*2
tiffs.3
*3
Walsh,
City
Lawrence E.
York
New
(Davis, Polk, Wardwell,
&
Sunderland
Although
liability
of
theories
for
Kiendl,
Nolan,
Richard E.
E.
Alfred
compensatory
damages
had been ad-
Schretter,
City,
New York
Robert M.
complaint, plaintiff
in
vanced
with-
Hallman, Costello, Ward, Tirabasso &
negligence
except
up-
all
drew
and fraud
Shea, Joseph M. Costello and Mortimer
Drug
on the
and
Food
Administration
Shea,
City,
counsel),
C.
New York
of
for
(FDA). Defendant
for
moved
a direct-
defendant-appellant.
injury by
ed verdict on all claims for
City
Rheingold,
York
Paul D.
New
unsupported
cataract
sufficient
Krause,
Shumate, Geoghan
(Speiser,
&
proof of causation and on the fraud and
Speiser,
F. X. Ge-
M.
William
Stuart
punitive damage.
unsupported
claims as
Gans,
oghan, Jr., and Alfred
New
W.
evidence;
de-
motions were
City,
counsel),
plaintiff-ap-
of
for
judge
jury
nied. The
instructed the
pellee.
must first determine the issue of causa-
;
plaintiff
that,
if
tion
it found for the
MOORE,
Before
FRIENDLY
and
issues,
pass upon
it should then
the other
HAYS,
Judges.
Circuit
explained
charge
which he
in a
to which
exception.
help-
defendant
took no
He
Judge:
FRIENDLY, Circuit
fully
separate questions:
six
submitted
diversity
Sidney Rogin-
In this
action1
causation,
negligence,
(1)
(2)
(3) fraud
sky sought
compensatory
to recover
and
FDA,
upon
(4)
compensa-
amount of
punitive damages
personal
injuries,
for
tory damages,
liability
exemplary
(5)
primarily cataracts,
taking
from
at his
damages,
(6)
and
the amount
thereof.
Pennsylvania
drug, MER/29,
in
home
jury gave
all
affirmative
answers to
developed by Richardson-Merrell
Com-
relating
liability
questions
and
pany
lowering
blood cholesterol
levels.
compensatory damages
$17,500
fixed
at
Roginsky’s was the first
to be tried of
damages
punitive
$100,000,
pending
some 75 similar cases now
in
judge
later
declined
eliminate
Court for
District
the Southern Dis-
reduce,
F.Supp.
rict of New
On
York. Several hundred ac-
elsewhere,
tions have been filed
appeal
its mo-
defendant
contends
Pennsylvania
1.
is a citizen of
Plaintiff
ty,
$5,000
husband for loss
to her
corporation
judge
is a Delaware
of services.
The trial
sustained
principal place
damages
in
compensatory
of business
al-
the award
York.
though plaintiff’s
been suc-
cataracts had
cessfully
removed,
new
but ordered a
parties
stipulated
2. The
that New York
consented to a reduc-
trial unless
she
applied.
law was
$100,000,
damages
punitive
tion of
case,
Richardson-Merrell,
Inc.,
figure previously
In
v.
Toole
No.
awarded in this
524722, Superior Court,
gee N.Y.L.J.,
11, 1967, p.
San Franciso
In
Jan.
County, Calif.,
jury
$175,-
Inc.,
Richardson-Merrell,
awarded
v.
Civ.
Golden
compensatory
$500,000
puni
ap-
W.D.Wash., Apr.,
No.
damages,
counsel,
peal
stipulation
tive
the latter of which the trial
dismissed on
$250,000
light
judgment
$150,000
court
reduced to
on a verdict of
pending
the other
cases and
California
who claimed the
rendered for a
requiring
relationship
injuries
taking
rule
a reasonable
same
MER/29
compensatory
punitive
juries
Roginsky.
between
dam
In two cases
have
does
gee
defendant,
ages.
Ostopowitz
Merrell
v. Wm. S.
returned verdicts for the
Co., Supreme Court,
County,
Richardson-Merrell,
Inc.,
Westchester
Cudmore
v.
g.W.2d
Y.,
(Tex.Civ.App.1965);
N.
Jan.
awarded
Lewis
$350,000
compensatory
$850,000
Baker,
(Or.1966).
P.2d 400
damages
injured
par-
1960, subject
April
sub-
release
should have
directed
tions
verdicts
label
approved
labels.
argues
granted;
mission
also that evi-
been
heading
EF-
stated,
“SIDE
erroneously admitted,
under
of it
much
dence
reports
have
facts,”
un-
“Isolated
support
of what
it considers
vomiting,
nausea,
tem-
been received
count,
fraud
could
substantiated
vaginal bleeding
dermatitis”
jury’s
porary
prejudiced
determination
negligence
heading
of conduct
issues of
“CAUTION”
and under
warranting
punitive dam-
the award of
warning
shown
has been
“MER/29
objections
ages.
It also raises other
entirely
periods the
safe in the
to be
complains
receipt
of evidence and
long-term or
studied,
damages,
“un-
the award
Periodic
effects are unknown.
lifetime
restricted
measurable
less
to fixed and
long-term
patients
examination
amounts,”
process. We af-
violates due
necessary.”
therapy is therefore
compensatory
firm the award
*4
During
began
Marketing
the
June
find that
the
was not suf-
100,000 persons used
of 1960 over
balance
puni-
ficient
to warrant
of the
submission
drug,
reports
of cataracts.
with
the
damage
jury.
issue
tive
Co.,
January 1961,
&
In
Merck
I.
and
sample of
a
had borrowed
MER/29
reported
synthesized
supply,
its
summary
undisputed
then
own
of
facts
certain
A
developed cataracts.
had
animals
that test
will be useful
from this enormous record
sending
Defendant,
a team
after
by way
was
of introduction. MER/29
laboratory,
make a
Merck’s
decided
developed in the
The Wm.
late 1950’s
experiment
selected
Company,
on animals
further
of defend-
Merrell
a division
S.
lowering
purpose
ant,
re-
blood
the Merck
for the
of
it but did
reveal
profes-
time most
port
cholesterol
levels. At
or
medical
to the FDA
the
high
February
physicians
of
believed that a
level
learned that
1 it
sion. On
significant
Anticouni,
precursor of
Angeles,
was
cholesterol
one Lee
user in Los
single
atherosclerosis,
leading
cause
cataract;
the
developed
were
facts
had
of death in the United States.
de-
later
run down for
reasons
never
veloped,
nor
and neither
the FDA
drug
placed
on the
Before
was
profession
Meanwhile
informed.
experiments
market
there had been 246
us-
patients were
thousands of
additional
involving
had been
3907 animals and it
cholesterol,
drug,
benefit
patients
to over
human
administered
im-
for the
without
moment
levels
Eighty
under close clinical observation.
reported
portant
effects.
adverse
per
patients
cent of these
had used
who
drug
longer experi-
days
for 90
or
ex-
rerun of
Merck
On defendant’s
enced a reduction of cholesterol
levels
dogs developed
periment,
cataracts
its
averaging
only reported side
20%.
