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.

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.

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 had the family known. Even though the doctor never treated the teenager, the family suggested he had a legal duty to Polaski. In 2015, a judge agreed. The outcome, which like any judicial decision can offer signposts for future cases, represents an expansion of a physician’s responsibility, says Gary Marchant, a law professor at Arizona State University in Tempe.




In another case, a woman in California was prescribed a seizure medication by a physician whom she consulted only by email. The drug, carbamazepine, can cause a devastating skin reaction called Stevens-Johnson syndrome, but usually only in people of Asian ancestry; the drug’s label recommends genetic testing for all patients of Asian descent before they take it. This woman’s ancestry fit the bill, but her doctor failed to recognize that, and she nearly died. “The doc who prescribed it didn’t see this patient,” says Marchant, and her surname wasn’t obviously Asian. (The case was settled through arbitration, and the outcome is not public.)

Testing for disease-related gene variants may not be enough. What is a doctor’s or a lab’s responsibility when understanding of a variant evolves after the initial testing? A DNA change of unknown significance may later be reclassified to raise risk of ovarian cancer, for example. “We try our darndest to recontact somebody who’s had a reinterpretation,” says Reed Pyeritz, a medical geneticist at the University of Pennsylvania who encounters this situation about once a month and assumes it will become more common. “But people move, they change their cellphones.” They’re usually reachable, but not always, he says.

In December 2018, Pyeritz and others published a policy statement on behalf of the American College of Medical Genetics and Genomics with “points to consider” about recontacting. The document suggested physicians do their best to recontact patients with updated information, but added that providers should caution patients they can’t promise to recontact if patients don’t initiate it.

Because science and standard medical practices are in flux, professional organizations can’t yet say “here is what you must do,” Pyeritz says. That may well change. “Some laboratories are starting to reanalyze [variants] annually,” says Amy Lynn McGuire, an attorney and medical ethicist at Baylor College of Medicine in Houston, Texas. If more and more labs adopt that practice, those that don’t could face legal risks, she says.

How substantial are those risks? Marchant and his colleague Rachel Lindor, now an emergency medicine physician at the Mayo Clinic in Phoenix, unearthed 202 genomics malpractice cases, which they analyzed in the Food and Drug Law Journal last year. On the one hand, they didn’t detect a surge in genomics lawsuits in recent years. But about 60% of genomics cases resulted in a payout to the plaintiff, they found, compared with at most 22% of those in other medical malpractice areas.

Many other cases are hidden, resolved “off the grid,” Marchant says—like that of the woman in California. Speaking once to an attorney for an insurance company, he wondered aloud about the dearth of cases involving sensitivity to the blood-thinning drug warfarin. Genetic testing easily detects the sensitivity, but Marchant suspected doctors were failing to check for it. According to Marchant, the attorney said, “Oh we’ve had two. We settle them right away before they’re filed.”



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