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Koho v. Forest Laboratories, Inc.

United States District Court, W.D. Washington, Seattle

April 8, 2015

LOIS ILICH KOHO, Plaintiff,
v.
FOREST LABORATORIES, INC., et al., Defendants.

ORDER DENYING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

ROBERT S. LASNIK, District Judge.

This matter comes before the Court on "Defendants' Motion For Summary Judgment." Dkt. # 96. Having reviewed the memoranda, declarations, and exhibits submitted by the parties, and the arguments presented at the March 19, 2015 hearing on this motion, the Court finds as follows.

I. BACKGROUND[1]

Ray Ilich was prescribed the Selective Serontin Reuptake Inhibitor (SSRI) Celexa by his physician, Dr. Randall Gould, on August 7, 2002 to treat situational depression. Dkt. # 39-16 (Gould Decl.) at 2. For two days prior to receiving his prescription, Ilich had received Celexa from plaintiff, his wife. Dkt. # 97-1 (Koho Dep.) at 6 (31:1-7). Ilich returned to Dr. Gould on August 9, reporting that his condition had deteriorated and that he was experiencing suicidal ideation. Dkt. # 39-16 at 2. On August 13, seven days after being prescribed Celexa, Ilich committed suicide. Id . Ilich was 48 years old. Dkt. # 39-18 (Autopsy) at 1.

The New Drug Application (NDA) for Celexa was submitted to the FDA on May 7, 1997. Dkt. # 48 (Defs.' Resp. MSJ) at 12. The FDA approved Celexa on July 17, 1998, for the treatment of depression in adults. Id . In 2002, the risk of suicide was referenced on the Celexa warning label as follows:

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 Celexa should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Dkt. #39-19 (Label) at 2. As the FDA gradually became more aware of the suicidality risks posed by SSRIs, the agency began mandating more stringent warnings. On March 19, 2004, the FDA required that the Celexa warning label be modified to add a new subsection entitled "Clinical Worsening and Suicide" which read:

Patients with major depressive disorder, both adult and pediatric, can 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. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases... Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications should be alerted about the need to monitor patients for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.

Dkt. #51 (Konnerth Decl.) Ex. Y at 2 (emphasis in original). On May 1, 2007, the FDA continued to mandate the following language: "All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases." Id . Ex. MM at 3 (emphasis in original).[2]

Since approving the first SSRI, Prozac, in 1987, the FDA has received three citizen petitions requesting that approval be withdrawn based on claims that the drug caused suicidality. Dkt. # 48 at 12-15. These petitions, which were reviewed in 1990, 1991, and 1997, were rejected due to the FDA's conclusion that there was insufficient causal evidence to support an association between SSRIs and suicidality. Id. at 14. Over time, the FDA began mandating suicidality warnings concerning pediatric and young adult patients, but it has yet to find an increased risk of suicide in adults taking SSRIs. See id. at 16-19.

Plaintiff filed her Complaint in the above-captioned case in April 2005, representing herself to be the personal representative of Mr. Ilich's estate. Dkt. # 1 (Compl.) at 1. Plaintiff claims that Mr. Ilich's death was caused by defendants' failure to warn about risks associated with Celexa. Specifically, plaintiff argues that, at some point prior to Ilich being prescribed the drug, defendants "should have added a warning of increased risk of suicidal thoughts and behaviors early in treatment, including an emphasis on the importance of communicating the risk to family members who would be the first to observe any telltale changes in behavior." Dkt. # 54 at 4.[3]

This case was transferred to the Eastern District of Missouri in 2006 for consolidated pre-trial proceedings. See Dkt. # 26 (Transfer Order) at 1. On August 28, 2013, the case was remanded to this Court. Dkt. # 28 (Remand Order) at 1. On April 30, 2014, this Court granted plaintiff's motion for partial summary judgment. Dkt. # 64 (Order). In ruling that defendants could not use Washington's learned intermediary doctrine as an affirmative defense, the Court notes that it was clear from Dr. Gould's declaration and deposition testimony that Gould would have acted differently in Ilich's case had the risks conveyed by plaintiff's proposed warning been known to him. Id. at 15. The Court also clarified that plaintiff's proposed warning was not a warning that Celexa "increases the likelihood of suicide among adult patients." Id. at 13.

In August 2014, defendants filed the instant motion, Dkt. # 96, and a motion to exclude the testimony of plaintiff's expert witness for specific causation, Dr. David Healy, Dkt. # 98. In its motion for summary judgment, defendants argued that plaintiff had never been appointed the personal representative of Ilich's estate. Dkt. # 96 at 11. In response, plaintiff's counsel admitted that she had not in fact been appointed personal representative, that the Complaint was erroneous, and that the probate estate had yet not been opened. Dkt. # 101 (Pl. Resp.) at 7; Dkt. # 101-2 (Yackulic Decl.) at 1-2. Plaintiff's counsel claimed that this was a mistake and that counsel sought to rectify the problem as soon as it was brought to their attention. Dkt. # 101-1 at 1. Probate was opened in state court and plaintiff was made the estate's personal representative on September 10, 2014. Dkt. # 103 (Yackulic Decl. and ...


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