934 COMMENTARIES
Boston City Hospital/Boston
University School of
Medicine
Boston, MA 02118
ACKNOWLEDGMENTS
This work was completed while I was a Scholar-in-Residence at
the Center for the Future of Children at the David and Lucile
Packard Foundation. I would like to thank Dick Behrman and
Gene Lewitt of the Foundation for their continuing support and
critical comments. Birt Harvey was also kind enough to share his
experience and wisdom. Finally, I thank the Rand Corporation’s
Children’s Quality of Care Clinical Group-particularly Beth
McGlynn, Neal Halfon, and David Bergman.
REFERENCES
1. Jost iS. Health system reform-forward or backward with quality
oversight? JAMA. 1994;271 :1508-1511
2. Kelly JT. Evaluating quality performance in alternate health care delivery systems. JA.MA. 1994;271 :1620-1621
3. Andersen Consulting. Kaiser Permanente-Northern California Region-1993
Quality Report Card. South Carolina: Arthur Andersen and Co; 1993
4. Siu AL, McGlynn EA, Beers MH, et al. Choosing quality-of-care
mea-sures based on the expected impact of improved quality of care for the
major causes of mortality and morbidity. Santa Monica, CA: Rand; 1992
5. American Academy of Pediatrics Committee on Practice and Ambula-tory Medicine. Guidelines for Health Supervision. Elk Grove Village, IL:
American Academy of Pediatrics; 1981
6. Shildes JL, Jojokian AB, Keenan MP, et a!. Preventive Health Care For
Children-Experience From Selected Foreign Countries. GAO/HRD-93-62.
Washington, DC: United States General Accounting Office; 1993
7. Centers for Disease Control. Hepatitis B virus: a comprehensive strategy
for eliminating transmission in the United States through uruversal
childhood vaccination. MMWR. 1991;40:11-19
8. Freed GL, Bordley WC, Clark SJ, Konrad TR. Universal Hepatitis B
immunization of infants: reactions of pediatricians and family physi-cians over time. Pediatrics. 1994;93:747-751
9. Ryan AS, Rush D, Krieger FW, Lewandowski GE. Recent declines in
breast-feeding in the United States, 1984 through 1989. Pediatrics. 1991;
88:719-727
10. Cunningham AS, Jelliffe DB, Patrice Jelliffe EF. Breast-feeding and
health in the 1980s: a global epidemiologic review. JPediatr. 1991;118:
659-666
I I. Mitchell EA, Scragg R, Steward AW, et al. Results from the first year of
the New Zealand cot death study. N Z Med I. 1991;104:71-76
12. Dwyer T, Ponsonby A-L, Gibbons LE, Newman NM. Prospective cohort
study of prone sleeping position and sudden infant death syndrome.
Lancet. 1991;337:1244-1247
13. Wiffinger M, Hoffman HJ, Hartford RB. Infant sleep position and risk
for sudden infant death syndrome: report of meeting held January 13
and 14, 1994, National Institutes of Health, Bethesda, MD. Pediatrics.
1994;93:814-819
14. AAP Task Force on Infant Positioning and 5105. Infant sleep position
and sudden infant death syndrome (SIDS) in the United States: joint
commentary from the American Academy of Pediatrics and Selected
Agencies of the Federal Government. Pediatrics. 1994;93:820
15. American Academy of Pediatrics. Policy Reference Guide of the American
Academy of Pediatrics, A Comprehensive Guide to AAP Policy Statements
Issued Through December 1993. Elk Grove Village, IL: American Academy
of Pediatrics; 1994
16. Bass JL, Christoffel KK, Widome M, et al. Childhood injury prevention
counseling in primary care settings: a critical review of the literature. Pediatrics. 1993;92:544-550
17. US Preventive Services Task Force. Guide to Clinical Preventive Services:
An Assessment of the Effectiveness of 169 Interventions. Baltimore, MD:
