International Journal of Risk & Safety in Medicine - Volume 24, issue 1

Authors: Edwards, I. Ralph | Body, David

Article Type: Other

DOI: 10.3233/JRS-2012-0555

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 1-2, 2012

Authors: Aronson, Jeffrey K.

Article Type: Research Article

Abstract: A thorough analysis of a case that involves a medication that may have caused or contributed to an adverse outcome, or a comparison of two compounds in a patent dispute, requires consideration of many processes that affect the clinical effects of a medication. These include its chemical structure, its pharmacological actions (pharmacodynamics), the pharmaceutical formulation, and its absorption, distribution, metabolism, and excretion (pharmacokinetics). They also include analysis of clinical details, including the diagnosis, the quality of the prescribing decisions, the accuracy of the prescription, dispensing, and administration of medications, and how appropriately the case was managed, including monitoring. A causality …assessment should be attempted for both the general case and the particular case. Knowledge of the systems that describe a medication's mechanisms of action (EIDOS) and the dose-relationships and time-courses of adverse outcomes and individual susceptibilities to them (DoTS) can inform several aspects of the analysis. Reports should be written in clear English and should not contain statements that rely on expertise that the expert does not possess. Show more

Keywords: Basic pharmacology, clinical pharmacology, evidence

DOI: 10.3233/JRS-2012-0547

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 3-12, 2012

Authors: Ferner, R.E.

Article Type: Research Article

Abstract: Laboratory evidence of the presence and concentration of a drug in a person who has come to harm is often helpful in forensic pharmacology, and may be crucial. However, its value depends on two critical interpretations by the expert. First, the expert must make a careful analysis of the relationship between the results as measured in the sample and the drug in the patient at the time that harm occurred. That is especially difficult with post-mortem samples. Secondly, the expert must syntheses the laboratory information with the available clinical history and clinical or pathological findings. Even in the most favourable …circumstances, when the sample is correctly obtained, identified, and analyzed, it can be hard to say that beyond reasonable doubt a given concentration had a given effect. Show more

Keywords: Forensic toxicology, analysis, concentration measurement, postmortem diagnosis, postmortem changes

DOI: 10.3233/JRS-2012-0548

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 13-21, 2012

Authors: Herxheimer, Andrew | Healy, David | Menkes, David B.

Article Type: Research Article

Abstract: In courts case histories play a central part when a crime may have resulted from an effect of a prescribed drug; in civil cases where a person may have suffered damage from a drug; and in coroners' enquiries into the cause of unexplained deaths. The court must decide two important questions: 1. Can the suspected medication(s) cause this kind of effect? 2. Did it (or they) do so in this particular case? Many judges and coroners have not addressed these questions clearly and have not used expert witnesses consistently, on occasion disregarding scientific evidence. Courts need to appoint experts to …explain and interpret the scientific evidence. Few judges are equipped to resolve contradictions between different experts. Brief accounts of five cases from four countries illustrate these points. The reluctance of legal processes to implicate drugs as a possible cause of violent behaviour leads to injustice. Courts must be required to obtain appropriate expert evidence, and be given independent data on which drugs can cause such behaviour. Show more

Keywords: Case history, expert witnesses, criminal court, civil court, coroner's court, medication-induced violence, homicide, suicide

DOI: 10.3233/JRS-2012-0549

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 23-29, 2012

Authors: Persaud, Nav | Healy, David

Article Type: Research Article

Abstract: Until recently epidemiological evidence was not regarded as helpful in determining cause and effect. It generated associations that then had to be explained in terms of bio-mechanisms and applied to individual patients. A series of legal cases surrounding possible birth defects triggered by doxylamine (Bendectin) and connective tissue disorders linked to breast implants made it clear that in some instances epidemiological evidence might have a more important role, but the pendulum swung too far so that epidemiological evidence has in recent decades been given an unwarranted primacy, partly perhaps because it suits the interests of certain stakeholders. Older and more …recent epidemiological studies on doxylamine and other antihistamines are reviewed to bring out the ambiguities and pitfalls of an undue reliance on epidemiological studies. Show more

