Latest 5 Cases This Week: Vapor Technology Association v. United States Food and Drug Administration (6th Cir.), Nasello v. Eagleson (7th Cir.), ...

“Might as Well Carry a Purse with That Mask, Joe”: COVID-19, Toxic Masculinity, and the Sad State of National Politics

JOANNA L. GROSSMAN, LINDA C. MCCLAIN

SMU Dedman School of Law professor Joanna L. Grossman and Boston University law professor Linda C. McClain comment on COVID-19, toxic masculinity, and the state of national politics today. Grossman and McClain contrast President Trump’s reckless bravado that endangers the lives of Americans with the empathy of Democratic presidential nominee former Vice President Joe Biden’s in asking people to be patriotic by doing their part by wearing masks to protect other Americans.

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Should Department of Justice Lawyers Defy William Barr?

AUSTIN SARAT

Austin Sarat—Associate Provost, Associate Dean of the Faculty, and William Nelson Cromwell Professor of Jurisprudence and Political Science at Amherst College—comments on an open letter addressed to the 100,000 professionals working in the U.S. Department of Justice and published by Lawyers Defending Democracy. In the letter, more than 600 members of the bar from across the United States call on their DOJ colleagues to refrain from “participating in political misuse of the DOJ in the elction period ahead.” Sarat argues that the letter rightly recognizes that Attorney General Barr’s blatant partisanship endangers the integrity of the DOJ itself and its role in preserving the rule of law.

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Vapor Technology Association v. United States Food and Drug Administration

Court: US Court of Appeals for the Sixth Circuit

Docket: 20-5199

Opinion Date: October 5, 2020

Judge: Per Curiam

Areas of Law: Civil Procedure, Government & Administrative Law, Health Law

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) allows the FDA to regulate tobacco products. Tobacco products that were not on the market in February 2007 or that were modified after that date must obtain premarket authorization. The 2016 “Deeming Rule” subjected cigars, pipe tobacco, and electronic nicotine delivery systems to the TCA; about 25,000 existing products became subject to 21 U.S.C. 387j(a). The FDA planned to stagger compliance periods for deemed tobacco products. In 2018, public health organizations challenged FDA “guidance” issued under the TCA. The Maryland district court granted them summary judgment. Compliance deadlines had passed but the court concluded that it could impose a deadline because the case presented extraordinary circumstances. The court ordered the FDA to require that premarket applications be filed within 10 months (May 2020) but declined to require enforcement actions. The FDA issued new guidance in January 2020, stating that it intended to prioritize enforcement of the premarket-review requirements for e-cigarettes beginning in May 2020. Before the Fourth Circuit ruled, the district court amended its injunction, in light of the pandemic, to require that applications be submitted by September 2020. The FDA revised its guidance accordingly. The Fourth Circuit dismissed the appeal. An e-cigarette trade organization sought a declaration that FDA’s deadline was unlawful agency action under the APA in the Eastern District of Kentucky, arguing the FDA’s brief and an attached declaration motivated the Maryland court to impose that deadline, which significantly accelerated the original FDA deadline. The Sixth Circuit affirmed that the plaintiffs lacked standing. The Maryland court’s injunction was independent of the FDA’s brief and declaration; the allegedly unauthorized court submissions do not form a plausible legal basis for an injunction against subsequent, independently-caused FDA enforcement proceedings.

Nasello v. Eagleson

Court: US Court of Appeals for the Seventh Circuit

Docket: 19-3215

Opinion Date: October 6, 2020

Judge: Frank Hoover Easterbrook

Areas of Law: Civil Rights, Constitutional Law, Government & Administrative Law, Health Law, Public Benefits

Most people eligible for Medicaid benefits are “categorically needy” because their income falls below a threshold of eligibility. People with higher income but steep medical expenses are “medically needy” once they spend enough of their own assets to qualify, 42 U.S.C. 1396a(a)(10). Plaintiffs contend that medical expenses they incurred before being classified as “medically needy” should be treated as money spent on medical care, whether or not those bills have been paid, which would increase Illinois's payments for their ongoing care. The Seventh Circuit affirmed the dismissal of their suit. Medicaid is a cooperative program through which the federal government reimburses certain expenses of states that abide by the program’s rules. Medicaid does not establish anyone’s entitlement to receive particular payments. The federal-state agreement is not enforceable by potential beneficiaries. Plaintiffs bypassed their administrative remedies and do not have a judicial remedy under 1396a(r)(1)(A). Section 1396a(a)(8) provides that a state’s plan must provide that all individuals wishing to apply for medical assistance under Medicaid shall have the opportunity to do so and that assistance shall be furnished with reasonable promptness to all eligible individuals; some courts have held that this requirement can be enforced in private suits. If such a claim were available, it would fail. Plaintiffs are receiving benefits. The court also rejected claims under the Americans with Disabilities Act, 42 U.S.C. 12131–34, and the Rehabilitation Act, 29 U.S.C. 794. Plaintiffs receive more governmental aid than nondisabled persons.

