Preemption in the abortion context – recent cases shed light on limits of federal law to supersede state restrictions
“It is far from certain that a historical tilt to federal drug-approval authority will prevail in the context of abortion, particularly given the forceful language of the Dobbs opinion and broader trends away from agency deference.”
Dobbs v. Jackson Whole Women’s Health Organization overturned the federal constitutional right to abortion and returned “the issue of abortion to the people’s elected representatives.” 597 U.S. __, 142 S. Ct. 2288, 2243 (Jun. 24, 2022). In the wake of Dobbs, states have responded by expanding access to abortions or, conversely, by resurrecting or passing numerous laws restricting abortion. The federal government has also taken action through executive orders, agency guidance, and litigation designed to bolster the current federal statutory protections for abortion.
This article briefly explores some federal standards at issue and then considers their preemptive effect, as is being tested in court cases across the country.
The implications of these preemption issues on certain stakeholders, such as healthcare providers performing abortions, prescribing medication for abortions, or furnishing abortion in emergency room settings, are not to be understated.
I. FEDERAL LAWS CONCERNING ABORTION PROCEDURES
In Dobbs, the Supreme Court held that there is no federal constitutional right to abortion; but, in the wake of that decision, many wondered which federal statutory provisions might nevertheless protect abortion and thereby preempt conflicting state provisions. Two areas of federal law concerning abortion – emergency medical treatment and medication abortion – have come to the forefront this summer as court cases show the limits of federal preemption of state restrictions.
The Emergency Medical Treatment and Labor Act (EMTALA) was passed in 1986 to prevent “patient dumping” and provider discrimination against patients who lack the ability to pay for necessary emergency care. The statute specifically forbids emergency departments or facilities who receive any Medicare funding from declining to provide medical care to patients experiencing an emergency medical condition if doing so would place the health of the individual in serious jeopardy.
With respect to pregnant women, EMTALA’s protections extend to the “health of the woman or her unborn child,” specifically in situations when women present to the department or facility with labor-related conditions. 42 U.S.C. § 1395dd(e)(1). The sanctions for violating EMTALA include monetary penalties by HHS, suits by patients and families, and exclusion from Medicare or other federal programs. See id. §§ 1395dd(d)(1)-(2), 1395cc(b)(2). The statute addresses preemption, noting that it does not preempt state law except to the extent the state law “directly conflicts with a requirement of this section.” Id. § 1395dd(f).
In the wake of Dobbs, the federal government invoked EMTALA’s protections and the preemption provision. In July 2022, President Joe Biden issued an Executive Order encouraging the Secretary of the Department of Health and Human Services (HHS) to identify potential actions to “protect and expand access to abortion” and ensure pregnant women receive full protections for emergency care under EMTALA. 87 Fed. Reg. 42,053 (July 8, 2022). HHS Secretary Xavier Becerra then issued guidance to state healthcare-agency directors encouraging them to follow federal law in providing abortions under certain circumstances. Centers for Medicare & Medicaid Services, Reinforcement of EMTALA Obligations Specific to Patients Who Are Pregnant or Are Experiencing Pregnancy Loss, Centers for Medicare & Medicaid Services (July 11, 2022). The guidance specifically noted that state laws were preempted to the degree they do not except from restrictions abortions that protect the life and health of the pregnant person or draw the emergency definition more narrowly than EMTALA, and that EMTALA could be invoked against state enforcement actions that conflicted with its protections.
2. US Food and Drug Administration approval of medication abortion
In 2000, the FDA approved medication abortion by approving Mifeprex (brand name version), the first drug in a two-drug regimen by which women can terminate pregnancies. Mifeprix (mifepristone) Information, U.S. Food & Drug Admin. (last updated Dec. 16, 2021). The second drug, Misoprostol, is not FDA approved, but its off-label use stimulates contractions to expel the pregnancy from the uterus. In 2016, the FDA approved a supplemental application for Mifeprex and determined that the drug was safe and effective when used to terminate pregnancies. Three years later, in 2019, the FDA approved Mifepristone, the generic version of Mifeprex. Mifepristone is approved, in a regimen with Misoprostol, to end a pregnancy through 70 days (or less) gestation since the first day of a woman’s last menstrual period.
As a condition of approval, FDA requires Mifepristone to comply with a risk evaluation mitigation strategy (REMS). Generally, a REMS is an “FDA-imposed drug safety plan designed to ensure that the benefits of a drug with serious potential safety concerns outweigh its risks.” Congressional Research Service, Medication Abortion: A Changing Legal Landscape (July 8, 2022). The REMS issued in 2019 restricted dispensing of Mifepristone to certain clinics, medical offices, and hospitals, or under the supervision of certified prescribers. In December 2021, based on decades of safety data, the FDA removed the requirement that these drugs be furnished in person, thereby allowing patients to receive these abortion medications by mail. Response Letter from FDA CDER to American Association of Pro-Life Obstetricians and Gynecologists and American College of Pediatrics (Dec. 16, 2021).
