SANDOZ PHARMACEUTICALS CORPORATION (N/K/A NORVATIS PHARMACEUTICALS CORPORATION) V. RONALD GUNDERSON (ADMINISTRATOR OF THE ESTATE OF MARY MARGARET GUNDERSON), ET AL.
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2006-SC-000175-DG
HYMAN & ARMSTRONG, P.S .C., ET AL.
V
ON REVIEW FROM COURT OF APPEALS
CASE NOS. 2004-CA-001536 & 2004-CA-001537
JEFFERSON CIRCUIT COURT NO . 94-CI-004680
RONALD GUNDERSON
(ADMINISTRATOR OF THE ESTATE OF MARY
MARGARET GUNDERSON), ET AL .
AND
APPELLEES
2006-SC-000179-DG
SANDOZ PHARMACEUTICALS CORPORATION
(N/K/A NOVARTIS PHARMACEUTICALS
CORPORATION)
V
APPELLANTS
APPELLANT
ON REVIEW FROM COURT OF APPEALS
CASE NOS . 2004-CA-001536 & 2004-CA-001537
JEFFERSON CIRCUIT COURT NO . 94-CI-004680
RONALD GUNDERSON
(ADMINISTRATOR OF THE ESTATE OF MARY
MARGARET GUNDERSON), ET AL .
OPINION OF THE COURT BY JUSTICE SCHRODER
AFFIRMING
APPELLEES
While we find it was error in the trial of this products liability/medical malpractice
case to allow evidence of the cross-claim to be admitted, we adjudge it to be harmless
error. We find no error in the Appellant's other allegations . Hence, we affirm the
decision of the Court of Appeals.
FACTS
On September 28, 1993, Mary Gunderson, age thirty-two, gave birth by cesarean
section to her second child, Wesley Gunderson . Because Mary did not want to
breastfeed, Mary's obstetrician, Dr. Lyman Armstrong, prescribed the drug Parlodel
(bromocriptine mesylate) to stop lactation . Mary began taking Parlodel on September
from the hospital on October 1
29, and was discharged
to recover at home . Mary's
recovery was uneventful until October 4, when Mary complained of a severe headache
and pain between her shoulder blades radiating down her back. Mary went to bed that
night at around 11 :30 p .m . The next morning Mary's mother discovered Mary dead in
her bed . Authorities were called and Detective David Burks of the Jeffersontown Police
Department began a death scene investigation . Mary was found in bed lying on her
back with her arms bent backwards by her head in a gravity-defying position . Mary was
also found to have voided from her bladder.
The police report filed on November 23, 1993, listed the cause of death as
unknown . In conducting the autopsy, the Kentucky Medical Examiner's Office found no
anatomic cause of death . After further investigation of the death and research into the
drug Parlodel, the Medical Examiner's report, completed on December 29, 1993,
concluded the following:
Autopsy and toxicologic examinations disclose no
cause of death in this case . Review of
circumstances, literature and case reports concerning
bromocriptine, used in this case for suppression of
2
lactation, reveals an association with hypertension,
vascular complications, headache[J convulsive
seizure, and death . Death is attributed to seizure,
which is expected to provide no findings at autopsy.
On September 8, 199, Mary's Estate, her husband, Ronald Gunderson, and her
'
ƒN0minor children (hereinafter "the GUndBr8Ons")filed suit against Sandoz
Pharmaceutical Corporation /"S@OdUz"\.fhe maker OfP8rlOde[Bnd HVDl8n &
Armstrong, P .S.C. (hereinafter "Dr. Armstrong"),' alleging products liability and medical
malpractice in causing Mary's death . The case was tried from February 2, 2004, to
February 28, 2[]04 ' and resulted in a judgment for the Plaintiffs totaling $19,098,263.
Apportioning 90% liability to SandC]z and 100% to Dr. Armstrong, the jury awarded
$7.848 .263 in compensatory damages Qn0011000 for loss of parental consortium and
$1 ' 848 .263 for loss of services and earning power) . $11 ' 250 ' 000 in punitive damages
was assessed against Sandoz.
On appeal to the Court of Appeals, the court vacated the portion of the judgment
awarding punitive damages because the trial court failed to instruct the jury that punitive
damages could not be based on conduct that occurred outside of Kentucky. The court
thus remanded the @cbOn fOr@MeVVtrial "onthBamount ofS@ndOz's punitive damage's
liability ." The judgment was affirmed in all other respects . Sandoz and Dr. Armstrong
filed separate motions for discretionary review, which were granted and consolidated for
review before this Court.
LACK OF A DAUBERT HE RING
Prior tOtrial, the Defend 8nts/Appel la nts moved for a hearing pursuant to Daubert
Merrrell Dow Pharmaceuticals, Inc., 509 U.S .579,113 S .Ct 2786, 125 [Ed.2d 469
1 Hyman and Armstrong, P.S.C. was the name of Dr. Armmedical
Dr. Armstrong died in
February 1Q97 prior totrial inthis case, andh!aestate was substituted oaedefendant /nthecase .
3
(1993), to determine the admissibility of the Gundersons' causation experts who were
slated to testify that Parlodel causes seizures in women taking the drug for postpartum
lactation suppression . Sandoz and Dr. Armstrong argue that the trial court did not
satisfy its gatekeeping obligations when it failed to hold a formal Daubert hearing and
enter specific findings regarding the testimony of the Gundersons' causation experts . In
Commonwealth v. Christie, 98 &TAM 485, 488-89 (Ky. 2002), this Court stated the
following relative to the proper application of Daubert in Kentucky:
When faced with a proffer of expert testimony under KRE
702, the trial judge's task is to determine whether the expert
is proposing to testify to (1) scientific, technical, or other
specialized knowledge that (2) will assist the Crier of fact to
understand or determine a fact in issue. This calls upon the
trial court to assess whether the proffered testimony is both
relevant and reliable. This assessment does not require a
trial court to hold a hearing on the admissibility of the
expert's testimony. But a trial court should only rule on the
admissibility of expert testimony without first holding a
hearing when the record [before it] is complete enough to
measure the proffered testimony against the proper
standards of reliability and relevance .
Usually, the record upon which a trial court can make an
admissibility decision without a hearing will consist of the
proposed expels reports, affidavits, deposition testimony,
existing precedent, and the like . Such a record is necessary
in order to give a trial court an adequate basis for making its
decision on the relevancy and reliability of the proposed
expert's testimony and to allow for appellate review of the
trial court's decision . Failure to make a determination on the
admissibility of expert testimony without an adequate record
is an abuse of discretion by the trial court.
(internal quotations and citations omitted) .
In the instant case, the trial court had before it a mountain of discovery material,
including lengthy depositions of the causation experts, affidavits of the experts, reports
of the experts, a voluminous amount of scientific studies, reports and publications relied
on by experts, and extensive briefing by the parties. At one point, the judge remarked
4
on the record that the pre-trial record occupied an entire room in his chambers and that
he had spent weeks reading the material. Further, on January 19, 2004, the court
devoted an entire day to addressing the parties' motions in limine, many of which
related to the admissibility of specific pieces of scientific evidence that were relied on by
the Gundersons' causation experts and were challenged as being unreliable and
irrelevant . The challenged evidence included case reports, adverse drug experience
reports, and animal studies. Although this may not have technically been a Daubert
hearing, the court heard lengthy arguments on the reliability and relevancy of the
scientific evidence underlying the Gundersons' causation experts' opinions . We
its
adjudge that the trial court did not abuse
discretion in its method of evaluating the
reliability and relevancy of the testimony of the Gundersons' causation experts . The
court had more than an adequate record before it to make its Daubert ruling, and it was
apparent at the January 19, 2004, hearing that the trial judge was well versed on the
copious record .
LACK OF EXPRESS FINDINGS
F FACT ON THE DAUBERT RULING
While the trial court may not have entered express findings of fact, the court
articulated some basis for its Daubers ruling when it stated the following at the January
19,2004,hearing :
I have to make a requisite minimal determination whether or
not I believe that the testimony is reliable, whether it is
sufficiently trustworthy, and whether it's the general type of
data upon which, in this case physicians or scientists,
typically rely upon in forming their opinions . And it appears
to me that both sides have that. You've got eminently well
qualified experts and the subject of the majority of the attack
with these experts is going to be on cross-examination in
terms of the appropriate weight that the jury ought to afford
their testimony and whether it is affected by this data on
which they rely.
The trial court affirmatively stated on the record that it had reviewed the material
submitted by the parties relative to the testimony of the Gundersons' causation experts
and concluded that the testimony was reliable. This is the minimum required for a
Daubert ruling . City of Owensboro v. Adams , 136 S.W.3d 446, 451 (Ky. 2004). "In
doing so, however, the court need not recite any of the Daubert factors, so long as the
record is clear that the court effectively conducted a Daubert inquiry." Id . While this
Court would prefer trial courts to include findings of fact in their Daubert rulings, "failure
to include those findings and conclusions is not automatically indicative of arbitrariness,
unreasonableness, unfairness, or application of the wrong legal standard[,]" and "is not
grounds for reversal ." Miller v. Eldridge , 146 S .W .3d 909, 921-22 (Ky. 2004). "[T]he
proper appellate approach when the trial court fails to make express findings of fact is to
engage in a clear error review by looking at the record to see if the trial court's ruling is
supported by substantial evidence." Id . at 922. From our review of the record, the trial
court conducted an effective Daubert inquiry .
