pliva
et
al
mensing
argued
march
decided
june
five
years
food
drug
administration
fda
first
approved
metoclopramide
drug
commonly
used
treat
digestive
tract
problems
brand
name
reglan
generic
manufacturers
petitioners
also
began
producing
drug
accumulating
evidence
metoclopramide
use
cause
tardive
dyskinesia
severe
neurological
disorder
warning
labels
drug
strengthened
clarified
several
times
recently
respondents
prescribed
reglan
received
generic
drug
pharmacists
taking
drug
prescribed
several
years
developed
tardive
dyskinesia
separate
tort
actions
sued
petitioners
generic
drug
manufacturers
produced
metoclopramide
took
manufacturers
respondent
alleged
inter
alia
metoclopramide
use
caused
disorder
manufacturers
liable
state
tort
law
failing
provide
adequate
warning
labels
suits
manufacturers
urged
federal
statutes
fda
regulations
state
tort
claims
requiring
safety
efficacy
labeling
generic
metoclopramide
mandated
time
reglan
fifth
eighth
circuits
rejected
arguments
holding
respondents
claims
held
judgment
reversed
cases
remanded
reversed
remanded
justice
thomas
delivered
opinion
respect
part
concluding
federal
drug
regulations
applicable
generic
drug
manufacturers
directly
conflict
thus
state
claims
pp
analysis
requires
comparison
federal
state
law
begins
identifying
state
tort
duties
federal
labeling
requirements
applicable
manufacturers
pp
state
tort
law
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manufacturer
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label
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pleaded
manufacturers
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products
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risk
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duty
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label
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actually
used
pp
hand
federal
drug
regulations
interpreted
fda
prevented
manufacturers
independently
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drugs
safety
labels
manufacturer
seeking
federal
approval
market
new
drug
must
prove
safe
effective
proposed
label
accurate
adequate
although
rules
originally
applied
drugs
law
commonly
called
amendments
allows
generic
drug
manufacturer
gain
fda
approval
simply
showing
drug
equivalent
drug
safety
efficacy
labeling
proposed
drug
approved
drug
respondents
contend
federal
law
nevertheless
provides
avenues
manufacturers
altered
metoclopramide
labels
time
prevent
injuries
include
fda
cbe
process
permits
drug
manufacturers
without
preapproval
add
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label
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dear
doctor
letters
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prescribing
physicians
healthcare
professionals
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denies
manufacturers
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views
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auer
robbins
assuming
without
deciding
fda
correct
federal
law
nevertheless
required
manufacturers
ask
agency
assistance
convincing
manufacturer
adopt
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label
turns
question
pp
state
federal
law
directly
conflict
state
law
must
give
way
see
wyeth
levine
conflict
exists
impossible
private
party
comply
state
federal
requirements
freightliner
myrick
pp
finds
impossibility
manufacturers
independently
changed
labels
satisfy
duty
attach
safer
label
generic
metoclopramide
violated
federal
requirement
generic
drug
labels
corresponding
drug
labels
thus
impossible
comply
state
federal
law
even
fulfilled
federal
duty
ask
fda
help
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duty
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state
law
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law
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manufacturers
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wyeth
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tort
action
drug
manufacturer
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provide
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warning
label
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federal
law
fda
cbe
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statutes
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drug
manufacturers
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design
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drug
manufacturers
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pp
thomas
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roberts
scalia
alito
joined
opinion
full
kennedy
joined
part
sotomayor
filed
dissenting
opinion
ginsburg
breyer
kagan
joined
pliva
et
petitioners
gladys
mensing
actavis
elizabeth
llc
petitioner
gladys
mensing
actavis
petitioner
julie
demahy
writs
certiorari
courts
appeals
eighth
fifth
circuits
june
justice
thomas
delivered
opinion
part
consolidated
lawsuits
involve
state
claims
based
certain
drug
manufacturers
alleged
failure
provide
adequate
warning
labels
generic
metoclopramide
question
presented
whether
federal
drug
regulations
applicable
generic
drug
manufacturers
directly
conflict
thus
claims
hold
metoclopramide
drug
designed
speed
movement
food
digestive
system
food
drug
administration
fda
first
approved
metoclopramide
tablets
brand
name
reglan
five
years
later
generic
manufacturers
also
began
producing
drug
commonly
used
treat
digestive
tract
problems
diabetic
gastroparesis
gastroesophageal
reflux
disorder
evidence
accumulated
metoclopramide
use
cause
tardive
dyskinesia
severe
neurological
disorder
studies
shown
patients
take
metoclopramide
several
years
develop
condition
mcneil
wyeth
see
also
shaffer
butterfield
pamer
mackey
tardive
dyskinesia
risks
metoclopramide
use
market
withdrawal
cisapride
pharmacists
assn
noting
cases
tardive
dyskinesia
reported
fda
adverse
event
reporting
system
accordingly
warning
labels
drug
strengthened
clarified
several
times
label
modified
warn
tardive
dyskinesia
may
develop
patients
treated
metoclopramide
drug
package
insert
added
herapy
longer
weeks
evaluated
recommended
physician
desk
reference
ed
see
also
brief
petitioner
pliva
et
al
hereinafter
pliva
brief
reglan
manufacturer
requested
fda
approved
label
change
add
herapy
exceed
weeks
duration
brief
