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OCR Page 1 of 706/30/97 MON 18:57 FAX 202 514 8071
CIVIL OAAG
I
010
U.S. Department of Justice
DRAFT
Washington, D.C. 20530
TOBACCO- LEGAL
June 30, 1997
Memorandum
To: Stephen Preston, George Phillips
Fr: Michael Raab
Re: Preemption Issues Raised By Proposed Tobacco Settlement
This memorandum considers preemption issues presented by the
Proposed Resolution dated June 20, 1997, which provides for the
settlement of numerous lawsuits relating to tobacco products.
Part I of the memorandum briefly summarizes current law governing
the preemption of state and local requirements regarding medical
devices. Part II provides a preliminary analysis of relevant
provisions of the Proposed Resolution.
I. Current Law.
Section 521 (a) of the Federal Food, Drug and Cosmetic Act of
1938, as amended ("Act"), preempts any state-law "requirement" with
respect to a medical device that is "different from, or in addition
to," federal requirements imposed under the Act. 21 U.S.C.
360k(a). The Supreme Court has held that Section 521 (a) does not
preempt state common-law claims that are premised on the failure of
a medical device to satisfy federal requirements. Medtronic, Inc.
v. Lohr, 116 S. Ct. 2240, 2255 (1996); id. at 2264 (O' Connor, J.,
concurring in part and dissenting in part). However, state-law
requirements that are more stringent than specific counterpart
requirements imposed under federal law are subject to preemption
under Section 521 (a). See id. at 2257-2258; id. at 2260-2261
(Breyer, J., concurring in part and concurring in the judgment) ; 21
C.F.R. 808.1(d).
Section 521 (b) of the Act permits States and their political
subdivisions to apply to the FDA for an exemption from Section
521 (a). 21 U.S.C. 360k (b). The FDA can exempt a state-law
requirement if (1) the requirement "is more stringent than" its
federal counterpart or (2) the requirement "is required by
compelling and local conditions" and "compliance with the
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