Excerpt from memo requesting psychiatric evaluation:
954 of 5513 words
Margaret Eve Miyasaki



Daubert v. Merrel Dow Pharmaceuticals, Inc.

Two recent United States Supreme Court decisions addressed the admissibility of scientific expert testimony and the testimony of non-scientific or "soft expert" testimony: Daubert v. Merrel Dow Pharmaceuticals, Inc. (1993) 509 U.S. 579, and Kumho Tire Company, Ltd. v. Carmichael (1999) 119 S.Ct. 1167.

The Court in Daubert set forth specific factors which may be used in determining whether theory or scientific knowledge will assist the trier of fact, and whether the evidence is admissible:

(1) whether the theory or technique can be, and has been tested

(2) whether the theory or technique has been subjected to peer review and publication

(3) the known or potential rate of error and existence and maintenance of standard's controlling technique's operation

Data from SSRI trial tests and research would be considered to be a component of Daubert. Whether it is scientifically valid to say that suicide and homicide are caused by SSRIs has been tested at seven Daubert hearings. SSRI manufacturers have paid out millions of dollars in damages to survivors of families of those who have suicided and committed homicide. Eli Lilly, for Prozac (fluoxetine), has settled some 200 cases. Aropax and Eflexor been withdrawn in the UK as for children and adolescents, a number of whom, treated for minor disorders, killed their entire families. The signs of violence and suicidality were there since Prozac (fluoxetine) was tested in premarketing trials.

By May 1984, Germany's regulatory agency (GBA) had already rejected Prozac (fluoxetine) as "totally unsuitable for treating depression." In July 1985, Eli Lilly's own data analysis from a pool of 1,427 patients showed high incidence of adverse drug effects and evidence of drug-induced violence in some patients.

SOURCE: Eli Lilly Controversy

LINK: http//

In May 1985, FDA's (then) chief safety investigator, Dr. Richard Kapit, wrote:

"Unlike traditional tricyclic antidepressants fluoxetine's profile of adverse side effects more closely resembles that of a stimulant drug than one that causes sedation." He warned "It is fluoxetine's particular profile of adverse side-effects which may perhaps, in the future give rise to the greatest clinical liabilities in the use of this medication to treat depression."

"Dr. Kapit's safety review described the clinical trial data from 46 trials with a total of 1,427 patients. He noted under the section, "Catastrophic and Serious Events," 52 cases of "egregiously abnormal laboratory reports which were the reason for early termination," and "additional adverse event reports not reported by the company [which] were revealed on microfiche." Dr. Kapit reported: "In most cases, these adverse events involved the onset of an unreported psychotic episode." There were 10 reports of psychotic episodes; 2 reports of completed suicides; 13 attempted suicides; 4 seizures, including a healthy volunteer; and 4 reports of movement disorders.

In 1985 Dr. Kapit recommended "labeling warning [for] the physician that such signs and symptoms of depression may be exacerbated by this drug"."


LINK: http//

Twenty years later, more suppressed data was revealed about adverse drug reactions of Prozac.

"In 2005, an internal document purportedly from Eli Lilly and Co. made public showed that the drug maker had data more than 15 years old showing that patients on its antidepressant Prozac were far more likely to attempt suicide and show hostility than were patients on other antidepressants and that the company attempted to minimize public awareness of the side effects. The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants. The document, which cited clinical trials of 14,198 patients on fluoxetine (Prozac) also stated that 2.3 percent of users suffered psychotic depression while on the drug, more than double the next-highest rate of patients using another antidepressant. The FDA has since issued strengthened warnings and broadened its public health advisories for "suicidality" in adults being treated with anti-depressant medications."


LINK: http//

Kumho Tire Company, Ltd. v. Carmichael

In Kumho, the court found that the gatekeeping obligation of a trial judge applies not only to scientific testimony but to all expert testimony.

" would prove difficult, if not impossible , for judges to administer evidentiary rules under which a 'gatekeeping' obligation depended upon a distinction between 'scientific' knowledge and 'technical' or 'other specialized' knowledge, since there is no clear line dividing the one from the others and no convincing need to make such distinction." Id., at pp. 1174-1175.

The Kumho decision also focuses on the shift in the role of the trial judge as gatekeeper.

"To say this is not to deny the importance of Daubert's gatekeeping requirement. The objective of that requirement is to ensure the reliability and relevancy of expert testimony. It is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho, 1176.

In a concurrence by Justice O'Connor and Justice Thomas:

"I think it worth noting that it is not discretion to perform the function inadequately. Rather, it is the discretion to choose among reasonable means of excluding expertise that is fausse and science that is junky." Id., at 1179.

The most significant aspect of Kumho is the emphasis on "gatekeeping"-- the court has a duty to ensure that evidence presented to a jury is both relevant and reliable--whether an expert is offered to opine on scientific matters or matters that fall outside of traditional lab study. Kumho stands for the proposition that evidence brought by expert testimony must pass the appropriate standard for scientific review.