Rice & Bloomfield
Melanoma: A Medical-Legal Perspective
Two trends in medicine are putting an entire population of patients at serious risk: the alarming increase in the incidence of malignant melanoma in the general population during the past twenty-five years and the reliance by most managed care organizations on primary care providers to determine under what circumstances a patient should be referred to a specialist. In no other area of medicine is the restriction of access potentially as deadly as it is in cases involving malignant melanoma.
The incidence of malignant melanoma, 1 in 1500 in 1935, projected to be 1 in 90 for those born in 1990 and as high as 1 in 75 for those born in the year 2000, has increased at the rate of 4 - 6% each year since 1973.1 Despite these alarming statistics, the survival rate for those diagnosed with the disease has more than doubled from 40% in the 1940's to over 80% in the 1980's.2 The increase in survival is attributed primarily to an emphasis on early diagnosis at a stage when skin lesions are localized and relatively easily treated with surgical excision. Today, more than 80% of all melanomas are diagnosed at this early stage and the ten-year survival for patients in this category is in excess of 90%.3 The long term prognosis for those with more advanced disease is not as favorable, however, making early diagnosis especially critical to successful treatment.
Unfortunately, the doctors most likely to see skin lesions which may represent malignant melanoma may be those least likely to make the proper diagnosis. By at least one estimate, 60% of all patients with skin complaints are treated by non-dermatologists.4 As early as 1981, when reliance on managed health care was far less prevalent than it is today, 87% of managed care systems surveyed limited access to specialists such as dermatologists.5 As the number of people who obtain health care through managed care systems has increased during the past fifteen years, so too has the number of patients whose access to specialists is limited. There is no reason to believe that this trend will abate any time soon although, ironically, one large health maintenance organization, Kaiser Permanente, found that the cost of dermatologic care was cheaper and of better quality when patients with skin problems were seen by dermatologists rather than primary care providers.6
Most patients consult a physician with the expectation that he or she will have a minimal level of competence to diagnose and treat conditions such as skin disease. Unfortunately, that assumption is not supported by available data. The "gatekeepers" or primary care providers who typically decide whether referral to a specialist is warranted or not are generally trained as family practitioners, general practitioners or internists. The training they receive in dermatology may consist of as little as a two-week rotation in medical school.7 In numerous studies, primary care providers have proven far less proficient than dermatologists at correctly diagnosing and treating skin disease.
In one study, dermatologists correctly identified 20 common skin diseases from color Kodachrome transparencies in 96% of cases. In contrast, general practitioners diagnosed only 60% accurately; internists were the least accurate, diagnosing 52% accurately.8 In another study, dermatologists were accurate 98% of the time compared with family practitioners who diagnosed common skin diseases such as acne, psoriasis, actinic keratosis and basal cell carcinoma just 60% of the time.9 A more recent study in which patients, and not color transparencies, were evaluated by physicians with different backgrounds, yielded similar results. Internal medicine residents (doctors who have finished medical school but are in the process of completing their clinical study in internal medicine) diagnosed only 43% of patients with skin disorders accurately; practicing internists (those who have completed all training) were accurate only 52% of the time. More than half the biopsies ordered by non-dermatologists were unnecessary; inappropriate treatment was given nearly 50% of the time. Even when the diagnosis was correctly made, appropriate treatment occurred less than 75% of the time.10 The inevitable conclusion of these studies is that the physicians who provide most day-to-day medical care and control access to specialists perform poorly in diagnosing and treating skin disease compared to dermatologists.11
In short, it is naive at best to assume that all doctors are equally qualified to recognize and treat conditions such as melanoma.12 While most general practitioners and internists may be suspicious if a lesion exhibits the classic signs of melanoma — a change in size, appearance and/or margins of a pigmented lesion — the risk of misdiagnosis, especially when the lesion does not look like a "typical" melanoma, is significant.
It is not surprising that there are medical-legal ramifications to these statistics. Malpractice or medical negligence does occur and occurs more often than the public appreciates. When the negligence of a health care provider results in the delayed diagnosis of malignant melanoma, the consequences can be deadly. The Harvard School of Public Health launched a comprehensive investigation to examine medical malpractice issues, the results of which were published in 1993.13 After review of 30,195 hospital records, researchers concluded that 1 in 100 patients admitted to the hospital in 1984 suffered a disabling injury caused by health care provider negligence.
Even more troubling was the finding that 34% of all patients who suffer permanent disability and 51% of deaths during hospitalization are the result of medical negligence by a health care provider. Weighted to produce a population estimate, an estimated 13,400 patients died during hospitalization in New York in 1984, fully half of which deaths were directly caused by medical negligence. Interestingly enough, the actual number of legal claims which resulted was extremely small. The chances that a claim would be filed by a patient with an identifiable negligently caused medical injury was 1 in 50.
I recently handled a medical malpractice case involving the alleged failure to timely diagnose and treat malignant melanoma. The patient, my client, a member of a large health maintenance organization was seen by a nurse practitioner for a general physical examination. The nurse practitioner had a Bachelor of Nursing degree and fifteen months training as a "physician's assistant." The patient was a redhead with blue eyes who grew up in southern California with a history of blistering sunburns as a child and a grandfather who died of "skin cancer" in the 50's. None of these risk factors was noted in the chart or appreciated by the nurse practitioner as part of her evaluation.
