Patient with cervical cancer sues pathologist for misreading Pap smears

Washington Hospital

A female patient is suing Washington Hospital in Washington, PA, the hospital lab, her gynecologists and at least one pathologist, claiming, among other things, her Pap smears were misread for five consecutive years.

The article jumps around a little, and there are several pieces of critical information not yet available, but I will do my best to put it all together.

Jennifer Beiswenger, 30, was diagnosed with cervical cancer in May 2011, two months after giving birth to her son. She found this to be strange, as she had had normal Pap smears for the previous five years. At some point she hired Deborah Maliver, an internist turned attorney, to look into her case.

Dr. Richard Pataki, 74, a pathologist and the laboratory director at Washington Hospital for 37 years, is named in the suit as being the pathologist who misread the woman’s Pap smears.

When Dr. Pataki learned of the diagnosis, he and two other pathologists in his practice reviewed her Paps from 2006-2010; in retrospect, they felt several were actually AGUS.

Dr. Maliver sent the same Paps to her experts, who said the Paps showed “a clear progression from pre-cancerous cells to an invasive carcinoma.”

Deborah Maliver, MD, JD

At this point, Dr. Maliver became concerned that the Paps from other women at Washington Hospital also could have been misread. ┬áIn her opinion, five straight years of “misses” may indicate a “potential public health risk.” So, she sent letters to various entities, informing them of her client’s situation.

Now, CMS, the Pennsylvania Department of State, The Joint Commission, CAP and the American Society of Cytotechnology are all conducting investigations into Washington Hospital.

For its part, Washington Hospital voluntarily submitted 500 Pap smears (including Ms. Beiswenger’s) to Magee-Womens Hospital at UPMC for review.

It should be noted the patient’s Pap history does not contain all normals. In 2003, she had an AGUS and in 2006, she had an ASCUS with a positive HPV. According to Dr. Pataki, “…nothing was done [clinically].”

I am presuming that is why her gynecologists are also named in the suit.

It is because of these abnormal Paps that Dr. Pataki says he showed her Paps during the five year period in question to other pathologists before he signed them out; all apparently agreed they were normal.

The results of the Magee-Womens slide review and the investigations from the various organizations are not yet available, but Dr. Pataki said the lab “…did very well” in the CMS review.

Commentary

This is an interesting case, and at this point, it appears as though multiple issues are at play here. Until the review from Magee-Womens is made available, it will be difficult to determine the culpability of the pathologist involved. This despite the fact he and two of his colleagues retrospectively changed at least a few of the diagnoses to AGUS from normal. Hindsight is always 20/20.

If Dr. Pataki did show the Pap smears to his colleagues at the time (and documented it contemporaneously), then he has a good chance of demonstrating at trial he met or exceeded the standard of care. I know personally of a pathologist who, along with a colleague, called adenocarcinoma on a stomach biopsy. The patient had a gastrectomy, and no carcinoma was found. The patient sued, and the original pathologist was not found to have committed malpractice at trial, simply because he exceeded the standard of care by showing the case to a colleague.

Furthermore, it is important for lay people (and even some physicians) to understand the Pap smear is notoriously unreliable for glandular pathology, and, to my knowledge, was only conceived to assess squamous pathology.

In addition, if her gynecologists indeed did not do further testing in 2003 and 2006 when she had an AGUS and ASCUS with + HPV, respectively, then that is likely a problem. I believe the guidelines on how to work-up atypical Paps are quite clear, at least today. I don’t know what they said in 2003 and 2006 about following up atypical Pap findings.


Source: Washington Hospital reviewing hundreds of Pap tests after lawsuit-Pittsburgh Post-Gazette

 

The Washington Hospital is reviewing at least 500 Pap smear slides analyzed by its laboratory after a woman claimed in a lawsuit that one of the hospital’s pathologists misread her tests for five consecutive years before she was diagnosed with cervical cancer, according to the attorney who filed the case.

While refusing to answer specific questions about the case, the hospital said in an emailed statement that it takes “these allegations very seriously.”

“Immediately upon learning of this complaint, the hospital consulted with independent experts to evaluate the claims at issue, and is working diligently to identify any patient safety concerns,” the hospital in Washington, Pa., also said. “The Hospital is also cooperating with independent agencies to evaluate the quality of pathology services, and preliminary results have not identified any widespread deficiencies in PAP smear interpretation. In the event that patient safety concerns are identified or verified, the Hospital is prepared to follow up with individual patients and their physicians.”

Among the groups investigating the allegation are the Pennsylvania Department of State, the federal Centers for Medicare and Medicaid Services, and accrediting organizations such as The Joint Commission and the College of American Pathology.

None of those agencies has completed its investigation, although the hospital’s pathologist accused of misreading the five Pap smear slides, Richard Pataki, said Thursday that the Centers for Medicare and Medicaid Services has conducted its onsite review.

“I was concerned” about the review, said Dr. Pataki, 74, who has worked at The Washington Hospital for nearly 50 years and has been the lab’s medical director since 1975. “But we did very well” in the review, he said.

