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Riegel v. Medtronic

A phenomenally good 7-2 or 8-1 decision (depending on how one reads Stevens's concurrence) in Riegel v. Medtronic (Nov. 2) bodes well for the cause of federal preemption in the pending Warner-Lambert v. Kent and Wyeth v. Levine cases. Beck and Herrmann have a comprehensive take; see also SCOTUSblog.

AEI is holding a panel tomorrow
afternoon discussing Riegel and the other pending preemption cases, featuring Michael Greve (AEI), Dan Troy (Sidley), Cathy Sharkey (NYU), and Brian Wolfman (Public Citizen).

Of note is yet another indicator of the Supreme Court's increasing concern over excessive liability, something I discussed in a Liability Outlook last summer:

[E]xcluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer's catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. As JUSTICE BREYER explained in Lohr, it is implausible that the MDA was meant to "grant greater power (to set state standards 'different from, or in addition to' federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes." 518 U. S., at 504. That perverse distinction is not required or even suggested by the broad language Congress chose in the MDA, and we will not turn somersaults to create it.

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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.