This was 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”).
The Plaintiffs, Espinoza’s ex-husband and her parents, obtained the opinion of psychiatrist and mental health expert John T. Maltsberger, M.D. to determine the cause of this homicide-suicide. 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 Selective serotonin reuptake inhibitor (SSRI) drugs generally and Prozac specifically. 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 health care 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), neuropharmacology, epidemiology (the science of the incidence, distribution and etiology of disease), or forensic toxicology (the science of poisons, their effect and treatment in criminal cases).
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” 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. 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.”
Lilly contended that Dr. Maltsberger’s general causation opinion, to the extent that it was based on case reports and clinical experience, was not reliable and therefore not admissible. Specifically it argued that his methods did not satisfy the factors set forth in Daubert because that they have not been tested; are not generally accepted in the medical and scientific community; have not been subjected to peer review; have an unknown rate of error; are not employed outside the courtroom; and do not derive from research independent of SSRI litigation. Lilly also contended that Dr. Maltsberger’s general causation testimony did not fit the facts of this case, and is therefore not relevant.
The Court began its analysis by confirming that Dr. Maltsberger was qualified to opine on the causation of suicide. Dr. Maltsberger made no claim to be expert in clinical pharmacology, epidemiology, or toxicology. A physician, or psychiatrist, need not be a specialist in a particular field in order to qualify as an expert, but rather simply have the “knowledge, skill, experience, training, or education” to assist the jury in determining a fact in issue. In the Court’s opinion, Dr. Maltsberger’s credentials and experience undoubtedly qualified him to testify concerning the cause or causes of suicide.
The Court then proceeded to its evaluation of the reliability and relevancy of Dr. Malstberger’s testimony. Dr. Maltsberger stated that he used inductive reasoning in reaching his opinions on both general and specific causation. In his process of inductive reasoning he stated that he employed the “Bradford Hill criteria”, a set of conditions which are useful in assessing general causation.
In addition, Dr. Maltsberger relied on two case report discussions, including a 1991 article in the Journal of Clinical Psychiatry describing three cases in which patients who had previously made serious suicide attempts while taking Prozac again took Prozac and again developed suicidal ideation. The article stated that when the patients had taken Prozac previously they had developed severe akathisia, and they stated that the development of this syndrome precipitated their suicide attempts. The akathisia and suicidal thinking abated upon discontinuing Prozac or adding an anti-anxiety drug to the treatment regime.
The authors observed this emergence of suicidal ideation secondary to akathisia in 3 of 1500 patients treated with Prozac, or 0.2%. Conservatively, they did not claim a causal relationship between Prozac and suicidal ideation. The article described a causal connection between Prozac and akathisia, and an association between akathisia and suicidal ideation.
Dr. Maltsberger also relied on a recent article in the British Journal of Psychiatry in which the authors compared the rates of “deliberate self-harm” between patients who had been prescribed a tricyclic antidepressant and patients who had been prescribed an SSRI such as Prozac. Although the authors found significantly more occasions of deliberate self-harm occurred following the prescription of an SSRI than a tricyclic antidepressant, the authors cautioned that establishing a cause and effect as opposed to an associational relationship between SSRIs and deliberate self-harm or attempted suicide was “almost impossible.” The authors noted that SSRIs may be prescribed to patients who are at greater risk for suicide because SSRIs are less likely to be fatally toxic in overdose, perhaps accounting for the link between SSRIs and higher rates of deliberate self-harm.
The psychiatric community acknowledged a controversy concerning whether the observed association between SSRI ingestion and suicide or violent behavior is causal. None of the published material submitted to the Court however went so far as to opine that SSRIs in general or Prozac in particular trigger suicidal thoughts or violent behavior. The Court noted that this was not determinative of whether an opinion indicating a causal link is admissible evidence.
Although Dr. Maltsberger testified at deposition that he was generally familiar with the range of scientific literature on the issue of SSRIs and violent or suicidal behavior, he did not discuss the methodology or his agreement or disagreement in any detail. The medical and scientific literature that disagreed with or contradicted Dr. Maltsberger’s opinion that Prozac can cause suicide or violent behavior did not factor into Dr. Maltsberger’s opinion on general or specific causation. According to the Court, simply stating without discussion that this material carried no weight with him does not constitute solid support for his contrary opinion.
Whether or not Dr. Maltsberger’s general causation opinion was sufficiently reliable to be admissible, however, the Court concluded that his opinion was inadmissible under Daubert because it does not fit the facts of this case. On whether Dr. Maltsberger’s opinion that Prozac can cause suicide and violent behavior passed a reliability scrutiny, Plaintiffs failed to show that his opinions support a conclusion that in Espinoza’s case Prozac caused disinhibition followed by shame and loss of self-respect so profound as to cause her to commit suicide. On this, Plaintiffs failed to satisfy Rule 702’s factor that “the witness has applied the principles and methods reliably to the facts of the case.”
In reaching this conclusion the Court stressed that it was not holding that Dr. Maltsberger’s methods cannot provide a reliable basis for an expert opinion on causation, but that in this particular case the information upon which Dr. Maltsberger based his opinion could not reliably determine the cause of this particular double homicide-suicide.
The problem was that Dr. Maltsberger’s conclusion was not adequately supported by the data on which he relied. Dr. Maltsberger relied on his clinical experience, but he had no direct clinical experience with patients who have experienced newly emergent suicidal thoughts, attempted or committed suicide or become violent while taking Prozac or any SSRIs. The scientific literature on which he relied did not opine on causation.
More importantly to the Court was that the Plaintiffs did not show that Dr. Maltsberger had any data, from clinical experience, scientific literature or elsewhere, that SSRIs trigger suicidal thoughts or violent behavior in individuals who are not contemporaneously experiencing the agitation of symptoms of akathisia, mania, hypomania or disinhibition. Espinoza did not suffer from any of these conditions when she committed her violent acts. Dr. Maltsberger believed that an individual in whom an SSRI had produced disinhibition can deteriorate psychologically over time to a point where her self-respect is so eroded that she may calmly and not impulsively plan to kill her children and herself. However, a belief without scientific backing is not reliable enough in the Court’s eyes.
In this case it is was thus not necessary to decide whether case studies, clinical experience, inductive reasoning and anecdotal evidence can be combined to form a proper foundation for an opinion on causation, because, regardless, the information these sources provided did not adequately support Dr. Maltsberger’s opinion. Even if the available information concerning causal links between (1) SSRIs; (2) akathisia, mania, hypomania, mixed states or disinhibition; and (3) suicidal thoughts or violent behavior is sufficiently reliable to be admissible, it was not probative of whether Prozac could cause suicide or violent behavior in one who appeared to have calmly planned her actions. The available information was connected to the circumstances surrounding the deaths in this case only by the beliefs of the expert. Accordingly, the opinion and testimony of Dr. Maltsberger that Prozac can and did trigger disinhibition succeeded over time by shame and loss of self-respect so profound as to cause murder and suicide was inadmissible as failing to meet the standards of Daubert and Rule 702. Without testimony that Prozac contributed to the deaths in this case, testimony about a causal connection in general between SSRIs and suicide or violent behavior, even if reliable, will not be helpful to the jury. The opinion and testimony that Prozac can cause suicide and violent behavior was therefore excluded as well.