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 27, 2020

Case Ongoing

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 (“the 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-h…

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 (“the 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. Behavioral Research Institute v. Secretary of Administration, Petition of Kaufman, and Judge Rotenberg Educational Center, Inc. v. Commissioner of the Department of Mental Retardation (see related cases), are some of the cases brought surrounding various issues related to JRC's use of aversive therapies and funding. 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 a 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 17-2092, 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 defendants moved for summary judgment on May 4, 2020. However, on August 24, 2020, Judge Howell issued an order staying the motion for summary judgment to allow the parties to narrow the issues remaining in the case. 

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, 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 ruling of the D.C. Circuit vacating the FDA’s rule did not become final until February 2, 2022 (after the D.C. Circuit declined to rehear the case en banc and the FDA did not petition the Supreme Court for certiorari). 

After the D.C. Circuit’s decision, the issues remaining related to outstanding FOIA requests of records that the defendants continued to withhold or were produced with redactions. On August 19, 2022, the plaintiffs moved to amend their complaint to add a new FOIA request submitted that year. However, Chief Judge Howell denied the plaintiffs’ motion to amend their complaint on November 1, 2022. The court began by noting that the case should be nearing a resolution, with only the defendants’ motion for summary judgment pending (which had been stayed in 2020). In a Rule 15(d) analysis, the court noted that the FOIA request at issue came nearly six years after the initial FOIA requests giving rise to this litigation, and that they were directed to purported lobbying efforts to have the vacated rule reestablished by legislative action. The court found that allowing the plaintiffs’ proposed supplement would (1) prevent the economic and speedy disposition of the existing controversy between the parties, (2) cause undue delay by further “putting off” the pending motion for summary judgment, and (3) prejudice the rights of the defendants. The court concluded by advising that if the plaintiffs were dissatisfied with the FDA’s response to their new FOIA request, the proper course of action would be to file a new lawsuit. 2022 WL 16845801.

On March 29, 2023, the plaintiffs filed a cross-motion for summary judgment. Both plaintiffs' and defendants’ motions for summary judgment remain and the case is ongoing as of June 2024.

Summary Authors

Jonah Hudson-Erdman (4/7/2022)

Stephanie Chin (3/17/2023)

Related Cases

Petition of Kaufman, Massachusetts state trial court (1986)

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

Behavioral Research Institute v. Secretary of Administration, Massachusetts state trial court (1989)

People

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


Judge(s)
Attorney for Plaintiff
Attorney for Defendant

Aguilar, Daniel (District of Columbia)

Expert/Monitor/Master/Other

Attorney, Edward John (District of Columbia)

Attorney, Felicia H. (District of Columbia)

Attorney, Daniel J. (District of Columbia)

Attorney, Scott R. (District of Columbia)

Attorney for Defendant

Aguilar, Daniel (District of Columbia)

Baer, Michael Hendry (District of Columbia)

Bennett, Michelle (District of Columbia)

Berwick, Benjamin Leon (District of Columbia)

Braswell, Marina Utgoff (District of Columbia)

Burch, Alan R. (District of Columbia)

Burnham, James Mahoney (District of Columbia)

Caplen, Robert Aaron (District of Columbia)

Cirino, Paul (District of Columbia)

Clark, Andrew E. (District of Columbia)

Cohen, Jason Todd (District of Columbia)

Coles-Huff, Doris Denise (District of Columbia)

Cutini, Drake S. (District of Columbia)

Ellison, James Philip (District of Columbia)

Ellsworth, Felicia H. (Massachusetts)

Fowler, Adrienne Elise (District of Columbia)

Goulka, Jeremiah (District of Columbia)

Grogg, Adam (District of Columbia)

Gural, Roger Joseph (District of Columbia)

Hammond, Derek S. (District of Columbia)

Harvey, Gordon Michael (District of Columbia)

Haynes, Fred Elmore (District of Columbia)

Humphreys, Bradley P. (District of Columbia)

Kade, Elizabeth L. (District of Columbia)

Kell, Gerald Cooper (District of Columbia)

Kirschner, Adam D. (District of Columbia)

Kolsky, Joshua M. (District of Columbia)

Kopplin, Rebecca Michelle (District of Columbia)

Layton, Elisabeth (District of Columbia)

Littman, M. Jared (District of Columbia)

Lyons, Jane M. (District of Columbia)

Maier, Peter Rolf (District of Columbia)

McBarnette, Andrea (District of Columbia)

McIntosh, Scott R. (District of Columbia)

Momeni, Mercedeh (District of Columbia)

Myers, Steven A. (District of Columbia)

Nebeker, William Mark (District of Columbia)

Peterson, Benton Gregory (District of Columbia)

