Case: Bryant v. Stein

1:23-cv-00077 | U.S. District Court for the Middle District of North Carolina

Filed Date: Jan. 25, 2023

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Case Summary

This is a case about medication abortion in North Carolina. This lawsuit was filed on January 25, 2023, in the U.S. District Court for the Middle District of North Carolina. The plaintiff, a North Carolina physician, sued North Carolina, alleging that it was unconstitutional for the state to regulate mifepristone, an abortion medication, because the federal government already did so through the FDA and the federal regulations should preempt those imposed by the state. The plaintiff, represented…

This case was filed on the same day as a similar case, GenBioPro, Inc. v. Sorsaia, that challenged a West Virginia law regulating mifepristone based on the same legal reasoning.

In this case, the plaintiff alleged that North Carolina’s restrictions on mifepristone, including the state’s regulations about both abortion generally and medication abortion specifically, were unconstitutional because they were much more restrictive than the FDA’s. North Carolina’s laws made physicians the only legal prescribers and providers of mifepristone, and required that patients take the medication in the presence of the physician, in a particular type of facility meeting certain building and certification requirements. By contrast, under the FDA’s rules, a patient could get a mifepristone prescription from non-physician healthcare providers, including virtually, and they were allowed to pick it up at a pharmacy and take it anywhere. North Carolina also included counseling and ultrasound requirements beyond the FDA’s rules, and the state mandated a 72-hour waiting period before taking the medication. North Carolina's law included civil or criminal penalties for those who performed abortions, and physicians who broke the law could lose their medical licenses.

According to the plaintiff, North Carolina’s regulations violated the Supremacy Clause of the U.S. Constitution, which requires federal law to preempt state law when the two come into conflict. The plaintiff argued that since the FDA has exclusive control over the regulation of mifepristone, and since the FDA chose not to impose the requirements that North Carolina did, the state’s requirements should be overridden by the FDA’s regulations. The plaintiff alleged that these unconstitutional requirements would harm her and her patients by making it more difficult to prescribe and take mifepristone and therefore creating more risks for patients.

The plaintiff sought a declaratory judgment that federal law preempted North Carolina’s law, an injunction to stop the enforcement of these laws and prevent the state from regulating mifepristone in any other unconstitutional way, and attorney’s fees. The case was assigned to Judge William L. Osteen

On February 21, 2023, Philip E. Berger, President Pro Tempore of the North Carolina Senate, and Timothy K. Moore, Speaker of the North Carolina House of Representatives, filed a motion to intervene on behalf of the General Assembly and as agents of the State of North Carolina. On March 10, 2023, the court granted their motion to intervene.

On March 24, 2023, the legislative-intervenor defendants filed a motion to dismiss for failure to state a claim.

On May 16, 2023, the North Carolina legislature passed Senate Bill 20 (which then became Session Law 2023-14), overriding the Governor’s veto of the bill, with an effective date of July 1, 2023. Session Law 2023-14 carried forward or expanded many of the state’s pre-existing abortion restrictions. Specifically relating to medication abortion, it required that the physician prescribing, administering or dispensing mifepristone to examine the patient in person before administering the drug, schedule an in-person followup, and make all reasonable efforts to ensure the patient attended the follow-up visit.

On June 2, 2023, plaintiffs requested leave to file an amended complaint. The court granted plaintiffs’ request on August 7 and, as defendants’ motion to dismiss was no longer responsive to the operative pleading, the court denied it without prejudice as moot. The same day, plaintiffs filed their amended complaint, which included Session Law 2023-14 in its challenge. The next week, on August 14, defendants filed a motion to dismiss the amended complaint.

The case was reassigned to Chief District Judge Catherine Eagles on December 21, 2023, .

On January 17, 2024, there was a hearing on the motion to dismiss. In a minute entry entered on the same day, the court converted the motion to dismiss to a cross motion for summary judgment, with agreement and consent of all parties. The court requested supplemental briefs from each party.

Following parties’ briefing, on April 30, 2024, Judge Eagles issued an order regarding the cross-motions for summary judgment, granting in part both the legislative intervenor-defendants and plaintiffs’ motions. In the order, Judge Eagles held that, to the extent the state imposed safety restrictions on mifepristone that the FDA had implemented and then later affirmatively rejected and removed, those restrictions frustrated Congress’ goal of establishing a comprehensive regulatory framework where the FDA determined conditions for safe drug distribution. As such, those restrictions were “obstacles to Congress’ purpose and are preempted.” However, restrictions that had not been affirmatively considered and rejected by the FDA did not frustrate Congress’ purpose and so were not preempted.

