Medical Negligence

Page 1 of 11 Review Applied forensic epidemiology, part 1: medical negligence 1 2 2 Methods Development MD Freeman *, PJ Cahn , FA Franklin Abstract Conclusion demiology, is generally described as Introduction Causation in cases of alleged medi- concerning the intersection of epide- The evaluation of the causal relation- cal malpractice is commonly disput- ship between an alleged act of medical provides a systematic approach to the negligence and an adverse health out- causation is not a viable alternative miology and law. More specifically, FE come is an essential element of a med- (i.e.ed. Inthe cases diagnosis in which can directhave multiple specific causation in civil and criminal mat- ical malpractice legal action. In such causes), the indirect evaluation of tersinvestigation3–5. In a clinical of general setting, and the specific evalu- an action, the question of causation is ation of causation is invariably per- also known as the “but-for” question; described in this article provides a formed by clinicians (e.g. a patient’s i.e. but for the negligent act, would the reliablespecific methodologiccausation via framework the methods for ischaemic stroke was caused by his plaintiff still have suffered the adverse uncontrolled high blood pressure), outcome at the same point in time? of causation suitable for presenta- and as such it is rare that a causal de- Forensic epidemiology provides a sys- tionthe quantificationin a court of law. of the probability termination is ever revisited or chal- tematic approach to the investigation lenged. In the legal setting, however, of causation, with conclusions suitable Introduction causation is routinely disputed. FE for presentation in a medicolegal set- Causation plays a pivotal role in the - ting. Such an evaluation relies on the evaluation of legal actions involving fers from the clinical evaluation of following steps: (1) the application an allegation of medical negligence. causationevaluation in of that specific the former causation focuses dif Once it is established that an action on an analysis of the risk of injury or conclusion that an investigated negli- (either commission or omission) has disease from the investigated hazard gentof the action Hill criteriawas a plausible to first causearrive of at an a occurred and that an adverse health versus the competing risk of the inju- adverse outcome; (2) an assessment outcome has followed that action, ry or disease absent in the exposure of the temporo-spatial relationship there are two questions that must to the hazard, whereas the latter fo- between the negligent action and the be answered in order for the claim to cuses more on the differential diag- advance legally. First, the action (al- nosis and patient history6. - leged ‘hazard’) must be plausibly re- In many instances, there is no need ityfirst of indication causation of via the an adverse estimate outcome of the lated to the adverse outcome. In legal for an FE evaluation of causation in riskand (3)of quantificationinjury associated of the with probabil negli- settings, this relationship is often re- a legal setting; e.g. it is unlikely that gent action versus the risk of known ferred to as general causation1. Next, there will be a dispute over cause of contemporaneous alternative causes it must be demonstrated, on a more death when the hazard is a gunshot likely than not basis (>50% probabil- wound to the head. This form of spe- of a three-part series on applied fo- ity), that in the absence of exposure direct, since there rensicof the epidemiology,adverse outcome. we demonstrateIn this first to the hazard, the outcome would not - forensic epidemiology methods with a have occurred in the individual1,2. In tweencific causation the diagnosis is of the condition description of the investigation of the a tort action for personal injury, this andis a thehigh cause degree of theof specificitycondition; bei.e. probability of causation in three cases is known as the ‘but-for’ question; the death was caused by a gunshot of serious neurologic injury following but for the hazard, would the plaintiff wound, and such wounds are only an alleged act of medical negligence. still have suffered the adverse outcome at the same point in time? The causation is only practical when the process of answering this question is diagnosiscaused by andgunshots. the cause Direct are specific essen- * Corresponding author declared in the article. Conflict of interests: Email: [email protected] tially inseparable. 