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Are Pharmacologists/Toxicologists Without Medical Degrees or MDs Best Qualified to Testify About Drugs?

by By David M. Benjamin, PhD

By David M. Benjamin, PhD  Email: >medlaw@channel1.com

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.