Drugs - Liability / Evidence & Causation

Court allows expert to speculate that Zoloft use is associated with suicide over defendant's argument that the expert's testimony did not meet the Daubert standard. Court finds that expert does not need to show methodology and does not need to show causation, only that they are possibly related.

Court allows expert speculation over Daubert objections - Miller v. Pfizer, Inc., 2000 U.S.Dist. LEXIS 9816 (D.Kan. 20000)

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF KANSAS

MEMORANDUM AND ORDER

This matter comes before the Court on Defendant Pfizer Inc's Motion To Exclude Opinion Testimony Of Morton M. Silverman (Doc. # 200) and Defendant Pfizer Inc's Motion To Exclude Opinion Testimony Of Donald H. Marks (Doc. # 202), both filed April 18, 2000.

Analysis

Rule 702, Fed. R. Evid., provides that a witness who is qualified by knowledge, skill, experience, training or education, may testify in the form of opinion as to scientific, technical or other specialized knowledge if such testimony will assist the trier of fact to understand the evidence or to determine a fact in issue. Under Daubert, when expert testimony is offered, a district court must determine at the outset, pursuant to Rule 104(a), Fed. R. Evid., whether the expert testimony is reliable and whether it will assist the trier of fact to understand or determine a fact in issue. See id. at 592. The district court may consider several nondispositive factors in determining whether a particular scientific theory or technique is reliable. These factors include (1) whether the proffered technique can and has been tested; (2) whether the technique or theory has been subject to peer review; (3) the known or potential rate of error; and (4) the general acceptance of a technique in the relevant scientific community. Id. at 593-94. The proponent of expert testimony must show "a grounding in the methods and procedures of science which must be based on actual knowledge and not subjective belief or unaccepted speculation." Mitchell v. Gencorp. Inc., 165 F.3d 778, 780 (10th Cir. 1999). An expert's qualifications are relevant to the reliability inquiry. See United States v. Taylor, 154 F.3d 675, 683 (7th Cir. 1998); In re Indep. Serv. Org. Antitrust Litig., 85 F. Supp.2d 1130, 1163 (D. Kan. 2000).

1. Dr. Silverman

In his expert report of December 15, 1999, Dr. Silverman opines that Matthew Miller experienced increased psychological and interpersonal difficulties beginning in the spring of 1997, but that his "symptom picture" did not fit the usual profile for a pre-adolescent at high risk for suicide. Defendant does not challenge Dr. Silverman's expert qualifications but argues that his testimony, in its entirety, is inadmissible. (1) Specifically, defendant claims that (1) Dr. Silverman has not tested his methodology; (2) his rate of error is unacceptably high; and (3) he lacks an adequate factual basis for his opinions regarding suicide.

At his deposition, Dr. Silverman conceded that the medical community has a dismal record for predicting human behavior and that persons who predict suicide are incorrect between 80 and 82 percent of the time. Armed with this concession, plus the fact that Dr. Silverman has never tested the rate of error of his specific methodology, defendant reasons that Dr. Silverman's testimony should be excluded.

While the rate of error is not a dispositive factor, see Daubert, 509 U.S. at 593-94, the Court agrees that "[c]onjectures that are probably wrong are of little use . . . in the project of reaching a quick, final, and binding legal judgment--often of great consequence--about a particular set of events in the past." 509 U.S. at 597. In this case, however, the Court is in no position to agree that Dr. Silverman's testimony, as reflected in his original expert report, should be entirely excluded. The record which defendant has submitted in support of its motion is highly incomplete. It omits three of the six pages of Dr. Silverman's expert report and the pages which are missing apparently contain the heart of his analysis. (2) The record is supplemented by random pages from Dr. Silverman's deposition on March 2, 2000. It also includes a "supplemental report" dated March 7, 2000 which purports to incorporate all opinions advanced in the deposition as well as "those expressly set forth" in the supplemental report. Defendant has not sought to strike the supplemental report, but neither has it explained any agreement of counsel or other arrangement which would give the supplemental report equal stature to the original report. (3) In other words, the Court cannot evaluate the limited record which is before it in a way which might persuade it that defendant's motion is well taken.

