Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Giles v. Wyeth

February 12, 2009

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.

The opinion of the court was delivered by: Williams, Circuit Judge.

ARGUED FEBRUARY 14, 2008

Before MANION, ROVNER, and WILLIAMS, Circuit Judges.

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 manufacturer 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 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 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 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. 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 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 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 ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.