About the Author(s)
Recent Developments
Evidence Based Testimony
Anthony Catena

Abstract: Under the 2009 American Recovery and Reinvestment Act, there is a federally spearheaded push towards making evidence-based medicine (EBM) the standard practice in American healthcare. Within this emerging EBM evolution, opportunity exists to improve quality of patient care and simultaneously reform the current practice of opinion-based testimony in medical-legal cases. By utilizing state-of-the-art technologies and services to aggregate and assist in analyzing evidence from clinical trials, the testimony of expert witnesses will become more objective. With evidence-based testimony, fairness, efficiency, and accuracy for standard of care and causation questions will be maximized in medical-legal litigation.

Keywords: Evidence based testimony; standard of care; evidence based medicine

Published: 19 July 2013
Cite as: Catena A. Evidence Based Testimony.
Bull Health L Policy. 2013;2(1).

In the American legal system, a majority of medical-legal cases will inevitably hinge on the testimony from experts retained by each respective party. Based on the expert’s knowledge and experience, and the highly scientific nature of the testimony, these opinions are heavily relied upon by plaintiff and defense counsel to support or refute the elements of causation and standard of care.1 However, an expert witness, like any other witness, is subject to inherent human fallibility,2 and as a result, the outcome of litigation often turns on what amount to the expert’s subjective opinions and the attorney’s skillful trial advocacy skills, rather than the objective clinical standard and/or the objective scientific proof of causation.

With the 2009 American Recovery and Reinvestment Act (ARRA) funding comparative effectiveness research
3 and promoting EBM on a national scale,4 there lies potential for evidence from clinical trials to become the foundation for expert testimony and revolutionize the determination of standard of care and causation questions in the American medical-legal system.

Evidence Based Medicine and Current Standards of Evidence Admissibility
Evidence Based Medicine, Standard of Care, Causation
Currently, the practice of medicine is largely one based on clinical practice guidelines and independent judgment by the individual physician based on their years of experience and knowledge in the field.5 Using these personal experiences as a guide, physicians have been held to a professional standard of care that is difficult to concretely ascertain. However, EBM is a concept that has been defined as “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.”6 With EBM, medical evidence will no longer be passingly referred to in clinical care decisions; it will be relied upon and will inform the standard of medical care.

As a medical-legal term, the standard of care (SOC) is defined as the level at which a prudent, ordinary physician would provide care to a patient under the same or similar circumstances.
7 Due to the often scientific and highly technical nature of the subject matter, the courts often rely on expert opinion testimony to assist the fact finder in determining whether the physician’s conduct breached the standard of care.8

Under the causation element of negligence law, a plaintiff must be able to prove both factual and legal causation.
9 Factual causation simply requires the plaintiff to prove the defendant’s actions caused injury.10 Legal causation requires a showing that plaintiff’s injuries were a reasonably foreseeable result of defendant’s conduct.11 Historically, this has been a relatively difficult standard to prove in medical-legal litigation, and can be attacked;12 however, using modern technologies, evidence from clinical trials can be efficiently analyzed to provide an accurate measure of causation based on objective, factual evidence.

Federal Court Evidence
Evolving beyond the “generally accepted in the field” standard in Frye,13 recent case law and the Federal Rules of Evidence have adopted the more critical Daubert14 standard when presented with expert testimony. Under this standard, “expert testimony regarding causation based upon judgment and inferences, as opposed to a detailed and objective analysis of the best evidence will not meet the requisite standards under Daubert and Rule 702.”15 Using this Daubert analysis, the federal courts have given considerably more breadth to the scope of admissible scientific evidence.
State Court Evidence

At the state level, the courts have been divided between the traditional
Frye standard and the more recent Daubert standard.16 For example, Texas17 and Michigan18 have adopted the broader considerations of the Daubert standard; however, California19 still applies the narrower Frye standard when considering the admissibility of scientific evidence.

Issue: Opinion Testimony vs. Evidence from Clinical Trials

Perhaps unsurprisingly, there are a number of concerns about relying on evidence from clinical trials as evidence of the standard of care and causation in medical-legal litigation. One of the most significant concerns is the belief that reliance on statistical evidence fails to respect the independent judgment of the treating physicians.
20 Some critics claim every patient interaction varies and that the treating physician should be given significant deference regarding clinical care decisions. Courts have also been hesitant to admit scientific evidence in its raw form (without the independent interpretation of an expert witness) out of concern for the limited technical knowledge of the jury as fact finder.21 However, both of these concerns appear to be outweighed by the potential benefits in litigation of providing more relevant information to a fact-finder in order to promote a more just outcome.

As stated by Dr. William Meadow, “in determining, the ‘standard of medical care’ the legal system should rely on … statistical data about doctors’ performance, rather than on the opinions of experts about doctors’ performance.”
22 Furthermore, although expert testimony may reflect his or her opinion on whether the physician’s conduct caused the injury, the element of causation must be proved using factual evidence. In the modern age of EBM, and with the data-mining technologies available to synthesize and conduct meta-analysis of outcomes from clinical trials,23 opinion-based expert testimony should not be admitted without first being subject to strict scrutiny against the relevant clinical evidence.