The attack on Dr. Silverman's methodology must ultimately fail because defendant does not inform the Court what the metholodogy is, much less how it is fatally untested. Defendant characterizes Dr. Silverman's "methodology" as a "methodology in predicting suicide." In the limited portions of the one expert report which appears to be properly before the Court, however, Dr. Silverman merely opines that Matthew Miller's "symptom picture" did not fit the usual profile for a pre-adolescent at high risk for suicide. This opinion does not strike the Court as a "methodology in predicting suicide," but rather a diagnostic evaluation - in retrospect - of Matthew Miller's psychological condition relative to his environment. Dr. Silverman does not go so far as to state that Matthew Miller would not have committed suicide but for Zoloft and the rate of error for predicting suicide is therefore not a reason for striking his evaluation of Matthew Miller's psychological condition.

Further, while suicidologists may not be able to accurately predict which given individuals will successfully attempt suicide, various Daubert factors weigh in favor of admitting evidence whether Matthew Miller was at risk of committing suicide. Publications regarding suicide assessment note both "risk factors" and "protective factors" which help determine whether a person is at increased risk of committing suicide. The factors which Dr. Silverman used have therefore apparently received peer review. In addition to their appearance in medical literature, Dr. John Mann, defendant's expert, concedes that the scientific community has generally accepted the use of such factors. Because risk factors and protective factors are so widely accepted by the scientific community, the Court must reject any effort to prevent Dr. Silverman from testifying to the existence of generally accepted risk factors. See Gier v. Educational Serv. Unit No. 16, 845 F. Supp. 1342, 1353 (D. Neb. 1994) (allowing expert to provide characteristics of abused children but not testify that plaintiffs were abused).

In his supplemental report, Dr. Silverman states that (1) "SSRI drugs like Zoloft can cause akathisia that, in turn, are [sic] likely to trigger suicidal behavior;" (4) and (2) "[t]here is evidence to indicate that Matthew Miller may have had a drug-induced akathisia." Dr. Silverman does not state that Zoloft probably caused Matthew Miller to commit suicide and at his deposition, Dr. Silverman admitted that he could not state to a reasonable degree of medical certainty that Matthew Miller had a drug-induced akathisia or that SSRI drugs like Zoloft (by producing akathisia) were "likely to trigger suicidal behavior."

Defendant argues that these opinions in the supplemental expert report are inadmissible because Dr. Silverman cannot testify that Zoloft probably caused Matthew Miller to commit suicide. Specifically, defendant insists that Dr. Silverman cannot state to a reasonable degree of medical certainty that Zoloft causes suicide or that Matthew Miller akathisia. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Defendant is correct, to the extent that Dr. Silverman might opine at trial that Zoloft caused Matthew Miller to commit suicide. This prospect appears to raise a straw man argument, however, for nowhere in the record before the Court does Dr. Silverman purport to advance such an opinion. Indeed, he appears to stop gingerly short of any such claim. Therefore the Court need not exclude Dr. Silverman's testimony on that ground. Dr. Silverman merely opines that Zoloft can cause akathisia and that Matthew Miller may have had akathisia. Such language constitutes nothing more than speculation, when measured against an unequivocal claim that Zoloft caused akathisia, which in turn caused Matthew Miller to commit suicide. See Nunez v. Wilson, 211 Kan. 443, 447 (1973). The Court is unconvinced, however, that either tenet, standing alone, is speculative. Defendant has not cited compelling evidence that Zoloft does not cause akathisia, that Matthew Miller did not have akathisia, or that Matthew Miller did not commit suicide. (5) To the extent that these matters may be called into question at trial, Dr. Silverman's testimony may be relevant if not sufficient to carry the burden of proof on the issue of causation. Defendant does not argue that this evidence should be excluded under Rule 403, and on this record the Court is not prepared to address that difficult issue.

