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Giles v. Wyeth Inc

June 18, 2007

JACQUELYN GILES, INDIVIDUALLY AND AS SPECIAL ADMINISTRATOR OF THE ESTATE OF JEFF L. GILES, DECEASED, PLAINTIFF,
v.
WYETH INC, A DELAWARE CORPORATION AND ITS WHOLLY-OWNED SUBSIDIARY, WYETH PHARMACEUTICALS, FORMERLY KNOWN AS AMERICAN HOME PRODUCTS CORPORATION, DEFENDANTS.



The opinion of the court was delivered by: Gilbert, District Judge

MEMORANDUM AND ORDER

I. Introduction

Jeff Giles, a forty-six-year-old white male, committed suicide on October 30, 2002. Several days earlier, his family physician diagnosed him with depression and prescribed Effexor, an antidepressant. Jacquelyn Giles (Giles), Jeff's widow, contends that Effexor was a proximate cause of his suicide.

In her complaint, Giles alleges that Jeff was a member of a "small vulnerable subpopulation" in whom Effexor and other selective serotonin reuptake inhibitors (SSRIs) and selective seratonin norepinephrine reuptake inhibitors (SNRIs) increase the risk for violence and suicide. Giles brings this action against Wyeth*fn1 , the manufacturer of Effexor, alleging that it has known about this small vulnerable subpopulation for years, but "has failed to conduct any prospective tests to determine the frequency of this phenomenon or to develop means of identifying, screening, and protecting those patients who are in this risk group." (Amend. Compl. at 3). Giles believes Wyeth should have warned doctors, pharmacists, and patients about this risk.

To show Effexor caused her husband to commit suicide, Giles intends to rely on the opinions of two experts: Joseph Glenmullen and Ronald Maris. After deposing Glenmullen and Maris and perusing their reports, Wyeth filed a motion to exclude their testimony as both irrelevant and unreliable under Federal Rule of Evidence 702 (Doc. 88). It contends "there is no evidence to 'rule in' [the experts'] theory of general causation and . . . [that] their views on specific causation do not 'fit' the facts of this case." (Doc. 88 at 1). Giles has responded to Wyeth's motion (Doc. 103) and Wyeth has replied to the response (Doc. 110). Having reviewed the motions and the record, and having heard the parties orally argue the motion, the Court is now prepared to rule.

II. The Expert Reports

A. Glenmullen

Glenmullen*fn2 has concluded that Jeff "developed classic symptoms of antidepressant-induced decompensation leading to suicidality." (Glen. Rep. at 1). He thinks the side effects of taking the drug -- principally akathisia -- caused Jeff to commit suicide. He based this opinion on his interviews with Giles and her son, his review of the record in this case, his clinical experience, and his reading of the relevant medical literature.

i. General Causation

Glenmullen's opinion on general causation*fn3 -- whether Effexor can cause suicidality as a general matter -- is based on an amalgamation of different sources, including his experience in treating patients with "this side effect," Food and Drug Administration (FDA) warnings on the risk of suicide, and academic journal articles.*fn4

Glenmullen first points to the warnings currently given with antidepressants, including Effexor, indicating they may cause "anxiety, agitation, panic attacks, insomnia, irritability, hostility, akathisia (severe restlessness), hypomania, and mania" and may cause or worsen suicidality. (Glen. Rep. at 5). Glenmullen focuses on akathisia, a condition which causes individuals to become anxious, agitated, panicky, sleepless, and look manic or hypomanic. He believes akathisia can cause patients to commit suicide and that it was a primary factor leading to Jeff's suicide. (Glen. Rep. at 7).

Glenmullen relies on the research of Drs. Teicher and Cole, pioneers in the field, which suggests that antidepressant-induced suicidal thoughts "involve an intense violent suicidal preoccupation." (Glen. Rep. at 8) (internal quotation marks omitted). Finally, Glenmullen relies on internal Eli Lilly documents from the early 1990's suggesting the potential for a suicidal reaction to antidepressants. (Glen. Rep. at 9).

ii. Specific Causation

Glenmullen based his opinion on specific causation -- whether Effexor caused Jeff to commit suicide -- on his post-mortem, differential diagnosis of Jeff's case.*fn5 Jeff took three Effexor pills in the two days before he killed himself. Though he was on Effexor for a short time, Glenmullen believes Jeff developed akathisia and other side effects because the night before he died, Jeff was agitated, restless, anxious, had trouble sleeping and acted out of character in a number of ways. (Glen. Rep. at 13).