October,
the-
1961. At
same time
effects were
of several differ-
dermatitis
two,
reported
Mayo
cataracts
Clinic
types,
reports
loss,
ent
two
of hair
using-
three, patients who were
later
vomiting,
report
nausea and
one
of
of these-
effect
The combined
MER/29.
drop
count,
in white blood cell
two cases
defendant,
towas
cause the
two incidents
vaginal bleeding
spotting,
three
18,1961,
request
FDA’s-
on October
tearing
watering
eyes,
cases of
warning
permission
letter to all
to issue
one
blurred vision.
In December
being-
permission
physicians,
then
many
of the clinicians
who
by law,
required
F.R.
administering
drug reported
been
Believing
(1963 ed.).
130.9
21 C.F.R. §
a conference of eminent
scientists
proposed
too
letter
to be
defendant’s
physicians
held under defendant’s
au-
permission
weak,
FDA
withheld
spices
Princeton,
N. J.
stronger
on a much
one which
insisted
July
approved
mailed
on
27 and
defendant
filed with the
November
Drug
every
Application
(NDA)
FDA a
doctor
on December
country
and also to
salesmen.
FDA cleared
defendant’s
MER/29.
reports of
With additional
ing
cataracts com-
the doctor’s admission
cross-examina-
early
during
testimony
from the field
tion and the
experts
of defendant’s
two
plaintiff’s
months of
point
on the
cataracts were
holding
high-level
deep
intra-com-
cortex and nucleus of the lens
pany
upon
likely
with- where
conference
decide
senile cataracts are most
when,
April
develop,
about
drawal
rather than nearer the surface
MER/29
Mayo
reported
usually
ain
Clinic
cataracts
toxic
manifest
where
cataracts
given
year
boy
six
high dosages
old
who
been
themselves. To this defendant added
testimony
experts
to counteract a
case
slow
severe
development
Roginsky’s cataracts,
unusual in a child.
excessive cholesterol
Early April
largely
to with- which had
at the
defendant decided
been
arrested
market;
being
trial, pointed
draw
from the
to their
senile
time
MER/29
April 17,
toxic,
than
skin ail-
was done
rather
and that his
type
had not
that had
ment
using
aged
began
Plaintiff,
then
generally preceded
induced cat-
February
1961. In June
MER/29
noticed
However, plaintiff’s medical
aracts.
wit-
scaling,
falling
hair
rashes
ness denied such
distinctions
universal
reported
physician.
which he
to his
between the manifestation of senile
aggravated
became
These conditions
despite
plaintiff’s
toxic cataracts and between
treatment;
year-end
around the
others,
form of dermatitis and
disturbing eye symptoms
he noted
experts
*5
cross-examination of defendant’s
taking
drug.
stopped
In about six
the
not
all this
without effect. With
months
appeared
skin and hair conditions dis-
supplemented by the
abundant
eye
diag-
ailment,
but the
later
Roginsky’s
symptoms generally
that
like
cataracts,
nosed as
became somewhat
by
cata-
had often been followed
toxic
worse; however, it has not
suf-
become
rightly
racts, the issue of causation was
ficiently serious for him to have them
jury,
though
to
on our own
left
appraisal
even
removed.
might
find defendant’s
well
II.
convincing.
experts
to be
Defendant’s broadest contention
III.
is that a verdict should have been direct
complaint
Defendant’s next
is that an
sought
plaintiff
ed in its favor insofar as
refusal
erroneous
to direct a
for
verdict
damages for
cataracts because of lack
prejudiced
it on the fraud count
adequate proof
induced
that these were
jury’s
neg-
consideration of the
by
issues
Plaintiff
on
relied
the tes
MER/29.4
ligence
liability
punitive
timony
for
dam-
single physician,
of a
chief of
ages.
holding
While our
the evi-
ophthalmology at the well-known Guthrie
dence was insufficient
to warrant sub-
Hospital
Clinic in
Sayre,
Robert
Packer
physician
mission of
Pa.
the issue of
testified
in November 1963 and
later dates
various
moots the latter branch of defendant’s
slight
eyes
complaint,
remains;
found
cataracts in both
the former
indeed
opinion
plain-
and that he was of the
awith rea
force
increased since one
certainty
arguments,
amount of
sonable
medical
tiff’s
that much of the evi-
taking
complained
properly
these were caused
dence
of was
sub-
MER/29;
jury
he relied on
litera
“medical
mitted to
dam-
on the
many per
ages issue,
wayside.
ture”
“conversations” that
falls
changes
developed
sons who
skin and hair
rejoinder,
Plaintiff’s further
Roginsky’s
taking
like
after
also
in the
vice
admission of evidence
developed cataracts.
special'
fraud
cured
counts was
jury
Defendant
claims
afforded too
found defendant
verdict wherein the
fraud,
opinion
negligence
for an
weak
basis
in view of
as for
liable
as well
challenge
adequacy
plaintiff’s
does not
hair
Defendant
of the
skin and
evidence that
ailments were so induced.
generally
liability
unacceptable.
One’s
ob-
is likewise
Defendant’s
only
to extend
“to the
jection
fraud has been said
suf-
is not that
lacked
persons
persons
he in
whom
negligence
or class
but
ficient evidence
find
expect
act or
tends or has reason to
may
evi-
acted on irrelevant
have
upon
reliance
from action in
dence,
refrain
much
admitted
since
material
misrepresentation”
in fact so
and who
sins of omis-
the fraud count dealt with
rely,
(Second), Torts
Restatement
relation
§
sion
commission that had no
(Tent.