amicus
curiae
hereinafter
brief
fda
ordered
black
box
warning
strongest
treatment
metoclopramide
cause
tardive
dyskinesia
serious
movement
disorder
often
irreversible
treatment
metoclopramide
longer
weeks
avoided
rare
cases
see
physician
desk
reference
ed
gladys
mensing
julie
demahy
plaintiffs
consolidated
cases
prescribed
reglan
respectively
received
generic
metoclopramide
pharmacists
taking
drug
prescribed
several
years
women
developed
tardive
dyskinesia
separate
suits
mensing
demahy
sued
generic
drug
manufacturers
produced
metoclopramide
took
manufacturers
alleged
relevant
metoclopramide
use
caused
dyskinesia
manufacturers
liable
state
tort
law
specifically
minnesota
louisiana
failing
provide
adequate
warning
labels
claimed
despite
mounting
evidence
long
term
metoclopramide
use
carries
risk
tardive
dyskinesia
far
greater
indicated
label
none
manufacturers
changed
labels
adequately
warn
danger
mensing
wyeth
see
also
demahy
actavis
suits
manufacturers
urged
federal
law
state
tort
claims
according
manufacturers
federal
statutes
fda
regulations
required
use
safety
efficacy
labeling
counterparts
means
argued
impossible
simultaneously
comply
federal
law
state
duty
required
use
different
label
courts
appeals
fifth
eighth
circuits
rejected
manufacturers
arguments
held
demahy
claims
see
granted
certiorari
consolidated
cases
reverse
ii
analysis
requires
us
compare
federal
state
law
therefore
begin
identifying
state
tort
duties
federal
labeling
requirements
applicable
manufacturers
undisputed
minnesota
louisiana
tort
law
require
drug
manufacturer
aware
product
danger
label
product
way
renders
reasonably
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minnesota
law
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mensing
lawsuit
manufacturer
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constructive
knowledge
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warning
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frey
montgomery
ward
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louisiana
law
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lawsuit
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novartis
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law
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act
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et
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levine
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generic
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demahy
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several
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manufacturers
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time
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manufacturers
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state
law
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regulation
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today
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manufacturers
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brief
henry
waxman
amicus
curiae
majority
pins
expansion
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drug
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special
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regulation
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generic
manufacturers
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drugs
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drugs
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physicians
state
legislators
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drugs
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drugs
sue
manufacturers
inadequate
warnings
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generic
drugs
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liability
rules
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reduce
consumer
demand
generics
least
among
consumers
afford
drugs
may
pose
ethical
dilemma
prescribing
physicians
brief
american
medical
association
et
al
amici
curiae
may
well
cause
rethink
longstanding
efforts
promote
generic
use
generic
substitution
laws
see
brief
national
conference
state
legislators
amicus
curiae
state
generic
substitution
laws
proceeded
premise
generic
drugs
citizens
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materially
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brand
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lower
price
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directly
odds
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consumption
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drugs
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opinion
convinces
enacting
requirement
generic
labels
match
corresponding
labels
congress
intended
absurd
results
certainly
shown
clear
manifest
purpose
congress
wyeth
internal
quotation
marks
omitted
emphasis
added
contrary
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law
affords
generic
manufacturers
mechanism
attempting
comply
duties
warn
hold
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law
categorically
claims
generic
manufacturers
especially
light
presumption
burden
fall
generic
manufacturers
show
compliance
impossible
particular
facts
case
holding
possibility
possibility
insufficient
defea
cases
ante
contorts
doctrine
exempts
defendants
burden
establish
impossibility
respect
dissent
footnotes
together
actavis
elizabeth
llc
mensing
also
certiorari
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demahy
certiorari
appeals
fifth
circuit
footnotes
justice
kennedy
joins
part
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relevant
events
cases
predate
food
drug
administration
amendments
act
stat
therefore
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exclusively
statutes
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view
impact
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copy
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drug
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drug
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active
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safety
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reference
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drug