Williams and Wilkins; 1989;xix-xxxvii:315-329; 387-391
18. Dworkin PH. Developmental screening-expecting the impossible?
Pediatrics. 1989;83:619-622
19. Brown MS. Vision screening of preschool children: how to check on
visual acuity and heterophoria as part of a routine physical examina-hon. Clin Pediatr. 1975;14:968-973
20. Wasserman RC, Croft CA, Brotherton SE. Preschool vision screening in
pediatric practice: study from the pediatric research in office settings
(PROS) network. Pediatrics. 1992;89:834-838
21. Crouch ERJr, Crouch ER. Pediatric vision screening: why? when? what?
how? Contemporary Pediatrics. 1991;10:9-30
22. Dallman PR, Yip R. Changing characteristics of childhood anemia.
IPediatr. 1989;114:161-164
23. Yip R, Walsh KM, Goldfarb MG, Binkin NJ. Declining prevalence of
anemia in childhood in a middle-class setting: a pediatric success story? Pediatrics. 1987;80:330-334
24. Lozoff B, Jimenez E, Wolf AW. Long-term developmental outcome of
infants with iron deficiency. N Engi JMed. 1991;325:687-694
25. Harvey B. Should blood lead screening recommendations be revised?
Pediatrics. 1994;93:201-204
26. Charleton RA, Dwyer J, Finberg L, et al. Report of the Expert Panel on
Population Strategies for Blood Cholesterol Reduction. A statement
from the National Cholesterol Education Program, National Heart,
Lung, and Blood Institute. Circulation. 1991;83:2154-2232
27. Centers for Disease Control. Preventing Lead Poisoning in Young Children:
A Statement by the Centers for Disease Control. Atlanta, GA: US
Depart-ment of Health and Human Services; 1991
28. American Academy of Pediatrics, Committee on Infectious Diseases.
Universal hepatitis B immunization. Pediatrics. 1992;89:795-799 29. Cleary PD, McNeil BJ. Patient satisfaction as an indicator of quality care.
Inquiry. 1988;25:25-36
30. Berwick DM, Godrey AB, Roessner J. Curing health care: new strategies
for quality improvement. San Francisco, CA: Jossey-Bass; 1990
31. Berwick DM, Enthoven A, Bunker JP. Quality management in NHS: the
doctor’s role-I. Br Med J.1992;304:235-239
32. Safran DG, Tarlov AR, Rogers WH. Primary care performance in
fee-for-service and prepaid health care systems-results from the medical
outcomes study. IA/vIA. 1994;271:1579-1586
33. Institute of Medicine. Report of a Study: A Manpower Policy for Primary
Health Care. Washington DC: National Academy of Sciences; May 1978
34. Cartland J, Yudkowsky BK. Barriers to pediatric referral in managed
care systems. Pediatrics. 1992;89:183-188
35. Newacheck PW, Hughes DC, Stoddard J, Halfon J. Children with chronic illness and Medicaid managed care. Pediatrics. 1994;93:497-500
United
States
Supreme
Court
Rules
on
Expert
Testimony
Many medical and legal commentators have
ex-pressed concern about the validity of scientific
evi-dence that is proffered by expert witnesses at
depo-sitions and in courts of law.1’2 The sparse research
that is available on the testimony of medical expert
witnesses suggests that it is frequently flawed and
erroneous.3
On June 28, 1993, the United States (US) Supreme
Court ruled on the proper standard for admissibility
of scientific evidence in the courtroom.4 Although
the ruling establishes guidelines that are binding
only in federal courts, it is expected that many state
courts will follow the Count’s ruling. This
commen-tary reviews the Court’s guidelines for admissibility
of expert testimony, and expresses concern about
their applicability in future cases involving scientific
testimony.
The case from which the Supreme Count
estab-lished its guidelines was Daubert v Merrell Dow
Phar-maceuticals.4 The scientific evidence at issue in
Daub-ert related to whether the plaintiffs’ (childnens’)
congenital limb deformities were caused by
Bendec-tin, the anti-nausea drug that was taken by the
moth-ens during pregnancy. The expert witnesses for the
plaintiffs attributed causation of the limb deformity
Received for publication Jan 17, 1994; accepted Feb 6, 1995.
PEDIATRICS (ISSN 0031 4005). Copyright © 1995 by the American
Acad-emy of Pediatrics.
