Retrospective Analysis of US Litigations Involving Dermatologists From 2011 to 2022.

BACKGROUND: Physician malpractice lawsuits are climbing, and the reasons underlying litigation against dermatologists are unclear. OBJECTIVE: To determine the reasons patients pursue litigation against dermatologists or dermatology practices. MATERIALS AND METHODS: A retrospective analysis of all state and federal cases between 2011 and 2022 was performed after a query using "Dermatology" and "dermatologist" as search terms on 2 national legal data repositories. RESULTS: The authors identified a total of 48 (37 state and 11 federal) lawsuits in which a practicing dermatologist or dermatology group practice was the defendant. The most common reason for litigation was unexpected harm (26 cases, 54.2%), followed by diagnostic error (e.g. incorrect or delayed diagnoses) (16 cases, 33.3%). Six cases resulted from the dermatologist failing to communicate important information, such as medication side effects or obtaining informed consent. Male dermatologists were sued at a rate 3.1 times higher than female dermatologists. CONCLUSION: Although lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed diagnoses and ensure critical information is shared with patients to safeguard against easily avoidable litigation.

Submental fat reduction using sequential treatment approach with cryolipolysis and ATX-101.

BACKGROUND: Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image. AIMS: To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF. METHODS: A prospective, open-label, interventional, single-site study enrolling 22- to 65-year-old participants rated as Grade 4 (extreme) on the Clinician-Rated SMF Rating Scale (CR-SMFRS). Co-primary effectiveness endpoints were proportions of participants with ≥1-grade and ≥2-grade improvement on CR-SMFRS at 12 weeks post final treatment. Additional assessments included ultrasound measurement of fat thickness and Subject Self-Rating Scale (SSRS) scores at 12 weeks post final treatment. Safety was assessed throughout the study. RESULTS: Of 16 enrolled participants, 62.5% were female, mean age of 43, and mean body mass index of 31.8 kg/m2 . 100% of participants achieved ≥1-grade improvement, and 71.4% achieved ≥2-grade CR-SMFRS improvement. Mean (SD) reduction in SMF thickness was 0.2 mm (1.3), and SSRS scores ≥4 (slightly to extremely satisfied) were reported by 71.4% of participants. Adverse events (AEs) were mild and resolved by study end. No unanticipated adverse device effects or serious or unexpected AEs occurred. CONCLUSION: Sequential treatment with cryolipolysis and ATX-101 was found safe and effective for reducing extreme SMF, resulting in approximately a 2-grade improvement.

Physical modalities for treating acne and rosacea.

Physical modalities provide an important adjunct to medical treatment of acne and rosacea. In patients who cannot tolerate or fail medical treatments, physical modalities offer an alternative approach. For cases of acne scarring, phymatous changes of rosacea, and rosacea-associated telangiectasia, physical modalities such as laser and light treatments represent the treatment of choice. We will review the use of laser and light treatments, photodynamic therapy, and other physical modalities such as targeted therapies for the treatment of acne and rosacea.

Medical professional liability claims for Mohs micrographic surgery from 1989 to 2011.

IMPORTANCE: Few studies specifically address lawsuits involving Mohs surgery. OBJECTIVE: To better characterize the types of medical professional liability claims involving Mohs surgery. DESIGN, SETTING, AND PARTICIPANTS: Retrospective legal document review of an online national database. Any legal proceeding involving the search words Mohs and cancer was included. MAIN OUTCOMES AND MEASURES: Number of medical professional liability claims involving Mohs surgery for factors including year of litigation, location, physician specialty, injury sustained, cause of legal action, and verdict. RESULTS: Forty-two cases were identified, which occurred from 1989 to 2011. Of the cases identified, 26 involved non-Mohs surgeons as the primary defendant, mostly due to a delay of or failure in diagnosis (n = 16), cosmetic outcome issues (n = 8), lack of informed consent (n = 7), and a delay of or failure in referral to a Mohs surgeon (n = 6). Common causes for litigation against Mohs surgeons as the primary defendant (n = 16) were lack of proper informed consent (n = 5) and cosmetic outcome issues (n = 4). Only 1 case against a Mohs surgeon was judged for the plaintiff. CONCLUSIONS AND RELEVANCE: The most common lawsuits pertaining to Mohs surgery list non-Mohs surgeons as the primary defendants. Closer coordination between non-Mohs surgeons and Mohs surgeons may help minimize risk to both parties and lead to better patient care. Small sample size is the primary limitation, in part owing to exclusion of out-of-court settlements from the database.

