Case: Judge Rotenburg Center v. Food and Drug Administration

1:17-cv-02092 | U. S. Court of Appeals for the District of Columbia Circuit

Filed Date: March 26, 2020

Closed Date: Nov. 22, 2021

Clearinghouse coding complete

Case Summary

This case concerns the Food and Drug Administration’s (FDA) ability to ban the use of electrical stimulation devices to treat self-injurious or aggressive behavior. The petitioners are the Judge Rotenburg Center, a facility in Massachusetts that provides treatment and education to people with serious mental disabilities, like autism, and a group of parents of patients at the Center. The Center is the only place in the country where electrical stimulation is used to prevent self-harm or aggressi…

This case concerns the Food and Drug Administration’s (FDA) ability to ban the use of electrical stimulation devices to treat self-injurious or aggressive behavior. The petitioners are the Judge Rotenburg Center, a facility in Massachusetts that provides treatment and education to people with serious mental disabilities, like autism, and a group of parents of patients at the Center. The Center is the only place in the country where electrical stimulation is used to prevent self-harm or aggression in people with mental disabilities. This treatment functions by administering an electric shock to a patient when they behave in a certain way, thus discouraging or stopping the behavior. Using electrical shocks on people with disabilities is extremely controversial and the Center has been engaged in litigation since the 1980s with Massachusetts authorities about its use of “aversive therapies” like electrical stimulation. See ID-MA-0002. In fact, the Center’s present name comes from the state trial judge who enjoined the Commonwealth’s attempt to revoke its license to provide services in 1986.

On March 6, 2020, the FDA issued a ban on the device used by the Center to administer electrical stimulation treatment. The FDA had previously issued proposed ban of the device in 2016. The Center responded by filing a Freedom of Information Act request for records from the FDA related to the ban, which itself was the subject of litigation. See 376 F. Supp .3d 47. Shortly after the final ban was enacted, the facility and parents, represented by private counsel, filed a petition for review of the agency’s rule in the U.S. Court of Appeals for the D.C. Circuit. They argued that the FDA's ban was arbitrary and capricious, in violation of the Administrative Procedures Act and that the process which led to the ban was characterized by bad faith and undue political pressure.

The case was assigned to a panel consisting of Chief Judge Sri Srinivasan, and Judges Gregory G. Katsas and David B. Sentelle. The panel heard argument on April 23, 2021 and issued an opinion on July 6, 2021. 3 F.4th 390, 2021 WL 2799891. Judge Sentelle wrote the majority opinion, joined by Judge Katsas, vacating the FDA's rule. The majority found that the rule violated two statutes: 21 U.S.C. § 360f, which allows the FDA to ban medical devices and 21 U.S.C. § 396, which prevents the FDA from regulating the practice of medicine. In the majority’s view, the FDA’s choice to, in effect, ban the use of electrical stimulation to treat people with mental disabilities, but not other patients, overstepped its statutory authorities. Instead of banning a medical device, the FDA was impermissibly regulating the practice of medicine. It also noted that allowing FDA regulation of medical practice, an area traditionally left to state regulation, the rule raised federalism concerns. Chief Judge Srinivasan dissented, arguing that the FDA was permitted by statute to impose a more tailored ban on medical devices for particular purposes, given that was permitted to impose a blanket ban.

The same day the court issued its opinion, it also issued an order staying the mandate until the end of any rehearing procedures. However, on November 22, 2021, the full D.C. Circuit declined to hear the case en banc. The deadline for filing a petition for certiorari has now passed and the case is now closed.

Summary Authors

Jonah Hudson-Erdman (7/11/2021)

Jonah Hudson-Erdman (4/7/2022)

Related Cases

Judge Rotenberg Educational Center, Inc. v. Commissioner of the Department of Mental Retardation, Massachusetts state trial court (1986)

People

For PACER's information on parties and their attrorneys, see: https://www.courtlistener.com/docket/6166919/parties/judge-rotenberg-educational-center-inc-v-us-food-and-drug/


Judge(s)

Howell, Beryl Alaine (District of Columbia)

Sentelle, David Bryan (District of Columbia)

Srinivasan, Srikanth (District of Columbia)

Attorneys(s) for Plaintiff

Cacace, Joseph M (Massachusetts)

