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Food and Drug Administration v. Alliance for Hippocratic Medicine

Issues

Should the Court uphold the FDA’s modifications to the usage conditions of the drug mifepristone and defer to the FDA’s expertise before issuing preliminary relief, and do associations of doctors or medical groups have Article III legal standing to challenge the FDA's modifications due to safety concerns?

This case presents the Supreme Court with the issue of whether the Food and Drug Administration (“FDA”) can uphold its modifications to the usage guidelines of the drug mifepristone despite challenges from the Alliance for Hippocratic Medicine, who assert that these changes are capricious and unnecessarily elevate patient risk. Petitioner, the FDA, argues that Respondent, the Alliance for Hippocratic Medicine, lacks standing and that the FDA’s mifepristone-related decisions were based on solid clinical data and expert evaluations affirming the drug's safety and effectiveness. Respondent, the Alliance for Hippocratic Medicine, contends that it has standing and that the FDA's actions in 2016 and 2021 lack adequate safety studies and do not provide a cogent rationale for the modifications, thereby jeopardizing patient and healthcare provider safety. The Court's decision will determine whether mifepristone will stay subject to the lower court's injunction or if the FDA's decision to relax usage guidelines in 2016 and 2021 stands as justified.

Questions as Framed for the Court by the Parties

(1) Whether respondents have Article III standing to challenge the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use; (2) whether the FDA’s 2016 and 2021 actions were arbitrary and capricious; and (3) whether the district court properly granted preliminary relief.

In 1996, the United States Food and Drug Administration (“FDA”) received a new drug application (“NDA”) for the drug mifepristone from the Population Council.

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June Medical Services LLC v. Gee

Issues

Under Supreme Court precedent, can a state law require physicians who administer abortions to obtain admitting privileges at hospitals?

This case asks the Supreme Court to determine whether Louisiana’s law, requiring physicians who perform abortions to have admitting privileges at local hospitals, comports with the Court’s precedent. The parties agree that the Louisiana law at issue in this case is substantially similar to the Texas law that the Supreme Court struck down in Whole Woman’s Health v. Hellerstedt. June Medical Services argues that precedent from Whole Woman’s Health and Planned Parenthood of Southeastern Pennsylvania v. Casey control and that Louisiana’s Act is unconstitutional because it unduly burdens women seeking abortions. Doctor Rebekah Gee on behalf of Louisiana argues that June Medical Services lacks standing to bring forth a claim on behalf of their patients and further asserts that Whole Woman’s Health does not control the outcome of this case because the Louisiana Act does not unduly burden women seeking abortions. The outcome of this case has important implications on access to abortion services for women of color and could impact lower courts’ fact-finding authority.

Questions as Framed for the Court by the Parties

Whether the U.S. Court of Appeals for the Fifth Circuit’s decision upholding Louisiana’s law requiring physicians who perform abortions to have admitting privileges at a local hospital conflicts with the Supreme Court’s binding precedent in Whole Woman’s Health v. Hellerstedt.

In 2014, the Louisiana Legislature passed the Unsafe Abortion Protection Act (“Louisiana Act”), which required abortion providers who perform abortions at local clinics to have admitting privileges at a hospital within thirty miles of the clinic. June Medical Services LLC v.

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McCullen v. Coakley

Issues

Are state-mandated buffer zones around reproductive health care facilities that prohibit pro-life activists from approaching patients constitutional?

To dissuade women from having abortions, pro-life activists in Massachusetts sometimes attempt to communicate with women as they enter and exit reproductive healthcare facilities. To promote public safety, the Massachusetts legislature passed a law that imposes a thirty-five foot buffer zone around the access points to those clinics, and prohibits people from remaining in the buffer zone with a few exceptions. McCullen represents a group of Massachusetts residents who engage in pro-life counseling and who claim that the buffer zones put them at a disadvantage in their mission. McCullen also argues that the statute violates the First Amendment because it prevents patients who are contemplating having an abortion from obtaining information about alternatives. Coakley, the Massachusetts Attorney General, counters that the purpose of the statute is to prevent violence and facilitate access in and out of those healthcare facilities. The Supreme Court will have the opportunity to consider whether these buffer zones surrounding reproductive healthcare facilities are constitutional. The Court’s ruling will implicate the rights of pro-life and pro-choice activists in promoting their views near these facilities, as well as the rights of individuals seeking services there.

Questions as Framed for the Court by the Parties

Massachusetts has made it a crime for speakers to “enter or remain on a public way or sidewalk” within 35 feet of an entrance, exit, or driveway of “a reproductive health care facility.” The law applies only at abortion clinics. The law also exempts, among others, clinic “employees or agents . . . acting within the scope of their employment.” In effect, the law restricts the speech of only those who wish to use public areas near abortion clinics to speak about abortion from a different point of view. 

