NEW YORK (GenomeWeb) – In a move that surprised legal experts, a South Carolina federal district court has denied Quest Diagnostics' motion to dismiss several allegations it is facing in a wrongful death lawsuit, allowing the case to move to discovery.
In Williams v Quest/Athena, the US District Court for the District of South Carolina last week determined that the majority of plaintiff Amy Williams' claims can move to discovery, including the wrongful death of her son Christian, a survivorship action, negligent misrepresentation, constructive fraud, and violation of the state's Unfair Trade Practices Act. The only claim the court dismissed was the civil conspiracy Williams' alleged against Quest and subsidiary Athena Diagnostics.
Judge Margaret Seymour's order is positive for Williams, who has said she hopes to bring much needed accountability and transparency to the lab testing industry with this lawsuit. "Getting to discovery was a big goal for the plaintiff," said Jennifer Wagner, a lawyer specializing in genetics rights. "I think for the attorneys for the laboratory it has to be a serious consideration at this point whether to settle this or to continue fighting."
Williams sued Quest and Athena in 2016 alleging that Athena made a grave error over a decade ago when it tested her two-year old son Christian and classified a variant in the SCN1A gene as having unclear links to a rare epileptic condition, called Dravet syndrome. She argues that there was enough evidence at the time Athena issued the test report in 2007 to classify the variant as causing Dravet, but that the lab didn't follow federal lab standards to ensure its test results are accurate and in how it furnished lab reports to physicians. (See our archive of past articles to catch up on everything that has happened in this case.)
Williams claims that as a result of Athena's misclassification of the SCN1A variant, her two-year-old son died in 2008. She is hoping her lawsuit will encourage Quest and Athena to commit to sharing data in public databases, which these and other labs are already doing to a certain extent and which has shed light on how critical it is for industry to work together to gather evidence on the role of variants in disease. Williams is also seeking monetary relief for a genetic counseling scholarship and lecture program in honor of her son, and a National Academy of Medicine study on data-sharing standards.
Judge Seymour's order allowing Williams' claims to move to discovery gives Quest more incentive to come to the table with a settlement offer, because of the protracted and expensive nature of the process. Gary Marchant, a professor at Arizona State University's Sandra Day O'Connor College of Law, noted that the defendant has to consider the cost of having to produce all the documents, answer interrogatories, and produce people for depositions during discovery. "It could disclose all kinds of internal information that the company may not want to expose, [because it] could be used against them in other ways," Marchant said.
No clear line
Quest had asked Judge Seymour to dismiss the case, arguing that Williams is alleging Athena "misdiagnosed" her son's variant, which describes medical malpractice, and in doing so her case is time barred. In South Carolina, individuals 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. Williams' lawyers have argued that Athena was negligent in misclassifying the SCN1A variant. In negligence cases there is a three-year limitation but also the "discovery rule," which gives Williams three years from the time she says she realized she had a claim against Quest in 2014.
Before making her decision about whether to advance this case to discovery, Judge Seymour sought the input of the South Carolina Supreme Court as to whether genetic testing labs like Quest and Athena are considered healthcare providers under state statute and can be sued for medical malpractice. In July, the higher court ruled four-to-one that Athena acted as a healthcare provider in furnishing genetic testing to Christian in 2007.
However, Judge Seymour explained in her order last week that healthcare providers can still be sued for ordinary negligence when they make "nonmedical, administrative, ministerial, or routine care" mistakes that impact their responsibility to care for patients. "Medical malpractice is a category of negligence," she wrote, but the distinction between the two are "subtle" and there isn't a "rigid analytical line separating the two causes of action."
Quest's lawyers have argued that Williams is alleging medical malpractice because she is taking issue with professional services that informed her child's medical care, and to assert these claims she has relied on affidavits from two MDs. Williams' lawyers have argued that Athena was negligent in misclassifying Christian's SCN1A variant, because it had access to the information that would have allowed for the correct classification, but due to an administrative error or a variant database that didn't contain the most up-to-date information from the published literature, the lab reported it incorrectly in 2007.
