Giles, Jacquelyn v. Wyeth Lab Inc ( 2009 )

In the
United States Court of Appeals
For the Seventh Circuit
No. 07-3149
JACQUELYN G ILES, individually and as
Special Administrator of the Estate of
Jeff L. Giles, Deceased,
Plaintiff-Appellant,
v.
W YETH, INC., and W YETH P HARMACEUTICALS,
formerly known as A MERICAN H OME P RODUCTS
C ORPORATION,
Defendants-Appellees.
Appeal from the United States District Court
for the Southern District of Illinois.
No. 04 C 4245—J. Phil Gilbert, Judge.
A RGUED F EBRUARY 14, 2008—D ECIDED F EBRUARY 12, 2009
Before M ANION, R OVNER, and W ILLIAMS, Circuit Judges.
W ILLIAMS, Circuit Judge. This case arises out of a tragic
event, the death of Jeff Giles, a forty-six-year-old married
father who took his life in the fall of 2002. His widow
filed a wrongful death suit against Wyeth, the manufac-
2 No. 07-3149
turer of Effexor, the antidepressant Mr. Giles began taking
two days before his death. A jury found in favor of Wyeth.
On appeal, Mrs. Giles argues that she should have been
allowed to introduce warnings that accompanied Effexor
in the years following Mr. Giles’s death. Because these
later warnings focused on the risk of suicide in younger
persons, not adults of Mr. Giles’s age, and there is no
evidence that Wyeth knew or should have known the
information contained in the later warnings at the time
of Mr. Giles’s death, the district court did not abuse
its discretion when it excluded the later warnings. We
therefore affirm the judgment of the district court.
I. BACKGROUND
Jeff Giles worked as a coal miner. He suffered a serious
injury on the job in the mid-1990s, and, in the years that
followed, continued to experience neck pain that lim-
ited his ability to move. In July 2002, the coal mine
laid Mr. Giles off from his job. A few months later, on
September 12, he had neck surgery in an attempt to
alleviate the effects of his neck injury. Unfortunately, he
did not heal as quickly from the surgery as he hoped, and
he also learned around the same time that the coal mine
from which he had been laid off would close permanently.
On October 28, 2002, Mr. Giles visited his primary care
physician. Mr. Giles told him that he felt tired and de-
pressed, lacked motivation, and had insomnia. His doctor
diagnosed him with major depressive disorder and pre-
scribed the antidepressant Effexor. Mr. Giles took three
Effexor pills over the next two days. On the morning of
No. 07-3149 3
October 30, 2002, he pulled over to the side of an isolated
road and died from a self-inflicted gunshot wound.
Mr. Giles was forty-six years old at the time and left
behind a wife and son.
Various warnings accompanied the Effexor Mr. Giles
took. Among them, in accordance with a United States
Food and Drug Administration requirement, was a
suicide precaution that stated:
Suicide—The possibility of a suicide attempt is
inherent in depression and may persist until
significant remission occurs. Close supervision of
high risk patients should accompany initial drug
therapy. Prescriptions for Effexor should be writ-
ten for the smallest quantity of capsules con-
sistent with good patient management in order
to reduce the risk of overdose.
In June 2003, the FDA announced it was reviewing
reports of a possible relationship between Paxil, an antide-
pressant not manufactured by Wyeth, and an increased
risk of suicidal thinking and suicide attempts in children
and adolescents. The FDA’s statement also said there
was no evidence that Paxil was associated with an in-
creased risk of suicidal thinking in adults. The FDA then
began collecting data from antidepressant manufacturers’
pediatric clinical trials. In August 2003, Wyeth changed
Effexor’s labeling to reflect that its pediatric clinical
trials showed an increased risk of suicidal ideation in
children using the drug.
In the spring of 2004, the FDA issued a new antidepres-
sant warning, and Wyeth adjusted its Effexor warnings
4 No. 07-3149
accordingly. Effexor’s 2004 warning stated that “Patients
with major depressive order, both adult and pediatric, may
experience worsening of their depression and/or
the emergence of suicidal ideation and behavior
(suicidality), whether or not they are taking antidepressant
medications, and this risk may persist until significant
remission occurs.” The warning also stated that although
a causal role for antidepressants in inducing suicidality
had not been established, “patients being treated with
antidepressants should be observed closely for clinical
trial worsening and suicidality, especially at the beginning
of a course of drug therapy . . . .”
