Litigation in a Post-Dobbs World: Providers and Allies Beware

• February 03, 2023

• Noam B. Fischman , Akerman LLP
• Jeremy Burnette , Akerman LLP
• Lauren F. Gandle , Akerman LLP

When the U.S. Supreme Court issued its seismic decision in Dobbs v. Jackson Women’s Health Organization (Dobbs), the nationwide aftershocks created a perilous legal landscape for providers, health care workers, patients, and allies. In addition to upending approximately 50 years of privacy precedent, the Dobbs decision raised a series of new questions about the primacy of federal health care laws vis a vis state laws, with state-based anti-abortion statutes as the crucible. This article discusses some post-Dobbs litigation trends that have materialized as courts attempt to balance state and federal laws.

Context for this discussion matters. The Supreme Court decided Dobbs on June 24, 2022.[1] Nineteen days later, President Biden issued Executive Order No. 14,076 (Executive Order), which instructed the U.S. Department of Health and Human Services (HHS) to take steps to "protect health care service delivery and promote access to critical reproductive health care services, including abortion" and to coordinate federal efforts to protect reproductive rights and access to health care.[2] Among other things, the President ordered the HHS Secretary to protect and expand access to abortion care, including abortion pills through pharmacies, and to consider updates to the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd (EMTALA) (these efforts will be discussed further below).[3]

The Executive Order proved to be prescient. Litigation ensued within weeks. Parties have challenged the legality of state abortion restrictions under state constitutional theories. Parties also have challenged conflicting guidance between federal and state laws for pharmacies dispensing abortion-inducing medications. Further, parties have identified EMTALA as an epicenter for the question of whether new rigors for protecting the life of the unborn countenance placing expectant mothers at risk. This article briefly discusses several of these litigation issues and begins to describe the new legal landscape that is emerging in America related to reproductive health care, with Dobbs as the impetus.

Rapidly Changing State Abortion Laws

The right to an abortion is now determined on a state-by-state basis. Providers and health care workers must consider the rapidly changing laws of the states in which they live and practice to ensure compliance. Georgia provides a critical example.

In 2019, Georgia passed the Living Infants Fairness and Equality (LIFE) Act. The LIFE Act prohibits providers from performing abortions after a gestational age of six weeks, absent special circumstances.[4] On November 15, 2022, a state trial court held that the LIFE Act was void ab initio, meaning that it had no legal effect from the start, because the statute violated Georgia's Constitution when it was passed in 2019 due to an inescapable conflict between the LIFE Act and the then-applicable standard codified by Roe v. Wade.[5] Eight days later, the Georgia Supreme Court stayed this decision while the substantive appeal remains pending.[6] In only a matter of months, the Georgia abortion law shifted multiple times—Roe governed, then the LIFE Act governed, then the LIFE Act was found void, and now the LIFE Act governs once again, pending the Georgia Supreme Court's review of the appeal.

Georgia is a microcosm. On January 5, 2023, the Supreme Courts of Idaho and South Carolina ruled on the constitutionality of their states' respective abortion laws.[7] In Idaho, Planned Parenthood organizations sued the state seeking a writ of prohibition and declaratory relief to block implementation and enforcement of the Idaho anti-abortion laws. They argued, in part, that these laws violate an implicit fundamental right to abortion purportedly contained in the Idaho Constitution.[8] The Supreme Court of Idaho emphasized the political nature of the question and ultimately ruled that the Idaho Constitution does not protect the right to abortion as a fundamental right.[9]

In contrast, in South Carolina, Planned Parenthood organizations sued the state, arguing that South Carolina's abortion law violates a woman's right to privacy under the state constitution. There, the South Carolina Supreme Court struck down the state anti-abortion law ruling that it is "an unreasonable restriction upon a woman's right to privacy and is therefore unconstitutional."[10]

Ultimately, these three states highlight the need for practitioners and citizens alike to pay close attention to the current and evolving state of the law.

