The new federalization movement and the Roberts Court.

• Author: Landers, Renee M.

1. THEME (1)

   When I was working as a lawyer in the Clinton administration, first in the Department of Justice (DOJ), and then as Deputy General Counsel in the Department of Health and Human Services (HHS), I was involved in the debate about the merits of what I call the federalization movement of the 1990s. (2) I arrived to work in the administration just before the passage of the Violent Crime Control and Enforcement Act of 1994, which included a plethora of new federal crimes and enhanced penalties for existing crimes. (3) Among the additions were the Violence Against Women Act (VAWA) (4) and the Freedom of Access to Clinic Entrances Act. (5) Earlier the Congress had enacted the Child Support Recovery Act of 1992 (6) and the Gun-Free School Zones Act of 1990. (7)

   These expansions of federal jurisdiction into areas of criminal-law enforcement traditionally within the purview of the states spawned energetic criticism. Federal judges expressed concern that these legislative enactments expanded the reach of federal jurisdiction and that the resulting effects on federal court dockets would cause an erosion of the traditional mission of the federal courts. (8) In their view, constitutional and policy considerations indicated the wisdom of a limited role for the federal courts in these areas, and continued expansion of the role of federal courts would threaten quality and competence. (9)

   In some of these statutory initiatives, congressional conservatives and liberals were united in the view that federal judicial power should be invoked to address criminal activity that crossed state boundaries. (10) In the case of the Freedom of Access to Clinic Entrances Act (FACE), Congress sought to address activity that interfered with the exercise of a federal constitutional right. (11) Like earlier actions by Congress that gave federal courts jurisdiction to deal with civil-rights crimes of violence, (12) these enactments introduced federal enforcement as an additional tool designed to protect the public, but did not preempt state law-enforcement activities. The states, however, were concerned that overlapping jurisdiction would result in duplicative and competitive law enforcement activities. (13)

   Congress relied on its authority to regulate commerce in enacting many of these statutes. (14) Two Supreme Court decisions demonstrate the Court's displeasure at Congress's attempt to use its commerce power to regulate noneconomic activity. In United States v. Lopez, (15) the Court invalidated the Gun Free School Zones Act as an impermissible infringement on state police power, and in United States v. Morrison, (16) the Court overturned a federal VAWA civil damages remedy on similar grounds. Until Lopez, the Court had not invalidated a federal statute as exceeding Congress's commerce power for nearly sixty years. (17)

2. VARIATIONS (18)

   When I made the move from DOJ to HHS in 1996, my first task was to work with lawyers in both agencies on the government's amicus brief in a case called Medtronic v. Lohr. (19) The case raised the issue of whether the declaration of the Food and Drug Administration (FDA) that a device is "substantially equivalent" to devices already on the market under the premarket notification provisions of the Medical Devices Amendments (MDA) preempted state tort claims. (20) Lora Lohr had received an implanted Medtronic pacemaker equipped with a lead, the part of the pacemaker that transmits the electrical signal from the "pulse generator" to the heart, which the FDA had found to be "substantially equivalent" to devices already on the market. (21) When the pacemaker failed, Lohr and her husband sued Medtronic in state court on negligence and strict-liability claims. (22)

   The Supreme Court considered whether the claims against Medtronic were preempted by a provision of the MDA which provides that no state may establish or continue in effect any requirement "which is different from, or in addition to, any requirement" applicable to the device under the MDA. (23) The government's amicus position was that the statute created only a very limited range of preemption, mostly of states' positive regulation. (24) Medtronic essentially argued that FDA's authorization for the device to be marketed--even though the device had not been approved under the rigorous premarket approval process--should insulate manufacturers from state tort claims. (25)

   A fractured Court, in a plurality opinion written by Justice Stevens, held that the Lohrs' defective design, defective manufacture, and failure-to-warn claims were not preempted. (26) The plurality concluded that the statute had a limited preemptive effect because its legislative history indicated that "[section] 360(k) simply was not intended to pre-empt most, let alone all, general common-law duties enforced by damages actions." (27)

