SANDOZ PHARMACEUTICALS CORPORATION N/K/A NOVARTIS PHARMACEUTICALS CORPORATION v. RONALD GUNDERSON, AS ADMINISTRATOR OF THE ESTATE OF MARY MARGARET GUNDERSON, AND NICHOLAS GUNDERSON, A MINOR, AND WESLEY GUNDERSON, A MINOR, BY THEIR CONSERVATOR, JOHN J. FORD and HYMAN & ARMSTRONG, P.S.C., AND KAREN ARMSTRONG, AS EXECUTRIX OF THE ESTATE OF LYMAN ARMSTRONG, M.D. v. RONALD GUNDERSON, AS ADMINISTRATOR OF THE ESTATE OF MARY MARGARET GUNDERSON, AND NICHOLAS GUNDERSON, A MINOR, AND WESLEY GUNDERSON, A MINOR, BY THEIR CONSERVATOR, JOHN J. FORD
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RENDERED:
OCTOBER 21, 2005; 2:00 P.M.
TO BE PUBLISHED
MODIFIED:
FEBRUARY 3, 2006; 10:00 A.M.
C ommonwealth O f K entucky
C ourt O f A ppeals
NO.
2004-CA-001536-MR
SANDOZ PHARMACEUTICALS
CORPORATION N/K/A NOVARTIS
PHARMACEUTICALS CORPORATION
v.
APPEAL FROM JEFFERSON CIRCUIT COURT
HONORABLE BARRY WILLETT, JUDGE
ACTION NO. 94-CI-004680
RONALD GUNDERSON, AS ADMINISTRATOR OF THE
ESTATE OF MARY MARGARET GUNDERSON, AND
NICHOLAS GUNDERSON, A MINOR, AND WESLEY
GUNDERSON, A MINOR, BY THEIR CONSERVATOR,
JOHN J. FORD
AND
NO.
APPELLEES
2004-CA-001537-MR
HYMAN & ARMSTRONG, P.S.C., AND
KAREN ARMSTRONG, AS EXECUTRIX OF
THE ESTATE OF LYMAN ARMSTRONG, M.D.
v.
APPELLANT
APPELLANTS
APPEAL FROM JEFFERSON CIRCUIT COURT
HONORABLE BARRY WILLETT, JUDGE
ACTION NO. 94-CI-004680
RONALD GUNDERSON, AS ADMINISTRATOR OF
THE ESTATE OF MARY MARGARET GUNDERSON,
AND NICHOLAS GUNDERSON, A MINOR,
AND WESLEY GUNDERSON, A MINOR,
BY THEIR CONSERVATOR, JOHN J. FORD
APPELLEES
OPINION
AFFIRMING IN PART,
VACATING IN PART,
AND REMANDING
** ** ** ** **
BEFORE:
KNOPF AND TACKETT, JUDGES; ROSENBLUM, SENIOR JUDGE.1
KNOPF, JUDGE:
On September 28, 1993, Mary Margaret Gunderson
gave birth by Caesarean section to her and her husband’s, Ronald
Gunderson’s, second child.
died.
Tragically, seven days later, Mary
Mary’s estate blamed her death on the medication,
Parlodel®, which Mary had taken to suppress postpartum
lactation.
The estate, represented by Ronald, and Mary’s two
children, Nicholas and Wesley Gunderson, sued Parlodel’s®
manufacturer, Sandoz Pharmaceuticals Corporation,2 and Mary’s
obstetrician, Lyman Armstrong, M.D.,3 in Jefferson Circuit Court
under theories of products liability and medical malpractice.
The case came to trial in February and March 2004, and resulted
in a judgment for the plaintiffs of more than nineteen million
dollars.
The estate was awarded compensatory damages for the
1
Senior Judge Paul W. Rosenblum sitting as Special Judge by
assignment of the Chief Justice pursuant to Section 110(5)(b) of
the Kentucky Constitution and KRS 21.580.
2
Sandoz has since changed its name to Novartis Pharmaceuticals
Corporation.
3
Dr. Armstrong died in 1997 and his estate was substituted as a
party. The Gundersons also sued Dr. Armstrong’s practice, Hyman
and Armstrong, P.S.C. We shall refer to the estate and the
practice as “Armstrong.”
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loss of Mary’s services and earning power in the amount of
$1,848,263.00, and Nicholas and Wesley were awarded compensatory
damages of $3,000,000.00 apiece for the loss of their mother’s
consortium.
These compensatory awards were apportioned 90% to
Sandoz and 10% to Armstrong.
Sandoz was also found liable for
$11,250,000.00 in punitive damages.
appeal.
Sandoz and Armstrong now
They both contend that the trial court abused its
discretion by failing to exclude unreliable expert causation
testimony as required by Daubert v. Merrell Dow Pharmaceuticals,
Inc.4 and Mitchell v. Commonwealth.5
Both appellants also claim
to have been entitled to directed verdicts on the issues of
strict products liability and medical negligence, respectively.
They both challenge certain evidentiary rulings.
And Sandoz
alleges errors with respect to the award of punitive damages
including a claim that the jury was improperly instructed.
Except for this last claim, we reject all of the appellants’
contentions.
Because we agree with Sandoz, however, that the
punitive damages instruction was fatally flawed, we must vacate
the award of punitive damages and remand the matter for
additional proceedings.
4
509 U.S. 579, 113 S. Ct. 2786, 125 L.Ed.2d 469 (1993).
5
908 S.W.2d 100 (Ky. 1995).
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BACKGROUND.
The Food and Drug Administration (FDA) originally
approved the use of Parlodel® for the prevention of postpartum
lactation (PPL) in 1980.
By 1983, reports of adverse reactions,
including seizures, strokes, and heart attacks, led the FDA to
request that Sandoz place a warning of the adverse experiences
on its labeling.
Sandoz initially resisted the request, but in
1984, and again in 1987, it agreed to make labeling changes, and
in conjunction with the 1987 changes it agreed to notify doctors
by letter of the potential hazards of using Parlodel® for
lactation suppression.
Sandoz also undertook a comprehensive study of the
drug.
The study, carried out by Epidemiology Resources, Inc.
(ERI) and published in 1988, did not conclusively show a
relationship between Parlodel® and either stroke or seizure, but
because of flaws in the study and its small size, the FDA
determined that it did not allay concerns about those potential
hazards.
Because of different but also serious concerns with
respect to other lactation suppressing drugs, the FDA’s
Fertility and Maternal Health Drugs Advisory Committee
recommended that no drug, including Parlodel®, be routinely used
to suppress lactation.
Agreeing with the committee’s
recommendation, the FDA in 1989 informally requested that all
manufacturers voluntarily withdraw the lactation suppression
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indication from their drug products.
Again, Sandoz resisted the
request until 1994 when, in the face of FDA proceedings to
withdraw approval for the indication, Sandoz voluntarily
withdrew the Parlodel® indication for the prevention of
lactation.
Approximately ten million women in the United States
had taken the drug for that purpose.
Mary Gunderson was thirty-two years old and in good
health at the time of her second son, Wesley’s, birth in 1993.
Her pregnancy and the delivery at Suburban Hospital in
Louisville were uneventful, although during her hospitalization
she had periods of slight hypertension both before and after the
birth.
Because Mary intended a prompt return to work she
decided against breast feeding, and Dr. Armstrong prescribed a
two-week course of Parlodel® to suppress lactation.
Mary had
taken Parlodel® for similar reasons following the birth of the
couple’s first child, Nicholas, in 1989.
from the hospital on October 1.
Mary returned home
On October 4 she complained to
family members of a severe headache and of pain in her back.
The next morning her mother discovered her dead in her bed.
Initially, the state medical examiner could not
determine the cause of Mary’s death.
The autopsy revealed no
evidence of brain or pulmonary abnormalities and though Mary’s
heart was somewhat enlarged, the examiner found no other cardiac
abnormality and did not think the enlargement significant.
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There was evidence that Mary may have taken as many as twentyeight Percocet tablets during the three days leading up to her
death, but the toxicology screen indicated no more than a
therapeutic level of that drug’s ingredients.
Although Mary
smoked and was somewhat overweight, the examiner found no
evidence that smoking or obesity had caused her death.
No other
cause appearing, the examiner referred to FDA warnings and to
case reports of women who had suffered seizures and strokes
while taking Parlodel®, noted that in many of those reports the
harmful event had been preceded by a severe headache, and
concluded that Mary had probably suffered a primary seizure due
to Parlodel® that had led to heart failure.