Pharmacies Are Impacted

Weeks after the Supreme Court issued its Dobbs decision, HHS issued its Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services (Guidance) to address a growing concern about the impact of Dobbs on the prescribing of medications that either are directly intended to facilitate, or that could have the incidental impact of facilitating, the end of an otherwise healthy pregnancy.[11] HHS' Guidance emphasized the duty under federal civil rights laws of pharmacies and pharmacists to fill lawfully prescribed medications.[12] Litigation and uncertainty exists nonetheless.

Federal law prohibits pharmacies that receive federal financial assistance (including, as the largest examples, Medicare and Medicaid) from discriminating against customers on the basis of race, color, national origin, sex, age, and disability in their programs and activities, such as supplying, making determinations on, and advising about prescription medications.[13] These anti-discrimination protections are derived from the confluence of several statutes:

1. the Americans with Disabilities Act (ADA) of 1990[14];
2. Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794; and
3. Section 1557 of the Patient Protection and Affordable Care Act (ACA).[15]

According to HHS' Guidance, several anti-discrimination laws apply to pregnancy. First, pregnancy discrimination can be characterized as a form of sex discrimination.[16] Second, the medical repercussions from a pregnancy may qualify as a disability, warranting federal protections.[17] Third, under federal law, pregnancy discrimination includes discrimination based on a current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.[18] The Guidance reminds pharmacies that they are prohibited from discriminating against customers who fall within protected classes of individuals. Most are familiar with the legal prohibition against discrimination in the workplace based on a host of protected factors (including, among others, sex).[19] The same prohibition applies in other contexts as well.[20] But these known discrimination protections seldom touch upon the concern for what prescription a pharmacist may fill and the possible repercussions for refusing to fill that prescription.[21] In the post-Dobbs world, however, they do.

HHS' Guidance creates tension between the prohibition of discrimination against pregnant individuals in the dispensing of medicine and restrictive state abortion laws.[22] Abortion inducing medications like mifepristone, misoprostol, and methotrexate are also used, for example, for severe and chronic stomach ulcers or to decrease the risk of pregnancy complications.[23] When states criminalize abortion, pharmacists are forced to decide whether and under what conditions to fill otherwise lawful prescriptions given the risk that those same medications could be used to facilitate unlawful abortions. This may lead pharmacists to choose not to fill certain prescriptions, perhaps in violation of federal law.[24]

This dilemma also raises the question of the role pharmacists should play in policing the use of potentially problematic medications. For example, in Missouri, a female customer was unable to obtain her lawfully prescribed prescription for methotrexate, which was being used to treat her rheumatoid arthritis, until she received confirmation from her prescribing physician that the medication would not be used to induce an abortion.[25] Such forced confirmations could have privacy concerns and impact privilege requirements.[26] Notably, Missouri's anti-abortion law designates conduct that induces or aids in the inducement of an abortion as a Class B felony.[27]

The evolving state of abortion laws has also impacted pharmaceutical manufacturers. For example, GenBioPro, Inc., a manufacturer of generic mifepristone, sued the state of Mississippi over its ban of the drug.[28] GenBioPro argued that the federal FDA's approval of the drug preempted the state abortion law.[29] GenBioPro also argued that Mississippi's ban impedes the free flow of trade among the states and may violate the Commerce Clause of the U.S. Constitution because regulations of one state impact access to abortion across several states, affecting interstate commerce overall.[30] The defendant, Mississippi State Health Officer Dr. Thomas Dobbs, rebutted these claims by arguing that "there is no evidence that Congress ever intended the FDA to have the power to nullify a state’s ability to regulate in the controversial and highly sensitive area of abortion" and the issues do not violate the Commerce Clause because the laws are non-discriminatory and do not unreasonably burden interstate commerce.[31] Ultimately, GenBioPro voluntarily dismissed this matter.[32] On January 25, 2023, GenBioPro resurrected these arguments in a similar lawsuit filed against the state of West Virginia.[33] This new matter remains pending.

Uncertainty has led to government intervention as well. On October 14, 2022, HHS announced an investigation against Walgreens and CVS due to reports that pharmacists were refusing to fill prescriptions for misoprostol and methotrexate.[34] This investigation, in concert with the above-referenced HHS Guidance emphasizing pharmacy obligations under federal civil rights laws, demonstrates that HHS is doubling down on the obligation of pharmacies to fill prescriptions regardless of whether those prescriptions can be utilized to induce an abortion. Pharmacies that do not comply risk being investigated for and potentially violating federal civil rights laws.

