The Senate Judiciary Committee held a hearing Sept. 12 about federal agencies' practice of inserting into regulations language that removes consumers' ability to sue under state tort law those corporations whose products cause harm. In addition, the use of this preemption language limits the ability of state and local governments to protect the health, safety and welfare of their citizens. Federal preemption removes the targeted policy area from state and local jurisdiction and makes it almost exclusively a federal policy issue.

According to the legal website USLegal,

Preemption is the rule of law that if the federal government through Congress has enacted legislation on a subject matter it shall be controlling over state laws and/or preclude the state from enacting laws on the same subject if Congress has specifically declared it has "occupied the field." Preemption can occur by Congress passing a law, preempting state or local law. If Congress has not clearly claimed preemption, a federal or state court may examine legislative history to determine the lawmakers' intent toward preemption.

As this definition clearly states, preemption usually is done through congressional action and intent. Current legislative proposals show Congress struggling with the question of preemption in diverse policy areas. For example, BNA reports ($) that the House and Senate versions of the Mental Health Parity Act of 2007 reflect different views on preemption, but that the Senate's bill is moving toward the House version by removing preemption language that would have prevented states from having stronger mental health laws.

In another BNA summary, this time about the reauthorization of user fees to fund U.S. Food and Drug Administration (FDA) drug approval activities, the Senate's version included a provision that would have jeopardized consumers' ability to sue drug companies for harm from drugs like Vioxx. This provision was removed from the final legislation.

In the absence of a clear indication from Congress about preemption, the courts are left to determine congressional intent when federal and state laws conflict. At the hearing, witnesses pointed out numerous occasions when federal agencies inserted preemption language into regulations, thereby usurping both expressed congressional intent and state law.

Donna D. Stone, a Delaware state representative and president of the National Conference of State Legislatures, provided numerous examples in her testimony in which the Center for Medicare and Medicaid Services (CMS) tried to change Medicaid statutory intent in 2007 by issuing rules without congressional authorization or consultation with state and local governments.

In his written testimony, David Vladeck, a Georgetown University law professor and OMB Watch board member, described three cases of agencies inserting preemption language into rules directly impacting consumer safety:

• In 2006, FDA "announced that its approval of a drug's label immunizes the manufacturer" from claims by consumers that they were inadequately warned of dangers from using the drug.
• "The National Highway Traffic Safety Administration [NHTSA] now routinely claims that its regulatory actions preempt state law — both state statutory and regulatory law and state damages actions."
• In 2006, the Consumer Product Safety Commission inserted language into the preamble of a regulation on mattress flammability standards. "As with the FDA and NHTSA, nowhere does the CPSC explain why it has reversed field and, for the first time in the agency's history, taken the position that its regulatory action extinguishes tort law remedies."

These agency preemptions have real consequences according to an attorney who brought claims on behalf of consumers. Collyn Peddie described two consumers who suffered harm, a 62-year-old woman from Vioxx and a toddler from an injection of a faulty vaccine. In both cases, judges prevented the claims from going forward due to preemption language even when, in the case of the toddler, Congress expressly upheld the right to seek damages under the Vaccine Act. Traditionally, judges give great deference to agencies' rulemakings, so they may not look beyond the regulation.

The panelists proposed solutions to this growing trend of agencies' use of preemption. Recommendations included 1) an increase in congressional oversight of agencies like FDA, 2) use of explicit language indicating Congress's intentions regarding preemption, and 3) federal legislation limiting and advising state court judges' interpretations of the preemption doctrine. No specific proposals have been introduced in Congress.

The hearing is an important first step according to Gerie Voss, regulatory counsel for the American Association for Justice. "The Senate Judiciary's preemption hearing shed light on what appears to be a coordinated effort by Bush Administration agencies to take away the rights of Americans to hold negligent corporations accountable for dangerous products," she told OMB Watch.