EXPERT CAUSATION TESTIMONY.
The Gundersons filed their suit in 1994.
In addition
to the testimony of the chief state medical examiner, George
Nichols, M.D., a physician board certified in forensic pathology
with twenty years’ experience as chief of the examiner’s office,
they supported their allegation that Parlodel® caused Mary’s
death by proffering two other experts, Denis Petro, M.D. and
Kenneth Kulig, M.D.
Dr. Petro is a board-certified neurologist
with extensive experience in both the development and the
regulation of neurologic drugs.
He has published at least
twenty peer-reviewed journal articles.
Dr. Kulig is board
certified in toxicology and emergency medicine and has more than
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twenty years’ experience in those fields, both as a practitioner
and as a professor.
He has published in excess of 145 journal
articles.
The opinion of these experts was that Parlodel® caused
a seizure in Mary Gunderson which in turn caused a sudden death
syndrome such as apnea (the absence of breathing) or cardiac
arrhythmia (irregularity of the heartbeat).
Underlying this
conclusion is the experts’ additional opinion that Parlodel®,
the active ingredient of which is bromocriptine, can cause
seizures by causing vasoconstriction (narrowing of blood
vessels) in the brain.
Sandoz and Armstrong moved to exclude
this expert testimony on the ground that it is not
scientifically reliable and thus not admissible under KRE 702.
They also moved for directed verdicts on essentially the same
ground: that the expert causation evidence was unreliable and
hence insufficient.
The trial court abused its discretion, they
maintain, by denying those motions.
KRE 702 provides that
[i]f scientific, technical, or other
specialized knowledge will assist the trier
of fact to understand the evidence or to
determine a fact in issue, a witness
qualified as an expert . . . may testify
thereto in the form of an opinion or
otherwise.
To be admissible, then, expert testimony must concern
specialized knowledge and must aid the trier of fact.
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The first
requirement is one of reliability.
The expert’s opinion must be
sufficiently validated, by sound reason and method, to be
trustworthy.6
The second requirement is one of relevance.
opinion must be relevant to the facts at issue.
The
Thus, an
expert’s testimony is admissible under KRE 702 only if it “both
rests on a reliable foundation and is relevant to the task at
hand.”7
Because there is no dispute that causation evidence is
relevant to the Gundersons’ claim, the issue before the trial
court was whether that evidence was reliable.
Under KRE 702, the assessment of reliability is meant
to be flexible and concerned more with the “principles and
methodology” the expert employs than with his or her
conclusions.8
Factors bearing on the reliability of expert
testimony include
(1) whether a theory or technique can be and
has been tested; (2) whether the theory or
technique has been subjected to peer review
and publication; (3) whether, with respect
to a particular technique, there is a high
known or potential rate of error and whether
there are standards controlling the
technique’s operation; and (4) whether the
6
Mitchell v. Commonwealth, 908 S.W.2d 100 (Ky. 1995) (adopting
Daubert v. Merrell Dow Pharmaceuticals., Inc., 509 U.S. 579, 113
S. Ct. 2786, 125 L.Ed.2d 469 (1993)).
7
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141, 119 S. Ct.
1167, 1171, 143 L.Ed.2d 238 (1999) (internal quotation marks
omitted); Goodyear Tire and Rubber Company v. Thompson, 11
S.W.3d 575 (Ky. 2000).
8
Daubert v. Merrell Dow Pharmaceuticals., Inc., supra.
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theory or technique enjoys general
acceptance within the relevant scientific,
technical, or other specialized community.9
These factors are not the only ones that may indicate
reliability, and the court has broad discretion to consider
others suggested by the unique circumstances of the expert
testimony involved.10
The court should, however,
be conscious of two guiding, and sometimes
competing, principles. On the one hand, the
court should be mindful that Rule 702 was
intended to liberalize the introduction of
relevant expert evidence. . . . And, the
court need not determine that the expert
testimony a litigant seeks to offer into
evidence is irrefutable or certainly
correct. . . . As with all other admissible
evidence, expert testimony is subject to
being tested by “[v]igorous crossexamination, presentation of contrary
evidence, and careful instruction on the
burden of proof.” Daubert, 509 U.S. at 596,
113 S.Ct. 2786. On the other hand, the
court must recognize that due to the
difficulty of evaluating their testimony,
expert witnesses have the potential to “be
both powerful and quite misleading.” Id. at
595, 113 S.Ct. 2786 (internal quotation
marks omitted). And, given the potential
persuasiveness of expert testimony,
proffered evidence that has a greater
potential to mislead than to enlighten
should be excluded.11
9
10
Miller v. Eldridge, 146 S.W.3d 909, 914 (Ky. 2004).
Kumho Tire Co. v. Carmichael, supra.
11
Westberry v. Gislaved Gummi AB, 178 F3d 257, 261 (4th Cir.
1999).
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Where, as in this case, the experts’ qualifications
have not been challenged and are not in doubt, the trial court
must determine whether the proffered testimony falls “outside
the range where experts might reasonably differ, and where the
jury must decide among the conflicting views of different
experts, even though the evidence is ‘shaky.’”12
Although
experts are not permitted merely to speculate,13 if their
opinions are supported by good grounds based on what is known,
it is for the fact finder to decide if they are deserving of
credence.14
This Court reviews the trial court’s decision to admit
or exclude evidence for an abuse of discretion.15
“The test for
abuse of discretion is whether the trial judge’s decision was
arbitrary, unreasonable, unfair, or unsupported by sound legal
principles.”16
The appellants first contend that the trial court
abused its discretion by failing to hold a Daubert hearing prior
12
Kumho Tire Company, LTD., v. Carmichael, 526 U.S. at 153, 119
S.Ct. at 1177.
13
Mondie v. Commonwealth, 158 S.W.3d 203 (Ky. 2005); Rosen v.
Ciba-Geigy Corporation, 78 F.3d 316 (7th Cir. 1996).
14
Daubert v. Merrell Dow Pharms., Inc., supra.
15
Toyota Motor Corporation v. Gregory, 136 S.W.3d 35 (Ky. 2004).
16
Goodyear Tire and Rubber Company v. Thompson, 11 S.W.3d at
581.
- 10 -
to ruling on the admissibility of the experts’ causation
opinions and by failing to enter findings in support of its
ruling.
Our Supreme Court has held, however, that the trial
court need not conduct a Daubert hearing if the record before it
is complete enough to measure the proffered
testimony against the proper standards of
reliability and relevance. . . . [T]he
record upon which a trial court can make an
admissibility decision without a hearing
usually will consist of ‘the proposed
expert’s reports, affidavits, deposition
testimony, and existing precedent.17
The voluminous record in this case, which included the experts’
depositions and affidavits, much of the material upon which they
relied, extensive briefing by the parties, and precedent from
other Parlodel® litigation, satisfied that standard.
The trial
court did not abuse its discretion by forgoing a Daubert
hearing.
City of Owensboro v. Adams,18 on which the appellants
rely, is not to the contrary.
In Adams our Supreme Court
emphasized the importance of the trial court’s gate-keeping
function in assessing the reliability of proffered expert
testimony and noted that
[t]he trial court’s broad latitude to make
the reliability determination does not
include the discretion to abdicate
completely its responsibility to do so
17
Dixon v. Commonwealth, 149 S.W.3d 426, 430 (Ky. 2004).
18
136 S.W.3d 446 (Ky. 2004).
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. . . . A trial court must, at least, state
on the record its Daubert conclusion with
respect to reliability.19
Here, however, there is absolutely no suggestion that the trial
court abdicated its gate-keeping responsibility under Daubert.
On the contrary, as the court stated, it spent weeks studying
the parties’ extensive submissions on this question and then
concluded, on the record, that the plaintiff’s expert evidence
was reliable.
Nor did the court abuse its discretion by failing to
enter findings of fact in support of its Daubert ruling.
While
it is certainly preferable for a trial court to make such
findings,20 our Supreme Court has recently held that “[w]here the
trial court fails to make express [Daubert] findings of fact,
. . . an appellate court should engage in [a] clear error review
by looking at the record to see if there is substantial evidence
to support the trial court’s ruling.”21
highly deferential.
Our review is thus
We do not ask whether we agree with the
trial court’s ruling, but only whether the record includes
substantial evidence to support it.22
19
Id. at 451 (emphasis in original; citation and internal
quotation marks omitted).
