Feature Article

Steering clear of malpractice claims

November 2002
Edward P. Fody, MD

Marva West Tan, RN, ARM

Last in a series on pathology claims managed by the St. Paul and MMI Companies Inc., St. Paul, Minn. This month: prostate cancer claims. Analyses of breast pathology claims were published in the April and May issues, and analyses of melanoma cases were published in the August issue. Some facts may have been changed in the following cases to protect confidentiality.

Case 1 - Prostate cancer diagnosed in core needle biopsy, radical prostatectomy specimens negative for cancer

Allegation: Misdiagnosis of core needle biopsy specimen, unnecessary radical prostatectomy with sequelae.

Defendants: Pathologist No. 1 and pathology group practice.

Facts of case: In August 1998, a 53-year-old man had a core needle biopsy of the prostate performed in a urologist’s office with the specimen sent to a pathologist for analysis.

On Aug. 18, Pathologist No. 1 reported that one of six specimens was positive for adenocarcinoma:

• Prostate, core biopsy (left mid gland). Small focus of infiltrating adenocarcinoma (Gleason’s 3 + 3: 6).
• Benign glandular and stromal prostatic hyperplasia.

On Aug. 19, Pathologist No. 1 issued an amended report with the additional comment that an immunohistochemical stain for high-molecular-weight keratin was performed on three of six core needle biopsy specimens. A few small glands did not stain with high-molecular-weight keratin and were "thus suspicious for confirming the diagnosis of a small focus of cancer."

On Oct. 26, the patient had a radical prostatectomy with bilateral pelvic node dissection.

On Oct. 28, the hospital pathologist (Pathologist No. 2) issued a report:

• Prostate, radical prostatectomy—marked acute and chronic prostatitis, moderate hyperplasia and peripheral atrophy—no tumor identified.
• Bilateral obturator lymph nodes—no tumor seen in three total nodes.
• Bladder neck biopsy—no tumor seen.

Loss prevention issues

Clinical issues and standard of care
This case raises several issues concerning the proper handling of difficult cases. These cases and the issues they raise occur frequently in the day-to-day practice of surgical pathology. That Pathologist No. 1 took advantage of several quality assurance procedures was key to the successful outcome of the claim.

Use internal consultation
When several pathologists are working in a group practice, difficult cases should always be shared with the group. For pathologists in solo practice, a sharing agreement with nearby pathologists may fulfill the same function. Many groups follow the practice of having all cancer cases and unusual cases reviewed by at least one other pathologist, and some groups have all biopsies reviewed. Sometimes, when appropriate, multiple pathologists are asked to review the same case. Document all of these reviews, either on the surgical pathology report or in the department’s internal quality assurance file. In this case, Pathologist No. 1 was careful to show the prostate biopsy to other members of his group and to inform the urologist of their concurrence with his diagnosis.

Perform additional studies
Additional studies may take the form of submitting additional tissue, obtaining recuts of certain tissue blocks, or performing special stains. In biopsies, the tissue is generally submitted so there will be no additional tissue to process. In this case, Pathologist No. 1 performed an immunohistochemical stain for high-molecular-weight keratin on three of six core needle biopsy specimens. A few small glands did not stain, which confirmed the diagnosis of carcinoma.

Obtain outside consultation
Outside consultation with a recognized expert is valuable in difficult or unusual cases. When such a consultation is sought, discuss your plan with the referring physician. Although the final choice of a consultant always rests with the pathologist, generally the clinician will be asked to concur in the selection. Such consultation may delay the diagnosis for up to two weeks, but the final result will generally be worth it. The clinician and patient will appreciate that a world-class expert at a prominent medical center has reviewed the case. Outside consultation was not obtained in this case, probably because Pathologist No. 1 was confident of his diagnosis.

Using an outside consultation demonstrates good practice, brings additional expertise to the diagnostic process, and generally increases defensibility of a claim. But outside consultation is not a guarantee against a malpractice claim. Plaintiffs determine whom to name as defendants in a lawsuit and may name both the primary and the consulting pathologist who will be held individually to the pathologists’ standard of care.

