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Malpractice Lawsuit Calls Out Lack of Genetic Counseling

A 36-year-old Oregon woman filed a $1.8 million medical malpractice lawsuit against her doctors and a southwest Oregon medical center for "negligent diagnosis and treatment" resulting from misinterpretation of genetic test results by a nurse practitioner, gynecologist, and a surgeon. Additionally, the lawsuit cites a failure of providers to refer to a genetic counselor.

Elisha Cooke-Moore was erroneously told her she had the MLH1 gene mutation associated with Lynch syndrome. Cooke-Moore underwent genetic testing for hereditary cancer risk (Myriad’s MyRisk test) due to family history—her mother and grandmother’s cancers.

While the test report stated, "no clinically significant mutation has been identified," it also flagged a variant of unknown significance (VUS) in the MLH1 gene (MLH1 c.191A>G). Based on a misinterpretation of the results by her physicians, Cooke-Moore was diagnosed with Lynch Syndrome and underwent a preventive double mastectomy and hysterectomy in 2016. It was only after her surgeries, when seeking consultation for complications, that another doctor caught the misdiagnosis.

The American College of Medical Genetics and Genomics states in its 2015 guidelines for the interpretation of sequence variants that a VUS should not be used in clinical decision making. The guideline goes on to say that while efforts to reclassify the variant are underway, additional patient monitoring may be wise.

The complaint states the "plaintiff was not sufficiently informed about Lynch Syndrome or the meaning of genetic testing results." Additionally, the lawsuit specially states that the plaintiffs did not refer to a genetic counselor "before or after undergoing testing, as recommended by the National Cancer Institute."

This case highlights the importance of appropriately counseling patients about genetic risk factors particularly when non-genetic experts are ordering tests and in settings, like southern Oregon, where there are shortages of genetic counselors.

Takeaway: While this lawsuit does represent an individual case, clinical laboratories can play an important role in assisting providers regarding variant interpretation and patient counseling.

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