Will Whole-Genome Sequencing Create New Liability Woes for Physicians?

What's to come?
Nov. 25 2011 12:21 AM

The Doctor Will See Your Genome Now

Will whole-genome sequencing create a new liability tsunami for physicians?

(Continued from Page 1)

Even doctors who eagerly adopt WGS will be vulnerable to lawsuits. It is estimated that each of us have more than 100 variants that could significantly increase our risk of genetic diseases. WGS can detect every one of those variants. That’s an overwhelming number of potential problems for doctors to evaluate. There are nowhere near enough genetic counselors or medical geneticists to meet this demand, leaving the burden of understanding and communicating this information to doctors who have little or no training in genetics. Under these circumstances, it is likely that many doctors will fail to recognize some of these variants’ potential significance—and if that happens, a doctor can expect a major malpractice claim when his patient suffers illness or death that could have been prevented. A number of court cases dealing with existing genetic testing demonstrate that juries fully expect doctors to recognize and understand a broad range of genetic conditions, no matter how rare. For example, a Florida doctor recently was hit with a $23.5 million verdict for failing to recognize a rare genetic condition called Smith-Lemli-Opitz syndrome. When these expectations are applied to the hundreds of variants that will inevitably be revealed in every use of WGS, doctors will be easy prey for savvy trial lawyers.

Yet another potential source of liability will relate to a doctor’s duty to disclose medically significant genetic findings to a patient’s relatives. Unlike most medical tests, genetic information is relevant not only to the individual patients being tested but also to their family members, since they may harbor the same genetic variants. While physicians’ professional codes of ethics and federal laws discourage disclosure of genetic test results to family members, courts have decided this issue inconsistently to date, in some cases holding doctors liable for failing to warn family members about potential genetic risks. Settled legal and ethical principles on confidentiality and disclosure issues will be upended by widespread use of WGS.


Other dynamics of WGS will exacerbate these physician liability risks. There will be constant and rapid changes in our knowledge about the significance of various genetic variants, requiring doctors to constantly re-evaluate the diagnosis, prognosis, and treatment of their patients. Moreover, as patients become increasingly familiar with genetics, they’ll start asking more informed and nuanced questions of their doctors about genetic factors, creating new liability risks if the physician fails to respond accurately or completely. For example, consider a patient who expresses concern about his or her risk for a particular type of cancer, which may be affected by dozens of genes. If the doctor fails to note a significant mutation in one of those genes, she may be at an increased risk for liability given her affirmative assurance to the patient. In this environment, doctors will be forced to learn genetics on the job (and quickly) or will be spending much of their time and income in litigation. Perhaps the greatest hope is that a new generation of doctors being trained today will respond to these potential issues before they are overwhelmed by them, though most medical schools are not training today’s students to deal with the challenges and implications of WGS.

There is one thing we do know. As instructors of a Genetics & Law course at a law school, a new generation of law students will be ready and hungry to jump on the coming tidal wave of genetics-based medical malpractice lawsuits. It remains to be seen whether the medical profession will step up to the plate and meet this challenge, but they better start soon. If not, it will be a good time to be a patient, and a lawyer, but perhaps not a physician.

Gary Marchant is Lincoln professor of emerging technologies, law, and ethics and faculty director of the Center for Law, Science, and Innovation at ASU.


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