wyeth
levine
argued
november
decided
march
petitioner
wyeth
manufactures
antinausea
drug
phenergan
clinician
injected
respondent
levine
phenergan
method
whereby
drug
injected
directly
patient
vein
drug
entered
levine
artery
developed
gangrene
doctors
amputated
forearm
levine
brought
damages
action
alleging
inter
alia
wyeth
failed
provide
adequate
warning
significant
risks
administering
phenergan
method
vermont
jury
determined
levine
injury
occurred
phenergan
label
included
adequate
warning
awarded
damages
pain
suffering
substantial
medical
expenses
loss
livelihood
professional
musician
declining
overturn
verdict
trial
rejected
wyeth
argument
levine
claims
federal
law
phenergan
labeling
approved
federal
food
drug
administration
fda
vermont
affirmed
held
federal
law
levine
claim
phenergan
label
contain
adequate
warning
method
administration
pp
argument
levine
claims
impossible
wyeth
comply
duties
underlying
claims
federal
labeling
duties
rejected
although
manufacturer
generally
may
change
drug
label
fda
approves
supplemental
application
agency
changes
effected
cbe
regulation
permits
certain
preapproval
labeling
changes
add
strengthen
warning
improve
drug
safety
pursuant
cbe
regulation
wyeth
unilaterally
added
stronger
warning
administration
evidence
fda
ultimately
rejected
labeling
change
wyeth
cramped
reading
cbe
regulation
broad
assertion
unilaterally
changing
phenergan
label
violated
federal
law
governing
unauthorized
distribution
misbranding
drugs
based
fundamental
misunderstanding
fda
rather
manufacturer
bears
primary
responsibility
drug
labeling
central
premise
food
drug
cosmetic
act
fdca
fda
regulations
manufacturer
bears
responsibility
content
label
times
pp
wyeth
argument
requiring
comply
duty
provide
stronger
warning
interfere
congress
purpose
entrusting
expert
agency
drug
labeling
decisions
meritless
relies
untenable
interpretation
congressional
intent
overbroad
view
agency
power
state
law
history
fdca
shows
congress
intend
actions
advancing
argument
fda
must
presumed
established
specific
labeling
standard
leaves
room
different
judgments
wyeth
relies
statement
congress
preamble
fda
regulation
declaring
claims
threaten
fda
statutorily
prescribed
role
although
agency
regulation
force
law
conflicting
state
requirements
case
involves
regulation
merely
agency
assertion
state
law
obstacle
achieving
statutory
objectives
congress
authorized
federal
agency
state
law
directly
weight
accords
agency
explanation
state
law
impact
federal
scheme
depends
thoroughness
consistency
persuasiveness
skidmore
swift
standard
fda
preamble
merit
deference
inherently
suspect
light
fda
failure
offer
interested
parties
notice
opportunity
comment
question
odds
available
evidence
congress
purposes
reverses
fda
longstanding
position
state
law
complementary
form
drug
regulation
without
providing
reasoned
explanation
geier
american
honda
motor
distinguished
pp
affirmed
stevens
delivered
opinion
kennedy
souter
ginsburg
breyer
joined
breyer
filed
concurring
opinion
thomas
filed
opinion
concurring
judgment
alito
filed
dissenting
opinion
roberts
scalia
joined
wyeth
petitioner
diana
levine
writ
certiorari
vermont
march
justice
stevens
delivered
opinion
directly
injecting
drug
phenergan
patient
vein
creates
significant
risk
catastrophic
consequences
vermont
jury
found
petitioner
wyeth
manufacturer
drug
failed
provide
adequate
warning
risk
awarded
damages
respondent
diana
levine
compensate
amputation
arm
warnings
phenergan
label
deemed
sufficient
federal
food
drug
administration
fda
approved
wyeth
new
drug
application
later
approved
changes
drug
labeling
question
must
decide
whether
fda
approvals
provide
wyeth
complete
defense
levine
tort
claims
conclude
phenergan
wyeth
brand
name
promethazine
hydrochloride
antihistamine
used
treat
nausea
injectable
form
phenergan
administered
intramuscularly
intravenously
administered
intravenously
either
method
whereby
drug
injected
directly
patient
vein
method
whereby
drug
introduced
saline
solution
hanging
intravenous
bag
slowly
descends
catheter
inserted
patient
vein
drug
corrosive
causes
irreversible
gangrene
enters
patient
artery
levine
injury
resulted
injection
phenergan
april
previous
visits
local
clinic
treatment
migraine
headache
received
intramuscular
injection
demerol
headache
phenergan
nausea
combination
provide
relief
returned
later
day
received
second
injection
drugs
time
physician
assistant
administered
drugs
method
phenergan
entered
levine
artery
either
needle
penetrated
artery
directly
drug
escaped
vein
surrounding
tissue
phenomenon
called
perivascular
extravasation
came
contact
arterial
blood
result
levine
developed
gangrene
doctors
amputated
first
right
hand
entire
forearm
addition
pain
suffering
levine
incurred
substantial
medical
expenses
loss