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COMMENTARIES 935
to Bendectin, citing in vivo animal teratology studies,
in vitro data, analysis of the chemical structure of
Bendectin and its similarity to other tenatogens, as
well as a reanalysis of previously published human
statistical studies. This reanalysis was unpublished,
not peer-reviewed, and prepared solely for use in
litigation.
The expert witness for the defendant Merrell Dow
opined that, after a published literature review
in-volving 30 studies and 130 000 patients, no properly
designed epidemiologic study demonstrated that
Bendectin caused the limb deformities alleged in the
case. The defendant’s theory was accepted by the
federal trial judge who dismissed the case. This
judg-ment was affirmed by a federal appellate court
which noted that the unorthodox approach of the
plaintiffs’ experts failed to meet the standard
neces-sary for scientific evidence to be admitted in a federal
trial, ie, that it lacked “general acceptance among
scientists in the field.”
The US Supreme Court rejected both lower courts’
reasoning, and remanded the case back to the trial
count for further evaluation consistent with its
guide-lines. These less rigid guidelines provide for the trial
judge to act as a “gatekeeper” to secure that an expert
witness’s opinion is relevant and is based on a
reli-able foundation. In determining this, the trial judge
should rely on whether the expert’s underlying
rea-soning on methodology is scientifically valid, rather
than focusing on the conclusion to which the
meth-ods lead. The following parameters regarding
scien-tific methods and theories will be relevant, but need
not be controlling, in determining their validity,
ne-liability, and subsequent admissibility in court:
whether the methods or theories have been (or can be)
tested; their known or potential error rate; publication
or peer review; and their widespread acceptance
within a relevant scientific community. The Supreme
Court then established that the appropriate way to
challenge contested scientific evidence was through
cross examination, presentation of contrary evidence,
and instruction to the jury on the burden of proof,
rather than refusing to allow it to be admitted at trial.
It is unclear what effect the Daubert opinion will
have in improving the expert witness process in this
country. The primary responsibility placed on the
trial judge in determining what scientific evidence
should be admitted at trial may place an undue
burden on many judges who are likely to have
in-sufficient background to evaluate complex and
tech-nical scientific testimony.8 It is likely that the liberal
guidelines sanctioned by the Supreme Court will
induce many trial judges to admit most scientific
evidence and allow the jury to make the final
deci-sion as to its importance. This raises the obvious
concern that juries, trapped in a “battle of the
ex-perts,” may decide complex scientific cases on the
basis of empathy towards one of the parties rather
than on the scientific merits at issue.
The potential effect of Daubert on future medical
malpractice cases should force established medical
on-ganizations to take a more proactive role in excluding
“junk science” from admission at trial. Judges will
likely need, and probably be willing to accept,
assis-tance from valid medical specialty organizations in
producing statements that represent accepted majority
views of specific medical tenets and practice. Examples
of such statements currently exist for many medical
issues.9”#{176}These statements, enacted by panels of
recog-nized experts in specialty societies, and preferably
ap-proved by the membership of these societies, are good
starting points but need to be expanded both in
num-ben and in content. They should also be made more
accessible to attorneys for both plaintiff and defense as
well as to judges. These statements can provide a
foun-dation for the judge before trial that an opposing expert
should be allowed to overcome only by presenting
credible contrary evidence why the majority view is not
controlling in the case at issue.
Rigorous guidelines relating to experts, devised by
some specialty organizations, are exemplary and
should be more openly publicized.”2 Sections on
ex-pert witnesses are needed in each specialty
organiza-tion to monitor experts and enforce their guidelines.
