DNA testing is changing the practice of medicine, but laws in the US aren't keeping up with the progress of technology. Now, doctors are already facing a pile of lawsuits that sometimes hold them liable for how they offer, interpret, and counsel patients about genetic tests.
The LawSeq project is aiming to ameliorate that dynamic, Science Magazine reports. The 3-year, $2 million project is building a legal foundation to support genomic medicine.
At a LawSeq conference at the University of Minnesota last month, attendees discussed possible recommendations for doctors, laboratories, hospitals, and others about how they can care for patients while protecting themselves from lawsuits, Science says. Doctors normally do that by adhering to a legal "standard of care" that's closely tied to medical standards. But genomic technology is changing so fast that medical standards may not be clear, the article adds.
Testing for disease-related gene variants may not be enough. A doctor or lab may have additional responsibility to recontact a patient when a variant of unknown significance is later reclassified, for example.
Because science and standard medical practices are in flux, professional organizations can't yet say "here is what you must do," Reed Pyeritz, a medical geneticist at the University of Pennsylvania, tells Science. But that could change. "Some laboratories are starting to reanalyze [variants] annually," Amy Lynn McGuire, an attorney and medical ethicist at Baylor College of Medicine tells Science. If more and more labs adopt that practice, those that don't could face legal risks, she adds.
And the risks are substantial. In a review paper published in the Food and Drug Law Journal last year, researchers found that although there wasn't an increase in genomics lawsuits in recent years, about 60 percent of genomics cases resulted in a payout to the plaintiff, compared with 22 percent of cases, at most, in other medical malpractice areas.