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Koho v. Forest Laboratories, Inc.

United States District Court, W.D. Washington

April 30, 2014

LOIS ILICH KOHO, Plaintiff,
v.
FOREST LABORATORIES, INC., and FOREST PHARMACEUTICALS, INC., Defendants

For Lois Ilich, Individually and as Guardian of Monica Ilich, a minor, and as Personal Representative of the Estate of Raymond Ilich, Deceased, Plaintiff: Arnold Anderson (Andy) Vickery, LEAD ATTORNEY, PRO HAC VICE, PERDUE KIDD & VICKERY, HOUSTON, TX; Corrie Johnson Yackulic, LEAD ATTORNEY, Corrie Yackulic Law Firm, PLLC, SEATTLE, WA; Paul F Waldner, LEAD ATTORNEY, VICKERY & WALDNER, HOUSTON, TX.

For Forest Laboratories Inc, a foreign corporation, Defendant: Cash H. Mischka, LEAD ATTORNEY, PRO HAC VICE, ULMER & BERNE (CLEVELAND), CLEVELAND, OH; Jeffrey Royal Johnson, LEAD ATTORNEY, SCHEER & ZEHNDER LLP, SEATTLE, WA; Jeffrey F. Peck, LEAD ATTORNEY, PRO HAC VICE, John Ipsaro, Mary Lynn Tate, LEAD ATTORNEYS, ULMER & BERNE (CINCINNATI), CINCINNATI, OH; Joseph P Thomas, LEAD ATTORNEY, ULMER & BERNE, CINCINNATI, OH.

For Forest Pharmaceuticals Inc, a foreign corporation, Defendant: Cash H. Mischka, LEAD ATTORNEY, PRO HAC VICE, ULMER & BERNE (CLEVELAND), CLEVELAND, OH; Jeffrey Royal Johnson, LEAD ATTORNEY, SCHEER & ZEHNDER LLP, SEATTLE, WA; John Ipsaro, Mary Lynn Tate, LEAD ATTORNEYS, ULMER & BERNE (CINCINNATI), CINCINNATI, OH; Joseph P Thomas, LEAD ATTORNEY, ULMER & BERNE, CINCINNATI, OH.

OPINION

Page 1110

ORDER GRANTING PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT

Robert S. Lasnik, United States District Judge.

I. INTRODUCTION

This matter comes before the Court on plaintiff's " Motion for Partial Summary

Page 1111

Judgment" (Dkt. #39) and " Motion to Supplement Summary Judgment Record" (Dkt. #55). Defendants respond with motions to strike a number of plaintiff's exhibits (Dkt. #48). Plaintiff has alleged products liability claims against defendants related to the 2002 death of her husband Ray Ilich. See Complaint (Dkt. #1) at 2-3. Plaintiff seeks summary judgment on two of defendants' affirmative defenses: preemption and the learned intermediary doctrine.

The Court has reviewed the parties' submissions and heard oral argument on the motion. For the reasons discussed below, the Court GRANTS in part and DENIES in part defendants' motions to strike,[1] GRANTS plaintiff's motion to supplement summary judgment record, and GRANTS plaintiff's motion for partial summary judgment.

II. DISCUSSION

A. Background

Ray Ilich was prescribed the Selective Serotonin Reuptake Inhibitor (SSRI) Celexa by his physician, Dr. Randall Gould, in 2002 to treat situational depression. Motion (Dkt. #39) Ex. 16 at 2. Ilich returned to Dr. Gould a few days later reporting that his condition had deteriorated. Id. On August 13, seven days after being prescribed with Celexa, Ilich committed suicide. Id. Ilich was 48 years old. Id. Ex. 18 at 1.

The New Drug Application (NDA) for Celexa was submitted to the FDA on May 7, 1997. Response (Dkt. #48) 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.

Motion (Dkt. #39) Ex. 19 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

Page 1112

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.

Konnerth Decl. (Dkt. #51) 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. Response (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. Complaint (Dkt. #1) at 1. The case was transferred to the Eastern District of Missouri in 2006 for consolidated pre-trial proceedings. See Transfer Order (Dkt. #26) at 1. While conducting the Multi-District Litigation, the court ruled that plaintiff's warnings expert, Dr. Michael Hamrell, was qualified to give expert testimony concerning the Celexa warning label. See In re Celexa and Lexapro Products Liab. Litig., MDL No. 1736, 2013 WL 791784, at *6 (E.D. Mo. March 4, 2013). On August 28, 2013, the case was remanded to this Court. Remand Order (Dkt. #28) at 1.

B. Motions to Strike

Defendants have moved to strike Exhibits 1, 2, 8, 16, 17, 18, 20, 22, 23, 25, 26, 27, 28, 29, and 30 in support of plaintiff's motion for partial summary judgment. Response (Dkt. #57) at 2. Plaintiff responds by moving to supplement the record with the Declaration of Arnold Vickery (Dkt. #55-1) and the deposition of Dr. Randall Gould. Motion (Dkt. #55) at 1-2. As many of the contested exhibits can ...


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