   Under the administration of President George W. Bush, however, the FDA has changed its position on whether the MDA preempts state regulation, including state common-law tort claims. It has filed briefs in several cases siding with manufacturers to argue for preemption. (28) In addition, in issuing new drug labeling regulations in 2006, the FDA stated in a preamble to the regulations that it viewed the drug labeling act as preempting state law, including state tort claims. (29) Similar changes in position on regulatory preemption have been advanced by the Consumer Product Safety Commission and the National Highway Traffic Safety Administration (NHTSA). (30) These positions threaten to eviscerate any ability for individuals injured by defective products to receive compensation for their injuries under state law. At the same time, preemption would remove the additional incentive that the potential for tort claims provides to encourage manufacturers to err on the side of safety in the design, manufacture, and marketing of products.

   These movements toward preemption also are taking place against a background of what Georgetown Law Professor David Vladeck calls "regulatory failure." (31) While the agencies mentioned and others are arguing that state tort claims would interfere with federal safety regulation, many of their regulatory programs are in crisis. The air-traffic gridlock experienced in March and April of 2008 by much of the country was caused by FAA efforts to return once again to vigorously enforcing safety regulations. (32) Meanwhile, despite this recent history of weak enforcement, the United States Court of Appeals for the Second Circuit recently agreed with the Air Transport Association of America, an airline industry group, that the Airline Deregulation Act of 1978 preempts New York's Airline Passenger Bill of Rights, on the grounds that the New York statute hinders the Federal Aviation Administration's ability to maintain uniform standards for air travel. (33)

   News reports of regulatory failures of the FDA, which is responsible for regulating nearly 25 percent of the GDP, are frequent. (34) A recent television expose about diseased cattle being kicked, prodded, and otherwise forced to slaughter presented graphic evidence of diseased meat entering the food supply. (35) In April 2008, the New York Times reported that contaminated heparin imported from China was implicated in more than sixty deaths in this country. (36) A 2007 Institute of Medicine (IOM) study pointed out numerous inadequacies in the process for initial approval and ongoing monitoring of the safety of drugs during their entire lifespan on the market. (37) Critics question whether the FDA has sufficient resources to regulate effectively in all the areas over which it has jurisdiction, including the safety and efficacy of drugs and medical devices and protecting the public from contaminated food. (38) Indeed, FDA Commissioner Andrew C. von Eschenbach recently wrote Congress to request an immediate infusion of $275 million to upgrade oversight of foods, drugs, and devices produced abroad. (39) Legislation is pending in Congress to authorize the FDA to regulate tobacco products--overruling the Court's decision in FDA v. Brown & Williamson. (40) The tobacco industry is arguing that the FDA is too overwhelmed by its current responsibilities to have tobacco added to its jurisdiction. (41) This position seems inconsistent with the arguments by the pharmaceutical device and drug manufacturers that FDA regulation provides adequate protection for consumers.

   What has the Supreme Court's response been to these developments? In February 2008, the Court decided in Riegel v. Medtronic, Inc. that state common-law tort claims were preempted by the premarket approval provisions of the MDA. (42) Unlike the closely divided Court in the Lohr case, Justice Ginsburg was the lone dissenter in Riegel, reasoning that because Congress failed to create any compensatory remedy for consumers injured by products approved through the premarket approval process, it did not intend a broad preemption of state common-law suits. (43) In November 2008, the Court will review a case, Wyeth v. Levine, that may involve the new FDA preamble on preemption, although the cause of action arose before the preamble was issued. (44) The case causes the Court to review a decision of the Vermont Supreme Court that FDA approval of the drug in question did not preempt a state law failure-to-warn claim. (45)

   The issues decided in Riegel and presented in Levine share at least one feature with the Court's decision of last term in...