Stick to the evidence-based medicine

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Medical Negligence

May 2014, Volume 50, No. 5

Stick to the evidence-based medicine 

Ron Simon

A solid understanding of clinical practice guidelines and evidence-based medicine can help you show how and why the defendant medical provider should have followed the appropriate guidelines.

To succeed in a medical malpractice case, you must overcome powerful biases. Jurors are inclined to excuse doctors’ errors based on the belief that the doctor was trying to help the patient, and the jurors will cling to almost any detail for which they can blame the patient. One way to combat juror biases when you challenge a doctor’s actions is to use clinical practice guidelines (CPGs).

Initially, plaintiff lawyers thought CPGs could be used to establish a bright-line standard of care,1 while tort “reformers” passed statutes hoping that compliance with CPGs would immunize doctors from malpractice claims.2 Both efforts had limited success. But a deeper understanding of CPGs’ principles make them powerful weapons for attorneys, because they are consensus recommendations founded on medical evidence that the medical community has formally adopted.

First, it is important to understand the process in which CPGs are developed. The underpinning of CPGs is evidence-based medicine. The development of contemporary evidence-based medicine is generally traced to Archie Cochrane’s 1972 book Effectiveness & Efficiency: Random Reflections on Health Services.3 Cochrane recognized that there was little evidence to prove that many standard medical treatments were effective, and he argued that many, if not most, medical interventions were the result of custom practice and not based on clinical studies. For a medical intervention to be proved beneficial, Cochrane argued that it must be based on reliable medical evidence.

Evidence-based medicine is formulated on evidence that is extracted from the rigorous review of clinical studies and then translated into recommendations for medical practice. These recommendations are CPGs. The methodology by which CPGs are created is a strong argument for admitting them into evidence.4

CPGs for cardiovascular emergencies are a good example of their usefulness in litigation. Errors in cardiovascular emergencies are responsible for a large percentage of malpractice claims and payments.5 CPGs not only give specific recommendations about examinations (such as EKG and blood tests), medication, and time frames in which they should be given; they also make recommendations about hospitals’ organization and operations so that they can meet examination and treatment targets. CPGs also provide checklists of necessary tests and timelines to avoid common errors such as discharging an emergency room patient who is having a heart attack.

CPGs incorporate the basic premise of Patrick Malone and Rick Friedman’s Winning Medical Malpractice Cases With the Rules of the Road Technique.6 For example, CPGs consider two rules Malone and Friedman discuss in their book: the necessity of addressing the most immediately life-threatening condition first (“worst first”), and not guessing about a condition when a test to rule it out can be performed (“test, don’t guess”). You can use CPGs to create “rules of the road” for your case—a powerful tool, because the rules are founded on evidence.

In the same vein, you can blunt defense efforts to blame the victims of malpractice by using evidence-based medicine, CPGs, and medical science that is directed at preventing recognized medical errors. Checklists, protocols, and a host of devices, systems, and techniques are designed to take the medical professional through a series of actions to make sure that diagnostic, medication, and other common errors are not made.

CPGs are premised on the notion that both medical professionals and patients are human, and that misunderstandings, errors, and injuries are inevitable without systems and checklists. A heightened focus on institutions’ failure to put systems in place to prevent common misunderstandings of both patients and doctors can direct the jury’s thinking away from the supposedly well-intentioned doctor and less-than-perfect patient to the institution, which was responsible for preventing these kinds of errors.7

How medical providers are supposed to use guidelines. Guidelines are intended to be woven into the fabric of medical care and used in the clinical decision-making process. Standing orders, protocols, checklists, treatment pathways, and mnemonics exist in a variety of forms in the clinical setting. The GuideLine Interchange Format, Epocrates (an app for smartphones and tablets), and the Smart Medicine program of the American College of Physicians are examples of software that provide up-to-date CPGs to assist medical professionals in the clinical decision-making process.

