MEDICOLEGAL ASPECTS OF DERMATOLOGY

Dec
2013
Vol. 32. No. 4

Introduction

Unlike most persons with medical and legal degrees, I attended law school later in life, after I was already an attending-level physician and medical school professor. Similar to the recollections of others,1 I was told from the outset that law school would alter my life-perspective. Having already attended medical school, where similar invocations abound upon matriculation, I found this a plausible statement— in hindsight, it is true. Medicine and law are entwined in a Gordian knot. The malpractice insurance industry depends upon the plaintiffs’ attorneys for relevance, and the plaintiffs’ attorneys are dependent upon the malpractice insurance industry for revenue. This is not the only level of interaction between medicine and law (see below), but, should you doubt this, consider what would be the prevailing rate for malpractice insurance were it irrelevant. The “malpractice-malpractice insurance complex” is just as real as the “military-industrial complex,” the latter a sociopolitical term coined in the 1960’s.2 Other conjoined “complexes” that impact upon medicine might include: the “board certification-board preparation complex,” the “maintenance of certification-graduate medical education complex,” or especially, in dermatology and dermatopathology, the alleged “nevi-melanocytic industrial complex.”3 A recent study of malpractice claims among various medical specialties found dermatology to be of “low risk” overall, but that is not to say that “low-risk” fields are “worry-free.”4 The very same study estimated that by 65 years of age, 75% of physicians in “low-risk” specialties could expect to face a claim of malpractice. Additionally, studies from a national insurer demonstrated melanoma to be the most common cause of malpractice claims against pathologists and dermatopathologists.5,6 More recent data demonstrated a drop in the number of claims overall, but melanoma has remained the single most common cause of malpractice claims in pathology. Furthermore, melanoma claims typically result in an indemnity payment that is two-fold higher than the average malpractice award.7 The latter is of keen interest to dermatologists, who are currently embroiled in a struggle, politically and economically, to retain the right to review their own self-referred skin pathology specimens.8 The threat of malpractice is probably the most direct means by which physicians are impacted by law – or at least – the most terrifying. Fierce debate transpires with regard to just how much “defensive medicine” (the ordering of tests not because of high pre-test probability, but because of fear of litigation), impacts upon the costs of health care.9,10 During law school, I was asked, both by optimistic law students and deluded law professors, “Does defensive medicine exist?” While I am but one man (a man named Whitney), I have practiced medicine in various environments, in different regions of the country, and in both private-practice dermatology and academic dermatopathology, and for myself, the confident answer is, “Absolutely.” Moreover, defensive medicine is not the only way that malpractice impacts upon the cost of health care. A recent study found that even in cases that resulted in no indemnity payment at all, defensive legal costs, on average, were nearly $25,000.00.11 Tort reform is debated as a possible way to reduce malpractice costs, to lessen the use of defensive medicine, and to decrease overall health care spending. In fact, just this year, Texas is approaching the end of a decade-long experiment with tort reform. Perspectives regarding the success or failure of this endeavor fall, predictability, upon political lines. Proreform activists point to a record number of providers per capita now in Texas,12 and greatly reduced defensive costs to academic centers.13 Detractors either contest the proponents assertions,14 or cite cases where the clearly injured were grossly undercompensated. However, tort reform directed at medical malpractice alone may have unintended consequences, such as encouraging the growth of product liability lawsuits. Such lawsuits, typically against corporations, who manufacture drugs or medical devices, may be persecuted in a multitude of forums, sometimes as multi-district litigation, or even as class actions, and these suits stay purposefully beyond the reach of damage caps and tort reform. Growth in this same arena may also pertain to the increased use of drugs and medical devices. From 1990 to 2008, expenditures on prescription drugs in the United States rose from $40 billion to $234 billion dollars.15 Predictions call for an additional 67% growth in specialty drugs by 2015.16 Even if physicians are not the target of product lia-bility actions, they may find themselves deposed, either as experts, or because the drug was used in their practices. Yet, malpractice and product liability is not the only way, or even the most pervasive way, that law interacts with medicine. The relationships between physicians and employers are often defined by a legally-binding contract, and such a document may contain non-compete agreements, or other fiercely contested provisions. Regulations regarding professional licensing and patient privacy impact upon one’s ability to practice medicine, and upon record keeping. This is particularly true in dermatology, a visually-based specialty, where transmitted images, used for diagnosis, are ascending in prominence. Lastly, for the entrepreneurial physician, patent law and intellectual property may provide another area of overlap between medicine and the law. For all these reasons, the editors of Seminars in Cutaneous Medicine and Surgery, in their wisdom, have endeavored, with modest assistance from me, to bring forth an issue dedicated to the interactions between medicine and law as it pertains to dermatology and pathology. In this issue, there are articles devoted to malpractice, to product liability, and to the use of medications or devices in certain “high risk” populations (medication use in pregnancy and tanning booth use in children). There are also articles on the risks and obligations of serving as an expert witness, contracting and asset protection for physicians, compliance with patient privacy laws, the proper and lawful relationship between private laboratories and dermatology practices, and the tribulations of medical licensing and interstate medicine. There is even a chapter introducing the concepts of patent law and intellectual property in dermatology. In sum, it is our sincere wish that these articles both broaden the readers’ appreciation for the myriad ways that medicine and law interact, and serve as a stepping stone for further exploration of the subject matter.