Three-dimensional volumetric quantification of fat loss following cryolipolysis.

BACKGROUND AND OBJECTIVES: Cryolipolysis is a noninvasive and well-tolerated treatment for reduction of localized subcutaneous fat. Although several studies demonstrate the safety and efficacy of this procedure, volumetric fat reduction from this treatment has not been quantified. This prospective study investigated the change in volume of fat after cryolipolysis treatment using three-dimensional (3D) photography. MATERIALS AND METHODS: A prospective study of subjects treated with cryolipolysis on the flank (love handle) was performed at Massachusetts General Hospital. Volume measurements were performed with a Canfield Scientific Vectra three-dimensional camera and software to evaluate the amount of post procedure volume change. Clinical outcomes were assessed with caliper measurements, subject surveys, and blinded physician assessment of photographs. RESULTS: Eleven subjects were enrolled in this study. Each subject underwent a single cycle of cryolipolysis to one flank. The untreated flank served as an internal control. The follow-up time after treatment was 2 months. The mean amount of calculated absolute fat volume loss using 3D photography from baseline to 2 months follow-up visit was 56.2 ± 25.6 from the treatment site and 16.6 ± 17.6 cc from the control (P < 0.0001). A mean absolute difference of 39.6 cc between the treated and untreated sides was calculated at 2 months post-treatment. Comparison of caliper measurements from baseline to 2 months post-treatment demonstrated significant reduction of the treated flank from 45.6 ± 5.8 mm at baseline to 38.6 ± 4.6 mm at 2 months post-treatment (P < 0.001). The untreated flank did not show significant reduction with caliper measurements demonstrating 45.3 ± 5.0 mm at baseline and 44.6 ± 5.1 mm at 2 months post-treatment (P = 0.360). No unexpected side effects or adverse events were reported. Post-treatment satisfaction surveys demonstrated 82% of subjects were satisfied with the results. CONCLUSIONS: Cryolipolysis is a safe, well-tolerated, and effective noninvasive fat removal methodology that on average leads to 39.6 cc of fat loss of the treated flank at 2 months after a single treatment cycle.

Paradoxical adipose hyperplasia after cryolipolysis.

IMPORTANCE: Cryolipolysis is the noninvasive reduction of fat with localized cutaneous cooling. Since initial introduction, over 650,000 cryolipolysis treatment cycles have been performed worldwide. We present a previously unreported, rare adverse effect following cryolipolysis: paradoxical adipose hyperplasia. OBSERVATIONS: A man in his 40s underwent a single cycle of cryolipolysis to his abdomen. Three months following his treatment, a gradual enlargement of the treatment area was noted. This enlargement was a large, well-demarcated subcutaneous mass, slightly tender to palpation. Imaging studies revealed accumulation of adipose tissue with normal signal intensity within the treatment area. CONCLUSIONS AND RELEVANCE: Paradoxical adipose hyperplasia is a rare, previously unreported adverse effect of cryolipolysis with an incidence of 0.0051%. No single unifying risk factor has been identified. The phenomenon seems to be more common in male patients undergoing cryolipolysis. At this time, there is no evidence of spontaneous resolution. Further studies are needed to characterize the pathogenesis and histologic findings of this rare adverse event.

Combined 585 nm pulsed-dye and 1,064 nm Nd:YAG lasers for the treatment of basal cell carcinoma.

BACKGROUND AND OBJECTIVE: Basal cell carcinomas (BCCs) have supporting vasculature that serves as a target for vascular selective lasers. The objective of this study was to determine the effect of repeated treatment with a combined 585 nm pulsed dye laser (PDL) and 1,064 nm Neodymium Yttrium Aluminum Garnet (Nd:YAG) laser on BCCs of superficial and nodular subtypes of varying diameters. STUDY DESIGN/MATERIALS AND METHODS: Ten subjects with 13 biopsy-proven BCCs received four combined PDL and Nd:YAG at treatments 2-4 week intervals. None of the BCCs met the criteria for Mohs micrographic surgery. The tumor and 4 mm of peripheral skin were treated using standardized parameters delivered with a 7 mm spot with 10% overlap. The treated area was excised and evaluated histologically for residual tumor. The primary study endpoint was histologic clearance of tumor. The secondary study endpoint was blinded investigator assessment of clinical endpoint and adverse effects. RESULTS: Approximately half of all tumors showed a complete response to four combined PDL and Nd:YAG treatments (n = 7/12, 58%). When stratified by size, 75% of all tumors <1 cm in diameter (n = 6/8) showed complete response. Tumor histologic types among the complete responders included superficial and nodular BCCs. All subjects with incompletely responding BCCs were on various forms of anticoagulation, which we hypothesize, may inhibit laser-mediated thrombosis necessary for the clinical effect. Blinded investigator assessment suggests that biopsy related erythema improves with subsequent laser treatments. CONCLUSIONS: Combined PDL and Nd:YAG laser is an effective means of reducing tumor burden in patients with BCC and may be a promising, emerging alternative therapy. Factors influencing treatment response includes the concomitant use of anticoagulation. Further studies are needed to investigate and optimize the utility of this treatment protocol.

