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Knowing when to test
While medical malpractice lawsuits have been around for decades, the issue of liability for genetics is fairly new. Most general physicians have had little training in genetics, and there are too few specialists to go around.
“There are only 20-something genetic counselors in all of Arizona,” says Marchant. Yet there are more than 2,500 commercially available genetic tests that a doctor can order or a patient can purchase directly from genetic testing companies. These tests check for gene variations associated with a range of diseases, from the fairly rare, like cystic fibrosis, to the more common, such as breast cancer.
For example, the BRCA 1 and 2 gene mutations are known to indicate a higher risk of breast cancer in women. If a woman informs her doctor that breast cancer runs in the family, he can refer her to a testing facility to check for those mutations, but many doctors don’t. In most cases, they haven’t had the training necessary to interpret data produced by a genetic test, or they are simply unaware that genetic testing is a viable option for their patient.
“If you’re a woman with a mutation in the BRCA 1 or 2 genes, you have a 50 to 70 percent chance of getting breast cancer. And so sure enough, a lot of those women end up getting breast cancer and saying that their doctors should have told them about this and told them about the risks based on their family history,” says Marchant, who is faculty director of ASU’s Center for the Study of Law, Science and Innovation.
This issue puts the pressure on doctors to educate themselves on genetics. In addition, more and more states are moving toward holding doctors to a national standard of care. That means small town physicians may be responsible for providing their patients with the same standard of care as doctors in a big city. This includes the use of cutting-edge technology, like genome sequencing.
“That’s going to be tough for a lot of places. If you’re in a big metropolitan area like Phoenix, the top standard is what you live up to. But if you’re in a small town like Payson or Yuma or even smaller, it will be very challenging for those doctors to live up to the same standard. The trend towards a national standard of care is going to push toward more liability,” Marchant says.
Liability cases also arise from prenatal testing issues, in which a couple having a baby has reason to believe they are at risk for a genetic disease. If their doctor fails to refer them to get a genetic test, and the baby is born with a debilitating disorder, the couple can bring forth a wrongful birth case. This means the couple would have terminated the pregnancy had they known their child would be born with a disease that drastically impacts his or her quality of life.
“Doctors are sort of caught unprepared to deal with this, and if they make mistakes, people die and babies get born with bad diseases,” Marchant says.
In Arizona, Gov. Jan Brewer recently signed a law that makes these types of lawsuits illegal. Doctors cannot be sued in a wrongful birth case and cannot be held accountable if they fail to diagnose a birth defect that may have prompted the mother to seek an abortion, unless the doctor acted with “gross or intentional negligence.” However, feminist groups have criticized the law, saying it allows anti-abortion doctors to withhold important information from women in order to prevent them from having the procedure.
The controversy illustrates how complicated legal issues can become as technology advances. In August, the National Institute of Health’s National Human Genome Research Institute awarded nearly $900,000 to ASU's Center for Law, Science and Innovation to study liability as it relates to personalized medicine. Marchant will lead the research team.
He notes that education is a key tool for dealing with the issue. The majority of current doctors don’t have training in genetics, and there is no authoritative guideline for them to rely on when making decisions about whether to refer patients to a geneticist. Marchant says practicing physicians need a way to stay updated in genetics and personalized medicine, which are constantly changing.
Up-and-coming doctors studying at the future Mayo Medical School–Arizona Campus will undergo training in genetics. The school is being developed in collaboration with ASU.
“ASU’s partnership with Mayo is going to be very proactive in teaching young doctors about this technology,” Marchant says.
Driving away innovation
Other liability issues arise from new “intelligent” technologies, such as autonomous vehicles, which are being developed by Google and other manufacturers.
“These vehicles can pilot themselves under certain conditions without direct participation of the drivers,” Marchant says. Google’s self-driving cars have already completed more than 200,000 miles of accident-free driving and will almost certainly be safer that human-controlled vehicles.
“I don’t think they’ll be deployed until they are safer, so there will be fewer accidents overall,” Marchant says, “But whenever there is an accident, you’ll be able to say the car manufacturer and the robot are to blame for it. We’re going to take the driver out of the equation, so now it will be easier to sue the car manufacturer whenever there is an accident.”
Anytime authority is handed over from person to machine, there is the question of who’s to blame if something goes wrong. Cruise control in cars, airplane autopilot features and robots in the workplace are all examples of this.
“It raises issues of who should be responsible – the programmer, the manufacturer of the product with the computer in it, the person who delegates the decisions to the machine?” Marchant says, adding that there is currently no clear precedent in these liability cases.
The risk of being sued may discourage manufactures from developing new technologies that are actually safer. Marchant identifies vaccines as an example of this paradox. Vaccines may benefit the majority, but if a small number of people experience negative side effects, they can sue the vaccine manufacturer for millions and put it out of business.
“You have an ironic situation of a safer technology being deterred from being developed because there will be more liability for the party developing it, even though the product will be safer over all,” Marchant says. To protect this from occurring in cases with vaccines, the Congress has enacted policy solutions that provide a compensation system separate from general law and court systems. Marchant says a similar intervention might be in order for manufacturers of autonomous vehicles.
“We don’t want to take away the incentive to have safer products, but on the other hand, we don’t want to deter manufacturers from developing these products altogether,” he says.
Written by Allie Nicodemo, Office of Knowledge Enterprise Development. This article first appeared on ASU Research Matters.