20
Miller v. Eldridge, 146 S.W.3d at 921-22.
21
Miller v. Eldridge, 146 S.W.3d at 917.
22
Id.
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As the appellants note, the appellees bore the burden
of proving both that Parlodel® is capable of causing seizures
and that it probably did so in this case.
With respect to the
first question, whether Parlodel® is a possible cause of
seizures, the appellees’ experts adduced extensive evidence
along two fronts.
They sought to show that bromocriptine, the
active ingredient in Parlodel®, can have vasoconstrictive
effects, vasoconstriction being a recognized cause of
hypertension and seizure.
And they sought to show that
Parlodel® itself has been meaningfully associated with cerebral
vascular problems such as headache, hypertension, seizure, and
stroke.
The first sort of evidence includes the fact that
bromocriptine is a semi-synthetic ergot alkaloid, a family of
chemicals which includes many members known to cause
vasoconstriction.
Notwithstanding the fact that bromocriptine
typically lowers blood pressure by dilating blood vessels, the
Gundersons’ experts cited animal studies and a human hand-vein
study indicating that in some circumstances bromocriptine can
cause the paradoxical effect of vasoconstriction.
One study
suggests that low initial vascular resistance permits
vasoconstriction, and, as the Gundersons’ experts argue, a
woman’s vascular resistance is low during the postpartum period.
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This evidence, the experts contend, lends substantial
support to numerous adverse drug events and case reports,
internal Sandoz documents acknowledging a possible causal
relation between bromocriptine and adverse cerebral events, and
an epidemiological study allegedly linking Parlodel® to
seizures.
The Sandoz package insert for Parlodel® lists eighty-
nine cases of hypertension, seventy-two seizures, and thirty
strokes when the drug was used during the postpartum period.
Although these numbers are not overwhelming given the fact that
as many as ten million women used Parlodel® to suppress
lactation, they were sufficient to induce the FDA to initiate
proceedings to withdraw Parlodel’s® lactation suppression
indication.
Case reports have also appeared in the peer-
reviewed medical literature to support statements to the effect
that Parlodel® can cause vasoconstriction and possibly seizure,
stroke, and heart attack.
A very few of the case reports indicate that the
adverse symptoms disappeared when Parlodel® was withdrawn and
then reappeared when Parlodel® was reintroduced.
These “de-
challenge, re-challenge” experiments are generally regarded as
offering substantially better evidence of a causal relationship
than an adverse reaction alone.
Finally, the experts all cited a 1986-88
epidemiological study sponsored by Sandoz and performed by
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Epidemiology Resources, Inc. (ERI) that initially reported that
women taking Parlodel® in the late postpartum period (more than
seventy-two hours after delivery) were more than twice as likely
to suffer seizures than such women not exposed to Parlodel®.
In
the final report, however, the author reclassified some of the
late postpartum data to account, he said, for seizure history
and the concomitant presence of another drug (ergonovine).
He
thus arrived at a relative risk figure suggesting that for
women, such as Mary, with no history of seizure and who had not
been exposed to ergonovine, Parlodel® actually reduced the risk
of seizure.
The appellees, of course, rely on the initial
report, and contend that the modification was undertaken at the
behest of Sandoz.
Although the experts concede that the ERI
study was significantly flawed (several peer-reviewed journals
declined to publish it) and does not by itself establish a
causal relationship between Parlodel® and seizure, it is
nevertheless, they contend, substantial evidence of such a
relationship, which, in conjunction with the other evidence
linking Parlodel® both with vasoconstriction and adverse
cerebral events, permits a reasonable inference that Parlodel®
can cause seizures.
The trial court ruled that this inference was
reliable; that is, not that it was necessarily correct but that
it was sufficiently based on good grounds and sound scientific
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methodology to be admissible.
As Sandoz and Armstrong note,
several federal district courts have considered very similar
evidence in other Parlodel® cases and have reached the opposite
conclusion.23
result.24
Three federal circuit courts have upheld that
Generally, those courts have discounted the ERI study
as not statistically meaningful, dismissed case studies and
adverse drug reports as showing merely a temporal but not a
causal relationship, objected to the animal studies as involving
doses and processes removed by too great an analytical gap from
the plaintiff’s ingestion of Parlodel®, and noted that the FDA
expressly disavowed having established a causal relationship
between Parlodel® and any serious adverse event, but merely
determined that the limited utility of lactation suppression was
outweighed by the possible risk of serious side effects.
As noted above, however, the question before us is not
whether we or other courts agree with the trial court’s
reliability finding, but only whether substantial evidence
23
Dunn v. Sandoz, 275 F.Supp.2d 672 (M.D.N.C. 2003); Soldo v.
Sandoz, 244 F.Supp.2d 434 (W.D.Pa. 2003); Caraker v. Sandoz, 188
F.Supp.2d 1026 (S.D.Ill. 2001); Siharath v. Sandoz, 131
F.Supp.2d 1347 (N.D.Ga. 2001); Glastetter v. Novartis, 107
F.Supp.2d 1015 (E.D.Mo. 2000); Hollander v. Sandoz, 95 F.Supp.2d
1230 (W.D.Okla. 2000); Brumbaugh v. Sandoz, 77 F.Supp.2d 1153
(D.Mont. 1999).
24
Rider v. Sandoz, 295 F.3d 1194 (11th Cir. 2002) (affirming
Siharath); Hollander v. Sandoz, 289 F.3d 1193 (10th Cir. 2002);
Glastetter v. Novartis, 252 F.3d 986 (8th Cir. 2001).
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supports it.
Indeed, as the Tenth Circuit observed, given the
deferential standard of review for Daubert rulings,
[i]n theory judges are free to select
different procedures and apply different
factors to a particular expert or type of
expertise than their colleagues do . . . and
. . . as a consequence, similar cases could
be resolved differently on the basis of
inconsistent determinations about
admissibility.25
Nor is the trial court alone in its determination to
admit this evidence.
In two cases a federal district court has
rejected Sandoz’s Daubert arguments,26 and the Supreme Court of
Kansas has ruled in another Parlodel® seizure case that, under
that state’s rules of evidence (Kansas has not adopted Daubert),
the plaintiff’s causation evidence raised material issues of
fact sufficient to withstand a motion for summary judgment.27
one of the federal courts observed,
animal studies, the medical literature
reviews, the ADRs reported to the FDA, the
“general acceptance” of the association
[between Parlodel® and adverse cerebral
events] reflected in several medical texts,
. . . [and] the [de-challenge, re-challenge]
experiment[s] . . . are recognized and
accepted scientific methodologies, used for
25
Hollander v. Sandoz, 289 F.3d 1193, 1206-07 (citation and
internal quotation marks omitted).
26
Brasher v. Sandoz, 160 F.Supp.2d 1291 (N.D.Alab. 2001);
Globetti v. Sandoz, 111 F.Supp.2d 1774 (N.D.Alab. 2000).
27
Kuhn v. Sandoz, 14 P.3d 1170 (Kan. 2000).
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As
assessing the possible side-effects and
hazards associated with particular drugs.28
We cannot say that the trial court either abused its discretion
or clearly erred by ruling that the plaintiffs’ experts’ general
causation opinion based on these methods was sufficiently
reliable to be admitted into evidence and tested in the usual
way by cross examination and the presentation of contrary
evidence.
Nor did the trial court abuse its discretion or
clearly err by admitting the experts’ special causation opinion
that Parlodel® caused Mary’s seizure and death.
The method
employed by all the experts to arrive at this conclusion was the
differential diagnosis, a well-recognized, peer-reviewed
technique whereby medical clinicians identify medical conditions
and their causes.29
The physician lists the possible diseases or
causes of the condition, then engages in a process of
elimination by performing diagnostic tests until he or she is
left with the most likely diagnosis.
In this case the experts relied upon a thorough
autopsy, including microscopic studies of the lung, heart, and
brain tissues, a toxicology report, and Mary’s family and
28
Globetti v. Sandoz, 111 F.Supp.2d at 1179.
29
Kennedy v. Collagen Corp., 161 F.3d 1226 (9th Cir. 1998);
Glaser v. Thompson Medical Company, Inc., 32 F.3d 969 (6th Cir.
1994) Perkins v. Origin Medsystems Inc., 299 F.Supp.2d 45
(D.Conn. 2004).
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medical history.
