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Quest, Athena File Motion to Dismiss Negligence Suit

NEW YORK (GenomeWeb) – Quest Diagnostics and subsidiary Athena Diagnostics filed a motion asking the US District Court in the District of South Carolina to dismiss Amy Williams' wrongful death lawsuit.

In a memorandum supporting their motion to dismiss, the companies argue that Williams cannot sue them because the three-year statutes of limitation and six-year statute of repose time frames have expired since Athena issued a 2007 genetic test report for her deceased son. The statute of limitations is particularly important in this case, the defendants note, since in the field of genetics "quantum leaps have been made in knowledge and technology during the past five [to] 10 years."

As previously reported by GenomeWeb, Williams is accusing Athena of failing to follow federal lab regulations outlined in Clinical Laboratory Improvement Amendments nine years ago when testing her son, Christian Millare, for mutations in the SCN1A gene and reporting the results. She alleges Athena misclassified the detected mutation as a variant of unknown significance (VUS) when two papers — published before Athena issued Christian's June 2007 test report — had identified the same mutation in another patient who had epileptic encephalopathy.

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.

Christian's geneticists at the time were trying to pin down the cause of his seizures and believed based on tests performed at the time that they may be due to a possible mitochondrial disorder. For the seizures, his neurologist had prescribed sodium channel-blocking drugs carbamazepine, oxcarbazepine, and lamotrigine, which are standard treatments for epileptic seizures.

But Christian's seizures only worsened, and he passed away from a seizure at the age of two in January 2008. Williams is alleging that because of Athena's negligence in misdiagnosing Christian's SCN1A mutation as a VUS, his doctors continued to treat him as if he had a mitochondrial disorder, give him drugs that are known to worsen seizures in Dravet patients, and as a result, he died.

Quest and Athena highlight in their memo supporting the motion to dismiss the lawsuit that the 2007 test report includes language warning that the results are inconclusive and that Dravet syndrome could be the cause of Christian's seizures. 

According to the companies, before Christian died, they had given "explicit written notice" to Williams that she and the child's father needed to be tested to resolve the uncertain classification of the variant. "Neither the mother nor the father submitted to such tests," Quest and Athena wrote in their memo to the court. "Instead, she brings this lawsuit almost a decade later and attempts to plead around the statute of limitations and statute of repose."

Williams maintains that neither her son's doctors nor Athena informed her about the 2007 SCN1A genetic test result. When she learned about its existence in 2014 while investigating Christian's death, Williams said she contacted Athena and saw the VUS result for the first time. Athena told her at the time it would issue an amended report and did so in 2015, in which the SCN1A VUS result is reclassified as disease causing.

However, Williams noted in her complaint that the lab does not cite any new published studies to justify the reclassification in the 2015 report, and accused the lab of trying to cover up its misclassification of the SCN1A mutation as a VUS in 2007.

Quest and Athena state that the lab was "simply report[ing] a reclassification" of Christian's mutation in a revised report in 2015. The companies further take issue with the plaintiff's accusation that the lab tried to "cover up the supposed error in the 2007 report," calling it a "reckless and unfounded accusation."

Last week, Quest and Athena had filed a notice for the case to be moved from the South Carolina Court of Common Pleas for Richland County to the US District Court in the District of South Carolina. Also, in answers to written questions from the plaintiff, Quest and Athena said that Christian's doctors "may be liable in whole or in part to the plaintiff or to the defendants."

The plaintiff's lawyers have 14 days to respond to the defendants' motion to dismiss.