In his supplemental report, Dr. Silverman states that "SSRI drug manufacturers like Pfizer should definitely give explicit and prominent warnings about the potential for their drugs to trigger suicidal behavior and the protective measures that clinicians, patients and their parents should employ," particularly in the early phase of drug therapy. Defendant argues that this opinion is inadmissible because Dr. Silverman lacks the qualifications to testify regarding the sufficiency of defendant's warnings.

Under FDA rules, defendant must change the warnings "as soon as there is evidence of a reasonable association" between a drug and a harmful side effect and "a causal relationship need not have been proved." 21 C.F.R. § 201.57(e). While Dr. Silverman's testimony might be offered to prove the existence of a "reasonable association" between Zoloft and suicide, however, plaintiffs provide no evidence that Dr. Silverman is aware that this is the FDA standard. For all that the record reveals, Dr. Silverman's opinion on the duty to warn is strictly a personal opinion on what is ultimately a legal question, and it would not be helpful to the jury. The Court therefore excludes Dr. Silverman's opinion that defendant should have warned that Zoloft is associated with suicide.

Finally, defendant argues that the Court should exclude Dr. Silverman's testimony because he improperly formed his opinion and then looked for evidence to support it. Other than cryptic notes which Dr. Silverman made on the day before he issued his initial expert report, defendant has no evidence to support this allegation. Defendant reads these notes as establishing that plaintiffs' counsel told Dr. Silverman to rule out other explanations for Matthew Miller's suicide. Because Dr. Silverman's expert reports do not claim that Matthew Miller would not have committed suicide but for Zoloft, defendant's scenario is irrelevant. Therefore, the Court will not exclude Dr. Silverman's testimony on this ground.

2. Dr. Marks

Dr. Donald Marks is board certified in Internal Medicine, with a Ph.D. in both microbiology and immunology from UCLA. Dr. Marks has extensive experience as a research physician for the pharmaceutical industry, and has written and conducted randomized clinical trials. He also has experience in writing investigational new drug ("IND") applications, new drug applications ("NDA"), integrated summaries of safety, and annual safety reports. Dr. Marks has experience reporting adverse drug and vaccine effects to the FDA. Dr. Marks currently serves as a consultant to companies regarding FDA-related matters. Dr. Marks has offered his opinion that Pfizer had a duty to warn of a connection between Zoloft and suicide and that it had a duty to conduct further testing on the issue. Defendant argues that his testimony must be excluded because Dr. Marks lacks the necessary qualifications to testify concerning warnings and testing. Defendant also argues that the methodology which Dr. Marks used is unreliable and that he improperly formed his testimony to reach an outcome desired for this litigation.

Defendant argues that Dr. Marks lacks the necessary qualifications to testify about warnings, emphasizing that he lacks experience in psychiatry or psychotropic drugs. As plaintiffs note, however, Dr. Marks will not testify about the science behind SSRI drugs or what the FDA requires for approval of these drugs. Dr Marks will merely testify that based on his experience in the pharmaceutical industry, the information which suggests a link between Zoloft and suicide is sufficient to require warnings. He does not need specific knowledge about Zoloft or psychotropic drugs; he only needs to look at the data which suggests that such a link exists and rely on his experience in the pharmaceutical field to determine whether this data would require a reasonable pharmaceutical company to issue warnings. (6)

Similarly, defendant argues that Dr. Marks lacks the qualifications to testify whether further testing was required. Again, his lack of experience about psychiatry and psychotropic drugs does not mandate exclusion of his testimony. Defendant notes that Dr. Marks is generally unfamiliar with the testing which the FDA required before Zoloft was approved and that Dr. Marks is unable to create his own protocols for further testing. The Court is not persuaded. Plaintiffs have evidence that defendant has never conducted a study which is specifically designed to determine the connection (if any) between Zoloft and suicide. Plaintiffs also have evidence of such a connection. Based on his work in the pharmaceutical field, Dr. Marks has sufficient experience to testify whether the available information would cause a reasonable pharmaceutical company to conduct further testing to determine whether a link exists. Even though Dr. Marks cannot establish a specific protocol for further testing, further testing may be in order. Dr. Marks is not suggesting that defendant should perform a specific study of his own design; he only opines that defendant should conduct further testing. His lack of experience in creating the necessary protocols does not require that the Court exclude his testimony.