This evidence, they testified, eliminated all
possible causes of Mary’s death (pulmonary embolism, stroke, or
heart attack, for example) except some form of sudden death
syndrome, essentially a negative diagnosis.
Because of the
position in which Mary’s body was found, which was consistent
with her having suffered a seizure; her exposure to Parlodel®;
and the facts that, like other adverse events associated with
Parlodel®, Mary’s death occurred during the late postpartum
period and was preceded by a severe headache, the experts
concluded that the most likely cause of death was a Parlodel®induced seizure followed by heart or lung failure.
All of these
analyses are standard, well established autopsy and differential
diagnosis techniques.
The trial court did not clearly err by
deeming the opinion based on them reliable.
The appellants argue that the differential diagnosis
was not reliable in this case because the experts did not
adequately account for the fact that the postpartum period
itself is associated with seizures, strokes, and heart attacks.
The appellees’ experts opined that late postpartum events such
as Mary’s seizure are rare, however, making it likely that
Parlodel® was involved.
The trial court did not clearly err by
regarding this question as one involving the weight of the
experts’ testimony, not its admissibility.
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Finally, the appellants complain that the trial court
unfairly prevented them from cross-examining the Gundersons’
experts with respect to certain studies allegedly contrary to
their opinions.
Because the appellants did not preserve the
excluded cross-examination by avowal, however, this issue is not
subject to our review.30
In sum, the trial court’s finding that the plaintiffs’
experts’ causation testimony was reliable, that it represented
“good grounds based on what is known,” is not clearly erroneous.
There is substantial evidence that the methods the experts
employed are well established in their fields and yielded
genuinely scientific results within “the range where experts
might reasonably differ, and where the jury must decide among
the conflicting views of different experts.”31
Nor, for the same
reasons, did the court abuse its discretion by deeming the
experts’ causation testimony sufficient to withstand the
appellants’ motions for directed verdicts.
On the basis of that
testimony, a rational juror could conclude that Parlodel® caused
Mary’s seizure and death.
Accordingly, Sandoz and Armstrong are
not entitled to relief on this ground.
THE ADEQUACY OF SANDOZ’S WARNINGS.
30
Noel v. Commonwealth, 76 S.W.3d 923 (Ky. 2002).
31
Kumho Tire Company, LTD., v. Carmichael, supra, note 11.
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Kentucky law provides for strict product liability in
tort for sellers of any product “in a defective condition
unreasonably dangerous to the user.”32
A product may be
“defective because of inadequate instructions or warnings.”33
The Gundersons allege that the warnings accompanying the
Parlodel® Mary received were inadequate and that adequate
warnings would have prevented her death.
As Sandoz notes, under
the learned intermediary doctrine, manufacturers of prescription
drugs generally need not warn consumers directly of the risks
associated with a medication as long as they adequately instruct
and warn physicians who prescribe it.
Among the rationales for
this doctrine, as our Supreme Court has recently explained, is
the fact that generally “the prescribing physician is in a
superior position to impart the warning and can provide an
independent medical decision as to whether use of the drug is
appropriate for treatment of a particular patient.”34
Although the manufacturer’s duty to warn
runs only to the learned intermediary, that
warning must still be adequate. . . . If the
manufacturer fails to adequately warn the
learned intermediary, then it may be liable
to the injured patient-consumer. . . . An
adequate warning has been defined as one
32
Ford Motor Company v. Fulkerson, 812 S.W.2d 119, 122 (Ky.
1991) (citation and internal quotation marks omitted).
33
Restatement (Third) of Torts: Prod. Liab. § 2(c) (1998).
34
Larkin v. Pfizer, Inc., 153 S.W.3d 758, 763 (Ky. 2004).
- 21 -
sufficient to apprise the general
practitioner as well as the unusually
sophisticated medical man of the dangerous
propensities of the drug. . . . It is
incumbent upon the manufacturer to bring the
warning home to the doctor. . . . Several
cases have held that a package insert may be
sufficient for the warning to be adequate as
a matter of law. . . . The warning may also
be adequate if posted in the Physician’s
Desk Reference. . . . Thus, providing an
adequate warning to the prescribing
physician relieves the manufacturer of its
duty to warn the patient regardless of how
or if the physician warns the patient.35
The package insert that accompanied Parlodel® at the
time of Mary’s prescription and the Physician’s Desk Reference
(PDR) listing both provided the following warning:
While hypotension during the start of
therapy with Parlodel® . . . occurs in some
patients, 50 cases of hypertension have been
reported, sometimes at the initiation of
therapy, but often developing in the second
week of therapy. Seizures have been
reported in 38 cases (including 4 cases of
status epilepticus), both with and without
the prior development of hypertension
occurring mostly in postpartum patients up
to 14 days after initiation of treatment.
Fifteen cases of stroke during Parlodel®
... therapy have been reported mostly in
postpartum patients whose prenatal and
obstetric courses had been uncomplicated.
Many of these patients experiencing seizures
and or strokes reported developing a
constant and often progressively severe
headache hours to days prior to the acute
event. Some cases of strokes and seizures
during therapy with Parlodel® . . . were
also preceded by visual disturbances
(blurred vision and transient cortical
35
Id. at 764-65 (citations and internal quotation marks
omitted).
- 22 -
blindness). Four cases of acute myocardial
infarction have been reported, including 3
cases receiving Parlodel® . . . for the
prevention of physiologic lactation. The
relationship of these adverse reactions to
Parlodel® . . . administration is not
certain. The use of Parlodel® . . . is not
recommended for patients with uncontrolled
hypertension or toxemia of pregnancy.
Although there is no conclusive evidence
which demonstrates the interaction between
Parlodel® . . . and other ergot alkaloids,
the concomitant use of these medications is
not recommended. Particular attention
should be paid to patients who have recently
received other drugs that can alter the
blood pressure.
This warning was approved by the FDA in 1987.
In
conjunction with the then new warning, the FDA required Sandoz
to send a “Dear Doctor” letter to obstetricians noting the
changes and calling attention to the adverse reactions.
The
estate presented evidence tending to show that Sandoz attempted
to undermine the heightened warning by failing to send the “Dear
Doctor” letter to more than a small fraction of the doctors
registered in the college of obstetricians and gynecologists.
Because of its concern that so few doctors had
received the letter, in 1988 the FDA required Sandoz to send the
letter again to a wider audience and decided to include
consideration of Parlodel® as a lactation suppressant at a 1988
meeting of its Fertility and Maternal Health Drugs Advisory
Committee.
In the fall of that year the ERI study was
published.
Following its review of that study and the other
- 23 -
available data, the advisory committee determined that the
relatively minor discomfort and inconvenience of postpartum
lactation did not justify the potentially serious risks
associated with drug therapies, including Parlodel®.
The
committee recommended that that condition be treated
conservatively, as it traditionally had been, with breast
binding and analgesics, and that the indications of all drugs
for that purpose be withdrawn.
The FDA adopted the committee’s
recommendation in 1989 and asked manufacturers to voluntarily
withdraw their drugs’ lactation-suppression indications.
With
the exception of Sandoz, all manufacturers complied with the
FDA’s request.
Sandoz, however, continued to market Parlodel® for the
suppression of postpartum lactation.
In a May 1990 “Dear
Doctor” letter acknowledging the FDA’s request, the company
wrote,
Sandoz considers this request [to
voluntarily withdraw the PPL indication]
inappropriate for the following reasons:
The question of need is one that should be
determined between an informed patient and
her physician and not by a governmental
agency.
There is strong disagreement with the
conclusion that there is no need for a drug
to prevent lactation in the postpartum
period. Although not all women who elect
not to breast feed may require therapy to
prevent lactation, a significant number will
benefit from such therapy.
- 24 -
As demonstrated in controlled trials, the
use of Parlodel® therapy to prevent the
engorgement and pain that occur in many
women who elect not to breast feed is a more
effective approach than treating the
engorgement and pain once they occur with
analgesics and ice packs.
The estate presented evidence tending to show that
Sandoz instructed its sales force not to mention the associated
risks or the FDA’s concerns unless questioned by the doctor and
then to downplay those concerns.
Instead, the sales
representatives were to continue to urge that Parlodel® be
included on standing orders as a routine therapy for postpartum
lactation.
In 1994, after the FDA had initiated procedures to
withdraw its approval of Parlodel® for PPL, Sandoz withdrew that
indication voluntarily.
