Case: Judge Rotenburg Center v. Food and Drug Administration

20-01087 | 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-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.

	Document
20-01088	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
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
20-01088	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

ECF Number	Description	Date	Link Date / Link
1208213963	PETITION FOR REVIEW [1835490] of a decision by federal agency filed by The Judge Rotenberg Educational Center, Inc. [Service Date: 03/26/2020 ] Disclosure Statement: Not Attached; Certificate of Parties: Not Applicable to this Filing. [20-1087] [Entered: 03/26/2020 12:49 PM]	March 26, 2020	March 26, 2020 RECAP
1208213987	CERTIFIED COPY [1835497] of Petition for Review sent to respondent [1835490-2] [20-1087] [Entered: 03/26/2020 12:53 PM]	March 26, 2020	March 26, 2020
1208214082	CERTIFICATE OF SERVICE [1835544] to case opening document of federal agency decision [1835490-2] filed by The Judge Rotenberg Educational Center, Inc.. [20-1087] (Flammia, Michael) [Entered: 03/26/2020 02:57 PM]	March 26, 2020	March 26, 2020
1208214100	STATEMENT [1835550] with Disclosure Listing filed by The Judge Rotenberg Educational Center, Inc. [Service Date: 03/26/2020 ] [20-1087] (Flammia, Michael) [Entered: 03/26/2020 03:09 PM]	March 26, 2020	March 26, 2020
	PETITION FOR REVIEW CASE docketed. [20-1087] [Entered: 03/26/2020 12:48 PM]	March 26, 2020	March 26, 2020
1208214397	ENTRY OF APPEARANCE [1835690] filed by Daniel Aguilar and co-counsel Scott R. McIntosh on behalf of Respondents FDA, Stephen M. Hahn, HHS and Mr. Alex Michael Azar, II. [20-1087] (Aguilar, Daniel) [Entered: 03/27/2020 10:59 AM]	March 27, 2020	March 27, 2020
1208214630	CLERK'S ORDER [1835811] filed consolidating cases 20-1088 (Consolidation started 03/27/2020) with 20-1087 [20-1087, 20-1088] [Entered: 03/27/2020 04:09 PM]	March 27, 2020	March 27, 2020
1208214633	ENTRY OF APPEARANCE [1835812] filed by Michael P. Flammia on behalf of Petitioner The Judge Rotenberg Educational Center, Inc. in 20-1087. [20-1087, 20-1088] (Flammia, Michael) [Entered: 03/27/2020 04:24 PM]	March 27, 2020	March 27, 2020
1208214644	NOTICE [1835818] Notice of Filing of Administrative Stay filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 03/27/2020 ] [20-1087, 20-1088] (Flammia, Michael) [Entered: 03/27/2020 04:34 PM]	March 27, 2020	March 27, 2020
1208214647	CLERK'S ORDER [1835816] filed directing the parties to file initial submissions: PETITIONER docketing statements due 04/27/2020, PETITIONER certificates as to parties due 04/27/2020, PETITIONER statements of issues due 04/27/2020, PETITIONER underlying decision due 04/27/2020, PETITIONER deferred appendix statement due 04/27/2020, PETITIONER procedural motions due 04/27/2020, PETITIONER dispositive motions due 05/11/2020, RESPONDENT procedural motions due 04/27/2020, RESPONDENT certified index to record due 05/11/2020, RESPONDENT dispositive motions due 05/11/2020. [20-1087, 20-1088] [Entered: 03/27/2020 04:32 PM]	March 27, 2020	March 27, 2020
1208214653	ENTRY OF APPEARANCE [1835820] filed by Max D. Stern on behalf of Petitioners Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088. [20-1088, 20-1087] (Stern, Max) [Entered: 03/27/2020 04:36 PM]	March 27, 2020	March 27, 2020
1208214656	STATEMENT [1835822] with Disclosure Listing filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 03/27/2020 ] [20-1088, 20-1087] (Stern, Max) [Entered: 03/27/2020 04:43 PM]	March 27, 2020	March 27, 2020
1208214659	ENTRY OF APPEARANCE [1835823] filed by Michael P. Flammia and co-counsel Edward J. Longosz, II on behalf of Petitioner The Judge Rotenberg Educational Center, Inc. in 20-1087. [20-1087, 20-1088] (Flammia, Michael) [Entered: 03/27/2020 04:44 PM]	March 27, 2020	March 27, 2020
1208214662	NOTICE [1835824] Notice of Filing Administrative Stay filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 03/27/2020 ] [20-1088, 20-1087] (Stern, Max) [Entered: 03/27/2020 04:48 PM]	March 27, 2020	March 27, 2020
1208221787	DOCKETING STATEMENT [1839658] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 04/24/2020 ] [20-1087, 20-1088] (Flammia, Michael) [Entered: 04/24/2020 10:41 AM]	April 24, 2020	April 24, 2020