Most recently, on January 3, 2023, the Food & Drug Administration (FDA) redoubled its efforts to increase access to mifepristone, as the FDA announced a new pharmacy certification plan for the abortion pill.[35] This certification plan will create a quicker turnaround time for access to the medication and increase access overall.[36]

Balancing the Requirements of EMTALA with State Abortion Laws

Dobbs has also created uncertainty in the application of other federal health care laws such as EMTALA. Most hospitals have emergency rooms, and virtually all hospitals participate in federal payer programs. Those that do are governed by EMTALA, which mandates that such hospitals provide to emergency room patients (1) a medical screening examination to determine whether an emergency medical condition exists and (2) any necessary stabilizing treatment or a transfer to a facility that can do so.[37] In the context of Dobbs, an emergency medical condition includes symptoms of sufficient severity to result in "placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy."[38] Further, an emergency medical condition with respect to a woman who is having contractions includes a situation where a "transfer may pose a threat to the health or safety of the woman or the unborn child."[39]

If an emergency medical condition is diagnosed, EMTALA further requires that the hospital provide stabilizing treatment or an appropriate transfer to another hospital that has the capabilities to provide stabilizing treatment.[40] An appropriate transfer is one that "minimizes the risks to the individual's health and, in the case of a woman in labor, the health of the unborn child."[41] Critically, an emergency medical condition may require care that has the ancillary effect of harming a pregnancy.[42]

Weeks after Dobbs, CMS issued guidance that reinforced practitioners' EMTALA obligations irrespective of state laws or mandates that apply to abortion procedures.[43] Therefore, except possibly for pregnant patients located in Texas, if a physician believes that an abortion (or treatment that potentially could harm a fetus) is needed as the stabilizing treatment for a pregnant individual, the physician has an EMTALA-imposed duty to provide this treatment irrespective of any state law.[44] Failure to abide by EMTALA's requirements could lead to steep civil monetary penalties,[45] exclusion from participation in Medicare and state health care programs, a lawsuit for damages, or possible whistleblower lawsuits.[46]

Additionally, on July 11, 2022, HHS Secretary Xavier Becerra released a letter to health care providers further emphasizing that EMTALA "protects [their] clinical judgment and the action[s] that [they] take to provide stabilizing medical treatment to [] pregnant patients, regardless of the restrictions in the state where [they] practice."[47] Beccera specifically noted that stabilizing treatment under EMTALA can include, for example, abortion, removal of one or both fallopian tubes, anti-hypertensive therapy, or methotrexate therapy, regardless of state laws or mandates that apply to these procedures.[48] This letter reaffirmed that a physician must comply with EMTALA regardless of inconsistent state laws (including anti-abortion statutes).

Notwithstanding, two related federal cases testing the boundaries of HHS' Guidance have led to vastly conflicting results. First, in August 2022, the U.S. Justice Department filed suit against the state of Idaho claiming that Idaho Code § 18-622 conflicts with EMTALA's requirements.[49] Under the Idaho law, “[e]very person who performs or attempts to perform an abortion . . . commits the crime of criminal abortion,” a felony punishable by two to five years in prison.[50] A violation would result in the suspension of a professional license for a minimum of six months for a first offense and a permanent license revocation for a subsequent offense.[51]

Significantly, this statute inverts the burden of proof. The statutory presumption is that a doctor performing a procedure that harms a fetus is guilty unless and until the doctor proves that the procedure was justified under state law.[52] On August 24, 2022, the U.S. District Court for the District of Idaho held that this law conflicted with and therefore was preempted by EMTALA. The court ruled that it is impossible to comply with both statutes because Idaho's anti-abortion statute precluded the precise sort of stabilizing care that EMTALA mandates.[53]