The estate also presented evidence that well before
the time of Mary’s prescription in 1993 Sandoz knew of at least
ninety-eight cases of hypertension, eighty-six cases of seizure,
and thirty-three cases of stroke associated with Parlodel®, but
had made no effort to provide doctors with updated figures after
the 1987 revision to the package insert.
Sandoz also knew that,
in light of these potential risks, the FDA had determined that
PPL did not require routine drug therapy.
Nevertheless, Sandoz
withheld those concerns from doctors and continued to market
Parlodel® as a routine drug.
Dr. Armstrong, a member of the
college of obstetricians and gynecologists, testified that he
- 25 -
had not been made aware of increased concerns about Parlodel®.
He admitted that he had not read the 1987 package insert or PDR
entry, but testified that neither had he seen any of the “Dear
Doctor” letters.
Had he done so, he said, he would not have
prescribed Parlodel® for Mary.
Because the 1987 package insert refers expressly to a
possible risk of seizure, Sandoz contends that the warning
should be deemed adequate as a matter of law and thus that the
trial court should have granted its motion for directed verdict.
Giving the Gundersons’ evidence its most favorable inferences,
however, as we must when reviewing the denial of a directed
verdict motion,36 that evidence can reasonably be thought to
establish that by 1993 the 1987 package insert did not bring
home to a reasonable physician an adequate warning of the drug’s
dangerous propensities, and that nothing Sandoz had done in the
interim had made up for that inadequacy.
On the contrary, the
company had made no effort to update the adverse reaction
figures, the company’s warning letters were not widely
distributed, and its sales representatives did not discuss risks
36
Sand Hill Energy, Inc. v. Ford Motor Company, 83 S.W.3d 483
(Ky. 2002) (citing Lewis v. Bledsoe Surface Mining, 798 S.W.2d
459 (Ky. 1990).
- 26 -
except to discount them.
The trial court, therefore, properly
refused to direct a verdict against the Gundersons.37
Sandoz next contends that the Gundersons’ Kentucky-law
inadequate-warning claim has been impliedly preempted by federal
law.
As the company notes, warnings reviewed and approved by
the FDA are not to be second-guessed by state courts even where
the claim is that FDA approval was procured by fraud upon the
agency.38
Such claims “would open a pandora’s box of judicial
scrutiny of FDA decision-making,” which would not comport with
Congress’s delegation of broad authority to the FDA to regulate
drug labeling.39
Several courts have held, however, that FDA approval
of a drug label does not relieve a manufacturer of its
continuing duty to apprise consumers through their learned
intermediaries of new information bearing upon the drug’s risks
37
Cf. Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir. 1989)
(noting that over-promotion by a drug manufacturer can undermine
an otherwise adequate warning); Baldino v. Castagna, 478 A.2d
807 (Pa. 1984) (same); Stevens v. Parke, Davis & Company, 507
P.2d 653 (Cal. 1973) (same).
38
Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Ehlis v.
Shire Richwood, Inc., 233 F.Supp.2d 1189 (D.N.D. 2002); Bouchard
v. American Home Products Corp., 213 F.Supp.2d 802 (N.D.Ohio
2002).
39
Kemp v. Medtronic, Inc., 231 F.3d at 234. Cf. Buckman Company
v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350, 121 S.Ct.
1012, 1018, 148 L.Ed.2d 854 (2001) (“State-law fraud-on-the-FDA
claims inevitably conflict with the FDA’s responsibility to
police fraud consistently with the Administration’s judgment and
objectives”).
- 27 -
and that state-law claims based on breach of that duty are not
preempted.40
As one of the federal courts involved with
Parlodel® litigation explained,
[T]he [federal] regulations specifically
contemplate that the FDA determination of
drug safety given the warnings existing at
the time of application would not always be
accurate after additional post-application
information surfaces. . . . Sandoz may have
a federal duty to supplement the information
before the FDA, but Sandoz is not prohibited
from unilaterally strengthening the warnings
before FDA approval. It is exactly in this
situation that the State common law duty
would attach. That duty would require
Sandoz to timely alert patients (through
their learned intermediaries) of an
increased risk associated with Parlodel®.
The common law duty to promptly alert
physicians prescribing Parlodel® of an
elevation in the risk of taking Parlodel®
stands as no obstacle to the accomplishment
and execution of the full purposes and
objectives of the regulations.41
Although the Gundersons did offer proof that Sandoz
had not been completely forthcoming with the FDA as the 1987
package insert was being considered, and though any claim based
on that proof that the 1987 warning was inadequate when approved
would be preempted, the gravamen of the Gundersons’ claim is
that between 1987 and 1993 Sandoz failed to apprise physicians
40
Bell v. Lollar, 791 N.E.2d 849 (Ind.App. 2003); Caraker v.
Sandoz Pharmaceuticals Corp., 172 F.Supp.2d 1018 (S.D.Ill.
2001); Kemp v. Medtronic, Inc., supra (medical device case in
which the proposition was noted rather than held); Motus v.
Pfizer, Inc., 127 F.Supp.2d 1085 (C.D.Cal. 2000).
41
Caraker v. Sandoz Pharmaceuticals Corp., 172 F.Supp.2d 1018,
1037 (S.D.Ill. 2001) (emphasis in original).
- 28 -
of additional adverse reaction reports and of the FDA’s
determination that drug therapy for postpartum lactation was not
necessary in light of the potentially serious risks.
We agree
with those courts that have found such claims not to be in
conflict with the federal regulations and therefore not
preempted.
Sandoz was not entitled to a directed verdict on
this ground.
The trial court’s product liability instruction
provided as follows:
It is the plaintiff’s claim that Parlodel®
was in a defective condition unreasonably
dangerous, resulting in the death of Mary
Margaret Gunderson.
You will find for the Plaintiffs, . . .
if you are satisfied from the evidence as
follows:
A. As manufactured by Defendant Sandoz, the
drug Parlodel® was unreasonably dangerous
for the use of the drug’s ultimate users,
including Plaintiffs’ decedent, . . . . A
product is “unreasonably dangerous” if it
creates such a risk of injury to a potential
user that an ordinarily prudent manufacturer
of pharmaceutical products, being fully
aware of the risks, would not have placed or
kept the product on the market; and
B. The unreasonably dangerous condition of
the drug Parlodel® was a substantial factor
in causing Mary Margaret Gunderson’s death.
Otherwise you will find for Defendant
Sandoz.
Sandoz contends that this instruction was erroneous
because it did not specify that an adequate warning to the
prescribing doctor is a defense.
In Ford Motor Company v.
- 29 -
Fulkerson,42 however, our Supreme Court endorsed the bare-bones
products-liability instruction the trial court employed and
cautioned against instructions getting into evidentiary matters,
such as warnings, “which better practice suggests should be
omitted from the instructions and left to the lawyers to flesh
out in closing arguments.”43
While a more specific instruction
would not necessarily have been erroneous, the trial court did
not err or abuse its discretion by using a less specific but
well-established instruction which gave Sandoz a fair
opportunity to argue its theory of the case.
DR. ARMSTRONG’S NEGLIGENCE.
In medical malpractice actions, “the plaintiff must
prove that the treatment given was below the degree of care and
skill expected of a reasonably competent practitioner and that
the negligence proximately caused injury or death.”44
Armstrong
contends that there was insufficient evidence of his negligence
to submit the plaintiffs’ case to the jury.
Armstrong notes
that at the time of Mary’s prescription, Parlodel® still
technically enjoyed FDA approval for PPL as well as the approval
of the standing order committee at Suburban Hospital.
42
812 S.W.2d 119 (Ky. 1991).
43
He also
Id. at 123.
44
Reams v. Stutler, 642 S.W.2d 586, 588 (Ky. 1982); See Mitchell
v. Hadl, 816 S.W.2d 183 (Ky. 1991).
- 30 -
notes that he had been using Parlodel® for years with good
effect and no serious adverse reactions, including successful
treatment of Mary’s PPL following her delivery of Nicholas in
1989.
This evidence, Armstrong maintains, precludes a finding
that he deviated from the care and skill expected of a
reasonably competent practitioner.
The Gundersons presented the expert testimony of Dr.
Patrick Lavery, however, an OB-GYN with experience in
Louisville.
Dr. Lavery testified that by 1993 a reasonably
competent practitioner would have learned through the medical
literature, if not through the PDR and Sandoz, that serious
concerns had been raised about Parlodel®, particularly in
conjunction with hypertension.