Lorraine Ryan, spokeswoman for the centers, said in an email that the centers asked the American Society of Cytotechnology to do a “survey to rule out potential harm due to lack of quality practices in cytology,” but it was not yet completed.

The reviews were initiated after Jennifer Beiswenger, 30, of Canonsburg, filed a medical malpractice lawsuit Oct. 1 against the hospital, the hospital’s pathology lab and eight doctors, including her obstetrics and gynecological doctors, and Dr. Pataki.

She was diagnosed with cervical cancer in late May 2011, two months after giving birth. Ms. Beiswenger responded well to treatment and was found free of cancer by November 2011. A follow-up test Wednesday found that she remains cancer free.

“It was very good news,” said Ms. Beiswenger, an online math tutor.

Concerned that her case might not be the only one in which Pap smears were misread, Ms. Beiswenger’s attorney, Deborah Maliver, sent letters to various government and accrediting organizations telling them what happened to her client.

“It can’t be random that her tests were misread for five straight years,” said Dr. Maliver, a former physician now practicing law. “There’s a potential public health risk here.”

It is not known how many other women had their slides reviewed by The Washington Hospital’s laboratory.

But Dr. Maliver said she was told by a hospital official that the hospital turned over 500 slides — a sampling of potentially thousands of tests — from other women from the past five years to the pathology laboratory at Magee-Womens Hospital of UPMC for an outside review. Ms. Beiswinger’s five slides also were sent there.

Magee’s cytopathology department includes R. Marshall Austin, one of the leading experts on Pap smears and cervical cancer screening. Dr. Austin said Thursday he could not comment on the case.

The Pap smear, a test named for its inventor, George Papanicolaou, involves taking a sampling of cells from the cervix and analyzing those cells on a slide under a microscope. In the 75 years since it was first used, the death rate from cervical cancer has dropped by 80 to 90 percent for women who undergo regular Pap smears, medical experts say.

Over the past decade, the analysis of those slides has increasingly been aided by computers, which identify questionable Pap smears for closer examination and confirmation by cytotechnologists and then a pathologist. It is not known if The Washington Hospital uses a computer to aid in the analysis of its Pap smears.

The Washington Hospital asked for the review of its Pap smear slides because, among other missteps by her doctors, Ms. Beiswenger charges in the lawsuit that for at least five years — 2006 to 2010 — Dr. Pataki misread her Pap smear slides.

Instead of concluding that the slides showed abnormal cells, which would have required further testing, and then a growing cancer, Dr. Pataki found the tests were either normal or that no endocervical cells were present, according to the lawsuit.

Multiple pathology experts hired by Ms. Beiswenger’s attorney reviewed those same Pap smear slides and, according to the lawsuit, concluded that those five years of tests showed a clear progression from pre-cancerous cells to an invasive carcinoma.

That was the same conclusion Dr. Pataki and two of his colleagues came to on May 26, 2011, when, after learning that Ms. Beiswenger was diagnosed with cervical cancer, they reviewed the five years of her Pap smear slides that they had in their possession, according to the lawsuit.

According to hospital records obtained by Ms. Beiswenger, they wrote in part in their review: “We reviewed the Pap smears from 2006 to 2010 and we had multiple AGUS …,” an acronym for a finding of “atypical glandular cells of undetermined significance.”

Such a finding “should have been a red flag for a biopsy or other additional testing,” Dr. Maliver said.

But at least in the last four years of that period, Ms. Beiswenger never had additional testing that would have confirmed what the diagnostic Pap smear test seemed to find: that cervical cancer was growing inside her.

In 2006, she also was tested for human papillomavirus, or HPV, and it came back positive. Some strains of HPV can lead to cervical cancer. That same year Dr. Pataki found that her Pap smear was abnormal, showing “atypical squamous cells of uncertain significance” — a finding known as ASCUS.

Those two findings in 2006 — as well as a finding in 2003 of AGUS in her Pap smear by a different pathologist — also should have resulted in additional testing by her obstetrics and gynecological doctors when they were given those results, the lawsuit charges.

Those test results were seized Thursday by Dr. Pataki, who noted: “Earlier we did say she had AGUS and ASCUS and nothing was done.”

Asked if he was attempting to place blame on Ms. Beiswenger’s ob-gyns — who are also named in the lawsuit — Dr. Pataki said: “I’m not dumping on anyone.”

Dr. Pataki said because his practice was aware of those prior findings, “We had quite a few people look at [the slides in 2007 to 2010], and we just didn’t think [a finding of abnormal cells] was there.”

As for the experts Dr. Maliver hired to look at the slides who found a clear indication of a growing cancer in Ms. Beiswenger’s slides from 2006 to 2010, Dr. Pataki didn’t put much credence in their review.

“You can always look back and find something once you know the result,” he said.

Read more: http://www.post-gazette.com/stories/news/health/pennsylvania-hospital-reviewing-hundreds-of-pap-tests-after-lawsuit-662347/#ixzz2CPrQ4pGf

Comments

  1. RunFastDieYoung says:

    I blame the OBGYN in this case more than the lab. They flagged her as abnormal twice. She should have had better follow up. I wonder if there will be more or less lawsuits now that pap intervals have been changed to every 3-5 years? Pap slides only have to be kept 5 years so less cases will be around for review when a patient presents a high grade lesion. There is a lot of discussion about the use of slide imagers and the reckless productivity demands that are common place since their inception. CLIA 88 has pretty much been thrown out the window.

