In some respects, the Leapfrog standards are readily integrated into a legal definition of the standard of care. They are intended to improve patient safety, which is exactly the quality issue that malpractice litigation targets. Additionally, the Leapfrog standards are clear, explicit, and measurable it is easy to determine whether an institutional provider adheres to them. This clarity will appeal to a judge or jury, who otherwise could be confused by complicated medical testimony.
What would it mean, as a practical matter, for the Leapfrog standards to become the legal standard of care? A patient injured by a rare drug interaction while hospitalized could introduce expert testimony that this interaction, although rarely anticipated by practicing physicians, can be reliably identified and prevented by standard CPOE systems, as shown by Leapfrog's research. To take another example, a patient injured by complications from esophageal surgery at a hospital that does fewer such surgeries than Leapfrog's volume standard could argue that he should have been warned that he faced a greater risk of complications at the low-volume hospital than he would at a high-volume facility. Thus, hospitals could face tort liability for failing to adopt the Leapfrog measures. Additionally, hospitals that do adopt them could be held liable for implementing them in a negligent fashion for example, installing a faulty CPOE system that fails to detect a known drug interaction. We do not explore the latter point in depth, but we note that with the adoption of new technologies comes new responsibilities.
Persuading the Courts
Courts might flatly rebuff plaintiffs attempts to introduce the Leapfrog standards into evidence, on the basis that they do not represent medical custom. However, there are at least three avenues through which plaintiffs attorneys might succeed in persuading courts to admit the standards as evidence of the standard of care. The first is via the informed consent angle. Along the lines of Kokemoor, the court could reason that a patient cannot give truly informed consent without knowing that her risk might be lower at a Leapfrog-compliant hospital. This argument is potentially persuasive in both custom-based and reasonable-prudence jurisdictions.
The second avenue is through a Helling-type argument that the relevant Leapfrog standard is so imperative that for a hospital not to implement it is not justifiable. This argument may be quite effective in states that use a reasonableness test but less so in states with a custom standard. A defendant might protest that Helling-type reasoning is inappropriate as regards the Leapfrog standards because unlike the glaucoma test at issue in Helling, the Leapfrog measures are not simple or inexpensive to provide. However, modern analyses under the reasonable-prudence standard, such as the Washington opinion, do not appear excessively concerned with absolute costs but tend to focus more on the effectiveness or cost-effectiveness of the measure in question.
The third avenue is to draw on precedent concerning the admissibility and evidentiary weight of clinical practice guidelines. The plaintiff's attorney could argue that the Leapfrog criteria are a type of guideline that should be considered as evidence of the legal standard of care, just as other kinds of guidelines are. The Leapfrog standards do resemble clinical practice guidelines in terms of the process of research and deliberation that underpins them. They diverge from some guidelines in that Leapfrog does not claim that its criteria represent current medical custom, but some guidelines are intended as best practices rather than minimum quality baselines.[24] Both clinical practice guidelines and the Leapfrog criteria would be more difficult to get admitted into evidence in jurisdictions that use custom as the legal standard of care than in jurisdictions that have moved to the reasonable prudence standard.
The Role of Causation
It is important to keep in mind that a plaintiff must do more than simply persuade the trier of fact that a given Leapfrog criterion represents the legal standard of care; he must show that his injury was causally related to the defendant's failure to adhere to a Leapfrog standard.[25] This may be challenging, since acts of omission are not mechanistically linked to effects in the way that acts of commission are. However, as discussed earlier, a plaintiff might be able to present compelling evidence in the form of expert testimony that if a CPOE system or round-the-clock intensivist coverage had been in place, the problem that caused injury would have been detected before harm was done.
Reason for Concern?
Is there any reason for concern over the potential use of Leapfrog criteria in malpractice litigation? The threat of greater liability would likely boost hospitals incentives to devote resources and energy toward meeting the Leapfrog standards. The answer thus depends in part upon our confidence in the Leapfrog criteria as reasonable standards and partly upon our judgment about the appropriateness of using legal sanctions (as opposed to just economic leverage points) to induce compliance with them. A closer view of the standards gives some cause for disquiet on both fronts.