Because Mary had exhibited
slight hypertension both before and after her delivery, such a
practitioner, in Dr. Lavery’s opinion, would not have prescribed
that drug.
Dr. Armstrong himself testified that had he been
aware of the serious adverse reactions reported in the package
insert and the PDR and of the FDA’s determination that Parlodel®
was not needed for PPL, he would not have prescribed Parlodel®
for Mary.
Given the favorable inferences required by our
standard of review,45 this evidence can reasonably be thought to
show that Dr. Armstrong’s failure to keep abreast of the
concerns about Parlodel® was negligent and that the negligence
45
Sand Hill Energy, Inc. v. Ford Motor Company, 83 S.W.3d 483
(Ky. 2002); Reams v. Stutler, supra.
- 31 -
caused Mary’s exposure to that drug and her death.
The trial
court did not err, then, by denying Armstrong’s motion for a
directed verdict.
CROSS-CLAIM AS EVIDENCE.
In September 1998, Armstrong filed a cross-claim
against Sandoz alleging fraudulent misrepresentation and gross
negligence in Sandoz’s marketing of Parlodel® and seeking both
damages for injury to Dr. Armstrong’s reputation and
indemnification should Armstrong be found liable for Mary’s
death.
Prior to trial Sandoz entered into an indemnification
agreement with Armstrong whereby his claims were settled and
Sandoz took over his defense of the Gundersons’ claims against
him.
Accordingly, the cross-claim was dismissed and at trial
Armstrong presented no evidence critical of Sandoz.
The trial
court permitted the Gundersons to introduce Armstrong’s crossclaim as evidence of the defendants’ non-adverse relationship
and as relevant to the credibility of Armstrong’s evidence.
Sandoz contends that Armstrong’s allegations were actually
introduced against it to bolster the Gundersons’ similar
allegations and that for that purpose the cross-claim was
inadmissible hearsay.
KRE 801A(b) permits the introduction as non-hearsay of
an adverse party’s admissions, including admissions contained in
superseded or abandoned pleadings, but only against the
- 32 -
declaring party.
“Admissions are not admissible against a
declarant’s coparty.”46
As Sandoz points out, moreover, several
courts have excepted third-party pleadings from the general rule
of admissibility because
[s]trictly applied . . . (the general) rule
would place a litigant at his peril in
(that) . . . the allegations in third-party
complaints and cross-claims seeking recovery
over in the event of liability in the
principal action could be used in that
action as admissions establishing liability.
Thus, as a necessary exception to the
general rule, there is ample authority that
one of two inconsistent pleas cannot be used
as evidence in the trial of the other.47
Thus, according to Sandoz, Armstrong’s cross-claim was not
admissible against it as a co-party and was not admissible
against Armstrong because the cross-claim was a third-party
pleading.
On the other hand, as our Supreme Court has recently
made clear, evidence of a settlement that renders formerly
adverse parties no longer adverse will frequently be relevant to
expose the potential bias of the former adversaries, who now may
be motivated to downplay each other’s fault.
46
KRE 408 permits
Fisher v. Duckworth, 738 S.W.2d 810, 813 (Ky. 1987).
Schneider v. Lockheed Aircraft Corporation, 658 F.2d 835, 843
(D.C.Cir. 1981) (quoting Continental Insurance Co. v. Sherman,
439 F.2d 1294 (5th Cir. 1971), citations and internal quotation
marks omitted).
47
- 33 -
the introduction of settlement evidence for that purpose.48
Thus, although the cross-claim may not have been admissible
under KRE 801A, we do not believe the trial court abused its
discretion by admitting it under KRE 408 as evidence tending to
show that following the indemnity agreement Sandoz and Armstrong
had a potential motive to downplay each other’s wrong doing.
Even if the trial court erred by admitting the crossclaim, moreover, we are convinced that the error was harmless.49
The cross-claim was merely one exhibit out of 172; it was
introduced not through a witness but simply through a housekeeping motion after a recess; it occupied only three minutes of
an opening argument that was nearly two hours long and
comparable portions of lengthy voir dire proceedings and closing
argument.
weight.
The jury is thus not apt to have given it undue
It contributed no new facts but only reiterated
allegations the Gundersons had already made.
It was cumulative
even with respect to the facts that Sandoz was footing the bill
for Armstrong’s defense and had agreed to indemnify him.
There
is no reasonable possibility that had the cross-claim been
48
Miller ex. rel. Monticello Banking Company v. Marymount
Medical Center, 125 S.W.3d 274 (Ky. 2004); cf. Brocklesby v.
United States, 767 F.2d 1288 (9th Cir. 1985) (indemnity agreement
admissible to show that agreeing parties were no longer adverse
and to attack the credibility of their witnesses).
49
KRE 103(a).
- 34 -
excluded the result would have been different.50
Sandoz,
therefore, is not entitled to relief on this ground.
50
Heilman v. Snyder, 520 S.W.2d 321 (Ky. 1975) (erroneous
admission of cumulative evidence was harmless).
- 35 -
PUNITIVE DAMAGES.
Sandoz next contends that it was entitled to a
directed verdict on the issue of punitive damages.
Under
Kentucky law, punitive damages may be awarded for gross
negligence, which our Supreme Court has defined for this purpose
alternatively as “wanton or reckless disregard for the lives,
safety or property of other [persons]” or conduct “so outrageous
that malice could be implied [sic] from the facts of the
situation.”51
Sandoz maintains that even if its marketing of
Parlodel® be deemed negligent it cannot be deemed grossly
negligent, as thus defined, because Parlodel’s® ability to cause
seizures had not (and still has not) been conclusively
established; because the Parlodel® package insert warned
expressly of a potential risk of hypertension and seizures; and
because the Gundersons offered no evidence that Sandoz
representatives over-promoted Parlodel® directly to Dr.
Armstrong, who testified that Sandoz representatives rarely
visited him and that he based his prescription to Mary not on
the company’s representations concerning the drug but on his
experience with it.
The Gundersons presented evidence, however, tending to
show that by 1985 Sandoz officials knew of a likely causal link
51
Phelps v. Louisville Water Company, 103 S.W.3d 46, 52 (Ky.
2003) (citing Horton v. Union Light, Heat & Power Co., 690
S.W.2d 382 (Ky. 1985) and Cooper v. Barth, 464 S.W.2d 233 (Ky.
1971); internal quotation marks omitted).
- 36 -
between Parlodel® and hypertension and seizures and by 1988 knew
that the FDA had determined that Parlodel® should not be
prescribed routinely as a prophylactic for PPL.
Nevertheless,
the company not only continued to market the drug aggressively
for routine use, such as its inclusion on the standing order at
Suburban Hospital, but sought to keep concerns about the drug
from coming to the attention of doctors.
It did so by engaging
in such practices as denying the existence of adverse reaction
reports to physicians who inquired about them, misrepresenting
such reports to the FDA, publishing a false advertisement,
failing to ensure that the “dear doctor” letters calling
attention to the revised 1987 package insert reached its
intended audience, attempting to manipulate the ERI report, and
instructing its sales force not to mention those concerns unless
physicians inquired and then to minimize them.
This deliberate
policy of obfuscation and misrepresentation has a nexus with
this case in as much as Dr. Armstrong testified that had he
known of the mounting concerns about Parlodel® or the FDA’s
position he would not have prescribed the drug to Mary
notwithstanding his favorable experience with it.
The company’s
alleged misconduct could reasonably be thought to betray such a
wanton or reckless disregard for the safety of women such as
Mary as to be outrageous and implicitly malicious.
- 37 -
The trial
court did not err, therefore, by submitting the issue of
punitive damages to the jury.
Alternatively, Sandoz contends that it was entitled to
a directed verdict with respect to punitive damages because that
claim was preempted by federal law.
It characterizes the claim
as based on the fact that it continued to market Parlodel® for
PPL even after 1989 when the FDA requested that that indication
be withdrawn.
Under federal law, the company notes, it was
entitled to seek reconsideration of the FDA’s request and to
continue marketing the drug pending that reconsideration.
Kentucky may not punish it, it insists, for conduct that federal
law expressly allows.
As discussed above, however, the punitive damages
claim was not based on the fact that Sandoz refused to withdraw
the PPL indication or that it contested the FDA’s determination
that prophylactic lactation suppression was not needed.
It was
based on the fact that Sandoz continued to market Parlodel®
without adequately advising physicians of the concerns the drug
had aroused and of the FDA’s position.