1 Oregon Health & Science University School causation. With this information, a In circumstances in which medical of Medicine, Departments of Public Health & referred to as specific or individual- negligence is alleged as a cause of an Preventive Medicine and Psychiatry, Portland, mination of negligence and damages. adverse outcome, it is rare that there Oregon, USA 2 Forensic Research & Analysis, Portland, factThe finder practice can makeof forensic a further epidemiol deter- are not at least several alternative ex- Oregon, USA ogy (FE), also referred to as legal epi- planations for the outcome, including Licensee OA Publishing London 2014. Creative Commons Attribution License (CC-BY) Freeman MD, Cahn PJ, Franklin FA. Competing interests: none declared. interests: Competing the final manuscript. preparation, read and approved and design, manuscript conception to All authors contributed rules of disclosure. ethical Ethics (AME) for Medical the Association All authors abide by For citation purposes: Applied forensic epidemiology, part 1: medical negligence. OA Epidemiology 2014 Jan 18;2(1):2. Page 2 of 11 Review that it was a natural consequence of likelihood that the conduct falls with- predictive characteristics. This le- the disease or injury necessitating in the scope of liability. As a result, whether the defendant’s conduct is a In such cases, there will be differ- proximate cause of harm becomes a inquirygally accepted process approach used in toFE specificknown ingthe opinionsmedical careon causation, in the first typically place. function of risk probability. The court ascausation differential reflects aetiology the counterfactual11. Unlike the provided by clinicians on either side must ask what risks the defendant differential diagnosis approach of of the legal dispute. The differences should have anticipated at the time medical causation, differential ae- of opinion often stem from disputes he acted and compare those risks tiology generally does not rely on a over the magnitude of the competing with the injury that actually occurred. single case and frequently offers a causes of the outcome, and described The ‘risk rule’ approach adopted by more robust examination of causal (either quantitatively or qualitative- the law provides an analytical basis risk. Although inherently designed to ly) in terms of competing risks. This for consistent decision-making. address general causation, the juris- The RR is an epidemiologic metric prudential view of epidemiological is indirect, in that there is nothing used to quantify general causation or studies is that they are strong evi- form of specific causation evaluation the association between an exposure 9. to only one possible cause. Risk is and the risk probability of disease or aabout population-based the diagnosis thatparameter, is specific in- injury (i.e. harm)8. Given that proxi- Thedence Hill of specificcriteria: causation indirect tended to describe the probability of mate cause and general causation are estimation of the probability of a particular outcome, and opinions conceptually linked by the probability specific cause regarding risk are ultimately based of risk, then, inherently, epidemiology on epidemiologic concepts and data. becomes the most suitable tool to as- via adaptation of the Hill criteria to Thus, the purpose of FE in medical sess proximate cause and, ultimately, theSpecific circumstances causation isof assessed an individual in FE negligence actions is to provide an inform the legal question of liability. case3,12. The Hill criteria, named for evidence-based foundation for opin- If there is no direct evidence of causa- a 1965 publication by Sir Austin ions of comparative or relative risk tion for either an investigated or al- Bradford-Hill, consist of nine criteria (RR) intended to indirectly address ternative cause then a general causal or ‘viewpoints’ by which population- - based determinations of causation causation. tion determination1,9. Epidemiological can be made when there is substan- the ultimate question of specific inference can inform a specific causa- tial epidemiologic evidence linking a three-part series on the applications sation by providing the probability or disease or injury with an exposure13. of InFE the in present civil and article, criminal the first courts, of a likelihood evidence of that a RR the informs exposure specific caused cau The nine criteria, and how they can we describe the methods and data harm in a randomly selected case is at sources used in the investigation least the proportion described by the are as follows: attributable fraction (AF) and indicat- 1.apply Strength to a specific of association: causation Strengthanalysis, cases of alleged medical negligence ed by effect magnitude of the RR. To- of association is generally con- andof general illustrate and the specific methods causation with the in gether, the RR and AF inform the read- sidered to be the most important analyses of three actual cases. er of the minimum number of excess determinant of causation. Most cases among the exposed population simply stated, a strong associa- Causation and the law that can be attributed to the exposure tion is more likely to indicate a In the law, a legal element of negli- and not the total or maximum num- causal relationship than is a weak gence is whether or not the plaintiff’s ber of cases that can be attributed to association. Strength of associa- exposure to the defendant’s conduct the exposure10. proximately caused the plaintiff’s in- A study presenting a RR supports (the frequency of the condition juries7.

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