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 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, and ordered the parties to submit joint status reports every ninety days

As a result of the FDA review, the FDA issued an updated mifepristone REMS in January 2023. The court lifted its stay of the case, once the result of the FDA review was released.

On March 30, 2023, the plaintiffs filed motion for leave to file an amended complaint, which the court granted. Plaintiffs then filed their amended complaint on April 10. The amended complaint provided new facts outlining the FDA’s review: In January 2023, the FDA re-authorized mifepristone. As part of that process, the FDA permanently eliminated in-person dispensing, retained two existing REM strategies, and added a new REM strategy (which would require certification for pharmacies to dispense mifepristone). In the amended complaint, the plaintiffs argued that the FDA did not consider the necessary statutory factors in deciding whether to impose REMS or “Elements to Assure Safe Use” (“ETASU”) (which are more burdensome REMS), and as a result, critically never grappled with factos necessary to the mifepristone REMS analysis. For instance, plaintiffs observed that the pharmacy certification REMS requirement was put into place, even though pharmacies had dispensed the medication throughout the COVID-19 pandemic without issue, and did not have certification requirements in place at the time. Plaintiffs concluded that despite the FDA review, the 2023 REMS continued to meaningfully impede patient access to mifepristone, and urged that FDA restrictions be eliminated.

On May 4, 2023, defendants filed a motion to stay proceedings: Defendants observed that there was ongoing parallel litigation in Alliance for Hippocratic Medicine v. FDA, No. 2:22-cv-00223-Z, ECF No. 137 (N.D. Tex. Apr. 7, 2023), which involved a challenge to the FDA’s approval of mifepristone and its allegedly lax enforcement regime. In Alliance, the plaintiffs sought a preliminary injunction to suspend the FDA’s approval of mifepristone or otherwise suspend its REMS abatement. In April 2023, the federal district court overseeing the matter granted the injunction, imposing a nationwide suspension of the FDA’s approval of mifepristone. On appeal, the Fifth Circuit, decided to stay the portions of the preliminary injunction which stayed the approval of mifepristone, but left in place the “stay” on the FDA’s REMS modifications. The Supreme Court stayed the district court’s order pending final disposition of both the appeal in the Fifth Circuit and any timely petitions for a writ of certiorari. The Fifth Circuit had not yet issued a decision as of May 2023. Defendants also argued that a stay was appropriate, in the alternative, under Washington v. FDA, No. 1:23-cv-3026-TOR, 2023 WL 2825861 (E.D. Wash. Apr. 7, 2023), where several states had sued to challenge the FDA’s 2023 REMS. In Washington, the district court in the matter had just granted a preliminary injunction in April 2023, enjoining any change in the plaintiff states under the operative Mifepristone REMS program affecting the status or rights of the parties until a full determination was made on the merits of the case.

Noting that disposition of the appeal in Alliance may resolve or otherwise provide guidance on the issues in this case, defendants requested a stay of proceedings until Alliance is resolved. The court scheduled a hearing on the defendant’s motion to stay, which was held on June 15, 2023. A transcript of that hearing and its contents is not available to the Clearinghouse.

On August 8, 2023, the court issued its decision to deny defendants’ motion to stay the proceedings. The court found that the requested stays pending Alliance and Washington were not warranted here.

With respect to Alliance, the court noted that the Fifth Circuit had yet to issue its decision on the preliminary injunction appeal and, assuming the Fifth Circuit issued a decision within a few months, the Supreme Court would be unlikely to issue a final decision until March to July 2025. The court held that staying the action here until Alliance is resolved would cause unreasonable delay. With respect to Washington, the court held that the competing interests of the parties disfavored a stay: as with Alliance, any delay would further compound delay-induced prejudice to the plaintiffs, without countervailing litigation hardships to the defendants. The court therefore denied the motion to stay, and made the following order: Defendants must supplement the administrative record by October, and the parties must meet and confer to determine whether the record was considered complete. The court ordered the parties to file a joint status report, which the parties completed November 2023. In the joint status report, the parties noted they were at an impasse on the necessity of two documents for the administrative record. The parties continued discussions on the two documents through 2024.

On June 21, 2024, the parties filed a stipulation of voluntary dismissal and leave to amend. Plaintiffs sought to (1) replace one named plaintiff, who was intending to leave Hawaii for employment elsewhere, with a new named plaintiff with substantially similar facts, and (2) remove some allegations relating to the Patient Agreement Form, after review of the administrative record. The parties jointly stipulated to remove the aforementioned named plaintiff without prejudice, and plaintiffs submitted their proposed second amended complaint the same day. On August 2, 2024, plaintiffs submitted a corrected second amended complaint, largely to correct references to exhibits, and update hyperlinks. The corrected complaint however was otherwise largely unchanged.

