Case: Chelius v. Wright

1:17-cv-00493 | U.S. District Court for the District of Hawaii

Filed Date: Oct. 3, 2017

Case Ongoing

Clearinghouse coding complete

Case Summary

In 2000, the FDA approved the drug mifepristone under the brand name Mifeprex for use in terminating an early pregnancy. Mifeprex was the only drug approved for this purpose. However, the FDA subjected Mifeprex to a Risk Evaluation and Mitigation Strategy ("Mifeprex REMS") that burdened health care providers and limited patient access to the medication. The Mifeprex REMS provided that a patient could not obtain the medication by prescription at a retail pharmacy and instead had to be handed the…

In 2000, the FDA approved the drug mifepristone under the brand name Mifeprex for use in terminating an early pregnancy. Mifeprex was the only drug approved for this purpose. However, the FDA subjected Mifeprex to a Risk Evaluation and Mitigation Strategy ("Mifeprex REMS") that burdened health care providers and limited patient access to the medication. The Mifeprex REMS provided that a patient could not obtain the medication by prescription at a retail pharmacy and instead had to be handed the medication at a clinic, medical office, or hospital under the supervision of a health care provider who had registered with the drug manufacturer, attested to their ability to safely prescribe the drug, and then arranged to order and stock the medication in their health care facility.

On October 3, 2017, the Chief Medical Officer for the Hawaii Health Systems Corporation's Kaua'i Region in his individual capacity as a physician, the Society of Family Planning, the California Academy of Family Physicians, and Pharmacists Planning Services, Inc. (collectively "the plaintiffs") sued the Acting Secretary of the U.S. Department of Health and Human Services, the FDA, and the Commissioner of the FDA in the district of Hawaii for alleged violations of the plaintiffs' rights under the Fourteenth Amendment to the U.S. Constitution as well as the Administrative Procedure Act ("APA"). Specifically, the plaintiffs alleged that the FDA's 2016 reauthorization of the Mifeprex REMS imposed significant and undue burdens on abortion access that were not justified by the law's purported benefits, treated the plaintiffs differently from other similarly situated parties, and were an arbitrary and capricious abuse of discretion contrary to the Fifth Amendment of the U.S. Constitution. As such, the plaintiffs sought declaratory relief, injunctive relief, and costs and attorneys' fees.

On February 5, 2018, the defendants filed a motion to dismiss the complaint, but later withdraw their motion on May 18, 2018. After over a year of litigation, the parties filed cross motions for summary judgment on December 2, 2019.

On January 23, 2020, district court Judge Jill A. Otake stayed this matter pending resolution of the U.S. Supreme Court case Gee v. June Medical Services (subsequently June Medical Services, LLC. v. Russo, 591 U.S. ___, 140 S. Ct. 2103 (2020)). The district court found that Gee bore upon a threshold issue relevant to this case. One year later, the plaintiffs filed a motion to lift the stay on March 4, 2021. The district court granted that motion the next day but ordered the parties to refile their previous motions for summary judgment.

In response, the plaintiffs filed a motion for summary judgment with the district court on April 16, 2021, and also stipulated to the voluntary dismissal of Pharmacists Planning Services, Inc. as a plaintiff. The parties, however, filed a joint motion to stay the case pending FDA review. On May 7, 2021, Judge Otake stayed litigation until December 1, 2021, ordered the parties to submit joint status reports every ninety days, and administratively closed the case on May 10, 2021. The parties last filed a status report on November 3, 2021. As of May 5, 2022, this case is ongoing.

Summary Authors

Richa Bijlani (5/5/2022)

People

For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/7007501/parties/chelius-v-wright/


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Documents in the Clearinghouse

Document
1

1:17-cv-00493

Complaint

Oct. 3, 2017

Oct. 3, 2017

Complaint

Resources

Docket

See docket on RECAP: https://www.courtlistener.com/docket/7007501/chelius-v-wright/

Last updated Nov. 5, 2023, 8:36 p.m.

ECF Number Description Date Link Date / Link
1

COMPLAINT against Don J Wright ( Filing fee $ 400 receipt number 0975-1937627.), filed by Graham T Chelius. (Attachments: # 1 Exhibit Exhibit A, # 2 Exhibit Exhibit B, # 3 Exhibit Exhibit C, # 4 Exhibit Exhibit D, # 5 Exhibit Exhibit E, # 6 Exhibit Exhibit F, # 7 Exhibit Exhibit G, # 8 Exhibit Exhibit H, # 9 Exhibit Exhibit I, # 10 Exhibit Exhibit J, # 11 Exhibit Exhibit K, # 12 Civil Cover Sheet)(Caballero, Mateo) (Entered: 10/03/2017)

4

View on RECAP

Oct. 3, 2017

Oct. 3, 2017

Clearinghouse
2

Summons (Proposed) (Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
3

Summons (Proposed) (Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
4

Summons (Proposed) (Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
5

NOTICE of Case Assignment: Please reflect Civil case number CV 17-00493 DKW-KSC on all further pleadings. (emt, )CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry. (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
6

Summons Issued as to Don J. Wright, Acting Secretary, U.S. Department of Health and Human Services, U.S. Attorney for the District of Hawaii. (emt, ) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
7

Summons Issued as to United States Food and Drug Administration, U.S. Attorney, District of Hawaii. (emt, ) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
8

Summons Issued as to Scott Gottlieb, M.D., Commissioner of U.S. Food and Drug Administration, U.S. Attorney, District of Hawaii. (emt, ) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
9

