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Wrongful Death Suit Awaits Input From South Carolina Supreme Court

NEW YORK (GenomeWeb) – Federal District Judge Margaret Seymour last week asked the South Carolina Supreme Court to clarify whether under state law a genetic testing laboratory is a licensed healthcare provider.

The Supreme Court's answer — should the higher court decide to weigh in on the question — will be instrumental to whether Judge Seymour allows a jury to hear Amy Williams' wrongful death lawsuit against reference laboratory Quest Diagnostics and its subsidiary Athena Diagnostics. According to legal experts, the decisions by the South Carolina Supreme Court and the US District Court in the District of South Carolina will not bind courts in other states when similar legal issues arise. But because the Williams lawsuit raises unsettled questions about standard practices in genetic testing, a rapidly evolving and cutting edge field, lawyers and judges may reference the case for guidance in the future.

Williams sued Quest and Athena last year alleging that in 2007, Athena was negligent in classifying an SCN1A gene mutation in her two-year-old son Christian as a variant of unknown significance (VUS). Christian was suffering from worsening seizures, which his clinical geneticist thought was due to a mitochondrial disorder, but he had ordered the SCN1A test among many other diagnostics for further confirmation.

If the SCN1A genetic test had identified a pathogenic mutation, then it would have indicated Christian had a rare disorder called Dravet syndrome that sodium channel-blocking drugs are known to worsen. Williams alleges that because Athena reported a VUS in the SCN1A gene — indicating that it was unclear whether the variant was causing the seizures — his doctors continued to treat Christian with these types of drugs. She claims that because of Athena's negligent classification, Christian's seizures continued to get worse, and he died in January 2008.

In her complaint, Williams cites two papers, published before Athena issued Christian's 2007 result, that report the same variant in a girl with Dravet. Athena's own chief director of genetics is an author of one of these papers. Moreover, Williams maintains that she did not know about the 2007 report until 2014, when she requested it. Athena told her then that the variant had been reclassified and issued a revised report in 2015 reclassifying the VUS as disease causing. It is unclear from the 2007 and 2015 reports what additional evidence pushed the classification from a VUS to “disease causing,” since in that time, Christian's variant has only been reported in those same two publications flagged by Williams.

Quest and Athena have asked the court to dismiss the case, arguing that Williams is alleging medical malpractice, and the time has run out for her to seek relief for such a claim. Under South Carolina legal code (section 15-3-545), plaintiffs must sue for medical malpractice within three years of the date of the procedure or treatment, or three years from when they discovered they were harmed. But they cannot sue after six years have elapsed from the date of the procedure or treatment, even if they couldn't have known about the injury. In matters of negligence, however, there is the "discovery rule," which would allow Williams three years from the time she realized there was cause for a lawsuit, which she says was in 2014. 

This is where the question of whether a genetic testing lab is a licensed healthcare provider under South Carolina law becomes important for Williams' case. In another part of the South Carolina code (section 38-79-410 discussing regulations for creating a fund to pay for medical liability) "licensed healthcare providers" are defined as "physicians, surgeons, directors, officers, and trustee[s] of hospitals; nursing homes; or any similar category of licensed healthcare provider."

"It appears that the South Carolina Supreme Court has not squarely addressed the question of whether diagnostic laboratories are licensed healthcare providers within the meaning of" the state code, Judge Seymour wrote to the higher court last week. "A finding regarding the applicability of S.C. Code Ann. [section] 38-79-410 to diagnostic laboratories such as Athena will resolve the issue of whether plaintiff can proceed with her complaint."

The five justices of the South Carolina Supreme Court have discretion to take up the questions of law certified to it, and as part of the decision-making process, they can request any materials submitted for the record to the lower courts. Within 45 days of receiving an order, the Supreme Court is expected to decide whether it will answer or refuse to answer the question certified. If the court decides it will answer the question, then it can choose to allow briefs or oral arguments as it sees fit.

According to legal experts familiar with the details of Williams v Quest/Athena, the South Carolina Supreme Court's determination, while critical for the Williams case, will not bind courts in other states.

