FedSoc Forums

Two cases concerning the FDA’s approval of Mifepristone, Alliance for Hippocratic Medicine v. United States Food and Drug Administration (AHM v. FDA) and Washington v. United States Food and Drug Administration (WA v. FDA) have caused significant conversations concerning the FDA’s approval processes, statutes of limitation for challenges to approvals, standing, administrative review, and judicial authority. The cases present interesting questions concerning the regulatory process, separation of powers, and the role of judges.

In AHM v. FDA, a judge out of the Northern District of Texas blocked the FDA’s approval of the drug, meaning it could no longer be distributed as an FDA-approved drug. The same day, in WA v. FDA, however, a separate district judge ruled the FDA was being overly restrictive and barred it from altering the regulatory status of Mifepristone in approximately a third of the country. Perhaps due to the drastic split between the courts, both cases have quickly ascended through the courts of appeals.

Join our panel of experts, including Adam Unikowsky --a partner at Jenner & Block who has written substantively on the issue and and whose firm submitted an amicus brief on behalf of numerous organizations in support of the FDA in AHM v. FDA, and Thomas Jipping –a Senior Legal Fellow at the Heritage Foundation where he has published on these issues, in a conversation moderated by Jennie Lichter as they discuss these cases, their substance, and the possible ramifications of future decisions.

Featuring:

Thomas Jipping, Senior Legal Fellow, Edwin Meese III Center for Legal and Judicial Studies, The Heritage Foundation
Adam Unikowsky, Partner, Jenner & Block LLP
[Moderator] Jennie Lichter, Deputy General Counsel, The Catholic University of America

In February 2023, Russian President Vladimir Putin announced that Russia would withdraw from the New START arms reduction treaty, which was the last remaining arms control treaty between the two nations that together control almost 90% of the world’s nuclear warheads. Then, in March, Putin announced that Russia would place nuclear-capable ballistic missile systems in Belarus, which shares a border with Poland. Harvard Professor and national security expert Stephen P. Rosen discussed the implications of these events for the U.S. security and arms-control efforts, as well as the broader strategic landscape for nuclear weapons.


Featuring:
--Stephen P. Rosen, Beton Michael Kaneb Professor of National Security and Military Affairs, Harvard University
--Moderator: Dan West, Director, SCF Partners

In Sackett, the Court clarified one of the longest-standing environmental law challenges: defining “waters of the United States.” The Court unanimously rejected the “significant nexus” test for jurisdiction and adopted the “relatively permanent waters” test from the plurality decision in the 2006 case, Rapanos v. United States. Also in Sackett, a 5-4 majority narrowed the definition of adjacent wetlands significantly.

Listen to a recording of this panel as they discuss the Court’s decision, how it might impact the Biden EPA’s recently adopted regulation, and the future of the Clean Water Act.

Featuring:
--Moderator: Hon. Thomas Griffith, Fmr. Judge, US Court of Appeals, DC Circuit; Special Counsel, Hunton Andrews Kurth
--Deidre Duncan, Partner & Environmental Practice Group Leader, Hunton Andrews Kurth
--Tom Ward, Vice President for Litigation, National Association of Home Builders
--Sambhav Sankar, Senior Vice President of Programs, Earthjustice
Professor William W. Buzbee, Director, Environmental Law & Policy Program, Georgetown Law

On Thursday, June 8, 2023, the Supreme Court issued its decision in Allen v. Milligan. The case considered whether the districting plan adopted by the State of Alabama for its 2022 congressional elections violated §2 of the Voting Rights Act. §2 of the Voting Rights Act reads – “No voting qualification or prerequisite to voting, or standard, practice, or procedure shall be imposed or applied by any State or political subdivision to deny or abridge the right of any citizen of the United States to vote on account of race or color.”

In a 5-4 decision with one concurring and two dissenting opinions, the Court held that “plaintiffs demonstrated a reasonable likelihood of success on their claim that HB1 violates §2,” 598 U.S. ___ (2023). The 112-page opinion is complex; it examines a considerable body of court precedent and law. Some court watchers and media outlets have described the Court’s opinion as a surprise.

In this recorded webinar, Professor Michael R. Dimino discusses the Court’s opinion and what might come next.

Featuring:
--Professor Michael R. Dimino, Professor of Law, Widener University Commonwealth Law School

Most of the public debate about administrative deference has been focused on federal agencies and the Chevron and Auer doctrines. There is an old adage though that “You can’t fight City Hall.” This panel discussion among current and former local government attorneys took a critical look at this adage through the lens of administrative deference at the local level. Topics included an evaluation of Chevron and Auer-type deference at the local level when interpreting municipal ordinances (noting, for example, that Florida has recently barred Chevron deference for localities), whether the lack of separation of powers within local governments alters how administrative deference should be assessed, whether deferential standards of appellate review for local government decisions provides an adequate judicial check, and what procedural due process safeguards have been effective in ensuring that “you can fight City Hall” when a litigant has a meritorious case.

