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Entries in : Medical Spa Legal (44)

Wednesday
13Jan2010

The "Donda West Law" is in Effect

On January 1st the State of California put into effect the “Donda West Law”.

For those of you who are not aware of the details behind this law, Donda West was the mother of the much controversial rapper, Kanye West (the one who went up on stage and made an a** of himself when Taylor Swift was receiving her award).

Cosmetic Surgery Times reports that in 2007, Donda West died a day after she underwent an 8 hour procedure for breast reduction, liposuction and a tummy tuck. The L.A. County Coroner stated that Donda died of "coronary artery disease and multiple post-operative factors due to or as a consequence of liposuction and mammoplasty." Apparently, the autopsy results showed Donda died of pre-existing coronary artery disease and “multiple post-operative factors” a day after the procedures. The surgeon who operated on Donda surrendered his medical license in April.

The Donda West Law prohibits doctors from performing elective cosmetic surgery without a physical examination and clearance from a medical professional. The law requires an “appropriate” physical exam within 30 days before a procedure and “written clearance” from a doctor, nurse practitioner or physician’s assistant before cosmetic surgery is performed.

"Clearance of a medical professional" is the confusing part of the equation. Apparently, the plastic surgeon who performed her procedure wasn't declared a "medical professional" in the eyes of the lawmakers. For those practitioners who are currently performing invasive and minimally invasive procedures (such as laser liposuction) in other States, if you are not doing so already, you may want to re-evaluate your pre-operative procedure to include a physical examination, blood work and possibly a sign off from the patient's PCP or cardiologist.

In the infamous words of the sergeant on the 1981 episodes of "Hill Street Blues", "be careful, it's a jungle out there"!

by AuthorPaula D. Young RN: Medical Spa | Filed in , | Tagged
Comment1 Comment | |
Monday
14Dec2009

Nu U Medical Spas Sued By Illinois State Attorney General

Attorney General Lisa Madigan has filed a lawsuit against the Chicago-area medical spas, Nu U Med Spas, for performing unapproved procedures without a physician's supervision and luring patients through deceptive marketing.

This looks like it started with an expose by local Chicago television news.

The seven NuU Medspas in the Chicago area aggressively promote Lipodissolve, a series of injections that supposedly will melt your fat away.

The ads talk about reduced inches with no knives, no tubes, and no pain -- a deceptive ad, patients say.

NuU does not tell clients that Lipodissolve is not approved by the Food and Drug Administration.

"There is no study out there that shows clearly whether it works and what specifically are the risks of it," said Northwestern Memorial Hospital's Dr. Michael Lee.

That's not a problem, said NuU district supervisor Laura Rowsey, formerly a modeling school sales manager.

"This is a soy-based mineral with amino acids," Rowsey said. "Bruising and swelling is like your worst case scenario with this treatment."

But doctors have seen a number of Lipodissolve complications.

Cynthia Sacramento, who went to the Lincoln Park spa, suffered painful scar tissue buildup around her injection site that will require surgery.

Dr. David Song of University of Chicago Hospital said the entire injection area will have to be excised.

Sacramento said she's devastated.

Even proponents say Lipodissolve is for treating pockets of fat, not for bigger weight problems.

NuU in Lincoln Park signed another former client, who preferred to remain anonymous, up for $2,400 in treatments on his belly.

"I think it's a big scam, a waste of money," he said. "The only thing that got thin on me was my wallet."

NuU sales people are pressured to meet sales goals and arrange for many clients to finance their treatments. The money is collected up front and NuU claims it's not refundable.

"Our goal was to get $15,000 a day," said former NuU spa manager Patti Feinstein.

Feinstein recalled how Rowsey scolded her for turning away a skin cancer patient saying, "You are not going to make quota if you don't sell," Feinstein said.

Records show her spa sold made more than $200,000 a month.

