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Food And Drug Regulation: Statutory And Regulatory Supplement, Adam I. Muchmore

Books

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

The Twin Environmental Law Problems Of Preemption And Political Scale, Erin Ryan

Scholarly Publications

This is a daunting moment for the United States environmental movement. Since 2017, it often seems that federal environmental law is being systematically dismantled—most aggressively by the executive branch, but with tacit support from much of the sitting legislature, and likely with increasing support from the judiciary as well. For environmentalists, the assault on the regulatory accomplishments made over decades of previous lawmaking is cause for grief, but it also compels preparation for the challenges yet to come. This chapter advises environmentalists to resist federal preemption of state regulation and to think creatively about how to accomplish the goals of …

Environmental Rights For The 21st Century: A Comprehensive Analysis Of The Public Trust Doctrine And Rights Of Nature Movement, Erin Ryan, Holly Curry, Hayes Rule

Scholarly Publications

This Article contrasts two theoretically distinct approaches to pursuing related objectives of environmental protection: the public trust doctrine and the rights of nature movement. It reviews the development of public trust and rights of nature principles in both domestic and international legal contexts, and explores points of theoretical commonality and contrast between the two, giving special attention to the opposing systems of environmental ethics from which the anthropocentric public trust and ecocentric rights of nature principles arise. The marked jurisdictional variation associated with both approaches suggests their evolving and inchoate nature as a guarantor of environmental rights. Moreover, both are …

Pricing Drugs Fairly, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals passed by the House and proposed by Sens. Ron Wyden and Chuck Grassley have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair that identifies fair price with social value, argues for implementing fair …

Policy Brief: The Occ’S Repeated Failures To Comply With The Dodd-Frank Act And Other Legal Authorities Governing The Scope Of Preemption For National Banks And Federal Savings Associations, Arthur E. Wilmarth Jr.

GW Law Faculty Publications & Other Works

This policy brief examines several failures by the Office of the Comptroller of the Currency (OCC) to comply with the Dodd-Frank Act and other legal authorities governing the scope of preemption for national banks and federal savings associations. The policy brief argues that the OCC should promptly rescind or revise several of its existing rules, policies, and legal interpretations to bring those materials into compliance with the Dodd-Frank Act and other applicable laws.

Health Insurance Portability And Accountability Act Of 1996: Health & Public Welfare, Erin L. Hayes, Kathryn A. Vance

Georgia State University Law Review

The Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) establish a standard for the use and protection of individuals’ health information and apply to certain covered entities or their business associates. Covered entities may only disclose an individual’s protected health information in limited situations. Covered entities or individuals that fail to comply with the Privacy Rule standards may be subject to civil or criminal penalties.

Preemption: Executive Order By The Governor To Ensure A Safe & Healthy Georgia, Marisa P. Ahlzadeh, Fanny Chac

Georgia State University Law Review

The doctrine of preemption expresses the idea that “a higher authority of law will displace a lower authority of law when the two authorities come into conflict.” Preemption exists on both the federal and state level. According to the Georgia Constitution, local laws are permissible if they do not conflict with the state law on the subject. During a Public Health State of Emergency, the Governor of Georgia maintains certain expanded powers to take necessary action for the health and safety of the public. On April 2, 2020, Governor Brian Kemp (R) used these expanded powers to enact an Executive …

Torts: Covid-19 Pandemic Business Safety Act & Executive Order By The Governor Designating Auxiliary Management Workers And Emergency Management Activities, Angelena Velaj, Troy Viger

Georgia State University Law Review

The Executive Order expanded immunity from liability for volunteer health care workers as emergency management workers performing emergency management activities. The Order was not limited to only COVID-19-related activities. When the legislature reconvened, legislators passed the Georgia COVID-19 Pandemic Business Safety Act, which provided liability limitation to businesses against tort claims arising from the pandemic.

State Vehicle Electrification Mandates And Federal Preemption, Matthew N. Metz, Janelle London

Michigan Journal of Environmental & Administrative Law

By requiring that new vehicles sold after a certain date be electric, states can lower drivers’ vehicle operating costs, boost local employment, and lower electric rates. But there’s a widespread perception that states can’t take advantage of these opportunities because a state vehicle electrification mandate would be preempted by federal law.

Not so.

While the Federal Clean Air Act (CAA) prohibits state regulations “relating to” the control of emissions in motor vehicles, and the Federal Energy Policy and Conservation Act (EPCA) prohibits state regulations “related to” fuel economy standards, there is a strong rationale for federal courts to reject preemption …

Amici Curiae Brief Of The International Municipal Lawyers Association And Legal Scholars In Support Of Defendants-Appellees In Portland Pipe Line Corporation, Et Al. V. City Of South Portland, Et Al., Sarah J. Fox, Sara C. Bronin, Nestor M. Davidson, Keith H. Hirokawa, Ashira Pelman Ostrow, Dave Owen, Laurie Reynolds, Jonathan D. Rosenbloom, Sarah Schindler

Sturm College of Law: Faculty Scholarship

This brief to the Maine Supreme Judicial Court was filed in support of the City of South Portland by the Amici Curiae, including the International Municipal Lawyers Association and legal scholars, to provide the Court with a background on the role of local governments in land use planning, and to explain why the City of South Portland’s Clear Skies Ordinance falls easily within the City’s authority and was not preempted by state legislation.