Glenmullen concluded that Jeff's suicide was not due to his underlying depression, an underlying anxiety disorder, an underlying psychotic disorder, being laid off work or financial hardship, previous surgery, alcoholism, substance abuse, a character disorder, another concurrent psychiatric condition, concurrent medical condition, or another prescription medication. Having ruled these causes out in the course of his differential diagnosis and because Jeff had no prior history of depression or suicide, but the traditional characteristics of antidepressant-induced akathisia, he believes Effexor caused the suicide.

B. Maris

Maris is a "suicidologist/suicide expert" for the Psychiatry and Family Medicine Departments within the University of South Carolina School of Medicine. As a suicidologist, Maris has investigated and studied thousands of suicides. (Maris Rep. at 2). Like Glenmullen's, Maris's report concludes that Effexor caused Giles's suicide.

i. General Causation

Maris based his conclusions on general causation on his clinical experience and a number of studies that tie antidepressant-induced suicide to akathisia.

Maris devotes considerable effort to addressing the faults of randomized clinical trials (RCTs) for purposes of studying suicide. For one thing, researchers exclude "seriously suicidal subjects" from these studies for ethical reasons.*fn6 (Maris Rep. at 9). Because of this, Maris thinks RCTs "are not studying the populations most at risk." (Id. at 9). Two other concerns figure prominently in his critique. The first relates to clinical trials themselves. Maris believes the conditions of treatment in these trials differ greatly from those in a non-clinical setting. Second, he observes that the RCTs relied on by drug manufacturers were not specifically designed to examine Giles's hypothesis -- antidepressants cause a small population of patients to become suicidal. Because they were not designed primarily to detect suicide, and RCTs are not structured to detect rare outcomes anyway, Maris believes they are too obtuse to be the "gold standard" on causation here.

Maris's problems with RCTs lead him to give more weight to small studies designed specifically to test the potential of antidepressant-induced akathisia and suicidality. Therefore, in coming to his conclusion, he puts greater emphasis on challenge/dechallenge/rechallenge studies and case reports.*fn7 In support of his reliance on these studies, he points to the prior testimony of an Eli Lilly expert, who said he considered these tests to be the preferred methodology for detecting antidepressant-induced suicide.

ii. Specific Causation

Maris based his opinion on specific causation on a "psychological autopsy," which he defined as procedure "reconstructing an individual's psychological life . . . particularly the person's lifestyle and those thoughts, feelings, and behaviors manifested during the weeks preceding death." (Id. at 12).

Maris found it important that Jeff had not been abusing alcohol or taking any other psychiatric medications before his death and that he developed "classic adverse suicidogenic reactions" after taking Effexor. Maris reached his ultimate conclusion somewhat differently than Glenmullen, however, in that he found Jeff's other risk factors -- his family history of depression, physical injuries, chronic pain, and employment status -- were all suicidogenic as well. (Maris Rep. at 19). Because Jeff had had the other risk factors for many years without attempting suicide, and by all accounts, without suicidal thoughts, Maris sees his taking of Effexor as the "scale-tipper . . . that pushed [him] over the edge." (Id.). He admits that "Jeff's depressive disorder was one proximate cause of his suicide." (Id. at 22).

III. Standard

In Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), the Supreme Court held that Federal Rule of Evidence 702 did not incorporate the "general acceptance" test set forth in Frye v. United States, 54 App. D.C. 46 (D.C. Cir. 1923). Instead, the Court held that Rule 702 required district judges to be gatekeepers for proposed scientific evidence. Daubert, 509 U.S. at 589; see also Joiner, 522 U.S. at 142. For scientific evidence to be admissible, the Court found, a district court must find it both relevant and reliable: it must be scientific knowledge grounded "in the methods and procedures of science" and consist of more than "subjective belief or unsupported speculation." Daubert, 509 U.S. at 589-90.

When dealing with scientific evidence, the preliminary question is "whether the reasoning or methodology underlying the testimony is scientifically valid and . . . whether that reasoning or methodology properly can be applied to the facts in issue." Id. at 592-93. Considerations pertinent to this inquiry include whether a theory or technique is capable of being or has been tested, whether it has been subjected to peer review and publication, its known or potential rate of error when applied, and whether it has gained general acceptance. Id. at 593-94; accord United States v. Conn, 297 F.3d 548, 555 (7th Cir. 2002).

In 2000, Rule 702 was amended in response to Daubert. Conn, 297 F.3d at 555. In its current ...


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