Evidence-Based Medicine in the Courtroom

Since becoming more prevalent, evidence-based medicine is now taught in medical schools across the country and is widely used by physicians in medical decision-making and the selection of medical treatment. As such, it has facilitated considerable scholarly debate within legal journals attempting to reconcile its place in malpractice litigation.

The Debate

Some argue that standard-of-care opinion testimony should be based on evidence-based medicine as opposed to “customary practice.” (For more information, see, e.g., Carter L. Williams, Evidence-Based Medicine in the Law Beyond Clinical Practice Guidelines: What Effect Will EBM Have on the Standard of Care?, 61 Wash. & Lee L. Rev. 479 (2004), note 3; Nichole Hines, Why Technology Provides Compelling Reasons to Apply a Daubert Analysis to the Legal Standard of Care in Medical Malpractice Cases, 2006 Duke L. & Tech. Rev. 18 (2006).) This movement has gained some footing, as courts in some jurisdictions have started allowing a mix of evidence-based medicine and experience-based opinions in support of standard-of-care testimony. See generally Ann MacLean Massie, In Defense of the Professional Standard of Care: A Response to Carter Williams on “Evidence-Based Medicine, 61 Wash. & Lee L. Rev. 535 (2004). (Ms. Massie advocates that evidence-based medicine is already being encompassed in the standard of care's traditional experience/custom-based analysis by requiring physicians to stay abreast of the latest developments in the profession.)

Evidence-based medicine is particularly prominent in toxic tort/pharmaceutical litigations. In such cases, the issue most frequently debated is whether evidence-based medicine should stand on its own or whether expert testimony is still useful and needed. Rooted in the “reliability” factor from the decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), this issue is interesting in light of the stated purpose of the Federal Rules of Evidence to “elicit the truth.” Fed. R. Evid. 102. “These rules shall be construed ' to the end that the truth may be ascertained and proceedings justly determined.”

If evidence-based conclusions as to causality and causation can be determined from objectively reliable, scientifically proven (or disproven) data, the question becomes this: Why do courts still insist that juries consider conflicting expert testimony based upon differing personal experiences?

Standard for Admissibility

The legal standard for admissibility of expert testimony set forth in Daubert also seems to embrace evidence-based medicine. The standard evolved from the initial Supreme Court decision in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), in which the Court announced that trial courts should prevent the jury from considering evidence that is not “generally accepted” as reliable in the relevant scientific community. Later, in Daubert, the Court enunciated newer standards that expressly focused on scientific reliability as a way to eliminate “junk science.” However, despite Daubert's focus on reliability as a hallmark of science and the rise of evidence-based medicine, courts nationwide in medical malpractice cases have been slow to replace experience-based testimony.'

As an example, consider the case of Dickenson v. Cardiac & Thoracic Surgery of Eastern Tennessee, 388 F.3d 976 (6th Cir. 2004), in which the plaintiff sued a cardiac clinic and pulmonologist after suffering a brain injury allegedly sustained as the result of premature removal of the ventilation tube following surgery. The trial court excluded expert testimony based upon Daubert's reliability requirement, stating that the expert must “demonstrate a familiarity with accepted medical literature or published standards in these other areas of specialization in order for his testimony to be reliable.”

An appellate court overruled, holding that the expert's testimony was “supported by extensive relevant experience” and that “such exclusion [based upon reliability] is rarely justified in cases involving medical experts as opposed to supposed experts in the area of product liability.” The court went on to cite a law journal article saying Daubert and its progeny has had a significant effect on toxic tort and products liability litigation, but little to no effect on medical malpractice expert testimony. Id. at 982 (citing Daniel W. Shuman, Expertise In Law, Medicine, and Health Care, 26 J. Health Pol. Pol'y & L. 267 (2001).

Another example is Reichert v. Phipps, 84 P.3d 353 (Wyo. 2004). While Reichert was a personal injury case, the court's Daubert analysis of the medical testimony regarding the plaintiff's treatment is instructive.

