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The modern medical, hospital or pharmacy malpractice case often involves at least one claim addressing medication administration. These claims may allege improper medication, dose, timing, route, substitution or omission. Consider a hypothetical patient who suffers from a severe heart condition requiring surgery. During the hospitalization and before surgery, the patient suffers a cardiac arrest and is resuscitated. Although medications were prescribed immediately to support blood pressure and cardiac rhythm, the patient’s condition continued to deteriorate, and the patient suffered a second cardiac arrest and passed away. Subsequently, it was discovered that the physician prescribed, pharmacist filled and nurse administered an anti-arrhythmic (heart rhythm support) medication that was five times above the recommended dosage. In medical journals today, chances are good there will be at least one article or letter dedicated to medication errors. Direct-to-consumer advertising, media attention and scientific literature all keep the topic of medication errors in the public eye. A 2002 report in Archives of Internal Medicine estimated that 40 medication errors occur daily in the hospitals studied. This topic will continue to catch the public’s interest as it garners greater media and scientific attention. There are unique legal and pharmaceutical issues related to the dissection, analysis and evaluation of a medication error claim. Several of the health-care providers implicated in the above hypothetical case have different legal duty analyses under Texas law. While Chapter 74 of the Texas Civil Practice & Remedies Code (TCPRC) — referred to as 74.001, et seq. — governs all health-care liability claims against these health care providers, the issue of legal duty requires separate consideration. Absent special circumstance, pharmacists in Texas only have the duty to fill a prescription correctly; they do not have a general duty of “ordinary care” of the type required of physicians, according to Morgan v. Wal-Mart Stores Inc., decided by Austin’s 3rd Court of Appeals. In the hypothetical fact scenario and under Morgan, the pharmacist may not have a legal duty beyond correctly filling the doctor’s order for anti-arrhythmic medication even though an opposing expert pharmacist may contend the pharmacist filling the anti-arrhythmic medication prescription should have recognized the excessive dose. Specific allegations also may give rise to legal duty concerns. Section 74.104 of the TCPRC sets forth the legal duty of physicians or health care providers for meeting informed-consent requirements concerning the risks and benefits of treatment. In the above hypothetical, if the physician disclosed the risk of death to the patient before administering treatment, he may be entitled to a rebuttable presumption of compliance with the legal duty. CONTEXT OF CARE In many cases, the physician orders medication to treat or prevent a patient’s pre-existing disease or ailment. A lawyer should research fully the medical literature about the underlying medical condition and role of the medication in treatment or prevention. The patient’s pre-existing pathology and expected prognosis may have placed the patient at risk for the alleged injury long before administration of medication. Doctors often order anti-arrhythmic medications to prevent the heart from beating incorrectly or even stopping altogether. Ironically, one of the most frequent side effects of these medications is the known complication of heart rhythm disturbances. The anti-arrhythmic medication and underlying heart disease may have placed the patient at risk for the same potential complication: sudden cardiac death. This chicken-and-egg determination requires extensive literature research and expert analysis. Medical research should extend to textbook and primary medical journal scientific literature. The Internet is replete with free resources to investigate and research disease and medication effects, risks and benefits. Medline/Pubmed remains the premier primary medical literature search engine ( www.ncbi.nlm.nih.gov/entrez/query.fcgi). Other research tools can be found on the comprehensive MDExpress Web site ( www.mdexpress.com). Written and deposition discovery should focus on prior medical history, previous medication exposure and subsequent treatment. Discovering prior and subsequent insurance, pharmacy, medical, hospital, disability and counseling records is invaluable in determining underlying pathology and tolerance to the medication at issue. In addition to formal discovery, Texas law provides a new mechanism to investigate claims informally. Section 74.052 requires the execution of a valid Health Insurance Portability and Accountability Act (HIPAA) authorization expressly releasing “verbal as well as the written” medical information. Any discussion of medication exposure merits some mention of the terminology used by experts in the field. Pharmacologists define “pharmacokinetics” as the effect of the body on the drug (how the body metabolizes the drug). They also define “pharmacodynamics” as the effect of the drug on the body (desired and side effects of the medication). These concepts are best left to experts in the field who compare pharmacokinetic calculations to explain the metabolism of the medication in terms of bioavailability, absorption, first-pass effect, volume of distribution, terminal half life, onset of effect, peak plasma levels, peak effect and area under the curve. Toxicology testing of blood and tissue samples also may provide additional evidence of the timing of medication doses or other contributory explanations for injury or death. In the hypothetical example, pharmacokinetic calculations may reveal that the anti-arrhythmic dose metabolized to a sub-therapeutic level at the time of death, bringing into question whether the patient suffered an accepted complication of the disease as opposed to an adverse effect of the medication. QUALIFIED EXPERTS Identifying and retaining qualified experts takes time, effort and expense on both sides of a case. In the hypothetical example, the attorney should consider retaining liability experts in the fields of nursing, pharmacy and cardiology. Experts addressing cause of death also should be addressed. Cardiology and cardiothoracic surgery experts could address the underlying heart condition and its treatment. However, the medication exposure issues may require evaluation by a toxicologist or pharmacologist. In addition, if an autopsy was performed or if tissue, blood or other fluids are available for inspection and analysis a pathologist/medical examiner may contribute significantly to the case. TCPRC 74.351 requires a health care liability claimant to file one or more expert reports within 120 days of filing a health care liability claim. The failure to file expert reports that comply with these procedural requirements may result in dismissal of the claim, according to 74.351. The experts must be qualified and their theories must be scientifically reliable, as noted in E.I. duPont deNemours & Co. Inc. v. Robinson (1995), a Texas Supreme Court opinion. A medication error claim is fertile ground for a Daubert/Robinson challenge, especially in the absence of objective evidence such as confirmatory toxicology results to support expert conclusions. Texas attorneys have a number of formal and informal procedural tools available to investigate, discover and evaluate a medication-related claim. Proper understanding of the associated legal duties, background and research, necessary experts, applicable terminology, available testing and potential calculations remains the key to prosecuting or defending a medication error claim. A lawyer doesn’t need to be a pharmacist to evaluate the claim — just hire one. Derek S. Davis is a shareholder in Cooper & Scully in Dallas and dedicates his practice to the defense of hospitals, health plans, pharmacies and other health care providers in medical litigation. Davis holds a degree in pharmacy from the University of Texas and maintains a current license to practice pharmacy in the state of Texas. If you are interested in submitting an article to law.com, please click here for our submission guidelines.

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