Posted by Jonathan Adler:
*Wyeth* and Deference to Agencies:
http://volokh.com/archives/archive_2009_03_01-2009_03_07.shtml#1236208700
One interesting aspect of the Supreme Court's Wyeth decision is its
refusal to defer to the FDA's conclusion that state tort suits, of the
sort at issue here, conflict with the FDA's regulatory scheme. While
the Court does not foreclose deferring to similar agency
determinations in the future, Justice Stevens makes clear that it is
for courts, not agencies, to determine whether such a conflict exists.
While this might not matter much in the immediate future, as I doubt
the Obama Administation will be all that aggressive in urging
preemption, it will raise the bar for future, pro-preemption
administrations.
Here is a portion of the relevant language in the opinion.
In prior cases, we have given �some weight� to an agency�s views
about the impact of tort law on federal objectives when �the
subject matter is technica[l] and the relevant history and
background are complex and extensive.� . . . Even in such cases,
however, we have not deferred to an agency�s conclusion that state
law is pre-empted. Rather, we have attended to an agency�s
explanation of how state law affects the regulatory scheme. While
agencies have no special authority to pronounce on pre-emption
absent delegation by Congress, they do have a unique understanding
of the statutes they administer and an attendant ability to make
informed determinations about how state requirements may pose an
�obstacle to the accomplishment and execution of the full purposes
and objectives of Congress.� . . . The weight we accord the
agency�s explanation of state law�s impact on the federal scheme
depends on its thoroughness, consistency, and persuasiveness. . . .
. . . we have no occasion in this case to consider the pre-emptive
effect of a specific agency regulation bearing the force of law.
And the FDA�s newfound opinion, expressed in its 2006 preamble,
that state law �frustrate[s] the agency�s implementation of its
statutory mandate,� . . . does not merit deference for the reasons
we have explained. . . .
In short, Wyeth has not persuaded us that failure-to-warn claims
like Levine�s obstruct the federal regulation of drug labeling.
Congress has repeatedly declined to pre-empt state law, and the
FDA�s recently adopted position that state tort suits interfere
with its statutory mandate is entitled to no weight. Although we
recognize that some state-law claims might well frustrate the
achievement of congressional objectives, this is not such a case.
The folks at the Drug and Device Law blog have some initial thoughts
on the decision [1]here.
References
1.
http://druganddevicelaw.blogspot.com/2009/03/wyeth-v-levine-first-real-thoughts.html
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