10, 1964),
sense,
and in
injuries
No.
plaintiff’s
Draft
in the
save
required
specific
charge
negli-
of information
legally
case
insufficient on a
by statute,
persons
gence,
be filed
all
who
if
other-
done
justifiably
Id.
might
have
relied thereon.
released
wise the
not have
FDA
encompass
This
a fraudulent
at all.
misrepresentation
to or concealment
asserts,
plaintiff
Defendant
does
affecting
approved label
FDA
dispute,
that mere violation of the
patient’s
or from the
doctor if he is re
Food, Drug and Cosmetic Act does not
garded
agent,
plaintiff’s
see Wech
as the
give
private
rise
point
to a
claim —a
Hoffman-LaRoche,
Inc.,
Misc.
sler v.
which,
agreement
in view of the
(Sup.Ct. Bronx Co.
99 N.Y.S.2d
parties,
Develop-
we do not decide. See
J.).
(Rabin,
1950)
On the other hand
Law,
Food,
ments
The Federal
every
“agent”
regard
FDA as
Drug,
Act,
and Cosmetic
67 Harv.L.Rev.
person
States,
plaintiff
the United
Plaintiff
relies instead
urges, would be to use words as a sub
principle
on the
that a fraud action will
If we were forced
stitute
substance.
lie not
practices
when the defendant
decide,
say
plaintiff
we would
that a
directly
his deceit
on the
simply
out
of fraud
does not make
a case
also when he submits known false data
by showing
had been
if the facts
intermediary
to an
who
be reason-
fully stated,
the FDA
ably expected
pass
on,
the classical
*6
drug.5 However,
is an
this
released the
being
dispatch
case
of financial state-
growing,
Pros
where the law is
area
agency.
ments to a credit
See Tindle v.
ques
ser,
(1964), and the
Torts 717-19
Birkett,
171 N.Y.
While
why
of
thing
instant
some
the
award to
range,
$5000-$10,000
Toole in
off
California should walk
in the
still
compensatory leaving
$250,000
exposed
with
more
a
than
to several
damages.
recovery
Roginsky
exemplary
in the Southern million dollars of
Ostopo
nothing
of
perceive
District
and Mrs.
York
New York
in the New
We
County
$100,-
prevent
witz in
reduc
Westchester
with
that
decisions
would
000,
laymen
damage
judges
of
ing
punitive
most
and some
because
award
a
arising
understanding
difficulty
large
out
have
suits
the
number
why
worthy
by
presumably equally
plain
the defendant.12
same conduct
the
Judge
nothing
indicate
equally
tiffs
cases before
75
But there
such
follow
country
New York would
Croake or elsewhere in the
should that
willing get
course,
otherwise
And,
a state
less
none.
the
whatever
might be
self-denying
right
impose
limits
may
theory,
result
be in strict
until assured
disinclined
so
expect
think
do
it somewhat unrealistic to
say
suit.
judge,
others would follow
Mexico,
in New
to tell
jury that their fellow townsman should
Although multiple punitive awards
get very
by way
punitive
little
dam
running
add
hundreds
into the
ages because Toole in California
Ro
process, neverthe-
up
due
a denial of
ginsky
Ostopowitz
and Mrs.
highest
sitting as the
less we were
if
stripped
cupboard
had
bare,
even
con-
would wish
of New York we
court
assuming the defendant would want such
awarding
very seriously whether
sider
charge,
still
unrealistic to
respect
the
punitive damages
expect
jury
the
would follow such
negligent
highly
negligent
—manu-
—even
that,
they didn’t,
instruction or
if
governed
facture
sale
judge
the
would reduce the award be
drug requirements, es-
federal food and
low
going’
what had
become
rate.
strengthen-
light
pecially in
ju
There is more to be said for drastic
amendments,
76
these
the 1962
dicial
control of the amount of
vigor-
present
Stat. 780
keep
prospective
awards so as to
total
enforcement, would
ous
toward
attitude
manageable
within some
good. manu-
bounds. This
than
not more harm
A
plaintiffs,
although
ful
even
as to
of two
was reduced
each
defendants
apparent.
per-
against
$100,000
the difficulties are
appellate
But we
division
way
accomplishing
except
against
ceive
$50,000
cor
individual and
by legislation requiring
likely
all
porate
claims in re-
It
seems
defendant.
spect
drugs
supervised by
the FDA
dam
in that case
conduct
defendant’s
indeed,
asserted
aged
federal
courts
trial
others than Faulk —
—hardly a
justified
large jury
course.
desirable
verdict
court
punished
ground that
12. The New York
courts
shown con
con
effect
their
the defendants
many
siderable
“upon
readiness
to reduce
the livelihoods of
duct
damage
See,
g., Toomey
302,
awards.
e.
persons,”
v.
N.Y.S.2d
35 Misc.2d
Farley,
71,
840,
2 N.Y.2d
(N.Y.Co.1962)
appellate
156 N.Y.S.2d
di
—but
(1956);
N.E.2d 221
Kern v. News
con
it had
vision did not
indicate
Syndicate Co.,
multiple
possibility
A.D.2d
244 N.Y.S.
suits
sidered
(1st Dept.1963);
2d
Conceding
reducing
McMahon v.
award.
Publishing Co,
“vicious,
App.