Defendant next argues that the methodology which Dr. Marks has used is flawed because it disagrees with FDA regulations and with Kansas law regarding a duty to warn. Dr. Marks opines that defendant has a duty to warn when there is a reasonable possibility that Zoloft causes or contributes to suicide. Defendant first contends that this standard is lower than the FDA standard, which defendant defines as requiring a reasonable "probability." Defendant cites no evidence, however, which establishes that the FDA requires a reasonable "probability." FDA regulations specifically require a "reasonable association." They do not elucidate whether this standard requires a possible association or a probable association. Furthermore, FDA standards do not set the limit on defendant's duty to warn. Savina v. Sterling Drug, Inc., 247 Kan. 105, 127-28, 795 P.2d 915, 931 (1990). Further, while defendant notes that Kansas requires it to warn of side effects of which it knows or should know, defendant does not establish that Kansas requires a "reasonable probability" that the drug causes the side effect. The Kansas Supreme Court has noted that a duty to warn arises "where scientific or medical evidence exists tending to show that a certain danger is associated with use of the drug." Wooderson v. Ortho Pharmaceutical Corp., 235 Kan. 387, 406, 681 P.2d 1038, 1054 (1984). Kansas requires plaintiffs to prove that "a reasonably prudent product seller could and would have taken additional precautions." Savina, 247 Kan. at 128, 795 P.2d at 931. A jury could well find that a reasonably prudent product seller would take additional precautions when it becomes aware of a reasonable possibility that its drug causes suicide. Indeed, defendant's own Worldwide Director of Safety, Dr. Gretchen Dieck, testified that defendant uses the "reasonable possibility" standard in determining whether warnings are required. The Court is therefore not persuaded to exclude Dr. Marks' testimony because he believes that drug companies should warn of reasonable possibilities of harmful side effects.

Defendant then contends that Dr. Marks failed to fully investigate the studies which it has already performed. Defendant argues that Dr. Marks is therefore unaware of the scope of defendant's testing of Zoloft and that his methodology is therefore flawed. This statement is simply incorrect. While Dr. Marks is not aware of every test which defendant has completed, plaintiffs have provided evidence that defendant has never conducted a study which is specifically designed to determine whether Zoloft is connected to suicide or suicide ideation, even though scientists had designed studies specifically for defendant for just this purpose. It is therefore reasonable for Dr. Marks to testify that defendant could have done further testing. While defendant complains that Dr. Marks ignores the testing it has conducted, defendant does not contend that no further testing is possible. This is insufficient to show that Dr. Marks' opinion is unreliable.

Defendant also argues that the Court should prevent Dr. Marks from testifying that it had a duty to more fully investigate a 1993 incident where an eight year old boy attempted to harm himself. A Pfizer employee concluded that Zoloft had caused the attempt. Defendant contends that Dr. Marks did not consider its evidence before concluding that Pfizer did not fully investigate the incident. Dr. Marks has evidence regarding the incident, however, and how defendant reacted to it. Defendant only argues that Dr. Marks should have looked at more evidence before forming his opinion; it provides no evidence which suggests that it could not have investigated more fully. Therefore, the Court cannot say that Dr. Marks' opinion is so unsupported by the evidence that it is unreliable and excludable. If defendant has contrary evidence, it can present this evidence on cross-examination and attempt to create an issue of fact for the jury.

Finally, defendant argues that the Court should preclude Dr. Marks from testifying because he did not reach his opinion independently of the litigation. Defendant again complains of Dr. Marks' inexperience regarding suicide and psychiatry and argues that he "read up" on the subject after plaintiffs retained him. The Court has already found that Dr. Marks is suitably qualified for the opinions which he proffers. The Court is hardly surprised that an expert in a particular area would "read up" on facts and issues which could affect his opinion. Defendant does not cite any evidence that Dr. Marks improperly formed his opinion and then sought to justify it. The Court finds defendant's argument to be without merit.