1208221799	CERTIFICATE AS TO PARTIES, RULINGS AND RELATED CASES [1839662] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 04/24/2020 ] [20-1087, 20-1088] (Flammia, Michael) [Entered: 04/24/2020 10:46 AM]	April 24, 2020	April 24, 2020
1208221806	UNDERLYING DECISION IN CASE [1839667] submitted by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 04/24/2020 ] [20-1087, 20-1088] (Flammia, Michael) [Entered: 04/24/2020 11:04 AM]	April 24, 2020	April 24, 2020
1208221812	STATEMENT OF ISSUES [1839669] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 04/24/2020 ] [20-1087, 20-1088] (Flammia, Michael) [Entered: 04/24/2020 11:10 AM]	April 24, 2020	April 24, 2020 RECAP
1208222021	DOCKETING STATEMENT [1839773] filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 04/24/2020 ] [20-1088, 20-1087] (Stern, Max) [Entered: 04/24/2020 04:08 PM]	April 24, 2020	April 24, 2020
1208222026	CERTIFICATE AS TO PARTIES, RULINGS AND RELATED CASES [1839775] filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 04/24/2020 ] [20-1088, 20-1087] (Stern, Max) [Entered: 04/24/2020 04:12 PM]	April 24, 2020	April 24, 2020
1208222036	UNDERLYING DECISION IN CASE [1839778] submitted by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 04/24/2020 ] [20-1088, 20-1087] (Stern, Max) [Entered: 04/24/2020 04:22 PM]	April 24, 2020	April 24, 2020
1208222044	STATEMENT OF ISSUES [1839781] filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 04/24/2020 ] [20-1088, 20-1087] (Stern, Max) [Entered: 04/24/2020 04:26 PM]	April 24, 2020	April 24, 2020
1208222432	STATEMENT OF INTENT REGARDING APPENDIX DEFERRAL [1839995] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 04/27/2020 ] Intent: AppxDeferred [20-1087, 20-1088] (Flammia, Michael) [Entered: 04/27/2020 02:25 PM]	April 27, 2020	April 27, 2020
1208222444	STATEMENT OF INTENT REGARDING APPENDIX DEFERRAL [1839998] filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 04/27/2020 ] Intent: AppxDeferred [20-1087, 20-1088] (Stern, Max) [Entered: 04/27/2020 02:33 PM]	April 27, 2020	April 27, 2020
1208224591	ENTRY OF APPEARANCE [1841104] filed by Michael P. Flammia and co-counsel Christian B.W. Stephens; Matthew D. Rodgers on behalf of Petitioner The Judge Rotenberg Educational Center, Inc. in 20-1087. [20-1087, 20-1088] (Stephens, Christian) [Entered: 05/04/2020 12:24 PM]	May 4, 2020	May 4, 2020
1208225564	CONSENT UNOPPOSED MOTION [1841623] to extend time to file certified index to 05/26/2020 filed by Alex M. Azar, II, FDA, Stephen M. Hahn and HHS in 20-1087, 20-1088 [Service Date: 05/06/2020 ] Length Certification: 479 words. [20-1087, 20-1088] (Aguilar, Daniel) [Entered: 05/06/2020 09:13 PM]	May 6, 2020	May 6, 2020
1208225729	CLERK'S ORDER [1841720] filed granting motion to extend time [1841623-2]; PETITIONER and RESPONDENT dispositive motions due 05/26/2020. RESPONDENT certified index to record due 05/26/2020 [20-1087, 20-1088] [Entered: 05/07/2020 12:58 PM]	May 7, 2020	May 7, 2020
1208230528	CERTIFIED INDEX TO RECORD [1844255] filed by Alex M. Azar, II, FDA, Stephen M. Hahn and HHS in 20-1087, 20-1088 [Service Date: 05/26/2020 ] [20-1087, 20-1088] (Aguilar, Daniel) [Entered: 05/26/2020 01:52 PM]	May 26, 2020	May 26, 2020
1208230686	MOTION [1844326] to remand record and adduce additional eveidence filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 (Service Date: 05/26/2020 by CM/ECF NDA) Length Certification: 5,199 words. [20-1087, 20-1088]--[Edited 05/27/2020 by LMC-RELIEF REPLACED] (Flammia, Michael) [Entered: 05/26/2020 05:25 PM]	May 26, 2020	May 26, 2020
1208230701	SUPPLEMENT [1844328] to motion to remand case [1844326-2] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 05/26/2020 ] [20-1087, 20-1088]--[Edited 05/27/2020 by AY] (Flammia, Michael) [Entered: 05/26/2020 05:56 PM]	May 26, 2020	May 26, 2020
1208230716	SUPPLEMENT [1844330] to motion to remand case [1844326-2] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 05/26/2020 ] [20-1087, 20-1088]--[Edited 05/27/2020 by AY] (Flammia, Michael) [Entered: 05/26/2020 06:18 PM]	May 26, 2020	May 26, 2020
1208230728	SUPPLEMENT [1844331] to motion to remand case [1844326-2] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 [Service Date: 05/26/2020 ] [20-1087, 20-1088]--[Edited 05/27/2020 by AY] (Flammia, Michael) [Entered: 05/26/2020 06:33 PM]	May 26, 2020	May 26, 2020