Order Setting Rule 16 Scheduling Conference for 09:00AM on 12/4/2017 before MAGISTRATE JUDGE KEVIN S.C. CHANG - Signed by CHIEF JUDGE J. MICHAEL SEABRIGHT on 10/3/2017. (Attachments: # 1 Memo from Clerk Re: Corporate Disclosure Statements) (emt, )CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry. ATTACH THE SCHEDULING ORDER TO THE INITIATING DOCUMENT (COMPLAINT/NOTICE OF REMOVAL). THE SCHEDULING ORDER AND MEMO RE: CORPORATE DISCLOSURES MUST BE SERVED WITH THE DOCUMENT. (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
10

CIVIL Waiver of Service Packet ~ Notice to Parties Regarding Service Pursuant to Rule 4 of the Federal Rules of Civil Procedure. (Attachments: # 1 AO 398 Notice of Lawsuit and Request to Waive Service of Summons, # 2 AO 399 Waiver of Service of Summons) (emt, ) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
11

MOTION for Pro Hac Vice for Julia Kaye Filing fee $ 300, receipt number 0975-1937666.Mateo Caballero appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Declaration, # 2 Exhibit Proposed Order)(Caballero, Mateo) (Entered: 10/03/2017)

1 Declaration

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2 Exhibit Proposed Order

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Oct. 3, 2017

Oct. 3, 2017

PACER
12

MOTION for Pro Hac Vice for Susan Talcott Camp Filing fee $ 300, receipt number 0975-1937670.Mateo Caballero appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Declaration, # 2 Exhibit Proposed Order)(Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
13

Corporate Disclosure Statement by California Academy of Family Physicians. (Attachments: # 1 Certificate of Service)(Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
14

EO: On 10/3/17, Susan Talcott Camp filed a Motion to Appear Pro Hac Vice. Ms. Camp is directed to fully respond to paragraph 7 of her declaration, which asks for identification of the courts where she is a registered user of CM/ECF. Ms. Camp should file a supplemental declaration by 10/5/17 addressing this deficiency. (MAGISTRATE JUDGE KEVIN S.C. CHANG)(chang1)CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
15

Corporate Disclosure Statement by Pharmacists Planning Services Inc.. (Attachments: # 1 Certificate of Service)(Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
16

Corporate Disclosure Statement by Society of Family Planning. (Attachments: # 1 Certificate of Service)(Caballero, Mateo) (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
17

ORDER GRANTING MOTION APPEAR PRO HAC VICE AS TO JULIA KAYE re 11 - Signed by MAGISTRATE JUDGE KEVIN S.C. CHANG on 10/3/2017. (emt, )CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry (Entered: 10/03/2017)

Oct. 3, 2017

Oct. 3, 2017

PACER
18

SUPPLEMENT re 12 MOTION for Pro Hac Vice for Susan Talcott Camp Filing fee $ 300, receipt number 0975-1937670. filed by Pharmacists Planning Services Inc., Graham T. Chelius, California Academy of Family Physicians, Society of Family Planning by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning . (Caballero, Mateo) (Entered: 10/04/2017)

Oct. 4, 2017

Oct. 4, 2017

PACER
19

ORDER GRANTING MOTION TO APPEAR PRO HAC VICE AS TO SUSAN TALCOTT CAMP re 12 - Signed by MAGISTRATE JUDGE KEVIN S.C. CHANG on 10/5/2017. (emt, )CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry (Entered: 10/05/2017)

Oct. 5, 2017

Oct. 5, 2017

PACER
20

Plaintiffs' Scheduling Conference Statement . (Attachments: # 1 Certificate of Service)(Caballero, Mateo) Modified on 11/28/2017 (emt, ). (Entered: 11/27/2017)

Nov. 27, 2017

Nov. 27, 2017

PACER
21

Joint REPORT of Planning Meeting . (Attachments: # 1 Certificate of Service)(Caballero, Mateo) Modified on 11/28/2017 (emt, ). (Entered: 11/27/2017)

Nov. 27, 2017

Nov. 27, 2017

PACER
22

NOTICE of Appearance by Mary M. Englehart on behalf of Scott Gottlieb, United States Food and Drug Administration, Don J. Wright on behalf of Scott Gottlieb, United States Food and Drug Administration, Don J. Wright. (Attachments: # 1 Certificate of Service)(Englehart, Mary) (Entered: 11/28/2017)

1 Certificate of Service

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Nov. 28, 2017

Nov. 28, 2017

PACER
23

Defendants' Scheduling Conference Statement. (Attachments: # 1 Certificate of Service)(Englehart, Mary) Modified on 11/29/2017 (emt, ). (Entered: 11/28/2017)

Nov. 28, 2017

Nov. 28, 2017

PACER
24

EO: Mary Englehart, Shohshana Hutchinson, Susan Talcott Camp and Julia Kaye may appear by telephone for the Rule 16 Scheduling Conference set for 12/4/17 @ 9:00 a.m. Counsel are directed to call in:Date:12/4/17Time:9:00 a.m. Dial-In:888-684-8852Intl. Dial-In: N/AAccess Code:8427906Security Code: 8888 (MAGISTRATE JUDGE KEVIN S.C. CHANG)(tbf, )CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry (Entered: 11/29/2017)

Nov. 29, 2017

Nov. 29, 2017

PACER
25

STIPULATION Extending Time to Respond to Complaint by Scott Gottlieb, United States Food and Drug Administration, Don J. Wright. (Englehart, Mary) (Entered: 11/29/2017)

Nov. 29, 2017

Nov. 29, 2017

PACER

ADVISORY ENTRY. If the filing party has not already done so, the 25 First Stipulation Extending Time to Respond to Complaint filed by United States Food and Drug Administration, Don J. Wright, Scott Gottlieb, may be submitted by e-mail to Magistrate Judge Kevin S. C. Chang for consideration at chang_orders@hid.uscourts.gov. The filing party may refer to LR100.8.1. Proposed Orders, LR100.8.2. E-mailing of Proposed Orders and Stipulations, LR100.8.3. E-mail addresses for order and stipulation submission to Chambers. (emt, )

