Blanchard v. Eli Lilly & Co., 2:99-CV-256.

• Citation: 207 F.Supp.2d 308
• Decision Date: 29 March 2002
• Docket Number: No. 2:99-CV-393.,No. 2:99-CV-256.,2:99-CV-256.,2:99-CV-393.
• Court: U.S. District Court — District of Vermont
• Parties: Michael L. BLANCHARD, individually, and as Administrator of the Estate of Ross Allen Blanchard, and as the Administrator of the Estate of Rene Marie Blanchard, Plaintiff, v. ELI LILLY & COMPANY, Defendant. Jose G. Espinoza, individually, and as personal representative of the Estate of Elvira S. Espinoza, and Minnie T. Espinoza, Plaintiffs, v. Eli Lilly & Company, Defendant.

207 F.Supp.2d 308

Michael L. BLANCHARD, individually, and as Administrator of the Estate of Ross Allen Blanchard, and as the Administrator of the Estate of Rene Marie Blanchard, Plaintiff, v. ELI LILLY & COMPANY, Defendant.

Jose G. Espinoza, individually, and as personal representative of the Estate of Elvira S. Espinoza, and Minnie T. Espinoza, Plaintiffs, v. Eli Lilly & Company, Defendant.

No. 2:99-CV-256.

No. 2:99-CV-393.

United States District Court, D. Vermont.

March 29, 2002.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Arthur P. Anderson, Anderson & Buran, P.C., Burlington, VT, for Michael L. Blanchard.

Michael Frederick Hanley, Plante & Hanley, White River Junction, VT, Paul F. Waldner, Richard W. Ewing, Vickery & Waldner, Houston, TX, Arnold A. Vickery, Houston, TX, for Jose G. Espinoza, Minnie T. Espinoza.

Robert B. Hemley, Gravel and Shea, Burlington, VT, Michelle R. Mangrum, Erik M. Anielak, Andrew See, Margann M. Bennett, Shook, Hardy & Bacon, L.L., Kansas City, MO, Stephen E. Scheve, Shook Hardy and Bacon, Houston, TX, Paul D. Snyder, Polsinelli, White, Vardma Shalton, Kansas City, MO, for Eli Lilly & Co.

OPINION AND ORDER

SESSIONS, District Judge.

This is a drug product liability case in which the Plaintiffs claim that Elvira Espinoza shot and killed her children and then committed suicide as a result of her ingestion of Prozac, an antidepressant manufactured by Defendant Eli Lilly & Company ("Lilly"). Before the Court are Lilly's motions for summary judgment on the grounds of lack of admissible expert testimony on causation and lack of probable cause. For the reasons stated below, Lilly's motions (Docs. 96 & 101) are granted.

I. Background

For the purpose of resolving these summary judgment motions, the following facts are taken as true. On September 7, 1997 Elvira Espinoza ("Espinoza") shot her two children and immediately thereafter shot herself. All three died as a result of the gunshot wounds. At the time of her death and for some years previously, Espinoza was under treatment for depression and had been prescribed the antidepressant fluoxetine hydrochloride, commonly known as Prozac. During the last three months of her life, her dosage was increased from 20mg to 40 mg; however Espinoza was known to adjust her dosage as she saw fit, and it is uncertain how much Prozac Espinoza was taking when she died. Post mortem testing of Espinoza's blood revealed concentrations of Prozac and its metabolite norfluoxetine at ten times the approved therapeutic level.

Prozac is one of a class of drugs called selective serotonin reuptake inhibitors ("SSRIs"). There is medical and scientific evidence that SSRIs including Prozac are effective in treating major depressive disorders. This is because depression is associated with serotonin depletion in many people, and SSRIs are thought to increase the activity of the neurotransmitter serotonin in the brain.

Prozac is not effective for every patient suffering from depression however, and some patients have discontinued Prozac because of adverse side effects. For example, SSRIs may produce "extrapyramidal" side effects, described as abnormal bodily movement, such as "akathisia," a syndrome characterized by an inner sense of restlessness and an inability to sit or stand still. Roger M. Lane, SSRI-Induced Extrapyramidal Side-effects and Akathisia: Implications for Treatment, 12 J.Psychopharmacol. 192, 193 (1998). Mania (an abnormally elevated mood or irritability) or hypomania (a less severe form of mania) has been reported in a small proportion of patients treated with Prozac or other antidepressants. See Adrian Preda, et al., Antidepressant-Associated Mania and Psychosis Resulting in Psychiatric Admissions, 62 J.Clin. Psychiatry 30, 32 (2001). Antidepressant treatment may also trigger a "substance-induced mood disorder with mixed features," in which symptoms of both mania and depression are present. American Psychiatric Association, Diagnostic & Statistical Manual of Mental Disorders, 4th ed. (1994).