Deal, Alexandra H (Massachusetts)

Flammia, Michael P (Massachusetts)

Longosz, Edward John (District of Columbia)

Rodgers, Matthew D (Massachusetts)

Stephens, Christian (Massachusetts)

Stern, Max D. (Massachusetts)

Judge(s)

Howell, Beryl Alaine (District of Columbia)

Sentelle, David Bryan (District of Columbia)

Srinivasan, Srikanth (District of Columbia)

Attorneys(s) for Plaintiff

Cacace, Joseph M (Massachusetts)

Deal, Alexandra H (Massachusetts)

Flammia, Michael P (Massachusetts)

Longosz, Edward John (District of Columbia)

Rodgers, Matthew D (Massachusetts)

Stephens, Christian (Massachusetts)

Stern, Max D. (Massachusetts)

Attorneys(s) for Defendant

Aguilar, Daniel (District of Columbia)

Ellsworth, Felicia H. (Massachusetts)

McIntosh, Scott R. (District of Columbia)

Samp, Richard A. (District of Columbia)

Documents in the Clearinghouse

Document

20-01088

Docket [PACER]

The Judge Rotenberg Education v. FDA

July 6, 2021

July 6, 2021

Docket
39

1:17-cv-02092

Memorandum Opinion

The Judge Rotenberg Educational Center v. United States Food and Drug Administration

U.S. District Court for the District of Columbia

376 F.Supp.3d 47

March 21, 2019

March 21, 2019

Order/Opinion

20-01088

Opinion of the Court

The Judge Rotenberg Educational Center v. United States Food and Drug Administration

3 F.4th 390, 2021 WL 2799891

July 6, 2021

July 6, 2021

Order/Opinion

Resources

Docket

See docket on RECAP: https://www.courtlistener.com/docket/6166919/judge-rotenberg-educational-center-inc-v-us-food-and-drug/

Last updated July 29, 2022, 3:07 a.m.

ECF Number Description Date Link Date / Link
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)

Oct. 10, 2017

Oct. 10, 2017

RECAP
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)

Oct. 10, 2017

Oct. 10, 2017

PACER

Case Assigned to Chief Judge Beryl A. Howell. (sth)

Oct. 10, 2017

Oct. 10, 2017

PACER
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)

Oct. 11, 2017

Oct. 11, 2017

PACER
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)

Oct. 12, 2017

Oct. 12, 2017

PACER
5

Corporate Disclosure Statement by J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC.. (Longosz, Edward) (Entered: 10/13/2017)

Oct. 13, 2017

Oct. 13, 2017

PACER
6

STANDING ORDER. Signed by Chief Judge Beryl A. Howell on October 16, 2017. (lcbah1) (Entered: 10/16/2017)

Oct. 16, 2017

Oct. 16, 2017

PACER
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)

Nov. 14, 2017

Nov. 14, 2017

PACER
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)

Nov. 20, 2017

Nov. 20, 2017

RECAP
9

MEET AND CONFER STATEMENT. (Nebeker, William) (Entered: 12/04/2017)

Dec. 4, 2017

Dec. 4, 2017

PACER

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)

Dec. 6, 2017

Dec. 6, 2017

PACER

Set/Reset Deadlines: Joint Status Report due by 1/12/2018. (tg)

Dec. 6, 2017

Dec. 6, 2017

PACER
10

MEET AND CONFER STATEMENT. (Longosz, Edward) (Entered: 12/06/2017)

Dec. 6, 2017

Dec. 6, 2017

PACER

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)

Dec. 7, 2017

Dec. 7, 2017

PACER

Set/Reset Deadlines: Joint Meet & Confer Report due by 1/12/2018. (tg)

Dec. 8, 2017

Dec. 8, 2017

PACER
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)

Dec. 12, 2017

Dec. 12, 2017

PACER
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)

Dec. 12, 2017

Dec. 12, 2017

PACER

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)

Dec. 13, 2017

Dec. 13, 2017

PACER
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)

Jan. 5, 2018

Jan. 5, 2018

PACER
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)

Jan. 8, 2018

Jan. 8, 2018

PACER
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)

