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In 1993, the Supreme
Court asserted the need for District Court Judges to serve as gatekeepers in
qualifying experts to testify under Federal Rules of Evidence (FRE) 104 (a)
and 702, and ensure that proffered testimony is both relevant and reliable (Daubert
v. Merrell Dow Pharmaceuticals, 113 S.Ct. 2786). FRE 104 (a) states in pertinent
part, "Preliminary questions concerning the qualification of a person to be
a witness … shall be determined by the court …." FRE 702 states in pertinent
part that "if … specialized knowledge will assist the trier of fact … , a witness
qualified as an expert by knowledge, skill, experience, training or education,
may testify thereto in the form of an opinion …." Faced with objections like
"Not a medical doctor", or "Beyond the scope", courts have had to rule on the
appropriateness of permitting non-physicians to testify about the effects of
drugs. Frequently, the courts have erred in limiting the testimony of such experts
regarding drug effects, solely because the proffered expert was not an MD; however,
the courts have allowed MDs with no specialized training in pharmacology or
toxicology to testify erroneously about drug effects and the interpretation
of drug blood and urine concentrations because the courts apparently do not
adequately appreciate the severe limitations of the undergraduate medical curriculum
in teaching pharmacology and toxicology. The purposes of this paper are: (1)
to compare and contrast the knowledge, skill, experience, training and education
of medical doctors (MDs) with those of PhD-level pharmacologists/toxicologists
in order to provide attorneys and judges with the knowledge they require to
ensure that properly trained experts are qualified to testify about the effects
of drugs, and (2) to review pertinent case law regarding the qualifications
of PhD-level pharmacologists/toxicologists and MDs to testify as experts about
the effects of drugs.
In reviewing
the differences between the methods of science and clinical medicine, the Fifth
Circuit Court of Appeals noted that the objectives, functions, subject matter,
and methodology of hard science vary significantly from those of clinical medicine
[Moore v. Ashland Chem., Inc. 126 F.3d 679 (5th Cir.1997)]. Following up on
Daubert's emphasis on assessing the reliability of the methodology employed
to reach a conclusion, the Moore court opined that clinical medicine and hard
science have markedly different methodologies. While scientists basically test
and publish in order to gain new knowledge, traditional clinical medicine observes
many types of data including: physical examination, medical history, differential
diagnosis, other test results and reports for each patient in addition to the
relevant medical literature, as well as relying on their training and experience
to determine a diagnosis. However, in Joiner v. GE (78 F.3d 523 1996 US App.
LEXIS 5590), despite testimony from one MD that he "conducted a comprehensive
and traditional occupational medical assessment of Mr. Joiner" and "relied on
my extensive experience" and testimony from a second MD that he had "eliminated
other potential causes of Joiner's lung cancer to a reasonable degree of medical
certainty", the trial court "believed that the testimony … did not rise above
'subjective belief or unsupported speculation'" GE v. Joiner [1997 WL 764563
(U.S.), p.3] and the Supreme Court upheld, saying that neither Daubert nor FRE
702 require "a district court to admit opinion evidence which is connected to
existing data only by the ipse dixit of the expert" (Id at 5). Courts and litigators
must be cognizant of the differences between medicine and science and should
conduct an intensive review of any medical doctor's credentials in pharmacology
and toxicology when they are proffered as an expert on drugs. Much of clinical
medicine is subjective impression, based on experience, remember the Reggie
Lewis case?
In Sinkfield
v. Oh, 495 S.E.2d 94 (Ga.App.1997), the court cited Colusa Remedy Co. v. US,
176 F.2d 554, 558 (8th Cir. 1949), reminding us that "Pharmacology is 'the study
of drugs as to their chemistry, source, physical properties, preparation, and
physiological effects on living tissue, whether they be used in therapeutic
amounts or otherwise, their absorption, their fates, their excretion and therapeutic
indications for their use.'" The Sinkfield court also offered the following
analysis, "We question whether a medical doctor's pharmacological training is
generally comparable to that of a doctor of pharmacology. Thus it is difficult
to see what medically trained professional could have been more qualified to
testify about the effects of the particular drug at issue than Dr. Proctor,
who has earned a PhD with a double major of pharmacology and toxicology from
a prominent university."
In Genty v. Resolution
Trust Corp., 937 F.2d 899 (3rd Cir. 1991), in addressing the trial court's decision
to exclude the testimony of Brubaker, a PhD toxicologist, solely because he
was not a medical doctor, the court cited Re Paoli 916 F.2d 829 (1990), and
stated, "The only reason given by the trial court for the exclusion of Dr. Brubaker
is that he was not a medical doctor. Medical doctors, however, are not the only
experts qualified to render an opinion as to the harm caused by exposure to
toxic chemicals. The trial court's exclusion of Brubaker, without considering
his credentials as a doctor of toxicology, simply because he did not possess
a medical degree, is inconsistent with expert witness jurisprudence." The lack
of an MD degree is not an adequate basis to exclude an expert from testifying
about drug effects, and possessing an MD degree is not a sufficient basis to
permit it.
By: David M. Benjamin, PhD. Reprinted with permission
from Dr. Benjamin. Website: http://www.channel1.com/users/medlaw/
