address- 2 International Place, 16th Floor, Boston, MA 02110. Phone No. - 617-342-6854. Fax No. - 617-342-6899 Filing fee $ 100, receipt number 0090-5243811. Fee Status: Fee Paid. by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Exhibit A, # 2 Text of Proposed Order)(Longosz, Edward) (Entered: 12/12/2017)
2017-12-13		MINUTE ORDER (paperless) GRANTING the plaintiffs' 11 and 12 Unopposed Motions for Admission Pro Hac Vice of Max D. Stern and Michael P. Flammia. Messrs. Max D. Stern, Esq. and Michael P. Flammia, Esq. may enter appearances pro hac vice for the purpose of representing the plaintiffs in this action. Signed by Chief Judge Beryl A. Howell on December 13, 2017. (lcbah1) (Entered: 12/13/2017)
2018-01-05	13	NOTICE of Appearance by Max D. Stern on behalf of J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC. (Stern, Max) (Entered: 01/05/2018)
2018-01-08	14	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 11/6/2017., RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES served on 11/6/2017; U.S. FOOD AND DRUG ADMINISTRATION served on 11/6/2017, RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 11/6/2017. ( Answer due for ALL FEDERAL DEFENDANTS by 12/6/2017.) (Attachments: # 1 Affidavit of Service)(Longosz, Edward) (Entered: 01/08/2018)
2018-01-09	15	NOTICE of Appearance by Michael P. Flammia on behalf of JUDGE ROTENBERG EDUCATIONAL CENTER, INC. (Flammia, Michael) (Main Document 15 replaced on 1/10/2018) (znmw). (Entered: 01/09/2018)
2018-01-12	16	MEET AND CONFER STATEMENT. (Longosz, Edward) (Entered: 01/12/2018)
2018-01-19		NOTICE OF HEARING: The parties shall take notice that a Status Hearing is scheduled for 1/26/2018, at 9:00 AM in Courtroom 22A before Chief Judge Beryl A. Howell. (tg) (Entered: 01/19/2018)
2018-01-25		NOTICE OF RESCHEDULED HEARING: The parties shall take notice that the Status Hearing originally scheduled to be heard on January 26, 2018, is RESCHEDULED for February 2, 2018, at 9:00 AM in Courtroom 22A before Chief Judge Beryl A. Howell. (tg) (Entered: 01/25/2018)
2018-02-02		Minute Entry for proceedings held before Chief Judge Beryl A. Howell: Status Conference held on 2/2/2018. (Order forthcoming.) (Court Reporter Elizabeth Saint-Loth.) (tg) (Entered: 02/02/2018)
2018-02-02		MINUTE ORDER (paperless) DIRECTING, upon consideration of the parties' 16 Supplemental Joint Meet and Confer Statement and the proceedings held on Friday, February 2, 2018, see Minute Entry, dated Feb. 2, 2018, that, by 5 P.M. today, the plaintiffs shall submit a notice to the Court regarding the precise production to date of records responsive to the plaintiffs' requests under the Freedom of Information Act ("FOIA"); and the defendants shall notify the Court of the same, along with the dates of any referral of the plaintiffs' FOIA requests at issue to components of Health and Human Services ("HHS") other than the FDA; and ISSUING the following SCHEDULING ORDER: (1) by March 2, 2018, the defendants shall file a Vaughn Index for all documents produced, in full or in part, or withheld, by each FDA component other than the Center for Devices and Radiological Health ("CDRH"); (2) by April 2, 2018, the parties shall file any dispositive motions as to issues arising from the responses by each FDA component other than the Center for Devices and Radiological Health ("CDRH"), to the plaintiffs' FOIA requests; (3) by May 4, 2018, the parties shall file any oppositions; (4) by May 14, 2018, the parties shall file any replies; (5) the CDRH and any other HHS component to which a referral has been made shall make a rolling production of no fewer than 5,000 pages per month to the plaintiffs, beginning on March 1, 2018, and continuing every sixty days thereafter until production is complete; and (6) by September 5, 2018, and with every production thereafter, the parties shall file a joint status report advising the Court on the status of the CDRH production, including the number of records produced, in full or in part or withheld, and remaining for processing, and the estimated date for completion of such processing. Signed by Chief Judge Beryl A. Howell on February 2, 2018. (lcbah1) (Entered: 02/02/2018)
