President Barack Obama issued a memorandum to the heads of federal departments and agencies preempting preemption, in a move that sets the stage for a drastic overhaul of the way product liability law is applied to medical devices.
The memo bars department heads from including statements of preemption in regulations they issue:
“[P]reemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption. Executive departments and agencies should be mindful that in our Federal system, the citizens of the several States have distinctive circumstances and values, and that in many instances it is appropriate for them to apply to themselves rules and principles that reflect these circumstances and values.”
The Supreme Court upheld the concept in Riegel v. Medtronic last year, ruling that medical device companies are shielded from product liability suits brought in state courts if the device in question was already approved by the Food & Drug Administration (thereby “preempting” the state rules).
But with Democrats in control of both houses of Congress and the White House, the memo adds another brick to the anti-preemption edifice already begun with the introduction of the Medical Device Safety Act of 2009, which would nullify the Riegel decision. And the court itself seemed to contradict its own decision in that case last March in Wyeth v. Levine, when it ruled that the pharmaceutical industry cannot claim preemption in liability suits.
The Obama memo also directs department heads to review regulations from the past 10 years “that contain statements … intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption.”
If preemption can’t be legally upheld in any of those cases, the agency in question must strip it from its rulebook.
For the full text of the memo, see the attachment below (PDF).
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