livelihood
professional
musician
settling
claims
health
center
clinician
levine
brought
action
damages
wyeth
relying
negligence
theories
although
phenergan
labeling
warned
danger
gangrene
amputation
following
inadvertent
levine
alleged
labeling
defective
failed
instruct
clinicians
use
method
intravenous
administration
instead
higher
risk
method
broadly
alleged
phenergan
reasonably
safe
intravenous
administration
foreseeable
risks
gangrene
loss
limb
great
relation
drug
therapeutic
benefits
app
wyeth
filed
motion
summary
judgment
arguing
levine
claims
federal
law
found
merit
either
wyeth
field
argument
since
abandoned
conflict
argument
respect
contention
actual
conflict
specific
fda
order
levine
action
reviewed
sparse
correspondence
wyeth
fda
phenergan
labeling
found
evidence
wyeth
earnestly
attempted
strengthen
injection
warning
fda
specifically
disallowed
stronger
language
record
developed
lack
ed
evidence
fda
set
ceiling
matter
ibid
evidence
presented
jury
trial
showed
risk
injection
perivascular
extravasation
almost
entirely
eliminated
use
rather
administration
iv
drip
started
saline
flow
properly
catheter
vein
fluid
entering
artery
surrounding
tissue
see
contrast
even
careful
experienced
clinician
using
method
occasionally
expose
artery
phenergan
see
phenergan
labeling
warned
injection
perivascular
extravasation
advised
hen
administering
irritant
drug
intravenously
usually
preferable
inject
tubing
intravenous
infusion
set
known
functioning
satisfactorily
labeling
contain
specific
warning
risks
administration
trial
record
also
contains
correspondence
wyeth
fda
discussing
phenergan
label
fda
first
approved
injectable
phenergan
wyeth
submitted
supplemental
new
drug
applications
agency
approved
proposing
labeling
changes
wyeth
submitted
third
supplemental
application
response
new
fda
rule
governing
drug
labels
next
years
wyeth
fda
intermittently
corresponded
phenergan
label
notable
activity
occurred
fda
suggested
different
warnings
risk
arterial
exposure
wyeth
submitted
revised
labeling
incorporating
proposed
changes
fda
respond
instead
requested
wyeth
labeling
use
without
addressing
wyeth
submission
instructed
etain
verbiage
current
label
regarding
injection
changes
labeling
related
injection
fda
approved
wyeth
application
instructing
phenergan
final
printed
label
must
identical
approved
package
insert
based
regulatory
history
trial
judge
instructed
jury
consider
evidence
wyeth
compliance
fda
requirements
compliance
establish
warnings
adequate
also
instructed
without
objection
wyeth
fda
regulations
permit
drug
manufacturer
change
product
label
add
strengthen
warning
product
without
prior
fda
approval
long
later
submits
revised
warning
review
approval
answering
questions
special
verdict
form
jury
found
wyeth
negligent
phenergan
defective
product
result
inadequate
warnings
instructions
intervening
cause
broken
causal
connection
product
defects
plaintiff
injury
awarded
total
damages
reduced
account
levine
earlier
settlement
health
center
clinician
august
trial
filed
comprehensive
opinion
denying
wyeth
motion
judgment
matter
law
making
findings
fact
based
trial
record
supplemented
one
letter
wyeth
found
trial
rejected
wyeth
arguments
determined
direct
conflict
fda
regulations
levine
claims
regulations
permit
strengthened
warnings
without
fda
approval
interim
basis
record
contained
evidence
least
reports
amputations
similar
levine
since
also
found
state
tort
liability
case
obstruct
fda
work
agency
paid
passing
attention
question
whether
warn
administration
phenergan
addition
noted
state
law
serves
compensatory
function
distinct
federal
regulation
vermont
affirmed
held
jury
verdict
conflict
fda
labeling
requirements
phenergan
wyeth
warned
administration
without
prior
fda
approval
federal
labeling
requirements
create
floor
ceiling
state
regulation
dissent
chief
justice
reiber
argued
jury
verdict
conflicted
federal
law
inconsistent
fda
conclusion
intravenous
administration
phenergan
safe
effective
importance
issue
coupled
fact
fda
changed
position
state
tort
law
endorses
views
expressed
chief
justice
reiber
dissent
persuaded
us
grant
wyeth
petition
certiorari
question
presented
petition
whether
fda
drug
labeling
judgments
preempt
state
law
product
liability
claims
premised
theory
different
labeling
judgments
necessary
make
drugs
reasonably
safe
use
pet
cert
ii
wyeth
makes
two
separate
arguments
first
impossible
comply
duty
modify
phenergan
labeling
without
violating
federal
law
see
fidelity
fed
sav
loan
assn
de
la
cuesta
second
recognition
levine
state
tort
action
creates
unacceptable
obstacle
accomplishment
execution
full
purposes
objectives
congress
hines
davidowitz
substitutes
lay
jury
decision
drug
labeling
expert
judgment
fda
preface
evaluation
arguments
identify
two
