FDA embraces stealth tort 'reform' in proposed OTC drug rules.

Federal agencies continue to use preambles to regulatory rules as a means to preempt the rights of injured citizens to hold powerful corporations accountable for wrongdoing. One of the most recent attempts to preempt state tort law comes from the FDA, which has proposed new rules to regulate the labeling of over-the-counter (OTC) drugs.

The preamble to the proposed rules claims that the express preemption provision of the federal Food, Drug & Cosmetic Act (FDCA) applies not only to state laws or regulations but also to state common law duties. In addition, the FDA claims that the Supreme Court's decision in Geier v. American Honda Motor Co. (529 U.S. 861 (2000)) states that implied preemption may arise where the express pre-emption provision does not apply.

In response to the FDA's proposal, AAJ filed comments stating that the agency's attempt to preempt state common law exceeds its statutory authority under FDCA [section]751 (a). This subsection and [section]751 (e), which specifically excludes products liability claims from the preemptive effect of FDA action, are meant to be read together. When the section is read in its entirety, it is clear that Congress intended the statute to preempt state positive law (statutes and regulations), but not common law.

AAJ also argued that the FDA's reliance on Geier is misplaced. Geier is based on motor vehicle safety requirements, and its holding is limited to the particular circumstances of the case. AAJ pointed to another Supreme Court case, Medtronic v. Lohr (518 U.S. 470 (1996)), as the authority on this issue. Medtronic, a case addressing FDA safety standards, supports the proposition that in passing the Medical Device Amendments to the FDCA, Congress did not seek to preempt common law claims, leaving consumers with no recourse for injuries caused by defective medical products.

Although AAJ maintained that the preamble language has no substantive effect, it requested that the FDA revise the preamble to eliminate the rationale for federal preemption of state tort laws. The revision should reflect the settled interpretation of [section]751 (a) and FDA preemption case law, AAJ said.

The association will continue to monitor proposed rules, watching for similar preemption claims by other agencies. AAJ will file additional comments as necessary to oppose these attempts at stealth tort "reform."