In Reichert, the plaintiff called the treating physician to testify that an accident caused fibromyalgia. The defense challenged the opinion, citing to literature that asserts the medical community considers the link between trauma and fibromyalgia to be controversial. The appellate court held that “where an expert's opinion is based on his treatment of the patient, the patient's medical history, the physician's training and experience, and the use of differential diagnosis, a lack of textual authority for his opinion goes to the weight not the admissibility of the testimony.” Id. at 362. Apparently ignoring medical evidence to the contrary, the appellate court relied solely upon the physician's experience in allowing his causation testimony.'

In Reese v. Stroh, 128 Wash.2d 300 (1995) (en banc), a plaintiff sued a physician for negligently failing to treat emphysema with protein replacement therapy. The trial court excluded the plaintiff's expert's causation opinion because the expert could not offer a statistically significant basis for the efficacy of protein replacement therapy in treating emphysema. The appellate court reversed, holding that the proffered opinion testimony was admissible because the expert based that opinion on “extensive experience.”

While evidence-based medicine, particularly prospective studies, offers the opportunity to elevate the standards for forensic evidence, even randomized studies are subject to criticism. Courts in toxic tort and pharmaceutical products liability cases have used evidence-based medicine more extensively. Stephen Chris Pappas, Curing the Daubert Disappointment: Evidence-Based Medicine and Expert Medical Testimony, 46 S. Texas. L. Rev. 595 (2005), note 4 at 616. However, even in those cases, scholars argue that evidence-based medicine is underutilized and should instead be used to “distinguish medical knowledge from mere expert opinion.” Davidson, supra note 1 at742.

Obstacles to Acceptance

There are a number of challenges that one must face to convince judges that proven evidence-based theories should be employed in medical malpractice cases. Perhaps one of the biggest is convincing judges and fellow lawyers alike that the time-honored adversarial approach to the assessment of evidence should be cast aside. The adversarial model was developed under the premise that with this approach, we are more likely to uncover the truth. However, if the truth is already conclusively ascertained, this need gives way.'

Another criticism is that it takes advocacy out of litigation. The possibility of being foreclosed from poking holes in the opposing party's causation argument may seem unnatural to lawyers. However, the ability to advocate would still exist, it would simply lie within the realm of sound, objective medical evidence. This would rightfully eliminate testimony based solely on clinical experience, reputation, or anecdote where it is unneeded. It would also decrease the level of complexity a judge and jury is left to consider. Further, if a plaintiff's theory on causation has been established as impossible in the medical field, there is no reason for a claim to survive summary judgment, or for lawyers to second-guess scientific certainty.”

A judge may also be reluctant to accept causation based upon general evidence for a particular party. As stated previously, evidence-based medicine starts by looking from a broad scope and gradually narrows. Given a particular plaintiff's individual symptoms and medical history, a court may struggle to find this type of evaluation conclusive and choose to instead allow the evidence to go towards its weight. Another concern is that evidence-based medicine is not practiced by all physicians. If physicians' practices do not employ this type of an analysis, why should physicians be subjected to liability based upon it?

Conclusion

While there are some challenges to convincing judges that evidence-based theories should be used to prove or disprove causation, the benefits are glaringly obvious. Judges and juries have increasingly been considering this type of evidence in toxic tort and pharmaceutical litigations over the past few years with success, although not always perfectly employing its use.

The time has come for medical malpractice expert causation testimony to fall in line with that employed in toxic tort cases, rightfully valuing proven scientific conclusions over experience-based expert opinion. When an expert's opinion on causation is supported by objective evidence developed through the scientific method, a court sitting as the gate keeper should consider accepting these truths rather than forcing a lay jury to second-guess scientifically proven fact. It is time that advocacy gave way to scientific certainty in the proper context.

'

Gary Lovell is a partner practicing in the Atlanta office of Carlock Copeland & Stair, LLP. Kristen M. Kelley is an associate in the firm's Charleston, SC, office.