RELIABILITY AND RELEVANCE OF CAUSATION EVIDENCE
An appellate court's standard of review relative to a ruling on the reliability of
scientific evidence under Daubert is whether the ruling is supported by substantial
evidence . Id . at 917 . The ruling as to the relevance of the scientific evidence is
reviewed under an abuse of discretion standard . Id. Appellants maintain that the
scientific evidence relied on by the Gundersons' causation experts, specifically case
reports, animal studies, and chemical analogies, was unreliable and/or not relevant
because it did not prove that Parlodel causes seizures in women taking the drug for
postpartum lactation suppression ("PPLS") . Appellants argue that such evidence is
merely anecdotal and that the Only reliable method of proving that Parlodel causes
seizures in such women is an epidemiological study.
It was established at trial that there were two epidemiological studies looking at
postpartum women taking ParlCJdBl for PPLS ' the HC/A study commissioned by Sandoz,
and the ERI study, also commissioned by S@Odoz and conducted by Dr. Rothman from
EpidBmiOlOgVResources, Inc. ("ER/") . The evidence established that the HCIA study
had been rejected by the scientific community because some patients were not
trackable, and there were apparent misclassifications within the study . Even an
epidemiologist from S8Mdoz conceded that the HCIA study was too flawed to be
considered .
Shortly after P@rlOdBl was approved by the FDA for PPLS in 1981, the FDA
began receiving a significant amount of adverse drug reports of women experiencing
headaches, hypertension, heart attacks, seizures, and strokes after taking the drug for
[»PLS. Th8ER!study wBScommissioned by SaOdoz in 1986 to allay concerns of the
FDA that Parlodel was responsible for causing strokes and seizures in women taking
the drug for PP[S . The final report from the ERI study released in 1988 concluded that
women taking Pa7lOdel for PPLS had only @1 .61% greater risk of having a seizure than
women not getting the drug, which is considered statistically insignificant . At trial, three
of AppellBes'experts, [][.George NichOl8 .[]r .Kenneth KUlig and Dr. []BnniQPBtrO '
seriously Oribc{zed the final report from the ERI study because it was apparent to them
that the risk rate of seizure fO[that population had been lowered from 2.86% (which is
considered stabstically significant) due to changing the data analyzed to exclude women
with
B
history of seizures and women who had also taken @ related drug, ergonovine,
regardless Ofwhether that drug was known to b8 in the woman's system at the time of
the adverse event . In fact, the Gundersons offered into evidence a letter to ERI from
Sandoz requesting that it "recut the data on late-onset seizures" in the final report on the
ERI study. The final report on the ERI study was subsequently rejected for publication
by three peer review journals because it was misleading and discounted the positive
association between Parlodel and seizures . Dr. Kulig and Dr. Petro testified that the
ERI study actually supported their opinion that Parlodel can cause seizures late in the
postpartum period (more than seventy-two hours after delivery) .
The Gundersons' causation experts also relied on the myriad of case reports of
women experiencing postpartum seizures after taking Parlodel for PPLS . The case
reports filed with the FDA, known as adverse drug reports ("ADRs"), are filed by many
sources, including hospitals, physicians, and the patients who took the drugs. The
ADRs are relied on by the FDA after the drug is approved and released into the
marketplace to monitor whether there are side effects or adverse reactions to the drug
that did not show up in the initial clinical trials of the drug . Under federal regulations,
drug companies that receive information about an adverse drug reaction that involves
one of their drugs are required to report the reaction to the FDA. The package insert for
Parlodel listed eighty-nine cases of hypertension, seventy-two seizures, and thirty
strokes when the drug was used for PPLS . Several case reports were contained in
peer-reviewed medical literature as support for statements that Parlodel has been
known to cause vasoconstriction and possibly seizure, stroke and heart attacks . At
least two of the case reports indicated that the adverse symptoms disappeared when
Parlodel was withdrawn and then reappeared when Parlodel was reintroduced . Dr.
Petro testified that these cases of "de-challenge/re-challenge" were considered
substantially better evidence of a causal relationship than an adverse reaction alone .
The GUndeFsOns offered into evidence an internal Sandoz document from 1982
in which Sandoz acknowledged that it had received ten to twelve reports of seizures in
patients given Parlodel during the postpartum period and stated, "From our side, we felt
that these cases were probably related to episodes of hypertension, which we know can
occur under PaFodel in such patients."IDanother internal S@Ddoz memorandum from
1982, Dr. AbIlianm WestliU ' Director of the Medical Services Department at Sando
FespondBd as follows to reports of adverse reactions to Parlodel :
In view UfmVrecent conversation with Dr. WeiDBF@ ƒ FDA, I
think we should give this report serious consideration . I am
beginning to think that there is some association between
seizures, hypertension, and Parlodel therapy in the
postpartum period, even though it is rare and is, at present,
unexplainable .
D[PBƒn]testified that case reports are some evidence of an association between a
drug and a particular reaction, but not definitive evidence .
Although Parlodel is known to lower blood pressure by dilating blood vessels, the
GUDdB[s[)Ds'causation experts also relied on animal studies wherein Parlodel was
shown to cause the paradoxical effect of vasoconstriction . One study in particular, a
hind leg study on dogs, indicated that low initial vascular resistance, which women
typically experience after giving birth, permits vasoconstriction, which could account for
why women in a postpartum state are more susceptible to seizures from Parlodel . Dr.
P8fPo also cited a toxicology study on rats in which the rats experienced seizures when
given high doses of Parlodel . Appellants contend that the animal studies offer no proof
that p»arlOd8l causes seizures iMhumans, thus, Bne scientifically unreliable under
. Dr. NichOls,[]rPet[o and Dr. Kulig all testified that they looked at animal
studies OOParl{Jdel and found them insightful on the issue Ofcausation . Dr. KUlig
testified that animal reactions to drugs are relevant because they reflect a reaction that
a human may have to the drug.
Appellants also assert that evidence of the properties of the general class of
drugs within which Parlodel is contained, ergot alkaloids, was not scientifically relevant
or reliable . Dr. Kulig, a physician specializing in emergency medicine and medical
toxicology, testified that it is a well known and proven fact that ergot alkaloid drugs can
cause vasoconstriction, hypertension, and convulsive seizures, which supported his
opinion that the Parlodel caused the hypertensive episode which resulted in Mary
Gunderson's fatal seizure. Appellants maintain that the general propensities of the
broad class of ergot alkaloid drugs cannot be analogized to Parlodel because of the
diversity amongst the different ergot drugs .
The trial court ruled at the January 19, 2004 hearing that although the individual
pieces of evidence at issue (case reports, ADRRs, animal studies and chemical
analogies, articles in medical textbooks and scientific publications) may not by
themselves definitively prove that Parlodel causes postpartum seizures in women, when
considered together as an aggregate body of evidence with scientific underpinnings, it is
reliable enough evidence to put before the jury in this case . We agree .
The four factors that a court may look at in determining the reliability of an
expert's testimony include, but are not limited to:
(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
theory or technique enjoys general acceptance within the
relevant scientific, technical, or other specialized community .
Goodyear Tire and Rubber Co. v. Thompson, 11S .W .3d 575 .578-79 /KV .2000\(citing
'
509 [] .S . Bt 592-94 .113 S.Ct .8f2796~97.125 L .Ed.2d @t482-83\ . A trial
court's reliability analysis under Daubert is not Wed to the above factors and should
be tailored to the particular facts and science in the case.
146 S .W .3d aƒ 918-19 .
The Daubert factors are simply a way of distinguishing "between science and pseudoscience." Ld . at 919.
In applying Daubert to the type of evidence relied on by the causation experts in
the instant case . @ number Ofcourts in P8rlOdel cases from other jurisdictions have
rejected the evidence other than epidemiological studies /case reports, ADRs, animal
studies, temporal association between ingestion of Parlodel and adverse event,
hVperteDsiVe properties of ergot alkaloids, FDA withdrawal of approval of Parlodel's
indication fOrPP[S\as scientifically unreliable .
' 295
F .3d 1194/11 ƒh Cir.2002\(postpartum stroke c8se);
Corp., 252 F.3d 986 /8th Cir.2001\(postpartum stroke case) ;
Corp .,
275 F .SUpp.2d 672 (M .[].N.C .2003)(postpartum stroke case);
Corp ., 2u14F.SUpp.2d ^134/" .[].P8 .2003\(postpartum stroke case); Caraker
. 188 Fc . SUpp . 2d 1026 (S .D. /ll. 2001) (postpartum stroke
case);
.95 F .SUpp.2d 1230 /WD .Okla . 2000\ `
Whyed and remanded on other
.289 f~3d 1193 (1Oƒh Cir.2002) (causation
expert's testimony rejected inpostpartum stroke case) ;
Corp., 77F.SUpp .2d 1153 (D. Mont. 1999) (causation expert's testimony rejected in
postpartum seizure case) . However, we view those cases, as the court did in Globetti v.
. 111 F. SUpp. 2d 1174, 1180 /N .[]. /\l0 . 2000\
(expert testimony that Parlodel caused plaintiff's acute postpartum heart attack found to
be sufficiently reliable), as incorrectly requiring scientific certainty, which was not
intended by Daubert.
The court believes that in those cases the Daubert standard
was applied incorrectly, creating too high a standard of
admissibility . Both of these cases seem to equate Daubert's
reliability with scientific certainty, which is far from what the
Supreme Court intended in Daubert . Science, like many
other human endeavors, draws conclusions from
circumstantial evidence when other, better forms of evidence
is not available . . . . [O]ne cannot practically conduct an
epidemiological study of the association of Parlodel with
postpartum AMI. Moreover, one cannot ethically experiment
on human beings, exposing them to the near certainty of
some number of deaths, simply to satisfy some evidentiary
standard .
Id . at 1180. The Globetti court adjudged that much of the same type of evidence relied
on by the causation experts in the instant case was scientifically reliable under Daubert.
