A woman in West Virginia is suing LabCorp on behalf of her now-deceased family member for negligently misreading a Pap smear as negative. The patient was later diagnosed with advanced cervical cancer and died six months after diagnosis. The patient’s primary care physician is also named in the suit.
The patient presented to her primary care physician on December 21, 2009 with complaints of vaginal bleeding. A Pap smear was performed and sent to LabCorp and was signed out as “Negative for intraepithelial lesion and malignancy.”
It is unclear what kind of follow-up the patient had, but a year and a half later she went back to the same primary care physician with vaginal bleeding as well as signs and symptoms of significant anemia.
The patient was referred to a gynecologist, and was eventually diagnosed with advanced cervical cancer. Due to the advanced nature of the disease, her treatment options were apparently limited, and she died six months later.
Interestingly, the patient had a personal history of cervical carcinoma, but the Pap smear was sent to LabCorp from the primary care doc’s office with the history of “postmenopausal bleeding”; the history of cervical cancer was allegedly not mentioned.
The lawsuit asks for “compensatory and punitive damages with pre- and post-judgment interest.”
This lawsuit was first reported on about three weeks ago. I am just now writing about it because I have been trying to get my hands on the complaint for more details, but was unable to do so.
I do not know if a pathologist ever actually saw the Pap in question or if it was signed out by a cytotechnologist. My guess is the latter, since no pathologist is named in the article, whereas the primary care doc is.
I also do not know if the primary care doc knew about the patient’s history of cervical cancer and simply neglected to include that history on the requisition form, or if the patient never told him. Nonetheless, the complaint states the primary care doc “knew or should have known [the patient's] history of cervical cancer, but failed to include that vital history with the pap smear test and was otherwise negligent.”
This case reminds me of something one of my attendings in residency used to tell us: “A pathologist cannot live by glass alone.”
By this he of course meant it is not always possible to make a correct diagnosis just by looking at the slide; a pathologist also needs to know pertinent clinical history so the slide(s) can be evaluated in the context of that patient’s situation.
Now of course sometimes the diagnosis is obvious sans clinical history, but other times, just knowing an important medical fact about the patient can make all the difference in the world.
This point is discussed in a paper titled, “When is the practice of pathology malpractice?” It was written by RWM Giard, a pathologist and tort attorney and was published by the Rotterdam Institute of Private Law in 2010.
The inter-relatedness between pathology diagnosis and the clinical circumstances is evident. Lack of adequate information may be a source of latent causes of error. What clinical information was available? What is the clinical question? A lymph node biopsy with the question ‘Metastatic disease?’ in a patient with a history of rectal cancer but now with generalised lymphadenopathy may predispose to missing malignant lymphoma. In addition, is the form adequate with regard to patient characteristics, the anatomical origin and type of specimen and history? This information is essential for guiding the pathologist in both morphological interpretation and the use of ancillary techniques.
I know most clinicians do not understand this, and believe they do not need to provide us with clinical information, but they are wrong.