Executive activism not reciprocated with judicial activism: Wyeth v. Levine and Cuomo v. Clearing House return preemption to the legislative branch.

• Author: Coveny, Anthony C.

1. Introduction II. The Theory of Preemption: A Doctrine Rooted in the Legislative Branch of Government A. The Assignment of Governmental Power B. The Parameters of the Supremacy Clause C. Preemption as it Applies to State Lawsuits III. The Creation of Preemption A. Express Preemption: Riegel and Altria B. Absence of Preemptive Language: Executive Branch Manufacturing Congressional Intent for the Pharmaceutical Industry IV. Implied Preemption in the Absence of Clear Congressional Intent A. Conflict Preemption: Preemption Without Congressional Intent? B. Wyeth v. Levine: The Pharmaceutical Industry and FDA C. Can Agency Rule Making Provide Congressional Intent? D. Agency Rulemaking and Implied Preemption: Wyeth E. Agency Rulemaking and Express Preemption: Cuomo V. A Case Study in Executive Activism: Wyeth v. Levine A. The Case Brought Against Wyeth B. A Political Push for Preemption: The FDA and the Bush Administration C. Executive Activism in the Face of Legislative Unwillingness to Provide Preemption D. The Waxman Report E. Is Cuomo Another Example of Executive Activism? VI. Impediment Preemption: Do Lawsuits Frustrate Regulatory Aims? A. Tort Lawsuits and the FDA: Working in Tandem to Protect the Public VII. Obama: Executive Reversal VIII. Conclusion: The Future of Preemption I. INTRODUCTION

   The Supreme Court has taken a strong stand on the preemption issue, with both liberal and conservative justices agreeing to return preemptive authority to Congress. (3) In short, the Supreme Court has properly refused to reward Executive activism with Judicial activism. This article discusses the theoretical foundation of preemption; (4) the requirement of clear Congressional intent; (5) recent Executive Branch attempts to push preemption vis-a-vis agency regulation; (6) the Supreme Court's refusal to reward Executive activism with Judicial activism in Wyeth v. Levine and Cuomo v. Clearing House Ass'n, L.L.C.; (7) and the preemption landscape as it exists in 2009 going forward. (8)

2. THE THEORY OF PREEMPTION: A DOCTRINE ROOTED IN THE LEGISLATIVE BRANCH OF GOVERNMENT

   1. THE ASSIGNMENT OF GOVERNMENTAL POWER

      In the legal system of the United States, preemption generally refers to the displacing effect of federal law on conflicting or inconsistent state law. (9) As a doctrine, it has its roots and derives its power from the Supremacy Clause of the United States Constitution:

      This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding. (10) Under this rubric, when there is a conflict between a state law and federal law: "It is basic to this constitutional command that all conflicting state provisions be without effect." (11) This is perhaps the most fundamental principle that gave rise to the United States Constitution after the failure of the Articles of Confederation--precisely because the Articles failed to provide the central government with the power to overcome state objections to its actions and mandates. (12) Beginning with the near-disastrous Revolutionary War, a young America quickly realized that power must be vested, supremely, in a national government if a nation was to be forged. (13)

      Federalism would, however, be mere nomenclature if the Supremacy Clause was not hemmed in--and hence since its inception the newly empowered national government has been subject to Constitutional restraint. Nowhere is that restraint more succinctly articulated than in the Tenth Amendment: "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people." (14) The Tenth Amendment deemed by most scholars a doctrinal truism, simply states that the three branches of the government have the powers the Constitution provides and do not have the powers the Constitution does not provide.

