In the

United States Court of Appeals

For the Seventh Circuit

No. 07-3149

JACQUELYN GILES, individually and as

Special Administrator of the Estate of

Jeff L. Giles, Deceased,

Plaintiff-Appellant,

v.

WYETH, INC., and WYETH PHARMACEUTICALS,

formerly known as AMERICAN HOME PRODUCTS

CORPORATION,

Defendants-Appellees.

Appeal from the United States District Court 

for the Southern District of Illinois.

No. 04 C 4245—J. Phil Gilbert, Judge.

ARGUED FEBRUARY 14, 2008—DECIDED FEBRUARY 12, 2009

Before MANION, ROVNER, and WILLIAMS, Circuit Judges.

WILLIAMS, 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 limited 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 depressed, lacked motivation, and had insomnia. His doctor

diagnosed him with major depressive disorder and prescribed 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 written for the smallest quantity of capsules consistent 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 antidepressant 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 increased 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 antidepressant 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 warnings’ language. (The FDA requires that certain contraindications 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 adolescents with Major Depressive Disorder (MDD) and other

psychiatric disorders.” It also said that analyses of shortterm 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 antidepressants. 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 manufacturers’ clinical trials involving adults in 2006. It concluded that for adults aged 25 to 64, no increase in suicidal

behavior was demonstrated among those taking antidepressants. 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 antidepressants 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 suiciderelated 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 introducing 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 admissible. 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 substantially 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 deference. 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 discretion 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, however, 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 increased 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 disclaimed 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 excluded 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 warnings were based on information Wyeth knew or reasonably 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 conclusions 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 antidepressant use in adults, the 2004 FDA Pediatric Analysis

was based on an examination of all antidepressant manufacturers’ 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 substantially 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 prejudicial).

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

We note that the district court denied Wyeth’s request that 1

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 subjectmatter 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...)

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 manufacturer 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 inconsistent 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
No. 07-3149 13

(...continued) 1

decision, we also need not address Wyeth’s other arguments

in favor of upholding the verdict.

2-12-09

III. CONCLUSION

The judgment of the district court is AFFIRMED.