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Quest, Athena File Another Motion to Dismiss Amended Wrongful Death Complaint

NEW YORK (GenomeWeb) – Quest Diagnostics and subsidiary Athena Diagnostics have filed another motion to dismiss Amy Williams' wrongful death lawsuit against them.

GenomeWeb has been closely tracking the lawsuit in which Williams is accusing Athena of inaccurately classifying a mutation in the SCN1A gene that the lab detected in her son, Christian Millare, in 2007. Christian died in January 2008 from a seizure.

The child had been suffering from seizures since he was four months old. His doctors ordered an SCN1A genetic test as part of an extensive diagnostic workup to figure out the cause of his condition. Mutations in SCN1A are well known in the literature to cause Dravet syndrome, a severe form of epilepsy that impacts one in 21,000 infants. According to the Dravet Syndrome Foundation, 80 percent of patients have an SCN1A mutation.

Williams has alleged that Athena detected that Christian had an SCN1A mutation, but the lab was negligent in classifying it as a variant of unknown significance (VUS). Two papers — published before Athena issued Christian's June 30, 2007, test report — had identified the same mutation in another patient who had epileptic encephalopathy. Among the authors of one of these papers is Sat Dev Batish, who then was and continues to be Athena's chief director of genetics.

Christian died directly as a result of this misclassification, according Williams and her lawyers, because his doctor continued to treat him with drugs that worsened his seizures. Christian's neurologist Timothy Livingston was treating him with increasing doses of sodium channel blocking medications, which are standard treatments for epileptic seizures. However, studies show that sodium channel-blocking drugs worsen seizures in Dravet patients.

In April, Quest and Athena asked the US District Court in the District of South Carolina to dismiss the lawsuit because the six-year time limit for medical malpractice claims has expired since Athena issued the 2007 genetic test report. Quest did not provide comments for this article as it does not comment on pending litigation.

In response, Williams filed an amended complaint and argued against the defendants' motion to dismiss her lawsuit, claiming she did not know the lab had performed the SCN1A test for her son until 2014. Quest and Athena have now filed another motion to dismiss Williams' amended complaint. 

The new motion doesn't contain any surprises but reiterates Quest and Athena's original position that the clock has run out for Williams to sue the companies for medical malpractice. The defendants want the court to deem this a medical malpractice case, while the plaintiff is pushing for ordinary negligence.

Christian died eight years ago, and the genetic test in question was performed nine years ago. In South Carolina, plaintiffs have three years to bring a lawsuit against a licensed healthcare provider from the time they discover they were harmed by medical malpractice, but they lose the right to sue entirely after six years, even if they did not know they were harmed until much later.

Quest and Athena in their latest motion to dismiss reassert that the court should view this as medical malpractice, claiming the labs fit the definition of licensed healthcare providers under South Carolina law and under the Health Insurance Portability and Accountability Act. Additionally, they note that Williams used affidavits from MDs, Robert Cook-Deegan who is a research professor at Duke University's Sanford School of Public Policy and who holds an internal medicine appointment at the school of medicine, and Max Wiznitzer, a pediatric neurologist at Rainbow Babies and Children's Hospital.

Williams' lawyers, however, want the court to deem this an ordinary negligence case, since there is a three-year limitation but also the "discovery rule," which would give the plaintiff three years from the time she realized there is cause for a lawsuit. According to Williams, the clock should start from the time she became aware of the 2007 SCN1A report in 2014.

Williams also accused Quest and Athena of civil conspiracy to cover up the alleged error in the 2007 report. The defendants have countered that Williams doesn't state any new facts or special damages. Quest and Athena further argue, citing past rulings in South Carolina and by the US Supreme Court, that a corporation and its subsidiary can't conspire with each other because they are essentially one entity and share a common purpose.

The plaintiff's lawyers in their amended complaint tried to strengthen their allegations that Quest and Athena violated the South Carolina Unfair Trade Practices Act with their negligent actions and that this is a matter of public interest, because as many as 230,000 children in the US may be eligible for SCN1A testing and others may be harmed.

They further noted the case of another female child who received SCN1A testing from Athena in 2008 and received a VUS result. Athena reclassified her variant (2589+3A>T, IVS14+3A>T) as disease causing in 2010. The child's testing history with Athena came up during a vaccine injury lawsuit that her parents filed several years ago against the US government. 

In the latest motion to dismiss, Quest and Athena countered that this example is "fatal to the Plaintiff's lawsuit," because the parents were genetically tested to confirm whether their child's mutation was de novo or inherited. More than 90 percent of missense mutations that are associated with Dravet Syndrome are de novo. Quest and Athena asserted that despite the fact that Christian's 2007 report "explicitly" and "conspicuously" states that parental testing is necessary for a more definitive classification, neither Williams nor Christian's biological father got tested.

In the case of the other child, Athena indicated since she had a de novo mutation, it "further increase[d] the probability that this known disease-associated mutation could be causative of a severe phenotype." The details in the vaccine injury lawsuit also indicate that although the parents were tested following the 2008 report and Athena issued a revised report indicating the variant was de novo, the lab didn't reclassify the variant as disease causing until 2010. It's unclear from the documents why it took Athena nearly two years to move the VUS to a more definitive classification even with parental testing results in hand.

Moreover, Williams' lawyers pointed out in their amended complaint that this child's variant was reported in a Dravet patient in a 2007 paper, the same paper that featured Christian's mutation in an epileptic patient (see supplementary table). As such, the plaintiff's lawyers are accusing Athena of making the same type of mistake they made in Christian's case. 

Critical to the judge's determination as to whether to dismiss or allow Williams' lawsuit is whether she could have known about the SCN1A test results years ago. Quest and Athena seem to be arguing that by issuing the 2007 report to Christian's doctors it served as sufficient notice to Williams. Christian's SCN1A test report indicates Athena should have issued the report to his clinical geneticist John Shoffner, who was at Horizon Molecular Medicine, a practice that he dissolved in December 2007, while Christian was a patient there.

Williams has maintained she would have been happy to get parental testing, but neither the lab nor the doctor told her about Christian's 2007 SCN1A genetic test report. She did get tested soon after receiving Christian's amended report in 2015 and does not have the same SCN1A mutation.

The details of whether Williams could have known about the test results earlier will only come out if the case is allowed to go to discovery. Although industry observers have said this case could help clarify standards for genetic testing labs, tort cases in the US rarely go to trial. According to published data, less than 2 percent of civil cases are tried in federal courts because often lawsuits don't survive pretrial motions, such as a motion to dismiss, or are settled out of court.