The once-anonymous patient at the center of a whistleblower action filed against KU Hospital by one of its own pathologists is now suing the hospital herself for fraud, negligence and civil conspiracy.
Like the whistleblower case, the lawsuit by Wendy Ann Noon Berner accuses the hospital and the now-former chair of its pathology department of misdiagnosing her with pancreatic cancer and then covering up the misdiagnosis after parts of her pancreas and other body parts were surgically removed.
In her lawsuit, Berner says she only learned of the misdiagnosis after reading news accounts of the whistleblower case filed more than a year ago against the hospital by Dr. Lowell Tilzer, a veteran pathologist at KU and one-time chair of its pathology department.
Tilzer claimed the hospital rebuffed his efforts to do an analysis of what went wrong and to inform the patient, who at that point had not been told of the misdiagnosis.
Tilzer alleged in his lawsuit that KU Hospital President Bob Page berated and sought to retaliate against him after he called the matter to the attention of the Joint Commission, which accredits and certifies hospitals.
Tilzer later dropped his lawsuit, but in an unusual twist appended a statement by the then still-anonymous patient saying that she was “exploring her options regarding the circumstances” of her diagnosis and surgery.
Berner’s lawsuit, which was filed Tuesday in Wyandotte County District Court 13 months after Tilzer’s lawsuit, reveals for the first time that federal regulators investigated Tilzer’s allegations after making an unannounced visit to the hospital in July 2016. And in a scathing report, which is appended to the lawsuit, the regulatory body, the Centers for Medicare and Medicaid Services (CMS), concluded that the hospital’s “deficient practices placed all patients receiving services at [the] hospital at risk for receiving care that does not meet acceptable quality and standards.”
Dennis McCulloch, a spokesman for the hospital, said that the hospital was constrained in what it could say about Berner’s allegations.
“Ensuring the health and well-being of every patient at The University of Kansas Health System is our top priority,” he said in a statement. “We need to be respectful of patient privacy and confidentiality, and because of that we are limited in what we can say on this matter. That said, we do believe that our physicians and staff acted appropriately and with the best interests of our patient in mind.”
Berner’s lawsuit was filed just a day before the University of Kansas Health System, of which KU Hospital is a part, was scheduled to receive a national honor from the Joint Commission for meeting rigorous standards for quality care and developing a “patient-first” culture. The Joint Commission is the same agency to which Tilzer complained after he failed to get KU Hospital to address his concerns.
Chad Beaver, Berner’s attorney, said that Berner would not be available for comment.
“She looks forward to the opportunity to share her story when the time is right,” Beaver said. “But she does not plan to comment any further at this time, beyond what she has already alleged in the detailed lawsuit we filed yesterday.”
Tilzer, who is now semi-retired, also declined to comment.
Berner, now 46 and a resident of Shawnee, was misdiagnosed as having a pancreatic neuroendocrine tumor, a highly invasive cancer that is fatal in most cases within five years. In September 2015, she underwent Whipple surgery, a complex procedure that involves the removal of part of the pancreas and multiple other body parts.
The procedure is used on patients with bleak prognoses and typically involves lifelong complications. Berner’s appendix was also removed, although she only learned that during a follow-up visit after the surgery, according to her lawsuit.
The misdiagnosis was discovered following the surgery, when other members of KU’s pathology department examined tissue samples from Berner’s pancreas and determined that the organ was normal and not cancerous. A later examination performed by an outside pathologist reached the same conclusion, her lawsuit says.
The misdiagnosis was made by Dr. Meenakshi Singh, who had recently been promoted to chair of the pathology department, although she was not certified in cytopathology – the diagnosis of diseases through the examination of cells. The suit accuses Singh of falsely claiming she obtained a second opinion from another pathologist after she made her diagnosis, as KU Hospital requires when there’s a finding of cancer.
According to the lawsuit, Singh failed to recognized the difference between acinar cells and islet cells, “and covered up her misdiagnosis by placing an addendum to her original report stating the original cancer diagnosis and the normal removed organ matched, thereby concealing her original misdiagnosis and perpetuating Plaintiff’s mistaken belief that Plaintiff’s removed organ was cancerous.”
The lawsuit says the alleged cover-up was perpetuated by the hospital’s chief medical officer, who later refused Tilzer’s requests to talk to other pathologists. Instead, the chief medical officer insisted that Singh’s original diagnosis was correct because two other pathologists had signed her report – even though the two did not agree with the diagnosis and Singh simply wrote their names in the electronic medical record, Berner’s lawsuit alleges.
Singh remains on staff at KU Hospital and KU Medical Center, according to the medical center's website, although she is no longer listed as chair of the pathology department.
The lawsuit says that other mistakes made by Singh concerned Tilzer, and physicians in the department of pathology and laboratory medicine discussed their lack of confidence in her competence in a letter they sent to the hospital and to KU Medical Center.
Both Singh and Dr. Timothy M. Schmitt, who performed Berner’s surgery, are named as defendants in Berner’s lawsuit, along with the hospital, the University of Kansas Medical Center and the University of Kansas Physicians, which employs physicians who practice at the medical center.
‘Good news, no cancer’
The lawsuit accuses both Singh and Schmitt of attempting to cover up Berner’s misdiagnosis by pressuring hospital personnel to alter medical records and, in Schmitt’s case, telling Berner, “Good news, no cancer. It was pancreatitis,” after he learned that she’d been misdiagnosed. He later asked her to sign an affidavit stating that the treatment she received was “wonderful,” but Berner refused.
KU Med Center’s website lists Schmitt as a professor of surgery, division chief, and says his clinical focus is liver transplant and liver surgery. It says he was recruited “to come home to Kansas City” in 2011 to be the transplant director at the University of Kansas Center for Transplantation.
According to Berner’s lawsuit, the affidavit that Schmitt asked Berner to sign led her to suspect something was amiss, which prompted her to do some investigating and discover the news accounts of Tilzer’s lawsuit. It was only then, she says, that she learned that she had been misdiagnosed with cancer and undergone unnecessary surgery.
“This case is filed to pursue the rights of the anonymous patient referenced in Dr. Tilzer’s ‘whistleblower’ Petition; Wendy Ann Noon Berner is the person who had to read a news article in order to discover the grave medical mistakes that will affect her for the rest of her life,” Berner’s lawsuit states.
The investigation by the Centers for Medicare and Medicaid Services, conducted after Tilzer filed his lawsuit, found that “the hospital’s governing body failed to be responsible for the conduct of the hospital in that they failed to ensure the hospital adequately responded to and thoroughly investigated a misread lab sample and ensured the patient involved was fully informed of the misdiagnosis.”
The CMS report, known as an “ACTS Complaint/Incident Investigation Report,” further found that the hospital’s medical staff “failed to inform the patient of a misread lab specimen that revealed she did not ever have cancer; failed to inform the patient during her hospitalization that she did not have cancer and that her appendix had been removed during surgery; failed to update patient's medical record to remove the diagnosis of cancer, and failed to completely and thoroughly investigate the incident.”
The CMS investigation was based on interviews with Berner and hospital staff, medical records and other documents.
The Kansas Board of Healing Arts has also reportedly looked into the matter. A spokeswoman for the agency said it had no records of disciplinary action against either Singh or Schmitt.
Dan Margolies is KCUR’s health editor. You can reach him on Twitter @DanMargolies.