Nov. 30, 2017

Nov. 30, 2017

PACER

Advisory Entry

Nov. 30, 2017

Nov. 30, 2017

PACER
26

EO: On 11/29/17, the parties submitted a First Stipulation Extending Time to Respond to Complaint 52 25, wherein the parties stipulate to an extension of Defendants' deadline to answer or otherwise respond to the Complaint until 2/5/18. The parties additionally stipulate to a briefing schedule should Defendants file a motion to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. The Court APPROVES the stipulation to the extent the parties agree to extend Defendants' answer/response deadline until 2/5/18. The Court declines to approve the portion of the stipulation regarding the briefing schedule. It is premature to set a briefing schedule for a motion that has yet to be filed, and in the event Defendants file a motion to dismiss, briefing will be contingent upon the hearing date and/or would be subject to approval by Judge Watson. (MAGISTRATE JUDGE KEVIN S.C. CHANG)(chang1)CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry Modified on 11/30/2017 to correct linkage to related filing (emt, ). (Entered: 11/30/2017)

Nov. 30, 2017

Nov. 30, 2017

PACER
27

EP: Rule 16 Scheduling Conference - Counsel informed the Court that they agree to extend the deadline for the defendants to file a motion to dismiss until 2/5/18. The Rule 16 Scheduling Conference is continued to after the motion to dismiss is decided. Discovery is stayed until the motion to dismiss is ruled upon. If counsel wishes to pursue any discovery after the motion to dismiss is heard but before the decision is issued, they must first meet and confer. If counsel is unable to come to an agreement, they may contact the Court to schedule a status conference. Rule 16 Scheduling Conference held on 12/4/2017. (Court Reporter No Record.) (MAGISTRATE JUDGE KEVIN S.C. CHANG)(tbf, )No COS issued for this docket entry (Entered: 12/04/2017)

Dec. 4, 2017

Dec. 4, 2017

PACER
28

MOTION to Stay Mary M. Englehart appearing for Defendants Scott Gottlieb, United States Food and Drug Administration, Don J. Wright (Englehart, Mary) (Entered: 01/22/2018)

Jan. 22, 2018

Jan. 22, 2018

PACER
29

EO: On 1/22/18, Defendants filed a Motion for Stay of Proceedings in Light of Lapse of Appropriations 28, seeking a stay of the litigation for the duration of the government shutdown and for a corresponding extension of all deadlines. Insofar as the shutdown has ended, this Motion is moot and is accordingly DENIED. (MAGISTRATE JUDGE KEVIN S.C. CHANG)(chang1)CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry (Entered: 01/23/2018)

Jan. 23, 2018

Jan. 23, 2018

PACER
30

MOTION to Dismiss Mary M. Englehart appearing for Defendants Scott Gottlieb, United States Food and Drug Administration, Don J. Wright (Attachments: # 1 Memorandum in Support of Motion to Dismiss, # 2 Certificate of Service)(Englehart, Mary) (Entered: 02/05/2018)

Feb. 5, 2018

Feb. 5, 2018

PACER
31

NOTICE of Hearing on 30 Defendants' Motion To Dismiss Complaint set for 4/26/2018 @ 10:30 AM before JUDGE DERRICK K. WATSON. (tyk)CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry. (Entered: 02/06/2018)

Feb. 6, 2018

Feb. 6, 2018

PACER
32

EO: At the request of Mateo Caballero and agreement by opposing counsel, the hearing on 30 Defendants' Motion To Dismiss Complaint set for 4/26/2018 is CONTINUED to 6/1/2018 @ 9:30 a.m. before Judge Derrick K. Watson. The briefing schedule for this motion is governed by the Local Rules, based on the new hearing date of 6/1/2018. (JUDGE DERRICK K. WATSON)(tyk)CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry (Entered: 02/13/2018)

Feb. 13, 2018

Feb. 13, 2018

PACER
33

NOTICE by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning of Substitution of Party California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Caballero, Mateo) (Entered: 04/12/2018)

April 12, 2018

April 12, 2018

PACER
34

MEMORANDUM in Opposition re 30 MOTION to Dismiss filed by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E)(Caballero, Mateo) Modified on 4/13/2018 Note: The Memorandum is signed by Julia Kaye, Esq., the Certificate of Compliance and Certificate are Service are electronically signed by Mateo Caballero, Esq. This document is e-filed by Mateo Caballero, Esq. (emt, ). (Entered: 04/12/2018)

April 12, 2018

April 12, 2018

PACER
35

MOTION to Seal Unredacted Declaration and Permit Declarant to Proceed Under Pseudonym re 34 Memorandum in Opposition to Motion, Mateo Caballero appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Memorandum)(Caballero, Mateo) Modified on 4/13/2018 Note: The Motion is signed by Julia Kaye, Esq. The Certificate of Service is signed by Mateo Caballero, Esq. The document is e-filed by Mateo Caballero, Esq. (emt, ). (Entered: 04/12/2018)

1 Memorandum

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April 12, 2018

April 12, 2018

PACER
36

EO: On April 12, 2018, Plaintiffs filed a Motion to Seal Unredacted Declaration and Permit Declarant to Proceed Under Pseudonym ("Motion"). Dkt. No. 35. Pursuant to Local Rule 83.12(b), any party who contends that any information related to the Motion is not entitled to confidential treatment may challenge the designations by no later than seven (7) days after the filing of the Motion. If no objection is received, the Court intends to grant the Motion. IT IS SO ORDERED. (JUDGE DERRICK K. WATSON)(tyk) (Entered: 04/12/2018)

