LAWYERS CALL IT A ‘WRONGFUL BIRTH.’ When no one spots an error in prenatal genetic testing processes, a wrongful birth can result, and that’s what happened in a case that ended last month with a jury award of $50 million to a family in Burien, Washington.
Defendants Valley Medical Center in Renton, Washington, and Dynacare Laboratories Inc., a subsidiary of Laboratory Corporation of America, in Burlington, North Carolina, were each ordered to pay 50% of the $50 million award. The jury excluded a third defendant, obstetrician and perinatologist James Harding, M.D., from paying any part of the settlement to the family.
The case is an example of the substantial legal risks pathologists and medical laboratories face as they perform genetic testing and provide interpretations of the results.
“At the heart of this case is a series of errors that began at the Valley Medical Center and continued at Dynacare Laboratories,” stated Todd W. Gardner, the personal injury lawyer with Swanson Gardner. He represented the plaintiffs in this case who were the child, Oliver L. Wuth and his parents, Brock and Rhea Wuth.
“Any one of many medical professionals might have spotted the need for additional diagnostic testing, the need to ask more questions, or the need to request more information,” noted Gardner. “But no one did and now the Valley Medical Center and LabCorp are liable to pay $25 million each to the family, pending appeal.”
Gardner expects an appeal of the jury verdict announced December 10, in King County Superior Court. During the appeals, the Wuths will await payment to help cover the costs of care for Oliver Wuth, born July 12, 2008, with profound physical and cognitive disabilities as a result of a genetic defect known as unbalanced chromosome translocation, Gardner said in an interview with THE DARK REPORT. The child will need care 24/7 for the rest of his life.
Knowing this risk, Brock Wuth chose to have a chromosome study to assess the risk of fathering a child with this condition. This testing was done at Children’s Hospital & Regional Medical Center in Seattle in 2003. These tests showed Brock Wuth had a balanced chromosome translocation identified as 46,XY,t(2; 9)(q37.1;q34.3), court records show. Any future pregnancies for Brock and Rhea Wuth had a 50% chance of conceiving a fetus with an unbalanced chromosome translocation, according to the court filings.
Referred for Genetic Testing
When Rhea Wuth became pregnant in 2007, her obstetrician referred her to Valley Medical’s Maternal Fetal Medicine Clinic for genetic counseling and a CVS. The purpose of the referral was to determine if the fetus had an unbalanced chromosome translocation, court records show.
In December 2007, the cascade of errors began. Court records show that, upon being referred to Valley Medical, Brock and Rhea Wuth were given an appointment for December 31, despite the fact that no genetic counselor was scheduled to work that day.
Meeting with a genetic counselor was important to the Wuths “because they did not wish to give birth to a child with genetic defects,” court records show. In an orange folder, they had the results of Brock Wuth’s previous genetic testing, Gardner said, adding that Valley Medical also had copies of those lab test results that Rhea’s physician sent with the referral.
“The biggest problem from the standpoint of the Valley Medical Center was they had understaffed the center so no genetic counselors were there on the day Rhea Wuth arrived for cytogenetic counseling,” Gardner told THE DARK REPORT. “At Valley Medical Center, the genetic counselor fills out the test requisition paperwork, selects the tests to be done, and determines what clinical information needs to go with the test request.
“However, staff cuts at the center had reduced the number of days genetic counselors worked at the center from three days each week to once a week,” explained Gardner. Physicians had complained that more genetic counselors were needed, court records show. Also, records established that patient volume had doubled at this clinic in the past year, Gardner said.
“Not having a genetic counselor available for the Wuths that day was a mistake because the staff did chorionic villus sampling (CVS) and ordered a standard chromosomal analysis karyotype but did not send any additional paperwork that would have alerted LabCorp’s subsidiary, Dynacare Laboratories, that additional testing would be needed,” Gardner stated.
“The requisition says, ‘Check this box if paperwork is sent with the sample.’ That box was not checked,” he continued. “And no additional paperwork is referenced on the LabCorp report.
“This disaster could have been avoided if the staff at Valley Medical simply sent in the father’s prior lab test results that demonstrated that he had a balanced translocation of chromosomes 2 and 9 and where the exact break points occurred in that translocation,” explained Gardner.
No Call To The Lab
“The genetic counselor testified that if she had worked that day, she likely would have called the lab to ask if she needed to order any additional tests other than the standard chromosomal analysis karyotype,” he said.
Another error occurred when the lab ran the karyotype but did not add a FISH test, Gardner said. “Once the lab got the result of the first test, if it had the paperwork, it would have determined that a FISH test would have been needed to determine if this translocation was present,” he explained.
“At this point in the testing, the lab should have called Valley Medical to ask why a standard chromosomal analysis karyotype was ordered but no additional test was listed on the requisition,” said Gardner. “This is simple and it is the standard of care.
“During the trial, it was admitted that the only way to know of a family history of unbalanced translocation is if someone in the family had been tested in the past,” he emphasized. “And, in fact, Brock’s previous lab test results were available. But there is no mention that those earlier lab test results were sent with the test requisition.
“LabCorp had a specific error-prevention policy that said if clinical information is missing, the lab needs to call the ordering facility,” said Gardner. “In this case, LabCorp should have called Valley Medical, and asked, ‘What information do you have in the family’s clinical history that would let us know where to look?’
“Also, the medical technologist running the karyotype should have asked for more information,” he commented. “The med tech doing the testing should have recognized that it was a test for translocation, and asked, ‘What specifically am I looking for?’
