NEW YORK (GenomeWeb) – The South Carolina Supreme Court this week considered whether Quest Diagnostics was acting as a licensed healthcare provider when it genetically tested Christian Millare at the request of his doctors, who were trying to diagnose the cause of the two-year-old's seizures.
The US District Court for the District of South Carolina last year asked the state supreme court to weigh in on this question in an effort to determine whether the wrongful death lawsuit that Christian's mother, Amy Williams, has brought against Quest and its subsidiary Athena Diagnostics can go forward as a negligence case or if it should be dismissed on statute of limitations and repose grounds afforded to healthcare providers in medical malpractice cases. (To catch up on everything that's happened in this case since the complaint was filed in 2016, see here.)
In South Carolina, plaintiffs have three years to bring a medical malpractice suit against a licensed healthcare provider from the time they discover they were harmed, but they lose the right to sue entirely after six years. In negligence cases there is a three-year limitation but also the "discovery rule," which would give Williams three years from the time she realized there was cause for a lawsuit.
It has been nearly 11 years since Athena produced the SCN1A genetic test report at issue in this case. The test was ordered by Christian's clinical geneticist John Shoffner to see if he had any mutations in the SCN1A gene associated with a rare epileptic condition, called Dravet syndrome. Athena reported that Christian had a SCN1A variant but determined that there wasn't enough evidence at the time to establish if that change was disrupting the normal functioning of the gene and causing Christian's seizure's.
Williams claims she never knew about this report, and when she finally discovered its existence in 2014 — six years after her son died from a fatal seizure — she also found published studies that identified her son's variant in another girl with Dravet syndrome. These published reports were not only available around the time Christian was tested by Athena, but the lab's Chief Director of Genetics, Sat Dev Batish, was an author on one of the papers.
These publications, for Williams, are evidence of Athena's negligence in misclassifying Christian's SCN1A genetic alteration as a variant of unknown significance, particularly since a glossary in the test report notes that the only criteria for classifying a variant as disease causing is whether it was documented in the literature as such. In her complaint, Williams blames Athena for her son's death because from the lab's negligent misclassification of the SCN1A mutation, a cascade of wrong decisions followed.
In S.C. Code Ann. § 38-79-410, the legislature defines "licensed health care providers" as "physicians and surgeons; directors, officers, and trustees of hospitals; nurses; oral surgeons; dentists; pharmacists; chiropractors; optometrists; podiatrists; hospitals; nursing homes; or any similar category of licensed healthcare providers."
Christian's doctors stopped considering Dravet syndrome as a potential cause for his seizures and kept treating him as if he had a mitochondrial disorder. They prescribed increasing doses of sodium channel-blocking drugs, which are standard treatments for epileptic seizures, but known to worsen seizures in Dravet patients. Williams may never get the chance to tell her story before a jury, because Quest has asked the federal district court to dismiss the lawsuit on the grounds that what she's claiming is not negligence but medical malpractice.
In an effort to determine the nature of Williams' claims against Quest and Athena, Federal District Judge Margaret Seymour asked the state supreme court to weigh in on whether the labs can be covered under the medical malpractice statute of repose as a licensed healthcare provider. In S.C. Code Ann. § 38-79-410, the legislature defines "licensed health care providers" as "physicians and surgeons; directors, officers, and trustees of hospitals; nurses; oral surgeons; dentists; pharmacists; chiropractors; optometrists; podiatrists; hospitals; nursing homes; or any similar category of licensed healthcare providers."
This week, the Supreme Court justices heard from Quest and Williams' lawyers about whether the services provided by Quest are similar to the 14 examples explicitly listed in this section of the statute. John Moylan, representing Quest from the law firm Wyche, argued that his client fits the definition of a licensed healthcare provider in the statue because Athena provided services that Christian's doctors relied on to diagnose and treat him. However, the Justices could not get Moylan to identify the category in the statute that Quest was most similar to, despite repeatedly pressing him to do so.
Williams' lawyer Robert DeLoach, who joined Grier, Cox & Cranshaw last year partly for this case, urged the justices to determine that Quest is not like the healthcare providers listed in the statute. He further acknowledged that should the justices decide otherwise then Williams would be time barred from bringing the lawsuit against Quest and it would kill her case — a prospect that the Justices discussed and fretted over.
'Or any similar category'
The five South Carolina Supreme Court Justices spent most of the hearing trying to draw out from Quest's lawyer how the lab fit into the definition of a licensed healthcare provider under South Carolina statute.
