Misinterpreted Gene Test Shows Lab Got it Right

In unusual twist, lawyer praises genetic test lab in $1.8 million medical malpractice case

CEO SUMMARY: It’s almost a case of man bites dog. In malpractice cases involving genetic test results, labs are often assumed to be at fault. But in a lawsuit filed in Oregon, healthcare providers are alleged to have misinterpreted a genetic test. As a consequence, a patient underwent medically-unnecessary and life-changing surgery. This malpractice lawsuit has several elements of interest, particularly for pathologists and lab managers who perform genetic tests.

WHEN A LAWSUIT IS FILED OVER THE interpretation of a genetic test, there’s an inherent assumption that the clinical lab is responsible in some way. That assumption of error is what makes a recent case in Oregon so unusual.

In this malpractice lawsuit, the lab that performed the genetic test was recognized as having accurately reported the results to the ordering physician. The lawsuit alleges that the primary care provider and the specialist physician both misinterpreted the genetic test report.

Genetic Test Complexity

This case is an example of how the complexities of genetic testing can be confusing to physicians who order these tests and then must interpret the results when deciding how to diagnose and treat their patients. In the lawsuit, filed in October in Curry County Circuit Court, 36-year-old Elisha Cooke of Gold Beach, Ore., is suing her doctors after genetic tests were negative for breast cancer.

In its report to the patient’s doctor, Myriad Genetics tested the patient’s blood sample using its Integrated BRACAnalysis with Myriad myRisk Hereditary Cancer test on Feb. 18, 2016.

Court documents show that, when Myriad sent the lab test report to Cooke’s doctor, William Fitts, MD, an obstetrician and gynecologist in Gold Beach, Ore., the report clearly stated the result as: “Negative—No clinically significant mutation identified.”

Despite this result, Cooke’s attorney, Chris Cauble said, “Her gynecologist, Dr. William Fitts, ordered the test and misinterpreted the results. We will be amending the claim in the suit to make that clearer. The medical documents we have reviewed were not clear on this point but they are clearer now.

“Originally, we thought that the nurse practitioner, Lori Johns, ordered the test and initially interpreted it,” added Cauble of Cauble, Cauble and Selvig in Grants Pass, Ore. “It was, in fact, her gynecologist, Fitts.

“The other physicians either failed to independently check the results or they also misinterpreted them,” he added. “Johns is my client’s primary care provider. As a licensed nurse practitioner in the state of Oregon, she is required to provide followup care and also review test results, to ensure that the patient gets the right care.

Misinterpreted Results?

“This actually makes it more shocking because it was an actual, experienced MD who misinterpreted the results,” Cauble explained. “I want to make sure we are super accurate on that point.”

After reviewing the test results, Cooke’s doctors recommended a double mastectomy. In August 2016, Cooke had a total abdominal hysterectomy and less than two months later had a prophylactic bilateral nipple-sparing mastectomy with placement of implants.

The lawsuit states, “Plaintiff would not have consented to these procedures if she had known that Lynch Syndrome does not cause a significant increase in the risk of breast cancer.” Remarkably, the lawsuit does not name Myriad. “So far, we are not concerned with how Myriad conducted the test,” stated Cauble.

This case offers lessons for clinical lab managers and pathologists seeking to avoid liability when physicians’ actions following genetic testing result in patient harm. For all clinical labs, the lesson is: make the test results as clear as possible. In this case, the report from Myriad provided clear results that unfortunately were unheeded.

“Myriad did the myRisk Hereditary Cancer test, and the test results are clear,” Cauble said. “Our client didn’t have any significant genetic issues that would have indicated any kind of cancer abnormalities.”

Test Interpretation Was Key

In fact, the report included the mathematical sign for negative (a solid horizontal line inside a circle as on the negative end of a common household battery). In addition to the wording, “Negative—No clinically significant mutation identified,” Myriad explained further, “Note: ‘Clinically significant,’ as defined in this report is a genetic change that is associated with the potential to alter medical intervention.”