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filed
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views
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cf
talk
america
michigan
bell
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chase
bank
usa
mccoy
slip
although
defer
agency
interpretation
regulations
defer
agency
ultimate
conclusion
whether
state
law
wyeth
levine
address
whether
state
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law
directly
conflict
circumstances
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wyeth
thomas
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judgment
suggesting
might
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cf
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mazda
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judgment
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saving
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motor
vehicle
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drugs
long
use
generic
drugs
typically
appears
brief
patent
protections
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drugs
arriving
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number
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drug
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indeed
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fda
formal
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drug
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duty
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regulation
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process
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dissent
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even
approach
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drug
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establish
number
scenarios
post
footnotes
online
http
internet
materials
visited
june
available
clerk
case
file
addition
many
insurance
plans
structured
promote
generic
use
see
congressional
budget
office
effects
using
generic
drugs
medicare
prescription
drug
spending
online
http
state
medicaid
programs
similarly
promote
generic
use
see
kaiser
medicaid
uninsured
state
medicaid
outpatient
prescription
drug
policies
findings
national
survey
update
online
online
http
adverse
drug
experience
defined
ny
adverse
event
associated
use
drug
humans
whether
considered
drug
related
cfr
like
majority
refer
statutes
regulations
see
ante
congressional
hearings
amendments
representatives
generic
drug
manufacturers
confirmed
obligation
ability
conduct
postapproval
investigation
adverse
drug
experiences
see
drug
legislation
hearings
et
al
subcommittee
health
environment
house
committee
energy
commerce
statement
kenneth
larsen
chairman
generic
pharmaceutical
industry
association
gpha
generic
manufacturers
sensitive
importance
looking
adverse
reactions
provide
whatever
required
performed
meet
regulatory
requirement
provide
safety
using
drug
role
responsibility
obligation
business
statement
bill
haddad
executive
officer
president
gpha
every
single
generic
drug
company
know
large
research
staff
researches
drug
copying
bringing
market
researches
new
drugs
researches
adverse
reaction
fda
construction
regulation
mirrors
guidance
provided
generic
manufacturers
nearly
years
ago
announcing
final
rule
implementing
abbreviated
application
process
generic
drugs
anda
application
approval
generic
drug
applicant
believes
new
safety
information
added
product
labeling
contact
fda
fda
determine
whether
labeling
generic
listed
drugs
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holder
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new
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information
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fda
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labeling
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reg
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procedures
recognize
office
generic
drugs
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components
labeling
reviews
manual
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may
consultations
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possible
serious
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receive
highest
priority
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eighth
circuit
suggested
manufacturers
show
impossibility
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law
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drugs
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see
mensing
wyeth
generic
defendants
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realized
label
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believe
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label
change
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see
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case
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drug
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global
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frequently
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thomas
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expressed
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mazda
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america
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judgment
slip
wyeth
levine
opinion
concurring
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novel
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law
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carefully
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discussing
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longstanding
presumption
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fda
generic
drug
industry
spend
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consumers
affordable
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drugs
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law
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pricier
counterparts
brief
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curiae
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cert
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