Pharmacology Expert Witness

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PHARMACOLOGY is a branch of medical science concerned with the use, effects, metabolism, mechanism of action, and interactions of pharmaceutical compounds (i.e. drugs). In other words, Pharmacologists study the ways in which drugs interact with living organisms. This differs from the practice of Pharmacy, which relates to the preparation and dispensing of drugs.

When Pharmacologists study, develop, and synthesize new medications, they are particularly concerned with toxicity and the potential to cause harm. As dozens of new drugs enter the marketplace every year, the role of the Pharmacologist becomes more complex, and more important, than ever. Adverse outcomes from prescribed medications are far more complicated than just prescribing the wrong drug or the wrong dose for a given diagnosis. Side effects, toxicities, and contraindications can commonly be predicted by, and are directly related to, the pharmacology of the drug.

Drug interactions causing treatment failures or undesired adverse outcomes are increasingly the result of complicated drug metabolism and transport processes, some of which are genetically predetermined. For example, in 2013 the FDA issued a “Black Box Warning” — the highest degree of safety warning — stating that codeine may not be given to children for tonsillectomy pain. The reason is that some children have a genetic variant that causes a specific enzyme (CPY2D6) to quickly metabolize codeine into lethal levels of morphine. Following the deaths of over a dozen children, the prevalence of the genetic abnormality led to the FDA ruling.

Given the inherent complexity of drug science, a leading Pharmacology expert is an invaluable resource for educating the trier of fact on the pharmacologic basis for clinical outcomes and for determining causation in drug-related litigation. Equally as important, the same expert may also determine that an adverse medication event was idiosyncratic or otherwise unrelated to the prescribing, dispensing, or administration of a drug.