None. Conflicts of Interest: Good News! NEJM 2011

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1 Napa Dermatoathology Meeting 2018: Medicolegal Issues in Dermpath Whitney A. High, MD, JD, MEng Professor of Dermatology & Pathology Vice-Chairman, Dermatology Director of Dermatopathology Director of Adult Dermatology Clinic University of Colorado School of Medicine May 18, 2018 Napa, CA Conflicts of Interest: None I am a practicing dermatologist/dermatopathologist. I hold a law degree. I do not practice law. This lecture is not legal advice. Good News! NEJM 2011 Examined claims: 40,000 docs 6 year period overall 7.4%/year were sued medical specialty 55% sued by 65 y/o surgical specialty 74% sued by 45 y/o Jena et al. N Engl J Med 2011; 365:

2 January 26, 2016 Approximately 1% of all physicians accounted for 32% of paid claims Laser accidents 2 Cosmetic filler 1 Isotretinoin complications 3 Missed melanoma 6 Chloroquine 1 TEN/SJS 1 NMSC 1 Potent steroids 2 Light therapy 1 Connective tissue disease 1 Cryosurgery 1 Merkel cell 1 Balanitis obliterans with SCC 1 Litigation In Derm & Dermpath Misdiagnosis of melanoma and skin cancer = major risk points Pathology Claims The Doctors Company : skin cancer and/or melanoma 8.6% of all claims against pathologists 14.2% of all claims against dermatologists : melanoma #1 specific claim (7/yr) 95% false negative, 5% false positive : melanoma #1 specific claim (2/yr) 96% false negative, 6% false positive Troxel et al. Am J Surg Pathol 2012;36:e1 e5 2

3 Purpose of Malpractice Law To identify a party injured because of substandard care and compensate the party, so as to make them whole. Malpractice is tort law Controlled by state law It is a civil action Preponderance of the evidence (>50%) Elements of Malpractice Six elements of a prima facie case 1. Duty 2. Standard of Care 3. Breach of Duty 4. Cause in Fact 5. Proximate Cause (Legal Cause) 6. Damages (failure to prove a single element is fatal) Causation Simple Pyramidal Structure Duty To Act Negligent Action or Inaction Damage$ from Negligent Action/Inaction 3

4 Standard of Care Some states: reasonably prudent physician of same background, training, experience Other states: knowledge and skill common to members in good standing Notes The outcome does NOT have to be favorable! You do NOT have to be correct! STANDARD OF CARE IS ESTABLISHED DE NOVO IN EVERY CASE Attorneys Not Interested in Close Calls Average cost of lawsuit Plaintiff s Atty. = $ k Where s Waldo cases some pigmented lesions are difficult for ALL experts Farmer, et al. (1996) 37 classic pigmented lesions, 8 expert dermpaths only 1/3 of cases with complete agreement Chilling not only to physicians, but to patients, and sobering to lawyers for plaintiffs. - A.B. Ackerman,

5 The Doctor s Defense Attack validity of the required elements there was not duty there was no breach the standard of care there are no damages Assert an affirmative defense 1. Conflicting legal duty (psychiatrists) 2. Consent (most often employed defense for procedures) 3. Statute of Limitations (variable length) Statute of Limitations Time period when a suit must be filed Varies from state-to-state Tolled in children until a certain age age of majority, simply a specified age Point of argument in many situations: begins when one is reasonably alerted to an injury and not simply date of service Anonymous Pt v. Anonymous Derm Virginia 1997 Plaintiff sought care for mole upon leg Derm biopsied interpreted as benign Two years later pt. visited a surgeon Surgeon requested medical records Derm then re-assessed slide and amended the pathology report melanoma Was suit timely? 5

6 COMPENSATORY DAMAGES Court Decision SOL did not begin at misdiagnosis RULING: SOL began 2 years from when melanoma moved into the dermis (When the heck was that?) Important point: SOL begins when injured party should have been reasonably aware that an injury had transpired (and it is a point that may be argued). Show Me the Money! Special damages medical bills (past, present, future) lost wages (past, present, future) General damages pain & suffering (per diem vs. lump sum) loss of enjoyment/consortium RARELY PUNITIVE DAMAGES! There are few lawsuits. True Harvard study 1/25 persons harmed by medical error 2006 Harvard f/u study 1/25 of those harmed (1/625) brought litigation 6

7 Ten Suggestions To Reduce Medicolegal Risk Associated with Pigmented Lesions I. Beware of Partial Capture Cutis, Nov Number of shaves increased Volume of shaves decreased This impacts the accuracy of diagnosis 7