April 12, 2018

April 12, 2018

PACER

ADVISORY ENTRY. Re: The entry docket number 34 Memorandum of Law in Opposition to Defendants' 12(b)(1) Motion to Dismiss and 35 MOTION to Seal Unredacted Declaration and Permit Declarant to Proceed Under Pseudonym filed by Pharmacists Planning Services Inc., Graham T. Chelius, California Academy of Family Physicians, Society of Family Planning ~ The filing party may refer to LR100.5.1., which states "The name of the CM/ECF user under whose login and password the document is being electronically filed must be preceded by "/s/" and typed in the space where the signature otherwise would appear (e.g. /s/ John or Jane Lawyer)." Both documents are signed by Julia Kaye, Esq., but e-filed by Mateo Caballero, Esq., whose electronic signature appears on the Certificates of Service and Certificate of Compliance. No further action necessary. (emt, )

April 13, 2018

April 13, 2018

PACER

Advisory Entry

April 13, 2018

April 13, 2018

PACER
37

NOTICE of Erratum to Plaintiffs' Memorandum of Law in Opposition to Defendants' 12(b)(1) Motion to Dismiss re 34 by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Attachments: # 1 Exhibit E.)(Caballero, Mateo) <fnt size=1> Modified on 4/19/2018 (emt, ). (Entered: 04/18/2018)

1 Exhibit E.

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April 18, 2018

April 18, 2018

RECAP
38

EO: After review and consideration of Plaintiffs' Motion to Seal Unredacted Declaration and Permit Declarant to Proceed Under Pseudonym ("Motion"; Dkt. No. 35) and for good cause appearing, the Court hereby finds that compelling reasons exist to file the designated documents under seal and to permit declarant to proceed under the pseudonym "Jane Roe, M.D." for all further public purposes in this lawsuit. Accordingly, the Court GRANTS the Motion without objection.IT IS SO ORDERED. (JUDGE DERRICK K. WATSON)(tyk) (Entered: 04/20/2018)

April 20, 2018

April 20, 2018

PACER
39

SEALED EXHIBIT:EXHIBIT B re 34 Memorandum in Opposition to 30 MOTION to Dismiss filed by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. SEALED pursuant to 38 Order (emt, ) (emt, ). (Entered: 04/20/2018)

April 20, 2018

April 20, 2018

PACER
40

NOTICE of Withdrawal of 30 Defendants' Motion to Dismiss Complaint by Mary M. Englehart on behalf of Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration. (Englehart, Mary) Modified on 5/21/2018 (emt, ). (Entered: 05/18/2018)

May 18, 2018

May 18, 2018

PACER
41

EO: In light of the 40 Notice of Withdrawal of Defendants' Motion To Dismiss Complaint filed 5/18/2018, 30 Defendants' Motion To Dismiss Complaint set for hearing on 6/1/2018 is VACATED. (JUDGE DERRICK K. WATSON)(tyk) (Entered: 05/19/2018)

May 19, 2018

May 19, 2018

PACER
42

Consent MOTION for Extension of Time to File Answer re 1 Complaint, Mary M. Englehart appearing for Defendants Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration (Attachments: # 1 Memorandum in Support of Motion for Extension, # 2 Exhibit Proposed Order, # 3 Certificate of Service)(Englehart, Mary) (Entered: 06/01/2018)

1 Memorandum in Support of Motion for Extension

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2 Exhibit Proposed Order

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3 Certificate of Service

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June 1, 2018

June 1, 2018

RECAP
43

EO: On 6/1/18, Defendants filed an Unopposed Motion for Extension of Time to Respond to Complaint 42 . Defendants request that their deadline to respond to the Complaint be extended from 6/1/18 to 6/29/18. There being no opposition by Plaintiffs, and good cause appearing therefor, the Court GRANTS the Motion. For future reference, the parties may submit stipulations for the Court's consideration when they agree to extensions of deadlines, unless the deadlines pertain to hearings or briefing schedules for motions. (MAGISTRATE JUDGE KEVIN S.C. CHANG)(chang1) (Entered: 06/02/2018)

June 2, 2018

June 2, 2018

PACER
44

ANSWER to 1 Complaint, by Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration.(Englehart, Mary) (Entered: 06/29/2018)

June 29, 2018

June 29, 2018

PACER
45

ORDER REASSIGNING CASE. Case reassigned to JUDGE JILL A. OTAKE for all further proceedings. JUDGE DERRICK K. WATSON no longer assigned to case. Please reflect new case number CV 17-00493-JAO-KSC on all further pleadings . Signed by CHIEF JUDGE J. MICHAEL SEABRIGHT on 09/05/2018. (apg, dist) (Entered: 09/06/2018)

Sept. 5, 2018

Sept. 5, 2018

PACER
46

NOTICE of Case Reassignment; Case reassigned to MAGISTRATE JUDGE ROM TRADER for all further proceedings. MAGISTRATE JUDGE KEVIN S.C. CHANG no longer assigned to case. Please reflect new case number CV 17-00493-JAO-RT on all future pleadings . (afc) (Entered: 01/04/2019)

Jan. 4, 2019

Jan. 4, 2019

PACER
47

EO: The Court schedules a Rule 16 Scheduling Conference 09:00AM on 2/27/2019 before MAGISTRATE JUDGE ROM TRADER. Rule 16 Scheduling Conference statements to be filed by 2/20/19. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 02/14/2019)

Feb. 14, 2019

Feb. 14, 2019

PACER
48

EO: Pursuant to Julia Kay's request, and by agreement of counsel, the Rule 16 Scheduling Conference set for 2/27/19 @ 9:00 AM is continued to 4/10/2019 @ 9:00 AM before MAGISTRATE JUDGE ROM TRADER. Rule 16 Scheduling Conference statements to be filed by 4/3/19. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 02/21/2019)