The American Association of Neurological Surgeons
currently has a program addressing some of these
is-sues. Specialty organizations should also devise
meth-ods of ratifying on “certifying” individual experts
ac-cording to their area of expertise.’3 The recognition of
such experts by national medical organizations may
instill additional importance to their testimony and will
also subject them to peer review. Peer review of expert
witnesses has its proponents1’14’15 as well as its
pit-falls.’6’17 Many of these pitfalls can be overcome via
certification because the expert, who gains credibility
from certification, would be subject to the rules and
regulations of these same certifying organizations,
which could include voluntary peer review. In
addi-tion, the recognition of a certified expert may
encour-age judges to utilize them as court-appointed “neutral”
experts. This concept of a court-appointed expert,
pro-posed nearly a century ago by a prominent jurist,’8
continues to be advocated by medical8”4 and legal’3”9
commentators, as well as by a majority of state and
federal judges.2#{176}Such an expert may not be favored by
either plaintiff or defense attorneys who may desire to
exert their own level of “control” over their respective
witnesses. However, the “gatekeeper” role assigned to
the trial judge by the Daubert decision should
encour-age judges to utilize such witnesses, preferably at
pre-trial conferences, to assist them in deciding what
evi-dence will be admitted at trial. Not only are most state
judges and all federal judges21 permitted to utilize such
third party experts, but at least one prominent federal
judge, a recognized expert in legal evidence, has
sug-gested that judges might be more willing to utilize
court-appointed experts if they were more easily
acces-sible, and if their fairness and impartiality could be
assured by professional oversight and discipline.’3 Use
of these court-appointed experts at pre-trial
confer-ences might also provide better analysis of the
strengths and weaknesses of the case for both sides,
and diminish the number of cases actually going to trial
where outcome is less predictable, and money
judgments can potentially be exorbitant.
Society will be served best by more of a combined
and forceful effort of both the medical and legal
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936 COMMENTARIES
establishment in ensuring that trials involving
scientific evidence are fair and accurate.
GARY N. MCABEE, DO, JD
Departments of Pediatrics and Neurology
Nassau County Medical Center/SUNY at Stony Brook
East Meadow, NY 11554
REFERENCES
I. Brent RL. The irresponsible expert witness: a failure of biomedical
grad-uate education and professional accountability. Pediatrics. 1982;70:754-762 2. Huber PW. Galileo’s Revenge: Junk Science in the Courtroom. New York:
Basic Books, 1991
3. Safran A, Skydell B, Ropper S. Expert testimony in neurology: Massa-chusetts experience 1980-1990. Neurol Citron. 1992;2:1-6
4. Daubert v Merrell Don’ Pharmaceuticals, Inc. 113 SCt 2786 (1993)
5. Daubert v Merrell Doe’ Pharmaceuticals, Joe, 113 SCt 2786 (1993)
(Rehnquist J,dissenting)
6. Weinstein J. Role of expert testimony and novel scientific evidence in
proof of causation 12. Address presented before the ABA Annual
Meeting; August 9, 1987; San Francisco, CA
7. Ferebee p Chevron Chemical Cv, 736 F.2d. 1529, 1534-1535 (DC Cir), cert.
denied 469 US 1062 (1984)
8. Brennan T. Helping courts with toxic torts: some proposals regarding alternative methods for presenting and assessing scientific evidence in
common law courts. U Pitt L R 1989;51:1,2 nIl
9. American Academy of Neurology, Therapeutics & Technology
Assess-ment Subcommittee. Assessment: thermography in neurologic practice.
Neurol. 1990;40:523-525
10. Howson CP, Fineberg HV. Adverse effects following pertussis and
rubella vaccines: summary of a report of the Institute of Medicine. JAMA. 1992;267:393-397
I I. American Academy of Neurology. Qualifications and guidelines for the
physician expert witness. 1989
12. American Academy of Pediatrics Committee on Medical Liability.
Guidelines for expert witness testimony. Pediatrics. 1994;94:755-756
13. Weinstein JB. Improving expert testimony. U Rich,nond L Rev. 1986;20:
473-497
14. Lundberg GD. Expert witness for whom? JAMA. 1984;252:251
15. Shields WD. Peer review of expert medical-legal testimony: a proposal for child neurology. JChild Neurol. 1992;7:237-239
16. Short GF. The paladin problem. I Child Neurol. 1994;9:213-215
17. McAbee G. Peer review of medical expert witnesses (reply). JChild Neurol. 1994;9:216-217
18. Hand L. Historical and practical considerations regarding expert
testi-mony. Hare L Rev. 1901;15:40-58
19. Lee TV. Court-appointed experts and judicial reluctance: a proposal to
amend Rule 706 of the Federal Rules of Evidence. Yale Law Pol Rev.