factual
propositions
decided
trial
proceedings
emphasize
two
legal
principles
guide
analysis
review
history
controlling
federal
statute
trial
proceedings
established
levine
injury
occurred
phenergan
label
included
adequate
warning
risks
method
administering
drug
record
contains
evidence
physician
assistant
administered
greater
dose
label
prescribed
may
inadvertently
injected
drug
artery
rather
vein
continued
inject
drug
levine
complained
pain
nevertheless
jury
rejected
wyeth
argument
clinician
conduct
intervening
cause
absolved
liability
see
app
jury
verdict
finding
wyeth
negligent
well
strictly
liable
jury
also
determined
levine
injury
foreseeable
inadequate
label
proximate
cause
levine
injury
supported
record
longer
challenged
trial
proceedings
established
critical
defect
phenergan
label
lack
adequate
warning
risks
administration
levine
also
offered
evidence
method
contraindicated
phenergan
never
administered
intravenously
even
method
perhaps
reason
dissent
incorrectly
assumes
duty
issue
duty
contraindicate
method
see
post
vermont
explained
jury
verdict
established
phenergan
warning
insufficient
mandate
particular
replacement
warning
require
contraindicating
administration
may
number
ways
wyeth
strengthen
phenergan
warning
without
completely
eliminating
administration
therefore
need
decide
whether
state
rule
proscribing
intravenous
administration
narrower
question
presented
whether
federal
law
levine
claim
phenergan
label
contain
adequate
warning
using
method
administration
answer
question
must
guided
two
cornerstones
jurisprudence
first
purpose
congress
ultimate
touchstone
every
case
medtronic
lohr
internal
quotation
marks
omitted
see
retail
clerks
schermerhorn
second
cases
particularly
congress
field
traditionally
occupied
assumption
historic
police
powers
superseded
federal
act
unless
clear
manifest
purpose
congress
lohr
quoting
rice
santa
fe
elevator
order
identify
purpose
congress
appropriate
briefly
review
history
federal
regulation
drugs
drug
labeling
congress
enacted
first
significant
public
health
law
federal
food
drugs
act
ch
stat
act
prohibited
manufacture
interstate
shipment
adulterated
misbranded
drugs
supplemented
protection
consumers
already
provided
state
regulation
liability
congress
became
increasingly
concerned
unsafe
drugs
fraudulent
marketing
enacted
federal
food
drug
cosmetic
act
fdca
ch
stat
amended
et
seq
act
substantial
innovation
provision
premarket
approval
new
drugs
required
every
manufacturer
submit
new
drug
application
including
reports
investigations
specimens
proposed
labeling
fda
review
application
became
effective
manufacturer
prohibited
distributing
drug
fda
reject
application
determined
drug
safe
use
labeled
though
agency
failed
act
application
became
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days
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stat
congress
amended
fdca
shifted
burden
proof
fda
manufacturer
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prove
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drug
market
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manufacturer
demonstrate
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distribute
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prove
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effect
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represented
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suggested
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labeling
enlarged
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powers
protect
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health
assure
safety
effectiveness
reliability
drugs
congress
took
care
preserve
state
law
amendments
added
saving
clause
indicating
provision
state
law
invalidated
upon
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positive
conflict
fdca
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provision
state
suits
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regulation
riegel
medtronic
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ginsburg
dissenting
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collecting
state
cases
congress
enacted
express
provision
medical
devices
see
stat
codified
declined
enact
provision
prescription
drugs
levine
injury
lawsuit
congress
amended
fdca
stat
first
time
granted
fda
statutory
authority
require
manufacturer
change
drug
label
based
safety
information
becomes
available
drug
initial
approval
however
congress
enact
provision
senate
bill
required
fda
preapprove
changes
drug
labels
see
pp
passed
proposing
new
instead
adopted
rule
construction
make
clear
manufacturers
remain
responsible
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labels