8 Always punch the thickest area Pariser et al. DOJ 1999; 5(2):4 R/O angioma 8

9 The patient Different clinicians may not always appreciate the randomness of pathology. It is important that we educate our clients rather than merely appease. 4 mm Punch Biopsy by Volume - Assume 4 mm cylinder Volume of punch is = 50.3 mm 3 - Assume is two 3.5 um silhouettes on slide Volume inspected is = mm 3 The dermatopathologist is inspecting 1/450th of the overall volume of the sampling!!!! 9

10 5 cm Excision by Perimeter Analysis - Assume excision is 1:3.5 ratio (common) Circumference is = cm - Assume grossed into 7 pieces each 3.5 um thick Circumference inspected is = cm The dermatopathologist is inspecting just 1/2300th of the overall circumference of the excision!!!! Residual XYZ, completely excised. vs. Residual XYZ, margins uninvolved. vs. Residual XYZ, margins uninvolved in these planes of section. But trial attorneys are increasingly aware and can find data quickly! 10

11 II. Beware of Inflamed Lesions (which could be hiding malignancy) Case 79 year-old man Pigmented lesion on chest r/o NUB Old Adage: Lymphocytes recognize malignancy better than do pathologists! Histology 11

12 Case 79 year-old man Pigmented lesion on chest r/o NUB Old Adage: Lymphocytes recognize melanoma better than do pathologists! III. Beware of spitzoid lesions 12

13 Difficulty of Spitz nevus vs spitzoid melanoma ( All or Nothing ) Features that may suggest more strongly spitzoid melanoma: Age > 20 years Predominantly epithelioid cells Larger lesions (> 0.6 to 1.0 cm) Lesions on sun-damaged skin Lesion with multiple morphologies (new exception = BAPomas ) Adopted from Troxel DB, AM J Surg Pathol 2003; 22: Classic Spitz Nevus Spitzoid Melanoma 63 year-old man VA patient in Wyoming Agree this is a Spitz nevus. 13

14 IV. Beware of Regression Better the Devil you know than the Devil you don t know. - Old English Proverb Case June 2004 Sent by barber for lesion upon scalp Biopsy performed interpreted by dermatologist as blue nevus 14

15 Histology of Original Biopsy September 2006 Paradox - As treatments for melanoma improve, so to do the consequences (and damages) for missing melanoma at all stages of disease. 15

16 V. Beware of Desmoplastic Melanoma and Other Spindle-Cell Lesions You just ain t gonna think of it, if it doesn t enter your mind. Yogi Berra - Me Desmoplastic Melanoma 16

17 Recent DF From Idaho Factor XIIIa 17

18 PanCK CK 8/18 P63 CONCLUSION: NOT a DF at all Poorly differentiated SCC Spindled neoplasms require more than one screening stain! VI. Always Look at All the Sections on a Slide Ginsu-ed specimen 18

19 Always Look at All the Sections 19

20 VII. Work as a Team with the Clinician Prevent An Error Before It Transpires Teach simple mantra of Crap in = Crap out r/o melanoma on every specimen r/o cancer on every specimen rash or D48.5 for everything Discourage multiple specimens in same bottle Discourage curetting of a pigmented lesion Note mismarking shaves, punches, excisions Not new ideas. I promote doing biopsies in 3D : - Description - Diameter or Distribution - Diagnosis 20

21 It should be our expectation that any information that might impact the overall analysis is never withheld. Know your clientele. - training varies -experience varies -thresholds vary -practice dynamics vary 21

22 I don t have to worry too much about who reads my path if an error happens, it s on them. VIII. Do no harm! Don t cost someone else their skin just to save your own. 22

23 The Phenomenon As a response to medicolegal pressure two responses: Becoming malignant Fence sitting or hedging Neither improves patient care Both contribute to increased costs IX. Acknowledge Difficult Cases It was pride that changed angels into devils; it is humility that makes men as angels. - Saint Augustine Humility Is Not Just Good for Your Character Acknowledge differences in opinion: This is a difficult case The type of case for which reasonable opinions may vary At present, some pigmented lesions are classifiable only with benefit of hindsight With benefit of this larger sampling and clinical data Consensus Conference 23

24 X. Encourage Open Lines of Communication Tincture of Follow Up This is MELANOMA. If any other diagnosis returns from the dermatopathologist, it should be treated with great suspicion. Ultimately, the diagnosis was ALMM 1.6 mm deep. 24

25 Thank you 25