Follow quality assurance procedures
Proper quality assurance in surgical pathology protects the pathologist, the clinician, and the patient. The patient has a greater likelihood of a correct diagnosis. The clinician is guided as to the proper treatment. And the pathologist has some protection should the correctness of the diagnosis ever be questioned.

In this case, a lawsuit was filed after a 53-year-old man underwent a prostatectomy for carcinoma discovered on a needle biopsy and no tumor was found in the prostatectomy specimen. The original needle biopsy showed a small focus of carcinoma in one of six needle biopsy specimens. Pathologist No. 1 obtained and documented concurrence of other members of his group in the original diagnosis and further confirmed the diagnosis by immunohistochemical stains for high-molecular-weight keratin. These steps stood Pathologist No. 1 in good stead when the plaintiff’s expert witness, who concurred in the original diagnosis, reviewed the case.

Poor communication plays a part in many malpractice claims and may have influenced this claim. The management of patients with a single focus of well to moderately differentiated prostate carcinoma on needle biopsy is controversial. In this case, the patient’s relative youth (53 years) may have influenced the urologist and the patient to decide upon a prostatectomy. After an initial needle biopsy of a solitary focus of well-differentiated carcinoma, not all prostatectomy specimens reveal cancer. Had this possibility been discussed with the patient before the operation, a lawsuit may have been avoided.

Notice of potential claim
Pathologist No. 1 first became aware of a potential claim when the patient’s attorney requested the core needle biopsy slides. Pathologist No. 1 called his insurer for advice, and the claim consultant arranged for defense of the potential claim.

Early notification of a potential claim to your insurer and risk manager is an important step in the defense of any claim because evidence can be preserved and witness testimony obtained while memories are fresh. In some cases, early resolution of the patient’s complaints can prevent a formal lawsuit or moderate the settlement amount.

Pathologists should report the following to their insurer:

• Any adverse medical event resulting in a patient injury that could potentially result in a claim.
• Requests from a patient’s attorney for medical records or pathology slides. Some requests may be in relation to an automobile accident or workers’ compensation claim rather than a potential malpractice claim. If you are unsure about release of information, contact your insurer. Do not release any medical information without the patient’s written authorization.
• Any threat of legal action or demand for compensation. Complaints from angry, dissatisfied patients or family may fall into this category.
• The receipt of formal lawsuit papers, that is, summons and complaint. Do not ignore or fail to respond to a summons and complaint because you may lose the lawsuit if your defense attorney does not respond appropriately by certain deadlines.

Case 2 - Prostate cancer diagnosed in core needle biopsy, radical prostatectomy specimen negative for cancer

Allegation: Misdiagnosis of cancer, unnecessary surgery, pain and suffering, and loss of consortium.

Defendants: Pathologist No. 1 and pathology group practice.

Facts of case: A 65-year-old man had an increase in his prostate-specific antigen screening test from 1.7 in 1996 to 3.9 in 1997. On Jan. 28, 1998, the patient had an ultrasound-guided core needle biopsy of the prostate.

On Jan. 30, Pathologist No.1 reported that one of six samples was positive for cancer: Prostate biopsy, right mid: adenocarcinoma of prostate, histologic grade 2/5.

The patient’s urologist discussed treatment options with the patient and addressed possible complications of radical prostatectomy, including incontinence and impotence. On April 2, 1998, the patient had a radical perineal prostatectomy.

On April 9, Pathologist No. 2 issued a report:

• Bladder neck (biopsy)—fibromuscular stroma.
• Prostate (radical prostatectomy)—acute and chronic prostatitis with atrophic changes; chronically inflamed and hyperplastic periurethral glands. Unremarkable seminal vesicles. Margins of resection are free of neoplasia, further assessment pending extramural consultation.

• Prostate (radical prostatectomy)—benign prostatic tissue with a mixed diffuse atrophy, widespread chronic inflammation with multiple scattered lymphoid follicles. Nodular hyperplasia is present. No carcinoma identified.

