Latest 2 Cases: In re: Public Employees for Environmental Responsibility (Aviation), Pharmaceutical Manufacturing Research Services, Inc. v. FDA ...

Agency Guidance May Not Be Enough: Keeping Workers Safe and Avoiding Employer Workplace Liability During the COVID-19 Pandemic

SAMUEL ESTREICHER, ELISABETH CAMPBELL

NYU law professor Samuel Estreicher and 2L Elisabeth H. Campbell describe the wide array of laws that will need to come into play to keep workers safe and avoid employer liability as workplaces consider reopening amid the COVID-19 pandemic, cautioning that compliance will not necessarily relieve employers of the risk of litigation and liability. Estreicher and Campbell discuss applicable recommendations, guidelines, and requirements set forth by such agencies as the U.S. Department of Labor, which is responsible for administering the federal Occupational Safety and Health Act (OSHA), the Centers for Disease Control and Prevention (CDC), and the Equal Opportunity Employment Commission (EEOC).

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In re: Public Employees for Environmental Responsibility

Docket: 19-1044

Opinion Date: May 1, 2020

Judge: Thomas Beall Griffith

Areas of Law: Aviation, Government & Administrative Law

This case arose out of the FAA and NPS's efforts to regulate commercial sightseeing flights over national parks. The Air Tour Management Act of 2000 directs the FAA and NPS to "make every effort" to establish rules governing such flights within two years of the first application. After determining that it has jurisdiction over this mandamus petition under the All Writs Act, the DC Circuit held that petitioners had associational standing to seek relief. In this case, petitioners' members showed cognizable aesthetic and recreational injury that could be redressed by mandamus relief. On the merits, the court granted a writ of mandate compelling the FAA and NPS to regulate air tours at seven parks where they have injured members. The court analyzed the six TRAC factors and concluded that mandamus relief was warranted here where the agencies have failed to comply with their statutory mandate for the past nineteen years. The court ordered the agencies to produce a schedule within 120 days of the issuance of this opinion for bringing all twenty-three parks into compliance.

Pharmaceutical Manufacturing Research Services, Inc. v. FDA

Docket: 18-1335

Opinion Date: May 1, 2020

Judge: Rao

Areas of Law: Drugs & Biotech, Government & Administrative Law

PMRS petitioned for review of the FDA's denial of PMRS's application to market a prescription opioid drug. The DC Circuit rejected PMRS's challenges under the Administrative Procedure Act (APA), and held that the FDA's decision to deny the application was reasonable and consistent with law. The court held that the FDA examined the material factors, considered the record as a whole, and provided a reasonable explanation for its decision to deny PMRS's application. In this case, the court had no basis to question the agency's conclusion that the operative version of PMRS's proposed label created the false and misleading impression that the drug possessed abuse deterrent physical and chemical properties. The court also held that the FDA's decision to deny PMRS's request for a hearing was not an abuse of discretion.