Vanderwerf v. Smithklinebeecham

Decision Date09 January 2008
Docket NumberCivil Action No. 05-2271-KHV.
Citation529 F.Supp.2d 1294
PartiesDebra VANDERWERF, Individually and as Next Friend for Riley and Tanner Vanderwerf, Minors, and Estate of William K. Vanderwerf, Plaintiffs, v. SMITHKLINEBEECHAM CORPORATION d/b/a GlaxoSmithKline, and Eli Lilly and Company, Defendants.
CourtU.S. District Court — District of Kansas

Brian J. Madden, Thomas P. Cartmell, Wagstaff. & Cartmell, LLP, Derek H. Potts, Timothy L. Sifers, The Potts Law Firm, LLC, Kansas City, MO, for Plaintiffs.

Andrew T. Bayman, Chilton D. Varner, Jennifer C. Kane, S. Samuel Griffin, Sarah T. Sloan, Scott B. Pfahl, Todd P. Davis, King & Spalding LLP, Atlanta, GA, Elizabeth Raines, Kara Trouslot Stubbs, Thomas N. Sterchi, Baker, Sterchi, Cowden & Rice, L.L.C., Kansas City, MO, Mark S. Brown, King & Spalding, LLP, Washington, DC, Robert E. Glanville, Tamar P. Halpern, Phillips Lytle LLP, Buffalo, NY, for Defendants.

MEMORANDUM AND ORDER

KATHRYN H. VRATIL, District Judge.

Debra Vanderwerf, Riley and Tanner Vandwerf and the Estate of William K. Vanderwerf bring this products liability suit against SmithKlineBeecham Corporation d/b/a GlaxoSmithKline ("GSK"). Plaintiffs, the surviving wife and children of William Vanderwerf, allege that Mr. Vanderwerf committed suicide after taking Paxil, a prescription drug which GSK manufactured.1 This matter is before the Court on Defendant's Motion For Summary Judgment (Doc. # 163) filed August 31, 2007 and Defendant's Motion To Exclude The Testimony Of Peter R. Breggin (Doc. # 150) filed August 10, 2007.2 For reasons stated below, the Court sustains both motions.

Summary Judgment Standards

Summary judgment is appropriate if the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, show no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. See Fed.R.Civ.P. 56(c); accord Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Vitkus v. Beatrice Co., 11 F.3d 1535, 1538-39 (10th Cir.1993). A factual dispute is "material" only if it "might affect the outcome of the suit under the governing law." Anderson, 477 U.S. at 248, 106 S.Ct. 2505. A "genuine" factual dispute requires more than a mere scintilla of evidence. Id. at 252, 106 S.Ct. 2505.

The moving party bears the initial burden of showing the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Hicks v. City of Watonga, 942 F.2d 737, 743 (10th Cir. 1991). Once the moving party meets its burden, the burden shifts to the nonmoving parties to demonstrate that genuine issues remain for trial as to those dispositive matters for which they carry the burden of proof. Applied Genetics Int'l, Inc. v. First Affiliated Sec., Inc., 912 F.2d 1238, 1241 (10th Cir.1990); see also Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Bacchus Indus., Inc. v. Arvin Indus., Inc., 939 F.2d 887, 891 (10th Cir.1991). The nonmoving parties may not rest on their pleadings but must set forth specific facts. Applied Genetics, 912 F.2d at 1241.

"[W]e must view the record in a light most favorable to the parties opposing the motion for summary judgment." Deepwater Invs., Ltd. v. Jackson Hole Ski Corp., 938 F.2d 1105, 1110 (10th Cir.1991). Summary judgment may be granted if the nonmoving parties' evidence is merely colorable or is not significantly probative. Anderson, 477 U.S. at 250-51, 106 S.Ct. 2505. "In a response to a motion for summary judgment, a party cannot rely on ignorance of facts, on speculation; or on suspicion, and may not escape summary judgment in the mere hope that something will turn up at trial." Conaway v. Smith, 853 F.2d 789, 794 (10th Cir.1988). Essentially, the inquiry is "whether the evidence presents a sufficient disagreement to require submission to the jury or whether it is so one-sided that one party must prevail as a matter of law." Anderson, 477 U.S. at 251-52, 106 S.Ct. 2505.

Factual Background

For purposes of this motion, the following facts are uncontroverted, deemed admitted or, where disputed, viewed in the light most favorable to plaintiffs.