2018-02-02	17	NOTICE To The Court by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Longosz, Edward) (Entered: 02/02/2018)
2018-02-02		Set/Reset Deadlines: Rolling production of no fewer than 5,000 pages per month to begin by 3/1/2018; Vaughn Index due by 3/2/2018; Dispositive Motions due by 4/2/2018; Oppositions to Dispositive Motions due by 5/4/2018; Replies due by 5/14/2018; Joint Status Report due by 9/5/2018, and with every production thereafter. (tg) (Entered: 02/02/2018)
2018-02-02	18	STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 02/02/2018)
2018-03-02	19	NOTICE Of Filing Vaughn Index by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Exhibit Vaughn Index, # 2 Exhibit Cover Letter)(Nebeker, William) (Entered: 03/02/2018)
2018-03-27	20	Joint MOTION to Amend/Correct Scheduling Order by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Proposed Amended Scheduling Order)(Longosz, Edward) (Entered: 03/27/2018)
2018-03-29		MINUTE ORDER (paperless) AMENDING, upon consideration of the parties' 20 Joint Motion to Amend/Correct Scheduling Order, the SCHEDULING ORDER as follows: by May 11, 2018, the parties shall file a joint status report updating the Court as to the parties' progress in resolving any areas of disagreement. By June 8, 2018, the defendants shall file (i) an updated Vaughn index for all documents produced, in full or in part, or withheld by each FDA component other than CDRH, as well as (ii) any dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests. By July 13, 2018, the plaintiffs shall file any dispositive motions or cross-motions and/or any oppositions to the defendants' dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests. By August 17, 2018, the defendants shall file any replies in support of their dispositive motions and/or oppositions to the plaintiffs' dispositive motions. By August 31, 2018, the plaintiffs shall file any replies in support of their dispositive motions. Signed by Chief Judge Beryl A. Howell on March 29, 2018. (lcbah1) (Entered: 03/29/2018)
2018-03-30		Set/Reset Deadlines: Joint Status Report due by 5/11/2018; defendants' updated Vaughn Index and any dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests due by 6/8/2018; plaintiffs' Dispositive Motions or Cross-Motions and/or any oppositions to the defendants' dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests due by 7/13/2018; defendants' replies in support of Dispositive Motions and/or oppositions to the plaintiffs' dispositive motions due by 8/17/2018; plaintiffs' replies in support of their dispositive motions due by 8/31/2018.(tg) (Entered: 03/30/2018)
2018-05-11	21	Joint STATUS REPORT and Request to Extend the Scheduling Order by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 05/11/2018)
2018-05-11	22	MOTION to Extend the Scheduling Order by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (See docket entry 21 to view document)(zrdj) (Entered: 05/14/2018)
2018-05-15		MINUTE ORDER (paperless) MODIFYING the scheduling order as follows: by (1) June 15, 2018, the parties shall file a Joint Status Report updating the Court on their progress in resolving any areas of disagreement; (2) July 12, 2018, the defendants shall file any dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests, as well as an updated Vaughn index for all documents produced, in full or in part, or withheld by each FDA component other than CDRH; (3) August 10, 2018, the plaintiffs shall file any dispositive motions or cross-motions and/or any oppositions to the defendants' dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests; (4) September 7, 2018, the defendants shall file any replies in support of their dispositive motions and/or any oppositions to the plaintiffs' dispositive motions; (5) September 21, 2018, the plaintiffs shall file any replies in support of their dispositive motions. Signed by Chief Judge Beryl A. Howell on May 15, 2018. (lcbah1) (Entered: 05/15/2018)
