The Quest Case and Medical Malpractice Liability Risks of Genetic Testing Labs

For years, Quest Diagnostics has been embroiled in a poignant lawsuit testing the liability of genetic labs for faulty DNA test results. In 2018, Quest struck a decisive blow by getting the South Carolina Supreme Court to toss the wrongful death claims on a technicality, namely, the fact that the case was filed after the statute of limitations had expired. On Nov. 4, the South Carolina federal court wrote the latest, and perhaps last chapter in the drama by dismissing the remaining claims against Quest. What Happened Amy Williams was and is a sympathetic plaintiff with a highly compelling story. In 2007, the Myrtle Beach mother’s 2-year-old son Christian began experiencing regular seizures. Suspecting a mutation in the SCN1A gene, doctors sent Christian’s DNA for genetic testing to Athena Diagnostics (which Quest Diagnostics would later acquire in 2016). The test detected a glitch in the gene which the report described as a “#4: variant of unknown significance” (VUS) that, according to Athena’s classification “often has no effect” on normal gene activity. Sadly, though, it turned out that Christian had a rare and more dangerous condition called Dravet syndrome. Ms. Williams and her attorneys claimed that Athena should have detected that the VUS was pathogenic and that the doctors relied on the report to rule out Drevet and treat Christian with sodium-channel-blocking medications, which worsened his condition and intensified his seizures. A proper diagnosis would have prevented the fatal seizure Christian suffered on Jan. 5, 2008, according to the complaint. The Statute of Limitations Stumbling Block  After initially blaming herself for Christian’s death, Ms. Williams finally decided to sue Athena and its now parent company Quest (which for simplicity’s sake, we’ll refer to collectively as “Quest”) in 2017, 10 years after the fateful genetic testing lab report. That was a problem because in South Carolina, the statute of limitations for medical malpractice is six years. The apparent good news for Ms. Williams’ legal team was that the statute of limitations for negligence and wrongful death is three years from the date the plaintiff discovers that he/she has a cause of action. Accordingly, Ms. Williams contended that she didn’t discover that she had a legal case against Quest and thus still had time to file her suit as a wrongful death action. Not so fast, countered Quest, who claimed the case was essentially a wrongful death case based on medical malpractice and thus subject to the hard six-year cap. The key question: Was Quest acting as a licensed healthcare provider when it performed genetic testing on Christian? If so, the six-year medical malpractice statute of limitations would apply. The 2018 Ruling  On June 27, 2018, the South Carolina Supreme Court ruled 4 to 1 in favor of Quest. “A genetic testing laboratory that performs genetic testing to detect an existing disease or disorder at the request of a patient’s treating physician is acting as a ‘licensed health care provider’ under [state law],” the Court reasoned. As a result, the medical malpractice case was time-barred. The 2020 Case Having lost on the wrongful death front, Ms. Williams still had some legal cards to play, including ordinary negligence and deceptive trade practice. And those were the actions the South Carolina federal court dismissed without a trial in its Nov. 4 ruling. No Case for Negligence: Although medical malpractice was no longer on the table, Ms. Williams was still able to claim that the failure to detect that the VUS in the SCN1A gene was pathogenic constituted ordinary negligence. But the claim had a fatal flaw, namely, the lack of evidence showing that the treating physician had ever read, let alone relied on the 2007 report. The report wasn’t located in his file, and the doctor didn’t recall reviewing it. So, the negligence claim failed. No Case for Deceptive Trade Practices: Like most states, South Carolina has a law banning businesses from engaging in deceptive or unfair trade practices that have an impact on the public interest. Ms. Williams’ theory was that Athena crossed that line because at the time of the 2007 report, it was in violation of several different CLIA requirements relating to the analysis and reporting of positive test results. But the court pooh-poohed the arguments. First, there was no evidence that Athena violated the CLIA regulations. And even if it had, CLIA violations can’t be the basis of a deceptive trade practices claim because CLIA is enforced by HHS and CMS and doesn’t provide for a “private right of action.” In other words, private persons can’t sue a lab for money damages based on a CLIA violation. Belser v. Quest Diagnostics, Inc., 2020 U.S. Dist. LEXIS 207217, 2020 WL 6526084 Takeaway The moral of this story is that genetic testing labs can be sued for money damages if they make mistakes. While Quest ended up prevailing on all counts, the legal victories are of limited legal significance because they don’t get into the substantive issues governing a lab’s liability for inaccurate genetic testing, analysis and reporting. Thus, Quest won on wrongful death in 2018 because the statute of limitations had tolled. It won on negligence in the new case not because the lab didn’t commit negligence but because the plaintiff couldn’t show that the treating physician relied on the allegedly faulty test report. The one novel takeaway from the 2020 ruling is that a CLIA violation can’t be the basis of a state deceptive trade practices claim. But even that applies only to South Carolina. ‘Wrongful Birth’ Litigation  The Quest case is hardly the first time a genetic testing lab has been sued for medical malpractice. However, most of the cases have alleged not wrongful death but wrongful birth, i.e., failure to diagnose pre-natal genetic disorders resulting in births that should and would have been aborted had the correct genetic information about the fetus been provided. Here’s a quick summary of some of the notable cases.  Florida: Plaintiff Wins $21 Million Malpractice Award Parents sue Univ. of South Florida doctor for failing to diagnose their son’s genetic disorder (called Smith-Lemli-Optiz syndrome) impairing his ability to synthesize cholesterol, leading couple to have a second child with same disorder. Ruling: Jury finds malpractice and awards couple $21 million but state law caps damages at $200K. Virginia: LabCorp Can Be Sued for Malpractice Parents who are both “carriers only” of thalassemia beta decide to continue their pregnancy after genetic testing confirms that their unborn fetus is also “carrier only.” But when the results turn out to be wrong and the child has the more serious “affected person” version of the disorder, they sue LabCorp for “wrongful birth” malpractice. Ruling: The federal court refuses to dismiss the case but also finds that LabCorp is a “health care provider” and thus covered by the medical malpractice damages caps under state law. Montana: Giving Pregnant Mom Pamphlet Defeats Claim of Negligently Failing to Provide Screening Test Info After giving birth to a daughter with cystic fibrosis, a mother sues her doctor and prenatal care nurse for $14 million for not providing her any information on the availability of cystic fibrosis carrier screening testing. Ruling: The jury doesn’t buy it and finds the defendants did meet the standard of care in delivering prenatal treatment, including giving the patient a cystic fibrosis pamphlet during her first appointment that she never bothered to read.