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Mason v. Smithkline Beecham Corp.

July 7, 2010

BONNIE J. MASON, INDIVIDUALLY AND AS A CO-ADMINISTRATOR OF THE ESTATE OF TRICIA M. MASON, DECEASED, AND WILLIAM L. MASON, INDIVIDUALLY AND AS CO-ADMINISTRATOR OF THE ESTATE OF TRICIA M. MASON, DECEASED, PLAINTIFFS,
v.
SMITHKLINE BEECHAM CORP. D/B/A GLAXOSMITHKLINE, A PENNSYLVANIA CORPORATION, DEFENDANT.



The opinion of the court was delivered by: Hon. Michael M. Mihm U.S. District Judge

ORDER

This matter is before the Court on Defendant's Motion for Summary Judgment. For the reasons set forth below, the Motion for Summary Judgment [#76] is DENIED IN PART and GRANTED IN PART.

JURISDICTION

This Court has jurisdiction over the matter pursuant to 28 U.S.C. § 1332, since there is complete diversity of citizenship between the parties and the amount in controversy exceeds $75,000.00.

BACKGROUND

This is a wrongful death case brought by Plaintiffs, the parents of the deceased and co-administrators of her estate, against Defendant Smithkline Beecham Corporation, d/b/a/ Glaxosmithkline ("GSK"), the manufacturer and distributor of the antidepressant drug Paxil. Plaintiffs allege that Paxil caused their daughter, Tricia Mason ("Tricia"), to commit suicide, and that GSK failed to adequately warn prescribing physicians and patients of the risk that Paxil can increase the chances of suicidal behavior in patients suffering from depression and other psychiatric disorders.

Defendant GSK manufactures and distributes Paxil, an antidepressant commonly classified as a selective serotonin reuptake inhibitor ("SSRI"). (Defendant's Memorandum in Support of Summary Judgment at 2.) The drug was originally approved by the Food and Drug Administration ("FDA") as safe and effective for treating a variety of psychiatric disorders, including depression. Id. GSK included the following warning to prescribing physicians in the 2003 Package Insert for Paxil and in the Physician's Desk Reference ("PDR"):

PRECAUTIONS: Suicide. The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs.

Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Paxil (paroxetine hydrochloride) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Because of well established comorbidity between major depressive disorders and other psychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric disorders. (Def. Br. 3.)

On February 27, 2003, Tricia visited Nurse Practitioner Robin Schertz*fn1 ("Nurse Schertz") at the Carle Clinic in Bloomington, Illinois. (Plaintiff's Memorandum in Opposition to Summary Judgment at 4.) During the visit, Tricia told Nurse Schertz that she had been feeling depressed and that her family had a history of depression; specifically, her mother was taking an antidepressant and had attempted suicide. Id. Nurse Schertz asked if Tricia had any suicidal thoughts or ideation, which she denied. Id. She then diagnosed Tricia with depression, prescribed Paxil 12.5 mg, and gave her two sample packs of the medication. Id. Two days later, on March 2, 2003, Tricia committed suicide by ingesting cyanide. Id. She was 23 years old at the time. (Nurse Schertz Deposition, 41.)

Some evidence indicates that Tricia had suicidal thoughts prior to taking Paxil. Two of Tricia's friends, Danny Dones ("Dones") and Jason Pemberton ("Pemberton"), stated in depositions that Tricia had confided her suicidal thoughts with them on two different occasions. Dones testified that two months prior to taking Paxil, Tricia told him she was feeling depressed and "had mixed some chemicals together and was keeping them so that she could drink them and commit suicide" (Dones Dep., Defendant's Exhibit B at 39). He believed he talked her out of it, however, since she promised to pour out the mixture and speak with a therapist. Id. Pemberton testified that around Valentine's Day, two weeks before taking Paxil, Tricia had told him she had "contemplated" committing suicide. He believed that she was "down and lonely and depressed" and that if he could get her talking with her friends, she would get "out of the rut" (Pemberton Dep., Def.'s Ex. C, 38-39). Unlike her conversation with Dones, Tricia did not mention a method of how she might commit suicide that time. Id. at 38. Dr. Joseph Glenmullen, Plaintiff's designated expert witness, opined in his deposition that Tricia's statements to Dones and Pemberton were probably not serious statements, but cries for attention (Dr. Glenmullen Dep., Pl.'s Ex. 2, 291-292).

In May 2006, three years after Tricia's suicide, GSK changed the information provided in the "Warnings" section of the Package Insert and PDR to the following:

Young adults, especially those with MDD [Major Depressive Disorder], 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), no such increase was observed. In adults with MDD (all ages), there was a statistically significant increase in the frequency of suicidal behavior 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. (Def. Mem. Supp. Summ. J. 5.)

Also in May 2006, GSK released a "Dear Healthcare Professional" letter that drew attention to the changes in the "Warnings" section for Paxil. (Pl.'s Ex. A to Donald J. Farber Declaration.) In pertinent part, the letter stated that there was a "higher frequency of suicidal behavior in young adults (prospectively defined as age 18-24)," but that the finding "was not statistically significant." It also noted that for patients of all ages with Major Depressive Disorder, the difference was "statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution." The group with the greatest increase in suicidal activity was MDD patients between the ages of 18-30. The letter concluded by stating that it was "difficult to conclude a causal relationship between paroxetine and suicidality due to the small incidence and absolute number of events, the retrospective nature of this meta-analysis, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves."

Prior to prescribing Paxil, Nurse Schertz does not remember whether she had read the warnings contained in the 2003 Package Insert or PDR (Nurse Schertz dep., 88, 90), but she testified that it was her "custom and practice" to inform herself about the risks of medications by reading PDRs and package inserts, id. at 20. She also testified that she would have provided the 2006 warning about the increased suicide risk for young adults to Tricia prior to prescribing Paxil. Id. at 44-46. She stated that if she knew that Paxil would worsen Tricia's symptoms of depression and increase her risk for having suicidal behavior, she would not have prescribed Paxil. Id. at 74-75. At another point in the testimony, however, she stated she would still have prescribed the drug if she knew of the information from the 2006 warnings and "Dear Healthcare Provider" letter because Tricia denied ever having suicidal thoughts. Id. at 58, 62.

PROCEDURAL HISTORY

On August 31, 2005, Plaintiffs initiated this action against GSK, alleging that Paxil caused Tricia's death and that GSK failed to issue an adequate warning label because it "did not warn about the association with and risk of akathisia, did not warn about the risk of psychosis, and did not warn that Paxil is associated with acts of violence and/or self-harm." (Complaint at 6.) They allege that GSK was aware of the connection as early as February 1990 -- ...


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