“And the associate medical director in the lab also has an obligation to recommend additional necessary tests,” Gardner added. “The associate medical director should have said, ‘We don’t know what specific chromosomes we are looking for. Has anyone called to find out if we got more information?’
Additional Testing Needed
“In the lab, the associate medical director is the pathologist with the most knowledge,” he said. “This individual has the authority to recommend additional tests, which in this case would have been a FISH study with probes at those locations to see if the translocation was there or not.”
All of these errors resulted in an incomplete and inaccurate report that failed to show that Oliver Wuth had the genetic abnormalities that his parents feared. “There should have been specific language in the lab test result report, saying, ‘We were not advised of the break points for the chromosomes involved. Therefore, we can’t rule out a translocation,” noted Gardner.
When the results arrived at Valley Medical Center on January 8, 2008, the staff failed to question the results, Gardner said.
“At Valley Medical, the genetic counselor gets the lab test results, then reports to the doctor and to the family,” he explained. “When these results came back, the genetic counselor called Rhea and said, ‘Good news. The test is normal.’ Then the counselor asked if Rhea wanted to know the gender and Rhea said, ‘Yes.’ The counselor said, ‘It’s a chromosomally normal male.’
No Lab Report In Letter
“The counselor then sent a letter to the family and to the doctor saying the same thing, but the letter did not include the lab test report,” he added. “In the letter, there was no suggestion that there may be unanswered questions or the need for additional tests.
“The report says, ‘chromosomally normal male.’ The report also says there is an indication of translocation but does not reference the chromosomes and does not have the break points or the ISCN reference, meaning the International System for Human Cytogenetic Nomenclature,” Gardner said. “At that point, Valley Medical should have asked, ‘Did we ever send the lab the information we have here in the file?’
“Instead, the staff at Valley Medical made the assumption that because the paperwork should have been sent, it must have been sent. But it was never sent, the lab never called to get it, and that is the crux of the problem,” Gardner said. “This is one of those cases where there were multiple opportunities to catch this error.”
The Valley Medical Center stated publicly: “We are very sorry for the tragedy the Wuth family has suffered. We continue to believe that the Valley Medical Center staff members acted appropriately.” There was no comment about plans for an appeal.
The Seattle newspaper quoted a statement from LabCorp, saying, “We believe the facts and the law do not support the verdict. LabCorp acted properly and diligently in performing the test that was ordered by the physician. We will consider all available options, including post-trial motions and appeal, if necessary.”
Lawyer Asks: Does Business of Medicine Trump Delivery of High-Quality Patient Care?
IS THE FOCUS ON INCREASED productivity and efficiency among the reasons a medical center and a clinical laboratory in Washington state were hit with $50 million jury verdict in a wrongful birth case?
That’s the question a lawyer in this case has asked. Todd W. Gardner, a personal injury lawyer with Swanson Gardner in Renton, Washington, said the focus on productivity in healthcare and the focus on turn-around time in clinical labs are worrisome.
“I’m very concerned about the corporatization of medicine,” he said in an interview with THE DARK REPORT. “I’m concerned that the business of medicine has become more important than the practice of medicine.
“There is nothing wrong with earning a living and making a profit in medicine. But some entities are getting awfully big and it seems as if some of the focus on quality and patient care is being lost as a result,” he added.
“Management seems to have a focus on productivity, efficiency, and profitability, and medical providers are not as much in the management loop as they used to be,” he said. “This is true in hospitals and health systems, such as Valley Medical Center, and it’s the same thing at LabCorp.
“People who testified during the trial said LabCorp had productivity requirements for their technologists and these requirements resulted in errors because the technologists feel they had to get a certain number of tests done each week. When that happens, it means the laboratory scientist is overly focused on productivity and turnaround time.
“This case is a good example because there was a cascade of problems associated with the genetic testing that were just tragic,” Gardner added. “In this case, a trainee medical technologist did the karyotype analysis at LabCorp, and that analysis was not reviewed by a supervisor. Yet, during the progress of the case, this trainee said the analysis should be reviewed by a supervisor. In addition, the trainee had given his two-week notice and was three days away from his last day on the job. So he was the ultimate short-timer.
“You can see another example at Valley Medical Center where throughout 2007 the perinatologists said they needed more genetic counselors available for coverage,” he continued. “Every other perinatal center in the greater Seattle area has full-time genetic counselors but at Valley they had someone there only once a week. Then that counselor went on maternity leave and there was no manager of the unit to look for her replacement because the manager had quit. So, they borrowed someone from a different hospital one day a week.
Safe, Appropriate Staffing
“The question then becomes: Who has authority to make sure there is safe and appropriate staffing?” Gardner asked. “The physicians there were saying they needed more coverage because of understaffing. Instead the Center reduced its staffing. In the meantime that center was hugely profitable.
“When you don’t have enough people, you lose all the checks and balances that had been built into the system,” he said. “And look what happened: The medical assistant who submit- ted the test requisition paperwork to the reference laboratory failed to include a copy of the father’s lab report—even though the physicians had instructed her to do so. With something as serious as cytogenetic testing, which could result in a life changing case for a family or a test for cancer, patient safety makes it essential to have checks and balances built into the sys- tem and they were not in this case.
“Still, patients put an enormous amount of reliance on lab results. Patients don’t pick the lab where their samples are sent. They assume they are getting correct results. When those lab results come back, patients don’t think that the lab might have gotten it wrong,” concluded Gardner.