Monday, February 16, 2009
The recent opinion of the Seventh Circuit in Giles v. Wyeth, Inc., 2009 WL 331290 (7th Cir. 2009), provides me with the opportunity to discuss a couple of interesting aspects of Federal Rule of Evidence 407, the subsequent remedial measure rule.
In Giles, Jeff Giles, a forty-six-year-old man, took his life in the fall of 2002. His widow thereafter filed a wrongful death suit against Wyeth, the manufacturer of Effexor, the antidepressant Giles began taking two days before his death. A jury found in favor of Wyeth, and Giles' widow subsequently appealed, claiming, inter alia, that the district court erred by precluding her from introducing warnings that accompanied Effexor in the years following Giles' death.
The first question that the Seventh Circuit had to address was whether the district court excluded evidence of these warnings under Federal Rule of Evidence 407 or Federal Rule of Evidence 403. Rule 407 indicates in relevant part that:
When, after an injury or harm allegedly caused by an event, measures are taken that, if taken previously, would have made the injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove negligence, culpable conduct, a defect in a product, a defect in a product's design, or a need for a warning or instruction.
And, Rule 403 provides that:
Although relevant, evidence may be excluded if 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 Seventh Circuit concluded that the district court excluded evidence of these warnings under Rule 403 for two reasons. First, the district court initially granted Wyeth's motion in limine seeking to exclude this evidence by concluding that "[p]ost remedial measures will not be-they're not admissible. The Court is exercising its discretion not to admit that." If the court were applying Rule 407, its decision would have been mandatory, not discretionary whereas rulings under Rule 403 are discretionary. Secondly, and more importantly, during trial, the plaintiff's counsel asked the district court to revisit its pre-trial ruling, but the court still precluded the evidence, finding that "[u]nder 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."
So, why did this distinction matter? Well, if the district court had deemed the evidence inadmissible under Rule 407, its ruling would have been legal and as such reviewed by the Seventh Circuit de novo. But, because the district court excluded this evidence under Rule 403, its ruling was factual, and the Seventh Circuit could only have reversed for abuse of discretion. And the Seventh Circuit found no such abuse.
The Seventh Circuit engaged in a fairly extended review of the district court's opinion, but in the heart of its analysis, it found that the district court's Rule 403 ruling was proper because:
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. 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.
Of course, the above might lead one to wonder how the evidence of Wyeth's post-2002 warnings could have been admissible under Rule 407, which is the only way that the district court could ultimately have excluded that evidence under Rule 403. Well, Wyeth did not simply voluntarily change its warnings after 2002; instead, the changes were mandated by the FDA. And while the Seventh Circuit has not yet addressed this issue, it makes sense that the Rule would not apply under these circumstances because the main policy goal of Rule 407 -- encouraging defendants to take subsequent remedial measures without fear that evidence of those changes will be used against it at trial -- does not (really) apply when the defendant legally has to take the remedial measure at issue. Indeed, this is the argument that the plaintiff made in her brief in Giles, but it is one that the Seventh Circuit did not have to address because the district court's opinion was not based upon Rule 407.