In Williams v Quest, State Supreme Court Leaves Room for Plaintiff to Argue Ordinary Negligence

NEW YORK (GenomeWeb) – The South Carolina Supreme Court's determination that a genetic testing lab is a healthcare provider doesn't bode well for the viability of plaintiff Amy Williams' wrongful death lawsuit against Quest Diagnostics, though there is still a chance her case might be allowed to advance based on allegations of ordinary negligence against the lab.

In a 4-1 ruling last week, the state Supreme Court determined that Quest subsidiary Athena Diagnostics acted as a healthcare provider when in 2007 it furnished genetic testing to Williams' infant son Christian, who was suffering from seizures and subsequently died in 2008. In 2014, after learning that Athena conducted a genetic test that Williams believes was critical to determining the cause of her son's seizures, she filed a wrongful death suit against Quest and Athena.

The complaint, filed in 2016, alleges that Quest and Athena erroneously determined in a 2007 report that the SCN1A genetic variant detected in her son was a variant of unknown significance, meaning that it had unclear links to a rare epileptic condition, called Dravet syndrome. However, when Williams discovered the existence of this 2007 report in 2014, 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. (See our archive of past articles to catch up on everything that has happened in this case.)

In a glossary in the 2007 report, Athena noted a singular criteria for classifying a variant as disease causing: it had to be documented in the literature as being associated with the disease. Williams points to the published literature at the time the original report was issued, and importantly, to Athena's own variant classification criteria outlined in the same report, to allege that that the lab should have classified her son's SCN1A variant was associated with Dravet. This was the fatal mistake that caused her son's death, Williams believes, because it led Christian's doctors to not focus on Dravet as the cause of his seizures and they continued to treat him with drugs that are known to worsen seizures in patients with this condition.

Quest, meanwhile, has sought to have the lawsuit dismissed by arguing that Williams is accusing it of medical malpractice, not ordinary negligence, and as such, the case is time barred on statute of limitations and repose grounds. 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 cases of negligence, 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. (Because Williams claims she didn't know about the report until 2014, her lawyers have argued that the clock for discovery should start then.)

Before the US District Court for the District of South Carolina even considered Willaims' allegations, federal Judge Margaret Seymour asked the state Supreme Court to resolve the question of whether under state statute a genetic testing lab is a licensed healthcare provider that can be sued for medical malpractice. In the 14 examples of "licensed healthcare provider" enumerated in S.C. Code Ann § 38-79-410, "genetic testing lab" isn't listed specifically, but "hospital" is, and that's what the justices homed in on in their answer to Judge Seymour's question.

Justice John Kittredge wrote the majority opinion that the state statute comprises genetic testing labs because they perform testing at the request of a patient's treating physician to assist with diagnosing a disease, which is "a core function of hospitals."

Justice Kaye Hearn, the lone dissenting voice, pointed out that the thing that all the examples of healthcare providers listed in the statue have in common is they provide "direct, face-to-face treatment to patients," but Quest doesn't. Moreover, she noted that the specialized services provided by Quest bear little resemblance to the many services provided by hospitals.

"Although hospitals may contain in-house diagnostic laboratories … [i]t is the hospital at the institutional level, taken as the sum of its working parts, which is covered by the statute  not its individual components," Hearn wrote. "While Quest may provide a medical service sometimes available at hospitals, the similarities end there."

Ultimately, Hearn's rationale doesn't help Williams' case. "The dissent should be irrelevant to the federal judge [Seymour]," said University of North Carolina law professor John Conley, who has been following the case closely. "She certified the question and got the answer, which she has to follow on this question of state law, regardless of the dissent."

While Williams has little reason to celebrate the majority's opinion, the justices gave her some reason to be hopeful when they noted in a lengthy footnote that a healthcare provider may still be sued for ordinary negligence. "We are merely answering the narrow question certified by the federal court," Kittredge wrote. "We leave the determination of whether the statute of repose applies to this case in the capable hands of the United States District Judge."

It's not clear what the justices' rationale was for including the footnote, though during a hearing earlier this year, they seemed concerned that if they found that genetic testing labs were healthcare providers, then it would effectively kill Williams' case.

Legal experts GenomeWeb spoke to opined that Williams' lawyers will likely ask the state Supreme Court to reconsider their answer. Plaintiff's lawyers did not respond to a request for comment for this article, but if they do appeal and the justices' answer remains the same, then they can argue that Judge Seymour should allow the case to advance based on claimed injuries that result from ordinary negligence.

"The statute of repose, which should doom this claim if it applies, covers any suit for 'damages for injury to the person arising out of any medical, surgical, or dental treatment, omission, or operation by any licensed healthcare provider,'" explained Conley over email. The listed words are critical, he said, because although the justices have determined that Quest is a licensed healthcare provider, Williams' lawyers can still argue that this action did not arise out of one of the enumerated activities, but out of some clerical or administrative error.