Jan. 9, 2018

Jan. 9, 2018

PACER
16

MEET AND CONFER STATEMENT. (Longosz, Edward) (Entered: 01/12/2018)

Jan. 12, 2018

Jan. 12, 2018

PACER

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)

Jan. 19, 2018

Jan. 19, 2018

PACER

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)

Jan. 25, 2018

Jan. 25, 2018

PACER

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)

Feb. 2, 2018

Feb. 2, 2018

PACER

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)

Feb. 2, 2018

Feb. 2, 2018

PACER
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)

Feb. 2, 2018

Feb. 2, 2018

PACER

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)

Feb. 2, 2018

Feb. 2, 2018

PACER
18

STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 02/02/2018)

Feb. 2, 2018

Feb. 2, 2018

PACER
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)

March 2, 2018

March 2, 2018

PACER
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)

March 27, 2018

March 27, 2018

PACER

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)

March 29, 2018

March 29, 2018

PACER

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)

March 30, 2018

March 30, 2018

PACER
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)

May 11, 2018

May 11, 2018

PACER
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)

May 11, 2018

May 11, 2018

PACER

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)

May 15, 2018

May 15, 2018

PACER

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)

May 16, 2018

May 16, 2018

PACER
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)

June 15, 2018

June 15, 2018

PACER
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)

July 12, 2018

July 12, 2018

PACER
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)

July 12, 2018

July 12, 2018

PACER
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)

July 17, 2018

July 17, 2018

PACER

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)

July 24, 2018

July 24, 2018

PACER

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)

July 24, 2018

July 24, 2018

PACER
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)

Sept. 5, 2018

Sept. 5, 2018

PACER
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)

Sept. 7, 2018

Sept. 7, 2018

PACER
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)

Sept. 7, 2018

Sept. 7, 2018

PACER
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)

1 Text of Proposed Order

View on PACER

Sept. 7, 2018

Sept. 7, 2018

RECAP
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)

Oct. 5, 2018

Oct. 5, 2018

PACER

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)

Oct. 9, 2018

Oct. 9, 2018

PACER

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)

Oct. 9, 2018

Oct. 9, 2018

PACER
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)

Oct. 29, 2018

Oct. 29, 2018

PACER
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)

Nov. 9, 2018

Nov. 9, 2018

PACER
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)

Nov. 9, 2018

Nov. 9, 2018

PACER
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)

Dec. 10, 2018

Dec. 10, 2018

PACER
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)

Dec. 21, 2018

Dec. 21, 2018

PACER
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)

Feb. 19, 2019

Feb. 19, 2019

PACER

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)

Feb. 21, 2019

Feb. 21, 2019

PACER
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)

March 21, 2019

March 21, 2019

PACER
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)

March 21, 2019

March 21, 2019

Clearinghouse

Set/Reset Deadlines

March 22, 2019

March 22, 2019

PACER

Set/Reset Deadlines: Joint Status Report due by 4/19/2019. (tg)

March 22, 2019

March 22, 2019

PACER
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)

April 1, 2019

April 1, 2019

PACER
41

Joint STATUS REPORT by JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PAUL E. PETERSON. (Longosz, Edward) (Entered: 04/18/2019)

April 18, 2019

April 18, 2019

PACER

Set/Reset Deadlines

April 22, 2019

April 22, 2019

PACER

.Order

April 22, 2019

April 22, 2019

PACER

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)

April 22, 2019

April 22, 2019

PACER

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)

April 22, 2019

April 22, 2019

PACER
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)

May 30, 2019

May 30, 2019

RECAP
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)

June 10, 2019

June 10, 2019

PACER
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)

July 29, 2019

July 29, 2019

PACER

Set/Reset Deadlines

July 30, 2019

July 30, 2019

PACER

.Order

July 30, 2019

July 30, 2019

PACER

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)

July 30, 2019

July 30, 2019

PACER

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)

July 30, 2019

July 30, 2019

PACER
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)

Oct. 31, 2019

Oct. 31, 2019

PACER
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)

March 19, 2020

March 19, 2020

PACER
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)

March 19, 2020

March 19, 2020

PACER

Order on Motion for Extension of Time to

March 20, 2020

March 20, 2020

PACER

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)

