Tucker v. Smithkline Beecham Corp.

• Decision Date: 30 March 2010
• Docket Number: Case No. 1:04-cv-1748-DFH-DML.
• Citation: 701 F.Supp.2d 1040
• Parties: Debra L. TUCKER, Individually and as Personal Representative of the Estate of Rick G. Tucker, Plaintiff,v.SMITHKLINE BEECHAM CORP., d/b/a GlaxoSmithKline, a Pennsylvania Corporation, Defendant.
• Court: U.S. District Court — Southern District of Indiana

701 F.Supp.2d 1040

Debra L. TUCKER, Individually and as Personal Representative of the Estate of Rick G. Tucker, Plaintiff,v.SMITHKLINE BEECHAM CORP., d/b/a GlaxoSmithKline, a Pennsylvania Corporation, Defendant.

Case No. 1:04-cv-1748-DFH-DML.

United States District Court,

S.D. Indiana,

Indianapolis Division.

March 30, 2010.

COPYRIGHT MATERIAL OMITTED

Bijan Esfandiari, Frances M. Phares, George W. Murgatroyd, III, Ronald L.M. Goldman, Baum Hedlund Aristei & Goldman, P.C., Los Angeles, CA, Dylan A. Vigh, Dulik & Vigh, Indianapolis, IN, for Plaintiff.

Andrew T. Bayman, Chilton Davis Varner, David F. Norden, Todd P. Davis, King & Spalding LLP, Atlanta, GA, Bonnie L. Gallivan, Katherine A. Winchester, Ice Miller LLP, Indianapolis, IN, Mark S. Brown, King & Spalding LLP, Washington, DC, Robert E. Glanville, Tamar P. Halpern, Phillips Lytle LLP, Buffalo, NY, for Defendant.

ENTRY ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

DAVID F. HAMILTON, Circuit Judge.^*

Introduction

Plaintiff Debra Tucker has sued defendant SmithKline Beecham Corp. d/b/a GlaxoSmithKline (“GSK”) for negligence, strict liability, and breach of express and implied warranty.¹ Plaintiff's brother was Father Rick Tucker, a Roman Catholic priest who committed suicide in September 2002, a few weeks after he began taking Paxil, an anti-depressant drug manufactured and distributed by GSK. Plaintiff Tucker alleges that GSK failed to include in Paxil's packaging and inserts a warning advising doctors and their patients of an increased risk of suicide in adults taking Paxil and that GSK's failure to warn proximately caused Father Tucker's death. GSK has moved for summary judgment on the issue of causation. On summary judgment, the court does not engage in fact-finding and does not weigh the credibility of conflicting evidence. Instead, the court must view the conflicting evidence and the undisputed evidence in the light reasonably most favorable to Tucker as the non-moving party, giving her the benefit of all reasonable inferences in her favor. The essential question is “whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 251-52, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The facts in this entry are stated in view of this standard, which requires the court to deny GSK's motion for summary judgment.²

I. Undisputed FactsA. GSK and Paxil

GSK markets, promotes, distributes, and manufactures the prescription drug paroxetine under the trade name Paxil. Paxil is generally classified as a selective serotonin re-uptake inhibitor, or SSRI, and has been approved by the U.S. Food and Drug Administration for the treatment of depression, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. GSK Answer ¶¶ 8, 11. SSRIs operate by adjusting the manner in which the neurotransmitter serotonin is processed by brain cells. SSRIs are used to treat depression, along with other conditions.

B. Father Rick Tucker

Father Tucker committed suicide on September 18, 2002. He left behind a journal, in which he documented his thoughts and feelings and recorded day-to-day events and activities. In his journal, he wrote about his physical state:

“I have discovered that I am diabetic.... Whole lifestyle change.” Dkt. 99, Ex. 4 at 0620 (June 11, 1999).

“Had my visit [with] Dr. Bright. The regular stuff was fine however he discovered a blockage in my carotid artery so he had me take an ultrasound.” Id. at 0680 (July 18, 2000).

“July 20, 2000, Thursday, I am to have an MRI done on July 28 then ... I am to have a stress test done. At first there was such an anxious feeling, but tonight I feel at peace.” Id. at 0681.

“Aug. 17, 2000, Thursday, Saw Dr. Bright today. There is a problem [with] my heart. So I am to have a heart cath. In the near future. Then I may have angiplasti [sic]. Time will tell. There are days that I feel anxious, but in general very much at peace....” Id. at 0683.

“(Undated entry) I had surgery on October 13 [2000]. It was textbook ... I left the hospital a day ahead of schedule. Spent two weeks at St. Mary Muncie-had great care. Came home and resumed duties full time after a couple of weeks. Much to be thankful for this year.” Id. at 0684.

Other journal entries describe other outside stressors affecting Father Tucker during this time:

[Regarding sister's allegations of sexual abuse against the Diocese]: “Well today starts the first day we wait to hear from the atty's. Please God, let this be over this week. Let them settle.” Id. at 1044 (Aug. 12, 2002).