Although defendant is correct that there is no
epidemiological study showing an increased risk of AMI
[acute myocardial infarction] associated with bromocriptine,
there is more than adequate evidence of a scientific nature
from which a reliable conclusion can be drawn about the
association . While an epidemiological study may be the best
evidence, Daubert requires only that reliable evidence be
presented, and that evidence here consists of animal
studies, the medical literature reviews, the ADRs reported to
the FDA, the "general acceptance" of the association
reflected in several medical texts, the Larrazet experiment,
and Dr. Waller's observations in the Ayers case . These all
are recognized and accepted scientific methodologies, used
for assessing the possible side-effects and hazards
associated with particular drugs and the causes of disease .
The fact that Mrs. Globetti's AMI was caused by her
ingestion of Parlodel can be reliably inferred from the facts
known about the vasoconstrictive effect of bromocriptine.
Id . at 1179; see also Kuhn v. Sandoz Pharm. Corp . , 14 P.3d 1170 (Kan . 2000) (expert
testimony that Parlodel caused woman's postpartum seizure, cerebral edema and death
ruled admissible) .
Likewise, the court in Brasher v. Sandoz Pharmaceuticals
Corporation , 160 F. Supp. 2d 1291,1296 (N .D. Ala . 2001) (even without epidemiological
12
study establishing causation and with other possible explanations for strokes, experts'
opinions that Parlodel caused postpartum strokes found to be sufficiently reliable), ruled
that this type of evidence was reliable and rejected a requirement of scientific certainty
relative to causation evidence :
Daubert does not require proof to a scientific certainty, or even
proof convincing to the trial judge. The trial judge is not
required to find that the proffered opinion is scientifically
correct, but only that it is trustworthy because it is tied to good
scientific grounds. What Daubert does require is that the
expert's opinion be based on sound methodologies of the type
used by experts in the field in which the opinion is offered .
There can be little question that scientists routinely use animal
studies, case reports, and pharmacological comparisons of
similar classes of drugs to infer conclusions, which are
expressed in peer-reviewed journals and textbooks .
Unquestionably, epidemiological studies provide the best proof
of the general association of a particular substance with
particular effects, but it is not the only scientific basis on which
those effects can be predicted . In science, as in life, where
there is smoke, fire can be inferred, subject to debate and
further testing .
We believe the scientific evidence on which the Gundersons' causation experts
based their testimony was sufficiently reliable in the present case and that there was
substantial evidence supporting the court's ruling of reliability in this case. While Dr.
Petro admitted that epidemiological evidence 4 the god standard for determining
causation, the Gundersons' causation experts, including [Dr. Petro, testified that they
also relied on other scientific evidence to assess causation . Each of the disputed
pieces of evidence considered by the Gundersons' experts (case reports, animal
studies, and general chemical properties of ergot drugs) had scientific underpinnings,
was derived from recognized scientific methodologies, and was shown to have general
acceptance within the scientific community as a factor tending to show that Parlodel
causes postpartum seizures .
13
As for the relevancy of the causation evidence at issue, relevance is determined
by evaluating "whether [that] reasoning or methodology properly can be applied to the
facts in issue ." Daubert, 509 U .S . at 592-93, 113 S . Ct. at 2796. "The consideration of
relevance has been described as one of `fit ."' Thompson , 11 S.W .3d at 578 (quoting
Daubert, 509 U .S. at 591, 113 S. Ct. at 2796, 125 L . Ed . 2d at 481-82) . We deem the
case reports, animal studies, and general chemical properties of ergot drugs to be
relevant scientific . evidence that would assist the jury in making the determination of
general causation in this case - whether Parlodel was capable of causing a postpartum
seizure . Both Dr. Kulig and Dr. Petro testified that they considered this type of evidence
(among other evidence as shall be discussed below) because it tended to show how the
ingestion of Parlodel would have affected a postpartum woman and that it was capable
of causing a fatal seizure.
Accordingly, the trial court did not abuse its discretion in its
relevancy ruling.
SUFFICIENCY OF CAUSATION EVIDENCE
Dr. Armstrong argues that Appellants were entitled to a directed verdict because
Appellees did not present sufficient reliable evidence that Parlodel caused Mary
Gunderson's alleged seizure.
In ruling on a directed verdict motion, the trial court
should draw all inferences in favor of the nonmoving party, and a verdict should not be
directed unless the evidence is insufficient to sustain the verdict.
Kroqer Co. v.
Willgruber, 920 S .W.2d 6 1, 64 (Ky. 1996) (citing Spivey v. Sheeler, 514 S .W.2d 667,
673 (Ky. 1974)). Questions as to the weight and credibility to be given to the evidence
are reserved for the jury. Commonwealth v. Benham, 816 S .W.2d 186, 187 (Ky. 1991) .
Medical causation must be proved to a reasonable medical probability. BrownForman Corp . y. Upchurch , 127 S .W .3d 615, 621 (Ky. 2004); Turner v. Commonwealth ,
14
5 S .W .3d 119, 122 (Q. 1999) . As to general causation, Dr. Kulig and Dr. Petro testifed
that Parlodel causes late postpartum seizures, based on their review of case reports,
ADRs, animal studies, the ERI study, toxicology knowledge about ergot drugs, clinical
trial results and observations . Dr. Kulig testified that he also considered other factors medical textbooks and publications, SandoZs reports and causation analyses on
Padodel, FDA evaluations of Parlodel, his knowledge of pharmacokinetics, and his
observations of and experience with patients taking Parlodel . We agree with the trial
court's assessment that although the individual pieces of evidence may not conclusively
prove general causation, together they tend to show that Parlodel can cause
postpartum seizures in women taking the drug for PPLS.
As the court stated in
Brasher, 160 F. Supp. 2d at 1296, "Although it is true that none of these bits of evidence
establish conclusively that Parlodel can cause vasoconstriction and vasospasm, taken
together they present a compelling picture, one which can support a reasonable
scientific inference : Additionally, as noted earlier, Dr. Kulig and Dr. Petro both testified
that the ERI study actually supported their opinion because, contrary to Rothman's
analysis of the data, they viewed the data as showing that women taking Parlodel for
PPLS had a 2.86% greater risk of having a seizure than postpartum women not taking
Parlodel .
Even the internal Sandoz memos from 1982 acknowledged a connection
between Parlodel and postpartum hypertension and seizures .
The next question is whether the Gundersons presented sufficient evidence of
specific causation - that Mary Gunderson's death was actually caused by a seizure due
to her ingestion of Parlodel . All of the Gundersons' causation experts employed a
methodology called differential diagnosis in determining Mrs. Gunderson's cause of
death to be a Parlodel-induced seizure. Differential diagnosis is a well-recognized and
widely-used technique in the medical community to identify and isolate causes of
disease and death .
Globetti , 111 F. Supp. 2d at 1177 . "The differential diagnosis calls
for the physician to list the known possible causes of a disease or condition, usually
from most likely to least likely. Then, utilizing diagnostic tests, the physician attempts to
eliminate causes from the list until he is left with the most likely cause." Id . Differential
diagnosis has been accepted by many courts as a reliable method of ascertaining
medical causation . Kennedy v. Collagen Corp. , 161 F.3d 1226 (9th Cir. 1998) ; Glaser
n
v. Thompson Med . Co ., inc . , 32 F .3d 969 (6th Cir. 1994); Perkins v . Origin Medsystems,
Inc. , 299 F. Supp. 2d 45 (D. Conn . 2004) . Even in Dr. Armstrong's appellate brief, he
acknowledges that "differential diagnosis is an accepted methodology in choosing
among known causes of a disease in an individual."
Dr. George Nichols, a physician, board-certified in forensic pathology with twenty
years' experience as Chief of the Kentucky Medical Examiner's Office, looked at the
following in reaching his conclusion that Mrs . Gunderson died as a result of a seizure
caused by taking Parlodel : thorough examination of the body during the autopsy,
including microscopic studies of the lung, heart, and brain tissues; the police report and
photos of how the body was found; Mrs. Gunderson's medical history ; medical records
from her pregnancy ; the toxicology report ; dozens of depositions taken in the case; and
reports by the family about Gunderson's behavior and condition the night of her death .
Dr. Nichols also relied on much of the same evidence that Drs . Petro and Kulig did
regarding general causation - the ERI study, 73 case reports of women taking Parlodel
for PPLS having seizures, animal studies, and the vast amount of scientific literature on
Parlodel . Dr. Nichols estimated that he had conducted more than 10,000 autopsies in
his career as a pathologist and stated that he had spent more time investigating the
death of Mary Gunderson than any other case in his career.
Upon examination of Mrs. Gunderson's body, Dr. Nichols and Dr. McCloud,
another pathologist from the Medical Examiner's Office who conducted the first
examination of the body, could not find any anatomic cause of death . Dr . Nichols
testified that from the autopsy, he was able to eliminate all possible causes of death
(e.g ., pulmonary embolism, stroke, heart attack) except some form of sudden death
syndrome . The toxicology report revealed a normal therapeutic amount of
acetaminophen in the body, which was consistent with the prescription for the pain
medication Percocet (a combination of acetaminophen and oxycodone) that Mrs.
Gunderson was given upon her release from the hospital . Dr. Nichols rejected an
overdose of Percocet as a possible cause of death because she was not acting
intoxicated prior to going to bed, the therapeutic levels of acetaminophen in her system,
and the number of pills left in her prescription suggested she was taking the medication
according to the prescription .
In reviewing the photos of Mrs. Gunderson's body and the way her arms were
flexed up around her head and her hands were clenched, Dr. Nichols testified that it
was apparent that her muscles had contracted for a long enough amount of time to
develop rigor mortis . Dr. Nichols posited that only three things could account for such a
position at death - electrocution, military combat, or a seizure. After eliminating
electrocution and military combat as possible causes of death, Dr. Nichols concluded
that Mrs. Gunderson died from a seizure . According to Dr. Nichols, the fact that Mrs.