New York News
conduct
defendants’
*
*
*
(1st
maliciously
Dept.1900);
Div.
deliberately
841
many
against
distributing
bility
protect
policies
this
can
facturer
government
held,14the cost
have
under
risk as several courts
of users
thousands
regulation
scarcely requires
providing
probably
de-
addi-
needless
this
manifesting
terrence,
social
few manufac-
tional
for
measure
damages
punitive
for
assuring
disapproval
deterrence.
turers
whom
sought
compensa-
negligent
heavy
highly
but
penalties
are
conduct
Criminal
tory damages,
under
the thousands from whom it never will
recoverable
neg- be,
consuming public;
passed
proof of
is
without
on to the
circumstances even
they
ligence,
sufficiently
cannot,
these
if
meet
as is held
other courts
should
commentators,
6,
Note, supra
N.
objectives,
41
most
note
recommended
1171,
sufficiently egregious
factors
error as
one
and the other
a
product
Y.U.L.Rev. at
punitive
are
justifying
awards
cited as
can end the business life of
compensa-
lacking.13 Many
wrought
good
awards of
concern that has
much
damages
some-
past
might
tory
doubtless contain
con-
otherwise have
thing
element,
punitive
many
future,
of a
to do
tinued
so in the
separate
ex-
suffering
if a
award
would
so
innocent stockholders
extinc-
damages
Even
emplary
single
were eliminated.
tion of their investments for a
though products liability
management
insurance blunts
sin.
compensatory
deterrent effect
However, the New York cases
coverage
policies is often
under such
predicting
afford no basis for our
that-
extent, the total
to considerable
awards
Appeals
adopt
the Court of
rule
usually
limited,
experience is
reflect-
bad
disallowing punitive damages
rates,
affords
in a case
ed
future
and insurance
damage
protection
reputation
this,
wisely
such as
Erie
and the
doctrine
among
pharmacists
physicians
which
engaging
prevents our
in such extensive
present
inevita-
law-making
liability,
like the
must
instance
a sub
on local tort
bly
hand,
ap-
produce.
the other
ject
people
On
New
have
which
York
parent
impracticability
imposing an
legislature and,
entrusted to their
within
ceiling
punitive
courts,
effective
on
awards
appropriate limits,
their own
hundreds
courts
of suits
different
more modest
not to us.
task is the
Our
aggregate
which, when
sufficiency
result in an
assessing
one
damages,
large
piled
compensatory
framework of
within the
catastrophic
If lia-
could reach
amounts.
punitive
decisions on the award
Compare
Sheldon,
extraordinary
remedy
10 N.Y.2d
Walker v.
whether
401,
488,
punish-
N.E.2d 497
necessary
223 N.Y.S.2d
179
the desired
to achieve
(1961); Fittipaldi
Begassie,
deterrence,-
ment,
etc.,
A.D.2d
18
Pow-
see James v.
1963);
331,
(4th Dept.
ell,
we
convinced
(3d
1898);
Dept.
1026
v.
N.Y.S.
Rowe
damages
imposing punitive
case
Brooklyn
474,
Heights
R.,
R.
71 A.D.
present
like
are so serious
1902);
893,
(2d Dept.
75 N.Y.S.
894
Appeals
York
sub-
New
Court
Taylor,
App.Div.
Walker v. Lord &
236
ject
proof
particularly
careful
111,
1932).17
(1st Dept.
258
96
N.Y.S.
scrutiny.16
York,
words,
New
adheres
“complicity
holding
rule,”
V.
the cor
porate
damages
punitive
master liable for
parties
The
are in substantial
“only
order,
superior
when
officers either
agreement
point
on one
York
New
—that
participate
ratify
in,
outrageous
con
punitive
impose
damages
does not
on a
supra,
Morris,
6, 21
duct.”
See
note
corporation unless,
charged by Judge
as
Ohio St.L.J. at 221.18
Croake,
directors,
“the officers or
is,
management”
company
of the
York courts have
New
authorized,
variety
the relevant
phrases
division “either
used a
to describe
participated
in,
or,
culpability,”
consented to
after
the “moral
Walker v. Shel
discovery,
giving
don,
401, 404-405,
ratified the
10 N.Y.2d
conduct”
223 N.Y.S.
damages. Cleghorn
488,
rise to
491,
(1961),
2d
New
179
v.
N.E.2d 497
R.,
York
44,
support
damages
Cent.
punitive
& H. R. R.
56 N.Y.
which will
juncture,
applying
15. At
this
we shall assume
rule
at bar
case
parties
sufficiency
“management”
presi-
have done that
includes
vice-presidents
the evidence is to be determined accord-
dents and
of Richardson-
Division,
to state law. See
the discussion in
Merrell
its Wm. Merrell
S.
paragraph
opinion.
whether,
the last
of this
we need not decide
under New
law,
supervisory
the acts
inferior
16. We have considered whether it would
employees would
otherwise
deemed the
preferable
pending
to withhold decision
corporation
purposes
of the
acts
probable appeal
Ostopowitz case,
assessing punitive damages. See,
g.,
e.
3, through
hierarchy
see fn.
Corrigan
Co.,
v. Bobbs-Merrill
228 N.Y.
York courts. “Abstention” is not favored
58, 71-72,
260,
126 N.E.
843
15.05,
Consol.Laws,
40,
McKinney’s
c.
§
v.
In Caldwell
torts.19
nonintentional
subd, 3:
282,
Co.,
Jersey
N.Y.
47
Steamboat
spoke
Appeals
respect
(1872),
recklessly
person
296
the Court
acts
“A
*
**
it said
Later
recklessness.”
he is
of “utter
when
aware
result
disregards
consciously
and
be reckless
“must
sub-
conduct
of and
clearly
nature,
establish-
unjustifiable
risk that
criminal
stantial
Cleghorn
& H.
Cent.
New York
ed.”
v.
occur or that such
such result will
44,
(1874).
It has
R.,
R.
56
48
risk must
R.
N.Y.
circumstance exists.
or ma-
degree
as “wanton
also used such terms
dis-
be of such nature
outrageous,”
gross
gross
licious,
regard
Powers
or
de-
constitutes
thereof
178, 182,
Ry.,
v. Manhattan
120 N.Y.
standard
conduct
viation
295,
person
“conscious
observe
24 N.E.
296
that a reasonable
would
indifference
of his acts.”
effect
in the situation.”
Church
Gostkowski v. Roman Catholic
Obviously this definition would
320, 323,
Hearts,
of the Sacred
262 N.Y.
drug
placed a
met if
a manufacturer
798,
(1933). Very
186
recent-
N.E.
799
any
program,
test
the market without
ly
Department
spoken
the Third
practice
unlawful
fed
now rendered
“
recklessly
action
‘committed
or wanton-
management
legislation, or when its
eral
ly,
e.,
regard
rights
i.
without
to the
dangers
program had disclosed
knew the
plaintiff,
people
gen-
incomplete
serious mischance
” Soucy
eral,’
Greyhound Corp., A.
v.
