|Forensic Psychiatry & Medicine
A U.S. district court held that two physicians who had done substantial
research on the link between certain types of prescription drugs and suicide may
testify in a lawsuit against a pharmaceutical manufacturer.
Here, the parents of a boy, Miller, who committed suicide sued the
manufacturer of a psychotropic drug, Zoloft, that the boy had been using.
Plaintiffs sought to introduce the expert testimony of a professor psychiatry
who had written book chapters and peer-reviewed articles on suicide, and a
research physician for the pharmaceutical industry. Defendant moved to exclude
The trial court noted the professor's opinion that Miller's "symptom
picture" did not fit the usual profile for a boy of his age at high risk for
suicide. This observation is not so much a methodology of predicting suicide as
it is a retrospective diagnostic evaluation of this individual, the court said.
As the professor did not go so far as to say that Miller would not have
committed suicide but for his use of the drug, the concern raised by defendant
about the high rate of error in the medical profession in predicting suicide is
not a valid reason for barring his testimony.
While suicidologists may not be able to accurately predict which
individuals will kill themselves, the court said, various factors weight in
favor of allowing evidence concerning whether Miller was a risk. Publications on
suicide assessment note both risk factors and protective factors that help
determine which patients are at risk, and these are the types of factors used by
the professor, the court said.
The research physician intended to testify that, based on his experience
in the industry, the information suggesting a link between the drug and suicide
is sufficient to require warnings, the court observed. He does not need to have
specific knowledge about his drug or psychotropic drugs generally, the court
said. He need only look at the data that suggests a link and then give his
opinion as to what a reasonable company would have done.
by Law Reporter
FULL TEXT OF CASE
MARK MILLER, et al., Plaintiffs, v. PFIZER INC. (ROERIG
CIVIL ACTION No. 99-2326-KHV
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF KANSAS
2000 U.S. Dist. LEXIS 9816
June 23, 2000, Decided
June 23, 2000, Filed;
June 26, 2000, Entered on the Docket
[*1] Defendant Pfizer Inc's Motion To Exclude Opinion Testimony Of
Morton M. Silverman (Doc. # 200) filed April 18, 2000 SUSTAINED IN PART and
DENIED IN PART. Defendant Pfizer Inc's Motion To Exclude Opinion Testimony Of
Donald H. Marks (Doc. # 202) filed April 18, 2000 DENIED.
COUNSEL: For MARK MILLER, CHERYL MILLER, plaintiffs:
Paul F Waldner, Ruth M. Benien, Benien Law Offices, Chtd., Kansas City, KS.
For MARK MILLER, CHERYL MILLER, plaintiffs: Arnold Anderson
Vickery, Richard W Ewing, Vickery & Waldner, Houston, TX.
PFIZER INC, defendant: Patrick Lysaught, Robert J. E. Edwards, Polsinelli,
White, Vardeman & Shalton, Kansas City, MO.
For PFIZER INC,
defendant: James E Hooper, Malcolm E Wheeler, Amy L Padden, Michael L O'Donnell,
Wheeler Trigg & Kennedy, P.C., Denver, CO.
Kathryn H. Vratil, United States District Judge.
OPINIONBY: Kathryn H. Vratil
OPINION: 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.
702, Fed. [*2] 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 Daubert v. Merrell
Dow Pharms., 509 U.S. 579, 592, 113 S. Ct. 2786, 125 L. Ed. 2d 469. 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 [*3] 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. n1 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
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n1 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.
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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
"conjectures 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. n2 The record is supplemented by random [*5] 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. n3 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.
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n2 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.
n3 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 U.S. Dist. LEXIS 10799, 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).
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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
[*7] 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).
supplemental report, Dr. Silverman states that (1) "SSRI drugs like Zoloft can
cause akathisia that, in turn, are [sic] likely to trigger suicidal behavior;"
n4 and (2) "there is evidence to indicate that Matthew Miller may have had a
drug-induced akathisia." Dr. Silverman does not state that [*8]
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
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n4 Akathisia, loosely defined, is an inability
to sit still; a condition of motor restlessness.
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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, 125 L. Ed. 2d
469, 113 S. Ct. 2786 (1993). Defendant is correct, to the extent that Dr.
Silverman might opine at trial that Zoloft caused Matthew Miller to commit
suicide. [*9] 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, 507 P.2d 329 (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. n5 To the extent that these matters may be called
into question at trial, Dr. sHeaverman'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
[*10] 403, and on this record the Court is not prepared to address
that difficult issue.
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n5 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.
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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.
rules, defendant must change the warnings "as soon as there is evidence of a
reasonable [*11] 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
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
[*12] 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.
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
[*13] 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
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n6 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.
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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
[*15] 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 [*16] 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.
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 [*17] 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 [*18] 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
[*19] 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
Dated this 23rd day of June, 2000 at Kansas
Kathryn H. Vratil
United States District Judge