2018-05-16		Set/Reset Deadlines: Joint Status Report due by 6/15/2018; Dispositive Motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests, as well as an updated Vaughn index for all documents produced, in full or in part, or withheld by each FDA component other than CDRH due by 7/12/2018; Dispositive Motions or Cross-Motions and Oppositions to the dispositive motions concerning the responses by all FDA components other than CDRH to the plaintiffs' FOIA requests due by 8/10/2018. Reply in Support of Dispositive Motions or Oppositions to Dispositive Motions due by 9/7/2018; Reply in support of plaintiffs' dispositive Motions due by 9/21/2018. (tg) (Entered: 05/16/2018)
2018-06-15	23	Joint STATUS REPORT by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 06/15/2018)
2018-07-12	24	NOTICE (Notice of Filing in Support of Defendants' Motion for Partial Summary Judgment) by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Declaration (Declaration of Nelson D. Hermilla), # 2 Declaration (Declaration of Sarah Kotler), # 3 Declaration (Declaration of Michael S. Marquis), # 4 Declaration (Declaration of David Mednick), # 5 Declaration (Declaration of Richard Nicholls), # 6 Declaration (Declaration of Melissa Pickworth), # 7 Declaration (Declaration of Barbara A. Recupero), # 8 Declaration (Declaration of Eric F. Stein), # 9 (Updated Vaughn Index))(Nebeker, William) (Entered: 07/12/2018)
2018-07-12	25	MOTION for Partial Summary Judgment by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Nebeker, William) (Entered: 07/12/2018)
2018-07-17	26	Consent MOTION to Modify the Scheduling Order by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Proposed Amended Scheduling Order)(Longosz, Edward) (Entered: 07/17/2018)
2018-07-24		MINUTE ORDER (paperless) MODIFYING, upon consideration of the plaintiff's 26 Consent Motion to Modify the Scheduling Order, as follows: (1) by September 7, 2018, the plaintiffs shall file any dispositive motion or cross-motion and/or any opposition to the defendants' 25 Motion for Partial Summary Judgment; (2) by October 19, 2018, the defendants shall file any reply in support of their dispositive motion and/or any opposition to the plaintiffs' dispositive motion; (3) by November 2, 2018, the plaintiffs shall file any reply in support of their dispositive motion. The Scheduling Order otherwise remains unchanged. Signed by Chief Judge Beryl A. Howell on July 24, 2018. (lcbah1) (Entered: 07/24/2018)
2018-07-24		Set/Reset Deadlines: Plaintiffs' dispositive motion or cross-motion and/or any opposition to motion for summary judgment due by 9/7/2018; defendants' opposition to dispositive motion and reply to opposition to motion for summary judgment due by 10/19/2018; plaintiffs' reply to opposition to dispositive motion due by 11/2/2018. (tg) (Entered: 07/24/2018)
2018-09-05	27	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 09/05/2018)
2018-09-07	28	NOTICE of Filing by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Declaration of Glenda P. Crookes, # 2 Declaration of Matthew D. Rodgers (Part 1), # 3 Declaration of Matthew D. Rodgers (Part 2))(Longosz, Edward) (Entered: 09/07/2018)
2018-09-07	29	Memorandum in opposition to re 25 MOTION for Partial Summary Judgment filed by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Attachments: # 1 Text of Proposed Order)(Longosz, Edward) (Entered: 09/07/2018)
2018-09-07	30	Cross MOTION for Partial Summary Judgment and Memorandum in Support by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Text of Proposed Order)(Longosz, Edward) (Entered: 09/07/2018)
2018-10-05	31	Consent MOTION to Modify Briefing Schedule by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Nebeker, William) (Entered: 10/05/2018)
2018-10-09		MINUTE ORDER (paperless) GRANTING the 31 Defendants' Consent Motion to Modify the Scheduling Order and ISSUING the following scheduling order: (1) by November 9, 2018, the defendants shall file any replies in support of their dispositive motions and/or oppositions to the plaintiffs' dispositive motions; (2) by December 10, 2018, the plaintiffs shall file any replies in support of their dispositive motions. All other deadlines shall remain the same. Signed by Chief Judge Beryl A. Howell on October 9, 2018. (lcbah1) (Entered: 10/09/2018)
2018-10-09		Set/Reset Deadlines: Defendants' replies in support of their dispositive motions and/or oppositions to the plaintiffs' dispositive motions due by 11/9/2018; plaintiffs' replies in support of their dispositive motions due by 12/10/2018. (tg) (Entered: 10/09/2018)