      In the early 1930's, the Supreme Court made note of this in United States v. Sprague, stating that the Tenth Amendment added nothing to the Constitution as originally ratified. (15) This unusually stark judicial criticism of a Constitution Amendment, however correct, fails to comprehend the inherent fear of federal power felt by early Americans. This fear was also articulated in the Articles of Confederation, which provided a similar guarantee: "Each state retains its sovereignty, freedom, and independence, and every power, jurisdiction, and right, which is not by this Confederation expressly delegated to the United States, in Congress assembled." (16) The difference is that the new Constitution provided many more powers for the federal government, evinced by the long and oft vociferous debate before ratification. (17)

      A decade after Sprague, the Supreme Court would clarify its sentiment by taking note of this fact:

      The amendment states but a truism that all is retained which has not been surrendered. There is nothing in the history of its adoption to suggest that it was more than declaratory of the relationship between the national and state governments as it had been established by the Constitution before the amendment or that its purpose was other than to allay fears that the new national government might seek to exercise powers not granted.... (18) Historically, this doctrine became embedded in the American lexicon by McCulloch v. Maryland, a case in 1819, where the power of the federal government to establish a bank in the state of Maryland was challenged by the state's taxing authority. (19) In this famous case, Chief Justice John Marshall stated: "If any one proposition could command the universal assent of mankind, we might expect it would be this-that the government of the Union, though limited in its powers, is supreme within its sphere of action." (20) With that statement, and the jurisprudence that followed, this nation's division of power in a federal system has balanced the breadth of state government power against the supremacy of federal government power. (21)

      Within the sphere of federal power, the Constitution provides legitimate federal exercise of power with universality and superiority. But the founders did not seek only to balance the power of the federal government with that of the state governments. Part and parcel of the Madisonian doctrine of divided power is the separation of powers within the federal government. While federalism represents a vertical division of governmental power, the federal government is also divided horizontally. As one noted scholar has written: "In addition to the vertical division of power between federal and state governments common to all federal systems, some systems provide for horizontal fragmentation within the federal government." (22)

      This notion, termed Separation of Powers in the political vernacular, has at its heart the need for protections above and beyond democracy alone in safeguarding liberty. (23) Madison, in penning the fifty-first of the Federalist Papers, stated:

      In order to lay a due foundation for that separate and distinct exercise of the different powers of government, which to a certain extent is admitted on all hands to be essential to the preservation of liberty, it is evident that each department should have a will of its own; ... A dependence on the people is, no doubt, the primary control on the government; but experience has taught mankind the necessity of auxiliary precautions. (24) Among those auxiliary precautions was the dissolution of power centers--in other words, the reduction in concentrated power in any one person or entity such that the use of governmental power was slow and deliberate, preventing abuse of liberty by the interests of a small cadre of actors. (25) This dissolution was provided by the division of governmental powers into Articles I, II, and III of the Constitution, representing the three branches of the federal government. (26) While a paradigm shift has occurred placing the presidency at the center of the political machinery in Washington, (27) historically and constitutionally, Congress remains the most powerful branch of government as the only branch that can reach out and preempt state law and power though legislation and regulation. (28) Attempts to do so by the Judicial or Executive branch of the federal government are deemed activist. (29)

      Within American history, real and apparent power has continued to shift from institution to institution, and the Supremacy Clause has facilitated this transfer of power, in part vis-a-vis the preemption doctrine. (30) However, the preemption doctrine, is a sharp stick for a limited purpose, and must be wielded only by Congress and used only within the federal government's sphere of power. (31)

   2. THE PARAMETERS OF THE SUPREMACY CLAUSE

      It is of the very essence of supremacy, to remove all obstacles to its action within its own sphere, and so to modify every power vested in subordinate governments, as to exempt its own operations from their own influence. (32)

      From its earliest employ, the Supremacy Clause has been reigned-in by well established parameters that ensure that state legislatures have general welfare powers that occupy the full range of powers not curtailed by the Constitution, and the national Congress has only those powers specifically enumerated in the Constitution. (33) As long as an area is not preempted by federal law, the states are free to write any law not in violation of the Constitution. (34) In contrast, Congress can pass legislation in any area in which its power is explicit and in which it does not begin to encroach on the traditional powers reserved to the states:

      [A] criterion of what is constitutional, and of what is not so.... If the end be clearly comprehended within any of the...