"Which category, do you think Quest is similar to?" probed Justice Kaye Hearn. "Because they're not similar to nurses, not oral surgeons, dentists, pharmacists, chiropractors, optometrists, podiatrists. We can eliminate them."
"Here's the problem with that analysis," began Moylan.
"You don't like it," Hearn snapped. "That's the problem with it."
Throughout the hearing, several other Justices tried and failed to get Moylan to name the category of licensed healthcare provider that Quest would fall under. He maintained that Quest is similar to the enumerated categories of healthcare providers in the law because the thing these entities have in common is that they provide services integral to the diagnoses and treatment of a specific patient, and that's what Quest does.
The answer didn't satisfy the Justices. "You're having difficulty answering because actually you can't say it's similar to anything that's listed in the statute," Chief Justice Donald Beatty said at one point.
Central to the arguments on both sides about whether or not Quest is a licensed healthcare provider is Swanigan v Red Cross, a 1993 case in which the Red Cross was sued for providing HIV-positive blood to a patient. The Red Cross argued that the lawsuit was time barred because it was a healthcare provider and the plaintiff was alleging medical malpractice. However, the South Carolina Supreme Court determined that the Red Cross was not a healthcare provider, "because it plays no role in the care of patients."
In interpreting SC Code 38-79-410, the court in Swanigan further wrote that the entities listed in the statute are all similar in that they provide healthcare to patients, and so for an entity to be covered under that statute they, too, have to provide healthcare. DeLoach argued that Swanigan instructs a narrow interpretation of the "any similar category" phrase, because the statue lists and defines specific healthcare providers and conspicuously absent are genetic testing labs.
Moylan maintained that Quest is a healthcare provider under the statute because unlike the Red Cross it is providing genetic testing services used in the diagnosis and treatment of patients. He further argued that when the South Carolina statute was passed in 1976, the legislature couldn't have possibly imagined healthcare as it exists today. The field of genetics was in its infancy back then, but today genetic testing labs are frequently part of hospitals, he pointed out.
Healthcare may have changed over the years, Justice John Kittredge interrupted, but "that's not permission for us to expand or fudge in the statute," he said. "That's a policy decision for the legislature."
"My only point is that the legislature clearly didn't list entities that didn't exist at the time," Moylan responded.
Justice John Few recalled that Greenwood Genetic Center certainly existed in 1976, because he interned there in high school. Indeed, Greenwood Genetic was founded in 1974. Few brought up the example because he's from Greenwood, South Carolina, but perhaps also because Christian was a patient there, a point he would have only picked up in carefully reading the case.
"Your argument that things like this didn't exist back then is not a terrible argument at all, but … I find it difficult to imagine that there weren't those in existence in 1976, and yet those types of things are not specifically listed here [in the statute]," Few said.
Few said that while Moylan had compellingly argued that Quest provides the types of services healthcare providers do, he had stayed away from pinning down how that fits into the statutory language. "I think it's correct that you have to fit inside 'or any similar category of licensed healthcare providers,'" he said. "And it is apparent that your client is not similar to most of the items listed, and I think it's a fair question."
It is apparent that your client is not similar to most of the items listed, and I think it's a fair question.
This line of questioning points to a common problem that judges face in interpreting the application of a law to a modern problem that the writers of the law could not have foreseen. "Trying to map the Constitution on to abortion or on to same sex marriage, those are things that would have been completely beyond the intellectual processes of the drafters of the Constitution," said University of North Carolina law professor John Conley, who wasn't at the hearing in South Carolina but has been following the case closely. "Judges have to do this all the time."
They could hold strictly to the language of the law and say the statute of repose applies only to one of the 14 categories of healthcare providers. That would be an unusual move, Conley said, because it would freeze things in the 1970s when the law was written. "At the other extreme, you can be very flexible and try to fit this new development into the statute, and make the best analogy you can," he noted.
Based on the discussion at the hearing, it's difficult to say which way the Justices will decide. They spent some time debating whether it made sense to exclude independent genetic testing labs from the definition of a healthcare provider, when a genetic testing lab that was part of a hospital would fit the definition and therefore could benefit from the statute of repose.
Quest's argument that the reference lab does things that healthcare providers do made a lot of sense to Beatty, but he acknowledged at the same time genetic testing labs are not listed in the statute. "And the question is, are we to expand the statute because it makes sense to us to do so?" he posited.
