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While DNA testing upends the practice of medicine, U.S. laws aren’t keeping pace. That’s one message from a nearly finished 3-year, $2 million project called LawSeq, which aims to build a legal foundation to support genomic medicine. Doctors and other health care providers are already facing lawsuits that broach new legal terrain—and sometimes even hold them liable for how they offer, interpret, and counsel patients about genetic tests.
“To say that this is a gnarly issue is a wild understatement,” said Ellen Wright Clayton, an expert in law and genetics at Vanderbilt University in Nashville, last month at a symposium about LawSeq at the University of Minnesota in Minneapolis. Clayton helped plan the conference and co-leads LawSeq.
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At the meeting, attendees weighed recommendations for doctors, laboratories, hospitals, and others about how they can care for patients while protecting themselves from lawsuits. Traditionally, doctors could do both by adhering to a legal “standard of care” closely tied to medical standards. But genomic technology is changing so fast that medical standards may not be clear, for example for doctors assessing how much a particular variant increases a patient’s risk of breast cancer or heart disease.
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Failing to offer such tests carries legal risks of its own. One lawsuit came in response to the death of 16-year-old Joseph Polaski in Pennsylvania in 2010. He died from hypertrophic cardiomyopathy 2 years after his father had an electrocardiogram (EKG) as part of a medical checkup. In a lawsuit, Polaski’s family contended that the EKG results should have set off alarm bells for Polaski’s father’s doctor, which would have led to genetic testing for the patient—and ultimately for his son. Polaski inherited the condition, and the lawsuit charged that his life could have been saved...
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