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« Heller's Future in the Lower Courts | Main | What Riegel Portends for FDA Preemption of State Law Products Liability Claims (Part II) »

July 21, 2008


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» Preemption of State Law Products Liability Claims from Administrative Law Prof Blog
Catherine M. Sharkey (NYU) has published Part I of What Riegel Portends for FDA Preemption of State Law Products Liability Claims in Colloquy : Northwestern University Law Review. Thanks to the Drug and Device Law blog. EMM [Read More]

» Sharkey on Preemption from TortsProf Blog
This morning, the Northwestern University Law Review's Colloquy posted part I of Cathy Sharkey's What Riegel Portends for FDA Preemption of State Law Products Liability Claims. Part II will be available on Thursday. --CJR [Read More]


Hanoch Greenspan

I look forward to the next installment. This is powerful.

Just this clarifying quetion for Professor Sharkey:

If I follow you, you are moving beyond the preemption vs. no-preemption debate via the issue of the regulatory history of a specific product. This arises clearly in Wyeth v. Levine, where the history is complex and abundant.

So does it follow that the SC could rule rather narrowly in Levine, upholding preemption in cases where there has been extensive FDA review ("extensive" being always open to interpretation) but not necessarily where damage is claimed by a feature of the product essentially not reviewed by FDA (e.g., because not considered relevant, because relevant data somehow delayed or misrepresented, etc.)?

Am I getting the gist?

Thank you.

Catherine Sharkey

Hanoch: Yes, you are getting the gist of my argument, which will unfold in more detail in the next installment on Thursday (and will include an application to the upcoming Wyeth case). Let me say for now that you put your finger on an insight that has a further institutional dimension: namely, because (as you intuit) my approach to preemption is, in some sense, a "middle ground" position between the extremes of all-or-nothing preemption, it is less likely that Congress (alone) could arrive at the "right" answer by adding an express preemption (or anti-preemption) clause directly into the relevant statute. Hence, agencies not only do (by default, where Congress has not been clear)--but, as a normative matter, should--play a key role in preemption decisions. The debate, then, shifts (appropriately, to my mind) to defining the parameters for legitimate agency claims to authority both for its substantive determinations and for its interpretation of the statute.

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