Limiting Federal Agency Preemption: Recommendations for a New Federalism Executive Order

The structure of the U.S. Constitution reflects a profound respect for the principles of federalism and state sovereignty. These principles require the federal government to recognize and encourage opportunities for state and local governments to exercise their authority, especially in areas of traditional state concern such as the protection of the health, safety, and welfare of their citizens. However, over the last six years there has been a coordinated Executive Branch effortto use the regulatory process to shield certain product manufacturers from state tort liability. The Food and Drug Administration, National Highway Traffic Safety Administration, and Consumer Product Safety Commission, among others, have attempted to use the doctrine of preemption to block consumers’ access to state courts. During the Bush Administration, executive agencies have included assertions of preemption in regulatory preambles, filed amicus briefs in litigation in which other litigants have argued that federal statutes preempt state law, and submitted to Congress draft legislation that would preempt state and local authority to protect public health, safety, and the environment. The Obama administration should replace Executive Order 13132, which instructs administrative agencies to consider the federalism implications of their actions, with an Executive Order that is more protective of the legitimate interests of state governments in maintaining their traditional role in protecting the health, safety and welfare of their citizens. While the current order has some desirable features, it is inadequate to prompt the type of deliberations in which agencies should engage when they are considering whether to support the preemption of state law

The Clean Power Plan: Issues to Watch

Although the Clean Air Act is an imperfect tool for addressing the nation’s greenhouse gas emissions, it is the only available federal mechanism for directly addressing power plant carbon emissions. The Obama Administration’s Clean Power Plan, published in final form in August 2015, tackles the challenge. This paper from the Center for Progressive Reform (CPR) compiles 13 separately authored essays from 11 CPR Member Scholars, each addressing a different topic related to the Clean Power Plan, and each representing the expertise and views of its individual author(s). Published in July 2015, just before the release of the final rule, the essays tee up key questions about the rule’s legality, implications for the energy sector, and a series of discrete implementation questions, including the role of cap-and-trade (and offsets), the nature and distribution of state targets, and implications for environmental justice

The Clean Power Plan: Issues to Watch

Although the Clean Air Act is an imperfect tool for addressing the nation’s greenhouse gas emissions, it is the only available federal mechanism for directly addressing power plant carbon emissions. The Obama Administration’s Clean Power Plan, published in final form in August 2015, tackles the challenge. This paper from the Center for Progressive Reform (CPR) compiles 13 separately authored essays from 11 CPR Member Scholars, each addressing a different topic related to the Clean Power Plan, and each representing the expertise and views of its individual author(s). Published in July 2015, just before the release of the final rule, the essays tee up key questions about the rule’s legality, implications for the energy sector, and a series of discrete implementation questions, including the role of cap-and-trade (and offsets), the nature and distribution of state targets, and implications for environmental justice

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Argonne National Laboratory Reports

Three liquid-based solar heating systems employing different types of solar collectors were tested side by side near Chicago, Illinois for one year. The three different types of collectors were: (1) a flat plate collector with a black-chrome coated absorber plate and one low-iron glass cover; (2) an evacuated-tube compound parabolic concentrator (CPC) with a concentration ratio of 1.1, oriented with tubes and troughs along a north-south axis; and (3) an evacuated-tube CPC collector with a concentration ratio of 1.3 and one low-iron glass cover, with tubes and troughs oriented along an east-west axis. Results indicate that the flat plate collector system was the most efficient during warm weather, but the CPC systems were more efficient during cold weather, but the CPC systems were more efficient during cold weather, and the CPC systems operated under conditions too adverse for the flat plate collector. The computer simulation model ANSIM was validated by means of the side-by-side tests. The model uses analytical solutions to the storage energy balance. ANSIM is compared with the general simulation TRNSYS

The Truth About Torts: Rethinking Regulatory Preemption and Its Impact on Public Health

As consumers, we assume that the automobiles, pharmaceuticals, medical devices, and other products we purchase are generally safe for their intended uses. We rely on manufacturers to design and produce safe products, and we assume that federal regulators are conscientious watchdogs of the marketplace. In most instances, our assumptions are valid and we safely go about our lives. But the regulatory system is now frayed to the point that dangerous products sometimes slip through the cracks. Vioxx, Firestone/ATX tires, and toxics-laden children’s toys have endangered and harmed millions. In these cases, society depends on the state courts as a venue for injured people to seek justice. Over the years, product manufacturers have worked hard to deny injured consumers’ access to the courts – and during the Bush Administration, they had powerful allies in the White House and throughout the Executive Branch. Complaining of excessive damage awards and unpredictable legal terrain, manufacturers have adopted the argument that federal regulatory actions preempt injured consumers’ lawsuits for things like negligence, defective design, or failure to warn. The preemption argument is based on the Constitution’s Supremacy Clause, under which Congress has the power to invalidate, or “preempt,” state law through enactment of appropriate legislation. The defense bar has misappropriated that limited legal doctrine. Protective regulatory action should not be used to shield manufacturers from having to prove that their products are safe. But that is precisely what the regulatory preemption doctrine does: it gives judges the ability to throw legitimate victims out of court before they have even had a chance to make their case that their injuries were caused by a dangerous product. Furthermore, the claim asserted by numerous federal agencies late in the Bush Administration that federal actions could and should preempt state common law constituted an unsound and unprecedented policy shift. This white paper lays out a different perspective on regulatory preemption. Instead of looking at regulatory preemption as a tool for limiting corporate liability, this paper recognizes that preemption is a tool for structuring power between states and the federal government. Especially in the context of public health and safety, all levels of government have a legitimate interest in determining the ideal level of protective regulation. In addition, this paper treats the preemption debate as a question of the relative powers of Congress, the courts, and federal administrative agencies. The Supremacy Clause makes Congress the primary decisionmaker in setting federal preemption policy, though the courts and agencies have tried to usurp some of that authority in recent years

Fifty FDAs: An Argument for Federal Preemption of State Tort Law that is Less than Meets the Eye

A white paper whose purpose is to try to put to rest the “unhelpful and disingenuous” “50 FDAs” argument that proponents of federal regulatory preemption have supported for the last few decades. First, this paper examines the “50 FDAs” argument in greater detail, with an eye toward understanding the concerns that have motivate manufacturers of drugs and medical devices to adopt this argument. Second, it explains why the “50 FDAs” argument should be rejected. Third, it argues that preemption of state tort law would ultimately be counterproductive, since the displacement of a vibrant state tort law system would greatly undermine the valuable role that state tort law plays in U.S. governance.The Kay Bailey Hutchison Center for Energy, Law, and Busines