There is no doubt that technology continues to make healthcare more accessible to the general public. Having the ability to test for conditions via Skype conference or to send in DNA to a lab is not only convenient, but it is also probably diagnosing millions of illnesses that would never have otherwise been found.
With every technology comes legal repercussions for the physician, the manufacturer of the technology, and the patient. The newest trend of using DNA to diagnose conditions is allowing people to be diagnosed without ever being seen by a physician. So what is the liability of a genetics testing lab if their results aren’t right?
If a genetics testing facility gives a patient either a false positive or false negative, what happens if they are wrong? What is their responsibility if the test results in either emotional pain and suffering or not seeking necessary treatment? Are DNA companies providing a great service -- or could they potentially be giving an entire generation a false sense of security?
The Supreme Court in South Carolina is currently deciding a case involving a genetics laboratory that does DNA testing. They are reviewing whether a DNA lab is technically a healthcare provider and therefore able to be sued for medical malpractice. In 2008, South Carolina resident Amy Williams lost her son due to a misclassification of his disorder that stemmed from DNA testing done by Quest Labs.
Her son died because the doctors used the wrong drug for his seizures due to the laboratory reporting false findings. After taking the incorrectly-prescribed medication his seizures got worse, and he ended up dying in January of 2008.
The argument made by Quest and Athena’s personal injury attorney is that since the lawsuit is a medical malpractice one, it has already outrun the state’s statute of limitations for medical malpractice lawsuits. The state of South Carolina has a cap limit on the time that you have to file medical malpractice: a suit needs to be filed within three years from the operation, treatment or omission of treatment; that it has to be three years from the discovery that there was a problem, and no more than six years from the date of the incident.
If the Supreme Court rules that the DNA laboratory is deemed a healthcare provider, then the Williams case lies well outside the parameter of the statute of limitations and has to be thrown out of court. That leaves the family with no recourse for the wrongful death of their child, whether it is a real case or not.
The stipulation that might let this case stand, however, is one of discovery. If the DNA testing lab is classified as a non-medical entity, then negligence is still a problem for Quest and Athena. If the discovery rules are applied, then the plaintiff has a maximum of three years to file from the date that they discovered the discrepancy. In this case that means the plaintiff would have from when they knew reasonably that negligence was perpetrated -- and the six-year limitation would no longer apply. Williams maintains that she didn’t know about the laboratory’s misdiagnosis until well into 2014, which means that the case should be considered as negligence, not malpractice. That would mean that the case doesn’t have to adhere to the same stringent statute of limitations.
That leaves the Supreme Court at the helm of the specifics of this case and any others that follow. Until now, the specifics about how to define DNA laboratories in relation to healthcare providers has not been defined. No matter how the court rules, it will affect this specific case.
But there is very little evidence that it will affect DNA testing on a grand scale. With so many entities both in healthcare and on the internet to contend with, it is likely that it won’t set a precedent for more than just this one case; it will probably only affect Williams case.
DNA is a growing field and one that has huge implications for treatment and diagnosis of a variety of healthcare conditions. Whether the laboratory that does the testing or the clinician themselves is at fault for treatment mishaps is up for debate. Although the Williams case is before the Supreme Court, it will likely not have much effect on the rest of genetic testing across the nation.