2018-10-29	32	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 10/29/2018)
2018-11-09	33	Memorandum in opposition to re 30 Cross MOTION for Partial Summary Judgment and Memorandum in Support and Combined Reply in Support of Defendants' Summary Judgment Motion filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Statement of Facts Response, # 2 Supplemental Vaughn Index, # 3 Declaration (supplemental) of R. Nicholls, # 4 Declaration (supplemental) of B. Recupero (with Attachment A thereto), # 5 Declaration (supplemental) of M. Marquis, # 6 Declaration (supplemental) of S. Kotler)(Nebeker, William) (Entered: 11/09/2018)
2018-11-09	34	REPLY to opposition to motion re 25 MOTION for Partial Summary Judgment and Combined Opposition to Plaintiffs' Cross-Motion for Summary Judgment (attachments filed at ECF No. 33) filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 11/09/2018)
2018-12-10	35	REPLY to opposition to motion re 30 Cross MOTION for Partial Summary Judgment and Memorandum in Support of Plaintiffs' Cross-Motion for Partial Summary Judgment filed by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Attachments: # 1 Exhibit Exhibit a)(Longosz, Edward) (Entered: 12/10/2018)
2018-12-21	36	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 12/21/2018)
2019-02-19	37	Consent MOTION to Modify the Scheduling Order with proposed order by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Nebeker, William) Modified event title on 3/13/2019 (znmw). (Entered: 02/19/2019)
2019-02-21		MINUTE ORDER (paperless) GRANTING the 37 Defendants' Consent Motion to Modify the Scheduling Order and ISSUING the following SCHEDULING ORDER: (1) by April 1, 2019, the defendants shall produce no fewer than 10,000 pages of records from the Center for Devices and Radiological Health ("CDRH") and the parties shall file a joint status report advising the Court on the status of CDRH's production, including the number of records produced, in full or in part or withheld, and remaining for processing, and the estimated date for completion of such processing; (2) by May 30, 2019, the defendants shall produce no fewer than 10,000 pages of records from the CDRH and the parties shall file a joint status report advising the Court on the status of CDRH's production, including the number of records produced, in full or in part or withheld, and remaining for processing, and the estimated date for completion of such processing. The Scheduling Order otherwise remains unchanged. Signed by Chief Judge Beryl A. Howell on February 21, 2019. (lcbah1) (Entered: 02/21/2019)
2019-03-21	38	ORDER GRANTING in part and DENYING in part the defendants' 25 Motion for Partial Summary Judgment and GRANTING in part and DENYING in part the plaintiffs' 30 Cross-Motion for Partial Summary Judgment. See Order for further details. Signed by Chief Judge Beryl A. Howell on March 21, 2019. (lcbah1) (Main Document 38 replaced on 6/10/2019, pursuant to Errata docketed under ECF 43 .) (tg). (Entered: 03/21/2019)
2019-03-21	39	MEMORANDUM OPINION regarding the defendants' 25 Motion for Partial Summary Judgment and the plaintiffs' 30 Cross-Motion for Partial Summary Judgment. Signed by Chief Judge Beryl A. Howell on March 21, 2019. (lcbah1) (Main Document 39 replaced on 6/10/2019, pursuant to Errata docketed under ECF 43 .) (tg). (Entered: 03/21/2019)
2019-03-22		Set/Reset Deadlines: Joint Status Report due by 4/19/2019. (tg) (Entered: 03/22/2019)
2019-04-01	40	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 04/01/2019)
2019-04-18	41	Joint STATUS REPORT by JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 04/18/2019)
2019-04-22		MINUTE ORDER (paperless) ISSUING, upon consideration of the parties' 41 Joint Status Report, the following SCHEDULING ORDER to control the timing of proceedings in this matter: (1) by May 30, 2019, consistent with the February 21, 2019 minute order, the defendants shall produce no fewer than 10,000 pages of records from CDRH and the parties shall file a joint status report advising the Court on the status of CDRH's production and the parties' negotiations to narrow the issues in dispute; (2) by July 29, 2019, the defendants shall produce no fewer than 10,000 pages of records, unless fewer than 10,000 pages remain to be produced, and the parties shall file a joint status report advising the Court on the status of CDRH's production, updating the Court on the status of the parties' negotiations to narrow the issues in dispute, and proposing a schedule for any dispositive briefing. Signed by Chief Judge Beryl A. Howell on April 22, 2019. (lcbah1) (Entered: 04/22/2019)