II. RECENT LITIGATION INVOLVING FEDERAL AND STATE CONFLICTS OVER ABORTION
EMTALA preemption came to the forefront in two district court cases in Idaho and Texas in which both states granted a preliminary injunction enjoining authorities – but in opposing directions. The issue was whether EMTALA preempted each state’s recent trigger laws restricting abortion apart from specified circumstances. The divergent answer may lie in the state-law definitions at issue as well as the differing litigating positions the federal government took with respect to EMTALA.
In August this year, the United States brought suit against Idaho in the United States District Court of Idaho alleging that Idaho’s new criminal abortion law conflicted with the provisions set forth in EMTALA. U.S. v. State of Idaho, No. 1:2022-cv-00329-BLW (D. Idaho 2022). Under Idaho’s new law, every person who performs or attempts to perform an abortion commits the crime of criminal abortion, punishable by two to five years of imprisonment. Idaho Code § 18-622. The only codified exceptions – set forth as affirmative defenses to be proven by the physician at trial – were to prevent the “death” of the pregnant woman or to have made best efforts to save the life of the unborn child. Id. § 18-622(3)(a)(ii) and (iii). The court held that because EMTALA applies to every hospital with an emergency department accepting Medicare, and because Idaho’s abortion law restricted healthcare professionals’ abilities to perform abortions in various emergency situations, Idaho’s law was preempted as applied to medical care required by EMTALA. The decision did not strike down Idaho’s law overall, since the United States’ challenge was an as-applied challenge. Idaho, No. 1:2022-cv-00329 at *16-17.
In Texas, in contrast, the conflict between EMTALA and the state’s Human Life Protection Act was far less clear. The Human Life Protection Act, effective as of August 25, 2022, bans abortions except to protect the pregnant woman from a life-threatening condition or serious risk of substantial impairment of bodily function. Tex. Health & Safety Code § 170A.002(b). The penalties for violating these provisions include felony, civil penalty of $100,000 per violation, and potential loss of license. Tex. Health & Safety Code § 170A.004-.007. The HLPA includes provisions demanding that, even in qualifying situations for the pregnant woman’s health, the provider must attempt to save the life/preserve the health of the unborn child, though the HLPA also contains exceptions for removing dead fetuses and resolving ectopic pregnancies. Tex. Health & Safety Code § 245.002.
In July, Texas and two organizational plaintiffs sued HHS to enjoin the agency from enforcing EMTALA in accordance with the Guidance, since the Guidance– but not the statute – conflicted with Texas abortion law. State of Texas v. Becerra, No. 5:22-cv-185 (N.D. Tex. 2022). Texas plaintiffs therefore sought a preliminary injunction barring the Guidance’s enforcement prior to August 25. On August 24, a federal district court in Texas agreed with the Texas plaintiffs and enjoined HHS from issuing any penalties to providers who refuse to perform abortions that might conflict with Texas’s trigger law. Becerra, No. 5:22-cv-185. In the district court’s view, EMTALA’s language regarding stabilizing care did not speak to the potential “conflict between the health of the mother and the unborn child,” a void that Texas law filled by permitting abortions to protect the mother’s life or serious bodily impairment but demanding medical life-saving measures for the fetus. Id. at *44-49. And with respect to the guidance, the court held that the guidance was the consummation of HHS’s decision-making – a necessary factor in conferring jurisdiction on the federal court – but that HHS’s interpretation of EMTALA set forth in the guidance was an impermissible construction in part because it newly favored abortion over other procedures, contrary to the plain language of the statute. Id. at **31, 41, 53. Although the court denied the nationwide injunction sought by Texas, it granted an injunction in Texas and for all of the other plaintiffs’ members.
2. Medication abortion
In the wake of Dobbs, some states have wholly banned the use of medication abortion, notwithstanding FDA approval of it. Generally, any state with a total ban on abortion – such as Oklahoma, South Dakota, Alabama, Utah, and Arkansas – also completely bans medication abortion. See eg, Okla. Stat. §63-1-730; S.D. Codified L. §22-17-5.1; Ala. Code §26-23H-3.
Although other states may not place a total ban on medication abortions, many have placed significant restrictions on the accessibility of medication abortions. For example, in Tennessee and South Carolina, which both ban abortion after six weeks, medication abortions are likewise not permitted after that point. See Tenn. Code § 39-15-211; S.C. Code § 44-41-10. Further, to date, 19 states have banned medical professionals from prescribing abortion medication via telehealth. See, eg, Ariz. Rev. Stat. §36-3604; W.Va Code §30-3-13a.