After studying the potential for bulk loading of crude oil within its boundaries, the City of South Portland concluded that the infrastructure requirements and environmental impacts of …

Express Preclusion Of The Federal Arbitration Act For All Bankruptcy-Related Matters, John R. Hardison

St. John's Law Review

(Excerpt)

This Article sets forth a more solid justification for bankruptcy courts to refuse to order arbitration of any matter related to and affecting a bankruptcy case through express preclusion. First, this Article describes the historical development of the Supreme Court’s holdings on preclusion of the FAA in general and on the courts of appeals’ current formulation of a bankruptcy exception to the FAA. Next, this Article discusses the statutory, historical, and policy-based support for reading the bankruptcy jurisdictional provisions as creating an express exception to the FAA, or alternatively as supporting an implied exception to the FAA. As discussed, …

Comment Letter In Opposition To The Occ's Proposed "Valid-When-Made" Rule, Arthur E. Wilmarth Jr.

GW Law Faculty Publications & Other Works

This comment letter responds to a proposed rule issued by the Office of the Comptroller of the Currency (OCC), which would “codify” an alleged federal common-law “principle” known as “valid-when-made.” The proposed rule would amend two of the OCC’s regulations – 12 C.F.R. 7.4001 and 12 C.F.R. 160.110 – by providing that “interest on a loan that is permissible” for a national bank or a federal savings association, under 12 U.S.C. 85 or 12 U.S.C. 1463(g)(1), “shall not be affected by the sale, assignment, or other transfer of the loan.” 84 Fed. Reg. 64229, 64230-31 (Nov. 21, 2019). Thus, the …

The Occ's And Fdic's Attempts To Confer Banking Privileges On Nonbanks And Commercial Firms Violate Federal Laws And Are Contrary To Public Policy, Arthur E. Wilmarth Jr.

GW Law Faculty Publications & Other Works

The Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) have adopted several recent measures that attempt to confer benefits and privileges of banks on nonbank providers of financial services and commercial firms. The OCC’s and FDIC’s initiatives are unlawful and dangerous because they would allow nonbanks and commercial firms to subvert fundamental public policies embodied in federal laws governing banks and bank holding companies.

In 2018, the OCC announced that it would approve national bank charters for “fintech” firms that provide lending and payment services but do not accept deposits. The New York …

Federalism, Erisa, And State Single-Payer Health Care, Erin C. Fuse Brown, Elizabeth Mccuskey

Faculty Scholarship

While federal health reform sputters, states have begun to pursue their own transformative strategies for achieving universal coverage, the most ambitious of which are state-based single-payer plans. Since the passage of the Affordable Care Act in 2010, legislators in twenty-one states have proposed sixty-six unique bills to establish single-payer health care systems. This paper systematically surveys those state legislative efforts and exposes the federalism trap that threatens to derail them: ERISA's preemption of state regulation relating to employer-sponsored health insurance. ERISA's expansive preemption provision creates a narrow, risky path for state regulation to capture the employer health care expenditures crucial …

Commandeering, Preemption, And Vehicle Emissions Regulation Post-Murphy V. Ncaa, Amelia Raether

Northwestern University Law Review

The Clean Air Act is often heralded as a paragon of cooperative federalism. The Act’s approach to vehicle emissions regulation in particular prescribes a unique partnership between the federal government and the state of California: while all states are bound by federally mandated vehicle emissions requirements, California may set more stringent standards in recognition of its historic role on the leading edge of environmental protection. However, in August 2018, the Environmental Protection Agency proposed not only to roll back the national emissions regulations, but also to revoke California’s ability to set more stringent standards, which include limits on greenhouse gas …

Check State: Avoiding Preemption By Using Incentives, Michael Allan Wolf

UF Law Faculty Publications

No abstract provided.

Comment Letter In Opposition To The Occ's Proposed "True Lender" Rule, Arthur E. Wilmarth Jr.

GW Law Faculty Publications & Other Works

This comment letter opposes the adoption of a proposed rule published by the Office of the Comptroller of the Currency (“OCC”) on July 22, 2020. 85 Fed. Reg. 44223 (2020). The proposed rule would determine whether a national bank or federal savings association “makes a loan and is the ‘true lender’ in the context of a partnership between a bank and a third party, such as a marketplace lender.” Id. The proposed rule – to be codified at 12 C.F.R. 7.1031 – would provide that a national bank or federal savings association is deemed to “make” a loan if the …

Principles Of Home Rule For The Twenty-First Century, Richard Briffault, Nestor M. Davidson, Paul A. Diller, Sarah Fox, Laurie Reynolds, Erin A. Scharff, Richard Schragger, Rick Su