Feb. 21, 2019

Feb. 21, 2019

PACER
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EO: Megan Englehart and Julia Kay may appear by telephone at the Rule 16 Scheduling Conference set for 4/10/19 @ 9:00 a.m. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 02/21/2019)

Feb. 21, 2019

Feb. 21, 2019

PACER
50

Scheduling Conference Statement . (Caballero, Mateo) (Entered: 04/03/2019)

April 3, 2019

April 3, 2019

RECAP
51

Scheduling Conference Statement . (Englehart, Mary) (Entered: 04/04/2019)

April 4, 2019

April 4, 2019

RECAP
52

EP: Rule 16 Scheduling Conference - Discussion had concerning discovery. Counsel have reached agreement as to all discovery matters except a deadline for Defendants' production of emails and privilege logs to Plaintiffs. The Court sets 8/12/19 as the deadline for Defendants to produce these materials to Plaintiffs. Both sides agree to production on a rolling basis. Defendants to focus on review and production of records and privilege logs relating to the most relevant custodians (approximately 10) as a priority. The Court will monitor progress via monthly status conferences scheduled for the following dates: 6/7/19, 7/11/19, 8/14/19 and 9/11/19. All status conferences will be at 0900. Counsel to provide a written update, preferably a joint submission, 1 week prior to each status conference. Should any disputes arise concerning discovery, Counsel may seek further court assistance by requesting a status conference.Non-Jury Trial set for 4/13/20 @ 0900 before Judge Otake. Given the age of this case, counsel are advised this trial setting and associated deadlines will not be adjusted absent a compelling reason and only with the Court's approval. Rule 16 Scheduling Conference Order to be issued.Dates given: Non-Jury Trial is set for 4/13/2020 09:00 AM in Aha Kanawai before JUDGE JILL A. OTAKE. Final Pretrial Conference is set for 3/3/2020 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Settlement Conference is set for 1/14/2020 10:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference is set for 6/7/2019 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference 2 is set for 7/11/2019 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference 3 is set for 8/14/2019 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference 4 is set for 9/11/19 09:00AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Dispositive Motions filed by 11/13/2019. Discovery due by 2/14/2020. (Court Reporter No Record.) (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 04/10/2019)

April 10, 2019

April 10, 2019

PACER
53

EP: Rule 16 Scheduling Conference - (AMENDED) Discussion had concerning discovery. Counsel have reached agreement as to all discovery matters except a deadline for Defendants' production of emails and privilege logs to Plaintiffs. The Court sets 8 /12/19 as the deadline for Defendants to produce these materials to Plaintiffs. Both sides agree to production on a rolling basis. Defendants to focus on review and production of records and privilege logs relating to the most relevant custodians ( approximately 10) as a priority. The Court will monitor progress via monthly status conferences scheduled for the following dates: 6/7/19, 7/11/19, 8/14/19 and 9/11/19. All status conferences will be at 0900. Counsel to provide a written update, preferably a joint submission, 1 week prior to each status conference. Should any disputes arise concerning discovery, Counsel may seek further court assistance by requesting a status conference.Non-Jury Trial set for 4/13/20 @ 0900 before Judge Otake. Given the age of this case, counsel are advised this trial setting and associated deadlines will not be adjusted absent a compelling reason and only with the Court's approval. Rule 16 Scheduling Conference Order to be issued.Dates given:Non-Jury Trial is set for 4/13/2020 09:00 AM in Aha Kanawai before JUDGE JILL A. OTAKE. Final Pretrial Conference is set for 3/3/2020 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Settlement Conference is set for 1/14/2020 10:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference is set for 6/7/2019 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference 2 is set for 7/11/2019 09:00 AM in Courtroom 7 before M AGISTRATE JUDGE ROM TRADER. Status Conference 3 is set for 8/14/2019 09:00 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Status Conference 4 is set for 9/11/19 09:00AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. Dispositive Motions filed by 11/13/2019. Discovery due by 2/14/2020. re 52 Rule 16 Scheduling Conference,,,,,,,,. (Court Reporter No Record.) (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 04/10/2019)

April 10, 2019

April 10, 2019

RECAP
54

RULE 16 SCHEDULING ORDER - Signed by MAGISTRATE JUDGE ROM TRADER on 4/10/2019. (emt, ) (Entered: 04/11/2019)

April 11, 2019

April 11, 2019

RECAP
55

EO: The Court schedules a Status Conference re: Expert Reports is set for 4/25/2019 09:30 AM in Courtroom 7 before MAGISTRATE JUDGE ROM TRADER. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 04/24/2019)

April 24, 2019

April 24, 2019

PACER
56

EO: Roger Gural is allowed to appear by telephone tomorrow at the Status Conference set for 4/25/19 @ 9:30 a.m. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 04/24/2019)

April 24, 2019

April 24, 2019

PACER
57

EO: Julia Kaye, Mateo Caballero and Susan Talcott Camp are allowed to appear by telephone at the Status Conference set for 4/25/19 @ 9:30 a.m. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 04/24/2019)

April 24, 2019

April 24, 2019

PACER
58

EP: Status Conference re: Expert Reports -Discussion held re: elimination of expert deadlines from the Rule 16 Scheduling Conference Order.By agreement of the parties, the deadlines for expert reports are eliminated from the scheduling order, and any expert declarations attached to a dispositive motion or an opposition or reply brief on a dispositive motion, will take the place of expert reports. Ms. Kaye to prepare the stipulation, and to submit it to Magistrate Judge Traders orders box.Ms. Kay notified the Court that the parties intend to reach out to Judge Otake to set the cross motions for summary judgment for hearing, and if it impacts the scheduling order, they will contact the Court.Status Conference held on 4/25/2019. (Court Reporter No Record.) (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 04/25/2019)