Petitioners are individuals who believe that women often have abortions because they feel pressured, alone, unloved, and out of options. Petitioners try to position themselves near clinics in an attempt to reach this unique audience, at a unique moment, to offer support, information, and practical assistance. They are peaceful, non-confrontational, and do not obstruct access. Yet, the State prohibits them from entering or standing on large portions of the public sidewalk to proffer leaflets or seek to begin conversations with willing listeners. 

The questions presented are: 

  1. Whether the First Circuit erred in upholding Massachusetts' selective exclusion law under the First and Fourteenth Amendments, on its face and as applied to petitioners. 
  2. If Hill v. Colorado, 530 U.S. 703 (2000), permits enforcement of this law, whether Hill should be limited or overruled.

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Facts

For over three decades, pro-life and pro-choice advocates have battled each other over the best forums for expressing their ideas. See McCullen v. Coakley, 571 F.3d 171, 172 (1st. Cir 2009).

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Medina v. Planned Parenthood South Atlantic

Issues

Does the Medicaid Act’s any-qualified-provider provision give Medicaid beneficiaries a private right to choose their provider?

This case asks the Court to determine when an individual, private right is enforceable under 42 U.S.C. § 1983. South Carolina’s executive order deems abortion clinics enrolled in the Medicaid program as unqualified to provide family planning services. Planned Parenthood South Atlantic and its patient, Julie Edwards, contend that the executive order violates Ms. Edwards’s right to choose a qualified provider under 42 U.S.C. § 1396a(a)(23), the any-qualified-provider provision. South Carolina counters that the any-qualified-provider fails to create a private right of action enforceable through § 1983 because Congress did not use unambiguously clear rights-creating language. The outcome of this case has heavy implications for Medicaid beneficiaries and providers, the implementation of state and federal healthcare policy goals, and the litigation of private rights. 

Questions as Framed for the Court by the Parties

Whether the Medicaid Act’s any-qualified-provider provision unambiguously confers a private right upon a Medicaid beneficiary to choose a specific provider.

The Medicaid Act provides medical assistance to certain individuals and families who cannot cover the cost of necessary medical services due to insufficient income and resources. Planned Parenthood South Atlantic v. Medina, 95 F.4th 152 at 156 (4th Cir.

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Moyle v. United States

Issues

Does the federal government have authority under the Emergency Medical Treatment and Labor Act, which requires hospitals to provide stabilizing care to patients, to preempt Idaho’s Defense of Life Act by requiring Idaho to perform abortions under certain circumstances?

This case asks the Supreme Court to interpret whether the Emergency Medical Treatment and Labor Act (“EMTALA”), which requires hospitals to provide stabilizing care to patients, can preempt state abortion regulations. Idaho’s Defense of Life Act prohibits hospitals from performing abortion unless it is necessary to protect the pregnant mother from death. EMTALA states that it preempts any state law which directly conflicts with its requirements, which includes providing stabilizing care to patients.  Idaho and its House speaker Mike Moyle argue that EMTALA cannot preempt Idaho state law because preemption would violate state sovereignty where there is no conflict between the two laws. The United States counters that EMTALA imposes a broader standard than Idaho law, and the executive and legislature can preempt state law under EMTALA via the Supremacy Clause. The outcome of this case has important implications for abortion rights, separation of powers, and sovereignty of states.

Questions as Framed for the Court by the Parties

Whether the Supreme Court should stay the order by the U.S. District Court for the District of Idaho enjoining the enforcement of Idaho’s Defense of Life Act, which prohibits abortions unless necessary to save the life of the mother, on the ground that the Emergency Medical Treatment and Labor Act preempts it.

Idaho’s 2022 Defense of Life Act, enacted in the wake of Dobbs v. Jackson Women’s Health Organization, criminalizes the performance of abortions.

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National Institute of Family and Life Advocates v. Becerra

Issues

Does a California law requiring licensed pregnancy clinics to disseminate a notice containing information about state-funded family planning services including abortion and requiring unlicensed pregnancy clinics to disclose their unlicensed status violate the First Amendment’s free speech clause?

