Publication Date: June 2008
Roger J. Leslie
Medical Negligence, Legislation and Legislature, Medical Negligence, Technology
Beauty is only skin deep. In an effort to improve the appearance of patients’ skin, physicians performed 100 million laser procedures in 2003 based on an estimate of the American Society for Dermatologic Surgery. The procedures include wrinkle removal, tattoo removal, removal of naturally pigmented spots, reduction of varicose and spider veins, and the removal of unwanted hair. Laser treatments are usually provided in doctors’ offices, but some facilities are called "spas" where customers may expect low risk treatment.
While laser light treatments require as much sophisticated knowledge as any surgery, they are some times performed by inexperienced or poorly trained practitioners. Laser and light devices are sold to physicians and nurses with as little as two days of training from a representative of the manufacturer of the laser, who may have only a week of formal training himself. A Texas case illustrates the point.
After Cooper received the laser, Endres provided a one-day, in-service training, during which Cooper used the laser on two of his patients. Cooper had not previously performed surgery with a laser, did not make any effort to avail himself of other free training, and did not read the manual before the surgery.
Cooper v. Lyon Financial Services, Inc., 65 S.W.3d 197 (Texas, 14th Dist., 2002)
Physicians often delegate the procedures to nurses and physician assistants with similarly insufficient training. Laser or light treatments of the skin are the practice of medicine under RCW 18.71.011 (3) because the light ". . . penetrates the tissues of human beings." The treatment plan should be developed by a physician with knowledge and experience, and if the treatment is delegated to a physician assistant, the physician should closely monitor the treatment.
The Washington State Department of Health recently adopted regulations that define the use of laser, light, radiofrequency, and plasma devices (LLRP) as the practice of medicine and limit their use to physicians, and physician assistants. These regulations apply to lasers that are identified as prescriptive devices by FDA. The physician or physician assistant may delegate treatments to properly trained and licensed professionals who are under the direct supervision of a physician or a physician assistant. WAC 246-919-605 and WAC 246-918-125 (effective 3/1/2007). For example, a physician may delegate the procedure to an aesthetician, but the physician must supervise the treatments.
The Washington State Nursing Care Quality Assurance Commission takes the position that RCW 18.79.260(2) allows registered nurses to perform treatments provided they are under the direct supervision of a physician. Licensed practical nurses (LPN) are allowed to perform "specific designated laser procedures which do not carry significant risks or that are not complex in nature based on the patient’s condition or the degree of hazard concerning the laser usage, risk factors, or treatment outcomes." Washington State Nursing Care Quality Assurance Commission Position Statement on: Use of Lasers in Skin Care Treatment, November 7, 2003. The physician is ultimately responsible; however, nurses cannot avoid responsibility for the quality of nursing care by accepting orders or directions from another person. A standardized procedure is required for the RN/LPN to perform any laser treatment. Nurses assisting in laser care are required to have training in the use of lasers including didactic and clinical aspects of basic laser physics, laser safety protocols, safety standards from OSHA and ANSI Z136.3, laser-tissue interactions, laser operating procedures, potential hazards and complications, and post-procedure education and wound care.
The supervising physician must be appropriately trained in the physics, safety and techniques of using LLRP devices. The delegated procedure must not involve surgery and it must not treat the globe of the eye. The regulations require informed consent. A physician must ". . . obtain the patient’s informed consent (including informing the patient that a non- physician may operate the device). . .." WAC 246-919-605(6).
A physician must have a written office protocol that identifies the individual physician responsible for the device, for delegation, and a statement that includes details of the procedures authorized for each device. Under the regulations, the physician is responsible for the actions of the other supervised professionals. "The delegating physician ensures that the supervised professional uses the LLRP device only in accordance with the written office protocol, and does not exercise independent medical judgment when using the device." WAC 246-919-605(10) (f). A physician is required to be present on the immediate premises during the patient’s initial treatment.
Plaintiff’s discovery in skin treatment cases should include a request for production for the written protocol required by the regulations and an interrogatory asking for a full description of the physician’s training in the physics and safety of LLRP. The plaintiff’s attorney should work with his laser expert prior to the deposition of the defendant physician to develop case specific questions about the physics and operation of the laser.
For attorneys with clients who have been disfigured by negligently performed laser treatments, it is important to remember that by possessing basic knowledge of light/tissue interactions, a prudent physician can protect her patients from injuries such as full thickness burns, ulcers, permanent scarring, and disfigurement.
Factors that a prudent physician or physician assistant needs to consider when conducting laser skin treatments are the color of the light used, the duration of each pulse of light, the beam size, the depth of penetration of the light into the skin, the number of treatments at the same location on each visit, the recovery time between treatments, the total number of treatments, collateral damage to adjacent skin, the degree of cooling to the area of skin being treated, the fluence of the beam, the skin type and skin color of the patient, and the spectral absorbance of the pigments present in the skin being treated. It is beyond credibility that a one or two day training session could cover the level of sophistication that is required to protect patients from injury.
A physician performing laser treatments can protect his patients from injury in several ways. A safe facility will likely have multiple lasers available so that the practitioner can choose the best color of light to treat each patient. A physician may use several different lasers to treat one skin condition or some lasers, called pulsed dye lasers (PDL), can be adjusted between different colors by exchanging the dye medium that amplifies light. The defendant’s facility should have an appropriate selection of laser devices available to safely perform the procedure.
Injuries can be avoided if the practitioner tests a small area of the patient’s skin, preferably in a low visibility spot, before performing the complete treatment. A test can reveal unexpected effects such as allergic responses to pigments released by the treatment, hyperpigmentation or hypopigmentation of the target tissue or the surrounding normal skin, or extreme damage caused by unpredictable variability in the target pigments.