Medical Malpractice Lawsuits and the Value of Skilled and Diverse Legal Counsel

Alison C Sorkin, JD | Keith D Lapuyade, JD
Medical malpractice claims against dermatologists and dermapathologists arise mostly out of claims for negligence—when a patient claims a provider owed a duty to a patient, breached that duty, and caused damages to the patient. When a health care provider files a claim with his or her insurance company, the insurance company will usually retain and pay an attorney for the health care provider. It is important to understand the role the attorney retained by the insurance company plays to evaluate whether a health care provider should seek the advice of independent or “personal” counsel. Semin Cutan Med Surg 32:230-233 © 2013 Frontline Medical Communications
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Medicolegal Aspects of Prescribing Dermatological Medications in Pregnancy

Daniel C Butler, BS | Jenny E Murase, MD | Rishu Gupta, BS | Whitney A High, MD, JD, MEng
Medications are commonly used during pregnancy; in fact, female patients take an average of 2.9 medications during pregnancy. Due to this high prevalence, malpractice litigation poses a high legal risk to dermatologists who prescribe medications to female patients who are or may become pregnant. This article introduces the medicolegal risks involved in prescribing dermatological medications to a pregnant patient and discusses ways for a dermatologist to mitigate those risks. International safety classification systems are reviewed, and potential high risk dermatologic medications prescribed in acne, psoriasis, atopic dermatitis, and connective tissue disease are discussed. In addition, the article summarizes resources available to patients as well as the important elements for dermatologists to include when documenting their discussion with the patient in the medical record. Semin Cutan Med Surg 32:209-216 © 2013 Frontline Medical Communications
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Patent Law for the Dermatologist

Dan Feng Mei, JD | Josephine Liu, PhD, JD
An exciting discovery in the laboratory may translate to a commercial product. How does the patent system fit into the picture? We first discuss the circumstances under which an invention is granted a patent. What is the purpose of a patent and what are the functions of the patent system? Who can apply for a patent? What makes an invention patentable? A patent does not automatically grant a right to make or sell a product. This is because multiple patents can cover a single pharmaceutical product. Understanding the patent landscape covering a product of interest is key to evaluating the risk of infringing another’s exclusivity rights. We use a hypothetical example relating to skin cancer to guide a discussion of patent law. Semin Cutan Med Surg 32:242-246 © 2013 Frontline Medical Communications
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Tanning Bed Legislation and the Dermatologist

Alison C Sorkin, JD | Robert P Dellavalle, MD, PhD, MSPH | Teresa A Foo, MD
Indoor ultraviolet (UV) tanning correlates with increased risk of developing melanoma and other skin cancers. Because of the limited scope of individual counseling by physicians and other health care providers, prevention efforts now encompass population-based interventions in the form of legislation to discourage and decrease access to indoor tanning facilities. Legislation increasingly restricts indoor UV tanning at the national, territory, state, or local level and draws attention to the complexities surrounding enforcement and infraction penalties. Further research needs to better define the effect of decreased indoor UV tanning access on skin cancer incidence. Semin Cutan Med Surg 32:217-223 © 2013 Frontline Medical Communications
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Teledermatology, Teledermatopathology, Interstate Dermatopathology and the Law

Amanda Marsch, MD | Whitney A High, MD, JD, MEng
The expansion of telemedicine nationwide has resulted in many states adopting specific telemedicine regulations to avoid the issue of requiring a full medical license to practice telemedicine. How these laws and regulations relate to the practice of telepathology and teledermatology has not been well delineated. It is important to understand these regulations to avoid potential judicial penalties arising from non-compliance. This article aims to outline state-specific telemedicine regulations and penalties. Semin Cutan Med Surg 32:224-229 © 2013 Frontline Medical Communications
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