IT IS THEREFORE ORDERED that Defendant Pfizer Inc's Motion To Exclude Opinion Testimony Of Morton M. Silverman (Doc. # 200) filed April 18, 2000 be and hereby is SUSTAINED IN PART and DENIED IN PART. The Court will not allow Dr. Silverman to testify that "SSRI drug manufacturers like Pfizer should definitely give explicit and prominent warnings about the potential for their drugs to trigger suicidal behavior and the protective measures that clinicians, patients and their parents should employ," particularly in the early phase of drug therapy. In all other respects, defendant's motion is DENIED.

IT IS FURTHER ORDERED that Defendant Pfizer Inc's Motion To Exclude Opinion Testimony Of Donald H. Marks (Doc. # 202) filed April 18, 2000 be and hereby is DENIED.

Dated this 23rd day of June, 2000 at Kansas City, Kansas.

___________________________

Kathryn H. Vratil

United States District Judge

1. Dr. Silverman is clearly qualified in the field of suicidology. He is a licensed physician and professor of psychiatry at the University of Chicago. He has co-edited books on suicidology, authored or co-authored peer-reviewed journal articles and book chapters on suicide, lectured nationally and internationally regarding suicide and risk assessment, and serves as editor in chief of Suicide and Life-Threatening Behavior, the official journal of the American Association of Suicidology.

2. While plaintiffs bear the burden of proving that Dr. Silverman's testimony is admissible, see United States v. Kelley, 6 F. Supp.2d 1168, 1183 (D. Kan. 1998), defendant bears an initial burden of properly raising the issue. Defendant cannot make a reasonable argument that Dr. Silverman's methodology is improper without at least providing Dr. Silverman's methodology to the Court.

3. Defendant argues in its reply brief that the Court should exclude the supplemental opinions because they were not contained in Dr. Silverman's original report and defendant did not have an opportunity to depose him on the supplemental opinion. Defendant did not make this argument in its original motion, however, and the Court therefore does not consider it because plaintiffs have not had a chance to respond. See Medina v. City of Osawatomie, 992 F. Supp. 1269, 1272-73 (D. Kan. 1998) (court will not consider issues first raised in reply briefs); Mike v. Dymon, Inc.,1996 WL 427761 at *2 (D. Kan. July 25, 1996) ("In pursuit of fairness and proper notice, the court generally summarily denies or excludes all arguments and issues first raised in reply briefs.") (citations omitted). In footnote 2 of Defendant Pfizer Inc's Memorandum In Support Of Motion To Exclude Opinion Testimony Of Morton M. Silverman (Doc. #201), and again in footnote 3 of the Reply In Support Of Defendant Pfizer, Inc's Motion To Exclude Opinion Testimony Of Morton M. Silverman (Doc. #407), defendant asks the Court to order that Dr. Silverman be re-deposed at plaintiff's cost if his warning opinions are not stricken. The proper procedure would be for Pfizer to file a separate motion to strike the supplemental report on grounds of untimeliness and to seek appropriate relief such as a further deposition on the terms described. Motion practice via footnotes is not recognized by either the Federal Rules of Civil Procedure or the local rules of court. See D. Kan. Rule 7.1(a) (all motions, unless made during a hearing or at trial, shall be in writing and shall be filed with the clerk; original and one copy shall be filed; motions shall be accompanied by a brief or memorandum unless otherwise provided in these rules).

4. Akathisia, loosely defined, is an inability to sit still; a condition of motor restlessness.

5. Defendant also complains that Dr. Silverman's opinion that Zoloft is associated with suicide contradicts statements which he has made in certain published works. This does not make his current opinion inadmissible. Defendant can sufficiently point out any contradictions on cross-examination. Daubert, 509 U.S. at 596.

6. Defendant also argues that Dr. Marks lacks the credentials to testify regarding a duty to warn because he does not know the difference between hyperkinesia and agitation -- two terms which are contained on the package insert for Zoloft. This has no bearing on the issue at hand. Dr. Marks can easily determine from reading the insert that it does not warn of a possible link between Zoloft and suicide. He therefore opines that this warning is insufficient.