Forty-one of the fifty-one rules proposed by NHTSA and FDA Contain Federal Pre-Emption Language

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Personal Injury

10/14/2008
James R. Carroll, Jr., Esquire
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Forty-one of the fifty-one rules proposed by NHTSA and FDA Contain Federal Pre-Emption Language

Due to an unfriendly Congress, the Bush administration is finding a quieter way to make it difficult for consumers to sue businesses over faulty products. It is rewriting the bureaucratic rulebook. Since 2005, lawsuit limits have been included in fifty-one rules proposed or adopted by agency bureaucrats. Forty-one of the fifty-one rules proposed by agency bureaucrats came from the Food and Drug Administration (FDA) and the National Highway Traffic Safety Administration (NHTSA) alone. Bureaucratic agencies' use of its rule-making power is the final act in the administration's drive to protect companies from lawsuits. NHTSA and the FDA, however, deny any designated rules to undercut lawsuits.

Since he was the governor of Texas, President Bush has campaigned for lawsuit reform. As president, however, he has made little progress on the issue because Democrats have blocked him every time he tries to tackle the issue directly. Limits on lawsuits have been proposed for drug labeling and packaging, along with rules ranging from mattress flammability standards to dietary sweeteners and roof-crush requirements in car rollovers. Clearly, this kind of limitation is more troubling and far more effective than the standards that they apply to. If pre-empted, a particular standard no longer is valuable to the consumer as a rule of law.

The chief executive office of the American Association for Justice says agencies are engaging in activities that are allowing negligent companies off the hook and knowingly putting American consumers at risk. According to Joan Claybrook, former head of the NHTSA, companies are looking for total immunity and the regulators in the Bush Administration are helping them achieve that. Later this year, the Supreme Court will determine whether or not federal preemption relates to lawsuits and prescription drug labeling because defendant drugmakers contend they should not be involved in lawsuits since the FDA approved the product and warning label on the drug

The concept of federal preemption, rooted in the Supremacy Clause of the Constitution, is underlying this bureaucratic version of lawsuit reform. Federal preemption refers to situations in which federal regulation and law trumps state law. The issue at hand is whether or not companies can use the broad preemption language in regulatory preambles to get the case thrown out. An expansive interpretation of the preemption doctrine leaves little room for consumers to sue, and that is what has been taking place recently.

Here is a fact paper offered by the Pennsylvania Association for Justice on Federal Preemption in relation to defective products.

Labels: defective products, preemption

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