“Debbie's Atty called and said he thought that we might not hear anything until Monday since strictly speaking they had until the end of business Friday to respond. Given their mindset I don't doubt that they will not do it this way. I also think they will fight this in some way.” Id. at 1044 (Aug. 15, 2002).

“Well, today begins another week of waiting. The Atty's meet Wednesday and map out the strategy to see how they will pursue the law suite [sic]. Mr. Veigh called Wednesday(?) to tell Debbie they were going to meet. There is a little fear in me that they will decide they can't win the case and need to drop it. However, I think that is just the anxiousness inside of me. I hope that when the diocese sees that she is serious, they will settle out of court. Bishop has this image he wants to portray, and I am hoping that plays in our favor.” Id. at 1046 (Aug. 26, 2002).

In May 1999, Father Tucker began seeing Thomas Bright, M.D., a practicing physician who is board certified in internal medicine, pulmonary disease, and critical care medicine. Dkt. 99 Ex. 1 at 7-9 (Bright Dep.). In September 1999, Dr. Bright prescribed Trazodone because Father Tucker was having difficulty sleeping. Id. at 47. He prescribed Ativan in September 2000 because Father Tucker was feeling anxious about an upcoming carotid artery surgery and pressures related to his work. Id. at 57-58.

On July 26, 2002, Father Tucker sought counseling from a psychologist, Dr. Thomas Murray. Dkt. 85 Ex. D at 33 (Murray Dep.). According to Dr. Murray, Father Tucker sought counsel because he had “little or no opportunity” to discuss, vent, or process his emotions. Id. Dr. Murray testified that Father Tucker was anxious regarding an upcoming audit by the diocese because he had “advanced himself some monies” and the Church would discover these “irregularities.” Id. at 34, 46. Dr. Murray also described Father Tucker as “angry and irritated at the diocese for not following through with what he thought they should have done” with regard to his sister's allegations. Id. at 34.

C. Father Tucker's Use of Paxil

On August 28, 2002, Dr. Bright prescribed Paxil for Father Tucker. Dkt. 85, Ex. C at 61-62 (Bright Dep.). Father Tucker had complained to Dr. Bright “that he had a problem with feeling panicked ... and said that it was making it difficult for him to perform his duties.” Id. at 62. Father Tucker advised Dr. Bright that “he was busy with church issues, and with a lawsuit ... he had things going on at the parish that he felt that he was experiencing these episodes of panic during the day that were new.” Id. at 62-63. Father Tucker reported that he was in counseling but that he wanted a prescription as well. Id. at 62.

Dr. Bright recommended that Father Tucker begin with a low dose of Paxil during the day. Before he prescribed Paxil, Dr. Bright took into consideration the risks and benefits of treatment. Id. at 62, 70. He discussed the potential side effects of the medication with Father Tucker. Id. at 64. Dr. Bright selected Paxil because, based upon local practice, it was the SSRI used most commonly for people with panic disorders and it “might be more beneficial.” Id. at 63. The doctor advised Father Tucker to let him know if he experienced any problems while on the medication or if he was not being benefitted. Id. at 64-65. Father Tucker never contacted Dr. Bright to discuss any perceived problems or lack of benefit from Paxil. Id. at 65, 66. Dr. Bright has no opinion either way as to whether Paxil caused or contributed to Father Tucker's death. Id. at 70.

Dr. Bright testified that prior to prescribing Paxil for Father Tucker, he had reviewed the package insert for Paxil. Id. at 34. He stated that in 2002, he was familiar with the package inserts for SSRIs. Dkt. 99, Bright Dec. ¶ 3. He did not recall any specific warnings in 2002 regarding an association between Paxil and suicide in adults. Nor did Dr. Bright have any independent knowledge in 2002 regarding any association between Paxil and suicide in adults. Id., ¶¶ 3-4. If he had been provided with a warning that Paxil was associated with suicide, he would have considered that warning in making his decision to prescribe Paxil to Father Tucker. Id., ¶ 6.

D Paxil, Other SSRIs, and Suicidality Generally

Even before Paxil was approved for use by the FDA, concerns existed that at least one other SSRI might actually cause patients to develop thoughts of suicide. A series of six Harvard case studies published in the American Journal of Psychiatry in February 1990 found that intense, violent, suicidal thoughts appeared to be associated with the use of fluoxetine (Prozac), a drug that operates in a manner similar to Paxil. See Teicher, M. H., et al Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment, Am. J. Psychiatry 147, 207-10 (1990). In 1991 the FDA convened a meeting of its Psychopharmacological Drugs Advisory Committee to evaluate the possible connection between fluoxetine and suicide. The PDAC and the FDA agreed that no credible evidence existed at the time that fluoxetine caused the “emergence and/or intensification of suicidality and/or other violent behaviors.” Dkt. 80, Ex. F at 294.

In evaluating the new drug application for Paxil, the lead FDA safety reviewer reported...