Ouch. You have to love how a reporter makes a point of stating that the Nu U spokesperson was fromerly a sales manager for a modeling school. Looks like another slap-down for Nu U Medspas. Madigan's complaint claims that Nu U Med Spas try to lure customers into buying "Lipodissolve, which is an injected therapy used to dissolve fat cells." Here's the full press release:

MADIGAN FILES LAWSUIT AGAINST CHICAGO AREA Nu U MEDICAL SPAS

Attorney General Alleges Nu U Performed Unapproved Procedures Without Physician Supervision And Used Deceptive Marketing to Lure Patients

Chicago — Attorney General Lisa Madigan today filed a lawsuit in Cook County Circuit Court against Nu U Med Spas for deceptively marketing and performing unapproved, unsupervised cosmetic treatments that caused some patients to experience extreme pain and lasting injuries.

“These procedures have yet to be thoroughly researched and sanctioned by the proper medical authorities,” Madigan said. “Despite lacking concrete scientific evidence, Nu U purposefully misleads consumers into believing that their medical spa treatments are safe and effective. I’m very concerned that the health and safety of Illinois consumers who visit Nu U Med Spas are at risk.”

The Chicago-based medical spa chain allegedly uses high-pressure sales tactics based on deceptive marketing claims to induce consumers into purchasing a series of medical and beauty treatments, including Lipodissolve, which is an injected therapy used to dissolve fat cells, according to Madigan’s complaint. Nu U allegedly claims its treatments will “liquefy fat quicker” and can “rid your system of that life long battle of the bulge,” but Nu U fails to inform consumers that its treatments haven’t been approved by the U.S. Food and Drug Administration (FDA) as safe and effective treatments. Both the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons do not recommend using Lipodissolve for fat reduction due to the lack of research that shows its effectiveness.

Further, because Lipodissolve is an injected treatment, it requires a physician’s order, but Nu U allegedly administers the fat-reducing treatment without a doctor’s order. In fact, despite its outward claims, Nu U allegedly fails altogether to monitor and evaluate patients by licensed physicians at all seven of its Chicago area locations.

Madigan’s complaint further alleges that the Nu U personnel rush consumers into signing contracts, medical consent forms and financing documentation for treatments but fail to review the documents with consumers. The defendants allegedly pressure consumers to sign up for health care financing but fail to inform consumers that by signing the financial documentation they are authorizing an automatic credit card charge. Nu U allegedly refuses to provide refunds when requested, even in the event that a consumer has not received all of the contracted treatments.

Madigan’s lawsuit charges Nu U with violating the Illinois Food, Drug and Cosmetic Act, the Illinois Medical Practice Act and the Illinois Consumer Fraud and Deceptive Business Practices Act. It asks the court to permanently enjoin the defendants from owning or operating medical or beauty clinics in Illinois and to order the company to pay civil penalties of $50,000, an additional $50,000 penalty for each violation committed with the intent to defraud, an additional $10,000 penalty for each violation committed against a senior citizen 65 years of age or older, and the costs associated with the investigation and prosecution of the lawsuit.

To be honest, this looks like some grandstanding on the part of the Attorney General. Lipodissolve is used in perhaps thousands of medical spas and cosmetic practices around the country without 'painfull scar tissue build up' and complications.

And what does it actually mean when. "Dr. David Song of University of Chicago Hospital said the entire injection area will have to be excised."? An entire treatment area excised from needle sticks? Seems fishy to me. Might well be something of a hatchet-job.

Anyone have thoughts on this?

by AuthorJeff, Medical Spa MD | Filed in , , , | Tagged , , ,
Comment5 Comments | |
Wednesday
21Oct2009

Medical Spa Lesson: The least recommend way for handling your medical spa PR problems.

Note: The identities that were in this post have been changed but the events are all as described.

A Medical Spa chain is not happy with what someone else has posted about them in the community forums of this site.

The negative comments are directed at one of the management team. I became aware of this medical spas concerns a few days ago after I received a string of emails from the medspa chain's 'CS Manager'. (Im guessing that CS is short for customer service.)