Faculty Scholarship

The National League of Cities’ “Principles of Home Rule for the Twenty-First Century” updates the American Municipal Association’s 1953 “Model Constitutional Provisions for Municipal Home Rule.” The AMA approach was widely adopted, but those provisions are now over 65 years old and intervening social, demographic, economic, and political changes necessitates a new approach to the legal structure of state-local relations. The NLC’s approach is organized around four basic principles, which are cashed-out in a model constitutional home rule provision, with commentary. The first principle states that a state’s law of home rule should provide local governments the full capacity to …

Virginia Uranium, Inc. V. Warren, Nyles G. Greer

Public Land & Resources Law Review

The Supreme Court of the United States recently ruled that the Atomic Energy Act did not preempt a Virginia law prohibiting uranium mining in the Commonwealth. The Court held that although the Act delegated substantial power over the nuclear life cycle to the Nuclear Regulatory Commission, it offered no indication that Congress sought to strip states of their traditional power to regulate mining on private lands within their borders.

The Non-Impact Of The United States Supreme Court Regulatory Takings Cases On The State Courts: Does The Supreme Court Really Matter?, Ronald H. Rosenberg

Ronald H. Rosenberg

No abstract provided.

Cooperative Failure: An Analysis Of Intergovernmental Relationships And The Problem Of Air Quality Non-Attainment, Ronald H. Rosenberg

Ronald H. Rosenberg

No abstract provided.

The Twin Aims Of Erie, Michael S. Green

Michael S. Green

We all remember the twin aims of the Erie rule from first-year civil procedure. A federal court sitting in diversity must use forum state law if it is necessary to avoid 'forum shopping" and the "inequitable administration of the laws." This Article offers a reading of the twin aims and a systematic analysis of their proper role in federal and state court. I argue that the twin aims apply in diversity cases not because they protect state interests, but because they serve the federal purposes standing behind the diversity statute. So understood, they are about separation of powers, not federalism. …

Protecting Local Authority In State Constitutions And Challenging Intrastate Preemption, Emily S.P. Baxter

University of Michigan Journal of Law Reform

In recent years, state legislatures have increasingly passed laws that prohibit or preempt local action on a variety of issues, including fracking, LGBTQIA nondiscrimination, and workplace protections, among others. Often, these preemption laws are a direct response to action at the local level. States pass preemption laws either directly before or directly after a locality passes an ordinance on the same subject. Scholars have seen these preemptive moves as the outcome of the urban disadvantage in state and national government due to partisan gerrymandering.

Preemption may be a feature of our governing system, but it has also become a problematic …

Method Matters: Statutory Construction Principles And The Illinois Trade Secrets Act Preemption Puzzle In The Northern District Of Illinois, William Lynch Schaller

Northern Illinois University Law Review

Appellate methodology makes a difference when it comes to the interplay between statutes and judge-made law. The Illinois Trade Secrets Act (ITSA) through its preemption provisions abolishes some non-statutory claims and preserves others, but the line between the two remains a mystery--a mystery of extraordinary importance to those with information not rising to the level of trade secrets. Illinois state and federal appellate decisions have not improved matters: for over 30 years these appeals courts have failed to follow standard statutory construction rules and have yet to articulate a rationale justifying their opinions for or against preemption. This flawed methodology …

Neglecting Nationalism, Gil Seinfeld

Articles

Federalism is a system of government that calls for the division of power between a central authority and member states. It is designed to secure benefits that flow from centralization and from devolution, as well as benefits that accrue from a simultaneous commitment to both. A student of modern American federalism, however, might have a very different impression, for significant swaths of the case law and scholarly commentary on the subject neglect the centralizing, nationalist side of the federal balance. This claim may come as a surprise, since it is obviously the case that our national government has become immensely …

Federalism And Investor Protection: Constitutional Restraints On Preemption Of State Remedies For Securities Fraud, Manning Gilbert Warren Iii

Manning G. Warren III

Warren discusses the Private Securities Litigation Reform Act and the National Securities Market Improvement Act, among other issues. Predominant federalism postulates foreclose the proposed intrusion into investors' tort remedies traditionally allowed by the states under common law.

States Empowering Plaintiff Cities, Eli Savit

University of Michigan Journal of Law Reform

Across the country, cities are becoming major players in plaintiff’s-side litigation. With increasing frequency, cities, counties, and other municipalities are filing lawsuits to vindicate the public interest. Cities’ aggressive use of lawsuits, however, has been met with some skepticism from both scholars and states. At times, states have taken action—both legislative and via litigation—to preempt city-initiated suits.

This Article contends that states should welcome city-initiated public-interest lawsuits. Such litigation, this Article demonstrates, vindicates the principles of local control that cities exist to facilitate. What is more, a motivated plaintiff city can accomplish public-policy goals that are important not just to …

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Is The Federal Circuit Learning Its Lessons? A Case Study Of Bpcia Preemption, Mary Lafleur

Chicago-Kent Journal of Intellectual Property

No abstract provided.