2019-04-22		Set/Reset Deadlines: Defendants' production of 10,000 pages and Joint Status Report due by 5/30/2019. Defendant's production of 10,000 pages and Joint Status Report due by 7/29/2019. (hmc) (Entered: 04/22/2019)
2019-05-30	42	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 05/30/2019)
2019-06-10	43	ERRATA as to the 38 Order and 39 Memorandum Opinion. See attachment for further details. Signed by Chief Judge Beryl A. Howell on June 10, 2019. (lcbah1) (Entered: 06/10/2019)
2019-07-29	44	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 07/29/2019)
2019-07-30		MINUTE ORDER (paperless) ISSUING, upon consideration of the parties' 44 Joint Status Report ("JSR"), the following SCHEDULING ORDER to control further proceedings: (1) by August 16, 2019, the defendants shall produce to the plaintiffs the remaining 63 pages of records which were referred to the State Department; (2) by October 31, 2019, the parties shall file a joint status report updating the Court about the status of the case and any progress made toward completion of the Vaughn indices; (3) by March 20, 2020, the parties shall file a joint status report updating the Court about the status of the case and any progress made toward completion of the Vaughn indices; (4) by May 4, 2020, the defendants shall file (i) any dispositive motion, (ii) the revised Supplemental Vaughn Index, in accordance with the Court's 39 Memorandum Opinion and the procedures set out in the parties' JSR, for the production of non-CDRH records; and (iii) the sample Vaughn Index, in accordance with procedures set out in the parties' JSR, for the production of CDRH records; (5) by June 30, 2020, the plaintiff shall file any dispositive motion or cross-motion and any opposition to the defendants' dispositive motion; (6) by July 30, 2020, the defendants shall file any reply in support of their dispositive motion and any opposition to the plaintiffs' dispositive motion; (7) by August 31, 2020, the plaintiffs shall file any reply in support of their dispositive motion. Signed by Chief Judge Beryl A. Howell on July 30, 2019. (lcbah1) (Entered: 07/30/2019)
2019-07-30		Set/Reset Deadlines: Defendants' production of the remaining 63 pages of records which were referred to the State Department due by 8/16/2019; Joint Status Report due by 10/31/2019; Joint Status Report due by 3/20/2020 ; Defendants' Dispositive Motion and other filings pursuant to Minute Order entered on 7/30/2019, due by 5/4/2020; Plaintiffs' Dispositive Motion or Cross-Motion and any Opposition to the Defendants' Dispositive Motion due by 6/30/2020; Defendants' Reply in Support of their Dispositive Motion and any Opposition to the Plaintiff's Dispositive Motion due by 7/30/2020; Plaintiffs' Reply in Support of their Dispositive Motion due by 8/31/2020. (tg) (Entered: 07/30/2019)
2019-10-31	45	Joint STATUS REPORT by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 10/31/2019)
2020-03-19	46	NOTICE OF SUBSTITUTION OF COUNSEL by Robert Aaron Caplen on behalf of U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION Substituting for attorney W. Mark Nebeker (Caplen, Robert) (Entered: 03/19/2020)
2020-03-19	47	Unopposed MOTION for Extension of Time to File Joint Status Report by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Caplen, Robert) (Entered: 03/19/2020)
2020-03-20		MINUTE ORDER (paperless) GRANTING the defendants' 47 Unopposed Motion for Enlargement of Time and DIRECTING the parties to file a joint status report by March 25, 2020. Signed by Chief Judge Beryl A. Howell on March 20, 2020. (lcbah1) (Entered: 03/20/2020)
2020-03-23		Set/Reset Deadlines: Joint status report due by 3/25/2020. (tg) (Entered: 03/23/2020)
2020-03-25	48	Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Caplen, Robert) (Entered: 03/25/2020)