I. Regulatory Approval Of Paxil And Its Labeling

Prescription Paxil (paroxetine hydrochloride) is one of a class of drugs known as selective serotonin reuptake inhibitors ("SSRIs"). On November 20, 1989, pursuant to Section 505(b) of the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 355(b), GSK filed a New Drug Application ("NDA") which asked the Food and Drug Administration ("FDA") to approve Paxil for treatment of depression in adults.

In connection with the Paxil NDA, because of a debate over a possible association between Prozac and suicide, the FDA asked GSK to report any relationship between Paxil and "violence-ideation and suicide-ideation."3 On May 10, 1991, GSK submitted an analysis of its worldwide clinical database which showed that patients randomized to Paxil therapy were at no greater risk for suicidal ideation or behavior than patients who were randomized to placebo or other active medication.4 See Exhibit 2 to Declaration Of Barbara E. Arning, M.D., attached to Defendant's Preemption Memorandum (Doc. # 171).

On December 29, 1992, having concluded that Paxil was safe and effective in the treatment of depression in adults, FDA issued an approval letter for Paxil.5 See Exhibit 5 to Arning Declaration. The original FDA-approved labeling did not include any warning or other statement that Paxil increased the risk of suicide or suicidality. The only references to "suicide" or "suicide attempt" appeared in the description of "a major depressive episode" and a precaution that suicide is an inherent risk for depressed patients.

On May 2, 2002 and February 6, 2003, GSK gave the FDA additional analyses of data which it had originally submitted on May 10, 1991, with regard to the original Paxil NDA. See Exhibits 15-16 to Arning Declaration. After reviewing that data, the FDA found neither an increased risk of suicidality from Paxil in adults nor a causal relationship between Paxil and suicidal thinking and behavior in adults.

On June 19, 2003, some four months after Mr. Vanderwerfs death, the FDA stated that it found "no evidence that Paxil is associated with an increased risk of suicidal thinking in adults." Extensive analyses of data from Paxil studies in adults and from postmarketing adverse event reports have revealed no increase in suicidal thoughts or suicide attempts compared to placebo. Exhibit 21 to Arning Declaration at 1; Exhibit 22 to Arning Declaration at 2.

In 2004, the year following Mr. Vanderwerf's death, the FDA asked GSK to reanalyze its adult Paxil data for suicidal behavior because of a 2004 finding of increased risk of suicidal behavior with antidepressant use by children.6 In March and April of 2006, GSK submitted to the FDA the results of its meta-analysis of Paxil placebo-controlled studies in adult patients with major depressive disorder ("MDD") and a similar meta-analysis of Paxil placebo-controlled studies in adult patients with non-MDD disorders.7 See Exhibit 36 to Arning Declaration. These analyses prompted GSK to consult with the FDA and to propose specific changes to Paxil labeling and warnings with respect to the risk of suicide.

On April 27, 2006, GSK submitted a labeling supplement which proposed to include in the Paxil prescribing information the following statement in the warnings section on Clinical Worsening and Suicide Risk:

Young adults, especially those with MDD, may be at increased risk for suicidal behavior during treatment with paroxetine. An analysis of placebo-controlled trials of adults with psychiatric disorders showed a higher frequency of suicidal behavior in young adults (prospectively defined as aged 18-24 years) treated with paroxetine compared with placebo (17/776 [2.19%] versus 5/542 [0.92%] ), although this difference was not statistically significant. In the older age groups (aged 25-64 years and R65 years), no such increase was observed. In adults with MDD (all ages), there was a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine compared With placebo (11/3,455 [0.32%] versus 1/1,978 [0.05%] ); all of the events were suicide attempts. However, the majority of these attempts for paroxetine (8 of 11) were in younger adults aged 18-30 years. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.

Exhibit 38 to Arning Declaration.8

In May of 2006, GSK implemented these changes to Paxil prescribing information and issued a "Dear Healthcare Professional" ("DHCP") letter to inform prescribers of new data on Paxil. The letter disclosed a "possible increase in risk of suicidal behavior" in adults of all ages who took Paxil for major depressive disorder. In its entirety, the letter stated as follows:

GlaxoSmithKline (GSK) would like to advise you of important changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the labels for PAXIL® (paroxetine HC1) and PAXIL CR® (paroxetine HC1 Controlled-Release Tablets). These labeling changes relate to your adult patients, particularly those who are younger adults....

Current prescribing information for paroxetine—and for all other antidepressants—contains information in the WARNINGS section (Clinical Worsening and Suicide Risk subsection) stating that "patients with MDD, 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."

GSK has...

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