Prozac was first sold in the United States in early 1988. In early 1990 an article was published in the American Journal of Psychiatry hypothesizing that Prozac might induce suicidal ideation in some people suffering from depression. Martin H. Teicher, et al., Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment, 147 Am.J. Psychiatry 207 (1990). The authors observed that six depressed patients who had not had serious suicidal thoughts before taking Prozac developed responses after beginning Prozac treatment that were characterized by intense, violent suicidal thoughts. Id. Akathisia has also been associated with the emergence of uncharacteristic suicidal ideation and behavior. Lane, 12 J.Psychopharmacol. at 193.

In 1991 Lilly submitted a draft protocol for a "rechallenge"¹ study of patients who developed suicidal ideation while under Prozac treatment to the Food and Drug Administration, but this study was not performed. Instead Lilly conducted a "metaanalysis" of the clinical trial database for Prozac, consisting of all double blind, randomized trials of Prozac controlled against placebos or tricycle antidepressants, analyzing data from more than three thousand patients. Charles M. Beasley Jr. et al., Fluoxetine and Suicide: a Meta-analysis of Controlled Trials of Treatment for Depression, 303 Brit.Med.J. 685 (1991). The researchers concluded that the data did not show either increased risk of suicidal acts or the emergence of substantial suicidal ideation among patients treated with Prozac, relative to those receiving tricyclic antidepressants or placebos. Id.

According to her health care providers and her medical records, Espinoza was diagnosed with major depression and dependent personality disorder. There were significant psychosocial stressors in her life, including the breakup of her marriage, poverty, single motherhood, her belief that her ex-husband had abandoned their children, behavioral problems with the children, a threat of losing custody of them, academic difficulties in a nursing program she was pursuing, dissatisfaction with her appearance, and the absence of any intimate adult relationship upon which she could depend. She suffered mental anguish, self-loathing and hopelessness. Although at times in 1995 she had exhibited frantic, impulsive or aggressive behavior which could be described as hypomanic, in the days before her death she was calm and her behavior, including giving away possessions, suggested that she planned her suicide. She was not suffering from akathisia, a mixed state, mania, hypomania or from hypomanic symptoms at that time.

The Plaintiffs, Espinoza's ex-husband and her parents, obtained the opinion of psychiatrist and suicidology expert John T. Maltsberger, M.D. to determine the cause of this homicide-suicide. He is offered as their sole expert on causation. Dr. Maltsberger received his M.D. from Harvard University in 1959, and graduated from the Boston Psychoanalytic Institute in 1970. He completed postdoctoral training at Pennsylvania Hospital in Philadelphia, the Massachusetts Mental Health Center in Boston and the Boston Psychoanalytic Institute. He is an associate clinical professor of psychiatry at Harvard Medical School and an associate attending psychiatrist at McLean Hospital in Belmont, Massachusetts.

Dr. Maltsberger has a full-time clinical practice in psychotherapy and psychoanalysis. Many of his patients suffer from serious depressive illnesses. Some of them are actively suicidal. He has considerable experience in prescribing psychoactive drugs, including SSRI drugs generally and Prozac specifically. He has never had a patient under his care experience newly emergent suicidal thinking, attempt or commit suicide, or engage in violent assaultive behavior against anyone. He has not himself conducted any research on the question whether Prozac causes suicidal thoughts or violent behavior.

Dr. Maltsberger is a member and past president of the American Association of Suicidology, and belongs to the International Association for Suicide Prevention and the International Academy of Suicide Research. He has extensive teaching and consulting experience in the care and treatment of suicidal patients and has written numerous articles and edited and contributed chapters to several books on the subjects of suicide and suicidal patients. Dr. Maltsberger claims expertise in the fields of psychiatry and suicidology. He claims no expertise in the areas of pharmacology (the science of the composition, uses and effects of drugs), epidemiology (the science of the incidence, distribution and etiology of disease) or toxicology (the science of poisons, their effect and treatment).

Dr. Maltsberger reviewed the autopsy reports on Espinoza and the children, her medical records, a letter from her psychiatrist providing a chronology of her treatment, and transcripts of depositions of her parents, her ex-husband, her social worker and others. Dr. Maltsberger performed a "psychological autopsy"² by reviewing this extensive material about Espinoza's life and, based on his knowledge about psychosocial stressors and suicide and evidence that Prozac can cause suicidal ideation, concluded that Prozac was a contributing cause of Espinoza's suicide. See Maltsberger Report (Doc. 85).³ He explained:

Prozac disinhibited her, ... it was because of the Prozac that she had poor self-control and impulsivity and difficulty controlling aggression over a stretch of time. I think that what she did in those states was harmful to her self-respect and that as she quieted down somewhat, which she did, the effect of the Prozac disinhibition would have deepened her shame and lowered her very low self-respect even more so that the Prozac experience for her became one of several contributing causes to her suicide.

Maltsberger Dep. at 131 (Doc. 106, Ex. 2).

II. Discussion

A. Summary Judgment Standard

Summary judgment...