Guidelines, checklists, and algorithms are available on plastic cards, pocket manuals, and apps. Many electronic medical record systems also incorporate checklists for doctors and nurses to use in directing patient care and putting results directly into the medical chart. When challenging a physician who has made an error, do not simply rely on expert testimony, medical texts, or academic articles to demonstrate the mistake. During trial, you can point to the various sources that were designed to help the physician avoid the error but were ignored.

The guideline creation process includes emergency physicians, internal medicine specialists, nurses, system engineers, public health officials, and safety experts to ensure that the recommendations reflect a wide range of expertise. You can create a compelling frame for your case by emphasizing that the CPG was created by experts from a wide range of expertise and was adopted by official bodies through formal processes.

The defense presentation at trial is designed to create an impression that expert physicians have acceptably different opinions about what should have been done and what the likely results of different treatment would have been. Focusing on the process by which CPGs are created enables you to frame the case as a choice between the generally accepted evidence about what should have been done and the guesses by physicians who do not pay attention to the evidence that should have been followed. You can create resonance by using the word “evidence” to identify both the treatment the patient received and the evidence-based rules the physician should have followed.

Whether to disclose CPGs before trial. A plaintiff lawyer preparing a case premised on medical care inconsistent with CPGs faces a strategic problem: Should the CPG be disclosed to the defendant before trial? Experienced malpractice attorneys recognize that sometimes, when we confront the defendant and defense experts with their errors at deposition, a detailed description of the errors only helps the defense’s trial preparation. There is generally no reason to disclose the violated guideline before trial, because it will only aid the defense.

Written discovery should ask the defendant doctor, physician group, and hospital to identify all CPGs, protocols, checklists, standing orders, treatment pathways, electronic systems, or programs that indicated how a person with the plaintiff’s condition should have been treated. If none are produced, send a request for admissions that the medical institution had no systems in place to prevent the error that took place.

The physician who does not know the guidelines. Defendant physicians frequently claim to be unaware of CPGs adopted by the board that certifies their medical specialty. In cross-examination, point out that the CPGs’ adoption by medical specialty boards, which certify the physician, is announced and discussed in the medical specialty’s journals, which physicians receive as board-certified members.

Board-certified medical specialists also must take examinations periodically to maintain their certification. You should ask their experts to review the subjects covered in recent exams, and be prepared to explain that the error was the subject of testing the doctor was required to pass. Physicians who are not aware of the guidelines can be confronted with the medical ethics that require a physician to keep current with medical knowledge.8

Institutional awareness. Counsel should also explore whether the adverse outcome is among the many metrics hospitals are required to report and on which hospitals are evaluated. For example, hospitals that are members of the Society of Cardiovascular Patient Care report on numerous performance measures.9 Similar metrics associated with cardiovascular emergencies must be reported to the American Heart Association.10 Plaintiff lawyers should conduct online research about the hospital and the larger medical organization it is a part of to find membership in organizations that commit the institution to following guidelines.

Hospital advertising is ubiquitous and typically includes representations that the hospital follows the most current and best practices. You can present these statements at trial to show the jury that the institution recognized the error in question—as well as the necessary steps to prevent it—but failed to take actions to prevent an unnecessary injury.

The physician who argues that guidelines do not trump clinical judgment. A witness who anticipates confrontation with a CPG may offer reasons why CPGs cannot be relied on. Typical arguments are that CPGs are “cookbook medicine” that do not take into account the individual patient, the diagnostic significance of the physical exam, and the physician’s experience. These typical lines of argument can be turned against the defendant using evidence-based medicine.

Ultimately, the witness will have to explain why it was appropriate that the guidelines were not followed. The witness will likely say that the treatment recommended by the guideline was not appropriate because it would have put the patient at risk or it would not likely have led to a better outcome. Plaintiff counsel can forcefully rebut these typical justifications for not following guidelines by using the guidelines themselves—because they explicitly and quantitatively assess risk, therapeutic effectiveness, and comorbidities.