'

Since becoming more prevalent, evidence-based medicine is now taught in medical schools across the country and is widely used by physicians in medical decision-making and the selection of medical treatment. As such, it has facilitated considerable scholarly debate within legal journals attempting to reconcile its place in malpractice litigation.

The Debate

Some argue that standard-of-care opinion testimony should be based on evidence-based medicine as opposed to “customary practice.” (For more information, see, e.g., Carter L. Williams, Evidence-Based Medicine in the Law Beyond Clinical Practice Guidelines: What Effect Will EBM Have on the Standard of Care?, 61 Wash. & Lee L. Rev. 479 (2004), note 3; Nichole Hines, Why Technology Provides Compelling Reasons to Apply a Daubert Analysis to the Legal Standard of Care in Medical Malpractice Cases, 2006 Duke L. & Tech. Rev. 18 (2006).) This movement has gained some footing, as courts in some jurisdictions have started allowing a mix of evidence-based medicine and experience-based opinions in support of standard-of-care testimony. See generally Ann MacLean Massie, In Defense of the Professional Standard of Care: A Response to Carter Williams on “Evidence-Based Medicine, 61 Wash. & Lee L. Rev. 535 (2004). (Ms. Massie advocates that evidence-based medicine is already being encompassed in the standard of care's traditional experience/custom-based analysis by requiring physicians to stay abreast of the latest developments in the profession.)

Evidence-based medicine is particularly prominent in toxic tort/pharmaceutical litigations. In such cases, the issue most frequently debated is whether evidence-based medicine should stand on its own or whether expert testimony is still useful and needed. Rooted in the “reliability” factor from the decision in Daubert v. Merrell Dow Pharmaceuticals , 509 U.S. 579 (1993), this issue is interesting in light of the stated purpose of the Federal Rules of Evidence to “elicit the truth.” Fed. R. Evid. 102. “These rules shall be construed ' to the end that the truth may be ascertained and proceedings justly determined.”

If evidence-based conclusions as to causality and causation can be determined from objectively reliable, scientifically proven (or disproven) data, the question becomes this: Why do courts still insist that juries consider conflicting expert testimony based upon differing personal experiences?

Standard for Admissibility

The legal standard for admissibility of expert testimony set forth in Daubert also seems to embrace evidence-based medicine. The standard evolved from the initial Supreme Court decision in Frye v. United States , 293 F. 1013 (D.C. Cir. 1923), in which the Court announced that trial courts should prevent the jury from considering evidence that is not “generally accepted” as reliable in the relevant scientific community. Later, in Daubert, the Court enunciated newer standards that expressly focused on scientific reliability as a way to eliminate “junk science.” However, despite Daubert's focus on reliability as a hallmark of science and the rise of evidence-based medicine, courts nationwide in medical malpractice cases have been slow to replace experience-based testimony.'

As an example, consider the case of Dickenson v. Cardiac & Thoracic Surgery of Eastern Tennessee , 388 F.3d 976 (6th Cir. 2004), in which the plaintiff sued a cardiac clinic and pulmonologist after suffering a brain injury allegedly sustained as the result of premature removal of the ventilation tube following surgery. The trial court excluded expert testimony based upon Daubert's reliability requirement, stating that the expert must “demonstrate a familiarity with accepted medical literature or published standards in these other areas of specialization in order for his testimony to be reliable.”

An appellate court overruled, holding that the expert's testimony was “supported by extensive relevant experience” and that “such exclusion [based upon reliability] is rarely justified in cases involving medical experts as opposed to supposed experts in the area of product liability.” The court went on to cite a law journal article saying Daubert and its progeny has had a significant effect on toxic tort and products liability litigation, but little to no effect on medical malpractice expert testimony. Id. at 982 (citing Daniel W. Shuman, Expertise In Law, Medicine, and Health Care, 26 J. Health Pol. Pol'y & L. 267 (2001).

Another example is Reichert v. Phipps , 84 P.3d 353 (Wyo. 2004). While Reichert was a personal injury case, the court's Daubert analysis of the medical testimony regarding the plaintiff's treatment is instructive.

