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Preemption: The legislative undermining under way

The attacks against federal preemption, a recurring topic of discussion around here, are stepping up in Congress.

On June 26 Rep. Frank Pallone (D-NJ) and Rep. Henry Waxman (D-CA) introduced H.R.6381, the Medical Device Safety Act. Being sold as overturning the Supreme Court's decision in Riegel v. Medtronic, it simply amends the Federal Food, Drug and Cosmetic Act with a clause: "Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."

Pallone's office issued a news release, "Health Leaders in Congress Introduce Legislative Reversing Supreme Court's Medical Device Decision."

The introduction of the legislation coincided with a letter from Waxman's Oversight Committee to FDA Administrator Andrew von Eschenbach, a typical document hunt to demonstrate that the FDA colludes with the drug and medical equipment industries to prevent state tort actions. By July 11, Waxman demands, the FDA must submit (and this is just a small sample)...

All documents since January 20, 2001, relating to communications between FDA officials and private persons, including representatives of drug or medical device companies, about preemption, including documents related to: (a) A intervention in specific product liability cases; (b) the development of Section D "Comments on the Product Liaiblity Implications of the Proposed Rule" in the preamble ot the 2006 drug labeling rule; and (c) policy documents and guidance relating to preemption.

The food and drug trade press has noticed (here and here, for example).

The letter follows an Oversight committee hearing in May on preemption, the one where Dennis Quaid and his wife testified.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.