Williams' complaint points to studies that identified her son's variant in another girl with Dravet syndrome, which were available around the time Christian was tested by Athena, and one of the papers was coauthored by the lab's Chief Director of Genetics, Sat Dev Batish. Athena's own classification criteria outlined in the glossary of the 2007 report states that in order for a variant to be classified as disease-causing, it has to be documented in the literature as being associated with the disease. However, these papers are neither listed in the 2007 report among the articles the lab looked at to classify the variant as inconclusive, nor are they in the updated 2015 report when the variant was reclassified as disease causing.
"The record is unclear as to what caused the staff at Athena to misclassify [Christian's] mutation," Judge Seymour wrote, noting that the plaintiff makes allegations that could be due to medical malpractice or ordinary negligence. "The matter should proceed to discovery for the purpose of determining what caused Athena's laboratory staff to misclassify the gene mutation."
The judge's rationale surprised legal experts GenomeWeb spoke to, because in other cases judges have tended to automatically check the medical malpractice box when a healthcare provider is accused of wrongdoing impacting patient care. They expected Judge Seymour would likely do the same after the South Carolina Supreme Court deemed Athena a healthcare provider.
But the judge points out that "there are some things a doctor or hospital or clinic does that are just plain negligence, basically administrative errors, that are not subject to medical malpractice, and then there are things that involve professional judgement that are," Marchant said. "It's really interesting how this court lays that out, because it hasn't been that clear in other states [where courts] haven't made that distinction."
Judge Seymour is "very careful and thoughtful," in dealing with this case, Wagner observed. "She does appear to want to proceed in a way that would give the plaintiff an opportunity to have her claims be decided based on the facts and not on a technicality."
Throughout the course of this case, experts have pointed out that state legislatures have adopted statutes of repose to protect doctors and big businesses from frivolous lawsuits, but they can also unjustly close off legal recourse for victims seeking relief for health-related injuries that they realize occurred all too late. Judge Seymour's clarification of the line between negligence and medical malpractice could have "tremendous implications" for cases in South Carolina and other states, Marchant noted, if certain things healthcare providers do can be defined as not medical malpractice.
On notice
Although Quest has fought to be recognized as a healthcare provider during the course of the case, the lab doesn't see it as its duty to communicate the results of her son's test to Williams. Changes to privacy laws now allow patients to request test results directly from labs, but in 2007, labs reported results to ordering physicians.
In her order, Judge Seymour spends a lot of time discussing whether Athena's furnishing of the 2007 report to Christian's doctors — containing inconclusive results and language about the need for parental testing to arrive at a more definitive classification — amounts to notifying Williams that a test had been done. Quest argues it does, and that the clock for statutory limitations should start from 2007.
Williams maintains she didn't see the report until she became aware of it and requested it from Quest in 2014. Even if Williams had seen the report in 2007, her lawyers have argued that the lab report contained complex, scientific jargon that would have been impossible for her to understand.
"I have seen a few lab test reports, and I don't have a clue what they mean," said Marchant, who has a PhD in genetics. "It's very hard for ordinary people, even doctors, to understand these lab reports. The argument that [Williams] should have been able to understand the 2007 lab report seems like a real stretch to me."
While her son's clinical geneticist may have seen Athena's report, Williams argues that the doctor had a right to rely on the lab's determination that the variant had uncertain links to Dravet. According to the complaint, Christian's doctors were trying to diagnose the cause of his seizures, but with the inconclusive genetic test results from Athena, they shifted the focus to a mitochondrial disorder as the possible cause and treated him with medications that worsened his seizures.