April 25, 2019

April 25, 2019

RECAP
59

STIPULATED ORDER AMENDING RULE 16 SCHEDULING ORDER re 54 - Signed by MAGISTRATE JUDGE ROM TRADER on 5/6/2019. (emt, ) (Entered: 05/06/2019)

May 6, 2019

May 6, 2019

PACER
60

NOTICE of Appearance by Jongwook Philip Kim on behalf of California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning on behalf of California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Kim, Jongwook) (Entered: 05/23/2019)

May 23, 2019

May 23, 2019

PACER
61

STATUS REPORT by Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration. (Englehart, Mary) (Entered: 05/31/2019)

May 31, 2019

May 31, 2019

PACER
62

MOTION for Pro Hac Vice for Anjali Dalal Filing fee $ 300, receipt number 0975-2212884.Mateo Caballero appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Declaration of Counsel)(Caballero, Mateo) (Entered: 06/05/2019)

June 5, 2019

June 5, 2019

PACER

ADVISORY ENTRY. Please be advised that the case numbers referenced on docket entry numbers 61 Status Report filed by United States Food and Drug Administration, Alex M. Azar, Scott Gottlieb and 62 MOTION for Pro Hac Vice for Anjali Dalal filed by Pharmacists Planning Services Inc., Graham T. Chelius, California Academy of Family Physicians, Society of Family Planning reflect the incorrect judge assignments. Please refer to the Notice of Reassignment, ECF No. 46, filed January 4, 2019 and reflect case number CV 17-00493 JAO-RT on all further filings. No further action necessary. (emt, )

June 6, 2019

June 6, 2019

PACER

Advisory Entry

June 6, 2019

June 6, 2019

PACER
63

EP: Status Conference by Telephone - Court has reviewed the Joint Status Report that was filed.Mr. Caballero informed the Court that the federal defendants are working hard to produce the documents.Discussion held.Deadlines maybe adjusted once counsel gets a better feel of what will be disclosed.The next Status Conference is set for 7/11/19 @ 9:00 a.m.Another status report to be filed prior to the hearing.Status Conference held on 6/7/2019. (Court Reporter No Record.) (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 06/07/2019)

June 7, 2019

June 7, 2019

PACER
64

ORDER GRANTING MOTION TO APPEAR PRO HAC VICE AS TO ANJALI DALAL re 62 - Signed by MAGISTRATE JUDGE ROM TRADER on 6/7/2019. (emt, ) (Entered: 06/10/2019)

June 10, 2019

June 10, 2019

PACER
65

Joint STATUS REPORT by Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration. (Englehart, Mary) Modified on 7/8/2019 (emt, ). (Entered: 07/03/2019)

July 3, 2019

July 3, 2019

PACER
66

EP: Status Conference held.Court has reviewed the Joint Status Report dated July 3, 2019 (Dkt. No. 65).Discussion held. Parties have been making progress on the production of documents, etc.Ms. Camp informed the Court that they are in receipt of the Declaration.A Further Status Conference has been set for 7/25/2019 at 9:15 a.m. before Judge Rom Trader to see where the parties are after sorting through the documents and address any issues re the protective order. (FTR-Ctrm. 5 - No Record) (MAGISTRATE JUDGE ROM TRADER)(tyk)(MAGISTRATE JUDGE ROM TRADER)(tyk, ) (Entered: 07/11/2019)

July 11, 2019

July 11, 2019

PACER
67

MOTION for Pro Hac Vice for Rachel Reeves Filing fee $ 300, receipt number 0975-2231354.Mateo Caballero appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Declaration of Rachel Reeves)(Caballero, Mateo) (Entered: 07/12/2019)

1

View on RECAP

July 12, 2019

July 12, 2019

PACER
68

EP: Status Conference - Ms. Talcott Camp informed the Court that they have not reached an agreement on either the wording for the stipulated protective order, or the wording for the declaration that allows the production of the redacted administrative record, however they are working on it.Counsel to continue to work on it until they reach a consensus, and this matter can be discussed at the Status Conference that was previously scheduled for 8/14/19 @ 9:00 a.m.If these issues are unresolved, Counsel to submit a joint or agreed upon statement of the issues limited to 2 - 3 pages to be included in the next joint status report.Court stated its general practice if this case proceeds to the LR 37.1 route.Status Conference held on 7/25/2019. (Court Reporter No Record.) (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 07/25/2019)

July 25, 2019

July 25, 2019

PACER
69

ORDER Granting Motion To Appear Pro Hac Vice Attorney Rachel Reeves as to all Plaintiffs re 67 . Signed by MAGISTRATE JUDGE ROM TRADER on 7/26/2019. (cib) (Entered: 07/26/2019)

July 26, 2019

July 26, 2019

PACER
70

EO: Pursuant to the Federal Defendants' request, and by agreement of the parties, the deadline to file the joint status report is extended until 8/9/19. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 08/07/2019)

Aug. 7, 2019

Aug. 7, 2019

PACER
71

STATUS REPORT by Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration. (Englehart, Mary) (Entered: 08/09/2019)

Aug. 9, 2019

Aug. 9, 2019

RECAP
72

EP: Telephonic Status Conference held on 8/14/2019. Discussion held. A Further Telephonic Status Conference is set for 9/11/2019 at 9:00AM. Status Conference Statements are due no later 9/06/2019. (Court Reporter C5 - not reported. 9:41 a.m. - 9:54 a.m.) (MAGISTRATE JUDGE ROM TRADER)(mrf) (Entered: 08/14/2019)

Aug. 14, 2019

Aug. 14, 2019

PACER
73

STATUS REPORT by Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration. (Englehart, Mary) (Entered: 09/06/2019)

