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THE
JUDGE'S
ROLE
AS
GATEKEEPER:
RESPONSIBILITIES
&
POWERS
CHAPTER
SEVEN
|
Differential Diagnosis Under Daubert
by Nicklas Akers and Nate Scott - Harvard Law School '99
What Is the Role, if any, of
Differential Clinical Diagnosis in Trials?
Physicians often make treatment decisions
based on conclusions that have been derived to be the nature and cause
of the illness. This is achieved through the method of differential diagnosis
that is commonly defined as "the determination of which of two or more
diseases or conditions a patient is suffering from by systematically comparing
and contrasting their clinical findings."(1)
Using this method a physician brings together information suggesting that
an agent can cause a specific disorder. Using information gathered from
the patient's exams along with patient history and research on the disorder,
the physician could draw conclusions about the cause and nature of the
patient's injury or illness. The quality and quantity of information available
for consideration varies, as does the certainty of the analysis.
In some cases examination of the patient reveals
clear symptoms of a "signature disease"(2)
known only to be caused by one agent, such as mesothelioma, known to be
caused by asbestos. These diagnoses are an accepted method of proving specific
causation in such a situation. When a signature disease is not present,
clinicians use information from animal studies, chemical analysis, epidemiology,
patient history, or the timing of symptoms to make treatment decisions.
Logically, this process has been likened to the making of soup(3)
or assembling a "mosaic,"(4)
putting together information from a variety of sources using professional
judgment. The degree of certainty to a diagnosis varies with the types
and quality of information used in its making, and is perhaps at its lowest
when the only link between alleged cause and illness is temporal.(5)
The suitability to the courtroom of this method so common in the exam room
is a subject of debate.
Should a Clinician's Testimony
Be Admitted As Evidence of Causation?
A. The Case For Admissibility
Commentators supporting admission of differential
diagnosis often argue that its long-standing and generally successful use
by the medical profession to draw conclusions good enough to guide medical
treatment demonstrates its legitimacy. While recognizing that it does not
provide "absolute certainty,"(6)
it is praised as providing information based on "wisdom, probity, and approbation"(7)
from the "actual practice of medicine"(8)
based upon a mix of medical knowledge, intuition and judgment.(9)
A number of courts have admitted testimony
based on differential diagnosis after Daubert. The Fourth Circuit
in Benedi v. McNeil upheld the admission of differential diagnosis
linking illness to the combination of Tylenol and alcohol.(10)
The court determined that methodology good enough for the "day in and day
out" practice of a diagnosing physician is sufficient for use in federal
courts even if not supported by epidemiology.(11)
A similar logic was used by the Second Circuit in
McCullock v. H.B.
Fuller,(12)
allowing physician testimony on causation based on differential diagnosis
using patient history, treatment, and pathology, holding that faults in
the physician's analysis went to the testimony's weight rather than its
admissibility. McCullock was cited in Becker v. National Health
Products to support the admission of two physicians' testimony on illness
caused by a dietary supplement because of their professional experience,
review of relevant literature and examination of the client.(13)
B. The Case Against Differential Diagnosis
A number of courts have taken issue with this
approach, attacking it for its inability to provide logical support for
a position, or reliance on bad methodology in reaching its conclusions.
Differential diagnosis may be appropriate to a health care situation where
the most likely cause of an illness must be identified and acted upon to
save lives but inappropriate as a method of fact-finding in adjudication.
In Daubert, Dr. Palmer's testimony based on differential diagnosis
was also rejected as proof of causation. Judge Kozinski cited the Sixth
Circuit's evaluation in Turpin of Palmer's testimony as lacking
any scientific basis. He further stated that the differential diagnosis
in that case seemed to be based only on a temporal association between
the birth defects and Bendectin use rather than a ruling out of other possible
causes.(14)
Courts have also attacked differential diagnosis
where it rules out other potential causes of disease, but fails to "rule
in" the alleged cause of the injury, where there is insufficient scientific
evidence to assert general causation.(15)
In Schmaltz v. Norfolk and Western Railway,(16)
a clinician's testimony was attacked for failing to show that the substance
in question could cause the illness claimed even if other substances had
been ruled out as causes.
Other courts have attacked specific differential
diagnoses as based on information that cannot justify the conclusions drawn
by the physician. In O'Connor v. Commonwealth Edison,(17)
the Seventh Circuit held that a physician who testified that visual examination
of the plaintiff's eyes indicated that his cataracts were caused by radiation
exposure could not have made that determination with the methodology used.(18)
Generally, some commentators have attacked the scientific value of a physician's
assertion as speculative and too reliant on individual judgment.(19)
Could a Differential Diagnosis
Provide Evidence Of Causation Where Epidemiology Shows Less Than a Doubling
of Background in a Test Population?