I can certainly understand why this medical spa is unhappy. Evidently the individual named in the comments was previously part of a failed franchise called Skin Nuvo and was one of three Skin Suvo operating officers who was sued by the SEC for 'Swindling investors of $11 million'. However, charges against the individual in question were dropped.

Here's an excerpt on the Skin Nuvo suit from the San Francisco Chronicle article:

Three men, including a Concord resident, were sued by the Securities and Exchange Commission on Wednesday on charges that they swindled more than $11 million from investors in a skin-care business that later filed for bankruptcy.

..."Skin Nuvo was projecting a glamorous image with their stores in very flashy and high-end malls, but beneath the surface, the company was in deep financial trouble," said Michael Dicke, an SEC supervising attorney.

Skin Nuvo, based in Henderson, has since filed for bankruptcy. During the alleged fraud from 2002 to 2004, the company's Bay Area stores -- which sold skin care and hair removal products -- were located in shopping malls in San Francisco, San Jose, Richmond, Concord, Corte Madera and Walnut Creek.

The SEC suit seeks to bar the men against any future violations of securities laws, a civil monetary penalty and the recovery of any ill-gotten gains.

So here's some of the emails that I received, and my response, over the course of the next three or four days. They start with an email from S.H. the CS (Customer Service?) Manager.

First email: S.H. of Nu U

Subject: Slanderous blog agiainst N.V./___ Medspa
Message: I need to speak with someone ASAP re: several slanderous remarks that have been made on your forum against N.V., owner of _____ Medspa.
Please contact me at 702-xxx-xxxx to discuss.

Thank you,
S.H.
CS Manager

My same-day response to S.H.:

Hello S,
What can I do for you?

S.H. want's to talk immediately. He's entirely too irate to just communicate that a comment may have gone over the line and violated Medical Spa MD's own terms. No, S.H. want's to talk. Now. Here's the next two emails:

Is it possible to call you?  Too much to put in an email.

S.H.

Jeff – there is a blog on your website re: N.V., owner of _____ Medspa.  The blog is dated 3/4/09 and is authored by “_____ Isn’t For You”.

The blog states Mr. V. only hires attractive females and then tries to date them / makes sexual advances towards them.  It goes on from there.

This is slanderous and libelous and a complete and total lie!  I am formally requesting this particular blog entry be removed immediately.  If you are unwilling to remove said blog then I will forward onto my legal department for further handling.  Please reply at your earliest convenience.

Thank you for your attention to this urgent matter.

S.H
CS Manager
_____ Medspa

I got another email amost immediately. Evidently my inability to grasp just how urgent this issue is and my lack of action in removing an anonymous post is getting under S.H's' skin. He dicides to forgo any more niceities and threaten me with his 'legal department'. Ouch. Here's S.H's next email.

This is slanderous and libelous and a complete and total lie! I am formally requesting this particular blog entry be removed immediately. If you are unwilling to remove said blog then I will forward onto my legal department for further handling. Please reply at your earliest convenience.

Have to give it to S, he's a silver-tongued devil. I mean, having an entire 'legal department' set on my like wild dogs? Terrifying.

So now I'm dealing with the 'legal department'. Here's what they sent.

Our firm, Kamensky Rubinstein Hochman & Delott, LLP, represents ___ medical spas.

Our client has informed us of various outrageous and defamatory blog postings/comments made on your website http://www.medicalspamd.com/ that impugn the character of Mr. N.V. of ___, specifically postings from "___ Isn't For You!" dated 3/4/09 and 4/10/09 and "former skin medique employee" dated 3/25/09.

