mutual
pharmaceutical
bartlett
argued
march
decided
june
federal
food
drug
cosmetic
act
fdca
requires
manufacturers
gain
food
drug
administration
fda
approval
marketing
generic
drug
interstate
commerce
drug
approved
manufacturer
prohibited
making
major
changes
qualitative
quantitative
formulation
drug
product
including
active
ingredients
specifications
provided
approved
application
cfr
generic
manufacturers
also
prohibited
making
unilateral
changes
drug
label
see
iii
respondent
prescribed
clinoril
version
nonsteroidal
drug
nsaid
sulindac
shoulder
pain
pharmacist
dispensed
generic
form
sulindac
manufactured
petitioner
mutual
pharmaceutical
respondent
soon
developed
acute
case
toxic
epidermal
necrolysis
severely
disfigured
physical
disabilities
nearly
blind
time
prescription
sulindac
label
specifically
refer
toxic
epidermal
necrolysis
however
fda
recommended
changing
nsaid
labeling
contain
explicit
toxic
epidermal
necrolysis
warning
respondent
sued
mutual
new
hampshire
state
mutual
removed
case
federal
jury
found
mutual
liable
respondent
claim
awarded
million
first
circuit
affirmed
relevant
found
neither
fdca
fda
regulations
respondent
claim
distinguished
pliva
mensing
held
claims
generic
manufacturers
fdca
prohibition
changes
generic
drug
labels
arguing
generic
manufacturers
facing
claims
comply
federal
state
law
simply
choosing
make
drug
held
claims
turn
adequacy
drug
warnings
federal
law
pliva
pp
supremacy
clause
state
laws
conflict
federal
law
without
effect
maryland
louisiana
even
absence
express
provision
state
law
may
impliedly
impossible
private
party
comply
state
federal
requirements
english
general
elec
impossible
mutual
comply
duty
alter
sulindac
label
composition
duty
either
strengthen
warnings
sulindac
label
change
sulindac
design
pp
new
hampshire
cause
action
imposes
affirmative
duties
manufacturers
including
duty
design
products
reasonably
safely
uses
foresee
thibault
sears
roebuck
pp
assess
whether
product
design
unreasonably
dangerous
user
vautour
body
masters
sports
industries
new
hampshire
employs
approach
asks
whether
danger
magnitude
outweighs
product
utility
repeatedly
identified
three
factors
germane
inquiry
usefulness
desirability
product
public
whole
whether
risk
danger
reduced
without
significantly
affecting
either
product
effectiveness
manufacturing
cost
presence
efficacy
warning
avoid
unreasonable
risk
harm
hidden
dangers
foreseeable
uses
ibid
increasing
drug
usefulness
reducing
risk
danger
require
redesigning
drug
since
factors
direct
results
drug
chemical
design
active
ingredients
however
redesign
possible
two
reasons
first
fdca
requires
generic
drug
active
ingredients
route
administration
dosage
form
strength
labeling
drug
equivalent
second
sulindac
simple
composition
drug
chemically
incapable
redesigned
accordingly
redesign
impossible
mutual
ameliorate
sulindac
profile
strengthening
warnings
thus
new
hampshire
law
ultimately
required
mutual
change
sulindac
labeling
pp
pliva
makes
clear
federal
law
prevents
generic
drug
manufacturers
changing
labels
see
accordingly
mutual
prohibited
taking
remedial
action
required
avoid
liability
new
hampshire
law
federal
law
forbids
action
required
state
law
state
law
without
effect
maryland
supra
impossible
mutual
comply
state
federal
law
new
hampshire
cause
action
respect
drugs
sold
interstate
commerce
pp
first
circuit
rationale
mutual
escape
impossibility
complying
duties
choosing
stop
selling
sulindac
incompatible
cases
presumed
actor
seeking
satisfy
obligations
required
cease
acting
altogether
pp
reversed
alito
delivered
opinion
roberts
scalia
kennedy
thomas
joined
breyer
filed
dissenting
opinion
kagan
joined
sotomayor
filed
dissenting
opinion
ginsburg
joined
opinion
notice
opinion
subject
formal
revision
publication
preliminary
print
reports
readers
requested
notify
reporter
decisions
washington
typographical
formal
errors
order
corrections
may
made
preliminary
print
goes
press
mutual
pharmaceutical
company
petitioner
karen
bartlett
writ
certiorari
appeals
first
circuit
june
justice
alito
delivered
opinion
must
decide
whether
federal
law
new
hampshire
claim
respondent
karen
bartlett
recovered
damages
petitioner
mutual
pharmaceutical
manufacturer
sulindac
generic
nonsteroidal
drug
nsaid
new
hampshire
law
imposes
duty
manufacturers
ensure
drugs
market
unreasonably
unsafe
drug
safety
evaluated
reference
chemical
properties
adequacy
warnings
mutual
unable
change
sulindac
composition
matter
federal
law
basic
chemistry
new
hampshire
cause
action
effectively
required
mutual
change
sulindac
labeling
provide
stronger
warnings
recognized
two
terms
ago
pliva
mensing
federal
law
prohibits
generic
drug
manufacturers
independently
changing
drugs
labels
accordingly
state
law
imposed
duty
mutual
comply