In August of 2004, the FDA completed its analysis of
all antidepressant manufacturers’ pediatric clinical trial
data. As a result of this analysis, in January 2005, the
FDA issued a suicide-related “black box” warning for
antidepressants and modified the antidepressant warn-
ings’ language. (The FDA requires that certain contraindi-
cations or serious warnings, particularly those that might
lead to death or serious injury, be presented in a box that
explains the risk and refers to more detailed information
elsewhere in the labeling. See 21 C.F.R. § 201.57(c)(1)).
Wyeth modified the Effexor warnings in compliance.
Effexor’s 2005 labeling contained a black box captioned
“Suicidality in Children and Adolescents.” Inside the black
box, in bold, the warning stated that “Antidepressants
increased the risk of suicidal thinking and behavior
(suicidality) in short-term studies in children and adoles-
cents with Major Depressive Disorder (MDD) and other
psychiatric disorders.” It also said that analyses of short-
term placebo-controlled trials in children and adolescents
No. 07-3149 5
with major depressive disorder, obsessive compulsive
disorder, or other psychiatric disorders revealed a greater
risk of adverse events representing suicidality during the
first few months of treatment in those receiving antidepres-
sants. Outside of the black box, the 2005 warnings included
that “Adults with MDD or co-morbid depression in the
setting of other psychiatric illness being treated with
antidepressants should be observed similarly for clinical
worsening and suicidality, especially during the initial few
months of a course of drug therapy, or at times of dose
changes, either increases or decreases.”
The FDA finalized a study of all antidepressant manu-
facturers’ clinical trials involving adults in 2006. It con-
cluded that for adults aged 25 to 64, no increase in suicidal
behavior was demonstrated among those taking antide-
pressants. The next year, the FDA issued a new black box
warning that expanded its previous suicidality black box
warning to include adults younger than twenty-five. The
2007 black box also stated that “[s]hort-term studies did
not show an increase in the risk of suicidality with antide-
pressants compared to placebo in adults beyond age 24.”
The warnings section advised that all patients being
treated with antidepressants should be monitored for
suicidality and other changes in behavior, especially
during the first few months on the drug.
Before the trial in this case, Wyeth filed a motion
in limine asking the district court to exclude: (1) all suicide-
related warnings that accompanied Effexor after Mr.
Giles’s death in 2002, and (2) scientific data related to
suicidality in pediatric patients taking antidepressants. The
6 No. 07-3149
district court granted the motion in part, ruling that
evidence of post-2002 suicide-related warnings was not
admissible. It also denied the motion in part and allowed
the use of scientific evidence relating to pediatric
patients, including such evidence from after Mr. Giles’s
death.
After a three-week trial, the jury returned a verdict in
Wyeth’s favor. Mrs. Giles appeals the judgment against
her on her claim that Wyeth was strictly liable for failing
to provide adequate warnings for Effexor.
II. ANALYSIS
A. Basis for exclusion of later warnings
Mrs. Giles’s principal argument on appeal is that the
district court should not have precluded her from intro-
ducing the warnings that accompanied Effexor after her
husband’s death. The parties first disagree about the
basis of the district court’s decision to exclude the later
warnings. Mrs. Giles maintains that the district court
excluded this evidence only upon its determination that
FDA-mandated warnings were “subsequent remedial
measures” within the scope of Federal Rule of Evidence
407. This determination, she argues, was a legal one that
we should review de novo.
Wyeth, on the other hand, maintains that the district
court excluded the evidence under not just Rule 407, but
also under Federal Rule of Evidence 403, which allows
a district court to exclude relevant evidence when its
“probative value is substantially outweighed by the
No. 07-3149 7
danger of unfair prejudice, confusion of the issues, or
misleading the jury, or by considerations of undue delay,
waste of time, or needless presentation of cumulative
evidence.” We agree with Wyeth. Before trial, Wyeth filed
a motion in limine to exclude suicide-related warnings
given after Mr. Giles’s suicide and to exclude scientific
data relating to suicidality in pediatric patients taking
antidepressants. Wyeth argued in the motion that
Rule 403 and Rule 407 each independently supported
exclusion of both types of evidence. The district court
heard argument on the motion and ruled orally. It
denied Wyeth’s motion in part, as it allowed the use of
scientific evidence relating to pediatric patients. The
district court also granted the motion in part, stating that
“[p]ost remedial measures will not be—they’re not ad-
missible. The Court is exercising its discretion not to
admit that.”