Accordingly, Judge Eagles granted in part plaintiffs’ motion for summary judgment, holding that the provisions of the challenged law physician only prescribing, in-person prescribing, dispensing, and administering, scheduling of an in-person follow-up appointment, and non-fatal adverse event reporting to the FDA violated the Supremacy Clause and were therefore unconstitutional. She also granted in part the legislative intervenor-defendants motion for summary judgment, holding that the provisions of the challenged laws that required an in-person 72-hour advance consultation, the use of an ultrasound, an in-person examination, blood testing and reporting non-fatal adverse events to the state were not preempted.

At the end of her order, Judge Eagles ordered the parties to file a joint submission with proposed judgments and injunctions. Parties filed their joint submission on May 21, 2023 and, on June 3, Judge Eagles issued a judgment and permanent injunction. The order enjoined defendants from enforcing or penalizing failure to comply with the regulations that the April 30th order had found to be preempted and therefore unconstitutional. It held that those regulations were preempted by federal law, and dismissed with prejudice the rest of plaintiffs’ claims.

On June 20, 2024, the legislative intervenor-defendants appealed the portion of the June 3rd order enjoining certain regulations to the Fourth Circuit. The next week, on June 28th, plaintiffs filed a cross-appeal to the Fourth Circuit, appealing the April 30th order, the June 3rd order, and all other orders that were adverse to plaintiffs in whole or in part.

On July 2, 2024, the Fourth Circuit consolidated the two appeals. The same day, defendants filed a cross appeal to the Fourth Circuit, appealing the April 30th order and the June 3rd order. The next week, on July 7, the Fourth Circuit consolidated defendants’ appeal with the other two cross-appeals.

The Fourth Circuit placed the case in abeyance, pending the decision in GenBioPro, Inc. v. Raynes (formerly GenBioPro, Inc. v. Sorsaia) on December 3, 2024. As of March 6, 2026, though a decision has been issued in GenBioPro, Inc., the appeal in this case is still pending.


1 1:23-cv-00077	Complaint	Jan. 25, 2023	Jan. 25, 2023 Complaint
82 1:23-cv-00077	First Amended Complaint	Aug. 7, 2023	Aug. 7, 2023 Complaint
103 1:23-cv-00077	Memorandum Opinion and Order	April 30, 2024	April 30, 2024 Order/Opinion 2024 WL 1886907
105 1:23-cv-00077	Judgment and Permanent Injunction	June 3, 2024	June 3, 2024 Order/Opinion 2024 WL 3107568
117 1:23-cv-00077	Order U.S. Court of Appeals for the Fourth Circuit	Dec. 3, 2024	Dec. 3, 2024 Order/Opinion