During discovery, both sides can request information and communications relevant to the case that's not protected by attorney/client privilege through interrogatories, access to relevant documents, and depositions. Because Athena's variant classification processes are central to Williams' case, her lawyers may ask to see the lab's policies in this regard. The lawyers may also ask to see records that shed light on the evidence Athena used to classify the SCN1A variant as a variant of unknown significance in 2007 and what additional evidence the lab used to eventually reclassify the variant at some point between 2007 and 2015, when Quest gave Williams her son's test report upon her request.
Quest may bring in Christian's clinical geneticists, John Shoffner and Frances Kendall, and ask them how they diagnosed the child, how the SCN1A test report factored into the diagnosis, and whether Williams was told about the test at any point.
Christian's 2007 report indicates that Athena should have issued the report to Shoffner, who managed patients with mitochondrial disorders for nearly 30 years and identified the first gene mutations that cause such diseases. Shoffner and Kendall started Horizon Molecular Medicine, but they dissolved the practice in December 2007, while Christian was a patient there.
In reporting about this case, GenomeWeb has attempted to contact Shoffner for an interview but has not heard back. GenomeWeb reached out to Kendall through VMP Genetics, a company she heads up that specializes in rare genetic disorders, and received the following response: "Dr. Kendall did not order the SCN1A test, receive the testing report or interpret the results. That would have been the responsibility of the ordering physician. The medical records attest to that fact."
Throughout the course of this lawsuit, industry observers have questioned whether Christian's doctors should have paid more attention to an uncertain variant in a gene associated with a severe epileptic condition, if they searched the published literature for more information on the variant, and whether they told Williams to submit parental testing.
Many variant classifications, particularly variants of uncertain significance, don't remain static, and a study published in JAMA last month demonstrated how important it is for labs to interpret variants in their databases regularly and inform physicians when there are changes. However, this study also put a spotlight on the reality that there are no standards for how often labs should reevaluate variant classifications, and there aren't any best practices for how labs and doctors should inform patients about changes that impact their health.
Toward discovery or settlement?
Judge Seymour's order also includes clues for Williams about the weaknesses of her case, Wagner pointed out. For example, the judge dismissed Williams' claim that Quest and Athena conspired to withhold information about the test report and cover up the misclassification, noting that this allegation lacked factual details.
And while the judge is allowing Williams' claim that Quest violated South Carolina's Unfair Trade Practices Act to move to discovery, she said the allegations aren't robust. Williams has alleged that because Athena is a leading provider of SCN1A testing, the mistake it made with Christian's test is capable of repetition and of adversely impacting members of the public, which falls under UTPA. "Plaintiff is advised that public harm 'must be proved by specific facts,'" Judge Seymour wrote.
While legal experts GenomeWeb spoke to were surprised by the Judge's decision to allow the case to go to discovery, they said it's difficult to know for sure which way the case will head.
If the case goes to discovery, based on the facts that come out, Quest or Williams could ask the judge for a summary judgment. "This would be supported by exhibits, declarations, or affidavits, showing the evidence is undisputed and supports one side or the other," Marchant said. "That's a more elaborate process, often with a hearing, because it actually looks at the evidence and asks if there is an actual dispute of evidence that requires a trial, or [whether] the judge [can] just decide on the basis of the facts."
Typically, defendants don't want to enter into the costly discovery process and at this stage start negotiations to compensate the plaintiff. "The lab could show some sympathy here," Wagner said. "Quest could recognize that the [South Carolina] Supreme Court's answer to the certified question was a win for them, and that this was an unfortunate scenario, and just put this matter to rest."
But because Williams has stated her primary motive is to improve lab standards and transparency, the negotiations may not be so straightforward. "If I were to bet, I'd still say this case will settle because that's what happens in 90 percent of cases that enter this stage," Marchant said. However, he noted that if Williams' motive is to effect a change in lab standards, then she may not easily agree to settle, where the details of the settlement are confidential and there is no admission of fault.
"When the only issue is money the parties can usually come to an agreement on that," he said. "When there are these other issues, the question is, is there room for an agreement that both sides can live with?"