CEO SUMMARY: In a wrongful birth lawsuit, a high-risk pregnancy physician in New Jersey requested a cytogenetics test on a pregnant mother, but LabCorp’s cytogenetics lab never did the test. After the baby was born with myotubular myopathy—the same deformity the mother had sought to prevent—she sued and won a jury verdict in her favor against her high-risk pregnancy doctor, LabCorp, and LabCorp’s cytogenetics lab director.
IN NEW JERSEY, a $28 million jury award against a physician, a national laboratory, and a cytogeneticist-laboratory director hinged on a cytogenetics test that was never performed.
The circumstances of the case have important legal implications for pathologists and laboratory directors. The case also demonstrates how the growing use of genetic testing has the potential to establish new legal precedents.
Following a February trial, a jury decided against defendants Aldo Khoury, M.D., the patient’s doctor; Laboratory Corporation of America; and James Tepperberg, M.D., who is director of LabCorp’s cytogenetics laboratory. The jury award was $28 million, with liability assigned as follows: 50% to Khoury ($14 million); 40% to LabCorp ($11.2 million); and, 10% to Tepperberg ($2.8 million).
Following the jury verdict, the defendents agreed to a settlement which totaled $18 million, of which Khoury and LabCorp will each pay $9 million.
The case of Wanda Tineo, as the guardian for son Justin Tineo v. St. Joseph’s Regional Medical Center, et al, offers important lessons for pathologists and lab directors. The issues turned on which party was negligent, LabCorp’s cytogenetics lab or the ordering physician. The ordering physician was Aldo Khoury, M.D., a specialist in high-risk pregnancies who is affiliated with St. Joseph’s Regional Medical Center in Paterson, New Jersey. Early in her pregnancy, Khoury’s patient, Wanda Tineo, had asked about her risk of transmitting myotubular myopathy to her unborn infant.
“In filling out the lab requisition, Khoury was not clear in requesting which tests LabCorp should perform,” said Gerald O’Connor of O’Connor & Dumas in Chatham, New Jersey. O’Connor was Tineo’s attorney. The baby, Justin, was born in 2003 and was diagnosed with myotubular myopathy.
“A number of mistakes were made,” stated O’Connor. “First, the doctor who wanted the test for myotubular myopathy called LabCorp on the phone and said he was testing for myotubular myopathy. He asked how much fluid he needed to submit for the test. On that phone call, LabCorp allegedly never told him they did not have the capability to perform the test and would need to refer the test to another laboratory.
“Second, the defendant, James Tepperberg, M.D., was LabCorp’s director of its cytogenetics lab. He testified at his deposition that the box that LabCorp uses on its requisition (which says ‘diagnosis, sign, or symptom’), means for what condition the doctor wants the lab to test. Written on the form was ‘myotubular myopathy.’ So the logical inference was that the laboratory knew the doctor wanted the test done for myotubular myopathy. But the doctor only checked off amniocentesis.
“However, before you can test for myotubular myopathy, you have to know whether the embryo is a male or a female,” O’Connor continued. “So they did a chromosomal amniocentesis. Nobody at LabCorp even knew what myotubular myopathy meant. Nor did they attempt to find out—even though they testified at the deposition that they rely on what the doctor writes on the form.”
An expert witness at the trial who is a pathologist and geneticist, and who asked not to be identified, told THE DARK REPORT that Khoury erred when he completed the requisition form. “Khoury requested standard tests and left blank the large box that ordering physicians use to order a test not listed in the check boxes,” the expert wit- ness explained. “Then, at the top, in the billing section in the ICD-9 box, someone in the ordering doctor’s office wrote ‘hx [history] mytuberal [sic] myopathy.’”
Rare Genetic Defect
Myotubular myopathy is a rare gene defect that affects muscle development. When Justin was born with the defect, his mother sued for wrongful birth. Under New Jersey law, a family can seek compensation for emotional distress and medical expenses when health professionals fail to warn parents about possible birth defects.
O’Connor said, “The doctor has some liability and LabCorp has some liability. In the form LabCorp sent back to the doctor under the diagnosis section at the very top, they wrote ‘history of myotubular myopathy.’ So the doctor—who had never seen a test result for myotubular myopathy— thought that, since they wrote ‘history of myotubular myopathy’ on the top of the report, that this chromosomal report indicated there was no myotubular myopathy.”
The expert witness told THE DARK REPORT that only a few laboratories in the United States do molecular testing for myotubular myopathy. “Because myotubular myopathy was combined with history, that could mean anything,” observed the expert witness. “And that is the crux of the case. The plaintiffs claimed that someone at the cytogenetics lab should have realized that Khoury wanted the myotubular myopathy test, which LabCorp doesn’t do. LabCorp should should have sent it out to a lab that does this test or called Khoury to learn more about it.
“Instead LabCorp simply did what was checked off in the checkboxes, which is what a lab should do,” the expert witness said. “A laboratory can’t go against the doctor’s orders. The laboratory reported out normal chromosomes and normal results. At that point, Khoury should have noticed that there was nothing in the report about mytubular myopathy, and he should have known that the test for myotubular myopathy is a molecular (DNA) test, not a cytogenetic (chromosome) test. Instead, he simply informed the patient that the tests came back normal and told the patient she didn’t have to worry anymore.”
Rare Genetic Defect
THE DARK REPORT observes that this case turned on two issues that labs face almost daily. First, ordering physicians often fill out requisitions in unusual ways. Second, when they do, some labs will tell ordering physicians: “Test not done.” Some experts said laboratories should have a consistent policy about calling ordering physicians to clarify requests on the test requisition that are unclear.
THE DARK REPORT also learned that LabCorp made another error in this case. During testimony, there was discussion about whether Tepperberg had sometimes called ordering physicians in some cases when there were questions about which tests were being ordered. In this case, Tepperberg allegedly didn’t call Khoury to explain that LabCorp did not do the test for myotubular myopathy and that Khoury should submit a request for this test to another laboratory.
As noted in the sidebar on the previous page, attorney Jane Pine Wood of McDonald Hopkins advises that all labs should implement specific policies to prevent miscommunication on lab requisition forms. Clearly, the failure to implement such procedures can expose a laboratory to large malpractice claims.