In the March 4, 2009 posting, "__ _ Isn't For You!" falsely states that Mr. V only hires attractive females and then tries to date them or makes sexual advances towards them. In addition, "__ _ Isn't For You!" falsely states that if such sexual advances are not accepted, the employee does not get paid. In addition, in "__ _ Isn't For You"'s April 10, 2009 posting it falsely accuses __ _ of "multiple violations of state and federal labor laws, multiple instances of unwanted sexual advances and harassment." Similarly, "former skin medique employee" falsely states that Mr. V is "crooked," a "con artist," and "shady" and further falsely states that "if N.V. is involved . . . It is a scam from the word go."

This is not the type of content expected from a thoughtful website regarding medspas. Accordingly, we request that you immediately remove the postings posted by "__ _ Isn't For You!" dated 3/4/09 and 4/10/09 and "former skin medique employee" dated 3/25/09. We also request that you provide us with the names and all information in your possession relating to "__ _ Isn't For You" and "former skin medique employee."

Now isn't that nice? Within something like 72 hours we've progressed from a simple email request to this Medical Spas' demand that I turn over information on individuals who've made negative comments about them. This medical spa went from trying to get a single comment removed, to making the front page of Medical Spa MD. (Medical spas usually have to pay for that privledge.)

Of course this may not be the kind of publicity that __ _, S.H, and N.V wanted. I can't think that this medspa would really want the fact that one of their corporate officers was once sued by the SEC. But with the nasty-grams that S and his legal department are sending me it made me wonder what all the hubbub's about.

__ _ Medspa: Lessons for S.

Let me take a moment here and discuss what I think S could have done that would have better fit his medical spas business needs.

First: Don't take it personally. Every medical spa is going to have unhappy patients and ex-employees. You can't shut them up. Don't try. Perhaps they're unhappy for a reason. Your best bet is to engage in civil conversation. If you're making decisions on behalf of your medical spa or laser clinic, you need to keep your emotions out of the way. You're going to have dissagreements and sometimes they'll get personal. Don't let it affect your 'actions'. Medical Spa MD doesn't have any interest in harming this medical spa and no Medspa MD author wrote those comments.

But I wasn't responding fast enought to S and he took that as a slight. It wasn't. I don't know S and my first response, 'how can I help you', was an invitation for him to lay out his case. He didn't take advantage of that. Instead he lost focus on what he was trying to accomplish.

Second: Focus on your goal. Sean's goal was simply to get me to remove a comment. It's not unreasonable. I've done it before. I've removed any number of comments that attacked individuals in a way that had nothing to do with their business and was just an attempt to hurt them personally. I don't like those attacks and when I find them, I often remove them and at times, block an IP address so they can't make more.

S lost sight of the goal which was to get a comment removed. Instead, he switched his goal to getting to me. If he'd not been so agressive he'd probably have gotten the offending comment edited or removed. Instead, S pulled a gun by threatening me with his 'legal department'.

Third: Never pull a gun unless you intend to use it. S went nuclear when he had his 'legal department' fire off a demand. If S was smarter, he would have done his homework and seen that Medical Spa MD has been threatened many times by medical spa francises and their lawyers and knows well how to handel cyber-slap lawsuits. Read this Medical Spa MD post on cyberslap lawsuits, legal rights and anonymous comments on the web.

S went 'legal team' way, way too fast. I wasn't being unreasonable. I didn't tell him to 'go to hell'. It just wasn't at the top of my list of things to do. Medial Spa MD can get twenty or thirty contacts a day. I could care less that S demands to talk to me on the phone right away. Get in line. A single anonymous comment doesn't rise to the need of emergency care. S would have done much better with a simple, "I know you're busy" and a written explianation of his need to get a medspa comment removed.

__ _ Medspas legal team doesn't have a leg to stand on demanding information about people who comment on Medical Spa MD either. Anyone has a perfectly legal right to post anonymously on the web. Comments on Medical Spa MD are most commonly anonymous for exactly that reason. Physicians don't want to be held liable for the advice they give to other doctors, and laser technicians working at some laser clinic franchise don't want to lose their job.