Featuring:
--Amanda Conn, General Counsel, WSSC Water; Professorial Lecturer in Law, George Washington Law School
--Craig E. Leen, Partner, K&L Gates; Professorial Lecturer in Law, George Washington Law School; Former OFCCP Director and Former Coral Gables City Attorney
--Michael Murawski, Executive Director, City of Naples Commission on Ethics and Government Integrity
--(Moderator) Hon. Alexander S. Bokor, Judge, Florida Third District Court of Appeal; Former Assistant County Attorney for Miami-Dade County

Artificial intelligence is a remarkable, disruptive force. AI services like ChatGPT already perform tasks once thought impossible for computers to complete. And AI's capabilities are growing exponentially. Although AI promises many benefits, it also carries risks and potential for abuse, which has led some commentators across the ideological spectrum to call on the government to regulate AI. What is the government's role, if any, in the AI revolution? Is the government capable of regulating AI without creating excessive externalities? Join three new voices in administrative law for a framing of the key debates emerging around AI regulation.
Featuring:

Eli Nachmany, Law Clerk to Hon. Steven J. Menashi, U.S. Court of Appeals for the Second Circuit
Laura Stanley, Law Clerk to Hon. Stephen Schwartz, U.S. Court of Federal Claims
Seanhenry VanDyke, Law Clerk to Hon. Gregory Katsas, U.S. D.C. Circuit Court of Appeals
[Moderator] Prof. Aram Gavoor, Associate Dean for Academic Affairs; Professorial Lecturer in Law, The George Washington University Law School

Section 504 of the Rehabilitation Act of 1973 protects qualified "individuals with disabilities" from discrimination by "programs or activities" that receive federal funding. The word disability is defined in Title 42 USC Section 12102, and it is noted that the definition "shall be construed in favor of broad coverage." Similarly, 504 regulations cover a wide array of "programs or activities" - colleges, corporations, state government entities, even local government entities, including public schools, can meet the definition of a covered "program or activity."

The Biden Administration has wrestled with Section 504 on issues like remote learning, masking, transgender status, child welfare, and more. Additionally, there has been increased discussion surrounding Section 504's applicability to private schools. Some disability advocates have argued that Section 504 is outdated and needs to be revamped before the end of President Biden's first term.

What updates to Section 504 can we expect? What trends have experts observed in 504 regulations before and after President Biden took office? Does Section 504 inadequately address disability discrimination today? Please join us as Kim Richey and Professor Robert Dinerstein consider these questions and more.

Recently, the application of Textualism by the Supreme Court of the United States--the predominant method of statutory interpretation that favors the plain meaning of text over legislative intent, statutory purpose, or legislative history--has given rise to rich debate as to its legitimacy, vitality, and future application. This webinar explored and advanced that debate with some of the leading minds in the field.

Featuring:

--Prof. Nicholas Bagley, Professor of Law, University of Michigan Law School
--Prof. William Baude, Professor of Law, University of Chicago Law School
--Prof. Emily Bremer, Associate Professor of Law, University of Notre Dame Law School
--Prof. Christopher J. Walker, Professor of Law, University of Michigan Law School
--[Moderator] Hon. Gregory G. Katsas, Circuit Judge, U.S. Court of Appeals for the District of Columbia Circuit


Related Links:
The 2023 Scalia Lecture: Beyond Textualism?, Harvard Journal of Law and Public Policy, Vol. 46, 2023, available at https://papers.ssrn.com/sol3/p...
Interpreting the Administrative Procedure Act: A Literature Review, 98 Notre Dame L. Rev. (forthcoming 2023), available at https://ssrn.com/abstract=4340363.

On May 18, the Supreme Court ruled unanimously in favor of Sanofi in its dispute with Amgen over alleged patent infringement. The case involved the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a "genus claim" as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein (“LDL”) cholesterol.

Specifically at issue was "whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to 'make and use' the claimed invention, or whether it must instead enable those skilled in the art 'to reach the full scope of claimed embodiments' without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial 'time and effort.'"

Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to unpack the decision.

Featuring:
--Robert J. Rando, Partner, Greenspoon Marder LLP

On Thursday, May 25, 2023, the Supreme Court issued a unanimous decision in Tyler v. Hennepin County, Minnesota, a landmark case addressing property rights under the Takings Clause. The case specifically focuses on the issue of "home equity theft," which refers to a practice of local governments seizing a property’s entire value to settle a much smaller delinquent property tax debt.

Hennepin County foreclosed on Geraldine Tyler's home to cover her delinquent property taxes, having sold the home for $40,000 and retained the $25,000 surplus as profit. Tyler argued that the county could not take the equity in her home and asked the Supreme Court to declare the forfeiture of her home's equity as an unconstitutional taking and excessive fine. The county maintained that Tyler had sufficient time to pay her taxes and was not entitled to any refund.

The Court unanimously ruled that such practices qualify as takings requiring the payment of "just compensation" under the Takings Clause of the Fifth Amendment. It also concluded that state law is not the sole source of the definition of property rights under the Takings Clause, and therefore state governments cannot seize private property without compensation simply by redefining it as the state's property.

Listen to Tony Francois's analysis of the decision and discussion the potential implications from this landmark ruling.

Featuring:
--Tony Francois, Partner, Briscoe Ivester & Bazel