NEW YORK (GenomeWeb) – The South Carolina Supreme Court ruled Wednesday that Quest Diagnostics was acting as a licensed healthcare provider when it genetically tested two-year-old Christian Millare at the request of his doctors who were trying to diagnose the cause of the toddler's seizures.
The 4-1 ruling in the wrongful death suit filed by Christian's mother, Amy Williams, against Quest and its Athena Diagnostics subsidiary, was a blow to the plaintiffs, whose lawyers had urged the justices to determine that Quest did not fit the definition of licensed healthcare providers provided by S.C. Code Ann § 38-79-410.
The ruling could affect whether the suit 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. 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 a negligence case there is a three-year limitation, but also a "discovery rule" that would give Williams three years from the time she realized there was cause for a lawsuit. Athena produced a report on the SCN1A genetic test of Christian nearly 11 years ago.
In the majority opinion written by Justice John Kittredge, the court ruled that "the genetic testing laboratory is performing diagnostic testing at the request of a treating physician for the purpose of diagnosis and treatment, which is a core function of hospitals in diagnosing and treating patients."
In her lone dissent, Justice Kaye Hearn wrote that unlike other healthcare providers to whom South Carolina's statute applies, Quest and Athena do not provide direct, face-to-face treatment to patients. In addition, while hospitals may contain in-house diagnostic laboratories, a hospital is a healthcare provider "as a sum of its working parts." She determined that Quest's "limited, specialized services" were insufficient to make it equal to hospitals as a healthcare provider.
According to the lawsuit, Quest's Athena produced a report stating that Christian had an SCN1A variant, but that there wasn't enough evidence to determine whether the change was disrupting the normal function of the gene and causing Christian's seizures.
Williams claims that she never knew about the report and only learned of its existence in 2014, six years after her son's death from a fatal seizure. She found published studies that were available around the time of Christian's testing that associated Christian's variant with Dravet syndrome, including one by Athena's Chief Director of Genetics, Sat Dev Batish.
Based on the report, Christian's doctors stopped considering Dravet syndrome as a potential cause for his seizures, and instead prescribed increasing doses of sodium channel blocking drugs that treat epileptic seizures but are known to worsen seizures in Dravet patients.
Federal District Judge Margaret Seymour of the US District Court for the district of South Carolina asked the state supreme court last year to answer the question of whether or not Quest was a healthcare provider. The state supreme court heard arguments in the case in February.