27
respect.
Sufficient
in some material
112, 113,
D.2d
276 N.Y.S.2d
175
if,
proof
after
also be furnished
(3d Dept.
quoting Magagnos
1967),
v.
market,
placed
Brooklyn Heights
R.,
App.Div.
R.
128
to have
was shown
manufacturer
danger
1908).
(2d Dept.
to have
N.Y.S.
aware of
become
closing
deliberately
its
nothing,
done
In an earlier decision that court had
hand,
in fail
eyes.
error
the other
On
negligence”
"culpable
held that
not
hindsight
demonstrates
to make what
enough
punitive damages.
to warrant
response
proper
to have been the
—even
Luther,
App.Div. 701,
Noonan v.
enough
“gross”
to warrant
not
error —is
1907).
(3d Dept.
One of the next study relates to a matory part ending February items was this: As rats 1960, of Drug Application to the New FDA, submitted thirty which received ten times the rec- reported a 16 month dose, thirty ommended human received study monkeys, pairs one. three times, thirty five trol, served as a con- being given pair each autopsied a third of each to be being plan a control. The three, respec- six and twelve months dosage times start the at two and a half tively. autopsy opac- At the first corneal dose, anticipated (not human and then cataracts, ities are lenticular opacities) eight were to ten times. raise first to five and then observed in out of twenty drugged experiment by the had conducted been rats. This was toxicologist, Smith, Getman, president known general had who left it; manager employ company’s reporting Division, of the Merrell before King, successor, reported write-up Murray, his Dr. the FDA. Dr. none, charge how- assistant to the contained numerous Vice President errors — ever, Research, shown to have man- wrote the FDA that a con- known.to agement thing sultant one was much had advised corneal —and laboratory changes laboratory worse. A testified technician were common in rats inflammatory. to an and he occasion when had submitted she them to believed graph weights believing final of the mon- record affords no basis for keys company’s opin- to a Van Maanen who directed this was Dr. sincere weight her to increase the shown for ion. Later there was an inci- increased weight monkey dropped drugged one dence whose cataracts rats weights rats; and to show for others as well as in some of the control 25% for although reported two weeks after in fact been ' former was not autopsied; complaining was, after to Dr. the latter is no there evidence subject qualification 21. This Van un- Maanen himself used MEB/29 properly market, could til have been con- its withdrawal from the as did proof finding Werner, president sidered if the warranted vice and research director, general manager Getman, president that misconduct was so subordinates widespread to indicate authorization of the Merrell Division. practice management or a deliberate eyes However, keeping closed. nei- predicates ther of these was established. through management with the addition- should follow was aware of the clinical work al animal work failure. prove analog out in order on this report King either Dr. also failed to inferiority superiority and or its relative management develop- the FDA a substitute thus have it available as dogs on a ment of cataracts two trouble, gets into the event MER-29 study February 1960, ending month three improved perhaps later as introduced descrip- modified his to which also goes on product.” The memorandum Again there tion of other abnormalities. pros licens- and cons various discuss management was is no evidence that *13 thoroughly analog tested not an this; furthermore, the whole aware of manufacturer pharmaceutical another dogs study were was since the worthless no findWe do the work. who would by distemper and viral contaminated plaintiff inference for the sinister basis hepatitis, it rerun with when draw; picture is rather the would dogs, opacities observed. sound were reasonably it company satisfied Plaintiff much makes of a memoran- despite known good product some May 17, 1960, shortly dum dated before con- “toxicity animals” in the lower put market, on the between MER/29 sidering another with do what company vice-presidents two copies prove might might better. not or higher officers, concerning still an brings receipt of the to the This us analog developed which had been in the January report & Co. from Merck experimentation. Seizing course of on a dogs which we 1961 as to cataracts phrase suggested desirability which this, mentioned at the outset. Since having analog “available as a sub- minds, information first was the gets stitute the event Mer-29 into management reaching in- which trouble,” argues plaintiff supports could have dicate that MER/29 an put inference that defendant MER/29 it un- make as to effects serious side on knowing the market it would qualities, despite safe its beneficial get trouble, very into at the time when severely scrutin- must be officers’ action product plain- better inwas hand. But ized. phrase quite tiff takes the of con- out text. The fact response is dis- letter immediate Defendant’s company’s general policy cusses the Werner, vice- research its Dr. to send licensing drugs King to other manufac- Dr. president, Maanen Dr. Van application policy laboratory. turers and the of this The decision Merck analog. says that ani- It was to rerun their MER/29 made on return performed mal work to date “indicates this was not experiment. On its face question toxicity conduct;23 as to the on the or reckless heedless analog (just in the lower animals contrary, accepted Merck re to have does), MER-29 itself work with ir port conclusive would analog possibility it indicates be even Apart better responsible. Although syn than MER-29. lot ani- Merck differences of chemical work mal would have to be done to tie drug, defend point on which thesized question toxicity, plain down better ac- heavily to which relies but ant product, effectively responds did etc., tion of the Merrell this could be tiff * * * significance of sample,24 done. view the tremendous for a not ask ques importance analog, was called MER-29 and this Merck results being beagles, probably dogs’ are by which will be decided that Merrell tion post sample litem 23. At the same was obtained time defendant an em- 24. When a library ployee motam, drug on its Merck do research on toxic cata- used impurities. signifi- racts. fail to contain We see the sinister found to animals was this; cance on the attributes contrary, entirely pru- such action seems dent reasonable. Werner, prone, find that Getman and and defend known to be cataract principal inbreeding suspicion on this which the two decision-makers ant’s matter, who continued to use the results. have further invalidated consciously disregarded themselves, Indeed, the serious criticism unjustifiable risk of substantial and over what defendant did but what aware. which were notify FDA, failed to the medi- do— profession, cal scale is both. does think the Plaintiff Neither regulations incident, tipped contend that FDA re- Anticouni quired report shortly Dr. Mc the Merck followed thereafter. results, requirements Master, being medical re then lim- associate director reporting Division, ited experiments had first results search the Merrell May done in the from a manufacturer’s own heard of Anticouni labora- tory investigator Angles cardiologist, an one of the clini who Los had been drug. administering furnished the who See cians had been C.F.R. § 130.4(c) (1963 ed.). experimental The claim basis. is rather that, though cardiologist reported even proof Anticouni is no then there direct *14 very that such notification was had severe dermatitis considered and exhibited rejected, logic its apparent he due to was so was unable to as which evaluate permit to taking, to patient’s an in addition inference that the defendant dose, didn’t want the to the FDA of the at twice recommended know MER/ several other drugs, Merck results for fear one of which order warning accompanying the drug be the from the market to since removed drug production stiffened or ef withdrawn, side the cause its toxic physicians including didn’t want Mc to know for fear fects severe dermatitis. unduly frightened. would be offered As- asked for records and Master suming jury investiga a provide could find that for further this was to funds so ; repeat