Gunderson had voided from her bladder was also consistent with a seizure .
Mrs . Gunderson's medical history indicated that she was generally healthy,
although she smoked and was somewhat overweight . She had no history of seizures .
Dr. Nichols rejected Sandoz's assertions that she had an enlarged heart at the time of
death, explaining that Mrs . Gunderson's heart was at the upper limit of normal, which is
normal for a postpartum woman and not significant. Dr. Jay Patrick Lavery testified that
in his opinion, Mrs. Gunderson had gestational hypertension during her delivery in 1993
and immediately after the birth. However, Dr. Lavery opined that the gestational
hypertension was not the cause of Mrs . Gunderson's death because her blood pressure
was steadily improving after the delivery. The medical records from Mrs. Gunderson's
pregnancy four years earlier indicated that she took Parlodel for PPLS and suffered no
ill effects. However, Dr. Nichols testified that it is not uncommon for a patient to not
have an adverse reaction to a drug the first time they take it, and then suffer an adverse
or paradoxical reaction upon the second or subsequent administration of the drug . Dr.
Nichols also testified that the evidence that Mrs . Gunderson had a severe headache
prior to her death was indicative of an adverse reaction to Parlodel . Both Dr. Nichols
and Dr. Petro noted that in many of the case reports for women taking Parlodel for
PPLS who suffered a stroke or seizure, the women reported a severe "crescendo"
headache prior to the adverse event . Dr. Nichols and Dr. Petro further stated that the
pain that Mrs. Gunderson was experiencing between her shoulder blades on the day
she died was consistent with an adverse brain event.
The Gundersons also presented the testimony of Dr. Michael Balco, a forensic
neuropathologist, who viewed the slides of Mary Gunderson's autopsy . Dr. Balco
testified that the slides of Mary Gunderson's brain showed evidence of damage to her
brain consistent with a seizure .
18
Dr. Petro and Dr. Kulig relied on much of the same facts and information as Dr.
Nichols in forming their opinions that Mrs . Gunderson died from a seizure caused by
taking Parlodel . Dr. Petro agreed that the symmetric, flexed, gravity-defying position of
Mrs . Gunderson's arms was proof that she died of a seizure . Dr. Petro also noted that
seizures are more common at night.
The Gundersons' causation experts all agreed that the fact the Mrs. Gunderson's
death occurred seven days after the birth was a significant factor in attributing the
seizure to Parlodel because the data from the ERI study and the case reports revealed
that the postpartum seizures suffered after the ingestion of Parlodel for PPLS were
more likely to occur late in the postpartum period - more than 72 hours after delivery.
Dr. Kulig and Dr. Petro acknowledged the studies showing that the postpartum period
itself is associated with seizures, strokes and heart attacks . However, they opined that
the seizure suffered by Mrs. Gunderson was Parlodel-induced because postpartum
seizures attributable to the postpartum status alone rarely occur late in the postpartum
period and are much more likely to occur soon after delivery.
In reviewing the record, we believe there was sufficient reliable and relevant
evidence that Mrs . Gunderson died as a result of a Parlodel-induced seizure to submit
the issue before the jury in this case . Hence, the trial court properly denied Appellants'
motions for directed verdict.
LIMITATION OF CROSS-EXAMINATION OF EXPERTS
Appellants argue they were denied due process when the trial court unfairly
limited their cross-examination of Appellees' causation experts . Appellants sought to
cross-examine the experts with certain scientific studies showing no association
between Parlodel and adverse health effects . The trial court adjudged that the
19
witnesses could not be cross-examined as to those studies unless the Appellants
established their reliability or the witness agreed the studies were reliable. Appellants
thereafter failed to put the desired cross-examination on the studies in the record by
avowal . Hence, the issue is not subject to our review . Noel v. Commonwealth, 76
S.W.3d 923 (Ky. 2002); KRE 103(a)(2) .
FAILURE TOGIVE LEARNED INTERMEDIARY INSTRUCTION
On the products liability claim, Sandoz tendered the following instruction with its
proposed jury instructions :
Sandoz has no duty to provide warnings directly to Mrs.
Gunderson, but only to Dr. Armstrong. Therefore, in order
for plaintiffs to prevail, you must be satisfied from the
evidence that Sandoz provided an inadequate warning to Dr.
Armstrong regarding the risk of seizure purportedly
associated with Parlodel . Otherwise, you will find for
Sandoz .
The trial court declined to give the above instruction to the jury. The court
instructed the jury as follows relative to Sandoz's duty to Mrs. Gunderson as a
consumer of Parlodel :
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. . . .
Approximately three months after the trial in the case at bar, this Court rendered
its decision in Larkin v. Pfizer, Inc., 153 S .W.3d 758, 762 (Ky. 2004), wherein we
adopted the learned intermediary doctrine from the Restatement (Third) of Torts: Prods.
20
Liab. § 6(d)(1) (1998). This doctrine, which is an exception to the general rule that a
manufacturer's duty to warn of any risks or dangers inherent in the product runs to the
ultimate consumer, relieves the prescription drug manufacturer from liability to the
ultimate consumer if it provides an adequate warning about the drug to the prescribing
physician . Id . at 764. As to what constitutes an adequate warning, the Larkin Court
stated
An adequate warning has been defined as one 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.
Id. at 764-65 (citations and internal quotations omitted) .
Sandoz argues that the information in the package insert for Parlodel and in the
Physician's Desk Reference, as well as "Dear Doctor" letters it sent directly to doctors,
constituted an adequate warning to Dr. Armstrong of the dangers of Parlodel, thus
entitling it to the tendered jury instruction on the learned intermediary doctrine . In
affirming the trial court's refusal to give the learned intermediary rule instruction, the
Court of Appeals ruled that a specific instruction on the doctrine's application in the case
was not required under Ford Motor Company v. Fulkerson , 812 S .W .2d 119, 123 (Ky.
1991) (rejecting a fact-specific instruction in products liability case in favor of general
instruction stating liability in terms of Restatement (Second) of Torts § 402A). In our
view, whether an instruction on the learned intermediary doctrine was required in the
present case was not a question of whether a general or fact-specific instruction was
warranted, as in Fulkerson . Rather, it was an issue of adequately and accurately
instructing the jury on the law of the case. See Shewmaker v. Richeson , 344 S .W .2d
21
802, 806 (Ky. 1961). If the evidence supported application of the learned intermediary
doctrine in the instant case, it was error for the trial court to not submit a learned
intermediary instruction because the instructions, as given, did not give the jury an
opportunity to find whether Sandoz provided an adequate warning to Dr. Armstrong of
the risks associated with Parlodel, which would have precluded a judgment against
Sandoz under the law.
The package insert
for Parlodel and
the Physician's Desk Reference (PDR)
information on Parlodel at the time of Mrs. Gunderson's prescription 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 during therapy with Parlodel . . . were
also preceded by visual disturbances (blurred vision and
transient cortical 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 .
The above warning was approved by the FDA in 1987. In conjunction with the
new warning, the FDA required Sandoz to send a "Dear Doctor" letter to obstetricians
22
noting the changes in the package insert and specifically calling attention to the adverse
reactions . At trial, the Gundersons presented evidence that Sandoz failed 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 the FDA's 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 reconsider Parlodel's indication for use as a lactation
suppressant at a 1988 FDA advisory committee meeting . Upon reviewing the available
data on Parlodel's use for PPLS during that meeting, including the results of the ERI
study and ADRs, the advisory committee recommended that Parlodel's indication for
PPLS should be withdrawn. The committee concluded that risks of potentially serious
side effects from Parlodel use outweighed the relatively minor discomfort of postpartum
lactation . The committee recommended that the condition be treated conservatively as
it had traditionally been, with breast binding and analgesics . The FDA adopted the
committee's recommendation in 1989 and asked manufacturers of bromocriptine to
voluntarily withdraw their drug's lactation suppression indications . With the exception of
Sandoz, all manufacturers complied with the
DA's request . Sandoz, however,
continued to market Parlodel for PPLS . In fact, in the second "Dear Doctor" letter sent
by Sandoz dated May 3, 1990, Sandoz wrote :
The results of the epidemiologic study, conducted by
Epidemiology Resources, Incorporated, were presented [to
the FDA Fertility and Maternal Health Advisory Committee]
showing no causal relationship between reported seizures
and the use of Parlodel .
Subsequently, the FDA requested Sandoz to voluntarily
withdraw this [PPLS] indication for Parlodel . Sandoz
considers this request inappropriate for the following
reasons:
23
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 .
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.
Prior to the above-mentioned change in the package insert, Sandoz had placed
an ad for Padodel in the March 1984 issue of Obstetrics and Gynecology (commonly
referred to in the obstetric community as "the green journal") claiming that Parlodel had
a "low order side effects, " was "natural," and left patients "completely free" of
engorgement . The Gundersons offered into evidence a letter to Sandoz from the FDA
maintaining that said ad was misleading as to those three claims, and further that the ad
failed to inform doctors of the high rate of rebound with Parlodel therapy. There was
also evidence that Sandoz instructed its sales force not to mention the risks or the
FDA's concerns about Parlodel unless questioned by the doctor . Instead, the sales
representatives were to continue to encourage doctors to include Parlodel on standing
orders as a routine therapy for PPLS. Further, the Gundersons presented evidence that
before Mrs. Gunderson's death in 1993, Sandoz knew of additional adverse reactions to
Parlodel and misrepresented them or failed to report them to the FDA as required by
law. In particular, there was evidence that prior to 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 made no effort to provide doctors with these
24
updated figures after the 1987 package insert . It was not until 1994, after the FDA had
initiated procedures to withdraw its approval for the PPLS indication for Parlodel, that
Sandoz voluntarily withdrew that indication .