2020-04-07	49	Supplemental STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Exhibit A, # 2 Exhibit B)(Caplen, Robert) (Entered: 04/07/2020)
2020-05-04	50	MOTION for Summary Judgment by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Memorandum in Support, # 2 Statement of Facts, # 3 Non-CDRH Vaughn Index, # 4 Declaration of Candace Boston, # 5 Sample Vaughn Index for CDRH Records (Attach. 1 to Boston Decl.), # 6 Declaration of Sarah Kotler (2d Suppl.), # 7 Declaration of David Mednick (Suppl.), # 8 Declaration of Barbara A. Recupero (2d Suppl.), # 9 Declaration of Melissa Pickworth, # 10 Declaration of Richard Nicholls (2d Suppl.), # 11 Declaration of Michael S. Marquis, # 12 Declaration of Michael S. Marquis (Suppl.), # 13 Declaration of Brandon J. Gaylord, # 14 Declaration of Gorka Garcia-Malene, # 15 Declaration of Nelson D. Hermilla, # 16 Declaration of Kilian Kagle, # 17 Declaration of Eric F. Stein (Suppl.), # 18 Declaration of Gregory Smith, # 19 Text of Proposed Order)(Caplen, Robert) (Entered: 05/04/2020)
2020-06-19	51	Unopposed MOTION to Modify Scheduling Order by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Text of Proposed Order)(Longosz, Edward) (Entered: 06/19/2020)
2020-06-19		MINUTE ORDER (paperless) GRANTING the plaintiffs' 51 Unopposed Motion to Modify the Scheduling Order and ISSUING the following SCHEDULING ORDER to control further proceedings: (1) by August 31, 2020, the plaintiffs shall file any dispositive cross-motion and any opposition to the defendants' 50 Motion for Summary Judgment; (2) by October 14, 2020, the defendants shall file any reply in support of their Motion for Summary Judgment and any opposition to the plaintiffs' dispositive cross-motion; (7) by November 13, 2020, the plaintiffs shall file any reply in support of their dispositive cross-motion. Signed by Chief Judge Beryl A. Howell on June 19, 2020. (lcbah1) (Entered: 06/19/2020)
2020-06-19		Set/Reset Deadlines: Cross-Motion and opposition to motion for summary judgment due by 8/31/2020; opposition to cross-motion and reply to opposition to motion for summary judgment due by 10/14/2020; reply to opposition to cross-motion due by 11/13/2020. (ztg) (Entered: 06/19/2020)
2020-08-21	52	Consent MOTION to Stay by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON (Attachments: # 1 Text of Proposed Order)(Longosz, Edward) (Entered: 08/21/2020)
2020-08-24		MINUTE ORDER (paperless) STAYING, upon consideration of plaintiffs' 52 Consent Motion to Stay the Scheduling Order, proceedings in this matter; and DIRECTING the parties to file a joint status report within 14 days of the D.C. Circuit's decision in case no. 20-1087 advising the Court whether further proceedings are necessary and, if so, proposing a schedule for further proceedings in this matter. Signed by Chief Judge Beryl A. Howell on August 24, 2020. (lcbah1) (Entered: 08/24/2020)
2021-06-28	53	NOTICE of Appearance by Sean Michael Tepe on behalf of All Defendants (Tepe, Sean) (Entered: 06/28/2021)
2021-07-20	54	Joint STATUS REPORT by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Attachments: # 1 Exhibit 1-3)(Longosz, Edward) (Entered: 07/20/2021)
2021-07-23		MINUTE ORDER (paperless) EXTENDING, upon consideration of the parties' 54 Joint Status Report, the stay in this action through September 3, 2021, and DIRECTING the parties to submit, by September 3, 2021, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule for further proceedings in this matter. Signed by Chief Judge Beryl A. Howell on July 23, 2021. (lcbah1) (Entered: 07/23/2021)
2021-07-23		Set/Reset Deadlines: Joint Status Report due by 9/3/2021. (ztg) (Entered: 07/23/2021)
2021-08-31	55	Joint STATUS REPORT by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 08/31/2021)
2021-08-31		MINUTE ORDER (paperless) EXTENDING, upon consideration of the parties' 55 Joint Status Report, the stay in this action through September 24, 2021, and DIRECTING the parties to submit, by September 24, 2021, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule for further proceedings in this matter. Signed by Chief Judge Beryl A. Howell on August 31, 2021. (lcbah1) (Entered: 08/31/2021)