March 20, 2020

March 20, 2020

PACER

Set/Reset Deadlines

March 23, 2020

March 23, 2020

PACER

Set/Reset Deadlines: Joint status report due by 3/25/2020. (tg)

March 23, 2020

March 23, 2020

PACER
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)

March 25, 2020

March 25, 2020

PACER
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)

April 7, 2020

April 7, 2020

PACER
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)

1 Memorandum in Support

View on RECAP

2 Statement of Facts

View on RECAP

3 Non-CDRH Vaughn Index

View on PACER

4 Declaration of Candace Boston

View on PACER

5 Sample Vaughn Index for CDRH Records (Attach. 1 to Boston Decl.)

View on PACER

6 Declaration of Sarah Kotler (2d Suppl.)

View on PACER

7 Declaration of David Mednick (Suppl.)

View on PACER

8 Declaration of Barbara A. Recupero (2d Suppl.)

View on PACER

9 Declaration of Melissa Pickworth

View on PACER

10 Declaration of Richard Nicholls (2d Suppl.)

View on PACER

11 Declaration of Michael S. Marquis

View on PACER

12 Declaration of Michael S. Marquis (Suppl.)

View on PACER

13 Declaration of Brandon J. Gaylord

View on PACER

14 Declaration of Gorka Garcia-Malene

View on PACER

15 Declaration of Nelson D. Hermilla

View on PACER

16 Declaration of Kilian Kagle

View on PACER

17 Declaration of Eric F. Stein (Suppl.)

View on PACER

18 Declaration of Gregory Smith

View on PACER

19 Text of Proposed Order

View on PACER

May 4, 2020

May 4, 2020

PACER
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)

June 19, 2020

June 19, 2020

PACER

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)

June 19, 2020

June 19, 2020

PACER

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)

June 19, 2020

June 19, 2020

PACER

Order on Motion to Modify

June 19, 2020

June 19, 2020

PACER

Set/Reset Deadlines

June 19, 2020

June 19, 2020

PACER
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)

Aug. 21, 2020

Aug. 21, 2020

PACER

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)

Aug. 24, 2020

Aug. 24, 2020

PACER

Order on Motion to Stay

Aug. 24, 2020

Aug. 24, 2020

PACER
53

NOTICE of Appearance by Sean Michael Tepe on behalf of All Defendants (Tepe, Sean) (Entered: 06/28/2021)

June 28, 2021

June 28, 2021

PACER
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)

July 20, 2021

July 20, 2021

PACER

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)

July 23, 2021

July 23, 2021

PACER

Set/Reset Deadlines: Joint Status Report due by 9/3/2021. (ztg)

July 23, 2021

July 23, 2021

PACER
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)

Aug. 31, 2021

Aug. 31, 2021

PACER

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)

Aug. 31, 2021

Aug. 31, 2021

PACER

Set/Reset Deadlines: Joint Status Report due by 9/24/2021. (hmc)

Aug. 31, 2021

Aug. 31, 2021

PACER

.Order

Aug. 31, 2021

Aug. 31, 2021

PACER

Case Details

State / Territory: District of Columbia

Case Type(s):

Intellectual Disability (Facility)

Key Dates

Filing Date: March 26, 2020

Closing Date: Nov. 22, 2021

Case Ongoing: No

Plaintiffs

Plaintiff Description:

A non profit facility providing education and therapy for people with mental disabilities and several parents of patients at that facility.

Plaintiff Type(s):

Private Plaintiff

Public Interest Lawyer: No

Filed Pro Se: No

Class Action Sought: No

Class Action Outcome: Not sought

Defendants

Food and Drug Administration (Washington, District of Columbia), Federal

Defendant Type(s):

Hospital/Health Department

Case Details

Causes of Action:

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.

Special Case Type(s):

Appellate Court is initial court

Availably Documents:

Trial Court Docket

Any published opinion

Outcome

Prevailing Party: Plaintiff

Nature of Relief:

Injunction / Injunctive-like Settlement

Source of Relief:

Litigation

Issues

General:

Aggressive behavior

Informed consent/involuntary medication

Disability:

Mental impairment

Mental Disability:

Autism

Medical/Mental Health:

Self-injurious behaviors

Type of Facility:

Non-government non-profit