A. The Case for Admission
Epidemiology showing less than a doubling
in the background rate of disease can be viewed as a starting point for
differential diagnosis. In re Joint East and South District Asbestos
Litigation(20)
provides an example. The claim of a causal connection between asbestos
and colon cancer was bolstered by a physician using epidemiological studies
showing a ratio between exposed and general population incidence of disease
falling between 1 and 2, a correlation possibly indicating causation.(21)
The physician used the tools of differential diagnosis to rule out other
causes, especially age and unhealthy diet, which account for much of the
background incidence of colon cancer, and backed up his assertion of general
causation with reference to research connecting asbestos to other types
of cancer. His medical opinion that the disease was caused by asbestos
was ruled admissible. Logically, the physician's approach was a qualitative
reevaluation of the background rate of disease and the general population
sample it was based on in relation to his patient's risk factors. In cases
like this, further epidemiological investigation may be too costly, or
impossible because of statistical error from a too small sample size.
B. The Case Against Admission
The physician using epidemiology to back up
differential diagnosis cannot be certain of causation, simply some correlation.
He also cannot often quantitatively isolate the effects of risks like age
or poor diet from one such as asbestos exposure by independently examining
the effect of one of those variables on cancer rates.(22)
The only certain way to determine whether individuals similar to the plaintiff
experience an elevated rate of cancer would be an epidemiological study
comparing populations of young, healthy eating people who were and were
not exposed to asbestos. It can be argued that allowing any other approach
to the information might encourage the sort of "conjecture" rejected by
the Ninth Circuit in Daubert.(23)
Assessment
The debate over the admissibility of differential
diagnosis operates at two levels. One is the question of whether it's good
science, based on time-tested and commonly used methods, or unreliable,
qualitative, and based on physicians' best guesses hopefully made in good
faith. On another level, this is a question of what is to be done with
cases that fall between what is believable, perhaps even probable, and
that which is scientifically proven.(24)
Admission brings the fear of juries unjustly finding liability on the basis
of quackery. Exclusion threatens that plaintiffs will be unjustly denied
recovery because science is not yet advanced enough to prove their claim,
or too expensive for them to access.
Endnotes
1.
Dorland's
Illustrated Medical Dictionary 461 (27th ed. 1988).
2.
Margarate
Berger, Federal Judicial Center Manual on Scientific Evidence,
Evidentiary
Framework, 56-67 (1994); Troyen Brennan, Causal Chains and Statistical
Links, 73 Cornell L. Rev. 469 (1988) .
3.
Charles
Nesson, Agent Orange Meets the Blue Bus: Factfinding at the Frontier
of Knowledge, 66 B.U. L.Rev. 521, 526 (1986).
4.
Merrel
Dow v. Havner, 907 S.W.2d 535, 548 (Tex.App.-Corpus Christi, March 17,
1994), rehearing en banc (Aug. 10, 1995), rehearing overruled (Sept. 28,
1995).
5.
This
logical approach is characterized as post hoc ergo propter hoc,
roughly translated as "after this, therefore because of this."
6.
Ellen
Relkin, Some Implications of Daubert and its Potential for Misuse:
Misapplication to Environmental Tort Cases and Abuse of Rule 706a Court
Appointed Experts,15 Cardozo L. Rev. 2255 at 2256.
7.
Nesson,
supra
note 3.
8.
Relkin,
supra
note 6 at 2256.
9.
Benedi
v. McNeil-P.P.C. Inc., 66 F.3d 1378, 1384 (4th Cir. 1995).
10.
Id.
at 1378.
11.
Id.
at 1378.
12.
McCullock
v. H.B. Fuller, 61 F.3d 1038 (2d Cir, 1995).
13.
Becker
v. National Health Products, 896 F.Supp. 100 (N.D.N.Y. 1995).
14.
Daubert
v. Merrell Dow, 43 F.3d 1311 (9th Cir. 1995).
15.
Cavallo
v. Star, 892 F.Supp 756, 771.
16.
Schmaltz
v. Norfolk and Western Railway, 878 F.Supp. 1122 (N.D.Ill. 1995).
17.
13
F.3d 1090 (7th Cir. 1994) cert. den. 114 S.Ct. 2711 (1994).
18.
Id.
at 1106.
19.
Brennan,
supra
note 2; Ronald Allen, Comment: Rationality, Mythology, and
the "Acceptability of Verdicts" Thesis, 66 B.U. L. Rev. 541 (1986).
20.
52
F.3d 1124 (2d Cir., 1995).
21.
This
ratio is referred to as "Relative Risk."
22.
Many
substances act synergistically in the body, where the effect together of
two agents is greater than the effect of each of them independently when
summed. As an example, tobacco smoke and asbestos act synergistically in
causing higher rates of some lung cancers than their individual added effects
would indicate.
23.
43
F.3d 1311.
24.
Nesson,
supra
note
3 at 526. |