During trial, Mrs. Giles’s counsel asked the district
court to revisit its pre-trial ruling that excluded evidence
of the warnings that accompanied Effexor after Mr. Giles’s
death. The district court declined to allow the evidence
of later warnings, stating that its ruling was “the same.
Under 403, although relevant, the Court’s going to exclude
this evidence finding that its probative value is substan-
tially outweighed by the confusion of the issues before
this . . . jury.” In its ruling at trial, then, the district court
invoked Rule 403 by name and used the language of Rule
403 to explain its decision to keep out the later warnings.
Even if the district court’s pre-trial ruling could be taken
to mean it had decided on the basis of Rule 407, the
district court clearly ruled during trial that the warnings
8 No. 07-3149
were excluded under Rule 403. We proceed, then, to
analyze whether exclusion under Rule 403 was proper.
B. Exclusion under Rule 403
We review a district court’s decision to exclude
evidence under Rule 403 for an abuse of discretion. Chlopek
v. Federal Ins. Co., 499 F.3d 692, 700 (7th Cir. 2007). In doing
so, we give the district court’s decision significant defer-
ence. Milhailovich v. Laatsch, 359 F.3d 892, 906 (7th Cir.
2004). Mrs. Giles’s claim is that Wyeth is strictly liable
under Illinois law for failure to provide adequate
warnings concerning Effexor, and that taking Effexor
caused Mr. Giles to take his life. In a strict liability case
based on a failure to warn in Illinois, “the plaintiff must
allege and prove that defendant knew or should have
known of the danger and this is tested on knowledge
existing at the time of production.” Smith v. Eli Lilly & Co.,
560 N.E.2d 324, 344 (Ill. 1990). We find no abuse of discre-
tion in the district court’s decision to exclude the later
warnings on the basis that their probative value was
substantially outweighed by the danger of confusing
the jury.
The warnings that accompanied Effexor after Mr. Giles’s
death had little, if any, probative value in this case.
First, and most significantly, the excluded warnings did
not help establish that Wyeth knew or should have
known about an increased risk of suicidality in adults
of Mr. Giles’s age. Mr. Giles was forty-six years old when
he took Effexor. The excluded post-2002 warnings, how-
ever, focused on children and adults younger than twenty-
No. 07-3149 9
five years old. The “black box” in the 2005 warning,
for example, was entitled “Suicidality in Children and
Adolescents” and warned that antidepressants had in-
creased the risk of suicidal thinking and behavior in
children and adolescents with major depressive disorder
and other psychiatric disorders. But it made no such
statement about adults. The 2007 warning expanded
the 2005 black box warning to “young adults,” meaning
persons younger than twenty-five, but Mr. Giles did not
fall within this age group either.
Instead of suggesting an increased risk of suicidality, the
Effexor warnings after 2002 actually more directly dis-
claimed any increased risk of suicidality in adults of
Mr. Giles’s age. The 2007 black box warning, the most
recent one at issue, made explicit that for a person in
Mr. Giles’s age group, no increased risk of suicidality
had been shown. It unambiguously stated: “Short-term
studies did not show an increase in the risk of suicidality
with antidepressants compared to placebo in adults
beyond age 24.” Warnings of an increased risk of
suicidality that pertained only to much younger persons
did not tend to show Wyeth’s knowledge of an increased
risk for persons of Mr. Giles’s age.
Mrs. Giles also points us to other language in the ex-
cluded warnings, untied to age, such as that stating that
“patients” should be observed closely for suicidality,
especially at the beginning of a course of drug therapy.
And it is true that Mr. Giles took his life two days after
he began taking Effexor. The precaution in place at the
time Mr. Giles took Effexor, however, already warned
that the possibility of a suicide attempt was inherent in
10 No. 07-3149
depression and that close supervision should accompany
initial therapy for high risk patients.
But even if the later warnings could be seen as
materially different from the 2002 precaution, Mrs. Giles
identifies no evidence that the excluded post-2002 warn-
ings were based on information Wyeth knew or rea-
sonably could have known at the time of Mr. Giles’s death.
