Laser Lawsuits

Deedra · October 18, 2013, 1:24am

Laser Lawsuits / From Skin & Allergy News:

Use lasers? Lawsuits soar when staff does the procedure

By: MARY ANN MOON, Skin & Allergy News Digital Network

10/16/13

Litigation concerning cutaneous laser surgery has surged in recent years, and the proportion involving nonphysician operators soared from 36% in 1999 to 78% in 2012, according to a report published online Oct. 16 in JAMA Dermatology.

For the most commonly performed laser procedure – hair removal – the proportion of lawsuits involving nonphysician operators is even higher. A “remarkable” 91% of the cases filed in the most recent year for which complete data are available were brought against nonphysician operators, said Dr. H. Ray Jalian of the division of dermatology, University of California, Los Angeles, and his associates.

"The overall trend in increased litigation for laser surgery is in part explained by greater numbers of nonphysician operators performing these procedures, in particular those practicing without direct supervision in ‘medical spas,’ " the investigators said.

Dr. Jalian and his colleagues searched a single legal database and identified 175 cases concerning injury arising from cutaneous laser surgery since 1999. Nonphysician operators included registered nurses, nurse practitioners, medical assistants, electrologists, technicians, aestheticians, and others.

Overall, nonphysician operators were sued in 43% of all cases. But this total is somewhat misleading, because that percentage has risen markedly over time. It represented 78% of all cases in 2011 and both of the two cases filed in early 2012.

Hair removal was the most frequent laser procedure involved in litigation. A total of 76% of the cases brought for hair removal–associated injury in 2004-2012 involved nonphysician operators. Again, this number is markedly higher when the data are categorized by time period: 86% of all lawsuits in 2008-2012 and 91% of all lawsuits in 2010-2012 involved nonphysicians performing laser hair removal.

When the data were analyzed by the location where laser procedures took place, the majority (64%) of cases involving nonphysician operators occurred at facilities such as spas and salons. Again, in more recent years (2008-2012), “nonphysician-operator procedures performed in ‘medical spas’ represented 77% of lawsuits,” Dr. Jalian and his associates said (JAMA Dermatology 2013 Oct. 16 [doi:10.1001/jamadermatol.2013. 7117]).

Clinicians also should be aware that almost all the malpractice cases arising from nonphysician operators’ negligence extend beyond the operator to his or her employer, be that a physician, a medical facility, or a spa.

By far the most common allegation against physicians was failure to supervise a nonphysician operator (27 cases), followed by failure to train or hire appropriate staff (23 cases).

The investigators noted that “the actual data likely understate the true incidence of nonphysician operator laser complications” since they were culled from the large legal database that excluded complaints that were handled outside the judicial system.

Laws regulating the use of cutaneous lasers vary widely by state, from edicts specifying that only physicians may operate lasers for hair removal (Maine) to no regulations at all on laser use (Nevada). Even when clinicians supervise so-called physician extenders, rules concerning the degree of supervision, protocol requirements, and employee training are ambiguous.

“Because laws and regulations are constantly evolving, it is imperative for [those] who use physician extenders to be up to date,” the researchers said.

Dr. Jalian reported no relevant financial conflicts of interest. One of his associates reported ties to Zeltiq Aesthetics, Cytrellis Biosystems, Unilever, and Allergan.

Copyright © 2013 International Medical News Group, LLC. All rights reserved.
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Bono · October 18, 2013, 3:12pm

More:

http://asdsa.asds.net/press-release/2013-laser-surgery-lawsuit-study.aspx

Full article:

ASDSA: Laser surgery lawsuit study highlights patient safety concerns
Oct. 16, 2013 Rolling Meadows, IL – A new study showing increasing numbers of lawsuits being filed against non-physicians performing laser surgery has important implications for patient safety, according to the American Society for Dermatologic Surgery Association (ASDSA).

The first-ever comprehensive study of laser surgery liability claims, published Wednesday in JAMA Dermatology, shows patients are filing more injury lawsuits in recent years when laser treatments are performed by non-physicians outside traditional medical settings.

