QUALITY OF CARE

New Lawsuit Tests Limits of Medical Malpractice in Age of Precision Medicine

Is a health care provider’s failure to refer a cancer patient for genetic counseling grounds for medical malpractice?

One patient claims it is and wants $1.8 million in damages because she never got it.

The Case
The novel case involves a 36-year-old Oregon woman who underwent genetic testing for hereditary cancer risk (Myriad’s MyRisk) due to her family history— her mother and grandmother had cancer. While the genetic test report found that "no clinically significant mutation has been identified," it also flagged a variant of unknown significance (VUS) in the MLH1 gene (MLH1 c.191A>G) associated with Lynch syndrome.

Ultimately, a court or jury will have to decide whether the providers committed malpractice.

Another doctor later determined that the diagnosis was wrong—but not before the patient had undergone a preventive double mastectomy and hysterectomy based on the diagnosis. The patient is now suing for $1.8 million in damages. Her medical malpractice lawsuit against her doctors and a southwest Oregon medical center cites not only "negligent diagnosis and treatment" resulting from misinterpretation of her genetic test results by a nurse practitioner, gynecologist, and a surgeon but a novel claim: the providers’ failure to refer her to a genetic counsellor.

Does She Have a Valid Malpractice Claim?
Ultimately, a court or jury will have to decide whether the providers committed malpractice. Like any other plaintiff, to prove medical malpractice the patient will have to show that the providers failed to meet a recognized standard of medical care in failing to refer her for genetic counseling. To make that case, her attorneys will no doubt rely on 2015 guidelines from the American College of Medical Genetics and Genomics for the interpretation of sequence variants stating that a VUS should not be used in clinical decision making. The guideline goes on to say that additional patient monitoring may be advisable while efforts to reclassify the variant are underway.

Takeaway: While not ascribing too much significance to any single case, this litigation takes place against a fascinating backdrop of 21st century precision medicine in which genetic counseling plays an increasingly important role. Although it may not yet be recognized as a standard of medical practice, it’s important to keep in mind that as medicine evolves, so does the standard of legal care. Thus regardless of the ultimate outcome, this case highlights the importance of appropriately counseling patients about genetic risk factors particularly when non-genetic experts are ordering tests.

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