See N. Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1038 (Ill.
App. Ct. 1991). The 2007 warning was based on conclu-
sions the FDA drew in 2006. Moreover, it drew these
conclusions from an analysis of adult clinical trial data
from all antidepressant manufacturers, not just from
Wyeth. Similarly, the bases for the 2004 warning and 2005
warning were pediatric trial results and the 2004 FDA
Pediatric Analysis, which the FDA did not begin until after
Mr. Giles’s death. Like the 2006 FDA analysis of antide-
pressant use in adults, the 2004 FDA Pediatric Analysis
was based on an examination of all antidepressant manu-
facturers’ clinical trial data. And there was no testimony
that data other than that for Effexor was available to Wyeth
before October 2002. Finally, although Mrs. Giles argues
that the burden was on Wyeth to analyze its data and then
to add an appropriate warning of the association between
Effexor and increased suicidality, she does not point us
to any evidence suggesting that analyzing Effexor’s
clinical trial data would have yielded results requiring
additional warnings for adults of Mr. Giles’s age.
The tendency of the later warnings to prove that Wyeth
knew of an increased risk of suicidality in persons of
Mr. Giles’s age was essentially nil in this case. Although
No. 07-3149 11
the later warnings might therefore seem to help Wyeth
in that they disclaim any relationship for adults of
Mr. Giles’s age, admitting these warnings which focused
on children, adolescents, and persons who were much
younger than Mr. Giles could have confused the jury. That
is, the jury might have thought that the warnings that
antidepressants had increased suicidal thinking and
behavior in certain adolescents and young adults also
had application to Mr. Giles, when there was no evidence
to support that. As a result, we do not find an abuse of
discretion in the district court’s determination that the
probative value of the post-2002 warnings was substan-
tially outweighed by the danger of confusing the jury. See
Chlopek, 499 F.3d at 700 (finding no abuse of discretion
in district court’s determination that evidence of a
changed warning label was excludable as unfairly prej-
udicial).
C. Admission of scientific evidence
Finally, Mrs. Giles argues that the district court’s
rulings prevented the jury from hearing “the whole truth.”
She maintains that it was error to let Wyeth introduce
scientific knowledge gained after Mr. Giles’s suicide,
including the FDA’s later data analyses, but not the
subsequent warnings. Mrs. Giles’s claim at trial was that
taking Effexor led her husband to commit suicide on
October 30, 2002. The jury therefore had to determine
whether Effexor caused Mr. Giles’s death, and scientific
evidence after 2002 that showed no increased risk of
suicidality when adults took Effexor was relevant to
12 No. 07-3149
whether Effexor caused Mr. Giles’s suicide. The question
at trial was not whether scientific knowledge in existence
in 2002 demonstrated that Effexor caused Mr. Giles to
take his life, it was whether Effexor caused him to take
his life. If later studies shed light on that answer, all the
better.
Whether Effexor’s warnings were adequate, on the other
hand, was time-dependent. Illinois law holds a manufac-
turer responsible for failing to warn only regarding
dangers it knew or should have known about at the time
it made the drug. See Smith, 560 N.E.2d at 344. It does not
hold a manufacturer liable for failure to warn about
dangers that might be revealed later if the manufacturer
had no reason to foresee them. It was therefore not incon-
sistent to allow post-2002 evidence on causation while
keeping out post-2002 warnings that did not pertain to
adults and was not based on information known when
Mr. Giles took Effexor.1
1
We note that the district court denied Wyeth’s request that
it be granted summary judgment on preemption grounds, and
Wyeth did not develop a preemption argument on appeal.
“[P]reemption is a defense and thus does not affect subject-
matter jurisdiction,” Baker v. IBP, Inc., 357 F.3d 685, 687 (7th
Cir. 2004), so we needed not address it here. Cf. Wyeth v. Levine,
128 S. Ct. 1118 (2008) (granting petition for writ of certiorari
on question of whether FDA drug labeling requirements
imposed on manufacturers preempt state law claims premised
on the theory that different labeling judgments were needed
to make the drugs reasonably safe for use). In light of our
(continued...)
No. 07-3149 13
III. CONCLUSION
The judgment of the district court is A FFIRMED.
1
(...continued)
decision, we also need not address Wyeth’s other arguments
in favor of upholding the verdict.
2-12-09