Faculty Directory Gary Marchant recently spoke at a LawSeq symposium discussing DNA sequencing and the legal aspects that come into play when introduced to the public as a direct-to-consumer option.
Marchant and his LawSeq colleagues met at the University of Minnesota to examine ways the legal world can keep up with the ever changing scientific landscape. LawSeq is an innovative project that gathers experts to analyze the current US federal and state laws and regulations on translational genomics so they can generate a consensus outline on what the law should be.
With DNA based tests becoming more available to the public, the concern for legal liability is on the rise. New problems are coming to light as these tests are being used, such as: the healthcare providers disconnect between the tests results and their level of care to provide, and the advancements of technology in the future finding new variants that were deemed meaningless years ago, but now have been proven to be harmful. With the level of care issue that health providers are facing, the typical fallback for most providers would be a rigorous standard of care, which is something that could act as a shield, legally speaking, against malpractice claims. Now this is becoming hazy considering that a patient’s results come from a testing company as opposed to a doctor’s office, which would mean that the doctor has all of the information needed to see what course of action to take. With that, a patient could take a test now, have the results come back with no malicious abnormalities and a certain genetic variant could be deemed meaningless. With new advancements it may come to light, possibly years later, the lab may contact a doctor and notify them that the genetic variant the patient was told to not worry about, is now known to be harmful and the patient is nowhere to be found. Now who can be held liable is up in the air, as the doctors didn’t have the results to notify the patient and the testing company may not have regularly reviewed scientific literature to track the understanding of the gene variants it tests for. Just last year, the South Carolina Supreme Court declared that a testing lab qualifies as a health care provider, therefore holding them liable under medical malpractice. The case that determined this decision was the death of a boy whose mother contends that the testing lab failed to classify the genetic mutation he carried as pathogenic, leading to inappropriate treatment.
Marchant also discussed at the symposium the various liability claims he anticipates as genomics starts in the clinical care world. Some of these claims could be: failing to test, over testing, and failing to warn family about a variant the patient carries that they might have as well. LawSeq is creating an outline of recommendations to help labs, health care providers, and others to protect them from the legal risks that could come up. This outline will be released in a forthcoming paper and LawSeq’s participants will write up their recommendations.