Indeed, as just noted,
the Gundersons presented evidence tending to show that Sandoz
engaged in a systematic campaign to keep that information from
physicians.
Federal law does not sanction such conduct, and
therefore the Gundersons’ punitive damages claim was not
preempted.
- 38 -
Finally with respect to punitive damages, Sandoz
contends that the trial court erred by failing to instruct the
jury that it was not to award punitive damages to punish Sandoz
for conduct that occurred outside Kentucky.
We agree, and so
must vacate the punitive damages award and remand.
In Sand Hill Energy, Inc. v. Smith,52 our Supreme Court
reconsidered a punitive damages award in light of the recent
United States Supreme Court opinion in State Farm Mutual
Insurance Co. v. Campbell.53
Our Supreme Court held that, under
Campbell, the jury could, with respect to a claim for punitive
damages, consider evidence of a defendant’s extraterritorial
conduct to determine whether and to what degree the defendant’s
conduct within Kentucky had been reprehensible, but it must be
instructed not to use out-of-state evidence to award punitive
damages for conduct that occurred outside Kentucky.
The
defendant had adequately requested such an instruction, the
Court noted, and thus the trial court’s failure to give one was
an error requiring vacation of the punitive damages award and
remand for a new determination of the amount of punitive
damages.
As did the plaintiff in Smith, in this case the
Gundersons relied heavily on evidence of conduct that did not
52
142 S.W.3d 153 (Ky. 2004).
53
538 U.S. 408, 123 S. Ct. 1513, 155 L.Ed.2d 585 (2003).
- 39 -
occur in Kentucky at all (for example Sandoz’s alleged
misrepresentations to a Texas physician and to the FDA) or that
occurred nationwide (such as the false advertisement that
appeared in a national medical journal or the alleged nationwide
sales tactics).
The estate also emphasized other serious
adverse reactions associated with Parlodel® almost all of which
occurred outside Kentucky.
Given this extra-territorial
evidence, much of which was introduced to prove that Sandoz had
conducted itself reprehensibly, we agree with Sandoz that, under
Campbell and Smith, it was entitled to an instruction limiting
punitive damages to its conduct within Kentucky.54
Although the trial court is not to be faulted much for
relying on what, until Campbell, had been a standard punitive
damages instruction in Kentucky, the trial court’s failure to
give the instruction required by Campbell was nevertheless an
error requiring that the punitive damages award be vacated and
the matter remanded for a new determination of the amount of
punitive damages by a properly instructed jury.
The court
should use an instruction substantially similar to the one our
Supreme Court suggested in Smith.55
54
The Gundersons do not dispute that Sandoz preserved this issue
by tendering an adequately accurate version of such an
instruction and by arguing during discussion of the instructions
for its use.
55
Sandoz contends that it was also entitled to an instruction
distinguishing the purposes of compensatory and punitive
- 40 -
LOSS OF CONSORTIUM EVIDENCE.
Both Armstrong and Sandoz contend that the trial court
made erroneous evidentiary rulings with respect to the claims by
Nicholas and Wesley Gunderson for damages to compensate them for
the loss of their mother’s consortium.
“Consortium” in this
context means the fundamental benefits, such as the society,
love, guidance, care, comfort, and protection, of the children’s
relationship with their mother.
Our Supreme Court first
recognized a minor child’s right to seek a remedy for the loss
of his or her parent’s consortium in Giuliani v. Guiler,56 which,
like this case, was a wrongful death action.
As noted above,
the jury awarded Nicholas and Wesley three million dollars each
on their loss of consortium claims.
The appellants maintain
that the trial court erred by excluding evidence of the boys’
father’s relationship with Janice Hays, his girlfriend of about
four years at the time of trial who often stayed overnight at
the Gunderson residence, fixed breakfast, made the boys’ school
lunches, helped care for them when the father was out of town,
damages. Although neither Campbell nor Smith requires such an
instruction as they do the instruction limiting punitive damages
to conduct within the jurisdiction, our Supreme Court’s sample
instruction includes a provision on the purpose of punitive
damages. We agree with Sandoz, therefore, that on remand it
will be entitled to a similar provision.
56
951 S.W.2d 318 (Ky. 1997).
- 41 -
and assisted with their schooling.
This was evidence, the
appellants insist, that the boys’ loss had been mitigated to
some extent, and was a factor the jury was entitled to consider.
As several courts, including our Supreme Court, have
noted, damages for the loss of consortium are not compensatory
in the way that damages for, say, lost wages are.57
Damages can
replace lost wages, but they cannot replace a relationship that
has been destroyed.
Assigning a monetary value to lost
consortium is thus notoriously difficult, but, as those same
courts have also noted, no more so than assigning a value to
pain and suffering or other intangible harms the law attempts to
remedy.
In an effort to provide some guidance to the trial
court and the finder of fact, other courts have observed that
the following factors are relevant in determining the amount of
damages to award the child who has suffered a compensable loss
of consortium: “the child’s age, the nature of the child’s
relationship with the parent, the child’s emotional and physical
characteristics, and whether other consortium-giving
57
Giuliani v. Guiler, supra; Pence v. Fox, 813 P.2d 429 (Mont.
1991); Williams v. Hook, 804 P.2d 1131 (Okla. 1990); Ueland v.
Reynolds Metals Company, 691 P.2d 190 (Wash. 1984). See Dan B.
Dobbs, The Law of Torts § 302 (2001) (discussing claims for
stand-alone emotional harm).
- 42 -
relationships are available for the child.”58
Seizing on the
last factor, the appellants contend that Janice Hays’s care of
and concern for Nicholas and Wesley were consortium-like
benefits and thus that their relationship with her was a fact
the jury should have been allowed to consider.
We are convinced, however, that “consortium-giving
relationship” does not refer to any and all relationships from
which a child might derive some measure of love, society, or
guidance, but that to be relevant to a child’s lost consortium
claim the other relationship must be sufficiently close and
intimate truly to compare to the relationship with a parent.
It
must have been of a significant duration and stability and to
have involved day-to-day emotional interdependence as well as
the child’s substantial physical, and financial dependence.59
Otherwise, the child’s claim is apt to be swamped by collateral
evidence of the surviving parent’s relationships.
Without denigrating the boys’ relationship with Janice
Hays, we do not think the trial court abused its discretion by
excluding that relationship from evidence.
The avowal testimony
indicated that Ms. Hays had known Mr. Gunderson for only about
58
Villareal v. State, Department of Transportation, 774 P.2d
213, 220-221 (Ariz. 1989); Reagan v. Vaughn, 804 S.W.2d 463
(Tex. 1990); Belcher v. Goins, 400 S.E.2d 830 (W.Va. 1990).
59
Cf. Fitzjerrell v. City of Gallup ex rel. Gallup Police, 79
P.3d 836 (N.M.App. 2003) (discussing elements of a consortiumgiving relationship).
- 43 -
four years, and that while she had to a considerable extent been
accepted in the Gunderson household, she did not live there
exclusively but still maintained her own residence.
She was, in
a word, Mr. Gunderson’s girlfriend whose relationship with the
boys was still derived from him and had not become so stable or
so mutually dependant and supportive as to be deemed consortiumgiving.
Not only was that relationship thus irrelevant, but
its admission into evidence would likely have necessitated the
admission of evidence of another of Mr. Gunderson’s
relationships of comparable duration.
The trial court could
rightly determine that the multiplication of such collateral
evidence was likely to confuse the jury and distract it from the
real issues in the case.60
The trial court did not abuse its
discretion, therefore, by excluding evidence of the boys’
relationship with Janice Hays.
Nor is this result affected by Justice Cooper’s aside
in Miller ex. rel. Monticello Banking Company v. Marymount
Medical Center,61 that whether the appellant in that case had
been living with his girlfriend was “a fact relevant to his
claim for loss [of spousal] consortium.”62
60
KRE 403.
61
125 S.W.3d 274 (Ky. 2004).
62
Id. at 285.
- 44 -
We do not understand
Justice Cooper’s remark to imply that all of a claimant’s
subsequent relationships will, without more, be relevant to a
lost consortium claim.
Finally, Armstrong and Sandoz also contend that the
trial court abused its discretion by admitting the expert
testimony of Dr. Barbara Bower.
Dr. Bower’s doctorate is in
education, and she is licensed as a psychological counselor.
