Pro Te: Solutio 76 Pro Te: Solutio
I
More than a year ago, the United States
Supreme Court, in Wyeth v. Levine, held
that state law failure-to-warn claims against
brand-name drug manufacturers are not
automatically preempted by the Food Drug
and Cosmetic Act (FDCA). Levine applies
only to branded pharmaceuticals, and the
Court did not address the implications of
its holding for generic drug manufacturers.
Before Levine, a number of courts found
that failure-to-warn claims against generic
manufacturers were preempted by the
Hatch-Waxman amendments to the FDCA.
e reasoning: because generic manufactur-
ers were required to maintain the “same” label
as the branded drug, generic manufacturers
could not initiate label changes independent
of the branded manufacturer. Generic man-
ufacturers therefore argued that state law
failure-to-warn claims could not succeed
when the generic manufacturer complied
with the FDCA and used the last approved
label for the brand-name equivalent drug.
After Levine, the trend is for courts to find
that failure-to-warn claims against generics
manufacturers are not preempted by the
FDCA. Both the Fifth and Eighth Circuits
have ruled against preemption.2 A petition
for certiorari was filed with the United
States Supreme Court in Mensing v. Wyeth,
and the Court has asked the Solicitor Gen-
eral to weigh in on the issue. e Court’s
request for input from the Solicitor General
suggests there may be enough interest from
the Court to hear the appeal.
Appeals currently are pending before the
Sixth and Ninth Circuits from decisions
that found in favor of preemption.3 e
Sixth Circuit has asked the FDA to submit a
brief explaining its view of generic preemp-
tion. at brief will be filed 14 days after the
ener
reeptn
after
e
“T E C’ [ ]
’ ; -
.”1
