In Wrongful Death Action, Subsequently Changed Antidepressant Warning Labels Were Properly Excluded Under FRE 403 | Federal Evidence Review

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In Wrongful Death Action, Subsequently Changed Antidepressant Warning Labels

Were Properly Excluded Under FRE 403

â Fri, 02/20/2009 â Editor's blogâ  â â Printer-friendly versionâ 

On strict liability claim, because the evidence was properly excluded by danger

of confusing issues in the case, it was not necessary to consider whether the

changed warnings were admissible as a subsequent remedial measure under FRE 407,

in Giles v. Wyeth, Inc., 556 F.3d 596 (7th Cir. Feb. 12, 2009) (NO. 07-3149)

A recent Seventh Circuit case demonstrated how subsequent changes to a drug

warning label, could be excluded in a wrongful death action as unfairly

prejudicial without considering whether the modified labels were admissible

under FRE 407.

In the case, a doctor had determined that Giles suffered from a major depressive

disorder and prescribed the antidepresent Effexor. Giles took three pills two

days before he shot himself in October 2002. His wife filed a wrongful death

action against the manufacturer of Effexor. At trial the court excluded evidence

that the manufacturer had later issued warnings about the risk of suicide in

younger persons. At the time he took the pills, the warning label included a

suicide precaution:

“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.â€

After the manufacturer conducted pediatric clinical trials, the label was

modified in August 2003 to note “an increased risk of suicidal ideation in

children using the drug.†Giles, 556 F.3d at 598. In 2004, the Food and Drug

Administration required a new warning. The company modified its warning:

“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 . . . .â€

After further review and analysis of clinical trial data from antidepressant

manufacturers, in January 2005, the FDA issued a “black box†warning for

antidepressants. In 2005, the company modified the label warning and included a

black box entitled “Suicidality in Children and Adolescents.†In bold text,

the warning cautioned:

“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.â€

The warning noted that “analyses of short term placebo-controlled trials in

children and adolescents 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.†, 556 F.3d at 599. The label outside the

black box, further noted:

“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.â€

In 2006, the FDA completed a study of the clinical trials and “concluded that

for adults aged 25 to 64, no increase in suicidal behavior was demonstrated

among those taking antidepressants.†Giles, 556 F.3d at 599. In 2007, a new

black box warning was issued by the FDA, which noted:

“Short-term studies did not show an increase in the risk of suicidality with

antidepressants compared to placebo in adults beyond age 24.â€

However, the warning noted “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.†Giles, 556 F.3d

at 599.

The manufacturer moved in limine to exclude the modified label warning after the

death under both FRE 407 and FRE 403. The trial court excluded evidence of

“[p]ost remedial measures†but allowed evidence of “scientific evidence

relating to pediatric patients.†Later, plaintiff’s counsel asked the court

to reconsider its ruling, and the trial court indicated the ruling had not

changed, and noted the probative value of the evidence was “outweighed by the

confusion of the issues before this . . . jury.†Giles, 556 F.3d at 600. The

jury’s verdict was in favor of the manufacturer. The plaintiff appealed the

exclusion of the subsequent warning labels.

The Seventh Circuit found no abuse of discretion in the exclusion of the

subsequent warning labels evidence. As the circuit explained:

“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-five years old.â€

Giles, 556 F.3d at 601.

Additionally, there was no showing “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.†Giles, 556 F.3d at 601 (citing N. Trust Co. v. Upjohn

Co., 572 N.E.2d 1030, 1038 (Ill. App. Ct. 1991)). In particular, the circuit

noted, “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.†Giles, 556

F.3d at 601.

The initial basis for the trial court ruling was unclear. The motion to exclude

the evidence was grounded on both FRE 407 and FRE 403. Nonetheless, the Giles

case demonstrates how FRE 403 operated to exclude evidence of label warning

changes, which were predicated on subsequent independent events.

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