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stat
iii
wyeth
first
argues
levine
claims
impossible
comply
duties
underlying
claims
federal
labeling
duties
see
de
la
cuesta
fda
premarket
approval
new
drug
application
includes
approval
exact
text
proposed
label
see
cfr
generally
speaking
manufacturer
may
change
drug
label
fda
approves
supplemental
application
however
fda
regulation
permits
manufacturer
make
certain
changes
label
receiving
agency
approval
among
things
changes
effected
cbe
regulation
provides
manufacturer
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label
add
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warning
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reaction
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dosage
administration
intended
increase
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use
drug
product
may
make
labeling
change
upon
filing
supplemental
application
fda
need
wait
fda
approval
iii
wyeth
argues
cbe
regulation
implicated
case
amendment
provides
manufacturer
may
change
label
reflect
newly
acquired
information
fed
reg
resting
language
wyeth
argues
simply
reaffirmed
interpretation
regulation
effect
case
tried
wyeth
contends
changed
phenergan
label
response
new
information
fda
considered
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pointed
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wyeth
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discharge
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provide
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federal
law
wyeth
argument
misapprehends
federal
drug
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burden
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need
decide
whether
cbe
regulation
consistent
fdca
previous
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wyeth
urge
wyeth
revised
phenergan
label
even
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fda
explained
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final
rule
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also
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rule
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time
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sponsor
submits
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fda
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type
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reports
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see
also
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acquired
information
wyeth
risks
administration
phenergan
wyeth
argue
trial
information
required
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labeling
change
levine
however
present
evidence
least
incidents
prior
injury
phenergan
injection
resulted
gangrene
amputation
see
app
first
incident
came
wyeth
attention
notified
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worked
agency
change
phenergan
label
later
years
amputations
continued
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wyeth
analyzed
accumulating
data
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stronger
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administration
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wyeth
argues
unilaterally
added
warning
violated
federal
law
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distribution
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argument
change
phenergan
labeling
subjected
liability
unauthorized
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assumption
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change
rendered
phenergan
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warning
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made
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see
defining
new
drug
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warning
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phenergan
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fdca
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simply
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label
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juries
resolve
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idea
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bring
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manufacturer
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cbe
regulation
difficult
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wyeth
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done
wyeth
cramped
reading
cbe
regulation
broad
reading
fdca
misbranding
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distribution