In his deposition read at trial, Dr. Armstrong admitted that he had not read the
1987 updated package insert for Parlodel . Dr. Armstrong testified that he did not
receive either "Dear Doctor" letter sent by Sandoz regarding Parlodel, and that if he
had, he would not have prescribed Parlodel for Mrs . Gunderson .
From our review of the record, we conclude that Sandoz failed to present
sufficient evidence of an adequate warning to Dr. Armstrong of the risks of Parlodel,
thus it was not error for the trial court to fail to give the jury instruction on the learned
intermediary doctrine . While the package insert and PDR entry for Parlodel contained
warnings of the risks of seizure and hypertension for postpartum patients, other
evidence undermined the effectiveness of these warnings
The evidence that Sandoz did not send the "Dear Doctor" letters to Dr.
Armstrong, the language in the second letter maintaining that Parlodel was a
reasonable and effective treatment for PPLS, the evidence that Sandoz misrepresented
or failed to report known additional ADRs (for seizures, strokes and hypertension), the
misleading ad in the journal of Obstetrics and G
and Sandoz's instructions to
its sales representatives to encourage the continued use of standing orders for Parlodel
for PPLS and not to mention the risks of the drug, was strong evidence of its efforts to
minimize or conceal the risks of Parlodel (much of which was undisputed) . This
evidence showed that Sandoz repeatedly attempted to downplay or conceal the risks of
Parlodel and intentionally undermined any existing warnings . This systematic approach
2 Dr. Armstrong's deposition was taken in July of 1996, some six months before his death.
25
to minimizing the risk posed by Parlodel tendered the various warnings that were
available inadequate tinder thBlearned-intermediary doctrine . Thus, \N8conclude that
the trial court did not err in failing to instruct the jury as to the learned-intermediary
defense.
FAILURE TO GIVE AN "UNAVOIDABLY UNSAFE" INSTRUCTION
Dr. Armstrong argues that the trial court erred in failing to instruct the jury that the
inherent risk of prescription drugs such as Parlodel makes them "unavoidably unsafe"
bUfDOfunreasonably dangerous pursuant {o Restatement /SBcOOd\OFTorts § 4[]2A
cmt. k.
ID
viewing Dr . Armstrong's brief before the Court {]fAppeals, we note that Dr.
Armstrong failed to argue this issue before the Court of Appeals. Hence, the argument
is precluded from our review.
.126 S.W .3d 747.753-54
(Kv .App.2003) .
FAILURE TO DIRECT A
VERDICT
ON MEDICAL MALPRACTICE CLAIM
Dr. Armstrong argues that he was entitled to a directed verdict because the
GUMder0Ons failed to show that his treatment of Mary Gunderson violated the applicable
standard of care. It is Dr. Armstrong's position that there was insufficient evidence that
he violated the standard of care owed to Mrs. Gunderson because the evidence
established {hat: Parlodel was approved by the FDA for PPLS in 1993; the prescription
for ParlOd8l for Mrs . Gunderson was not in violation of the contraindications in the
package insert ; P@FlOdel's use for PP[S was per a standing order of Suburban Hospital
in 1993|[]r Armstrong's partner had prescribed Parlodel to Mrs. GUDder8OOfO[PP[S
after her previous pregnancy in 1989 with no adverse reaction ; and Dr. Armstrong had
prescribed Parlodel for PPLS for years in his practice with no adverse results . Citing
,231K».678.22 S.VV .2d 115.117 (1929), Dr. Armstrong asserts that,
26
even assuming that the decedent died as a result of a Parlodel-induced seizure, it does
not necessarily follow that he was negligent in prescribing the drug because "[i]njury
may result from the use of the drug even when the doctor has proceeded with the
utmost care and skill."
We agree that "[i]t is necessary . . . in order to make out a case [for medical
negligence], that something more be shown than mere injury by the drug ." Id .
In a
medical malpractice case, 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 the injury or death . Reams v. Stutler, 642 S .W .2d
586 (Ky. 1982). A physician has the duty to use the degree of care and skill expected of
a competent practitioner of the same class and under similar circumstances . Grubbs ex
rel . Grubbs v. Barbourville Family Health Ctr., P.S.C. , 120 S.W.3d 682 (Ky. 2003) ;
Mitchell v. Hadl, 816 S.W .2d 183, 185 (Ky. 1991) ; Cordle v. Merck &-Co ., Inc . , 405 F.
Supp. 2d 800 (E .D . Ky. 2005).
Appellees presented the testimony of Dr. Jay Patrick Lavery, a board-certified
obstetrician/gynecologist who practiced in Louisville from 1975-1987 . During that time,
he had a private practice in Louisville and, from 1980-1987, was Director of Obstetrics
at University Hospital . From 1987 to the present, he has operated an obstetrics practice
in Michigan specializing in high risk pregnancies . Dr. Lavery stated that in his opinion, it
was not a breach of the applicable standard of care in 1989 to prescribe Mrs.
Gunderson Parlodel for PPLS after the birth of her first child . In Dr. Lavery's opinion it
was, however, a deviation of the standard of care for Dr. Armstrong to prescribe Mrs.
Gunderson Parlodel for PPLS in 1993. Dr. Lavery explained that by 1993, there was
information available in the medical literature indicating that Parlodel had adverse
27
vascular properties and was ineffective for PPLS because of its rebound propensity . Dr.
Lavery specifically noted two articles, one in the "green journal" and one in the
American Journal of Obstetrics and Gynecolog .QUestiOOing the safety of Parlodel's
Use for PP»LS because of an association between Parlodel and postpartum . .
GUOdBnSOn'8gesƒ2tioOal hypertension in 1993, he mould not have prescribed Parlodel
for PP[S because Uf ƒhe high risk of an adverse vascular event and low potential benefit
of the drug . []r. [averV testified that h8 ceased prescribing ParlOdel for PPLS in 1984 {]r
1985 ' when he was still practicing in Louisville, and since that time, he has successfully
treated postpartum breast pain and engorgement with traditional therapies such as
breast binding and analgesics .
When confronted on cross-examination with the fact, that prescribing Parlodel to
Mrs . Gunderson in 1993 was not contraindicated by the information in the FDAapproved package insert, Dr .L@V8rVtestified that it was nevertheless a breach of the
standard O[care fOprescribe ihe drug tOMrs. GUDderson@tthat time . Dr. [aVerV
testified that even though 0drUg is approved by the FDA for a certain use and may not
be contraindicated by the package insert, a reasonably prudent doctor still has to weigh
the risks and benefits ofthe drug rel@hve to a particular patient. This testimony is
consistent with the majority view that while the information about the drug in the
package insert and the PDR is relevant and useful information regarding the prescribing
physician's standard of care, it is not the sole determinant of the standard of care.
Miller, 44S .W.3d 1,16-17 / TeDM .Ct.App . 200O\;
N .E.2d 544.548 /N.Y,1999\|
,723
.706 A .2d 721 .728-
30 / N.j . 1998\; Waft v. Peeb5p, 893 F!2d 138 ' 150-52 (Haw. 1995\ . » The information
in the package insert and PDR can only be analyzed in the context of the medical
condition of the individual patient. Spensieri, 723 N .E.2d @{548;
706 A .2d 8{
730.
As a medical expert, the prescribing physician can take into
account the propensities of the drug, as well as the
susceptibilities of his patient. His is the task of weighing the
benefits of any medication against its potential dangers . The
choice he makes is an informed one, an individualized
medical judgment bottomed on a knowledge of both patient
and palliative .
498 [r .2d 1264, 1276 /5th
153 S .W.3d ft 763 / q
Cir. 1974\\.
Relative to the claim that Dr. Armstrong could not have violated the standard of
care when he prescribed PBrl0del to Mrs. Gunderson in 1993 because she had taken
the drug with her first pregnancy in 1989 with no adverse reaction, Dr. Nichols testified
&at R is not uncommon for a patent to not have an adverse reaction to a drug the first
time they take it,
nd then suffer 8Oadverse or paradoxical reaction upon the second or
subsequent administration of the drug . Moreover, as emphasized by Dr. Lavery, Mrs.
GUnde[GC]Ddid not have gestational hypertension with her first pregnancy . Thus, the
V@scU/0Fri8ks of the drug were more significant forMrs . GUMde[s0n in 1993.
As stated earlier, Dr. Armstrong admitted in his deposition that he had not read
the 1987 updated package insert for Parlodel . Although he maintained that he regularly
read the green journal and the PDR addendums, Dr. Armstrong denied having
knowledge of the potential VascUtBFrisk0 of Padodel and testified that the only side
o But see the minority view that
the
information in the drug's label and the PDR are prima
facie evidence of the standard of care V prescribing the d
681F.2d 2Q1 .803
(5th Cir. 1m82);
880 (!U. 1873);
Davis &~Co., lul m.vv .uo 882, Um/ (Minn. 187U); Mueller v. Mueller, 221 N.VV.2d 39, 42-43 kS.C>. 1974\.
29
effects he was aware of were headaches and nausea . Dr. Armstrong testified that had
he known about the information in the "Dear Doctor" letters sent by Sandoz, he would
not have prescribed P@rlOdel for Mrs. GUOd8FsOO in 1993. Incorporated in a physician's
duty of reasonable care to his patient is the duty of requisite knowledge . Jones v .
406 S.W.2d 15^4 ' 156 /K« . 1966\ . overruhl ( Y ppfhe F
/K» .1970\ .
