In medicolegal parlance, "causation" relates to the question: was clinical outcome negatively affected by the treatment rendered, or, alternatively, could the patient’s outcome have been affected positively if a given treatment had been applied? The precise legal definition of causation may differ from state to state, but generally there is included with the modifier of "more likely than not."
In regard to causation, where does the medical vs. legal disconnect arise? When one considers medical causation alone, for the physician confronted with a patient who has headache from intracerebral hermorrhage, it matters little to him or her whether the hemorrhage was caused by cocaine self-administered for recreational purposes, ephedra self-administered for weight loss, or a primary care physician’s failure to detect and adequately treat the patient’s chronic hypertension; the patient’s acute medical management will be more or less the same regardless of the etiology involved. For an attorney assessing liability and medicolegal causation, however, the distinction obviously is crucial. Therein lies an inherent disconnect.
If the medicolegal issue involves product liability rather than physician conduct, how then does one establish causation? In an ideal world, the process would be logical, stepwise, and employ rigorous scientific methodology; specifically, it might go something like this:
- Is the proposed cause/effect relationship scientifically plausible? In short, does it make any sense whatsoever, or is it simply too far-fetched to deserve any further consideration?
- Is there an association between the proposed etiology and the unfavorable clinical outcome that is greater than chance?
- In the general sense, is this association causal, i.e., does one cause the other?
- Is the etiology operative in the particular case under evaluation?
In the real world, however, this tidy process tends to collapse under external pressures. The Food and Drug Administration emptied phenylpropanolamine-containing products from the shelves following the results of a case-control epidemiologic study that suggested an association between the drug and brain hemorrhage in females. Merck voluntarily withdrew Vioxx from the market due to an imbalance of cardiovascular endpoints that arose after 18 months had elapsed within a clinical trial involving colonic polyps. Ephedra’s abrupt (and transient) exit was based on even less evidence.
Such actions/reactions are not the consequence of impartially applied scientific methodology and instead may reflect a cold-blooded financial calculation made by the defendant manufacturer rather than an implicit admission of guilt. Not surprisingly, physician defendants who consider themselves blameless typically find it difficult to remain so emotionally removed as to accept willingly a settlement favoring the plaintiff. What to an attorney (or insurance carrier) may be perceived as "strictly business" represents to the beleaguered doctor an exceedingly personal attack on his or her professional integrity and competence. Another disconnect.
As for treatment-modified clinical outcome, the medical threshold for "effectiveness" typically falls far below the "more likely than not" bar set for medicolegal causation. Even treatment interventions supported by positive results published in respected, peer-reviewed medical journals may be insufficient to that particular task. Just as "statistically significant" is not necessarily synonymous with "clinically relevant," a treatment of medically proven value may fail to meet the more rigorous definition of efficacy required to establish medicolegal causation. Yet another medical vs. legal disconnect.
Finally, there is that term much beloved of trial attorneys: "standard of care." As with pornography, we may admit to some difficulty attaching a specific definition to the mercurial concept, but we purport to "know it when we see it." In reality, and despite the strides we have made in developing an evidence-based approach to clinical practice, there is often more than one way to skin a cat, medically speaking. For many, many diseases and medical conditions, the "range of acceptable management" is a more realistic yardstick than "standard of care", especially if the latter is taken to imply that only one option is appropriate.
At the outset, and to avoid a "disconnect", malpractice attorneys would do well to ask their physician experts these simple questions:
- Did the care undertaken in this case fall within the range of what is considered acceptable management within the medical community generally?
- If not, did that failure harm the patient?
- If so, is it more likely than not that appropriate treatment would have led to a favorable out come?
Attorneys should not assume that the physician expert he or she has retained understands even the most basic legal tenets of liability and causation. In the end, all parties involved will benefit from a mutually clear-eyed and informed view of the evidence at hand set in the context of the "rules of law" as they apply to malpractice litigation.
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