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fundamental
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wyeth
suggests
fda
rather
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labeling
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many
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fdca
fda
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premise
federal
drug
regulation
manufacturer
bears
responsibility
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revise
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placing
responsibility
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reg
manufacturers
continue
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law
maintain
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federal
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regulations
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wyeth
duty
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law
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regulation
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manufacturers
produce
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citing
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reg
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establishes
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preempts
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law
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claims
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agency
regulation
force
law
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state
requirements
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hillsborough
county
automated
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cases
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law
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law
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law
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authorizing
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state
law
interfered
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regulation
drug
labeling
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plainly
reflect
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view
times
relevant
litigation
prior
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injury
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suggest
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tort
law
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instance
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believe
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state
tort
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development
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suits
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law
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subcommittee
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online
http
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drug
amendments
stat
nothing
amendments
made
act
federal
food
drug
cosmetic
act
shall
construed
invalidating
provision
state
law
unless
direct
positive
conflict
amendments
provision
state
law
provision
simply
recognizes
background
principles
conflict
traditional
saving
clause
even
displace
analysis
see
geier
american
honda
motor
saving
clause
bar
ordinary
working
conflict
principles
refused
read
general
provisions
tolerate
actual
conflict
cases
involving
impossibility
cases
emphasis
deleted
citation
omitted
fda
cited
numerous
articles
generally
discuss
costs
benefits
associated
iv
push
see
nahrwold
phelps
inadvertent
injection
mephenteramine
rocky
mountain
medical
cited
app
albo
cheung
ruth
snyder
beemtsma
effect
injections
barbituates
surgery
cited
app
corser
masey
jacob
kernoff
browne
ischaemia
following
injection
methylphenidate
diamorphine
anesthesiology
cited
app
correspondence
regarding
thiopental
thiamylal
letters
anesthesiology
cited
app
miller
arthur
stratigos
injection
barbituate
anesthesia
progress
cited
app
see
webb
lampert
accidental
arterial
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obstetrics
gynecology
cited
app
see
hager
wilson
gangrene
hand
following
injection
archives
surgery
cited
app
enloe
sylvester
morris
hazards
injection
hydroxyzine
canadian
anaesthetists
society
hereinafter
enloe
noting
recent
reports
occurrence
severe
necrosis
gangrene
following
administration
promethazine
cited
app
see
also
mostafavi
samimi
accidental
injection
promethazine
hcl
general
anesthesia
anesthesiology
reporting
case
gangrene
required
partial
amputation
three
fingers
phenergan
inadvertently
pushed
artery
antecubital
area
promethazine
clinical
pharmacology
gold
standard
multimedia
version