This case will determine how much a state can force a medical provider to say when that speech is antithetical to the provider’s religious beliefs. California’s Reproductive FACT Act (“the Act”) requires licensed pregnancy-service facilities to disseminate a notice stating that: “California has public programs that provide immediate free or low-cost access to comprehensive family planning services (including all FDA-approved methods of contraception), prenatal care, and abortion for eligible women” and providing a phone number that patients can call to seek more information. The Act also requires unlicensed clinics to distribute a notice disclosing that they are not licensed by the state. The National Institute of Family and Life Advocates (“NIFLA”) argues that the Act unconstitutionally compels speech and should be subjected to strict scrutiny, which it cannot survive. NIFLA further contends that the Act discriminates impermissibly against pro-life clinics based on their viewpoint. California responds that the Act is a permissible exercise of the government’s authority to regulate speech between professionals and their clients, which survives any level of scrutiny. California also claims that the Act addresses fraudulent practices affecting women’s understanding of their reproductive healthcare choices and does not suppress pro-life viewpoints. Will free speech prevail over regulation of doctors and will the result benefit pregnant women?

Questions as Framed for the Court by the Parties

Whether the disclosures required by the California Reproductive FACT Act violate the protections set forth in the Free Speech Clause of the First Amendment, applicable to the states through the Fourteenth Amendment.

In 2015, the California Legislature passed the Reproductive Freedom, Accountability, Comprehensive Care, and Transparency Act (“the Act”) into law, declaring in the bill’s text that “all California women, regardless of income, should have access to reproductive health services.” See Nat’l Inst.

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United States v. Texas

Issues

Does the United States have the authority to sue to enjoin Texas’s recent ban on medical providers performing abortion after fetal heartbeat and prohibit  the State, the State judiciary, or private citizens from enforcing it?  

This case asks the Supreme Court to determine whether the United States may sue to enjoin S.B. 8, Texas’s law prohibiting medical providers from performing abortions once a heartbeat has been detected. In Whole Woman’s Health v. Jackson, the Fifth Circuit stayed the enjoinment of S.B. 8, determining that, due to the enforcement scheme delegating the authority to enforce S.B. 8 to private citizens, Whole Woman’s Health could not seek to enjoin the enforcement of S.B. 8 in federal courts. In response, the United States filed suit seeking an injunction against S.B. 8. Petitioner the United States argues that it has the authority to enjoin state judicial officers from enforcing the law in federal courts to protect its sovereign interests in protecting federal constitutional rights. Respondent Texas contends that the United States has no standing to seek injunctive relief and that sovereign authority does not permit the United States to file suit in this instance. The case has significant implications for accessing abortions and for protecting other constitutional rights. 

Questions as Framed for the Court by the Parties

May the United States bring suit in federal court and obtain injunctive or declaratory relief against the State, state court judges, state court clerks, other state officials, or all private parties to prohibit S.B. 8 from being enforced?

In 2021, Texas enacted a law which, in part, prohibits physicians from performing abortions on pregnant women once the fetus has a discernable heartbeat. Whole Woman’s Health v. Jackson I, at 4–5. The law, referred to as Senate Bill 8 (“S.B.

Acknowledgments

The authors would like to thank Deborah Dinner and Michael Dorf for their insight and guidance in this case.

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Whole Woman’s Health v. Hellerstedt

Issues

Can a state enforce laws that significantly reduce the availability of abortion services while failing to advance any valid interest, including the state’s interest in promoting health?

 

In 2013, the Texas Legislature passed House Bill 2 (“H.B. 2”), which imposed new requirements on abortion clinics. For example, H.B. 2 required a physician performing an abortion to have admitting privileges at a hospital within thirty miles of the abortion clinic. Whole Woman’s Health, a private abortion clinic, sued the state of Texas to lift the new restrictions. The Supreme Court will determine whether a state can enforce laws that significantly reduce the availability of abortion services while failing to advance any valid interest, including the state’s interest in promoting health. Whole Woman’s Health argues that H.B. 2 imposes an undue burden on women’s access to abortions. Hellerstedt contends that H.B. 2’s justification of improving patient health is supported by substantial evidence, and H.B. 2 will not impose a burden in the majority of cases. This case implicates H.B. 2’s effect on women’s health and H.B. 2’s imposed costs on women seeking abortions.

Questions as Framed for the Court by the Parties

1a. When applying the Due Process Clause standard associated with the Planned Parenthood of Southeastern Pennsylvania v. Casey decision, does a court err by refusing to consider whether and to what extent laws that restrict abortion for the stated purpose of promoting health actually serve the government’s interest in promoting health?



1b. Did the Fifth Circuit err in concluding that this standard permits Texas to enforce, in nearly all circumstances, laws that would cause a significant reduction in the availability of abortion services while failing to advance the State’s interest in promoting health—or any other valid interest?

2. Did the Fifth Circuit err in holding that res judicata provides a basis for reversing the district court’s judgment in part?

In 2013, Texas passed House Bill Two (“H.B. 2”), which places specific requirements on abortion clinics. See Whole Woman’s Health v. Cole, 790 F.3d 563 (5th Cir. 2015) at 576. The Texas Legislature stated that it enacted H.B.

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