that defendant on was tion several later occasions he motivated request commercial considerations as ed former but result. well without as a potential February cardiologist 1, 1961, desire to benefit of On victims granting report atherosclerosis and agement Anti called Dr. that man- McMaster to that experiments knew had care said its own couni left his and was to had opacities developed disclosed rats, corneal to be con we cataracts and fail sulting attorneys. to physicians see how this meets the definition again reckless cardiolo to indifference human life McMaster asked question gist’s health. The He on files but did receive them. that score not is nothing when, not what did until on defendant feared the June a FDA Angeles, trip doctors would do he files to Los examined the what feared sought enlightened, would do. Here the but was not Merck re- MER/29 port, noted, ophthal with the infirmities we have obtain name of Anticouni’s against mologist episode had to be set the belief de- This without success. Getman, gener management, only fendant’s erroneous in was known to at least in a respect, argument one way. Despite minor that had al cataracts defendant’s reported hearsay, report ever been 4000 animals that mere that was previously including monkeys, drugs taking tested the other Anticouni was dogs humans, likely which are closer than were as as to have caused MER/29 patients cataracts, in the 2000 under clinical ob- a cataract in this car many months, senile, patient likely servation for or in diac of the 100,000 patients toxic, variety, who used could find had varying periods energy greater its in that failure since release to exert running report neglig June 1960. We cannot how these allowing down this However, circumstances warrant McMaster’ssloth would ent.25 Apparently directly McMaster made no Anticouni after had effort contact latter cardiologist. left the finding the memorandum to another un ferred vice support of recklessness Stormont, president top company, of the one the evidence warranted assumes less although promptly reported finding who time inconclusive, seriously apprehensive as to facts hair effects were reason to be weight humans, cataractogenic in- the evidence seems to “the MER/29 may produce dicate that assumption find no MER-29 we which changes very proportion hair in a small sufficient basis. warning should of cases” and that developments continuing with Before fine, proposed. far be revised as So cataracts, must recount “par- didn’t added but Stormont episode on heav- another suggestion ticularly like” Dr. McMaster’s ily participation relies because warning to read be broadened management plain. March On “changes color, texture, or amount” of the President Woodward Vice “loss,” sounds rath- since “this instead addressed memoran- Merrell Division frightening”; memoran- er McMaster’s par- Richardson dum President that of the 51 cases dum disclosed Getman, copies company, ent changes, in- five had of hair Murray, Werner, McMaster color and six Dr. Mc- cluded texture. hair, phe- side effects agreed sugges- Master with Stormont’s experience indicated nomenon which later proceeding tion. Richardson authorized infrequent precursor of cata- to be a not letter, along lines,26 these limited reported racts. Woodward com- April thinning, went forward pany reported “had initiated a review much about To us this seems ado rather thinning people taking of the hair of recognized company obli- little. The MER/29,” that this had 51 such disclosed *15 gation public to inform the FDA and reports users, 300,000 out of and that hair thin- what it learned about had “morally legally he and felt Getman ning though reported this been even had promptly warning bound” to alter only of the users. Decision in 0.017% accordingly. giving He recommended hair effects not of the other advise warning despite this the risk that reported by of the users does 0.003% might provide the FDA with an occasion fit our notion of reckless wanton to re-examine Merrell’s entire NDA: conduct. changes point “we have made no to this report had included literature, in Merck of our Since the basical- MER/29 dogs, ly defendant had rats27 as well because were afraid ‘stir study pot’ Washington” that a in addition to in initiated rat since “we have heard n eye began develop dogs. from rats on The several sources that at times FDA August, but there reopening has difficulties June and considered file NDA management but, frankly, learned is no that evidence we do whether not know later, this is true.” He a of a the ex- enclosed draft until much when of this proposed referring nearing completion. periment to the “to letter FDA What was concerning reports thinning they several 1961— did learn —on October changes changes although proposing texture of hair” that ocular Sep- warning dogs to add late as brochure had occurred as accompanying (including on words “and an examination tember MER/29 thinning September re- Merck scientist of the hair.” Richardson 20 in which a copy advised His memorandum Merck Woodward’s 27. Defendant claims following developed corneal bore the handwritten endorse- rats had opacities had ment : similar those “Summary rats; expect publications a memo- on noted defendant’s —can thinning. Important get hair from in the fall bro- Merck randum obtained developed change happens. cata- rats chure Also said the had before of 1961 play who desirable to ball with Talbot racts. through got protest. Talbot over #29 authority to OK.” Talbot was an FDA doctor. dog participated), developed reported had in a had memorandum from Dr. Murray September exactly Getman, a cataract six the FDA did pertinent months ther- not have after onset sufficient facts to de- MER/29 apy, warning letter, and had lat- become blind week cide that it feared 28; report develop- er also told of side effects be more severe opacities stated, ment of corneal extensive than “might, therefore, misleading most of that the letter synchronized rats. bad This news be and lead Mayo physician from the curity.” information Clinic at of se- false sense Rochester, Minnesota, patients two wanted all facts avail- FDA taking had able to the been found to have defendant “on the cases of eye changes, including question cataracts “and that there the actual case records,” having copy proposed the cataracts been associated a written letter, with administration of Dr. and a statement that defendant MER/29.” immediately Rochester, “supplied toxicity McMaster went had all data ani- patient including man, learned of a third who de- had mals that available veloped cataract, York, returned to to us from Dr. outside sources.” Nestor physicians and recommended that all recounted discussions of MER/29 warning sent experts letter. It is common with several who concerned were ground that, regulations as FDA then with “numerous other serious ef- side stood, (1963 ed.), enumerated, 21 C.F.R. 130.9 ad- fects” which had ex- permission by agency pressed vance quired. feeling re- the FDA’s enough suspend approval drug, had told of advice proposed pro- letter to the medical claims their statistician that Merrell’s fession was first read to the over FDA significant lowering cholesterol telephone began on October 18. It meeting A was ar- were true. levels ranged by saying purpose you “is to advise di- and Getman October therapy those cases where MER/29 requests fully rected that the FDA’s should be discontinued.” It recited apparently Meetings, met. them reports there had been “a number of stormy, rather held on October were loss, changes hair in color and texture again 2,29 and 21. November hair, -of and dermatitis” and that “more *16 Meanwhile, on October 20 defendant recently, opacities lens have been observ- wrote, do, as it was free to to clinicians ed in patients following four severe der- administering drug who had been immediately matitis.” drawing It advised with- high telling dosages, at ported of the re- them changes “if hair MER/29 cases, in num- cataract four now warning patients skin occur” and to ber, strongly urging and discontinuance report watch for symptoms. and changes ap- of the if hair or skin proposed letter went to describe peared. placing It new ad- discontinued n types of dematitis and hair loss that vertisements and to instructed salesmen