Vol. 32. No. 4


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.

Dermatology and Pathology Arrangements: Navigating the Compliance Risks

Bridget Cougevan, JD | Jenny McGovern, JD | Jane Pine Wood, JD
Purchased service arrangements, establishing in-house professional pathology services, conducting technical component histology within a dermatology practice, and electronic medical records technology donations are ways that dermatology practices are responding to the current health care delivery and payment changes. This article will provide a general framework for navigating the compliance risks and structure considerations associated with these relationships between dermatologists and pathologists. Semin Cutan Med Surg 32:185-194 © 2013 Frontline Medical Communications

Drug Safety: Implications for the Dermatologist and Dermatopathologist

John M Restaino, Jr, DPM, JD, MPH
The recent decades have seen a plethora of drugs removed from the world-wide market place over safety concerns and reported adverse events. In some cases, drugs with significant reports of adverse drugs events (ADEs) have remained on the market with either a Black Box warning, strict prescribing guidelines, or both. It has been reported that more than 2,000,000 Americans are harmed by ADEs each year. The financial costs associated with ADEs are staggering with over $170 billion spent annually in the United States as a result of ADEs. The implications for the dermatologist and dermatopathologist are daunting for the skin is the organ most frequently affected by ADEs. Many cases of drugs removed from the market are preceded by the filing of one or more product liability lawsuits. This means the dermatologist could be brought under claims of negligence, strict liability, breach of warranty, and consumer protection claims. The potential implications for the dermatologist or dermatopathologist are discussed along with an introduction to the legal process, which comes into play with the filing of the product liability lawsuit. Semin Cutan Med Surg 32:195-198 © 2013 Frontline Medical Communications

Employee Contract Issues for Dermatologists

Christopher E. Brown, JD | George F Indest, III, JD, MPA, LLM
Employees and employers routinely face negotiating and preparing physician employment contracts. It is important for both sides to know and understand the basic information on what a comprehensive employment contract for a dermatologist should contain. There are various employment contract provisions from both the employee’s perspective and the employer’s perspective that must be considered when preparing physician employment contracts. This article provides basic advice and recommendations on requirements that should be included in such contracts. It suggests legal pitfalls that can be avoided through various contract clauses. Semin Cutan Med Surg 32:236-241 © 2013 Frontline Medical Communications

HIPAA, Dermatology Images, and the Law

Allan C. Halpern, MD | Brooke Rothstein, BA | Noah Scheinfeld, MD, JD
From smart phones to iPads, the world has grown increasingly reliant on new technology. In this ever-expanding digital age, medicine is at the forefront of these new technologies. In the field of dermatology and general medicine, digital images have become an important tool used in patient management. Today, one can even find physicians who use their cellular phone cameras to take patient images and transmit them to other physicians. However, as digital imaging technology has become more prevalent so too have concerns about the impact of this technology on the electronic medical record, quality of patient care, and medicolegal issues. This article will discuss the advent of digital imaging technology in dermatology and the legal ramifications digital images have on medical care, abiding by HIPAA, the use of digital images as evidence, and the possible abuses digital images can pose in a health care setting. Semin Cutan Med Surg 32:199-204 © 2013 Frontline Medical Communications

LASERS and the LAW: What the Dermatologist Needs to Know

David J Goldberg, MD, JD
Dermatologic laser surgery is a continuously evolving field of medicine. According to the American Society for Dermatologic Surgery, over 100 million laser and light source cosmetic procedures were performed by its members in 2003. Procedures, which include hair removal, nonablative treatments, as well as removal of pigmented lesions, tattoos, and unwanted vascular lesions, have revolutionized this field. With an increasing number of physicians and nonphysicians performing these procedures and with the availability of increasingly powerful laser technologies, the potential for problems and their legal consequences continue to increase. This article will address the concept of negligence and the potential for a resultant medical malpractice lawsuit that may arise in such a setting. Inherent in this issue are the associated problems that arise when these procedures are performed by physician extenders. An understanding of the basic principals of a cause of action in medical malpractice will likely protect a physician from losing such a case in a court of law.