The patient had a small lesion on his neck which had been present for two months without healing. The "diagnosis" was "crusted over pimple" which was treated with an antibiotic cream and instructions to the patient to quit picking at it. Unfortunately, the patient had no idea that he was at high risk for malignant melanoma and the nurse practitioner did not discuss with him the possibility that the lesion might represent a skin cancer. He was next seen by a physician, an internist, nearly eight months later. Although the doctor recommended surgical removal of the lesion, he apparently did not feel there was any urgency in this regard so the surgery was not done for another month. By the time the lesion was diagnosed as malignant melanoma, it was deeply invasive and had metastasized to the lungs. The patient's claim was settled shortly before trial for a substantial amount.
In order to succeed in a medical malpractice case, the patient must prove three things to the satisfaction of the jury, judge or panel of arbitrators:14 that the health care provider being sued did not comply with the "standard of care," i.e., was negligent, in diagnosing or treating the patient; that the patient suffered injury and/or damage; and that the failure to provide appropriate care was a substantial factor in causing the injury and/or damage. We do not hold doctors legally liable for injuries which are accepted risks of certain procedures where there was no negligence in providing care. The "standard of care," what other physicians practicing under similar circumstances would consider appropriate medical treatment, invariably is the subject of expert testimony as only doctors can testify as to what would be required or acceptable in a given situation.15
The "burden of proof" in a medical malpractice case which is a civil, not criminal, proceeding is "preponderance of the evidence." In other words, the plaintiff/patient must prove that it is more likely than not that the facts as he or she presented them support a finding that the health care provider was negligent and that his or her negligence was a substantial factor in causing the claimed injury.
During the "discovery" portion of the pre-trial proceedings in the case mentioned above, the defense experts were deposed, questioned under oath. One was an internist with excellent credentials, the other a nurse practitioner who teaches in an accredited two-year degree program. Both had been hired by the attorney for the health care provider to testify that the nurse practitioner had complied with the standard of care which, they asserted, did not require that the patient be referred to a dermatologist or that he be warned of the possibility that the skin lesion might be a skin cancer. As defense experts, their testimony in this regard was not surprising. Were they not prepared to take that position, they would not have been designated as experts by the defense. What was startling was their failure to appreciate the risk of malignant melanoma in the general population. The doctor and nurse practitioner estimated that risk as one in 5,000 and "something less than" one in 10,000, respectively.
It is likely that this gross miscalculation of the risk of the disease impacts the "index of suspicion" health care providers have for including malignant melanoma in a differential diagnosis. If two experts designated to testify about the diagnosis and treatment of malignant melanoma were not better informed about its incidence, it is unlikely that the average practitioner with a very limited amount of dermatologic training and no particular need to know these facts and figures would be better informed. Hence, the increased likelihood that melanoma may not be suspected and, thus, go undiagnosed.
For you, the patient, this information has significant ramifications. If you have concerns or are suspicious about a skin lesion, insist on a referral to a dermatologist. Be prepared to confront your primary care provider with the information contained in this article and, if you cannot get authority to be seen by a specialist, promptly obtain a second opinion outside your health maintenance organization. If you raise a question relating to your skin and it does not seem to you that your doctor has an appropriate level of concern and/or refuses your request for a referral to a dermatologist, specifically request that he or she make a note in the chart about the condition and his or her diagnosis. If you have any doubts as to whether this was done, request a copy of the medical record.16 Doing so may create sufficient concern on the part of the health care provider about your intentions that he or she may have a change of heart about the advisability of making a referral. If not, your concern and the health care provider's response to it will be documented in the event litigation ensues.
Do not blindly accept the assurances of a general practitioner or internist that a particular lesion is benign. Continue to monitor any changes you perceive in the size, color or shape of the lesion and report them immediately. Most melanomas "spread" over the surface of the skin before they begin the vertical growth phase during which they become more dangerous. Bear in mind that a small percentage of melanomas present atypically and may not have the characteristic dark pigmentation usually associated with a mole or "beauty mark." An amelanotic lesion, one without distinct coloring, can be just as dangerous as the "typical" melanoma. If you notice a "bump" in the skin that itches and/or does not go away after a reasonable period, report it to a dermatologist.
It is always better for a patient to get timely and appropriate diagnosis and medical treatment than to have a good malpractice lawsuit. However, if you believe you have been the victim of medical negligence and think you may want to pursue a legal claim against the responsible party or parties, do not hesitate to consult a lawyer with a solid background in malpractice litigation. There is a limited time in which to initiate legal action. In California, a patient may have as little as six months in which to make a claim against a public hospital or health care provider employed by the government. Otherwise, an injured patient has only a year from the date her or she knew or could reasonably have discovered the medical negligence. Volumes have been written interpreting this "statute of limitations" which must be evaluated on a case by case basis. However, failure to file a lawsuit within the time period permitted by law will nullify the claim regardless of how meritorious it otherwise would have been or how serious the injuries are.
