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Even The FDA Is Against Complete Immunity Preemption?

One of the hottest topics in the personal injury arena right now is preemption. Generally, the argument for preemption is that if a product complies with federal regulations relating to the safety of that product  (even if the regulations are not adequate) then manufacturers should be completely immune from state tort lawsuits based on defects on that product because the federal law trumps state law.

Next Monday, the U.S. Supreme Court will hear the case of Wyeth v. Levine. In that case, the drug manufacturer and the U.S. Food and Drug Administration, with the consent of the Bush Administration, will argue that federal drug-approval and warning-label standards should trump stricter state law liability claims.  The plaintiff won a multi-million judgment after arguing that the drug she was using didn’t warn that gangrene was a side effect.  (The plaintiff, a musician, eventually lost her arm to gangrene.)  The manufacturer argues that they are entitled to complete immunity because the federal regulations don’t require them to warn of gangrene.

Prior to the Bush Administration, the FDA had taken the position that state tort laws worked in concert with regulations and provided an extra protection for consumers. The effort for preemption, not just with the FDA, but with almost all regulatory agencies, has been pushed by the Bush Administration as a long-term form of tort reform. The Bush Administration has urged the adoption of over 50 regulations that encourage preemption.

Yesterday, several FDA documents were released showing that even senior members of the FDA knew the dangers of preemption. John Jenkins, the top official in the FDA drug approval section, wrote in 2003:

Much 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.

The report that included the preemption memos concludes:

FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, the internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. This is a serious abuse of the agency’s publich health authorities.

One other story notes that the memos were forwarded to the FDA’s chief counsel, who is now the general counsel for pharmaceutical giant Glaxo-Smith-Kline.

To read more on preemption, check out:

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