To counter the defense that clinical judgment conquers all, one of the plaintiff’s experts should explain the process by which evidence-based medicine is used to create guidelines—to teach the jury about the principles behind ­evidence-based medicine and the extensive statistical evidence that is evaluated. The expert can use these principles and the resulting findings articulated in the CPG to demonstrate that the decisions and actions that are being challenged are guesses—which are not an acceptable alternative to following the direction of expert panels reviewing evidence that consider costs, benefits, and risks. Use words that change the frame from “a good-faith effort to help the patient” and “clinical judgment” to “lazy guesswork” and “an uncaring lack of effort to know and follow safety rules.”

Two trends in contemporary medicine will continue to make evidence-based medicine and CPGs powerful tools in litigation:

Concentration. The medical care industry is undergoing enormous organizational changes. Hospitals are becoming parts of larger organizations, corporations are being created to employ the medical staff of hospital departments, doctors are practicing in larger groups, and hospitals are buying physician groups.11

Effectiveness and efficiency. The Patient Protection and Affordable Care Act requires increased attention to making sure that treatments are cost- and medically effective. It requires “best practices” to improve safety and prevent errors and unnecessary readmission, and programs are being implemented to reduce payments when hospitals cause injuries.12

Despite the many forces that are pushing institutions to implement programs to make sure patients receive the highest quality medical care with the fewest possible errors, some new and larger entities have not taken the necessary steps to ensure that physicians and other care providers are employing evidence-based medicine or following CPGs.13 Experts in medical quality and medical errors recognize that better medicine and fewer errors can be achieved only by using systematic programs based on CPGs.14

An emphasis on the larger institution that did not take recommended actions to prevent anticipated errors allows you to change the focus of the trial. You can shift the focus away from the defense frame (a well-meaning physician trying to help a patient) to a picture of a large institution that knew exactly what errors to expect, the injuries they could cause, and the steps recommended to prevent these injuries—but decided not to take these steps to protect patients.

Ron Simon is the owner of Simon & Associates in Washington, D.C. He can be reached at rsimonlaw@gmail.com.

Notes:

  1. See Hinlicky v. Dreyfuss, 815 N.Y.S.2d 908 (N.Y. 2006); Frakes v. Cardiology Consultants, P.C., 1997 WL 536949 (Tenn. App. Aug. 29, 1997); Conn. v. U.S., 880 F. Supp. 2d 741 (S.D. Miss. 2012).
  2. Maxwell J. Mehlman, Medical Practice Guidelines as Malpractice Safe Harbors: Illusion or Deceit?, 40 J.L., Med. & Ethics 286 (Summer 2012).
  3. A.L. Cochrane, Effectiveness & Efficiency: Random Reflections on Health Services (Nuffield Provincial Hosps. Trust 1972).
  4. 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 (Winter 2004).
  5. C. McDonald et al., The Five Most Common Misdiagnoses: A Meta-Analysis of Autopsy and Malpractice Data, 7 Internet J. Fam. Prac. (2008).
  6. Trial Guides (2012).
  7. Darling v. Charleston Community Meml. Hosp., 211 N.E.2d 326 (Ill. 1965).
  8. Am. Med. Assn., Opinion 9.011—Continuing Medical Education, www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion9011.page.
  9. See Socy. of Cardiovascular Patient Care, Society of Cardiovascular Patient Care Performance Measures for Chest Pain, http://tinyurl.com/ldthjz7.
  10. See Robert O. Bonow et al., ACC/AHA Classification of Care Metrics: Performance Measures and Quality Metrics: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures, 118 Circulation 2662 (2008).
  11. Arthur S. Shorr, Hospital Negligence: Legal and Administrative Issues (West 2009).
  12. 42 U.S.C. §300gg-17a (2010).
  13. Christopher P. Landrigan et al., Temporal Trends in Rates of Patient Harm Resulting From Medical Care, 363 New Eng. J. Med. 2124 (Nov. 25, 2010).
  14. See Peter Pronovost & Eric Vohr, Safe Patients, Smart Hospitals: How One Doctor’s Checklist Can Help Us Change Health Care From the Inside Out (Plume 2011); Atul Gawande, The Checklist Manifesto: How To Get Things Right (Metropolitan Books 2009); Marty Makary, Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care (Bloomsbury Press 2012).


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