Sept. 6, 2019

Sept. 6, 2019

RECAP
74

EP: Status Conference by Telephone - Counsel updated the Court re: status of discovery.A Further Status Conference by Telephone is set for 10/16/19 @ 9:00 a.m.Counsel to submit another joint status report before the status conference. Status Conference is set for 10/16/2019 09:00 AM in Courtroom 5 before MAGISTRATE JUDGE ROM TRADER. (Court Reporter No Record.) (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 09/11/2019)

Sept. 11, 2019

Sept. 11, 2019

PACER
75

NOTICE of Appearance (of Roger J. Gural) by Mary M. Englehart on behalf of Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration, Don J. Wright on behalf of Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration, Don J. Wright. (Englehart, Mary) Docket text modified on 9/13/2019 (emt, ). (Entered: 09/12/2019)

Sept. 12, 2019

Sept. 12, 2019

RECAP

Advisory Entry

Sept. 12, 2019

Sept. 12, 2019

PACER

ADVISORY ENTRY. The entry docket number 75 Notice of Appearance of Rogert J. Gural, filed by United States Food and Drug Administration, Alex M. Azar, Don J. Wright, Scott Gottlieb was filed incorrectly in this case. The filing party may refer LR83.1(c)(1) Attorneys for the United States. (emt, )

Sept. 12, 2019

Sept. 12, 2019

PACER
76

STIPULATION Proposed Stipulated Protective Order by Alex M. Azar, Scott Gottlieb, United States Food and Drug Administration, Don J. Wright. (Englehart, Mary) (Entered: 10/10/2019)

Oct. 10, 2019

Oct. 10, 2019

PACER

ADVISORY ENTRY. If the filing party has not already done so, the docket number 76 Stipulated Protective Order; Exhibit A filed by United States Food and Drug Administration, Alex M. Azar, Don J. Wright, Scott Gottlieb, shall be submitted for consideration to Magistrate Judge Rom A. Trader at trader_orders@hid.uscourts.gov. The filing party may refer to Page 7 of the CM/ECF Guide, regarding Submission of Proposed Orders. Additionally, the filing party may refer to LR10.5. Form of Stipulations. (emt, )

Oct. 11, 2019

Oct. 11, 2019

PACER

Advisory Entry

Oct. 11, 2019

Oct. 11, 2019

PACER
77

STATUS REPORT by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Caballero, Mateo) (Entered: 10/11/2019)

Oct. 11, 2019

Oct. 11, 2019

PACER
78

EO: Pursuant to counsels' request, the Status Conference set for 10/16/19 @ 9:00 a.m. is vacated. (MAGISTRATE JUDGE ROM TRADER)(tbf, ) (Entered: 10/15/2019)

Oct. 15, 2019

Oct. 15, 2019

PACER
79

Joint MOTION for Leave to File Excess Pages re Cross-Motions for Summary Judgment Jongwook Philip Kim appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Kim, Jongwook) (Entered: 10/21/2019)

Oct. 21, 2019

Oct. 21, 2019

PACER
80

EO: In their 79 Joint Motion for (1) Leave to Exceed the Page/Word Limits for Briefing on Cross-Motions for Summary Judgment; and (2) Summary Judgment Hearing on Proposed Dates and Continuance of Trial Date, the parties request that the Court schedule the hearing on their anticipated cross-motions for summary judgment on specific dates in March or April of 2020 to accommodate their planned briefing schedule. However, the Joint Motion does not provide the briefing schedule nor the basis for an extended briefing schedule that would warrant setting the hearing four to five months after the motions are filed. The parties are directed to jointly file a supplemental memorandum, not to exceed three (3) pages, by 10/28/19, addressing specifically why such accommodation is necessary. (JUDGE JILL A. OTAKE)(otake1) (Entered: 10/21/2019)

Oct. 21, 2019

Oct. 21, 2019

PACER
81

MEMORANDUM in Support re 79 Joint MOTION for Leave to File Excess Pages re Cross-Motions for Summary Judgment filed by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Attachments: # 1 Exhibit A)(Kim, Jongwook) (Entered: 10/25/2019)

Oct. 25, 2019

Oct. 25, 2019

PACER
82

EO: On 10/21/19, the parties filed a 79 Joint Motion for (1) Leave to Exceed the Page/Word Limits for Briefing on Cross-Motions for Summary Judgment; and (2) Summary Judgment Hearing on Proposed Dates and Continuance of Trial Date. At the Court's direction, the parties filed a 81 Supplemental Memorandum setting forth the bases for their request for extended briefing and hearing. Plaintiffs are correct that the dispositive motions deadline includes motions for summary judgment. Nonetheless, the Court GRANTS the Joint Motion but not to the extent sought. The Court sets the following deadlines and hearing date: Dispositive Motions Deadline: December 2, 2019Deadline for Responses: January 10, 2020Deadline for Replies: February 7, 2020Hearing Date: March 6, 2020 at 9:00 a.m.The Court also notes that it is the master of its own calendar and docket. Pagtalunan v. Galaza, 291 F.3d 639, 642 (9th Cir. 2002). The request for a hearing on specific dates in March or April is attributable at least in part to counsel's convenience which is not particularly persuasive here, where the case has been pending for over two years. (JUDGE JILL A. OTAKE)(shm) (Entered: 10/28/2019)

Oct. 28, 2019

Oct. 28, 2019

PACER
83

Letter addressed to Judge Jill A. Otake from Mateo Caballero, Esq. and Mary M. Englehart, Esq., Re: Joint Request for Guidance, dated November 22, 2019. (emt, ) (Entered: 11/22/2019)

Nov. 22, 2019

Nov. 22, 2019

PACER
84

EO: In response to the parties' joint request by 83 a letter dated November 22, 2019, the Court responds that it prefers the first option.(JUDGE JILL A. OTAKE)(shm) (Entered: 11/22/2019)