Pruski, Jacek (District of Columbia)

Russell, Beverly Maria (District of Columbia)

Samp, Richard A. (District of Columbia)

Scannapieco, Gabriel H. (District of Columbia)

Schaefer, Daniel Patrick (District of Columbia)

Seabrook, April Denise (District of Columbia)

Simon, Jeremy S. (District of Columbia)

Tepe, Sean Michael (District of Columbia)

Yee, Marsha Wellknown (District of Columbia)

Documents in the Clearinghouse

Documents in this case

20-01087

Docket [PACER]

The Judge Rotenberg Education v. FDA

July 6, 2021

July 6, 2021

Docket
1

1:17-cv-02092

Complaint for Declaratory and Injunctive Relief

Judge Rotenburg Center v. Food and Drug

U.S. District Court for the District of District of Columbia

Oct. 10, 2017

Oct. 10, 2017

Complaint
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 District of Columbia

March 21, 2019

March 21, 2019

Order/Opinion

376 F.Supp.3d 47

1208213963

20-01087

Petition for Review

The Judge Rotenberg v. United States Food and Drug Administration

March 26, 2020

March 26, 2020

Pleading / Motion / Brief
1208343993

20-01087

On Petitions for Review of an Order of the Food and Drug Administration

July 6, 2021

July 6, 2021

Order/Opinion

3 F.4th 390

20-01087

Opinion of the Court

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

July 6, 2021

July 6, 2021

Order/Opinion

3 F.4th 390

1208378234

20-01087

Order

Nov. 22, 2021

Nov. 22, 2021

Order/Opinion
61

1:17-cv-02092

Joint Status Report

The Judge Rotenberg Educational Center, Inc. v. U.S. Food and Drug Adminsitration

U.S. District Court for the District of District of Columbia

July 14, 2022

July 14, 2022

Pleading / Motion / Brief

Resources

Resources related to this case
Title Description External URL Date / External URL

Report of the Special Rapporteur on torture and other cruel, inhuman or degrading treatment of punishment

Juan E. Mendez

March 4, 2013

March 4, 2013

https://www.documentcloud.org/...

Docket

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

Last updated Sept. 22, 2026, 6:01 a.m.

Docket for: JUDGE ROTENBERG EDUCATIONAL CENTER, INC. v. U.S. FOOD AND DRUG ADMINISTRATION
ECF Number Date Description Link
1 Oct. 10, 2017

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)

1 Exhibit A-1

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2 Exhibit A-2

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3 Exhibit A-3

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4 Exhibit A-4

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5 Exhibit A-5

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6 Exhibit A-6

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7 Exhibit B

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8 Exhibit C

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9 Exhibit D

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10 Exhibit E

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11 Exhibit F

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12 Exhibit G

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13 Exhibit H

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14 Exhibit I

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15 Exhibit J

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16 Exhibit K

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17 Exhibit L

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18 Exhibit M

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19 Exhibit N

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20 Exhibit O

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21 Exhibit P

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22 Exhibit Q

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23 Exhibit R

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24 Civil Cover Sheet

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25 Summons

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26 Summons

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27 Summons

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28 Summons

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RECAP
2 Oct. 10, 2017

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)

RECAP
Oct. 10, 2017

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

3 Oct. 11, 2017

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)

RECAP
Oct. 11, 2017

Case Assigned/Reassigned

4 Oct. 12, 2017

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)

RECAP
5 Oct. 13, 2017

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

RECAP
6 Oct. 16, 2017

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

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7 Nov. 14, 2017

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)

RECAP
8 Nov. 20, 2017

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)

RECAP
9 Dec. 4, 2017

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

RECAP
10 Dec. 6, 2017

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

RECAP
Dec. 6, 2017

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

Set/Reset Deadlines

Dec. 6, 2017

.Order

Dec. 6, 2017

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

Dec. 7, 2017

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

.Order

Dec. 8, 2017

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

Dec. 8, 2017

Set/Reset Deadlines

11 Dec. 12, 2017

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)

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12 Dec. 12, 2017

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)

RECAP
Dec. 13, 2017

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

Order on Motion for Leave to Appear Pro Hac Vice AND Order on Motion for Leave to Appear Pro Hac Vice

13 Jan. 5, 2018

NOTICE of Appearance by Max D. Stern on behalf of J.R.C. PARENTS AND FRIENDS ASSOCIATION, INC. (Stern, Max) (Entered: 01/05/2018)

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14 Jan. 8, 2018

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)

RECAP
15 Jan. 9, 2018

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)

RECAP
16 Jan. 12, 2018

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

RECAP
Jan. 19, 2018

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

Notice of Hearing

Jan. 25, 2018

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

Notice of Hearing

17 Feb. 2, 2018

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)