Last: Never pull a gun on the person holding the mic. If you don't know what that means... From the begnning, S is making demands and acting pretty agressive, but he's only got one weak pair of twos (his 'legal team') and he plays them right away. Now he's got nothing left. If he's emailing some ex-employee that kind of intimidation might work, but not in this case.

By threatening Medical Spa MD and myself directly he's chosen to make an adversarial relationship when he needed a helpful one. While I don't have any axe to grind against S or __ _ Medical Spas, I don't really appreciate this kind of interaction. Any new threatening communications S or his 'legal department' they'll be posted right here on Medical Spa MD's front page where our 50,000 monthly visitors can decide for themseleves. (I can't think that any named Medspa's physicians will welcome questions about it.)

So where does that leave Medical Spa MD and __ _ medical spas?

For my part I'll put a quick notice up on the Medical Spa comments and take a look at them sometime in the next few days. If there's something that violates our terms, I'll edit or delete it.

I can't think that S has solved his Medical Spas business needs though.

by AuthorJeff, Medical Spa MD | Filed in , , , , , | Tagged , , ,
Comment6 Comments | |
Thursday
19Mar2009

1800LaserHair.com: Another laser clinic directory wannabe spamming Med Spa MD.

Ok, I'm more than just a little tired of some of the bull shit that certain laser clinic and plastic surgery directories spamming the site and posting positive anonymous reviews of their services and laser hair removal listings.

So, there are about to be some very public spankings.

Medical Spa MD has attained some popularity, and some clout with physicians running laser clinics. I receive regular iquiries from docs looking for advice on cosmetic lasers and I personally know of a number of doctors who have printed out reviews from Med Spa MD and asked cosmetic laser sales reps about them. There are laser companies who are now Medspa MD members and (to my current understanding) are welcome members to the community.

However, there are some cheap laser clinc and plastic surgery directories that think that you're an idiot and post comments like those below. (There've also been some physicians offering their 'expertise' as trainers who have tried this to promote their training.) Don't. You've been warned.

1800laserhair.com: I don't know if 1800laserhair.com is posting these comments as part of their corporate policiy or if it's just a rogue individual salesman who's doing it for them. I also don't care. My guess is that they're some small little hack job outfit. It pisses me off personal that whoever this is thinks that this won't be found out.

Here's an example of laser clinc directory, 1800laserhair.com who posted this rave review to Med Spa MD under the name Dr. Don:

I have the two Candelas yag alexandrite and a light sheer diode. I use a service tech that is awesome and reasonable. I can't remember his name right off but I got his name from this great referral network I belong to. Call 1-800 Laser hair ask for Nancy or go to their website WWW.1800laserhair.com There may be a link but I think I got the guys name directly from Nancy. His name is Robert something... BTW anyone slow or having advertising or marketing issues, I am getting tons of referrals from the 1-800-laser hair network. You have to meet their criteria, they are very picky and exclusive but if they will accept you join!!! Two colleagues of mine were denied I am not sure why. The leads are great worth every dime. I resisted their advice at first, them I put my wife in charge of all of it, she followed their program to the letter now we are so overwhelmed with calls for laser (Not really what I want to be doing but I better not complain because laser hair removal is supporting my practice through this crappy economy. Nice plug for them...tell them Dr. Don sent you...I may get some referral bonus!! LOL

Back to Laser Hair removal service. I don't have a service contract. Don't get them. I regularly get laser check-ups. Robert (the service guy) calls my office when he is in my area. By getting him in when he is already in my area he gives me a break on service costs. I get the check-ups and do preventative laser maintenance. Also Nancy (the 1-800 laser hair removal lady) gave me a monthly weekly and daily check list that tells us how to properly maintain our lasers in between service visits. I have not had a significant laser repair cost in 7 years and I haven't had to replace a laser yet going on 10 years. After we got our staff to follow the checklist diligently we saw a significant drop in repair costs. My staff was going through thousands of dollars worth of parts yearly and I was watching our profits go to Candela, I too despise them. They have terrible service and they have been so shady. I think they would sell their grandmothers if they could make a buck!!! Their service contracts are totally over priced. bad plug!!

