Clinical OMICs - Issue 7 - (Page 17)

results may not be apparent to nonexpert physicians. For example, almost half of all women in the United States with a family history of breast cancer that meet the guidelines for BRCA testing are not advised of the option for genetic testing by their physician. Such deficiencies open the door to potential malpractice lawsuits. Second, the infrastructure needed for effective and timely utilization of genetic information in the clinic is often not available. Reimbursement is often not provided for genetic tests, making payment for such testing problematic. Clinical guidelines and clinical decision support systems frequently have not been updated to include the most recent genetic information and genetic testing recommendations. Moreover, point-of-care genetic testing is not available at most clinical facilities, resulting in delays in getting genetic test results that often make genetic testing impractical or of reduced utility. All of these factors create practical limitations to utilization of genetic data, but they generally don't immunize physicians from liability for failure to order or incorporate genetic tests. Third, uptake of genetic testing is very uneven, creating disparities in practice that again create the potential for malpractice lawsuits. Providers in many leading university and research hospitals are now routinely using genetic testing in cancer care and other clinical areas, whereas many physicians in smaller or less advanced www.clinicalomics.com practices have never ordered or uti- now holding physicians liable for not lized a genetic test. meeting an ideal standard of care In addition to these differences in suggested by the available evidence experience and practice, there are and literature, even if other physialso differences in expert opinion cians have not yet conformed to that on whether genetic testing is suf- higher standard. ficiently validated and useful to be Lastly, new theories of liability used in specific clinical contexts. For beyond malpractice, such as failure example, there are very different to provide informed consent or inflicviews among qualified experts about tion of psychological distress, along whether genetic testwith potential (but ing is warranted before highly uncertain) new Uptake of genetic prescribing drugs such legal duties, such as as Coumadin® (warfarin) testing is very uneven, disclosing genetic risk and Plavix® (clopidogrel). creating disparities in to a patient's family or Finally, the rapid pace at practice that create the updating advice to a which new data and findpatient based on new potential for malpractice ings are being discovered genetic findings, preslawsuits. make it very difficult for ent additional risks of clinical guidelines and liability in this area. individual practitioners to keep pace. To be sure, there are other facAll of these factors can be exploited tors and trends weighing in favor of by an effective malpractice plaintiff's physicians. The novelty of the claims attorney to argue that there were and the lack of genetic expertise by gaps or deficiencies in the treating the plaintiffs' bar will help constrain physician's use of genetic informa- genetic malpractice lawsuits, at least tion. in the short term. The limited availability of qualified physicians willing Expanding Liability Exposure to testify as expert witnesses against Fourth, there are important doctrinal their colleagues is always a limitshifts occurring in the law that can ing factor for medical malpractice further expand the liability exposure actions. In addition, many states have of physicians. While the traditional adopted legislative limitations on medical malpractice standard was medical malpractice lawsuits, such as based on the customary practice damage caps. standards of physicians of the same Notwithstanding these countervailspecialty in the same locality, there ing factors, personalized medicine has been a trend toward applying a will present a new source of liability national standard of care, elevating risk for all players in the personalized the expectations for physicians in medicine chain, but particularly for some less medically advanced juris- physicians. We have recently collected dictions. In addition, some states are (continued on p. 21) July 16, 2014 Clinical OMICs 17 http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Issue 7

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Clinical OMICs - Issue 7