The Seventh Circuit has affirmed a defense jury verdict in a suit by a woman whose husband killed himself two days after starting the drug Effexor to treat major depression. Giles v. Wyeth, 2009 WL 331290 (7th Cir. Feb. 12, 2009).

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 anti-depressants. The 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 appealed the judgment.

The district court excluded the later warning evidence based upon its determination that FDA-mandated warnings were “subsequent remedial measures” within the scope of Federal Rule of Evidence 407, and 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 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.”

The 7th Circuit focused on Rule 403, as the standard of review here was abuse of discretion,  The warnings that accompanied Effexor after Mr. Giles’s death had little, if any, probative value. 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. In fact, 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.

Plaintiff identified 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. The later warning was based on conclusions the FDA drew after the death, based mostly on data gathered after the death.  Moreover, it drew these conclusions from an analysis of adult clinical trial data from all antidepressant manufacturers, not just from Wyeth. There was no proof Wyeth could have known about other company’s data.

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.” The later 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, the court of appeals did 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.