The problem with Quest's claim that it’s a healthcare provider, observed personal injury lawyer Daniel Whitney, is that clinical labs don't have a relationship with the patient like a doctor or a nurse does, and the lab doesn't typically communicate test results directly to the patients, particularly for complex genetic tests. While clinical labs may play a vital role in the healthcare industry, "that does not make them healthcare providers, as the term is commonly understood," said Whitney, a lawyer who for more than 20 years represented large clinical labs, including Quest and the Laboratory Corporation of America, but today represents victims of clinical laboratory wrongdoing. Whitney is not involved in the Williams case but is aware of it.
Statutes limiting the time in which patients could claim an injury were advanced to restrict the types of lawsuits people can bring against doctors but weren't written with clinical labs in mind, because they have far more resources and don't get sued as much, Whitney noted. He further observed that clinical labs have not been consistent in their position that they are healthcare providers, and in fact have argued that they don't belong in healthcare arbitration because they're not healthcare providers when it suits them.
"When Quest makes statements about whether or not they are healthcare providers, there should be a factual record," Whitney said. "If you had the time and the resources, a lawyer could say, 'Okay, Quest, tell me all the times you've been sued in healthcare arbitration and you filed a motion to be excluded from it because you said you weren't a healthcare provider."
They're human, and they're concerned about the broader impact of the decision.
Narrow question, big impact
The South Carolina Supreme Court's determination as to whether Quest is a licensed healthcare provider will be a critical factor, if not the factor, in whether the federal district court dismisses Williams' case on statute of repose grounds. It was obvious from the discussion at the hearing that the Justices knew the case details and were aware of the impact their determination could have.
"Nothing we decided, if we were to answer the question 'yes,'" that Quest is a licensed healthcare provider, "would be used as a basis for dismissing the plaintiff's case?" Justice Hearn asked Moylan. "If they convince the district court that … some of their claims are ordinary negligence, then they wouldn't be barred in the event this court answered the question as 'yes'?
These questions suggest that some of the Justices are uncomfortable with the possibility that their answer to the federal district court's certified question could essentially quash Williams' case, Conley reflected. "They're human, and they're concerned about the broader impact of the decision," he said.
Quest's lawyer tried to mollify that discomfort during the hearing, while Williams' lawyer tried to play it up. Moylan told the justices that it is up to the district court to decide if Williams' case can go forward based on ordinary negligence claims. "I think we would argue to the district court that what they've alleged in their complaint is medical negligence and the finding that the statute of repose applies," he said.
DeLoach took the Justices' concerns as an opportunity to impress upon them that if they determined Quest was acting as a licensed healthcare provider, then Quest would surely use it to try to dismiss Williams' case. "It doesn't matter how we play it," DeLoach countered. "They're going to be arguing that the statute of repose applies to this case."
The Justices are, in theory, not supposed to consider the details of Williams' lawsuit in answering the very narrow question the federal district court has put before it, but that's difficult to do. "This is a big case. It's an important case. It's a case involving somebody's death," said Conley. "It's hard to make your judgment in the abstract, to put on those blinders, because you know all about the case."
Conley has previously reflected that this case could impact what constitutes the standard of care for a genetic testing lab by putting pressure on the industry to be more transparent, share data around genetic variants, and improve testing standards. The genetic testing industry is certainly watching Williams' case closely for this reason.
The genetic testing industry has expanded rapidly in recent years, the technology has gotten complex, and more and more people are getting genetic testing than ever before. Amid all this, there are growing concerns that the public is at increasing risk for getting inaccurate results due to inadequate regulatory oversight and lack of transparency. Yet, the lab industry has stymied regulation through the US Food and Drug Administration, and many commercial and academic genetic testing labs still balk at publicly sharing data on genetic variants.
Quest, for example, has launched a data-sharing effort focused on certain cancer risk variants, but has participated in industry-wide efforts like ClinVar in a more limited way. The firm certainly never submitted data on Christian's SCN1A variant to any public databases. As such, Williams still does not know when and using what information Quest and Athena eventually updated the classification of her son's result from variant of unknown significance to a "disease-associated mutation." (Quest sent her an updated report in 2015 without providing an explanation for the update).
Ultimately, the South Carolina Supreme Court can reflect on the case details and consider its broader impact when determining whether Quest is a licensed healthcare provider under state statute. "It's the South Carolina Supreme Court, the final authority on this question of South Carolina law," Conley said. "They can do whatever they want. If they want to be influenced by the broader implications, there is no body that can overrule them."