Medical Legal Issues In Pathology Error:

Complications for the Pathologist

Dirk E. Riemenschneider, Esq.

© College of American Pathologists 2004. Materials are used with the permission of

Dirk E. Riemenschneider, Esq.

I. DocumentationII. CommunicationIII. Interpretation IV. Practical Litigation Pointers

I. DOCUMENTATIONA Grammatical Overview of Medical

Records: “The Write Stuff”

Corey D. Fox, Ph.D.The following quotes were lifted verbatim from

the medical records of a general hospital in a

largemetropolitan area:

• “Patient suffers from headaches while menstruating on the top of her head.”

• “Patient had D&C a year ago and all of her eyebrows came off.”

• “This 54 year old female is complaining of abdominal cramps with BM’s on the one hand and constipation on the other.”

• “Patient has been married before, but denies any other serious illnesses.”

• “Patient is separated from his wife, and he also is allergic to Penicillin.”

• Dictated: “Patient has a Pap smear today.”Transcribed: “Patient had a Pabst beer today.”

Case Scenario 1• Allegation: Failure to document frozen

section; failure by pathologist to use clarifying terminology in pathology diagnosis, leading surgeon to perform unnecessary mastectomy without further testing

Facts of Case• 4/27: Radiologist completes mammogram

and reports to PCP the presence of suspicious lesion in R breast

• 4/27: PCP referred pt. to general surgeon who performed a right core needle biopsy

• 4/29: Pathologist issued a report on the right breast core needle biopsies with the diagnosis of invasive ductal carcinoma with apocrine features.

Facts of Case• 5/3: Pt. had sentinel node identification,

with right breast modified radical mastectomy and lymph node excisions.

• 5/21: Pathologist issued a report on the case stating right breast, modified right mastectomy-adenomyoepithelioma, margins negative for tumor; skin and nipple-negative for malignancy; 21 lymph nodes-negative for malignancy; first, second, and third sentinel lymph nodes-negative for malignancy.

Legal Action• Pt. filed a suit naming the pathologist,

pathology group practice, surgeon, and surgical group practice as defendants.

• Plaintiff's position was that no final diagnosis should have been made based on the core sample alone and that additional tissue samples or a frozen section were the standard of care.

• Case was settled.

Standard of Care• The pathology report of the mastectomy

specimen does not reveal the exact size of the mass; however, the gross description of "portion tumor right breast" describes a "2.5- by 1.3- by 1.1-cm portion of tissue with an indurated gray cut surface."

• Consensus of all expert witnesses was that performing a mastectomy without documentation by intraoperative frozen section or measurement of the entire mass was excessive.

Standard of Care

• Pathologists must practice defensively, using terminology such as "suspicious for malignancy, suggest excisional biopsy."

II. COMMUNICATION ISSUES

• Urgency• Sufficiency of Content• Manner Of Communication

ACR STANDARDDIRECT COMMUNICATION POLICY

If there are urgent or significant unexpectedfindings, radiologists should communicatedirectly with the referring physician, otherhealth care provider, or an appropriaterepresentative who will be providing clinicalfollow-up.

II. COMMUNICATION

• Pathology – typically send written report containing findings and interpretations to the treating physician.

• If not received by treating physician and a requesting physician and treater do not act, the Pathologist risks professional liability lawsuit.

Case Scenario 2• Allegation: Desmoplastic melanoma

misdiagnosed as nodular fasciitis; failure by physicians to communicate relevant clinical information to pathologist; failure of pathologist to review medical records and prior pathology report, leading to repeated incorrect diagnosis.

Facts of Case• 31 year old woman• 3/12/93 – lesion removed from her left

anterior chest wall by PCP • 3/14/93 – Pathologist 1 issued report “skin

biopsy, left anterior chest, actinic lentigo.”• Treated with plastic surgeon from 8/94-

5/96 – who never reviewed PCP medical records or 3/93 path report

• 8/24/95: Plastic surgeon performed an "excision of recurrent keloid scar of the left upper anterior chest in lateral infra clavicular area." Specimen sent to Lab B.

• 8/29/95: Path. No. 2 issued report -"proliferating fibroblasts and chronic inflammatory cells most consistent with nodular fasciitis."

• 12/28/95: Plastic surgeon performed another "excision of recurrent nodular fasciitis of left upper anterior lateral chest and left lateral clavicular area." Sent specimen to Lab B.

• April 1996: Path. No.2 was informed by the plastic surgeon that the pt. had a large axillary mass and apparently learned of the 1993 path report. Path. No. 2 then requested a S-100 stain on the 1995 specimens and contacted Lab A for slides, paraffin block, and a faxed copy of the 1993 path. report. The S-100 stain was strongly positive, and Path. No.2 felt that Path. No. 1's 1993 report indicated a "previous melanocytic lesion.“

• 12/29/95: Path.No. 2's report: "spindle cell proliferation with chronic inflammatory infiltrate consistent with nodular fasciitis, and focal foreign body-type giant cells and suture material consistent with previous excision." At the time of the 8/95 and 12/95 reports, Path. No. 2 was not aware of Path. No.1's 1993 report.

• 5/10/96: Path. No. 2 issued amended pathology reports from August 1995 and December 1995 as "desmoplasticmelanoma, Clark's level IV.”