In June 1998, Pathologist No. 1 sought an external consultative review of the prostate biopsy slides. External consulting Pathologist No.2 reported:

• Prostate, needle biopsy: benign prostatic hypertrophy: basal cell hyperplasia. Mild atrophy. Moderate chronic inflammation. Mild acute inflammation.

Legal action: On March 31, 2000, the plaintiff filed a claim naming Pathologist No. 1 and his pathology group practice as defendants. Allegations included misdiagnosis of cancer, unnecessary prostatectomy, pain and suffering, and loss of consortium. The defense expert witness pathologist interpreted the biopsy slides as negative for cancer.

The plaintiff and his wife made excellent witnesses at their deposition. The plaintiff testified that he had chronic pain, was incontinent and impotent, and tired easily. He said he had not had a positive response to Viagra or Prostin and did not want to undergo surgery for impotence. The defense attorney felt that the wife’s testimony was compelling. She testified, "My husband sits here in pain, wearing a diaper, we likely won’t be able to have a normal sex life together after 40 years of marriage, and he had this operation for no good reason." The suit was subsequently settled on behalf of Pathologist No.1 in the mid ranges.¹

Loss prevention issues

Clinical issues and standard of care
A 65-year-old man had serial determinations of serum PSA, which showed an increase, although the final value remained just below the upper limit of the reference range. A prostate biopsy was performed that was interpreted as showing adenocarcinoma. The patient underwent a prostatectomy that revealed no evidence of carcinoma. Upon subsequent review, several consultants could not confirm the presence of carcinoma in the original biopsy. The patient had an unfavorable postoperative course and filed a lawsuit against Pathologist No. 1 and his group.

In striking contrast to the prior case, Pathologist No. 1 did not follow useful quality control procedures. The biopsy was difficult to diagnose, but apparently no internal consultation was sought. No recuts or immunohistochemical studies were performed to attempt to better characterize the abnormal glandular focus thought to be carcinoma. Finally, no external consultation was sought until after the prostatectomy had been performed. Performance of any of these quality control measures may have avoided the erroneous diagnosis of carcinoma, the prostatectomy, and the lawsuit.

Cancer claims awards
Cancer-related claims are among the most costly claims experienced by physicians, and awards continue to rise. Jury Verdict Research, an organization that tracks and publishes jury awards in professional liability claims, recently reported an increase in the median award for all types of cancer claims, from $1 million in 1995 to $2.32 million in 2000.²

Seeking a second opinion in difficult or questionable cases is one way that pathologists can gain consensus on a diagnosis and increase defensibility of a potential claim. Consultations should follow established practice rather than be informal hallway or "curbside" consults. Second opinions may be even more prudent in cancer diagnoses. Some academic medical centers, such as M.D. Anderson in Houston, are beginning to offer second opinions via their Internet sites.³ Pathologists who use Internet sites to locate and obtain second opinions should be careful to deal with reputable centers, follow any state statute regarding telemedicine, and use organizations that have technology professional liability coverage.⁴

References
1.  For purposes of this article, mid ranges are from $100,000 to $500,000.

2.  Awards for cancer claims are on the rise. Personal Injury Verdict Awards, vol. 10, issue 3, Jan. 21, 2002: 1-2. See also www.juryverdictresearch.com.

3.  See Clinical & Scientific Resources on M.D. Anderson’s Web site at www.mdanderson.org.

4.  Weber DO, Toub D. Heading to the Internet for second medical opinions. Medicine on the Net, vol. 8, No. 1, January 2002: 1-5. See Medicine on the Net online at www.corhealth.com.

Susan Tannenbaum, MD, chair of the CAP Insurance Committee, concludes: Malignant melanoma is a serious and controversial subject. Experts sometimes differ on the best way to protect against liability in such cases. The experts do, however, agree that one must be diligent in documenting that every effort was made to render the proper diagnosis. This often includes seeking and documenting an expert second opinion.

Dr. Fody, a member of the CAP Insurance Committee, is chief of the Department of Pathology, Erlanger Medical Center, Chattanooga, Tenn. At the time of this writing, Tan was senior communicator, health care risk services, St. Paul.