Increased risk of litigation associated with laser surgery by nonphysician operators.

IMPORTANCE: Controversy exists regarding the role of nonphysicians performing laser surgery and the increased risk of injury associated with this practice. OBJECTIVE: To identify the incidence of medical professional liability claims stemming from cutaneous laser surgery performed by nonphysician operators (NPOs). DESIGN, SETTING, AND PARTICIPANTS: Search of an online national database of public legal documents involving laser surgery by NPOs. EXPOSURE: Laser surgery by nonphysicians. MAIN OUTCOMES AND MEASURES: Frequency and nature of cases, including year of litigation, certification of provider and operator, type of procedure performed, clinical setting of injury, and cause of legal action. RESULTS: From January 1999, to December 2012, we identified 175 cases related to injury secondary to cutaneous laser surgery. Of these, 75 (42.9%) were cases involving an NPO. From 2008 to 2011, the percentage of cases with NPOs increased from 36.3% to 77.8%. Laser hair removal was the most commonly performed procedure. Despite the fact that approximately only one-third of laser hair removal procedures are performed by NPOs, 75.5% of hair removal lawsuits from 2004 to 2012 were performed by NPOs. From 2008 to 2012, this number increased to 85.7%. Most cases (64.0%) by NPOs were performed outside of a traditional medical setting. CONCLUSIONS AND RELEVANCE: Claims related to cutaneous laser surgery by NPOs, particularly outside of a traditional medical setting, are increasing. Physicians and other laser operators should be aware of their state laws, especially in regard to physician supervision of NPOs.

Cryolipolysis: a historical perspective and current clinical practice.

Dermatologists have long used cold-based therapeutic approaches for a variety of applications. Based on the differences in chemical composition, it is possible to selectively target certain tissues rich with lipid, while sparing the surrounding tissue predominantly containing water. With historical observations of cold-induced panniculitis suggesting the feasibility of this strategy, cryolipolysis has emerged as a new methodology using controlled cooling to selectively target fat. Both preclinical and clinical studies have established the safety and efficacy of cryolipolysis for noninvasive body contouring. This review will focus on the evolution of cryolipolysis from initial case reports of cold-induced panniculitis, to preclinical and clinical studies, and the current clinical practice.

Analysis of botulinum toxin products and litigation in the United States.

BACKGROUND: Botulinum neurotoxin (BoNT) has diverse cosmetic and therapeutic applications, spanning multiple medical specialties. Recent lawsuits alleging complications from its clinical use have raised significant questions about medicolegal risk. OBJECTIVE: To identify and assess legal cases related to clinical complications of BoNT products. METHODS AND MATERIALS: Using the LexisNexis Academic online database, a search of U.S. federal and state cases between 1985 and 2012 was performed. A second search of U.S. newspapers and wires was also completed. In all but one case, the plaintiffs' legal complaints were obtained for review. RESULTS: Twenty-four relevant legal cases were found, mostly in state courts. All cases alleged adverse effects from onabotulinumtoxinA, and each named its manufacturer, Allergan, Inc., as a defendant. Most lawsuits against Allergan, Inc. were dismissed or settled. In three cases, physicians were codefendants, including one dermatologist. In two cases, jury verdicts resulted in multimillion-dollar judgments in favor of the plaintiffs. None of the lawsuits named a dermatologist when the complication arose from on-label indications and cosmetic use. CONCLUSION: Lawsuits related to complications from BoNT products are uncommon, are more likely to result from therapeutic than cosmetic applications, and typically involve product liability claims against the manufacturer.

Common causes of injury and legal action in laser surgery.

