By Sheryl Allenson, J.D.
Ten states failed to intervene in action alleging that the FDA’s failure to suspend certain requirements related to medication abortion for the duration of the current COVID-19 pandemic violated the Fifth Amendment.
The states filed a motion to intervene in the action commenced by, among others, the American College of Obstetricians and Gynecologists (ACOG) against the FDA and other agencies and administrators, arguing that they were entitled to intervention as a right, or in the alternative, permissive intervention (American College of Obstetricians and Gynecologists v. FDA, June 15, 2020, Chuang, T).
The underlying suit arose because the FDA did not suspend for the course of the current COVID-19 pandemic certain requirements relating to the distribution of drugs used for medication abortions. The FDA requires that the first drug, mifepristone, be picked up at the hospital, clinic or office of the clinician who prescribed it. The suit centers on the FDA’s requirements surrounding mifepristone.
In-person dispensing requirement. The in-person requirement, along with others, were imposed under certain FDA guidelines, including the Risk Evaluation and Mitigation Strategy (REMS) authority and Elements to Assure Safe Use (ETASU). Mifepristone has three ETASU, including the in-person dispensing requirement. However, given the COVID-19 pandemic, the CDC issued guidance encouraging health care providers to use telemedicine. ACOG claimed that in light of the COVID-19 crisis, the continuing requirement for in-person pick up of mifepristone creates an undue burden on women in violation of their constitutional rights.
Intervention. Ten states filed a motion to intervene. At the outset, the court explained that to intervene as of right, a party must meet four requirements. First, they must file a timely motion to intervene, which was not in dispute here. Second, they must demonstrate a "direct and substantial interest" in the transaction at issue. Third, the intervenors must prove that interest would be impaired in the absence of intervention. Finally, they must establish that the interest is inadequately represented by the existing parties.
The court first decided that the states did not have a direct and substantial interest, which it noted exists when a party gains or lose by operation of the court’s judgement. The court rejected the states’ argument that intervention was proper because resolution of the case could "impact the enforcement of each State’s own laws that relate to or reference the FDS’s regulation of mifepristone."
In its review, the court found that most of the state statutes were not facially linked to the enforcement of the relevant FDA requirements, such that a resolution of the underlying case would impair the states’ ability to enforce their own laws regarding the drug. Some of the state statutes were more restrictive than the FDA requirements, according to the court. Eight statutes failed to even reference the FDA regulations. The court found that those state statutes "are independent of the federal scheme and are not subject to ‘unitary enforcement.’" The court found those states lacked a direct interest in the case. Although the other two states did reference the FDA requirement, the states failed to demonstrate a direct and substantial interest.
Next, the court found that the states failed to show that in the face of a denial of their motion, that there would be a "[p]ractical impairment" of their ability to protect their interests. The court noted that the ACOG was not seeking to invalidate the states’ abortion laws. Rather, the court noted that a finding for ACOG would not directly render those laws unenforceable. Ultimately, the court ruled that there was no impairment of a direct and substantial interest warranting mandatory intervention.
Finally, the court rejected the states’ position that the FDA could not adequately represent their interests. Both the FDA and states have the same goal, the court said, which is to obtain a finding that the FDA regulations are constitutional. Thus, there is a presumption that he states’ interests would be adequately represented, and the states failed to provide a strong showing of inadequacy to the contrary. Accordingly, the court ruled that the states fell short on satisfying the four requirements for mandatory intervention, and therefore denied the states’ motion on that ground.
Similarly, the states failed to make out a sufficient argument for permissive intervention. The court cited a lack of judicial economy, stating that "the benefits of intervention are outweighed by the likely undue delay." The court also suggested that permissive intervention would lead to injection of issues relating to different state laws in a complaint that focuses plainly on federal regulation. Thus, the court denied the states’ motion for permissive intervention, as well.
The case is Civil Action No. TDC-20-1320.
Attorneys: Andrew T. Tutt (Arnold and Porter Kaye Scholder LLP) for American College of Obstetricians & Gynecologists, Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, Sistersong Women of Color Reproductive Justice Collective and Honor MacNaughton M.D. Hilary Keith Perkins, U.S. Department of Justice, for United States Food and Drug Administration, Stephan Hahn M.D. and United States Department of Health and Human Services.
Companies: American College of Obstetricians & Gynecologists; Council of University Chairs of Obstetrics and Gynecology; New York State Academy of Family Physicians; United States Food and Drug Administration; United States Department of Health and Human Services
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