' 459 S.W.2d 166
Drawing all reasonable inferences in favor of Appellees, we believe the
Appe(le098ppeseMted sufficient evidence that [][.Armstrong breached his standard of
care, by failing to have knowledge of the vascular risks of Parlodel in 1993 and
prescribing the drug h] Mrs. GUnd8[GOn for PPLS, to withstand the motion for directed
' 127 S'W'3d 663 ' 673 / KV .App .2004\ '
verdict . See
overruled crRO[har
. 171 S .W .3d 14 (Ky. 2005\. Dr. Lavery's expert testimony
was evidence that th6*standard of care fnr@Dobstetrician iDLouisville in 1993 was such
that Breasonably prudent doctor would have known Do{tUprescribe
P8[lOd8l
to
8
woman with gest0tional hypertension . Accordingly, [Jr. Armstrong's motion for directed
verdict was properly denied .
MITIGATION EVIDENCE ON LOSS OF PARENTAL CONSORTIUM CLAIM
At trial, Sandoz and Dr. Armstrong attempted to present evidence of Wesley and
Nicholas GUnderSOn'8clOse relationship with
jBD/ce
Hays, Ronald Gunderson's
girlfriend of the last four years, for the purpose of mitigating damages on their loss of
parental consortium claim . They offered avowal testimony that Ms. Hays often stayed
overnight at the Gunderson residence, fixed the children breakfast, packed their lunch,
helped with their schooling and generally helped C8M3fRo[them when. Ronald was
working . The Appellants also sought to admit a letter in which Nicholas spoke favorably
about Ms. Hays. Sandoz and Dr. Armstrong rgUed that Ms . Hays' relationship with
30
Wesley and Nicholas was relevant to their loss of parental consortium claim because
she provided consortium-giving benefits to the boys which mitigated the loss of
consortium with their mother . The Gundersons objected to the admission of such
evidence, arguing that the boys' relationship with Ms. Hays could never replace the loss
of their mother.
The trial court recognized that, while the evidence of the relationship with Hays
was arguably relevant to the loss of parental consortium claim, it was not admissible as
to Mr. Gunderson's wrongful death claim p ursuant to Adams v. Davis , 578 S.W.2d 899,
902 (Ky.App . 1979) (holding that evidence of surviving spouse's remarriage is
inadmissible in wrongful death action). Reasoning that an admonition limiting the
evidence to the parental consortium claim would not be effective, the trial court refused
to allow specific evidence of the relationship with Ms. Hays to be admitted . The court
did allow, however, general hypothetical questions about how any potential subsequent
relationships of Mr. Gunderson's might affect the boys. The Court of Appeals held that
evidence of other consortium-giving relationships can be relevant to a child's lost
consortium claim if the relationship is sufficiently close and intimate to compare to a
parental relationship . The court then concluded that Mr. Gunderson's relationship with
Ms . Hays was not of sufficient duration and stability to be admissible in the instant case .
The court noted that Mr. Gunderson had only known Ms. Hays for four years and that
Ms. Hays did not reside at the Gunderson household exclusively .
This issue of whether evidence of other consortium-giving relationships is
relevant in a loss of parental consortium claim is one of first impression in Kentucky.
This Court first recognized a minor child's independent claim for loss of parental
consortium in Kentucky in Giuliani v. Guiler, 951 S .W .2d 318 (Ky. 1997) . The Giuliani
31
decision, however, provided little guidance as to how such claim was to be proved and
the type of evidence that was considered relevant to the claim:
The proof of such loss and the necessary proof of monetary
loss resulting therefrom are factors to be considered by the
trier of fact separate from any wrongful death statute.
Id . at 323. Appellants urge this Court to allow the consideration of whether other
consortium-giving relationships are available to the child as one factor in determining
the amount of damages for loss of parental consortium, as some other jurisdictions
have allowed . See Reagan v. Vaug n, 804 &V12d 463, 467 (Tex . 1990); Belcher v.
Goins, 400 S .E-2d 830, 842 (W.Va . 1990) ; Villareal__v . Ariz. Dept. of Transp ., 774 P.2d
213, 220-21 (Ariz. 1980) . Appellants also point to Miller ex. rel. Monticello Baking Co . v.
Ma
mount Medical Center, 125 &Md 274, 285 (Ky. 2004), wherein this Court stated
that evidence of a spouse's live-in relationship with his girlfriend was relevant to his
claim for loss of spousal consortium .
While this Court does not seek to minimize the loss of a spouse's consortium, it
cannot be denied that a child's loss of a parental consortium is different than an adult's
loss of spousal consortium . The Giuliani Court recognized the necessity for protection
by the law of a child's unique right "to a parent's love, care and protection so as to
provide for the complete development of that child." 951 S.W .2d at 320. As
acknowledged in Giuliani, "[t]he loss suffered by each child in this case is separate and
distinct . . . from the loss suffered by their father[,]" and "in any disruption of the parentchild relationship, it is probably the child who suffers most." Id . at 320-21 .
"Furthermore, while an adult is capable of seeking out new relationships in an attempt to
fill in the void of his or her loss, a child may be virtually helpless in seeking out a new
adult companion ." Smith v. Vilvaramah, 57 &Md 839, 843 (Ky.App . 2000) (citing
32
Theama v. City of Kenosha , 344 N .W.2d 513, 516 (Wis . 1984)) . Accordingly, the fact
that evidence of the spouse's new relationship may be relevant in a loss of spousal
consortium case does not persuade this Court that the evidence of the parent's new
relationship should be admissible in the child's loss of parental consortium action .
The basis of this Court's ruling in Giuliani was that "[t]he claim of loss of parental
consortium is a reciprocal of the claim of the parents for loss of a child's consortium
which was recognized in KRS 411 .135 ." Id . at 321 . We agree with the views expressed
in Simmons v. University of Chicago Hospitals and Clinics , 642 N.E.2d 107, 114 (111.
1994), wherein the court held that evidence that parents subsequently had two more
children was irrelevant in parents' loss of child's consortium claim :
[T]he relationship between parent and child is different from
that of husband and wife . The parent-child relationship is not
replaceable and is not limited to the society of only one child .
Every child is unique, and the loss of society a parent suffers
upon a child's death cannot be replaced with the society of a
child subsequently born .
And so it is with a child's loss of a parent, who likewise cannot be replaced .
Accordingly, the trial court properly excluded the evidence of Janice Hays' relationship
with Nicholas and Wesley Gunderson .
TESTIMONY OF DR. BOWER
The Gundersons sought to present the expert testimony of Dr. Barbara Bower to
testify as to how the loss of their mother affected Nicholas and Wesley relative to their
loss of parental consortium claim . Dr. Bower established that she has a doctorate in
counseling psychology and is a certified/licensed mental health counselor in Indiana,
Ohio, and Kentucky. Dr. Bower testified that she had taught at two universities, had
twenty years of experience as a private children's counselor and fifteen years as a
school guidance counselor. The Gundersons asked Dr. Bower to perform a
33
psychological assessment of Nicholas and Wesley for purposes of this lawsuit. She
met with the boys eight times during 2000 and 2001 and attempted, through
observation, conversations, drawings, and writing assignments, to elicit their feelings
about themselves and the loss of their mother. Dr. Bower did not use any standard
psychological tests to evaluate the boys and did not attempt to diagnose or treat the
boys.
It was Dr. Bower's opinion that both boys had been deeply affected by the loss of
their mother . Relative to Nicholas, Dr. Bower testified that he expressed a sense of
abandonment and sadness, which she attributed to the fact that he was four years old
and had already bonded with his mother when she was abruptly taken away from him.
Dr. Bower explained that losing a mother at age four affects a child's sense of
appropriate behavior and their overall trust in the world . As to Wesley, Dr. Bower
testified that he had attachment and trust issues stemming from the fact that he was
never able to know or bond with his mother, and that his family was thrown into chaos
after her death . She stated that both boys would be at an increased risk for
developmental problems, risk-taking behavior, and depression as a result of losing their
mother at such a young age . Dr. Bower displayed to the jury pictures drawn by the
boys and, with some pictures, described the significance of the pictures relative to the
loss of their mother . She also read letters that she had asked the boys to write to their
mother.
Prior to trial, Appellants filed a motion in limine to exclude the testimony of Dr.
Bower on grounds that it was too subjective, speculative, and inflammatory, and the
subject matter was not outside the common knowledge of the jurors . Appellants
maintained that Dr. Bower's testimony was not in keeping with Daubert because it was
not based on good science or methodology such as an objective testing method.
We view Dr. Bower's testimony as properly within the scope of KRE 702 in this
case. Dr. Bower had specialized knowledge in child psychology by virtue of her
experience and education to assist the jury in understanding how the Gunderson
children were affected by their mother's death and the extent of the emotional injury
from that loss, which was clearly relevant in assessing damages on the loss of parental
consortium claim. KRE 402. Although laypersons are generally aware that children are
negatively affected by the loss of a parent, Dr. Bower was able, through her
observations of and conservations with the boys, to specifically describe and explain
certain emotional issues Nicholas and Wesley were contending with as a result of losing
their mother at such a young age . And while it is true that Nicholas and Wesley testified
at trial, the boys were only fifteen and eleven years old, respectively, at the time, and
Dr. Bower had specialized knowledge and skills in getting children to express emotions
they may not have otherwise been able to articulate at such a young age.
As to Appellants' claim that her testimony was too subjective and speculative, we
note that Dr. Bower was not ma king a definitive scientific diagnosis of the boys . See
Jenson v. Eveleth Taconite Co., 130 F.3d 1287, 1297-99 (8th Cir. 1997) . Rather, she
was assessing the emotional impact of the death of their mother. When asked why she
did not administer any objective psychological tests on the boys, Dr. Bower explained
that she felt that may have impeded their trust in her and hindered their willingness to
open up to her about their mother . Given Dr. Bower's extensive education and
experience in counseling children, and the limited purpose of her testimony, we adjudge
that it was sufficiently reliable under Daubert to be offered relative to the loss of parental
35
consortium claim . See Rogers v. Detroit Edison -Co., 328 F. Supp . 2d 687, 690-92 (E .D.