ECF Number	Date	Description	Link
1	Jan. 25, 2023	COMPLAINT against WILLIAM M. BRAWLEY, W. HOWARD HALL, SHARONA Y. JOHNSON, CHRISTINE M. KHANDELWAL, MICHAUX R. KILPATRICK, KODY KINSLEY, JOSHUA D. MALCOLM, JEFF NIEMAN, MIGUEL A. PINEIRO, MELINDA H. PRIVETTE, ANURADHA RAO-PATEL, ROBERT RICH, JR, JOHN W. RUSHER, DEVDUTTA G. SANGVAI, JOSHUA H. STEIN ( Filing fee $ 402 receipt number ANCMDC-3478658.), filed by AMY BRYANT, MD. (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 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Civil Cover Sheet)(COREY, CHELSEA) (Entered: 01/25/2023) 1 Exhibit A View on PACER 2 Exhibit B View on PACER 3 Exhibit C View on PACER 4 Exhibit D View on PACER 5 Exhibit E View on PACER 6 Exhibit F View on PACER 7 Exhibit G View on PACER 8 Exhibit H View on PACER 9 Exhibit I View on PACER 10 Exhibit J View on PACER 11 Exhibit K View on PACER 12 Exhibit L View on PACER 13 Exhibit M View on PACER 14 Exhibit N View on PACER 15 Exhibit O View on PACER 16 Exhibit P View on PACER 17 Exhibit Q View on PACER 18 Exhibit R View on PACER 19 Exhibit S View on PACER 20 Exhibit T View on PACER 21 Civil Cover Sheet View on PACER	Clearinghouse
2	Jan. 25, 2023	NOTICE of Attorney Appearance by attorney CHELSEA COREY on behalf of Plaintiff AMY BRYANT, MD (COREY, CHELSEA) (Entered: 01/25/2023)	RECAP
3	Jan. 25, 2023	NOTICE of Special Appearance by attorney EVA TEMKIN on behalf of Plaintiff AMY BRYANT, MD ( Filing fee $ 25 receipt number ANCMDC-3479352.) (TEMKIN, EVA) (Entered: 01/25/2023)	RECAP
4	Jan. 25, 2023	NOTICE of Special Appearance by attorney PAUL ALESSIO MEZZINA on behalf of Plaintiff AMY BRYANT, MD ( Filing fee $ 25 receipt number ANCMDC-3479363.) (MEZZINA, PAUL) (Entered: 01/25/2023)	RECAP
5	Jan. 25, 2023	NOTICE of Special Appearance by attorney JESSICA GREENBAUM on behalf of Plaintiff AMY BRYANT, MD ( Filing fee $ 25 receipt number ANCMDC-3479376.) (GREENBAUM, JESSICA) (Entered: 01/25/2023)	RECAP
6	Jan. 30, 2023	Summons Issued as to All Defendants. (Attachments: # 1 Summons - JEFF NIEMAN, # 2 Summons - KODY H. KINSLEY, # 3 Summons - MICHAUX R. KILPATRICK, MD, PHD, # 4 Summons - CHRISTINE M. KHANDELWAL, DO, # 5 Summons - DEVDUTTA G. SANGVAI, MD, MBA, # 6 Summons - JOHN W. RUSHER, MD, JD, # 7 Summons - WILLIAM M. BRAWLEY, # 8 Summons - W. HOWARD HALL, MD, # 9 Summons - SHARONA Y. JOHNSON, PHD, FNP-BC, # 10 Summons - JOSHUA D. MALCOLM, JD, # 11 Summons - MIGUEL A. PINEIRO, PA-C, MHPE, # 12 Summons - MELINDA H. PRIVETTE, MD, JD, # 13 Summons - ANURADHA RAO-PATEL, MD, # 14 Summons - ROBERT RICH, JR., MD) (Carter, Alexus) (Entered: 01/30/2023)	RECAP
7	Jan. 30, 2023	Notice of Right to Consent. Counsel shall serve the attached form on all parties. (Attachments: # 1 Consent Form) (Carter, Alexus) (Entered: 01/30/2023)	RECAP
	Jan. 30, 2023	Case Assigned
	Jan. 30, 2023	Case ASSIGNED to JUDGE WILLIAM L. OSTEEN, JR and MAG/JUDGE L. PATRICK AULD. (Carter, Alexus)
8	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to JOSHUA H. STEIN served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
9	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to JEFF NIEMAN served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
10	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to KODY H. KINSLEY served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
11	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to MICHAUX R. KILPATRICK, MD, PHD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
12	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to CHRISTINE M. KHANDELWAL, DO served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
13	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to DEVDUTTA G. SANGVAI, MD, MBA served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
14	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to JOHN W. RUSHER, MD, JD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
15	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to WILLIAM M. BRAWLEY served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
16	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to W. HOWARD HALL, MD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
17	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to SHARONA Y. JOHNSON, PHD, FNP-BC served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
18	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to JOSHUA D. MALCOLM, JD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
19	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to MIGUEL A. PINEIRO, PA-C, MHPE served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