noting
nadvertent
injection
phenergan
result
arteriospasm
development
gangrene
hager
wilson
noted
common
reactions
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drugs
like
phenergan
include
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severe
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pain
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archives
surgery
fda
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wyeth
include
hager
wilson
observations
phenergan
label
see
app
requiring
label
warn
first
sign
injection
may
patient
reaction
sensation
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pain
see
enloe
discussing
hydroxyzine
antihistamine
chemical
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phenergan
suggesting
temporary
benefits
never
outweigh
risks
injection
see
also
goldsmith
trieger
accidental
injection
medical
emergency
anesthesia
progress
noting
risks
administration
hydroxyzine
cited
app
klatte
brooks
rhamy
toxicity
barbituates
tranquilizing
drugs
radiology
cited
app
full
knowledge
risks
fda
retained
iv
push
phenergan
although
agency
required
wyeth
incorporate
observations
enloe
article
phenergan
label
compare
enloe
arguing
every
precaution
taken
avoid
inadvertent
injection
including
use
obviously
venoclysis
app
fda
changes
phenergan
label
contrast
time
around
fda
prohibited
intravenous
use
hydroxyzine
see
testimony
harold
green
fda
decision
regulate
two
drugs
differently
notwithstanding
agency
knowledge
risks
associated
drugs
agency
recognition
relevance
articles
case
reports
regulation
phenergan
demonstrates
fda
intentionally
preserved
administration
phenergan
see
also
haas
correspondence
anesthesia
progress
hydroxyzine
restriction
lie
medicine
practice
malpractice
intravenous
techniques
unfortunately
practitioner
knows
treat
injection
technique
problems
usually
practitioner
intravenous
technique
problems
see
also
engler
freeman
kanavage
ogden
moretz
production
gangrenous
extremities
injections
surgeon
accidental
arterial
injection
often
occurs
antecubital
region
favorite
site
venopuncture
area
ulnar
brachial
arteries
superficial
easily
entered
cited
app
engler
gangrenous
extremities
resulting
injections
archives
surgery
similar
cited
app
lynas
bisset
thiopentone
anaesthesia
anesthesiologists
agree
injections
medial
aspect
antecubital
fossa
best
avoided
cited
app
waters
thiopentone
anesthesia
risk
producing
gangrene
forearm
accidental
injection
sodium
thiopentone
artery
elbow
recognised
many
years
cited
app
see
also
hager
wilson
archives
surgery
emphasizing
one
best
ways
prevent
inadvertent
injections
aware
aberrant
superficial
arteries
antecubital
forearm
wrist
hand
level
mostafavi
samimi
supra
warning
antecubital
injections
see
app
requiring
phenergan
label
warn
practitioners
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close
proximity
arteries
veins
commonly
used
injection
sites
consider
possibility
aberrant
aspiration
refers
drawing
small
amount
blood
back
needle
determine
whether
needle
artery
vein
ordinarily
arterial
blood
brighter
venous
blood
contact
phenergan
causes
discoloration
makes
aspiration
unreliable
method
protecting
injection
see
therefore
label
warned
using
iv
push
medical
professional
beware
spiration
dark
blood
preclude
needle
placement
blood
discolored
upon
contact
phenergan
injection
addition
respondent
medical
expert
testified
trial
principle
basic
anatomy
antecubital
fossa
contains
aberrant
arteries
see
tr
mar
testimony
daniel
see
also
ibid
noting
gray
anatomy
bible
anatomy
also
warns
arteries
antecubital
space
thus
true
long
applied
presumption
conflict
cases
ante
majority
opinion
long
ago
gibbons
ogden
wheat
inquired
whether
state
law
interfer
ed
contrary
collision
federal
law
without
ever
invoking
presumption
see
also
davis
unmasking
presumption
favor
preemption
rev
noting
many
early
cases
resulted
almost
automatic
preemption
concurrent
state
regulation
subsequent
years
sometimes
acknowledged
limited
presumption
nonetheless
remained
open
question
today
whether
presumption
applied
conflict
cases
see
crosby
national
foreign
trade
council
leave
another
day
consideration
context
presumption
preemption
moreover
never
held
presumption
applies
area
drug
labeling
long
reserved
federal
regulation
locke
see
also
buckman
plaintiffs
legal
vesicants
may
cause
blistering
severe
tissue
injury
tissue
necrosis
upon
extravasation
even
drug
injected
artery
see
schulmeister
administering
vesicants
clinical
oncology
nursing
see
also
ante
majority
opinion
noting
phenergan
labeled
irritant
cf
brief
anju
budhwani
et
al
amici
curiae
suggesting
phenergan
considered
vesicant
fda
oncology
tools
product
label
details
online
http
visited
mar
available
clerk
case
file
ibid
true
fda
regulation
hydroxyzine
see
supra