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July 21, 2014

Will Liability Drive Personalized Medicine?

The rapid growth of genetic data and technologies might present additional liability risks to healthcare providers.

Will Liability Drive Personalized Medicine?

The threat of liability should be a warning to practitioners to exercise extra care in handling genetic information. [raven - Fotolia.com]

  • Medical malpractice lawsuits are a double-edged sword. On the one hand, liability can compensate injured patients and push providers to implement the most up-to-date technologies and practices. On the other, the threat of liability can result in wasteful defensive medicine and drive up insurance premiums.

    New medical technologies such as personalized medicine trigger both edges of the liability sword. On the positive side, the threat of liability may compel providers to more quickly uptake useful genetic tests and data, but on the negative new liability risks and uncertainties created by personalized medicine may incentivize premature or inappropriate utilization of genetic tests and drive up insurance premiums.

    After a somewhat slow start, there is now a rapid, albeit somewhat bumpy, acceleration in the clinical use of genetic and other molecular tests to customize healthcare diagnosis and treatment based on an individual patient’s profile. The emergence of whole-genome sequencing and noninvasive prenatal testing will further expand the clinical availability and use of genetic information.

    This new era of clinical genetics can pose new liability risks to all parties in the personalized medicine life cycle, including researchers, drug manufacturers, test developers, testing laboratories, physicians, genetic counselors, and even pharmacists. There are several warning signs, however, that this rapid growth in genetic data and technologies will present a particularly significant and growing liability risk to health care providers, in particular physicians.

  • Lack of Training and Knowledge

    First, most physicians lack significant training and knowledge in clinical genetics, and specialists in genetic medicine or genetic counseling are in extremely short supply. Important opportunities in which genetic testing could be useful in diagnosis or treatment are overlooked, and when genetic tests are conducted, the significance and implications of the 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 practices have never ordered or utilized a genetic test.

    In addition to these differences in experience and practice, there are also differences in expert opinion on whether genetic testing is sufficiently validated and useful to be used in specific clinical contexts. For example, there are very different views among qualified experts about whether genetic testing is warranted before prescribing drugs such as Coumadin® (warfarin) and Plavix® (clopidogrel). Finally, the rapid pace at which new data and findings are being discovered make it very difficult for clinical guidelines and individual practitioners to keep pace.

    All of these factors can be exploited by an effective malpractice plaintiff’s attorney to argue that there were gaps or deficiencies in the treating physician’s use of genetic information.

  • Expanding Liability Exposure

    Fourth, there are important doctrinal shifts occurring in the law that can further expand the liability exposure of physicians. While the traditional medical malpractice standard was based on the customary practice standards of physicians of the same specialty in the same locality, there has been a trend toward applying a national standard of care, elevating the expectations for physicians in some less medically advanced jurisdictions. In addition, some states are now holding physicians liable for not meeting an ideal standard of care suggested by the available evidence and literature, even if other physicians have not yet conformed to that higher standard.

    Lastly, new theories of liability beyond malpractice, such as failure to provide informed consent or infliction of psychological distress, along with potential (but highly uncertain) new legal duties, such as disclosing genetic risk to a patient’s family or updating advice to a patient based on new genetic findings, present additional risks of liability in this area.

    To be sure, there are other factors and trends weighing in favor of physicians. The novelty of the claims and the lack of genetic expertise by the plaintiffs’ bar will help constrain genetic malpractice lawsuits, at least in the short term. The limited availability of qualified physicians willing to testify as expert witnesses against their colleagues is always a limiting factor for medical malpractice actions. In addition, many states have adopted legislative limitations on medical malpractice lawsuits, such as damage caps.

    Notwithstanding these countervailing factors, personalized medicine will present a new source of liability risk for all players in the personalized medicine chain, but particularly for physicians. We have recently collected information on approximately 170 reported decisions in lawsuits alleging genetic malpractice. Many more such lawsuits no doubt have been filed and quietly settled. It remains to be seen whether this initial wave of lawsuits will be a gentle ripple, massive tidal wave, or something in between.

    But the threat of such liability should be a warning to practitioners to exercise extra care in handling genetic information. This would include being aware of and utilizing new genetic tests and data when appropriate and carefully documenting in a patient’s medical record the reasons for not recommending such tests when not appropriate or necessary.

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