Waiting to initiate legal action may have other adverse ramifications, as well. In California, the victim of medical malpractice can recover up to $250,000 in non-economic damages, those traditionally referred to as "pain and suffering," in addition to any economic losses suffered. The spouse may also recover up to $250,000 for his or her non-economic damages for "loss of consortium" or the loss of the "care, comfort and society" of the husband or wife who has been injured by the malpractice. However, in the event of death, the total potential recovery available to all of the legal heirs of the decedent is a $250,000, collectively — 50% less than would have been available during the life of the decedent.
It is no longer prudent, if it ever was, to rely entirely on a doctor to look out for your best health interests. In a medical landscape that is changing radically and redefining the relationship between doctor/health care provider and patient/consumer, the patient will be better served and less likely to suffer medical injury if her or she takes some responsibility for appreciating the limitations of the health care delivery system in an era when the practice of medicine is as much or more a business with a "bottom line" than a healing arts profession. Understanding the incidence and risk factors associated with malignant melanoma and that all physicians are not equally qualified to diagnose and treat skin problems may make the difference between early and late diagnosis of the disease - a difference which could save your life.
1Johnson TM, Smith II JW, Nelson BR, Chang A. Current therapy for cutaneous melanoma. J Am Acad Dermatol 1995; 32:689-707.
2Sober AJ. Cutaneous melanoma: opportunity for cure. Ca-A Cancer Journal for Clinicians. July/Aug. 1991; 41:197-226.
3Sober AJ. Cutaneous melanoma: opportunity for cure. Ca-A Cancer Journal for Clinicians. July/Aug. 1991; 41:204.
4Ramsay, DL. Weary, PE. Primary care in dermatology: whose role should it be? J Am Acad Dermatol 1996: 1005-1008.
5Weary, PE. Behold, the gatekeeper cometh. Int J Der,atp; 1984l 23:33-4.
6Engasser PG, Lyss R. Direct access in HMOs [Letter]. J Am Acad Dermatol 1981; 4:740-1.
7Kirsner RS, Federman DG. Managed care: the dermatologist as a primary care provider. J Am Acad Dermatol 1995; 33:535-7.
8Ramsay DL, Fox AB. The ability of primary care physicians to recognize the common dermatoses. Arch Dermatol 1981; 117:620-2.
9Clark RAF, Rietschel RL. The cost of initiating appropriate therapy for skin diseases; a comparison of dermatologists and family physicians. J Am Acad Dermatol Surg Oncol 1983; 11:476-9.
10Federman DG, Hogan D, Taylor JR, et al. A comparison of diagnosis, evaluation and treatment of patients with dermatologic disorders. J Am Acad Dermatol 1995; 32:726-9.
11Kirsner RS, Ferderman DG. Managed care: the dermatologist as primary care provider. J Am Acad Dermatol 1995; 33:535-7.
12It should be noted that some managed care providers are increasingly relying on nurse practitioners and physicians' assistants to perform routine physical examinations. The qualifications and scope of training for these paraprofessionals varies dramatically. Although the author is not aware of any studies evaluating their proficiency in recognizing and treating skin disease, there is also no reason to believe that they would be any more accurate than primary care physicians and, in fact, they are held to the same legal standard of care as those doctors.
13Weiler, PC, Hiatt, HH, Newhouse, JP, et al. A measure of malpractice: medical injury, malpractice litigation, and patient compensation. Harvard University Press, 1993.
14Although many patients do not realize it, membership in certain managed care systems such as Kaiser require that the patient "waive" his or her right to a jury trial and submit any disputes about care to a panel of three arbitrators for "binding" arbitration.
Although this system is represented to be less expensive and faster than traditional litigation in resolving disputes, there is substantial evidence to the contrary and this certainly has not been this author's experience. For a telling evaluation of the Kaiser arbitration system, see the California Supreme Court's decision in the case of Engalla v. Kaiser (1997) 15 Cal.4th 951, 64 Cal.Rptr.2d 843, 64 P.2d 903, in which the court found that the representations Kaiser made about the way arbitration worked were untrue and constituted fraud insofar as the patient in that case was concerned. The decision is unusual in that the Supreme Court has consistently upheld the rights of an organization such as Kaiser to impose arbitration on its membership.
15To a large degree, medical malpractice lawsuits are won or lost on the relative strength of the expert witness testimony. Notwithstanding public perception to the contrary, it is the author's experience that there are very few "frivolous" medical malpractice lawsuits. The time and costs involved in pursuing these claims, coupled with statutory limitations on damages and attorneys' fees in California make these cases unattractive to most lawyers. Furthermore, while it is possible for a patient's lawyer to find an expert to testify in a very questionable case, it is much more difficult than it is for the defendant physician's lawyer to locate and retain doctors who are willing to testify for the defense even in the most egregious case of medical negligence. While the lawyers may understand that the defense doctor's position is untenable and does not accurately reflect the standard of care, if the doctor qualifies well and is an effective witness, a jury presented with conflicting expert testimony may well believe his or her testimony.
16In California and most other jurisdictions, patients have the right to obtain copies of their medical records within fifteen days of submitting a written request for their release.