In Texas, however, similar arguments resulted in a far different outcome.[54] In Texas v. Becerra, Texas sued HHS claiming, in part, that the Guidance unlawfully required health care providers to perform abortions even though Texas outlaws them.[55] Unlike in Idaho, the Northern District Court of Texas granted a preliminary injunction holding that (i) the Guidance goes beyond EMTALA's statutory text, among other things, and (ii) HHS violated the federal Administrative Procedure Act in issuing the Guidance without the appropriate proposed rulemaking process.[56] The court further held that EMTALA protects both live patients and unborn children.[57] Finally, the district court held that because "EMTALA is unclear about the obligations of doctors in cases of conflict between the health of a pregnant woman and her unborn child," there is no direct conflict between EMTALA and state laws.[58]

Because two federal district courts have reached different results in addressing the tension between EMTALA and state abortion prohibitions, there is no developing consensus about whether HHS' Guidance or that of contrary state laws should govern scenarios in which pregnant individuals present to emergency rooms with unstable health. This divergence of judicial opinion potentially creates immense confusion for providers determining what emergency care can and should be provided (especially in Texas, where the federal government appears to be enjoined from enforcing EMTALA under certain scenarios).

Risks to Allies and Employers Supporting Abortion Services

Finally, following the Dobbs decision there has been an explosion of announcements by individuals, nonprofit agencies, and corporate actors publicizing efforts to help individuals obtain the abortive care they seek. These efforts can lead to many potential litigation risks (i.e., "Ally Risk"), including damages or even criminal liability under an aiding or abetting theory. For instance:

Employment—employers providing travel accommodations for employees' abortion access may spark allegations from states and anti-abortion organizations that these accommodations are aiding and abetting a prohibited abortion.[59] Notably, on July 7, 2022, an anti-abortion advocacy group warned a law firm that its decision to reimburse the travel costs of employees who leave Texas to have an abortion exposed the law firm to "felony criminal prosecution and disbarment" under Texas abortion law, the Texas Heartbeat Act.[60] Threats aside, as of the drafting of this article, we are not aware of litigation on this issue. Similarly, there is risk that such employers may face employment-law related risk from workers in need of other accommodations "because [employers] are not offering equivalent benefits for their medical needs."[61]

Tax and ERISA—Companies that sponsor Employee Retirement Income Security Act (ERISA)-governed group health plans could face tax consequences under the Internal Revenue Code and fiduciary duty issues under ERISA. Employee benefit law specialists should be consulted before changing the scope and benefits available under such a plan, like potentially adding tax-advantaged travel reimbursements where necessary for plan participants to attain any plan-covered services that may not be available in their geographic area, including but not limited to any abortive care that may be payable by the plan. Generally, ERISA-governed, fully-funded group health plans must comply with state coverage requirements, while self-insured plans have more freedom to amend their plans to add flexibility for this travel.[62] In all instances, plan fiduciaries must follow approved written plan terms.[63] Litigation is likely to ensue in the future that will provide clarity on whether states or anti-abortion organizations have the ability to bring legal action against employer health plans for providing abortion-related benefits.[64]

Corporate Governance—Ally risk is also present through Section 220 of the Delaware General Corporate Laws (DGCL), which requires for-profit Delaware companies to open their books and corporate records with shareholders under certain circumstances.[65] Other states have similar provisions allowing review of books and records, as well.[66] Section 220 is often used for shareholder derivative suits in which shareholders may seek to obtain information related to a claim of breach of a fiduciary duty. Corporations may be subject to litigation claiming corporate waste. Corporate officers may face claims that the use of corporate resources to enable employees to seek abortive care breaches a fiduciary duty to the organization. Moreover, there is an enhanced risk that laws like DGCL § 220 would lead to a breach of personal health information held by the company.[67]

Conclusion

The Dobbs decision has spurred litigation in an attempt to redefine and clarify abortion laws and access in the United States. The litigation implications are far-reaching. It is crucial for health care providers, patients, and allies to remain actively informed about the constantly evolving developments in abortion laws, federal guidance, and legal precedent. In this post-Dobbs world of often inconsistent and ill-defined abortion laws, questions will arise and inevitable litigation will occur in an effort to redraw the map of the legal landscape related to reproductive health care rights in the United States.

ARTICLE TAGS

• Reproductive Health Law Hub