"How a particular activity, such as running a hospital or a lab, is characterized is a question of state law," said Barbara Evans, director of the University of Houston's Center on Biotechnology & Law. "A laboratory might meet the definition of a 'healthcare provider' in one state but not meet another state's definition of the term."

Certainly, courts in other states have ruled that genetic testing labs are protected by statutes of limitations and repose afforded to licensed healthcare services. But Hank Greely, director of the Center for Law and Biosciences at Stanford University, noted that malpractice reform laws on statutes of limitations and repose "tend to be quite individual from state to state."

Despite the limited legal impact, Greely and Evans both acknowledged that Williams v Quest/Athena could be influential in other ways. "States often do exhibit a degree of similarity in how they define terms like 'healthcare provider,' and state courts sometimes do consider how other states are handling an issue when making decisions in their own state," Evans said. "A South Carolina decision would not be binding on other states' courts, but other states may look to it as background information as they decide similar questions under their own states' laws."

Depending on how the South Carolina Supreme Court decides and writes its opinion, Greely can also see it having a "persuasive influence" on other states that have statutes of limitations and repose for medical malpractice cases against "licensed healthcare providers," when the definition of that category is similarly vague with respect to genetic testing labs.

John Conley, a University of North Carolina law professor who has been teaching civil procedure for 35 years, further pointed out that the question Judge Seymour has certified to the state Supreme Court is extremely narrow, and takes a circuitous route to asking whether a genetic testing lab is a licensed healthcare by borrowing a definition from a section of the state code (38-79-410) that doesn't deal squarely with medical malpractice.

This means, that if another court in New York, for example, is faced with the same question of is a genetic testing lab a licensed healthcare provider, the South Carolina Supreme Court's answer won't be much help. "Whichever way the South Carolina Supreme Court comes out, it'll be an easy precedent to distinguish," Conley said, because a lawyer should be able to persuade a judge in another state to not apply the decision because it's not a matter of common law, but an idiosyncratic interpretation of a narrow question of law.

So, Conley's advice to those in the genetics space watching the Williams case closely: "Don't hyperventilate about this," at least in terms of its legal impact. However, in the absence of broadly applicable legal precedence in the genetic testing space, Conley believes the Williams lawsuit shines a light on unsettled questions about the standard of care that the scientific and medical community should weigh in on.

A key question that keeps coming up in Williams v Quest/Athena, for example, is whether a doctor should be able to rely on a report furnished by a genetic testing lab, or if the physician has a responsibility to pursue a more definitive classification for a patient with a VUS? Christian's 2007 report includes notifications that the child's parents should be tested to determine if the variant is inherited, and that this could help resolve the uncertainty. Williams claims she couldn't get tested because she didn't know about the report.

Quest and Athena's lawyer told Judge Seymour during a hearing in January that Williams could very well have a claim against Christian's clinical geneticist John Shoffner, who ordered the test and was ultimately responsible for acting on the report. 

Then there is the question of the extent of the genetic testing lab's responsibilities. In Christian's 2007 report, Athena states that in order for a variant to be deemed disease causing it needs to be noted in the literature as such, and at the time, Christian's variant was published as having been seen in a girl with Dravet. Williams alleges that Athena failed to follow its own variant classification criteria, and asserts that Christian's doctors wouldn't have made their mistake in diagnosing and treating her son if Athena hadn't incorrectly classified the SCN1A variant as a VUS in the first place.

Experts in the genetics space following the case have expressed a variety of opinions about the extent of a doctor and lab's responsibilities in this regard. But the lines are getting harder to define as cheaper genetic testing is allowing more people to be tested and identifying never before seen variants with unclear links to disease.

Conley advised recently in the Genomics Law Report blog that expert bodies in the genetics space should weigh in on these outstanding questions and help lawyers and judges who will be looking for "any precedent that might provide guidance" when other lawsuits like Williams' arise. This case has already garnered the attention of a National Academies of Sciences, Engineering, and Medicine committee focused on pressing issues impacting the technology and legal arenas.

"But if judges, legislators, and regulators are left to make it all up on their own, you probably won’t like the outcome," Conley wrote. Though the Williams case stands to have very limited impact on other genetic testing cases outside of South Carolina, he warned that "plaintiffs’ lawyers are given to herd behavior, so the Williams case may be only the first."