federal
law
supremacy
clause
state
laws
require
private
party
violate
federal
law
thus
without
effect
maryland
louisiana
appeals
solution
mutual
simply
pulled
sulindac
market
order
comply
state
federal
law
solution
rather
adopting
appeals
rationale
render
impossibility
dead
letter
work
revolution
case
law
accordingly
hold
claims
turn
adequacy
drug
warnings
federal
law
pliva
thus
reverse
decision
appeals
federal
food
drug
cosmetic
act
fdca
ch
stat
amended
et
drug
manufacturers
must
gain
approval
food
drug
administration
fda
marketing
drug
interstate
commerce
case
new
drug
fda
approval
secured
submitting
application
nda
nda
compilation
materials
must
include
full
reports
clinical
investigations
relevant
nonclinical
studies
data
information
relevant
evaluation
safety
effectiveness
drug
product
obtained
otherwise
received
applicant
source
cfr
iv
nda
must
also
include
labeling
proposed
used
drug
cfr
discussion
drug
benefits
exceed
risks
conditions
stated
labeling
cfr
viii
ix
fda
may
approve
nda
determines
drug
question
safe
use
conditions
use
prescribed
recommended
suggested
proposed
labeling
thereof
order
fda
consider
drug
safe
drug
probable
therapeutic
benefits
must
outweigh
risk
harm
fda
brown
williamson
tobacco
process
submitting
nda
onerous
lengthy
see
report
congressional
requesters
government
accountability
office
new
drug
development
biotechnology
typical
nda
spans
thousands
pages
based
clinical
trials
conducted
several
years
order
provide
swifter
route
approval
generic
drugs
congress
passed
drug
price
competition
patent
term
restoration
act
stat
popularly
known
act
generic
drug
may
approved
without
level
clinical
testing
required
approval
new
drug
provided
generic
drug
identical
drug
several
key
respects
first
proposed
generic
drug
must
chemically
equivalent
approved
drug
must
active
ingredient
active
ingredients
route
administration
dosage
form
strength
counterpart
ii
iii
second
proposed
generic
must
bioequivalent
approved
drug
iv
must
rate
extent
absorption
drug
third
generic
drug
manufacturer
must
show
labeling
proposed
new
drug
labeling
approved
approved
drug
drug
whether
generic
approved
manufacturer
prohibited
making
major
changes
qualitative
quantitative
formulation
drug
product
including
active
ingredients
specifications
provided
approved
application
cfr
generic
manufacturers
also
prohibited
making
unilateral
changes
drug
label
see
iii
approval
generic
drug
may
withdrawn
generic
drug
label
longer
consistent
drug
ii
fda
approved
nonsteroidal
pain
reliever
called
sulindac
brand
name
clinoril
clinoril
patent
expired
fda
approved
several
generic
sulindacs
including
one
manufactured
mutual
pharmaceutical
case
app
pet
cert
small
number
patients
nsaids
including
sulindac
popular
nsaids
ibuprofen
naproxen
serious
side
effect
causing
two
hypersensitivity
skin
reactions
characterized
necrosis
skin
mucous
membranes
toxic
epidermal
necrolysis
less
severe
cousin
syndrome
dorland
illustrated
medical
dictionary
ed
physicians
desk
reference
ed
friedman
orlet
still
law
toxic
epidermal
necrolysis
due
administration
celecobix
celebrex
southern
medical
december
respondent
karen
bartlett
prescribed
clinoril
shoulder
pain
pharmacist
dispensed
generic
form
sulindac
manufactured
petitioner
mutual
pharmaceutical
respondent
soon
developed
acute
case
toxic
epidermal
necrolysis
results
horrific
sixty
percent
surface
respondent
body
deteriorated
burned
turned
open
wound
spent
months
medically
induced
coma
underwent
eye
surgeries
year
severely
disfigured
number
physical
disabilities
nearly
blind
time
respondent
prescribed
sulindac
drug
label
specifically
refer
syndrome
toxic
epidermal
necrolysis
warn
drug
cause
severe
skin
reactions
atalities
app
supp
nh
internal
quotation
marks
omitted
however
syndrome
toxic
epidermal
necrolysis
listed
potential
adverse
reactions
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package
insert
respondent
already
suffering
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epidermal
necrolysis
fda
completed
comprehensive
review
risks
benefits
including
risk
toxic
epidermal
necrolysis
approved
nsaid
products
decision
letter
fda
docket
june
online
http
visited
june
available
clerk
case
file
result
review
fda
recommended
changes
labeling
nsaids
including
sulindac
explicitly
warn
toxic
epidermal
necrolysis
app
respondent
sued
mutual
new
hampshire
state
mutual
removed
case
federal
respondent
initially
asserted
claims
district
dismissed
claim
based
doctor
admi
ssion
read
box
label
insert
trial
respondent
claim
jury
found
mutual
liable
awarded
respondent
million
damages
appeals
affirmed
relevant
found
neither
fdca
fda
regulations
respondent
claims
distinguished
pliva
mensing
held
claims
generic
manufacturers
fdca
prohibition
changes
generic
drug
