FDA on Drug Pre-Emption Lawsuits-Not What You Might Think

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
Officially, the FDA supports federal drug-approval and warning-label standards trumping stricter state laws in the Supreme Court case, Wyeth v. Levine that will be heard this coming Monday. However, internal memoranda support the opposite. In internal FDA memos, two FDA officials state that it’s wrong to assume FDA drug labels are completely reliable or that they contain full disclosure of the drug’s risks.
According to a story in today’s Wall St. Journal, “‘[M]uch of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis,’ wrote John Jenkins, the top official in the drug approval section, in 2003.”
When the FDA was confronted with the apparent contradiction, an FDA spokesperson noted that any large orgnization is bound to have differing views. However, the contradictory notions coming from the FDA are bound to give anti-preemption legislators fodder for overturning the Bush preemption policies.
The injustice of the Levine case is the unwarranted extension of the preemption doctrine. The basic law is this: Congress can preempt state laws in areas of national concern by expressly providing in the language of a bill that state regulations are preempted or superseded by the federal law. That is called express preemption. Until the Bush administration the FDA had always taken the position that state consumer tort suits were a consumer protection that complemented the federal FDA regulation. The Levine case is a prescription drug labeling case. The FDA approves labeling including warnings for prescription drugs. In most drug lawsuits the consumer claims that the manufacturer did not warn of a danger of which it knew. Most of the time these dangers are not disclosed or are concealed from the FDA like with Fen Phen or Vioxx. The drug company argument in Levine is that consumer tort suits for failure to warn on the labeling should be preempted under implied preemption because the FDA reviewed and approved the label.
This preemption question is one that can be solved by legislation that has already been proposed that expressly states that the the FDA regulatory process is not intended by Congress to preempt state consumer lawsuits.