Keywords: Epidemiological evidence, cohort studies, case control studies, statistical significance

DOI: 10.3233/JRS-2012-0550

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 31-35, 2012

Authors: Labadie, Jerry

Article Type: Research Article

Abstract: Identification of harm in the form of adverse drug reactions that are caused by counterfeit or other substandard medicinal products by application of standard pharmacovigillance methods of registration, analysis and investigation could be forensic pharmacovigillance. As recent example of this type of forensic pharmacovigilance is the discovery and investigation into the adverse drug reactions caused by contaminated heparin in the USA in 2008 is discussed.

Keywords: Forensic pharmacovigillance, adverse drug reaction, contaminated heparin, oversulfated chondroitin sulfate

DOI: 10.3233/JRS-2012-0551

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 37-39, 2012

Authors: Edwards, I. Ralph

Article Type: Research Article

Abstract: Causality has been a topic of debate by philosophers, scientists, lawyers and for centuries. It is essential to define as precisely as possible all steps in the logical chain of events, since each may strengthen or confound an argument. Almost always there are issues of missing and conflicting data that need to be addressed specifically. In pharmacovigilance, as in many other situations, there is not just one possible causation for an effect but several. Each must be evaluated in the given context for probability. There is also likely to be a causal chain of events to the adverse effect under …consideration, and each must be considered. In an individual patient diagnosis the components of patient history, clinical findings and various laboratory test findings are combined to point to the probability of the patho-physiological diagnosis, which in turn is related to possible causes with a strength determined by the constellation of findings. The established Bradford-Hill criteria are valuable in considering all the possible causal factors. Pharmacoepidemiology allows for population incidences of causes for particular effects and therefore provides an a priori probability listing for competing possible causes, or at least of one possible cause against the background of all others in a control group. Since adverse effects of medicines are generally rare, it is not possible to exclude drug causation in an individual by reliance on epidemiological evidence alone, only to argue that the incidence is below a level determined by statistical power, of the study or studies combined. Other areas of society are concerned with the process of causal inference, and this is especially true in legal cases in which judgements are made on possible personal injury by drugs. Show more

Keywords: Causality, data quality, clinical diagnosis, pharmacoepidemiology, Bradford Hill criteria

DOI: 10.3233/JRS-2012-0552

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 41-54, 2012

Authors: Dukes, Graham

Article Type: Research Article

Abstract: In writing an expert report for any court or tribunal, account must be taken of that body's needs and where necessary of its strengths and weaknesses. The essential elements are truth, clarity and conciseness. The expert should indicate the nature and source of any standards that he applies. Above all he must beware of venturing into matters that lie in any sense outside his own defined area of expertise.

Keywords: Courts, tribunals, expert, witness, reports

DOI: 10.3233/JRS-2012-0553

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 55-58, 2012

Authors: Hartigan-Go, Kenneth

Article Type: Research Article

Abstract: The medical doctor is sometimes called upon to serve in the courts as expert witness. The work is challenging and has serious implications for the legal and justice system. The outcome of a case may adversely affect the lives of real people when the evidence is not presented appropriately. However, there is reluctance from doctors to participate in the court process. The health professional may not be trained in the art of being a court witness and while scientifically qualified, may not provide the due diligence in explaining the issues properly to the members of the court. Some of the …issues that may affect the outcome of a legal case include late discovery of conflicts of interest, inability to communicate well and stick to scientific facts, the inefficiencies of the legal system, and testifying against a medical colleague. There is merit to recommend that all medical doctors must undergo theoretical and practical training when presented as expert witness in courts. Five cases are presented here as illustrations of doctors involved in court cases. Show more

Keywords: Expert witness, medical evidence, justice system, pharmacovigilance

DOI: 10.3233/JRS-2012-0554

Citation: International Journal of Risk & Safety in Medicine, vol. 24, no. 1, pp. 59-63, 2012