“Based on the records we have discovered, it was first the gynecologist who misinterpreted the report,” Cauble explained. “However, there was no safeguard in the system for ensuring he was accurate. As is common in Oregon, Cooke’s PCP is a nurse practitioner. We believe that there should have been better safeguards. I also want to point out that her surgeon also had a duty to review and interpret the report and provide proper advice to Cooke.”

Yet, the patient’s physicians recommended surgery, as the court documents show. “The doctor seems to be relying on the part of the report that says there are variants of uncertain significance in the MLH1 gene,” Cauble added. “The genetic testing lab says that in certain patients, variants associated with the MLH1 gene can mean there is an increased cancer risk.”

Two Variants Identified

The report identified two variants on theMLH1 gene, but, again, the report identifies the two variants and then is clear about what the variants mean for this patient. “Uncertain clinical significance,” the report says about the MLH1 variants. “There are currently insufficient data to determine if these variants cause increased cancer risk.”

Variants on the MLH1 gene can be associated with Lynch syndrome, ovarian, and other cancers. The Myriad report does not mention these possibilities, saying only that the variants are of uncertain significance.

Given the clarity of the report, the physician should have recommended other actions, Cauble added. “Despite the clear language in the report, we think the physician’s advice to my client that she have her breasts removed and her uterus removed is a breach of the physician’s duty,” he explained. “At least, he should have told her about the fact that the results of the test were negative and that no clinically significant mutation was identified.

“So far, it looks like Myriad did a good job and is handling this well,” Cauble said. “Based on the evidence so far, we don’t have a problem with them. The result is clear and easy for anyone to understand.”

“Our position is that, based on this lab test report, the physician should have recommended the patient at least see a genetics specialist,” Cauble said. “But instead, the physician did the surgery based on this result and that’s what our case is about. Not only that, they botched her breast removal surgery, complicating the case still further.”

As a result of the botched surgery, Cooke sought an attorney and met with Cauble, he said. “She didn’t find out about her negative test result until after I recommended she see another surgeon about her surgical options,” he explained. “That surgeon saw that the genetic test result was negative. When the second surgeon informed Cooke about the negative genetic test result, it was the first time she heard this news,” Cauble said.

“At that point, she was quite shocked and upset and called Myriad to confirm that the test was negative,” Cauble added. “Myriad did a great job. I don’t have any problem with them. The genetic test result is very clear.”

One Error Gets Compounded

So, who is responsible for informing the patient about her genetic lab test results?

“There is no indication that the physician ever called the lab,” Cauble answered. “If he had, the lab would have told him that the test was negative. Instead, he seems to rely on the fact that the patient has a family history of cancer. In addition, the nurse practitioner had entered in the patient’s record that Cooke had Lynch syndrome.

Cooke has a family history of invasive breast cancer and endometrial or uterine cancer, the Myriad report notes. “However, based on the personal/family history, the patient’s cancer risk may still be increased over the general population,” the report says.

Test Results Need Clarity

Given that the surgeries were elective, Cauble questioned why the patient’s insurer, AllCare—which contracts with Oregon Medicaid—would have paid for these procedures without inquiring about the medical necessity. Cooke was covered under Oregon’s Medicaid program, he added.

In the lawsuit, Cauble seeks the maximum of $1.8 million allowed under Oregon law. “We may be making an argument that the amount we are entitled to should be higher,” Cauble said. “Currently, claims against ‘hospital districts’ and their employees are limited to just under $800,000 per person, per claim. The nurse practitioner Johns works for a private clinic so that cap would not apply to her.

“However, there is also a $500,000 cap on non-economic damages that would relate to Johns because she works for a private entity,” he added. “Actually, we are thinking of making three independent, $800,000 claims based on three different mistakes by three people.”

The lawsuit lists the defendants as the Curry County Health District, Curry Community Health, Curry Medical Practice, and Curry Medical Center. The lawsuit list other defendants as Fitts, Johns, and a surgeon, Jessica Carlson, MD.

The medical practice’s CEO and Fitts’ attorney told CBS News that they could not comment on pending litigation. An attorney for Carlson told The Washington Post she could not comment on pending litigation.

Contact Christopher Cauble at 541-476-8825 or ccauble@thecaublefirm.com.

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