In Reichert, the plaintiff called the treating physician to testify that an accident caused fibromyalgia. The defense challenged the opinion, citing to literature that asserts the medical community considers the link between trauma and fibromyalgia to be controversial. The appellate court held that “where an expert's opinion is based on his treatment of the patient, the patient's medical history, the physician's training and experience, and the use of differential diagnosis, a lack of textual authority for his opinion goes to the weight not the admissibility of the testimony.” Id. at 362. Apparently ignoring medical evidence to the contrary, the appellate court relied solely upon the physician's experience in allowing his causation testimony.'

In Reese v. Stroh , 128 Wash.2d 300 (1995) (en banc), a plaintiff sued a physician for negligently failing to treat emphysema with protein replacement therapy. The trial court excluded the plaintiff's expert's causation opinion because the expert could not offer a statistically significant basis for the efficacy of protein replacement therapy in treating emphysema. The appellate court reversed, holding that the proffered opinion testimony was admissible because the expert based that opinion on “extensive experience.”

While evidence-based medicine, particularly prospective studies, offers the opportunity to elevate the standards for forensic evidence, even randomized studies are subject to criticism. Courts in toxic tort and pharmaceutical products liability cases have used evidence-based medicine more extensively. Stephen Chris Pappas, Curing the Daubert Disappointment: Evidence-Based Medicine and Expert Medical Testimony, 46 S. Texas. L. Rev. 595 (2005), note 4 at 616. However, even in those cases, scholars argue that evidence-based medicine is underutilized and should instead be used to “distinguish medical knowledge from mere expert opinion.” Davidson, supra note 1 at742.

Obstacles to Acceptance

There are a number of challenges that one must face to convince judges that proven evidence-based theories should be employed in medical malpractice cases. Perhaps one of the biggest is convincing judges and fellow lawyers alike that the time-honored adversarial approach to the assessment of evidence should be cast aside. The adversarial model was developed under the premise that with this approach, we are more likely to uncover the truth. However, if the truth is already conclusively ascertained, this need gives way.'

Another criticism is that it takes advocacy out of litigation. The possibility of being foreclosed from poking holes in the opposing party's causation argument may seem unnatural to lawyers. However, the ability to advocate would still exist, it would simply lie within the realm of sound, objective medical evidence. This would rightfully eliminate testimony based solely on clinical experience, reputation, or anecdote where it is unneeded. It would also decrease the level of complexity a judge and jury is left to consider. Further, if a plaintiff's theory on causation has been established as impossible in the medical field, there is no reason for a claim to survive summary judgment, or for lawyers to second-guess scientific certainty.”

A judge may also be reluctant to accept causation based upon general evidence for a particular party. As stated previously, evidence-based medicine starts by looking from a broad scope and gradually narrows. Given a particular plaintiff's individual symptoms and medical history, a court may struggle to find this type of evaluation conclusive and choose to instead allow the evidence to go towards its weight. Another concern is that evidence-based medicine is not practiced by all physicians. If physicians' practices do not employ this type of an analysis, why should physicians be subjected to liability based upon it?

Conclusion

While there are some challenges to convincing judges that evidence-based theories should be used to prove or disprove causation, the benefits are glaringly obvious. Judges and juries have increasingly been considering this type of evidence in toxic tort and pharmaceutical litigations over the past few years with success, although not always perfectly employing its use.

The time has come for medical malpractice expert causation testimony to fall in line with that employed in toxic tort cases, rightfully valuing proven scientific conclusions over experience-based expert opinion. When an expert's opinion on causation is supported by objective evidence developed through the scientific method, a court sitting as the gate keeper should consider accepting these truths rather than forcing a lay jury to second-guess scientifically proven fact. It is time that advocacy gave way to scientific certainty in the proper context.

'

Gary Lovell is a partner practicing in the Atlanta office of Carlock Copeland & Stair, LLP. Kristen M. Kelley is an associate in the firm's Charleston, SC, office.

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