She testified to extensive experience as a guidance counselor,
as a university teacher, and as a private children’s counselor.
Trial counsel hired her in 2000 to perform an assessment of
Nicholas and Wesley.
She met with the boys eight times during
2000 and 2001 and attempted through conversations, drawings, and
writing assignments to elicit their feelings about themselves
and the loss of their mother.
She did not attempt to diagnose
or treat the boys, only to observe them, and her testimony was
largely limited to reporting her observations and showing the
jury the boys’ drawings and writings.
She testified, not
surprisingly, that the absence of their mother loomed large in
the boys’ lives; that Nicholas, the elder, remembered a good and
loving relationship with his mother; and that both boys would be
at some increased risk for developmental issues, risk taking
behaviors, and depression.
She interpreted certain “happy”
drawings by Nicholas, not, as appellants contend, as expressions
of a sense of abandonment, but rather as expressions of
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Nicholas’s need, in the wake of his abandonment, to be reassured
that it was possible and acceptable for him to feel happy—the
implication clearly being that he often did feel happy.
Appellants maintain that Dr. Bower’s testimony was not
sufficiently objective and scientific to pass muster under
Daubert.
They note that in Staggs v. Commonwealth,63 our Supreme
Court rejected testimony by an art therapist who purported to
characterize a child’s drawings as abnormal and indicative of
sexual abuse.
And they complain that Dr. Bower’s testimony
appealed unduly to the jury’s emotions.
Daubert and KRE 702 are not limited to scientific
testimony, however, but also apply to “other specialized
knowledge” that is reliable, relevant, and likely to be helpful
to the trier of fact.64
The trial court did not abuse its
discretion by determining that by virtue of her training and
experience Dr. Bower had specialized knowledge about children
dealing with emotional problems and about ways to help such
children express emotions they may not be able otherwise to
articulate.
Although “art therapy” may be of dubious value as a
diagnostic tool, Dr. Bower did not purport to diagnose Nicholas
and Wesley.
63
She merely used their drawings, as she did their
877 S.W.2d 604 (Ky. 1993).
64
The Goodyear Tire and Rubber Company v. Thompson, 11 S.W.3d
575 (Ky. 2000).
- 46 -
writings, to give some idea of how the boys were conscious of
and hurt by their mother’s loss.
The trial court did not abuse
its discretion by determining that Dr. Bower’s methods and
results were reliable for this modest purpose.
Nor did the trial court abuse its discretion by
deeming Dr. Bower’s testimony relevant.
It shed light on the
boys’ relationships to their mother and on their emotional
characteristics, both of which are among the factors listed
above as relevant to valuation.
Finally, although Dr. Bower’s testimony dealt with the
boys’ emotions, and though she presented Nicholas and Wesley as
unique individuals coping with a difficult loss, her testimony
was not inflammatory.
It consisted primarily of what the boys
themselves said, drew, and wrote, and as noted it included
evidence that the boys were adjusting to their grief in normal
ways.
We are convinced that this testimony was not unduly
prejudicial and was sufficiently likely to be helpful to the
jury to be admissible.
The trial court, in sum, did not abuse
its discretion by admitting the testimony of Dr. Bower.
We reject, thus, Armstrong’s argument that the size of
the boys’ awards indicates that Dr. Bower’s testimony was
inflammatory.
The jury was instructed that the damages for lost
consortium were not to exceed $10,000,000.00.
The $3,000.000.00
awards were well within that limit, suggesting that the jury’s
- 47 -
decision was a deliberate one, not one overborne by passion.
The appellants’ assertion that the boys’ awards were excessive
as a matter of law was not sufficiently developed to permit
review.65
In sum, it was not the Gundersons’ burden to establish
conclusively that Parlodel® causes such serious side effects as
the seizure that led to Mary’s death.
They were required to
show only that Parlodel® is a likely cause of such effects.
Their experts’ conclusion that it is, based on standard and the
best available scientific studies and techniques, was
sufficiently reliable under Daubert and KRE 702 to be
admissible.
That evidence together with Dr. Nichols’s
differential diagnosis adequately support the jury’s finding
that Parlodel® caused Mary’s death.
There was substantial evidence, moreover, that by the
time of Mary’s prescription Sandoz knew of concerns about
Parlodel’s® serious side effects and yet not only failed to
convey those concerns to the doctors, such as Dr. Armstrong, who
were routinely prescribing the drug for postpartum lactation,
but actively and at times dishonestly endeavored to keep the
concerns from being seriously considered.
Such an egregious
failure to warn justifies the jury’s award against Sandoz of
both compensatory and punitive damages.
65
CR 76.12.
- 48 -
The judgment against Dr. Armstrong was also adequately
supported.
Dr. Lasker’s testimony that by 1993 a reasonably
cautious obstetrician would have known not to prescribe
Parlodel® in the face of even slight hypertension was
substantial evidence of Dr. Armstrong’s negligence, without
which, by Dr. Armstrong’s own testimony, he would not have
prescribed the drug to Mary.
These results were not rendered unfair by the
admission into evidence of Dr. Armstrong’s counter-claim or the
testimony of Dr. Bower, or by the exclusion of evidence
concerning Nicholas and Wesley’s relationship with their
father’s girlfriend.
The award of punitive damages against Sandoz, however,
was rendered unfair by the omission from the jury instructions
of a provision directing the jury not to punish Sandoz for its
conduct outside Kentucky.
Accordingly, we affirm the March 11, 2004, judgment of
the Jefferson Circuit Court in all respects except its provision
awarding punitive damages.
That portion of the judgment is
vacated, and the matter is remanded for a new trial on the
amount of Sandoz’s punitive damages liability.
TACKETT, JUDGE, CONCURS.
ROSENBLUM, SENIOR JUDGE, CONCURS IN PART, DISSENTS IN
PART, AND FILES SEPARATE OPINION.
- 49 -
ROSENBLUM, SENIOR JUDGE, CONCURRING IN PART AND
DISSENTING IN PART: I respectfully dissent in part with respect
to two issues.
First, the trial court, despite acknowledging
its relevance to the quantum of loss of consortium damages,
excluded all evidence that the minor plaintiffs, Nicholas and
Wesley, were living with and had been cared for over a number of
years by their father’s girlfriend, Janice Hays.
Through avowal
testimony, appellants demonstrated that Ms. Hays has developed a
loving relationship with Nicholas and Wesley.
up” the parenting duties with Mr. Gunderson.
Ms. Hays “splits
Whether other
consortium-giving relationships are available to a child is a
factor which juries should consider in determining the amount of
damages.
The exclusion of this evidence entitles the appellants
to a new trial.
Second, the trial court’s ruling allowing appellees to
introduce the cross-claim filed by Dr. Armstrong’s estate as
affirmative evidence against Sandoz was prejudicial error.
cross-claim is hearsay for which no exception exists.
The
Although
pleadings may be admissions of a party that filed them, they are
not admissions of parties against whom they are filed.
Here,
the Armstrong cross-claim against Sandoz was not introduced
against Armstrong – it was completely exculpatory as to
Armstrong — but against Sandoz.
admission.
That pleading was not Sandoz’s
The cross-claim was particularly egregious hearsay
- 50 -
in that, crafted after Dr. Armstrong’s death, it contradicted
his testimony that he had not been persuaded by Sandoz to
prescribe Parlodel®.
Because the cross-claim is hearsay as to
Sandoz, it was improperly and prejudicially admitted.
Sandoz is
entitled to a new trial based upon this prejudicial error.
In
all other respects, I concur with the majority opinion of this
Court.
BRIEFS FOR APPELLANT SANDOZ:
BRIEFS AND ORAL ARGUMENT FOR
APPELLEE:
Joe G. Hollingsworth
Katharine R. Latimer
Bruce J. Berger
Spriggs & Hollingsworth
Washington, DC
Larry Franklin
Michael R. Hance
Franklin & Hance, P.S.C.
Louisville, Kentucky
Virginia Hamilton Snell
Deborah H. Patterson
Wyatt, Tarrant & Combs
Louisville, Kentucky
BRIEFS FOR APPELLANTS HYMAN &
ARMSTRONG, P.S.C., AND KAREN
ARMSTRONG:
Edward H. Stopher
Rod D. Payne
Boehl Stopher & Graves, LLP
Louisville, Kentucky
ORAL ARGUMENT FOR APPELLANT
SANDOZ:
Bruce J. Berger
Washington, DC
- 51 -
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