Prior to Mississippi’s abortion law resulting in the Supreme Court’s reversal of the federal constitutional right to abortion under Roe v. Wade, GenBioPro challenged Mississippi regulations governing Mifepristone administration as conflicting with FDA requirements and, therefore, subject to preemption. See Complaint, GenBioPro v. Dobbs, 3:20-cv-00652-HTW (D. Miss. Oct. 9, 2020). But within the same month that the district court in Mississippi held hearings on the state’s long-pending motion to dismiss, the Supreme Court issued Dobbs, generating a whole new round of briefing in Mississippi on the effect of Dobbs on the parties’ arguments. Prior to that briefing’s conclusion, GenBioPro voluntarily dismissed its case. Id. ECF No. 46.
Aside from GenBioPro, to date there have been several instances in which lawsuits were brought against states for restrictions placed on access to abortion medication. For example, in 2021, South Dakota Governor Kristi Noem signed an Executive Order restricting access to abortion medication. In response, Planned Parenthood and the ACLU of South Dakota filed a joint complaint against the governor and the state’s Department of Health, leading a federal judge to halt enforcement of the governor’s Executive Order. Planned Parenthood v. Kristi Noem, Joan Adam, and Philip Meyer, 4:22-cv-4009 (S.D. 2022). But in June, Planned Parenthood also dismissed its suit for lack of standing, no longer being able to perform abortions in South Dakota without risking felony. Id. ECF No. 37. With these recent withdrawals, there have not been high-profile litigation challenges to state restrictions on medication abortions. However, this does not mean there are not more to come.
III. PREEMPTION IMPLICATIONS OF THESE DECISIONS
Implied preemption is commonly invoked in the healthcare space given the significant role of the federal government in approving medications and devices butting up against states’ historical powers to regulate the health and safety of its individual citizens. See, eg, Patricia J. Zettler, Pharmaceutical Federalism, 92 Ind. L.J. 845, 862 (2017). There are then several forms of implied preemption. Impossibility preemption occurs where it is impossible for a private party to comply with both state and federal law. Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000). Obstacle preemption occurs where the state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Id. at 373.
As the District Court of Idaho found in the context of EMTALA, it was impossible for Idaho providers to comply with both EMTALA and Idaho restrictions when faced with emergency pregnancy situations, and the Idaho law stood as an obstacle to Congressional intent to establish a “bare minimum of emergency care that would be available to all people in Medicare-funded hospitals.” U.S. v. State of Idaho, No. 1:2022-cv-00329-BLW (D. Idaho 2022) at **24-25. The recent Idaho decision helps clarify the boundaries of implied preemption with respect to EMTALA. The decision may serve as a model for future challenges to similarly restrictive state laws, but also as a lesson to state legislatures crafting narrow exceptions to abortion restrictions, as the preemptive aspect of EMTALA may well turn on these emergency exceptions.
However, with respect to medication abortion, the preemption landscape is far from settled for several reasons. First, no statute explicitly demands that a provider administer medication abortion, as opposed to the EMTALA provisions regarding emergent situations involving pregnancy. Second, the fact of FDA approval and even risk mitigation strategies do not resolve the underlying conflict between states’ intent to protect an unborn child’s life with a federal agency’s sanction of safe and effective ways to end it. Historically, the conflict between FDA approval and states’ police powers has been untested and/or preliminarily tilted in favor of federal preemption. See Zogenix v. Patrick, 14-cv-11689, 2014 WL 1454696 (D. Mass. Apr. 15, 2014) (holding that FDA’s approval of a hydrocodone analgesic preempted Massachusetts’s emergency order specifically banning the prescription, ordering, and dispensing of that drug in connection with efforts to fight the opioid epidemic); see also Ouellette v. Mills, 91 F. Supp. 3d 1, 5-6 (D. Me. 2015) (striking down Maine’s law allowing citizens to purchase prescription drugs from certain foreign pharmacies on the basis of field preemption since Congress intended to occupy the field of pharmaceutical importation).
However, it is far from certain that a historical tilt to federal drug-approval authority will prevail in the context of abortion, particularly given the forceful language of the Dobbs opinion and broader trends away from agency deference. As may have already been revealed through the Texas case, HHS guidance and executive orders alone will not likely change a court’s evaluation of federal law supremacy.
The next challenge brought to the conflict between FDA’s approval and risk mitigation strategies of Mifepristone and state restrictions of medication abortion therefore not only has the potential to widely impact the ever-changing landscape of abortion post-Dobbs, but also to impact the interplay between states’ police powers to protect their citizens and the FDA’s authority. Until further clarity comes, healthcare providers face an abortion landscape that is variable, shifting, and well worth monitoring.
To learn more about the implications of these evolving developments, please contact any of the authors, or contact our Dobbs Task Force via DobbsTaskForce@dlapiper.com.