US Administrative Regulations and Preemption of State Law

The Wall Street Journal has an article about how "Bush administration officials, in their last weeks in office, are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states." The effort involves a number of federal agencies including the Food and Drug Administration the National Highway Traffic Safety Administration, the Consumer Product Safety Commission, the Transportation Security Administration and the Federal Railroad Administration. If successful, the effort to promulgate new regulations that preempt enforcement by the states will have a major impact on American tort law. So far, the issue has gone largely unnoticed. Tort reform has been a major goal of the Bush Administration to insulate the business community from higher regulatory standards imposed by the states as well from lawsuits filed by the plaintiff bar in the civil justice system. Having had little success in Congress, the Bush Administration initiative is for dramatic changes in federal agency positions on preemption of state law in environmental, health, safety, and consumer protection areas focused on the regulatory process to achieve that goal.

The American Association for Justice (AAJ) has just released a new report, Get out of Jail Free: a Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability, based in part on documents obtained through FOIA, detailing the Bush Administration's use of preemption as a deregulatory strategy. The report provides detailed examples of how federal agencies have tried to usurp state law and undermine consumer protections. AAJ's report explains how the administration's first attempts to preempt state-law protections consisted of amicus briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting regulatory agencies in charge of product safety oversight. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations are now using this legal theory to challenge verdicts in product liability cases.

A major case pending before the US Supreme Court on this issue is Wyeth v. Levine which will decide this term whether federal law preempts state torts claims imposing liability on drug labeling that the FDA had previously approved. The case involves a jury verdict in a failure-to-warn product liability case in amount of $6.5 million in favor of plaintiff Diana Levine, who suffered severe injury and the amputation of her arm as a result of being injected with the defendant's drug Phenergan directly into her artery as a treatment for nausea from a migraine headache. The pharmaceutical company defendant argues that Vermont's stricter regulations on administering the drug are preempted by less stringent federal regulations. The Supreme Court of Vermont issued its opinion in favor of the plaintiff in October 2006. For more on the Wyeth case, read former BLS Prof. Anthony Sebok’s FindLaw article More on the Upcoming Supreme Court Case of Wyeth v. Levine and the Preemption Temptation.

For reading on the issue, see in the BLS Library collection Federal Preemption of State and Local Law: Legislation, Regulation, and Litigation by James T. O'Reilly (Call # KF4600 .O74 2006) with chapters including: The basics on preemption -- Preemption categorizations -- Constituencies for preemption -- Constitutional background -- Political and policy debates -- Federal mechanisms for agency preemption -- Express congressional decisions to preempt -- Implied forms of preemption -- Defensive use of federal preemption in civil litigation.