therapy; would indicate cessation it samples promotional return all and litera- by saying concluded that “Your adher- approved ture other FDA than the label- presented ence to the cautions will here ling, cautioning them, however, not to permit you effectively to use MER/29 samples mention that their had been re- your practice.” sought called. Merrell also the advice Dr. telephoned Nestor of investigators the FDA independent ear- of two clinical ly following morning. said, professor He as and who had chaired the Later, by early November, history” important drug all of in Merrell most dogs developed cataracts. “intended to defend and that Merrell company every step,” that if the meeting, 29. At this Dr. when Nestor voiced out- that inherent risk “decided personal opinion his that should MER/29 efficacy, they (FDA) weighed withdrawn, expressed be Getman himself being would do have to action as we as not take shocked. Woodward told Nes- biggest tor “was the it first.” MER/29 attempt to the FDA to submit inade- whether conference Princeton quate report- version of what Merck from the withdrawn should be MER/29 market; ed, in its instructions deficiencies market- continued all favored discussed the most salesmen —we have warning. strengthened with a damaging the rest adds evidence approved The letter the FDA on issue, real little to a of the resolution November 27 and sent December reasonably could find whether physicians all all the defendant’s proposed letter defendant’s by noting began salesmen that while cover-up permit continued sale a mere “comparatively few serious clinical in- caring whether without MER/29 juries reported date, their have been Here, or not. would cause cataracts possible significance emphasized by is decision case of defendant’s findings from animal studies.” It next pro- the medical to alert the FDA cases, told of the four human cataract report, every- the Merck fession as to involving patient receiving one rec- thing depends If one starts. on where daily dosage mg., ommended concluding there fair basis was a opac- added and corneal that “cataracts of the rat and combined effect produced ities also reports dog experiments and the in animals.” It said slit MER/29 Mayo Clinic had convinced defend- lamp necessary examinations were management ant’s had a MER/29 early detection of cataracts thus were significant cataractogenic potential prior periodically “indicated to and dur- humans, certainly question could be ing therapy.” The letter went on with However, answered in the affirmative. changes saying changes, hair and skin find no sufficient warrant these related to be each other management a conclusion that enter- cataracts, and to and recommended that again tained such belief. Here therapy be discontinued im- by hindsight. easy all too to be misled mediately on their occurrence. It also dogs eye damage under in rats reported certain scattered cases of other necessarily heavy dosage indicate did effects in humans adverse and more in hu- this would be encountered observing animals. While that “the side many mans, more had of whom thousands types reported effects of all to us Mayo drug, and then taken the substantially per- date less total than one cases at- not certain their were treated,” patients including cent of the Neither is there tributable to MER/29. therapy under number more than suggest that defendant had evidence to year three, few in excess highly beneficial lost confidence “recommended letter that MER/29 Moreover, drug. and this effects patients used who can be case, goes good deal very supervision maintained close under weight given the human tend- *17 must frequent and observation” and never at ency of conduct once to follow a course day. mg. per than It con- upon considerations when decided even by saying cluded that further studies appeared have led a would have that way requesting any were in- under and outset, a tend- different at the decision physician formation the could contribute. large ency strong peculiarly in- when money have effort vestments of both Although plaintiff many makes other very made; initial fact of the in late criticisms of defendant’s conduct subsequent importantly affects decision alleged withholding of data as to 1961 — (The Psychology animals,30 James, Brief- toxicity ones. See other in forms of judge significance. 1961 Get- In October As defendant’s scientists to this position FDA view be fol- man that that directed taken the need submit lowed; good only subordinates follow in failure of faith to be data believed significant, warrant this would not FDA insisted direction whereas complicity- New York that under with Merrell late 1961 discussion rule. and that it would all be submitted data heavy places reli ed.). Plaintiff paperback Course) (1961 17-22 er Although though argument that even tendency pushed on to ance this can be analyzed of the incidents we have recklessness, no one point of a court should finding of reck a itself warrant low would too not to set the scale careful lessness, permits an discovery utility their combination is under when of social a height only plan strong inference of recklessness review. A case significance of each item ens the against could been mounted Colum- have acts permit would consideration to Palos with bus had returned lives including those we have detailed nothing found. lost quarrel have subordinates. We Furthermore, general principle; indeed we while this defendant’s proposed recently letter quite that, would have even a have said served as warning, entitled, case, first suggested it was never “The trier is criminal bound, it would be as a the last. the evidence fact to consider Defendant’s position along whole; and, life, all as in the effect that it in law should be permitted greater generally warning send than of out its much this is letter immediately on understanding parts.” the sum the Bottone, United States subject Cir.), (2 letter change would be cert. F.2d denied, result of further U.S. S.Ct. conferences investigations. fact, de L.Ed.2d Still the burden well public been better for the all than volves see that when what court accomplished. the FDA considered, there essentials evidence is thus enough finding which the December 1 letter differed warrant requires. from plain what defendant law here think volunteered to send And thorough discovery by October 19 were tiff fails. recommendations slit-lamp examinations his able has un be industrious and counsel made during fore therapy earthed countless instances of careless very be used under ness and even of wilfulness close subordi MER/29 supervision frequent observation, nate officials and of failure to exercise proper supervision possible judg reassuring omission of the con bad cluding paragraph. by higher that, say We ment ones. cannot Granted few on the basis knew, escape of what it human endeavors without then de searching propose strong scrutiny, fendant’s failure to from blemish so warning picture reasonably pretty could is not a one. But there be found proof reckless was no properly wanton. from which a could conclude defendant’s offi suggestion Plaintiff’s final is that disregard cers manifested deliberate was taken off the market welfare; this, human apart what shows toas April 1962 not because the increas- negligence policing sub ing reports cataracts, culminating in ordinates and a somewhat stiff-necked year boy that of Mayo the six old FDA, attitude toward the is rather that Clinic, surprise inspec- but because of a they were so convinced the value plant by tion of the Merrell the FDA public both to the and to welfare monkey which revealed the fabricated company’s main finances that Taking data discussed some time back. sanguine longer pru tained view than the evidence in the sense most favorable dence warranted. *18 plaintiff, to the utmost shown is that may the raid have accelerated the deci- Moreover, de York New by days; nothing sion a few there is might punish mands, to before as it have to warrant an inference but for to fines similar defendant with a this defendant would have continued charge, imposed on criminal a those marketing in- justi in the face of necessary quality of conduct “clearly creasing cataractogenic damages fy es evidence of must be Cleghom Cent. York v. New qualities. tablished.”