Mich. 2004) (psychologist's testimony about psychological problems caused by
appellant's accident deemed reliable given psychologist's education and professional
experience and the fact that the opinion was based on multiple therapy sessions with
appellant .) Accordingly, the trial court did not abuse its discretion in allowing it to be
admitted .
Appellants' argument as to the pictures drawn by Nicholas and Wesley and Dr.
Bower's testimony about the pictures was not properly preserved. KRE 103. Nowhere
in the record do we see that Appellants raise the issue of "art therapy" before the trial
court . See Payne v. Hall, 423 S.W.2d 530 (Ky. 1968). The argument was not part of
Appellants' motion in limine regarding Dr. Bower's testimony, and the only objection
made when the pictures were displayed at trial was Dr. Armstrong's objection that he
was not permitted to introduce a picture drawn about Ms . Hays.
EVIDENCE OF DR . ARMSTRONG'S CROSS-CLAIM
In September 1998, Dr. Armstrong's estate filed a cross-claim against Sandoz
alleging fraudulent misrepresentation and gross negligence in Sandoz's marketing of
Parlodel and seeking damages for injury to Dr. Armstrong's reputation as well as
indemnification in the event Dr. Armstrong was found liable for Mrs. Gunderson's death.
The cross-claim specifically alleged that Sandoz engaged in a deliberate marketing
effort to misrepresent to prescribing doctors that Parlodel was safe and effective for
PPLS when, in fact, it was not, and that had Sandoz fully disclosed the risks of the drug,
Dr. Armstrong would not have prescribed it to Mrs. Gunderson . Prior to trial, Sandoz
entered into an indemnification agreement with Dr. Armstrong whereby his claims were
settled and Sandoz took over defense of the claims against Dr. Armstrong . Accordingly,
36
the cross-claim was dismissed, and at trial, Dr . Armstrong offered no evidence against
Sandoz. In response to Sandoz's motion in limine to exclude evidence of the crossclaim, the trial court ruled that the Gundersons could introduce the cross-claim as
evidence of the Defendants' non-adverse relationship with each other pursuant to KRE
408 and as relevant to the credibility of Dr. Armstrong's evidence . The Gundersons
quoted and discussed the cross-claim during their opening and closing statements . The
cross-claim was also mentioned during voir dire (by Sandoz, apparently preemptively,
after the motion in limine had already been denied) and introduced into evidence by the
Gundersons.
The Gundersons claimed at trial that the purpose of introducing the cross-claim
was to show that prior to the settlement agreement, Dr. Armstrong claimed that Sandoz
had failed to adequately inform him of the risks of Parlodel and deceptively marketed
the drug. After the settlement agreement, Dr. Armstrong decided not to introduce any
evidence critical of Sandoz's warnings about Parlodel or its marketing of Parlodel . The
Gundersons argued that they were entitled to present the cross-claim pursuant to KRE
408 to expose to the jury how Dr. Armstrong's position changed after the settlement
agreement and the collusive nature of their relationship at trial, i .e., bias. Sandoz
argues that the cross-claim was blatant inadmissible hearsay introduced as substantive
evidence against Sandoz . KRE 801 . The Gundersons assert on appeal that the crossclaim was non-hearsay as an admission of a party-opponent (KRE 801 A(b)) because in
the cross-claim, Dr . Armstrong averred that Parlodel was unsafe and caused Mrs.
Gunderson's death, which directly contradicted Dr. Armstrong's position at trial that
Parlodel was safe and did not cause postpartum hypertension or seizures .
The Court of Appeals ruled that, although the cross-claim may not have been
admissible under
KRE
801/\,the trial court did not abuse its discretion in admitting the
cross-claim under KRE 408 as evidence
of
the Defendants' potential motive to
downplay each other's wrongdoing at trial. The Court
of
Appeals went on to state that
even if it was an abuse of discretion to admit the cross-claim, it was harmless error in
this case.
Under KRE 408 . eVidencB of a settlement agreement is not admissible to prove
liability or invalidity of the claim, but is admissible to show the potential bias
parties
of
who were previously adversaries in the litigation and who may now be motivated to
downplay each other's fault .
,125 S .W.3d 274.
Neither Defendant in the instant case questioned the admissibility
of
the settlement
agreement . Sandoz simply argues that the cross-claim is wholly independent
settlement agreement and, thus, does
DUt fall
Gundersons maintain that the admission
of
within the ambit
OfKRE 408.
of
the
The
the cross-claim was necessary to give
meaning to the settlement agreement . While this argument may be tenable in theory,
the cross-claim in this case- was clearly used by the Gundersons to try to prove
SBndoZs liability, 88VVe shall explain below, which is not permitted by KRE
408.
KRE 801A(b)l allows the introduction as non-hearsay of an adverse party's
admissions, including admissions contained in superceded or abandoned pleadings, but
,293 S .W.2d 470 /K« . l956\
only against the declaring party. aeg
(pre-Rules holding that Appellant! s abandoned pleading was admissible as competent
evidence against Appellant) . /\s this Court made clear in
S.W .2d 810,813 (Ky . 1987)
8 .10 /2d ed .
1984\) .
/qUobMg LBVVsOM .
"Admissions
are
The Kentucky Evidence Law HandbooR §
not admissible against
38
' 738
B
d8O)an3Dt's cOp8rtV ." See
also James v. Wilson, 95 EVTOd E875, 898 (Ky.App . 2002). The Gundersons contend
on appeal that the cross-claim was admissible pursuant KRE 801A(b) because it was
used against Dr. Armstrong to contradict his position at trial that Parlodel was safe and
could not have caused Mrs. Gunderson's fatal seizure . However, a review of the record
belies this contention. In arguing the admissibility of the cross-claim at trial, the
Gundersons' counsel stated, "this cross-claim only goes against the conduct of SandoK
and "would tend to . . . exculpate Dr. Armstrong ." He further stated, "this cross-claim is
very prejudicial against as far as the evidence, against Sandoz, not against Dr.
Armstrong ." In fact, all of the references to the cross-claim during the Gundersons'
opening and closing statements were made in the context of arguing the liability of
Sandoz (Dr. Armstrong's co-party), which is not permitted by either KRE 408 or KRE
801A(b) . The Gundersons primarily quoted and displayed pleadings alleging Sandoz's
deliberate marketing scheme misrepresenting the safety of Padodel and its failure to
warn Dr. Armstrong of the dangers of the drug . The Gundersons did not qualify these
references with any statement to the effect that these pleadings tended to show the bias
its
of Dr. Armstrong's estate or how
position changed at trial after the settlement
agreement had been executed . Accordingly, it was error to allow the cross-claim to be
admitted for the purpose of proving Sandoz's liability .
We must now determine if the error was reversible. KRE 103(a) . It must be
noted that Sandoz never asked for an admonition limiting the scope of the cross-claim
to show only the bias of Dr. Armstrong, pursuant to KRE 105(a), which provides :
When evidence which is admissible for one (1) purpose . . .
but not admissible . . . for another purpose is admitted, the
court, upon request, shall restrict the evidence to its proper
scope and admonish the jury accordingly . In the absence of
such a request, the admission of the evidence by the trial
39
judge without limitation shall not be a ground for complaint
on appeal, except under the palpable error rule.
As the Court of Appeals recognized in its analysis of whether the error was
harmless:
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 . The jury is thus not apt
to have given it undue weight. 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.
We would add that the evidence that was cumulative of the cross-claim was voluminous
and quite damning . In addition to evidence that we have discussed previously
(Sandoz's failure to send the "Dear Doctor" letters, the language in the second letter
maintaining that Padodel was a reasonable and effective treatment for PPLS, the
evidence that Sandoz misrepresented or failed to report known additional ADRs, the
misleading ad in the journal of Obstetrics and Gynecology, the attempt to manipulate
and downplay the risks of seizure in the ERI report, and Sandoz's instructions to their
sales representatives to encourage the continued use of Padodd for PPLS and not to
mention the risks of the drug), there was considerable evidence of Sandoz's sales
strategy to push Parlodel for PPLS and that Sandoz referred to Parlodel as their "cash
cow", despite the known problems with, and the FDA's position on, the drug . Dr.
Armstrong's deposition testimony was also cumulative in that he testified that he had
not received any information about the risks of Parlodd for PPLS from Sandoz, and that
if he had, he would not have prescribed the drug to Mrs. Gunderson . While we
recognize the bolstering nature of the allegations in the cross-claim in coming from a co40
defendant in the case, in light of the vast amount of persuasive evidence that was
cumulative of the allegations therein, we cannot say the error was palpable, i.e., no
manifest injustice resulted . KRE 103(e) ; CR 61 .02.
PUNITIVE DAMAGES
In 2003, the United States Supreme Court rendered its decision in State Farm
Mutual Automobile Insurance Company v. Campbell, 538 U .S . 408, 422-23, 123 S. Ct.
1513, 155 L. Ed . 2d 585 (2003), wherein it held that under the due process clause, out
of-state conduct of a defendant regarding a non-party cannot be used to award punitive
damages . While the Court allowed consideration of out-of-state conduct in assessing
the reprehensibility of the defendant's conduct, the Court stated that the out-of-state
conduct "must have a nexus to the specific harm suffered by the plaintiff." Ad . at 422 .
At trial in the instant case, Sandoz tendered a punitive damage instruction
pursuant to Campbell which provided that the jury could "not use punitive damages to
punish Sandoz for any conduct outside the state of Kentucky." The trial court declined
to submit the tendered instruction and instead submitted the standard punitive damage
instruction in Kentucky at the time .
