On January 18, 2006, the Food and Drug Administration, for the first time, issued a strong and clear statement on its position on the preemption of state tort law concerning the labeling of prescription drugs. In a rather dramatic fashion (but buried in the midst of a complicated announcement on a rule involving changes in the required labeling for prescription drugs), the FDA has now concluded that such state tort laws should, in most instances, be completely preempted. If adopted by the courts, this could affect almost every jury deliberation and almost every jury verdict where a question is, or has been, raised about the adequacy of FDA-approved labeling for prescription drugs.

The FDA’s preemption conclusions are set forth in the Preamble to the Agency’s Final Rule amending its regulations governing the content and format of labeling for human prescription drug products. Because the preemption conclusions are in the Preamble and not in the Rule itself, there is a question as to their full force and effect, but the clear language that FDA uses leaves little doubt as to the Agency’s position on the issue.

In the Preamble, FDA says that under existing preemption principles, it believes that approval of labeling during the NDA process – whether this labeling is in the old or new format – preempts all conflicting or contrary state laws, regulations, and even, in essence, any jury consideration of these matters. Indeed, FDA says that at least the following claims should be preempted: (1) claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substance of which appears anywhere in the labeling; (2) claims that a drug sponsor breached an obligation to warn by failing to include in an advertisement any information the substance of which appears anywhere in the labeling, in those cases where a drug’s sponsor has used Highlights consistently with the FDA draft guidance regarding the ‘brief summary’ in direct-to-consumer advertising; (3) claims that a sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in the rule; (4) claims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time a plaintiff claims the sponsor had an obligation to warn; (5) claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement the substance of which FDA has prohibited in labeling or advertising; and (6) claims that a drug’s sponsor breached an obligation to plaintiff by making statements that FDA approved for inclusion in the drug’s labeling.

The Agency goes on to state that preemption would include not only claims against manufacturers, but also against health care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling.

These statements are very broad and all-encompassing and many plaintiffs’ lawyers are extremely unhappy with the FDA’s conclusions. These plaintiffs’ lawyers are already arguing that the FDA pronouncements are not substantive law and that State courts can ignore them at will. However, the FDA is quite adamant that its own review of labeling should preempt, and thus disallow, lawsuits in state courts involving agency-approved drugs. As the Agency states, the FDA-review process should not be “second-guessed” by state courts and juries that do not have the scientific knowledge possessed by “the expert Federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading.”

For further information on the preemption provisions, please contact:

Wayne Matelski
202-857-6340
matelski.wayne@arentfox.com