What is the effect of the Daubert Trilogy on Medical Expert Testimony?

If a physician does not carefully support his opinion on the applicable standard of care his case may be lost on a “Daubert challenge”. A physician’s opinion should be based on reliable methodology [according to the Daubert-Joiner-Kumho rulings] and physicians should be prepared to precisely and articulately recite the methodology used, i.e. review of the peer reviewed medical literature along with the grading of the evidence used for his opinion on the standard of medical care

Viewed together, the Daubert-Joiner-Kumho trilogy stands for the following criteria:

Federal trial judges should act as vigilant “gatekeepers” regarding the admissibility of expert testimony (Daubert). They must do so regarding expert testimony of all types, both scientific and nonscientific (Kumho). They must ensure, at minimum, that testifying experts honor the same theories, employ the same methodologies, use the same tools, and follow the same standards as they do in the course of their ordinary, non-litigation work (Kumho). And trial court decisions to exclude expert witness testimony will be reversed only for abuse of discretion (Joiner). Federal judges are not only hearing many more motions to exclude experts, but they are becoming ever more willing to grant them.

Daubert [509 U.S. 579, 592-596] identified five factors that could be used to evaluate whether particular expert testimony was “scientifically valid”

I call these criteria PEAT which includes whether support for expert testimony opinions-

(1) was falsifiable or testable,

(2) had been peer-reviewed,

(3) had a known (or potentially knowable) rate of error,

(4) was accompanied by established standards controlling the technique’s operation and accuracy, and

(5) was generally accepted..

OR PEAT FOR Peer reviewed; Error rate known; Accepted by the medical community; Testability

Let’s see examples of the application of Daubert by the Courts and why a plaintiff’s lawyer in a medical malpractice case may want to avoid a Daubert Court and/or why a medical expert must be careful to have his/her opinions supported by *PEAT and the peer reviewed medical literature.

1. *Meister v. Medical Engineering Corp., 267 F.3d 1123 (D.C. Cir. 2001). Silicone breast-implant plaintiff with scleroderma offers treating physician and pathologist as causation experts. Trial court initially denies defendants' Daubert motions but later grants defendants' motion for judgment as matter of law or new trial after jury returns verdict for plaintiff. Exclusion affirmed. Treating physician performed differential diagnosis showing that symptoms of all other diagnoses were excluded except those caused by silicone. But, says the court, case study reports were not sufficient to "rule in" silicone as potential cause of scleroderma in face of strong body of epidemiological research showing no causal basis, and also that the pathologist's causation opinion was tentative and insufficient. The peer reviewed literature actually shows that "chemical, in vitro, and in vivo ... studies ... singly or in combination, are not capable of proving causation in human beings in the face of the overwhelming body of contradictory epidemiological evidence." Courts elsewhere are unanimous in rejecting similar causation evidence in silicone breast implant cases.

2. *Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254 (5^th Cir. 2002). Patient develops cholestatic hepatitis after his dermatologist prescribes Lamisil. In a products liability claim against manufacturer, district court awards summary judgment for defendant in partial reliance on affidavit from patient's treating physician stating that the manufacturer's warning was clear and reasonably apprised him of risks.

3. Clerc v. Chippewa County War Memorial Hospital No. 254940, Michigan Ct. App., August 4, 2005). The defendants moved to strike a medical expert's causation testimony on the grounds that it lacked a scientifically reliable basis because the expert opined on a proposed "backward staging" hypothesis in which seven months after a chest x-ray was mistakenly interpreted as normal by a radiologist the patient died with lung cancer. The medical expert “reasoning backwards” opined that a patient's cancer would have been either stage I or stage II at the time of the x-ray with a higher survival rate. The medical expert's opinion, therefore, that the patient would have had a better chance of survival had the cancer been definitively diagnosed at the time of the x-ray seven months earlier based on backward staging of stage I, II or III invited a Daubert challenge.

When affirmed Plaintiff then argues that the treating physician is not an expert in liver disease and against the adequacy of pharmaceutical warnings. The patient also argued that the district court should not have considered the primary care physician's affidavit without first conducting a Daubert hearing.

Furthermore says the plaintiff the primary care physician in testifying that warnings reasonably notified him of risks, physician was testifying only to personal knowledge, not as an expert documenting his opinions with peer reviewed material.

To review - opinions by a doctor on the Standard of medical care must be supported by the acronym PEAT: P for peer review, E for error rate, A for acceptance by the medical community, and T for testability of the data.

In addition if a hypothesis of 'backward staging" is to be opined by a medical expert, then he must definitely have scientific data to satisfy PEAT in the Daubert challenge.

• Opinions regarding standard of care, as well as all other opinions, should be backed up by research and facts to be persuasive.

• In medical malpractice cases, the medical standard of care the physician can expect to be asked is how he defines “standard of care” and how he arrived at his opinion as to what the standard of care was.

• In terms of defining the standard of care the physician needs to be aware that this opinion may not be admissible and will certainly be challenged on cross-examination if it is based only on the physician’s personal opinion, anecdotal experience, speculation, or conjecture.

• Once on the stand, physicians need to be prepared to justify the reasons for opinions on the standard of care in a cool, calm teaching manner.

• The physician’s testimony on the standard of care may not be based on his or her personal opinion, nor on mere speculation or conjecture. The physician’s opinion must reflect some evidence of a national standard, such as attendance at national seminars or meetings or conventions, or reference to published materials, when assessing a medical course of action or treatment.

The Daubert challenge:

Q. Is your opinion supported by the peer-reviewed medical publications? and

Q. What is the error rate attributable to these articles? Fortunately, most peer-reviewed articles in order to be published in peer reviewed journals will reveal the confidence level and the probability [P value] factor and all the other important accompanied statistics. .

Q. Have all the Daubert criteria been met [PEAT]?

Q. Do the RCTs (Randomized Controlled Trials) and/or meta-analysis support your opinion?

Q. How are the results applicable? You should be able to answer this question by your opinion on the standard of care.

*So if you remember the acronym PEAT in the Daubert questions (Peer review, Error rate, Acceptance by the medical community, and Testability of data), you will be safely ahead of the game.

Your retaining attorney should establish the relevance and reliability to summarize the legal foundation needed for the admission of your testimony.

You must, therefore, make sure that each of your opinions is supported by the above Daubert [PEAT] criteria, especially if your scientific testimony comes under attack by the opposing medical expert witness.

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Modified by Author from “Medical Malpractice Expert Witnessing: Introductory Guide for Physicians and Medical Professionals” (Hardcover) by Perry Hookman, MD (see profile page), Hardcover: 592 pages, Publisher: CRC; 11/26/07; Language: English ISBN-10: 1420058959 ISBN-13: 978-1420058956; Dimensions: 10.1 x 7.1 x 1.4 inches; Shipping Weight: 2.6 pounds; Price $239.95, FREE SHIPPING if you saw it here: mention promotion code "ADVICE12-30-08". To buy 24/7 call 800-247-6553.