    • A says:

      If the OB/gyn indeed did not follow up on the two atypical Paps in 03 and 06, then that is a problem. It remains to be seen, however, if those allegations are true. We’ll have to wait for more info.

      I think there may be more lawsuits as a result of the 3-5 year change. Before, if you missed an abnormal Pap, the patient only had 1-2 years to percolate before she got Papped again, and you might catch it then. Now it could be up to 5 years before her next Pap. That’s a long interval to grow a tumor. In other words, a miss could be more meaningful and cause more morbidity now. Do you agree?

      When you talk of slide imagers, do you mean slide scanners whereby the whole slide is digitally stored or one that is used to screen the slide prior to a cytotech looking at it?

      • RunFastDieYoung says:

        Labs only have to keep Pap slides for 5 years so there will be less slides around to review for misses. That can only mean less lawsuits I would think. More cancers being missed doesnt necessarily mean more litigation, unless they pass laws requiring labs to keep pap slides much longer.
        Slide imagers pick fields of interest for the techs to look at. The abnormal cells should be located within the fields for the tech to find, but the devices are far from perfect. The slide mill places are pushing staff to hit really high productivity even though studies have shown this causes a significant decrease in sensitivity (obviously). It’s been a highly debated issue. Many organizations (ASC included) support some new regulations on workload limits using these devices. So far their calls have been ignored.

        • A says:

          Sorry, I must have missed the part where you talk about Pap slides only being kept 5 years, and I didn’t take that fact into account. You’re right, if the slides are thrown away, then any misses will be gone and not available for review. But again, this won’t stop the patient from suing on the presumption something was missed on a Pap. Although culpability may not be proven at trial, one’s life can still be made miserable for the duration of the suit.

          Aren’t techs still limited to 100 slides per day, despite slide screener technology?

    • RunFastDieYoung says:

      With the imaging devices, techs can screen up to 200 cases a day. Slides only count as 0.5 IF they only look at the pre-selected fields. Now if the tech takes the time to fully screen the slide after looking at the pre-selected fields they have to count that as 1.5 slides. So obviously labs push the tech to not do a full review so they can be more productive. The slide mills are pushing staff to go as high as they can. Who can blame them since their client pricing is so low? We could be heading towards another CLIA 88 with extended intervals and unsafe productivity. Hopefully HPV co-testing will catch some lesions missed under the scope.

      • A says:

        Very interesting. I didn’t know those subtleties about cytology screening with image analysis. Thank you very much for letting me know.

  2. RunFastDieYoung says:

    I forgot to mention that imaged guided paps reimburse like 9 bucks more than a regular pap test so physician offices push for it since they LOVE to client bill paps. That was why we had to evaluate the system. Fortunantly client billing was outlawed and we were allowed to make a decision without worry. The scope you use is kind of awkward. You push buttons that take you through the selected fields. If you wanna do a full slide review, you move a joystick type of a thing. It seemed like more of a productivity instrument than quality.

    • A says:

      Unfortunately I am familiar with the increased reimbursement for digital image screening for Paps and how that influences what type of Pap test client-billing physicians order.

      Sigh.

  3. dr.cosell says:

    You can be certain that there will be expert pathologists who will testify that the pathologists committed malpractice. We don’t know if she has invasive adenocarcinoma or AIS. Hopefully, only the latter and she is not at risk of dying. Again, the outcome will be determined by whomever has the better attorney.

    • A says:

      I haven’t seen any studies on this issue, but I would be interested to see how juries respond to plaintiff attorneys who are also a physician (as in this case). I wonder if they side with the plaintiff more in these instances because they think the attorney, who is also a doctor, would not be going after “one of their own” unless it was a really egregious case of malpractice.

  4. dr.cosell says:

    Don’t forget that the plaintiff’s attorney will try to fill the jury box with the dumbest of the dumb. All that they will be capable of comprehending is that the patient has cancer and it must be somebody’s fault for not detecting it. It would be interesting to hear from anyone with knowledge regarding how much a pathologist’s insurance premiums go up after a significant monetary verdict against him/her. I have no idea (thankfully).

    • A says:

      I checked with a med mal carrier with whom I talk on occasion about your query and they said, “Underwriting has a complex formula for this that has a lot of variables. Therefore, there is no simple way to answer this question.”

      This is what I expected them to say. There are simply too many things that would play into a decision like that.

      Hopefully you (and I) never find out how much our premiums could go up.

  5. Trish says:

    I wonder how many of her cases were flagged abnormal and what was the interpretation of the screening cytotechnologist. Were they ever sent to the pathologist for review? Or were they sent as abnormal and he just downgraded them to negative. As a cytotechnologist, I am very concerned when a pathologist downgrades my significant calls – especially glandular cases – which are in fact probably the least reproducible interpretations across many screeners.

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