For example, in a 2011 products liability case, a woman underwent post-menopausal combination hormone replacement therapy (CHRT) and subsequently died of breast cancer. Despite plaintiff counsel’s objections, a Florida federal judge allowed a defense expert’s opinion testimony disputing the causation connection between CHRT and breast cancer. This testimony was admitted, even though there was consistent evidence of an average 24% increase in breast cancer over an eleven-year period of randomized clinical trials. If it can be assumed the true aim of the litigation system is to attain fairness and justice,
26 then testimony like this defense expert’s should be tested against the most relevant clinical evidence to ensure the testimony is factually sound. In cases such as this, where the testimony does not correlate with the evidence, the testimony should not be allowed into evidence.

The Role of Technology in Evidence Analysis
Historically, the compilation and analysis of the evidence from clinical trials has been a logistically daunting and time-consuming task. However, with innovative search and data-mining technologies, expert witnesses are now able to efficiently evaluate and re-evaluate relevant medical studies and published clinical trials when crafting their expert opinion testimony.27

Under the current legislative landscape, the trend of admissible scientific evidence in medical-legal litigation is clearly shifting. From courtrooms to federal agencies, there has been much validation for the merits of information and evidence technologies in the analysis of clinical trials to determine “evaluations of standard of care”29 and the true measure of causation.

With both the
Daubert standard of evidence and the federally supported implementation of EBM practice in American healthcare, it appears likely technology will play an increasingly larger role in reforming expert witness testimony. Using this technology, American medical-legal litigation will ultimately steer away from it’s long-standing reliance on individual opinion testimony and will instead move towards a reliance on the more objective evidence-based testimony founded on relevant evidence from clinical trials.

Competing Interests:
None reported

Anthony Catena is a Spring 2013 graduate of California Western School of Law and was an Associate Editor of the California Western Law Review. Anthony received his B.A. in Political Science from University of California at Santa Barbara.

References (Bluebook)
1 Carter L. Williams, Evidence-Based Medicine in the Law Beyond Clinical Practice Guidelines: What Effects Will EBM Have on the Standard of Care, 61 Wash & Lee L. Rev.  479, 484 (2004). 2 William Meadow, Evidence-Based Expert Testimony, 32 Clin. Perinatol. 251, 253 (2005).
3 Robert Rowley, EHR Data and Comparative Effectiveness Research, EHRBloggers (Dec. 15, 2009), available at http://www.practicefusion.com/ehrbloggers/2009/12/ehr-data-and-comparative-effectiveness.html. 4 U.S. Food and Drug Administration, ARRA Comparative Effectiveness Studies – Clinical Trial Repository and Paces Meeting (2011). 5 Telephone Interview with Todd Feinman, MD, Founder and Chief Medical Officer of Doctor Evidence, LLC, (Nov. 4, 2012). 6 Centre for Evidence Based Medicine, What is EBM? (Nov. 1, 2011), available at http://www.cebm.net/?o=1014. 7 Meadow, supra note 2, at 253. 8 Id. 9 Joseph Devine, Negligence-Legal Causation, EZine Art. (May 1, 2009), available at http://ezinearticles.com/?Negligence---Legal-Causation&id=2292629. 10 Id. 11 Id. 12 Id.
13 Frye v. United States, 293 F. 1013, 1013 (D.C. Cir. 1923).
14 Caroline Young, Medico-Legal Research Using Evidence-Based Medicine, 102 L. Lib. J. 449, 454 (2010) (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993)).
15 John D. Sear, Effective Use of Evidence-Based Medicine to Challenge Causation Testimony, 30 L. J. Newsl. Prod. Liab. & Strategy 1, 7 (2011) (citing Zenith Elecs. Corp. v. WH-TV Broad. Corp., 395 F.3d 416,419 (7th Cir. 2005)).
16 Karen S. Precella & Heather Bailey New, Federal and State Expert Testimony Under Daubert and Robinson: What’s the Difference? 1 (2009).
17 Id. at 3.
18 Sear, supra note 16.
19 M.C. Sungalia & David M. Axelrad, New Standards for Expert Testimony, Cal. Law., Jul. 2005, available at, http://www.horvitzlevy.com/images/ps_attachment/attachment104.pdf.
20 Meadow, supra note 2, at 266.
21 Id. at 252.
22 Id. at 272.
23 Id. at 269.
24 Terence M. Davidson & Christopher P. Guzelian, Evidence-Based Medicine (EBM): The (Only) Means for Distinguishing Knowledge of Medical Causation From Expert Opinion in the Courtroom, 47 Tort Trial & Ins. Prac. L.J. 741, 754 (2012). See, e.g., Cross v. Wyeth Pharm., Inc., U.S. Dist. LEXIS 89078, at *7-8 (M.D. Fla. Aug. 10, 2011).
25 Id. at 756.
26 Id.
27Hian Chye Koh & Gerald Tan, Data Mining Applications in Healthcare, 19 J. Healthcare Info. Mgmt. 64, 66 (2005).
28 U.S. Food & Drug Admin., Harnessing the Potential of Data Mining and Information Sharing (2011), available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274442.htm.

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