Some six months after the trial in this case, this Court rendered its decision in
Sand Hill Energy, Inc- v. Smith, 142 S .W .3d 153 (Ky. 2004), which had been remanded
by the United States Supreme Court for reconsideration in light of Campbell . In Sand
Hill, the jury heard abundant evidence regarding the out-of-state conduct of Ford Motor
Company in manufacturing and selling vehicles with the defect in question . Id . at 157.
Following the dictates of Campbell, we vacated the punitive damages award and
remanded for a new determination of punitive damages using a jury instruction with a
limitation regarding extraterritorial punishment. Id. at 166.
41
On appeal, Sandoz argued that the trial court erred in failing to submit its
tendered punitive damage instruction . Citing
' the Court of Appeals agreed
that given all of the evidence of the extraterritorial conduct OfSQndoz .SaMdOz was
entitled to an instruction limiting punitive damages to its conduct in Kentucky . The Court
of Appeals thus vacated the punitive damages award and remanded "for a new
determination of the amount of punitive damages."
Sandoz argues before us that the remand by the Court of Appeals for a new
determination only on the amount of punitive damages violated SaMd{)z's right to a fair
trial because it improperly assumed that the Gundersons were entitled to punitive
damages in the first place . In particular, Sandoz contends that there was no evidence
Of8nexus between SandC)z's out-of-state conduct relative to Parlodel and the harm
suffered bVMary GUDdersOn . Sandoz iSessentially arguing that the trial court erred in
failing to grant its motion for a directed verdict on the issue of punitive damages. We
agree with the Court of Appeals that the Gundersons presented sufficient evidence that
Sandoz acted with wanton or reckless disregard for Mary Gunderson to be outrageous
and implicitly malicious and, thus, a punibve damage instruction was warranted . See
.103 S .W .3d /16 .52 (Ky. 20(l3\ .
The GUMd8[sUMs presented evidence that by 1985 Sandoz knew of a causal link
between [za[lOd8l and hypertension and seizures, and by 1988 Sandoz was on notice
that the FDA had advised that Padodel should rat be prescribed routinely for PPLS .
Despite the fact that all other drug companies had taken b[ODMOCriptiOe DOe@Vlaf8 off the
market for PP[S . Sandoz continued to aggressively market Parlodel for routine use for
PPLS .
During this time,
aMdoz ASO engaged in conduct that sought to keep concerns
about the drug from coming to the attention of doctors . As we have already discussed,
42
the Gundersons presented evidence that Sandoz: misrepresented or underreported
known ADRs associated with Parlodel ; published a misleading ad regarding the safety
and effectiveness of Parlodel ; failed to send "Dear Doctor' letters calling attention to the
revised package insert to all members of the college of obstetrics and gynecology as
required by the FDA; sent out a "Dear Doctor" letter in 1990 flouting the FDA and
maintaining the safety and effectiveness of Parlodel for PPLS ; instructed its sales force
not to mention the risks of the drug unless specifically asked by a doctor ; and attempted
to manipulate and downplay the risks of seizure in the ERI report. This conduct evinced
a deliberate and systematic campaign to downplay or conceal the risks of Parlodel from
prescribing doctors for the purpose of continuing to sell the drug . Further, this evidence
of out-of-state conduct by Sandoz had a sufficient nexus with Mary Gunderson's death
in that Dr. Armstrong testified that had he known of information in the "Dear Doctor"
letter or the FDA's position on Parlodel at the time, he would not have prescribed
Parlodel to Mary in 1993. Accordingly, the court properly denied Sandoz's motion for
directed verdict on punitive damages .
Sandoz next asserts that remanding for a new trial solely on punitive damages
presupposes a finding by the jury that Sandoz's conduct was reprehensible . As the
suggested jury instruction in Sand Hill provides, the jury on remand should be explicitly
instructed that it can only consider Sandoz's out-of-state conduct "in determining
whether [Sandoz's] conduct occurring in Kentucky was reprehensible, and if so, the
degree of reprehensibility ." Sand Hill, 142 S.W.3d at 167 (emphasis added) . We would
also clarify that while the present case was remanded by the Court of Appeals "for a
new determination of the amount of punitive damages," as in Sand Hill, the instruction
and verdict form on remand should allow for a possible finding of no punitive damages .
43
Id. As this Court's proposed instruction properly stated in Sand Hill, "Whether you make
an award of punitive damages, in addition to the compensatory damages previously
awarded, is a matter exclusively within your discretion." Id.
Finally, Sandoz argues that the issues of compensatory liability and punitive
liability were so inextricably interwoven that a retrial solely on the issue of punitive
damages would be in error . We do not agree. Retrial on a distinct and severable issue
is permitted unless retrial would result in injustice . Deutsch v. Shein, 597 S.W.2d 141,
146 (Ky. 1980) . We cannot say that a retrial solely on the issue of punitive damages
would result in an injustice to Sandoz in this case.
CONCLUSION
While we deem it was error to fail to allow the cross-claim to be admitted in this
case, we adjudge it to be harmless error. Finding no other error, the opinion of the
Court of Appeals is affirmed .
Minton, CJ ; Cunningham, Noble, Schroder, Scott and Venters, JJ., concur.
Abramson, J ., not sitting .
COUNSEL FOR HYMAN & ARMSTRONG, P .S .C. ; AND KAREN ARMSTRONG,
EXECUTRIX OF THE ESTATE OF LYMAN ARMSTRONG, M.D.
Raymond Smith
Edward H . Stopher
Rodney Dale Payne
Boehl, Stopher & Graves, LLP
2300 Aegon Center
400 West Market Street
Louisville, KY 40202
COUNSEL FOR RONALD GUNDERSON, ADMINISTRATOR OF THE ESTATE OF
MARY MARGARET GUNDERSON ; NICHOLAS GUNDERSON, A MINOR ; WESLEY
GUNDERSON, A MINOR; JOHN J . FORD, CONSERVATOR OF NICHOLAS
GUNDERSON, A MINOR; AND JOHN J . FORD, CONSERVATOR OF WESLEY
GUNDERSON, A MINOR
Larry B . Franklin
Jennifer Mills Barbour
Franklin, Gray & White
505 West Ormsby Avenue
Louisville, Kentucky 40203
Michael R . Hance
Franklin and Hance
505 West Ormsby Avenue
Louisville, Kentucky 40203
COUNSEL FOR SANDOZ PHARMACEUTICALS CORPORATION, N/K/A NOVARTIS
PHARMACEUTICALS CORPORATION
Virginia Hamilton Snell
Deborah H. Patterson
Wyatt Tarrant & Combs
2800 PNC Plaza
500 West Jefferson Street
Louisville, Kentucky 40202-2898
Katharine R. Latimer
Bruce J. Berger
Joe G. Hollingsworth
Spriggs & Hollingsworth
1350 I . Street, N.W.
Washington, D.C. 20005
COUNSEL FOR KENTUCKY MEDICAL ASSOCIATION, AMICUS CURIAE
Charles J. Cronan, IV
Jennifer L . Elliott
Kimberly Kay Ballard
Stites & Harbison
400 West Market Street
Suite 1800
Louisville, Kentucky 40202
COUNSEL FOR CHAMBER OF COMMERCE OF THE UNITED STATES, AMICUS
CURIAE
Christopher M. Mussler
Frost Brown Todd
400 West Market Street
32 nd Floor
Louisville, Kentucky 40202-3363
Jonathan D. Hacker
Nicole A. Saharsky
O'Melveny & Myers
1625 Eye Street, N .W .
Washington, D.C. 20006
Robin S. Conrad
National Chamber Litigation Center, Inc .
1615 H Street, N.W.
Washington, D .C. 20062
COUNSEL FOR PRODUCT LIABILITY ADVISORY COUNCIL, INC., AMICUS CURIAE
William Kennedy Simpson
Thompson, Miller & Simpson
600 West Main Street
Suite 500
Louisville, Kentucky 40202-2923
,*uyrrme (~vurf of ~irufurhV
2006-SC-000175-DG
HYMAN & ARMSTRONG, P.S .C., ET AL .
V
APPELLANTS
ON REVIEW FROM COURT OF APPEALS
CASE NOS. 2004-CA-001536 & 2004-CA-001537
JEFFERSON CIRCUIT COURT NO. 94-CI-004680
RONALD GUNDERSON
(ADMINISTRATOR OF THE ESTATE OF MARY
MARGARET GUNDERSON), ET AL .
AND
APPELLEES
2006-SC-000179-DG
SANDOZ PHARMACEUTICALS CORPORATION
(N/K/A NOVARTIS PHARMACEUTICALS
CORPORATION)
V
APPELLANT
ON REVIEW FROM COURT OF APPEALS
CASE NOS . 2004-CA-001536 & 2004-CA-001537
JEFFERSON CIRCUIT COURT NO. 94-CI-004680
RONALD GUNDERSON
(ADMINISTRATOR OF THE ESTATE OF MARY
MARGARET GUNDERSON), ET AL.
_
APPELLEES
ORDE R GRANTING PETITION FOR REHEARING
On motion of the Appellant, Sandoz Pharmaceuticals Corporation (n/k/a Novartis
Pharmaceuticals Corporation), rehearing shall be granted, and the Opinion of the Court
by Justice Schroder rendered April 24, 2008 shall be modified . Due to pagination, the
entire Opinion shall be substituted, as attached hereto, in lieu of the Opinion as
originally rendered .
Minton, C .J .; Cunningham, Noble, Schroder, Scott and Venters, JJ., concur.
Abramson, J ., not sitting .
Entered : November 26, 2008 .
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