1988;6:480-503
20. Judges opinions on procedural issues: a survey of state and federal
judges who spent at least half their time on general civil cases. Boston U L Rev. 1989;69:731-779
21 . Federal Rule of Evidence 706
Adolescent
Immunization:
The
Access
and
Anchor
for
Health
Services?
Concern is escalating for the medical and social
health of our adolescents under the current
discoun-aging avalanche of statistics. The need for
compre-hensive health care visits for teens and pre-teens has
been highlighted as a national health objective for the
Received for publication Dec 9, 1994; accepted Jan 24, 1995.
Correspondence to: Caroline Breese Hall, MD, University of Rochester
School of Medicine, 601 Elmwood Ave. Box 689, Rochester, NY 14642-8689.
PEDIATRICS (ISSN 0031 4005). Copyright ©1995 by the American Acad-emy of Pediatrics.
year 2000,1 and emphasized by the recent goals and
guidelines of the American Academy of Pediatnics24
and the American Medical Association.5 The
fne-quency of pregnancies in early adolescence and the
steep rise of sexually transmitted diseases, hepatitis
B infections, drug abuse, and smoking in teens have
been documentedP Adolescence, if not the age of
reason, is the age of risk.
Despite this recognition and unanimity of
pun-pose, we have thus fan failed to give to many, if not
most, of our adolescents routine health care that
encompasses counseling, health education, and
pne-ventive measures. Adolescents have, on the average,
fewer contacts with a physician, and as of 1986, 28%
of 10- to 18-year-olds had no such contact for oven a
year.7 Furthermore, only 7% of the office visits made
by adolescents to physicians were general medical
visits for preventive care, and only 15% could be
considered health supervision visits.8’9 Programs that
offered comprehensive health cane for adolescents in
1990 served only 5.3% of our country’s 15- to
19-year-olds.’#{176}The reasons are legion-access, acceptability,
cost, and perhaps both the infra and supra
struc-tures.7”1’3 The solutions are not obvious and will
require creativity and coordination of community
capabilities-and perhaps examination of our
successes in the delivery of health care.
In what instances have our recommendations
worked? The need for routine immunizations in
early childhood is well accepted and woven into the
fabric designed for care of the young child. However,
only about half to two-thirds of children at 2 years of
age are immunized fully.’4 But at school entry 98%
are immunized completely. The lessons inferred are
that recommendations work when enforced and
when tied to schools. Can we apply this same bite to
the pne-adolescent years? What if middle school
en-try required the administration of immunizations
designated for this age?
Such a health cane visit, enforced by school
immu-nization laws, could ensure access to pre-adolescents
and be the sesame to comprehensive cane for the
coming turbulent years. This visit could be in private
offices on primarily school-based and would be best
accomplished at 10 to 12 years of age on middle
school, as 99% of children remain in school until 13
years of age.’5 The difficulties in implementing
vac-cination programs aimed at adolescents and schools
have been emphasized and, thus, perhaps
underuti-lized in this country.11 However, recent innovative
immunization programs for hepatitis B, based in
middle schools in California and Louisiana, as well
as in Canada, demonstrate this approach can be
suc-cessful.15”6 Furthermore, in a recent national survey
of programs offering comprehensive health service
programs for adolescents, 45% were school-based,
and 72% obtained federal funding.’#{176}”7
The new changes in the immunization schedule
recommended by the American Academy of
Pediat-nics, the Centers for Disease Control, and the
Amen-ican Academy for Family Practice would facilitate
this proposal.’8”9 In this schedule several
immuniza-tions are being concentrated in a pre-adolescent visit.
The tetanus-diphtheria vaccine may now be
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1995;95;934
Pediatrics
Gary N. McAbee
United States Supreme Court Rules on Expert Testimony
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Pediatrics
Gary N. McAbee
United States Supreme Court Rules on Expert Testimony
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been published continuously since 1948. Pediatrics is owned, published, and trademarked by the
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