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Are Genetic Testing Labs Liable for Medical Malpractice?

by | Jul 30, 2018 | Essential, Focus On-nir, National Lab Reporter, News-nir

From - National Intelligence Report Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth… . . . read more

Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth: malpractice liability. In the past decade, patients and trial attorneys have sought to hold labs and doctors legally responsible for faulty or unwelcome DNA test results. The latest case comes from South Carolina and involves one of the nation’s largest labs, Quest Diagnostics.

What Happened
You would be hard pressed to find a plaintiff more sympathetic than Amy Williams. In 2005, the Myrtle Beach mom’s 2-year-old son Christian began experiencing regular seizures. Suspecting a mutation in the SCN1A gene, doctors sent Christian’s DNA to Athena Diagnostics for genetic testing. The report found a glitch in the gene but described it as a “variant of unknown significance” that, according to Athena’s classification “often have no effect” on normal gene activity. What Christian really had, according to Ms. Williams’ attorneys, was a rare condition called Dravet syndrome.

Athena could have and should have detected that Christian had Drevet, the complaint alleged; instead, the lab’s report led doctors to rule out Drevet and treat him 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 Plaintiff’s Legal Conundrum
After initially blaming herself for Christian’s death, Ms. Williams finally decided to sue Athena and its parent company Quest Diagnostics in 2016 (which for simplicity’s sake, we’ll refer to collectively as “Quest”). The problem: In South Carolina, the statute of limitations for medical malpractice is six years. However, the statue of limitations for negligence and wrongful death is three years from the date the plaintiff discovers he/she has a cause of action. 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 wrongful death based on medical malpractice and thus subject to the hard six-year cap. The key question thus became whether Quest was acting as a licensed healthcare provider when it performed genetic testing on Christian?

The Ruling
On June 27, 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 concluded.  Result: The case was time-barred.

Takeaway: While Quest came away with the win, the significance of the ruling is limited to the extent it was based on procedure and thus didn’t address the substance of the malpractice claim. Moreover, the case is legally binding within South Carolina and will likely have little influence in other states.

The real significance of the case is that it portends the larger trend of holding providers of genetic testing to the standards of medical malpractice. This is not the first time that labs and physicians have been sued for malpractice for making a faulty diagnosis from DNA test results. So far, most of these 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. (See the Scorecard below for a summary of the leading cases.)

‘Wrongful Birth’ Litigation Scorecard
Malpractice lawsuits against labs and providers for failing to provide accurate DNA testing information during pregnancy

Florida: Plaintiff Wins $21 Million Malpractice Award (July 2007)

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 (November 2011)

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 (February 2016)

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.

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