OBJECTIVE: To identify common causes of legal action, injuries, claims, and decisions related to medical professional liability claims stemming from cutaneous laser surgery. DESIGN: Search of online public legal documents using a national database. MAIN OUTCOME MEASURES: Frequency and nature of cases, including year of litigation, location and certification of provider, injury sustained, cause of legal action, verdict, and indemnity payment. RESULTS: From 1985 to 2012, the authors identified 174 cases related to injury stemming from cutaneous laser surgery. The incidence of litigation related to laser surgery shows an increasing trend, with peak occurrence in 2010. Laser hair removal was the most common litigated procedure. Nonphysician operators accounted for a substantial subset of these cases, with their physician supervisors named as defendants, despite not performing the procedure. Plastic surgery was the specialty most frequently litigated against. Of the preventable causes of action, the most common was failure to obtain an informed consent. Of the 120 cases with public decisions, 61 (50.8%) resulted in decisions in favor of the plaintiff. The mean indemnity payment was $380 719. CONCLUSIONS: Claims related to cutaneous laser surgery are increasing and result in indemnity payments that exceed the previously reported average across all medical specialties. Nonphysicians performing these procedures will be held to a standard of care corresponding to an individual with appropriate training; thus, physicians are ultimately responsible for the actions of their nonphysician agents.

Fractionation: past, present, future.

The development of fractional photothermolysis is a milestone in the history of laser technology and cutaneous resurfacing. Based on the concept that skin is treated in a fractional manner, where narrow cylinders of tissue are thermally heated and normal adjacent skin is left unaffected, the fractional devices have shown effectiveness in treating a variety of conditions. Since its development, we are becoming more adept at using optimal parameters to induce near carbon dioxide laser benefits with a much more comfortable postoperative period and fewer complications. The future remains bright for fractionated laser devices and with new devices and wavelengths, the applications of this technology continue to grow.

Body contouring: the skinny on noninvasive fat removal.

Historically, the approach to body contouring has largely involved invasive procedures, such as liposuction. Recently, several new devices for noninvasive fat removal have received clearance by the Food and Drug Administration for the treatment of focal adiposity. Modalities are aimed primarily at targeting the physical properties of fat that differentiate it from the overlying epidermis and dermis, thus selectively resulting in removal. This review will focus on 3 novel approaches to noninvasive selective destruction of fat.

All-trans retinoic acid shifts Propionibacterium acnes-induced matrix degradation expression profile toward matrix preservation in human monocytes.

Propionibacterium acnes is a critical component in the pathogenesis of acne vulgaris, stimulating the production of various inflammatory mediators, such as cytokines and chemokines, important in the local inflammatory response found in acne. This study explored the role of P. acnes and its ability to induce matrix metalloproteinases (MMPs) in primary human monocytes and how this induction is regulated by retinoids. MMP-1- and MMP-9-expressing cells were present in perifollicular and dermal inflammatory infiltrates within acne lesions, suggesting their role in acne pathogenesis. In vitro, we found that P. acnes induced MMP-9 and MMP-1 mRNA, and the expression of MMP-9, but not of MMP-1, was found to be Toll-like receptor 2-dependent. P. acnes induced the mRNA expression of tissue inhibitors of metalloproteinase (TIMP)-1, the main regulator of MMP-9 and MMP-1. Treatment of monocytes with all-trans retinoic acid (ATRA) significantly decreased baseline MMP-9 expression. Furthermore, co-treatment of monocytes with ATRA and P. acnes inhibited MMP-9 and MMP-1 induction, while augmenting TIMP-1 expression. These data indicate that P. acnes-induced MMPs and TIMPs may be involved in acne pathogenesis and that retinoic acid modulates MMP and TIMP expression, shifting from a matrix-degradative phenotype to a matrix-preserving phenotype.

TGF-alpha regulates TLR expression and function on epidermal keratinocytes.

The expression of TLRs on epithelial cells provides a first line of defense against invading pathogens. We investigated the regulated expression and function of TLR5 and TLR9 on human keratinocytes, because we found by immunohistochemistry that these TLRs are expressed in distinct layers of the epidermis. We found that TGF-alpha, a growth and differentiation factor that is present during wound healing and in psoriasis, increased the expression of both TLR5 and TLR9 on keratinocytes. In addition, TGF-alpha regulated the function of TLR5 and TLR9, because activation with their respective ligands enhanced the production of IL-8 and human beta-defensins. These findings provide evidence that TGF-alpha up-regulates TLR expression and function, augmenting host defense mechanisms at epithelial surfaces.