20	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to MELINDA H. PRIVETTE, MD, JD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
21	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to ANURADHA RAO-PATEL, MD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
22	Feb. 6, 2023	AFFIDAVIT OF SERVICE as to ROBERT RICH, JR., MD served on 2/1/2023, answer due 2/22/2023. (COREY, CHELSEA) (Entered: 02/06/2023)	RECAP
23	Feb. 15, 2023	NOTICE of Attorney Appearance by attorney MICHAEL E. BULLERI on behalf of Defendants WILLIAM M. BRAWLEY, W. HOWARD HALL, MD, SHARONA Y. JOHNSON, PHD, FNP-BC, CHRISTINE M. KHANDELWAL, DO, MICHAUX R. KILPATRICK, MD, PHD, JOSHUA D. MALCOLM, JD, MIGUEL A. PINEIRO, PA-C, MHPE, MELINDA H. PRIVETTE, MD, JD, ANURADHA RAO-PATEL, MD, ROBERT RICH, JR., MD, JOHN W. RUSHER, MD, JD, DEVDUTTA G. SANGVAI, MD, MBA (BULLERI, MICHAEL) (Entered: 02/15/2023)	RECAP
24	Feb. 15, 2023	MOTION for Extension of Time to File Answer re 1 Complaint,,, by WILLIAM M. BRAWLEY, W. HOWARD HALL, MD, SHARONA Y. JOHNSON, PHD, FNP-BC, CHRISTINE M. KHANDELWAL, DO, MICHAUX R. KILPATRICK, MD, PHD, JOSHUA D. MALCOLM, JD, MIGUEL A. PINEIRO, PA-C, MHPE, MELINDA H. PRIVETTE, MD, JD, ANURADHA RAO-PATEL, MD, ROBERT RICH, JR., MD, JOHN W. RUSHER, MD, JD, DEVDUTTA G. SANGVAI, MD, MBA. (Attachments: # 1 Text of Proposed Order Proposed Order)(BULLERI, MICHAEL) (Entered: 02/15/2023)	RECAP
	Feb. 15, 2023	Order on Motion for Extension of Time to Answer
	Feb. 15, 2023	ORDER granting 24 Motion for Extension of Time to Answer for WILLIAM M. BRAWLEY, W. HOWARD HALL, MD, SHARONA Y. JOHNSON, PHD, FNP-BC, CHRISTINE M. KHANDELWAL, DO, MICHAUX R. KILPATRICK, MD, PHD, JOSHUA D. MALCOLM, JD, MIGUEL A. PINEIRO, PA-C, MHPE, MELINDA H. PRIVETTE, MD, JD, ANURADHA RAO-PATEL, MD, ROBERT RICH, JR., MD, JOHN W. RUSHER, MD, JD, and DEVDUTTA G. SANGVAI, MD, MBA. Answer due by 3/24/2023. Signed by John Brubaker, Clerk of Court, on 2/15/2023. (Brubaker, John)
25	Feb. 16, 2023	NOTICE of Attorney Appearance by attorney KATHRYN HICKS SHIELDS on behalf of Defendant JEFF NIEMAN (SHIELDS, KATHRYN) (Entered: 02/16/2023)	RECAP
26	Feb. 16, 2023	MOTION for Extension of Time to File Answer re 1 Complaint,,, by JEFF NIEMAN. (Attachments: # 1 Text of Proposed Order)(SHIELDS, KATHRYN) (Entered: 02/16/2023) 1 Text of Proposed Order View on PACER	RECAP
	Feb. 17, 2023	Order on Motion for Extension of Time to Answer
	Feb. 17, 2023	ORDER granting 26 Motion for Extension of Time to Answer for JEFF NIEMAN. Answer due by 3/24/2023. Signed by John Brubaker, Clerk of Court, on 02/17/2023. (Brubaker, John)
27	Feb. 21, 2023	NOTICE of Attorney Appearance by attorney MICHAEL T. WOOD on behalf of Defendant KODY H. KINSLEY (WOOD, MICHAEL) (Entered: 02/21/2023)	RECAP
28	Feb. 21, 2023	NOTICE of Attorney Appearance by attorney WILLIAM ELLIS BOYLE on behalf of Intervenor Defendants Timothy K. Moore, Philip E. Berger (BOYLE, WILLIAM) (Entered: 02/21/2023)	RECAP
29	Feb. 21, 2023	MOTION to Intervene by Philip E. Berger, Timothy K. Moore. Response to Motion due by 3/14/2023 (Attachments: # 1 Exhibit 1 - Proposed Answer)(BOYLE, WILLIAM) (Additional attachment(s) added on 2/21/2023: # 2 Text of Proposed Order) (Hicks, Samantha). (Entered: 02/21/2023) 1 Exhibit 1 - Proposed Answer View on PACER 2 Text of Proposed Order View on PACER	RECAP
30	Feb. 21, 2023	MEMORANDUM re 29 MOTION to Intervene (Memorandum in Support) by Intervenor Defendant Timothy K. Moore. (Attachments: # 1 Exhibit 1 - February 13, 2023, Letter)(BOYLE, WILLIAM) (Attachment 1 replaced on 2/21/2023) (Hicks, Samantha). (Entered: 02/21/2023) 1 Exhibit 1 - February 13, 2023, Letter View on PACER	RECAP
31	Feb. 21, 2023	*FILED IN ERROR* NOTICE by Philip E. Berger, Timothy K. Moore re 29 MOTION to Intervene, 30 Memorandum (PROPOSED ORDER) (BOYLE, WILLIAM) Modified on 2/21/2023 to mark as filed in error per attorney. (Hicks, Samantha) (Entered: 02/21/2023)	RECAP
32	Feb. 21, 2023	*FILED IN ERROR* MEMORANDUM re 30 Memorandum (Exhibit 1 - February 13, 2023)(Corrected) by Intervenor Defendant Timothy K. Moore. (BOYLE, WILLIAM) Modified on 2/21/2023 to mark as filed in error per attorney. (Hicks, Samantha) (Entered: 02/21/2023)	RECAP
33	Feb. 21, 2023	Corporate Disclosure Statement. (BOYLE, WILLIAM) (Entered: 02/21/2023)	RECAP
34	Feb. 21, 2023	Corporate Disclosure Statement. (BOYLE, WILLIAM) (Entered: 02/21/2023)	RECAP

Case: Bryant v. Stein

1:23-cv-00077 | U.S. District Court for the Middle District of North Carolina

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