I really don't use the light sheer much but I keep it for a back up, just in case. Robert can usually fly in for emergency repairs next day. So I have never really needed it.

Posted As: DrDon

Posted Email: wtawtawdba@yahoo.com

Posted Link: www.1800laserhair.com

Comment Posted From This IP Address: user-24-96-114-40.knology.net (24.96.114.40)

I have to laugh at these claims of exclusivity. "You have to meet their criteria, they are very picky and exclusive but if they will accept you join!!!" Sure.

If I were Candela I'd be contacting my legal department about now. This is a perfect case of liable; posting damaging comments as fact under an assumed name. Candella can't be happy that these laser hair removal guys are bad-mouthing them and servicing their lasers at the same time.

Does anyone fall for these laser hair removal guys? I'd be interested in hearing what any identified physician using 1800laserhair.com thinks about their "tons of referrals from the 1-800-laser hair network."

If anyone has an email from 1800laserhair.com that they have archived in their inbox, I'd be interested in seeing it since the IP address is included. We could compare the two. I'd expect that they change their IP address shortly if they happen to match.

PS: This IP address has been banned.

by AuthorJeff, Medical Spa MD | Filed in , , , , | Tagged , , ,
Comment3 Comments | |
Tuesday
17Mar2009

Doctor fined for injecting fake Botox in his med spa.

Some doc named Halliday in East Syracuse NY injected fake Botox into twelve of his patients and has now received a $20,000 find as put on probation for three years. He's also restricted to practicing medicine only when monitored by another doctor who periodically reviews his records. Nice.

Here's the article:

Halliday is an ear, nose and throat doctor who practices at 4939 Brittonfield Parkway. The state Board for Professional Medical Conduct charged Halliday with 10 counts of professional misconduct including gross negligence, gross incompetence, negligence on more than one occasion and incompetence on more than one occasion.

In a signed consent agreement, Halliday pleaded no contest to two negligence allegations that he failed to advise a patient of her treatment options and failed to obtain an adequate pre-operative history from another patient. The no-contest plea satisfied all the charges against him. The uncontested charges relate to the absence of documentation, said Charles Patton, Halliday's attorney.

"In consultation with me, Dr. Halliday considered the cost and time away from his patients, which defending himself against these allegations in a lengthy proceeding would require," Patton said. "He has elected to resolve this issue by consent agreement so that he might focus his attention entirely upon patient care."

In its statement of charges against Halliday, the board said he injected 12 patients in June 2004 with unapproved botulinum neurotoxin. That drug is made from the same highly potent toxin that can cause botulism, a severe form of foodborne illness. A purified version of the toxin is used to treat wrinkles. It affects the ability of muscles to contract, smoothing out frown lines to make them nearly invisible. Botox is the only type of botulinum toxin approved by the U.S. Food and Drug Administration.

The board said the version Halliday used was labeled, "For Research Purposes Only -- Not For Human Use."

In June 2005, Halliday wrote to the 12 patients and informed them the drug they received was unapproved and he was unaware of any patients who experienced harmful effects from it, according to the board.

Halliday ordered the botulinum neurotoxin from Toxin Research Inc., the board said. That Tuczon, Ariz., company sold the cheaper, unapproved Botox substitute to more than 200 doctors nationwide, according to the FDA.

Chad Livdahl and Zarah Karim, owners of the company, were convicted of fraud and misbranding a drug and sentenced to prison in 2006. Toxin Research Inc. sold the product to doctors from Manhattan to Las Vegas who learned about the drug at conferences put on by the company, according to the FDA.

UPDATE:

Medical Spa RX Beta is now online!

We've just launched our new international medical spa pharmacy program with the release of Medical Spa RX, a wholesale pharmacy in Canada that has the lowest price for Botox, Restylane, Juvederm and general products.