1208230741	MOTION [1844333] to remand record filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 (Service Date: 05/26/2020 by CM/ECF NDA) Length Certification: 348 words. [20-1087, 20-1088] (Stern, Max) [Entered: 05/26/2020 06:42 PM]	May 26, 2020	May 26, 2020
1208230744	MOTION [1844334] to hold case in abeyance filed by The Judge Rotenberg Educational Center, Inc. in 20-1087, Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 (Service Date: 05/26/2020 by CM/ECF NDA) Length Certification: 508 words. [20-1087, 20-1088] (Flammia, Michael) [Entered: 05/26/2020 06:55 PM]	May 26, 2020	May 26, 2020
1208233622	RESPONSE IN OPPOSITION [1845945] to motion [1844326-2], motion [1844326-3], motion [1844333-2], motion [1844334-2] filed by FDA, Stephen M. Hahn, HHS and Alex M. Azar, II in 20-1087, 20-1088 [Service Date: 06/05/2020 by CM/ECF NDA] Length Certification: 4,895 words. [20-1087, 20-1088] (Aguilar, Daniel) [Entered: 06/05/2020 01:56 PM]	June 5, 2020	June 5, 2020
1208233716	UNOPPOSED MOTION [1845993] to extend time to file reply to 06/17/2020 filed by The Judge Rotenberg Educational Center, Inc. in 20-1087, Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood and Sharon Wood in 20-1088 [Service Date: 06/05/2020 ] Length Certification: 539 words. [20-1087, 20-1088] (Flammia, Michael) [Entered: 06/05/2020 05:29 PM]	June 5, 2020	June 5, 2020
1208234431	CLERK'S ORDER [1846359] filed granting motion to extend time [1845993-2]; petitioners' replies to response [1845945-2] due 06/17/2020 [20-1087, 20-1088] [Entered: 06/09/2020 03:27 PM]	June 9, 2020	June 9, 2020
1208237104	REPLY [1847826] filed by The Judge Rotenberg Educational Center, Inc. in 20-1087 to response [1845945-2] [Service Date: 06/17/2020 by CM/ECF NDA] Length Certification: 2581 words. [20-1087, 20-1088] (Flammia, Michael) [Entered: 06/17/2020 08:02 PM]	June 17, 2020	June 17, 2020
1208237107	REPLY [1847827] filed by Luis Aponte, John Asare, Ophelia Asare, Maria Augusto, Nelson Bernardo, Richard Bevins, Indra Biggs, Carlo Casoria, Judy Casoria, Gail Cornish, Cornnis Crawford, Hannah Crawford, Patricia Crawford, Prudence Dellamano, Kathy Dion, Angela Disisto, Richard Doherty, Lauren Emmick, Martin Emmick, Stacy Engels, Barbara Forbes, Roger Forbes, Bruce Freeman, Lance Giuffrida, Yakuline Giuffrida, Louisa Goldberg, Robert Goldberg, Stephen Hanna, Lee Higgins, Judith Honore, Mathurin Honore, Erick Kemp, David Lewis, M.D., Cheryl Lloyd, Alfred Lopez, Carline Lopez, Mary Marini, Elizabeth Mesa, Ricardo Mesa, Trisha Moeder, Jean Murphy, Lainie Murphy, William Murphy, Cheryl Murray, Dollie Myrick, James Myrick, Donna Oldham, Malcolm Oldham, Carmen Pena, Carol Peterson, Paul Peterson, Joseph Pisano, Robin Pisano, Edward Prunckun, Pam Prunckun, Bridget Reaney, Colman Reaney, Ana Rivera, Marcia Shear, Mitchell Shear, James Shields, Amjad Siddiqi, Raul Sierra, Melody Simpson, Ilana Slaff-Galatan, Claudia Soucy, Leo Soucy, Ellen Stahler, Gary Tam, Jamie Tam, The B.R.I. Parents and Friends Association, Inc., Carmen Torres, Carlos Vollenweider, Kelly Walker, Laura J. Walker, Jenkin Washington, Marie Washington, Corine Watson, Charles Winters, Michele Winters, Roger Wood, Sharon Wood and Stephen M. Hahn in 20-1088 to response [1845945-2] [Service Date: 06/17/2020 by CM/ECF NDA] Length Certification: 132 words. [20-1087, 20-1088] (Stern, Max) [Entered: 06/17/2020 08:07 PM]	June 17, 2020	June 17, 2020
1208248695	PER CURIAM ORDER [1853887] filed referring motions to remand the record to the merits panel to which this petition for review is assigned [1844333-2] [1844326-3]. The parties are directed to address in their briefs the issues presented in the motions to remand the record rather than incorporate those arguments by reference. Denying motion to hold case in abeyance [1844334-2]. The Clerk is directed to enter a briefing schedule. Before Judges: Rogers, Griffith and Pillard. [20-1087, 20-1088] [Entered: 07/29/2020 09:44 AM]	July 29, 2020	July 29, 2020

Case: Judge Rotenburg Center v. Food and Drug Administration

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

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