• 5/23/96: The patient underwent a wide excision of skin and subcutaneous tissue from the lateral chest wall. The tissue demonstrated residual desmoplasticmelanoma as well as metastasis to one of 21 axillary lymph nodes.

• 6/28/96: Pt. had an axillary node dissection that showed reactive fibrosis (doubt recurrence of desmoplastic melanoma) and foreign body giant cell reaction. An oncologist treated the patient with interferon.

• 2/6/97: Pt. underwent a radical neck dissection for recurrence of malignant melanoma. Pathology showed metastatic desmoplasticmalignant melanoma with 21 negative cervical lymph nodes.

• 3/18/97:A bone biopsy of the right femur showed fragments of marrow tissue with fragments of desmoplasticmalignant melanoma, metastatic.

Legal Action• Suit filed against pathologists, pathology

labs, and plastic surgeon.• Plaintiff claimed that Paths. and Path.

Labs failed to correctly diagnose cancer and failed to correctly report cancer to the treating physician.

• Case was settled.

Standard of Care• Failure to communicate relevant clinical

information was a quality weakness and a liability in this case.

• Pathologists should have a system to pursue additional clinical information when they have questions about the limited data supplied in the request for specimen analysis.

III. INTERPRETATION

• Over reading • Under reading • Artifact

CASE SCENERIO 3

• Allegations: Failure to timely diagnose colon cancer ultimately resulting in death

FACTS• 34-year-old female • ER with RUQ pain and cramping after

eating popcorn • Hx of ulcerative colitis since age 13 • 11/5/90: Colonoscopy and biopsy -

multiple nodules suggestive of pseudopolyps

• 11/6/90: Path. #1 report - segments of benign colonic mucosa with moderate to severe chronic and focal inflammation –changes benign; few glands exhibiting reactive epithelial atypia with mild nuclear enlargement and increased chromaticity

• 1/13/92: Colonoscopy and biopsy - no other pathology other than sessile polyp

• 1/14/92: Pathologist #1 report - no evidence of dysplasia

• Diagnosis - segments of benign colonic mucosa with moderate to severe chronic inflammation

• 10/27/92: Repeat colonoscopy and biopsy for evolution of RLQ pain

• Small bowel x-ray - nonspecific inflammation in cecal area

• CT scan - nonspecific inflammatory changes in cecal area

• 10/29/92: Pathologist #2 report -ulcerative colitis with neoplastictransformation and carcinoma in situ

• 11/30/92: Subtotal colectomy for metastatic adenocarcinoma of colon; 1 large tumor (1/2 cm from ileoceccal valve and 5 cm in length) and another 2 x 2.5 cm tumor closer to rectum

• 12/11/92: Tumor review board -mucus producing adenocarcinomawith gross metastasis in abdomen, T4N2MX, Stage III

• Dies in 1997

Legal Action

• A wrongful death action against Pathologist #1 and his pathology group was first brought in 1999. The case was voluntarily dismissed twice, the last without prejudice against all parties.

Standard of Care• In retrospect, Pathologist #1 indicated

Plaintiff would probably call the “few glands of reactive epithelial atypia with mild nuclear enlargement.” He noted on the 11/90 pathology as dysplasia, claiming there were hyperplastic changes as well as mitotic figures.

• If Pathologist #1 would have called it dysplasia or even questionable dysplasia, specimens would have been sent to a GI pathologist for a second review.

• A clinician would probably also have done closer follow-up, every 3 to 6 months with a colonoscopy.

Case Scenario 4• Allegations: Negligent inclusion of

contaminants in pathology leading to false diagnosis of uterine cancer

FACTS OF CASE

• 66-year-old female • 5/6/99: D&C for postmenopausal bleeding• Pathologist report - adenocarcinoma in

stromal cells• 6/3/99: Total abdominal hysterectomy and

bilateral salpingo-oophorectomy

• Pathologist report - no evidence of cancer in any organs

• Patient told post-surgical pathology negative for cancer

• Patient falls, fractures shoulder due to leg paresis from nerve injury during hysterectomy

• Currently alive, no signs and symptoms of cancer

Legal Action• Patient brought a medical malpractice

action in March, 2000, claiming the finding of undifferentiated carcinoma resulted from the negligent inclusion of contaminant tissue in the biopsiedmaterial. Claims included unnecessary surgery causing physical and mental suffering, permanent walking difficulties due to nerve injury, and lost income for 5 months following surgery.

• Case was settled.

Standard of Care• Preservation of evidence. Plaintiff had

taken the pathology slides and subsequently lost them; the pathologist had no way to defend herself without these slides.

• Consult with other pathologists before issuing a final report. Pathologist in case consulted two other pathologists before issuing her final report.

• Important point: Contamination can occur in the absence of negligence.

IV. PRACTICAL LITIGATION POINTERS• Filing of lawsuit

- Immediate contact insurer- Sequester path file

• Once Lawsuit Filed - Do not speak with anyone except

attorney. - No literature. - No independent investigation.

• Deposition pointers – Integrity & Preparation- Avoid traps of legal language. - Prepare weeks before. - How deposition is used at trial.

IV. CONCLUSIONARY REMARKS