On October 2, 2024, plaintiffs filed a motion for summary judgment. Plaintiffs argued that the 2023 REMS significantly impeded patients’ access to mifepristone in a variety of ways: creating an administrative morass for clinicians; creating logistical and technological challenges for patients and providers; deterring qualified clinicians from prescribing mifepristone; creating certification burdens; impeding research and training on mifepristone via the REMS classification; and mandating unnecessary counseling. Plaintiffs therefore urged the court to grant summary judgment in their favor. On December 3, 2024, defendants submitted their combined cross-motion for summary judgment, and opposition to plaintiffs’ summary judgment motion. Defendants noted that the 2023 REMS modifications made access to mifepristone less burdensome than ever before, and urged the court to reject the plaintiffs’ arguments. Defendants argued the following: (1) Plaintiffs lacked Article III standing, as plaintiffs failed to allege an injury particular to them. (2) Plantiffs’ APA claims, grounded on the theory that defendants failed to consider relevant statutory factors, fail because defendants either did consider those factors or the factors were not relevant to defendants’ decisions. (3) Plaintiffs’ constitutional claims fail, as defendants argued the REMS modifications pass rational basis scrutiny.

The court has not yet ruled on the parties’ motions for summary judgment. The case is still active, and pending future updates as of April 7, 2025.

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Summary Authors

Richa Bijlani (5/5/2022)

Keren Yi (4/7/2025)

People

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

Judge(s)

Attorney for Plaintiff

Brack, Taylor Shantrell (Hawaii)

Caballero, Mateo (Hawaii)

Camp, Susan Talcott (Hawaii)

Attorney for Defendant

Amgott, Jonathan E. (Hawaii)

Belfer, Isaac C. (Hawaii)

Judge(s)

Otake, Jill Aiko (Hawaii)

Attorney for Plaintiff

Brack, Taylor Shantrell (Hawaii)

Caballero, Mateo (Hawaii)

Camp, Susan Talcott (Hawaii)

Chaiten, Lorie (Hawaii)

Dalal, Anjali (Hawaii)

Dalven, Jennifer (Hawaii)

Freedman, John A. (Hawaii)

Harlow, Ruth (Hawaii)

Hills, Emily M. (Hawaii)

Kaye, Julia (Hawaii)

Kim, Jongwook Philip (Hawaii)

Reeves, Rachel (Hawaii)

White, Whitney (Hawaii)

Zacarias, Johanna (Hawaii)

Attorney for Defendant

Amgott, Jonathan E. (Hawaii)

Belfer, Isaac C. (Hawaii)

Englehart, Mary M. (Hawaii)

Gural, Roger J. (Hawaii)

Katzen, Noah T. (Hawaii)

Attorney Contact Information via CourtListener

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Documents in the Clearinghouse

	Document
1 1:17-cv-00493	Complaint	Oct. 3, 2017	Oct. 3, 2017 Complaint
169 1:17-cv-00493	Amended and Supplemental Complaint Chelius v. Becerra	April 10, 2023	April 10, 2023 Complaint
191 1:17-cv-00493	Order Denying Defendants' Motion to Stay Proceedings Chelius v. Becerra	Aug. 8, 2023	Aug. 8, 2023 Order/Opinion 2023 WL 5041616
209 1:17-cv-00493	Second Amended and Supplemental Complaint Purcell v. Becerra	June 21, 2024	June 21, 2024 Complaint
208 1:17-cv-00493	Stipulation of Voluntary Dismissal and Leave to Amend Chelius v. Becerra	June 21, 2024	June 21, 2024 Pleading / Motion / Brief
212 1:17-cv-00493	Corrected Second Amended and Supplemental Complaint Purcell v. Becerra	Aug. 2, 2024	Aug. 2, 2024 Complaint
221 1:17-cv-00493	Plaintiffs' Motion for Summary Judgment, Memorandum of Law, and Certificate of Service Purcell v. Becerra	Oct. 2, 2024	Oct. 2, 2024 Pleading / Motion / Brief
226 1:17-cv-00493	Defendants' Combined Memorandum in Support of Cross-Motion for Summary Judgment and in Opposition to Plaintiffs' Motion for Summary Judgment Purcell v. Becerra	Dec. 3, 2024	Dec. 3, 2024 Pleading / Motion / Brief
228 1:17-cv-00493	Defendants' Cross-Motion for Summary Judgment; Memorandum of Law Purcell v. Becerra	Dec. 3, 2024	Dec. 3, 2024 Pleading / Motion / Brief

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Resources

Title	Description		External URL Date / External URL
Chelius v. Becerra ACLU	The American Civil Liberties Union (ACLU), the ACLU of Hawaii, and Arnold & Porter Kaye Scholar LLP, are challenging a U.S. Food & Drug Administration (FDA) restriction that severely limits where and…	October 3rd, 2017	Oct. 3, 2017 https://www.aclu.org/...

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Docket

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

Last updated Aug. 11, 2025, 6:41 a.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 View on PACER 2 Exhibit Proposed Order View on PACER	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 View on PACER	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 View on PACER	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. View on RECAP	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 View on RECAP 2 Exhibit Proposed Order View on PACER 3 Certificate of Service View on PACER	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
49	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

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Case Details

State / Territory: Hawaii

Case Type(s):

Healthcare Access and 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