A practitioner can avoid serious injury to his patient by applying multiple mild treatments over a long period. A reasonably prudent practitioner may apply as many as 10 treatments spaced over the period of a year to treat a single area of skin.
It is hard for an ordinary person or even an untrained physician to imagine that light can cause serious damages when the ordinary person typically only encounters light at the level of room illumination or sunlight. However, laser light can cause effects in human tissue variously described in the medical literature as "vaporization," "tissue splattering," and "aerosolization." Public advertisements for clinics providing laser tattoo removal, laser hair removal, or laser skin resurfacing emphasize the safety of the procedures and rarely admit the risks. A patient seeking help at a facility called a "spa" would not expect to have areas on his skin vaporized or turned to an aerosol by powerful lasers.
The disfigurement caused by negligent use of lasers includes delayed wound healing, permanent scars, and permanent alterations of pigments that leave dark or unnaturally light areas of the skin. Delayed wound healing results from tissue ablation that penetrates too deeply in the skin and causes a full thickness injury. The ulcers thus created do not heal well because of damage to the proliferative layer of skin. Overly aggressive treatment of spider veins or varicose veins can destroy the blood supply to the skin. The treated area is starved for oxygen and nutrients supplied by blood, which inhibits the growth of a new layer of skin (re-epithelialization).
Scars become permanent when the natural repair of the wound area leaves either a divot or a raised area. The divot (atrophic) scar is caused by impaired wound healing from excessive exposure to laser light. The raised (hypertrophic) scar is caused by a build up of scar tissue during the wound healing process.
Darkening of skin results from laser irradiation of a light pigment that causes the pigment to undergo a chemical change and darken. Depigmentation of skin (hypopigmentation) is a serious risk for patients with olive colored skin. The laser irradiation targeting artificial pigments may collaterally destroy natural skin pigments and leave the treated area permanently lighter than the surrounding normal skin.
The defense of cases involving disfigurement by laser treatments sometimes focuses on blame-the-victim arguments. For example, the defense may argue that the kind of person who would have themselves tattooed is the kind of person who would not comply with physician’s instructions. Contributory negligence by the plaintiff may be based on a claim that the plaintiff allowed the treated area to be exposed to sunlight against physician’s orders. In general, exposure to sunlight can cause pigmentation of the treated area, but post-treatment sun damage is not usually disfiguring.
The FDA approves laser and IPL devices for use in medical procedures. Defendants may argue that the FDA somehow approved the settings of the machine for a specific purpose. However, standard of care requires that the practitioner evaluate each patient as a new case and that she choose lasers and their settings to best treat that patient. No honest dermatologist experienced in the use of lasers would support the defense that the defendant can rely on factory suggested settings without individually testing the laser on each patient.
The "stuff happens" defense appears in laser cases. The argument is that the defendant did everything right and the patient suffered a bad outcome. The plaintiff should emphasize that the defendant can protect the patient from injury by performing the proper tests and by exercising reasonable judgment and restraint during treatments.
The courts in other jurisdictions may not identify laser treatments of skin conditions as the practice of medicine. In Missouri, the appellate court held that the trial court did not have evidence necessary to conclude that laser hair removal was the practice of medicine for purposes of applying the two year statute of limitations for actions involving health care. Mitchell v. McEvoy, MOACE ED89333-110607 (2007). The primary evidentiary issue for the Missouri court was whether the laser used was capable of coagulating tissue. The coagulation-of- tissue threshold for determining whether the use of a laser is the practice of medicine is comparable to Washington’s standard from RCW 18.71.011(3) that is applied in regulations from the Department of Health, which defines treatment that penetrates the tissues of human beings as the practice of medicine.
Some laser treatments that end in damage to a patient are res ipsa loquitur cases. In general, laser treatments can result in minor discontinuities in skin texture or pigmentation, but severe damage such as ulcers and extensive scarring would not happen without negligence. The physician has complete control of the instrumentality and severe damage will not happen in the absence of negligence.
However, at trial, plaintiffs can expect to encounter juror bias against people who choose to have cosmetic surgery. The Florida Appellate Court ordered a new trial in a laser resurfacing case when the trial court did not strike a prospective juror after he revealed in voir dire that he thought anyone who had surgery just to correct her nose was a fool and that someone who suffers injuries after she has an elective procedure for cosmetic reasons is partly at fault. Jaffe v. Applebaum, 830 So.2d 136 (Fla.App. Dist 4, 2002). The feeling that anyone who elects to have cosmetic surgery shares some fault for a bad outcome is common. During voir dire, plaintiffs’ attorneys need to be prepared to challenge prospective jurors regarding their bias against cosmetic surgery patients.
Laser skin treatment is a rapidly expanding area of medicine that is attractive to physicians who would like to open their own practice or expand an existing practice. Most physicians are well prepared to provide safe treatment; however, some physicians are entering the practice with insufficient training and experience. Fortunately, the regulations recently adopted by the Department of Health will help plaintiffs hold negligent physicians accountable. We can expect to see increasing numbers of medical negligence cases involving laser skin treatments as more practitioners enter the field.
is an EAGLE member of WSTLA and he practices in the areas of medical negligence and products liability. He was a bio-medical research scientist and he has a Ph.D. in biology. His scientific research included laser and ultraviolet light microbeam experiments on organelles within single cells. He is of counsel at Chemnick Moen Greenstreet.
Medical Negligence, Legislation and Legislature, Medical Negligence, Technology Roger J. Leslie 43-10 June 2008