RECAP
18 Feb. 2, 2018

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

RECAP
Feb. 2, 2018

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

Status Conference

Feb. 2, 2018

Set/Reset Deadlines

Feb. 2, 2018

.Order

Feb. 2, 2018

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

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)

19 March 2, 2018

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)

RECAP
20 March 27, 2018

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)

RECAP
March 29, 2018

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

Order on Motion to Amend/Correct

March 30, 2018

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

Set/Reset Deadlines

21 May 11, 2018

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)

RECAP
22 May 11, 2018

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)

RECAP
May 15, 2018

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 16, 2018

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)

23 June 15, 2018

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)

RECAP
24 July 12, 2018

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)

RECAP
25 July 12, 2018

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)

RECAP
26 July 17, 2018

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)

RECAP
July 24, 2018

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

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)

27 Sept. 5, 2018

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 09/05/2018)

RECAP
28 Sept. 7, 2018

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)

RECAP
29 Sept. 7, 2018

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)

RECAP
30 Sept. 7, 2018

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

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RECAP
31 Oct. 5, 2018

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)

RECAP
Oct. 9, 2018

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

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)

32 Oct. 29, 2018

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 10/29/2018)

RECAP
33 Nov. 9, 2018

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)

RECAP
34 Nov. 9, 2018

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)

RECAP
35 Dec. 10, 2018

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)

RECAP
36 Dec. 21, 2018

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 12/21/2018)

RECAP
37 Feb. 19, 2019

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)

RECAP
Feb. 21, 2019

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)

38 March 21, 2019

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)

RECAP
39 March 21, 2019

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).

RECAP
March 22, 2019

Set/Reset Deadlines

March 22, 2019

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

40 April 1, 2019

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 04/01/2019)

RECAP
41 April 18, 2019

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

RECAP
April 22, 2019

Set/Reset Deadlines

April 22, 2019

.Order

April 22, 2019

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

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)

42 May 30, 2019

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 05/30/2019)

RECAP
43 June 10, 2019

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)

RECAP
44 July 29, 2019

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Nebeker, William) (Entered: 07/29/2019)

RECAP
July 30, 2019

Set/Reset Deadlines

July 30, 2019

.Order

July 30, 2019

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

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)

45 Oct. 31, 2019

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)

RECAP
46 March 19, 2020

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)

RECAP
47 March 19, 2020

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)

RECAP
March 20, 2020

Order on Motion for Extension of Time to

March 20, 2020

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 23, 2020

Set/Reset Deadlines

March 23, 2020

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

48 March 25, 2020

Joint STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION. (Caplen, Robert) (Entered: 03/25/2020)

RECAP
49 April 7, 2020

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)

RECAP
50 May 4, 2020

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

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4 Declaration of Candace Boston

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

View on PACER

6 Declaration of Sarah Kotler (2d Suppl.)

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7 Declaration of David Mednick (Suppl.)

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

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9 Declaration of Melissa Pickworth

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10 Declaration of Richard Nicholls (2d Suppl.)

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11 Declaration of Michael S. Marquis

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12 Declaration of Michael S. Marquis (Suppl.)

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13 Declaration of Brandon J. Gaylord

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14 Declaration of Gorka Garcia-Malene

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15 Declaration of Nelson D. Hermilla

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16 Declaration of Kilian Kagle

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17 Declaration of Eric F. Stein (Suppl.)

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18 Declaration of Gregory Smith

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19 Text of Proposed Order

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RECAP
51 June 19, 2020

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)

RECAP
June 19, 2020

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

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)

Case Details

State / Territory:

District of Columbia

Case Type(s):

Intellectual Disability (Facility)

Key Dates

Filing Date: March 27, 2020

Case Ongoing: Yes

Plaintiffs

Plaintiff Description:

A nonprofit 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

Federal

Food and Drug Administration

Defendant Type(s):

Hospital/Health Department

Facility Type(s):

Non-government non-profit

Case Details

Causes of Action:

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

Other Dockets:

U.S. Court of Appeals for the District of Columbia Circuit 20-01087

U.S. Court of Appeals for the District of Columbia Circuit 20-01087

District of District of Columbia 1:17-cv-02092

Special Case Type(s):

Appellate Court is initial court

Available Documents:

Any published opinion

Complaint (any)

Trial Court Docket

Outcome

Prevailing Party: Plaintiff OR Mixed

Relief Granted:

Injunction / Injunctive-like Settlement

Source of Relief:

Litigation

Issues

General/Misc.:

Aggressive behavior

Informed consent/involuntary medication

Disability and Disability Rights:

Autism

Mental impairment

Medical/Mental Health Care:

Self-injurious behaviors

Recommended Citation