851
contending
we
44,
(1874-).
While
Cf.
R.,
48
R. R.
56N.Y.
&H.
judge’s
by
decision
trial
concluded
Jebiley,
346 are
N.Y.S.2d
198
v.
Hedrick
Co.,
Merrell
Su
Ostopowitz
1960).
v. Wm. S.
Supreme
in
City
(N.Y.
As the
County,
Court,
New
us,
recently
preme
reminded
Westchester
Court
5879/63,
to our
clear, unequivocal York,
fn.
“by
3
proof
No.
of
standard
*
* *
appeal
defend
convincing
opinion,
is
now under
Division,
Woodby
Appellate
Second
stranger
v.
to the civil law.”
ant
483,
285,
urges,
Roginsky
“the
S.,
Department,
as
276,
87 S.Ct.
N.
385 U.S.
I.
Wig-
“suspend”
(1966), citing
sought,”
9
that we
relief
853
forget
required by
per-
the
that even
burden of
the care
when the
evidence with
by
ordinary
pre-
petition
coun-
one of
the
suasion is but
the
earnestness of
referring
ponderance,
technique
to
en-
testi-
the winner of a verdict
is
sel’s
mony
man-
titled
the
staccato
to inferences
evidence
and exhibits
a
impression
fairly supports.
an
creates
that often
ner
than when the evidence
different
rather
may
point
final
is that
Counsel’s
nothing
persuade us
to
read.
find
We
try
the case
been mistake
summary was in
'While
that our
error.4
argue
appeal
com-
on the basis that
right
quite
we did
counsel are
that
plicity
presidents or vice-
defendant’s
every item of
on
mention
which
presidents
must
be shown
warrant
opinion
plaintiff
relied,
clear-
had
as our
award,
They
842,
p.
n.
17.
carefully
844,
ly
p.
con-
stated
we had
at
support
find
acts
view that
cited. The
sidered the
items
additional
supervisory employees
of inferior
and we
case was indeed a close one
Soucy
enough
opinion
in the brief
had “no
not decide that
did
Greyhound
112,
Corp.,
276
v.
27 A.D.2d
unjustifia-
proof”
petition quite
as his
(3d
1967),
Dept.
case
N.Y.S.2d
bly says
proof
from
rather
“no.
but
pleadings
cited
decided on the
which we
properly conclude
could
which
point although
had not
a different
de-
manifested
defendant’s officers
that
to us
cited
and which we
welfare,”
disregard for human
liberate
very helpful
ques-
find
on the instant
thorough
p.
tion,6
reconsideration
Acceptance
850. After
and in
Motors
General
;5
Corp.
Froelich,
U.S.App.D.C.
tend
counsel
our view
v.
that
remains
they
request
anticipated
statement
he
or order
4.
counsel characterize
Since
surprise inspection
thought
concerning
of the
withdrawal
would allow
1962, p.
April,
plant
as
to be
until
the week
Merrell
decision
deferred
company
April
of all” and in-
indefensible
23 because of absences
“the most
Europe.
“laughable,”
“if
this as
as
we take
officials
He added that
deed
testimony
Getman,
rapidly, changes
develop
example. The
conditions
plans
general manager
president
to be
in these
will have
made
Division,
de-
a witness called
decision made earlier.”
fact
Merrell
April
plaintiff,
made
12. We fail
Division
con-
cision was
was
Friday, April 6,
with-
this is
distinguished
what
cluded on
see how
inconsistent
super-
drug
from
we are
on the
of the
what
draw the
basis
said
year
imposition
report
six
to the
have said.
of the
said to
boy
Mayo
upon the in-
old
at the
Clinic
perceive
5.
are unable to
the inconsisten
We
creasing reports of
“a number
cataracts
cy
plaintiff finds between our de
which,
opinion
who
of those
re-
Rey
cision and the well-known ease of
connection,
them,
had no
viewed
Pegler,
F.Supp.
(S.D.N.Y.
nolds
drug.”
possible
with the
connection
Get-
(2 Cir.),
1954), aff’d,
ceded in shown,” participation must be officer us
under Plaintiff asks law. grant judge him direct district new trial theory present or, alterna-
he can this judge
tively, so. that we allow On direction.
We shall make hand, nothing judgment granting prevent judge extraordinary relief if in exer- think
cise of a sound discretion he should
it to be warranted. petition rehearing is denied. Judge
HAYS, (dissenting): Circuit
I dissent. HABER, Moen,
Edward A. Robert H. Ron Tamillo, Winning ald P. John Sisson, Appellants, Robert D. CORPORATION,
The AMERICANA corporation, Appellee.
Nos. 20711-20714. Appeals
United States Court of
Ninth Circuit.
May 15, 1967.