Nov. 22, 2019

Nov. 22, 2019

PACER
85

STIPULATION as to Facts by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Certificate of Service)(Kim, Jongwook) (Entered: 11/27/2019)

Nov. 27, 2019

Nov. 27, 2019

PACER
86

MOTION for Summary Judgment Jongwook Philip Kim appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Memorandum, # 2 Certificate of Service)(Kim, Jongwook) (Entered: 12/02/2019)

1 Memorandum

View on PACER

2 Certificate of Service

View on PACER

Dec. 2, 2019

Dec. 2, 2019

PACER
87

CONCISE STATEMENT in Support re 86 MOTION for Summary Judgment filed by California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Certificate of Service)(Kim, Jongwook) (Additional attachment(s) added on 12/11/2019: # 14 Exhibit C - Declaration of Jane Roe, M.D. (SEALED) ) (emt, ). Modified on 12/11/2019 Exhibit C is SEALED pursuant to ECF No. 94 ORDER GRANTING LEAVE TO SEAL DECLARATION OF JANE ROE, M.D (emt, ). (Entered: 12/02/2019)

Dec. 2, 2019

Dec. 2, 2019

PACER
88

Unopposed MOTION to Seal Document [to File Unredacted Declaration Under Seal] Exhibit C (Roe Declaration) to Plaintiffs' Concise Statement in Support of Plaintiffs' Motion for Summary Judgment Jongwook Philip Kim appearing for Plaintiffs California Academy of Family Physicians, Graham T. Chelius, Pharmacists Planning Services Inc., Society of Family Planning (Attachments: # 1 Memorandum, # 2 Certificate of Service)(Kim, Jongwook) Modified on 12/3/2019 (emt, ). (Entered: 12/02/2019)

Dec. 2, 2019

Dec. 2, 2019

PACER
89

Defendants' Cross-MOTION for Summary Judgment Mary M. Englehart appearing for Defendants Alex M. Azar, United States Food and Drug Administration (Attachments: # 1 Memorandum, # 2 Certificate of Service)(Englehart, Mary) Modified on 12/3/2019 The motion, memorandum and certificate of service are signed "/s/ Roger J. Gural" (emt, ). (Entered: 12/02/2019)

Dec. 2, 2019

Dec. 2, 2019

PACER
90

CONCISE STATEMENT of Facts re 89 MOTION for Summary Judgment filed by Alex M. Azar, United States Food and Drug Administration. (Attachments: # 1 Exhibit 0001-0002, # 2 Exhibit 0003-0005, # 3 Exhibit 0006-0017, # 4 Exhibit 0018-0027, # 5 Exhibit 0028-0034, # 6 Exhibit 0035-0077, # 7 Exhibit 0078-0089, # 8 Exhibit 0090-0111, # 9 Exhibit 0112-0142, # 10 Exhibit 0143-0158, # 11 Exhibit 0159-0222, # 12 Exhibit 0223-0230, # 13 Exhibit 0231-0257, # 14 Exhibit 0269-0291, # 15 Exhibit 0292-0306, # 16 Exhibit 0307-0330, # 17 Exhibit 0331-0341, # 18 Exhibit 0361-0370, # 19 Exhibit 0371-0381, # 20 Exhibit 0412-0439, # 21 Exhibit 0440-0526, # 22 Exhibit 0527-0634, # 23 Exhibit 0635-0644, # 24 Exhibit 0645-0649, # 25 Exhibit 0650-0653, # 26 Exhibit 0654-0672, # 27 Exhibit 0710-0792, # 28 Exhibit 0793-0846, # 29 Exhibit 0847-0848, # 30 Exhibit 0849-0851, # 31 Exhibit 0852-0855, # 32 Exhibit 0856-0888, # 33 Exhibit Shared REMS, # 34 Exhibit ANDA Approval, # 35 Exhibit REMS Guidance, # 36 Exhibit AR Index, # 37 Exhibit Prescriber Agreements, # 38 Exhibit Patient Agreement)(Englehart, Mary) Modified on 12/3/2019 Document is signed "/s/ Roger J. Gural" (emt, ). (Entered: 12/02/2019)

Dec. 2, 2019

Dec. 2, 2019

PACER

Case Details

State / Territory: Hawaii

Case Type(s):

Reproductive Issues

Key Dates

Filing Date: Oct. 3, 2017

Case Ongoing: Yes

Plaintiffs

Plaintiff Description:

the Chief Medical Officer for the Hawaii Health Systems Corporation's Kaua'i Region in his individual capacity as a physician, the Society of Family Planning, the California Academy of Family Physicians, and Pharmacists Planning Services, Inc.

Plaintiff Type(s):

Private Plaintiff

Non-profit NON-religious organization

Attorney Organizations:

ACLU National (all projects)

ACLU Affiliates (any)

Public Interest Lawyer: Yes

Filed Pro Se: No

Class Action Sought: No

Class Action Outcome: Not sought

Defendants

Secretary (- United States (national) -), Federal

Food and Drug Administration (- United States (national) -), Federal

Commissioner for Food and Drugs (- United States (national) -), Federal

Defendant Type(s):

Jurisdiction-wide

Case Details

Causes of Action:

42 U.S.C. § 1983

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

Declaratory Judgment Act, 28 U.S.C. § 2201

Constitutional Clause(s):

Due Process

Due Process: Substantive Due Process

Available Documents:

Trial Court Docket

Complaint (any)

Outcome

Prevailing Party: None Yet / None

Nature of Relief:

None yet

Source of Relief:

None yet

Issues

Reproductive rights:

Medication abortion

Method-based abortion procedures

Undue Burden

Reproductive health care (including birth control, abortion, and others)

Abortion