labels
arguing
generic
manufacturers
facing
claims
simply
choose
make
drug
thus
comply
federal
state
law
granted
certiorari
iii
supremacy
clause
provides
laws
treaties
shall
law
land
thing
constitution
laws
state
contrary
notwithstanding
art
vi
cl
accordingly
long
settled
state
laws
conflict
federal
law
without
effect
maryland
louisiana
mcculloch
maryland
wheat
see
also
gade
national
solid
wastes
management
nder
supremacy
clause
doctrine
derived
state
law
however
clearly
within
state
acknowledged
power
interferes
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law
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internal
quotation
marks
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even
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express
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state
law
impliedly
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party
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state
federal
requirements
english
general
elec
see
also
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lime
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holding
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law
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state
regulations
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hampshire
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hampshire
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hampshire
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doctrine
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hampshire
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hampshire
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hampshire
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active
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component
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diagnosis
cure
mitigation
treatment
prevention
disease
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humans
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ii
cfr
consequently
appeals
correct
recognize
mutual
legally
make
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giving
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considers
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hampshire
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hampshire
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law
far
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federal
law
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generic
drug
manufacturers
changing
labels
see
slip
federal
drug
regulations
interpreted
fda
prevented
manufacturers
independently
changing
generic
drugs
safety
labels
see
also
labeling
proposed
new
drug
labeling
approved
approved
drug
cfr
iii
approval
generic
drug
may
withdrawn
generic
drug
label
longer
consistent
drug
thus
federal
law
prohibited
mutual
taking
remedial
action
required
avoid
liability
new
hampshire
law
federal
law
forbids
action
state
law
requires
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law
without
effect
maryland
impossible
mutual
similarly
situated
manufacturers
comply
state
federal
new
hampshire
cause
action
respect
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sold
interstate
iv
appeals
reasoned
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ing
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bartlett
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ginsburg
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bartlett
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levine
basic
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national
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government
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drug
safety
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fda
postmarket
oversight
process
noting
drugs
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safety
reasons
wysowski
swartz
adverse
drug
event
surveillance
drug
withdrawals
archives
internal
med
noting
drugs
drug
products
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market
safety
reasons
defending
policy
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guarantor
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task
light
evidence
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legal
authority
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kessler
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critical
examination
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claims
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breyer
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ante
see
pesticides
food
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