During the course of the case, Williams' lawyers have accused Quest and Athena of errors that they may present in this light. For example, Williams accuses Quest and Athena of violating federal lab regulations, the Clinical Laboratory Improvement Amendments (CLIA), by asserting that they failed to follow their own classification criteria; they didn't update the 2007 report or communicate the updated results in a timely manner; and they issued a 2015 revised report without indicating the new evidence that led to the variant reclassification and inaccurately listed the experts responsible for the report. The complaint also accuses the labs of conspiring to cover up their mistaken classification in Christian's case, and suggests that their "negligent laboratory practices" may have impacted many other children.  

While Williams' lawyers can argue that the case should advance based on alleged injuries resulting from ordinary negligence, the difficulty, in Conley's view, is that the state Supreme Court tied its finding that a genetic testing lab is a healthcare provider to the specific services that Quest provided. "The federal judge would have to decide that in performing the services at issue here, Quest was a healthcare provider … but that its alleged negligence involved some activity other than medical treatment," Conley said. "Seems contradictory to me."

According to Stephen Hixson, a Kentucky-based medical malpractice lawyer, the additional allegations in Williams' complaint does leave room for the federal district court judge to rule that the statute of repose does not prevent Williams from proceeding. "Given the record as it now stands, I feel the judge can rule for or against [Williams] and not be reversed on appeal," said Hixson, who was the plaintiff's lawyer in Watts v Laboratory Corporation of America. In this 1999 medical negligence case, a jury determined that a dermatopathologist employed by LabCorp had misdiagnosed Brent Watts' melanoma as benign and awarded him more than $2.8 million. By the time Watts' cancer was diagnosed, it had spread, and he died shortly after the trial ended.

In this case against Quest, Williams' lawyers "will likely argue that the arbitrary six-year repose period should not stop them from proceeding because their failure to discover the true facts was not their fault due to Quest actively concealing the truth for all those years," he said.

In Hixson's view, strict limits on the time a person has to discover an injury and bring a lawsuit often leads to an unjust end result for victims. "Make no mistake: statutes of repose are a creature of lobbyists for big business, and are based on the notion that it is unfair to subject a wrongdoer to liability more than [a certain number of] years after an injury because evidence gets lost and memories fade," he said. "But every case is different, and an arbitrary time period often produces injustice. An open-ended discovery rule represents the better balance of rights between wrongdoer and victim."

In the present case, Quest certainly got the answer it wanted out of the state Supreme Court. Conley noted that other labs in South Carolina (or in other states following this case) will also view this determination as a positive because medical malpractice cases are increasingly hard to win, requiring expensive, expert affidavits, and a $350,000 cap on non-economic damages unless the jury finds gross negligence. (Quest does not comment on pending litigation.)

"Unless you have a high-earning potential, a relatively young plaintiff, some lawyers will tell you that it's hardly worth the cost of bringing a medical malpractice case," Conley reflected. "Thus, despite all the horror stories about doctors being persecuted by medical malpractice lawyers, there aren't that many cases filed and defendants usually win or their insurer pays out a pretty modest settlement."

The barriers for patients seeking relief when they feel they've been injured by a genetic testing lab are particularly worrisome when one considers how quickly the field is growing but that regulation of the broader lab industry has stagnated. After fighting against the US Food and Drug Administration's oversight for two decades, many in the lab industry in recent years have acknowledged existing lab regulations under CLIA need to be updated, but there is still no consensus on how that might be achieved. 

Williams' case, "underscores a problem we have with ensuring adequate quality of genetic testing laboratories," said Jennifer Wagner, associate director of bioethics research at Geisinger Health and a lawyer specializing in genetics rights. "Americans currently place heavy reliance upon CLIA accreditations of laboratories for consumer protection. I think this reliance is misplaced."

Many in the lab industry, including CMS, have recognized that the agency is increasingly asked to do more with limited resources, and that the agency's budget is not increasing in line with growth in the lab industry. "If CMS isn't able to ensure compliance with CLIA regulations with their current resources, and if individual plaintiffs face substantial difficulties using litigation to compel performance or seek redress when CLIA violations have affected them personally, how do we hold laboratories accountable?" Wagner said.

The limited recourse for patients can, in the end, diminish people's trust in genetic testing in medical care and in research, she reflected. "There is considerable work to do to ensure the burdens of receiving unreliable or incorrect data and interpreted information is not on the shoulders of the individual who is ill-suited to avoid or correct the problems, but instead the responsibility of the appropriate parties who are," Wagner said.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.

NPR reports that government and private insurers are being slow to cover recently approved CAR-T cell therapies.

CNBC reports that there are thousands of genetic tests available for consumers to chose between.

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