Among other findings, the study shows that despite only one-third of laser hair removal procedures being performed by non-physicians – including registered nurses, nurse practitioners, aestheticians or “technicians” – they accounted for about 76 percent of injury lawsuits from 2004 to 2012. That number jumped to 85.7 percent in the time period from 2008 to 2012, with 64 percent of procedures being performed outside a traditional medical setting.

“This study is critically important in demonstrating to policymakers that laser hair removal is indeed a medical procedure and should be treated as such,” said ASDS/ASDSA President Mitchel P. Goldman, M.D. “Increasingly, electrologists, cosmetologists and other non-physicians are seeking the legal right to perform laser hair removal, arguing that these are not ‘serious’ procedures because they are cosmetic. The health and well-being of patients is at stake.”

ASDS surveys show that cutaneous laser surgery is growing in popularity in recent years. The ASDS Survey on Dermatologic Procedures shows dermatologic surgeons alone performed 1.68 million laser treatments in 2012 – up from 1.6 million in 2011. However, ASDS members performed 34 percent fewer laser hair removal procedures in 2012 – down to 318,000 from 480,000 in 2011.

In recent years, study authors said laser surgery – laser hair removal in particular – has been more widely available in medical spas, defined as “non-medical facilities offering aesthetic and cosmetic procedures.” The majority of laser treatments in medical spas are performed by non-physicians of varying certifications as permitted by state regulation, the study found.

“Whether a state legally defines laser hair removal or other laser procedures as the practice of medicine directly affects what types of patient protections are in place,” said Dr. Goldman. “Cosmetic medical procedure laws vary greatly from state to state, and that means so do patient safety protections.”

“Despite these trends and clear inconsistencies in state regulations, no study to date has quantified the effect of these practices on medical professional liability claims with regard to cutaneous laser surgery,” said co-author Mathew M. Avram, M.D., J.D., a member of the ASDS/ASDSA Board of Directors, in the study, “Increased Risk of Litigation Associated with Laser Surgery by Nonphysician Operators.”

Some states require physicians to assess patients before procedures are performed to make sure they are good candidates and do not have any pre-existing conditions that could be worsened by the procedure. Others specify training and licensure requirements for any individual performing the procedure. Still others require that a physician be onsite and immediately available during the performance of laser medical procedures.

Currently, only Georgia, Iowa, New York and Virginia explicitly consider laser hair removal to be outside of the definition of the practice of medicine. Thirty-three states define the use of lasers, including laser hair removal, as the practice of medicine. Many of these also consider the use of lasers to be the practice of surgery, which is consistent with American Medical Association and American College of Surgeons definitions.

“The remaining states leave the question of whether these procedures are the practice of medicine vague,” said Dr. Goldman. “It is this vagary that leaves the door open to allowing laypeople to perform procedures using FDA-designated prescriptive medical devices.”

The ASDSA Board-approved position statement asserts that the practice of medicine includes any act or procedure using a mechanical device, or displaced energy form of any kind, if it damages – or is capable of damaging – living tissue. This includes laser hair removal, with the exception of FDA-designated over-the-counter devices.

As such, these procedures should only be performed by appropriately trained, licensed physicians or appropriately trained licensed allied health professionals with a physician onsite and immediately available, Goldman said.

Full article:

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.

ofass · October 20, 2013, 3:36am

“By far the most common allegation against physicians was failure to supervise a nonphysician operator (27 cases), followed by failure to train or hire appropriate staff (23 cases).”

Sounds like it’s more about the regulations in the US rather an actual harm that is caused to people.
I bet most of those are freeloaders trying to get rich by claiming there was no physician to supervise the treatment.

I honestly don’t understand why they don’t do it like in Canada where it’s considered to be of cosmetic nature so you don’t need a doctor.

beate_r · October 20, 2013, 8:19am

In Germany it is almost impossible to sue a physician for his mistakes; it is a lot easier to to that with a cosmetician. Such special regulations are necessary, otherwise many medical treatments were simply impossible. What about other countries, notably the USA? Obviously such a legal situation would trigger statistical results like the above: meaningless without a close look to the background - the number of juristical relevant outcomes would not correspond to the actual quality of the outcomes. (Traue keiner Statistik, die Du nicht selbst gefälscht hast ) An attempt to bring hair removal completely under control of physicians?