Premier Health Care Investments, LLC v. UHS of Anchor, LP

Court: Supreme Court of Georgia

Docket: S19G1491

Opinion Date: October 5, 2020

Judge: Warren

Areas of Law: Government & Administrative Law, Health Law, Zoning, Planning & Land Use

In 2005, the Georgia Department of Community Health (Department) promulgated a rule, commonly known as the “Psychiatric Rule” (“the Rule”), that required hospitals to obtain a Certificate of Need (“CON”) “prior to the establishment of a new or the expansion of an existing acute care adult psychiatric and/or substance abuse inpatient program,” and defined “expansion” as “the addition of beds to an existing CON-authorized or grandfathered psychiatric and/or substance abuse inpatient program.” The issue this case presented for the Georgia Supreme Court's review centered on whether the Department could, through the Rule, require a licensed hospital with a psychiatric/substance-abuse program authorized by a CON, to obtain an additional CON to redistribute inpatient beds in excess of those identified in its CON to operate a psychiatric/substance-abuse program, but within its total licensed bed capacity. In UHS of Anchor, L.P. v. Department of Community Health, 830 SE2d 413 (2019), the Court of Appeals held that the Department could. The Supreme Court determined the appellate court erred in that conclusion, and reversed. "The General Assembly’s delegation of legislative authority to the Department to promulgate rules as part of its administration of the CON program does not include the authority to define additional new institutional health services requiring a CON, beyond those listed in OCGA 31-6-40 (a)."

In re Judiciary’s Response to COVID-19 Outbreak

Court: Supreme Court of Hawaii

Docket: SCMF-20-0000152

Opinion Date: October 5, 2020

Judge: Per Curiam

Areas of Law: Criminal Law, Health Law, Legal Ethics

The Supreme Court extended an August 27, 2020 order for first circuit criminal matters, which was extended pursuant to a September 11, 2020 order, until November 16, 2020, determining that changing conditions wrought by the COVID-19 pandemic required flexibility and vigilance regarding the need to protect the health and safety of court users and Judiciary personnel. In July 2020, there was a surge of COVID-19 cases in Hawaii, included cases in community correctional centers and facilities, particularly at the O'ahu Community Correctional Center. As a result, the time requirements for preliminary hearings under Haw. R. Pen. P. (HRPP) 5(c)(3) was impacted. In August 2020, the Supreme Court entered an order providing that the first circuit may temporarily extend the time requirements for preliminary hearings no longer than reasonably necessary to protect public health and safety. In September, the order was extended. Because the transports of custody defendants from all O'ahu correctional facilities remained suspended and the exponential number of citations issued for Haw. Rev. Stat. ch. 127A violations remained high, the Supreme Court extended the August order for first circuit criminal matters until November 16, 2020.

In re ACTD LLC, d/b/a The Green Mountain Surgery Center

Court: Vermont Supreme Court

Citation: 2020 VT 89

Opinion Date: October 2, 2020

Judge: Eaton

Areas of Law: Government & Administrative Law, Health Law, Zoning, Planning & Land Use

During the certificate of need (CON) application process, applicant ACTD, LLC (operator of the Green Mountain Surgery Center (GMSC), a for-profit multi-specialty ambulatory surgery center), indicated that it initially planned to offer surgical services in five identified specialties. After the CON was issued, applicant notified the Board that in addition to these five specialties, it planned to offer plastic surgery and ophthalmology procedures. The Board chose to review these changes and, after hearing, issued a decision clarifying that the original CON was limited in scope to the five specialties applicant had identified in its application, and that the proposed addition of plastic surgery and ophthalmology procedures was a nonmaterial change to the project. The Board concluded that applicant had demonstrated a need for greater access to plastic surgery and ophthalmology procedures currently performed in a hospital setting and approved the addition of these services. However, it rejected applicant’s proposal to offer ophthalmology procedures already available at another ambulatory surgery center nearby. The Board also extended applicant’s implementation reporting period for two additional years. Applicant argued on appeal of the Board's decision that the Board improperly restricted the scope of the CON and lacked the power to extend the reporting requirement. Finding that the Board acted within its authority, the Vermont Supreme Court affirmed its decision.