2021-08-31		Set/Reset Deadlines: Joint Status Report due by 9/24/2021. (hmc) (Entered: 08/31/2021)
2021-09-22	56	Joint STATUS REPORT by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 09/22/2021)
2021-09-22		MINUTE ORDER (paperless) EXTENDING, upon consideration of the parties' 56 Joint Status Report, the stay in this action until 14 days after the D.C. Circuit's judgment in case no. 20-1087 becomes final; and DIRECTING the parties to file, within 14 days of the D.C. Circuit's decision on whether to rehear en banc the appeal in case no. 20-1087, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule for further proceedings in this matter. Signed by Chief Judge Beryl A. Howell on September 22, 2021. (lcbah1) (Entered: 09/22/2021)
2021-12-06	57	Joint STATUS REPORT by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC., JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 12/06/2021)
2021-12-06		MINUTE ORDER (paperless) EXTENDING, upon consideration of the parties' 57 Joint Status Report, the stay in this action and DIRECTING the parties to file, within 14 days of the earlier of (1) February 22, 2022, or (2) the date on which the FDA files a petition for a writ of certiorari to the U.S. Supreme Court for the appeal in D.C. Circuit case no. 20-1087, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule for further proceedings in this matter. Signed by Chief Judge Beryl A. Howell on December 6, 2021. (lcbah1) (Entered: 12/06/2021)
2021-12-07		ENTERED IN ERROR.....Set/Reset Deadlines: Summary judgment motion due by 12/13/2021; cross-motion and opposition to motion for summary judgment due by 1/19/2022; opposition to cross-motion and reply to opposition to motion for summary judgment due by 2/21/2022; reply to opposition to cross-motion due by 3/18/2022. (ztg) Modified on 12/7/2021 (ztg). (Entered: 12/07/2021)
2021-12-07		NOTICE OF CORRECTED DOCKET ENTRY: The Set/Reset Deadline entry dated 12/7/2021, was entered in error in this case, the parties shall disregard the entry. (ztg) (Entered: 12/07/2021)
2022-03-08	58	Joint STATUS REPORT by JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 03/08/2022)
2022-03-08		MINUTE ORDER (paperless) EXTENDING, upon consideration of the parties' 58 Joint Status Report, the stay in this action through May 9, 2022, and DIRECTING the parties to file, by May 9, 2022, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule to govern further proceedings in this matter, unless a stipulation of dismissal has been filed. Signed by Chief Judge Beryl A. Howell on March 8, 2022. (lcbah1) (Entered: 03/08/2022)
2022-03-08		Set/Reset Deadlines: Joint Status Report due by 5/9/2022. (ztg) (Entered: 03/08/2022)
2022-05-09	59	Joint STATUS REPORT by JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 05/09/2022)
2022-05-10		MINUTE ORDER (paperless) EXTENDING, upon consideration of the parties' 59 Joint Status Report, the stay in this action through June 23, 2022, and DIRECTING the parties to file, by June 23, 2022, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule to govern further proceedings in this matter, unless a stipulation of dismissal has been filed. Signed by Chief Judge Beryl A. Howell on May 10, 2022. (lcbah1) (Entered: 05/10/2022)
2022-05-10		Set/Reset Deadlines: Joint Status Report due by 6/23/2022. (ztg) (Entered: 05/10/2022)
2022-06-23	60	Joint MOTION for Extension of Time to File Joint Status Report by JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Attachments: # 1 Text of Proposed Order Proposed Order)(Longosz, Edward) (Entered: 06/23/2022)
2022-06-23		MINUTE ORDER (paperless) GRANTING the parties' 60 Joint Motion for Extension of Time to File Joint Status Report; and EXTENDING the stay in this action through July 14, 2022; and further DIRECTING the parties to file, by July 14, 2022, a joint status report advising the Court whether further proceedings are necessary and, if so, proposing a schedule to govern further proceedings in this matter, unless a stipulation of dismissal has been filed. Signed by Chief Judge Beryl A. Howell on June 23, 2022. (lcbah1) (Entered: 06/23/2022)
2022-06-23		Set/Reset Deadlines: Joint Status Report due by 7/14/2022. (ztg) (Entered: 06/23/2022)
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