Please take a look and consider a test order. We're anxious to provide the very best service and quality through all of our partners and we'll welcome feedback around any issue as we look to imporve the quality of services and make Medical Spa MD the portal for physicians in cosmetic medicine. As part of the innovative services we're offering is the ability to lean on the more than 3500 medical provider members of Medical Spa MD for pricing breaks and special offers.

Among the many unique offerings is the ability to participate in a 'group buy' with group discounting... but wihout the need to organize or oversee the group. I'll be discussing this in detail as it grows.

Anyway, please take a look and consider a small order to test the performance and value. If you've got thoughts on ways to improve either site, please leave a comment below.

by AuthorJeff, Medical Spa MD | Filed in , , | Tagged ,
Comment1 Comment | |
Friday
13Mar2009

Massachusetts Medical Spa Task Force Report

Massachusetts has just delivered it's Medical Spa Task Force Report: Download it here as a PDF.

MA has launched a multi-party task force to recommend legal and oversight requirements for medial spas, skin clinics, laser clinics and for IPL and laser treatments.

EXECUTIVE SUMMARY

In recent years a new type of business enterprise has emerged, one that mixes traditional salon
treatments, like hair and nail care, with medical procedures like Botox B injections and laser skin  treatments. These so-called "medical spas" have proven popular with an aging population of baby
boomers and others seeking an expanded menu of services to enhance beauty, "restore" youth and improve self-esteem.

The International Spa Association reports that the number of medical spas in the United States grew
from 472 to 976 between 2004 and 2007, a 105% increase in just three years. No figures specific to
Massachusetts are available, but there is no reason to think that the growth of medical spas here is any
different from the growth nationally.

Medical spas combine many different licensed professions under one roof. This presents regulators
with the distinct challenge to create a regulatory structure that respects consumer demand and the free
market, but still holds p;blic safety as paramo;nt. How can the ~immonwealthe nsure that patients
receive treatment of whatever form only by professionals who are properly trained and licensed?
In the spring of 2006, Senator Joan Menard introduced legislation to create a task force to study this
issue. The bill, which was enacted as Chapter 81 of the Acts of 2006, provided for a Task Force
composed of representatives of the separate Boards of Registration in Cosmetology, Electrology,
Nursing and Medicine, as well as dermatologists, plastic surgeons, nurses and consumers.

The Task Force first met in November 2006, and began its work by conceptualizing the issue as a matter of determining three factors:

  • What procedures are at issue?
  • Who may perform these procedures, and under what conditions and supervision?
  • Where may these procedures appropriately be performed?

The Task Force heard from representatives of the spa industry and device manufacturers and received
overviews of the current regulatory environment from the various Commonwealth Boards of Registration. The Task Force also reviewed information from national organizations involved in the
industry and articles from the medical literature and surveyed what other states have done in this area.
At the conclusion of this fact-finding process, the Task Force set about addressing the three guiding
questions above.

A list of procedures, both traditional salon treatments and medical procedures, was developed, and the
Task Force adopted a three-tiered system of classification based on risk to the patient. Level I
procedures were defined as those strictly cosmetic in nature, such as hair and nail care. Procedures that
met the definition of the practice of medicine or nursing and that must be performed by a licensed
physician, or a nurse in collaboration with a physician, were classified as Level 111. Those procedures that are of an intermediate nature -laser hair removal, for example - are classified as Level 11, and the ; Task Force recommends a level of training for licensed professionals performing such procedures and defines the appropriate supervision for each. As a general matter, most Level I1 procedures would require a registered nurse or advanced practice nurse to perform them, although electrologists could
perform laser hair removal, for example. Recognizing that new procedures and devices used in medical
spas are being developed almost monthly, the Task Force also recommends creating a standing
advisory committee to periodically review new technologies and procedures and determine how they 4
should be classified and what level of training and supervision should be required for those licensed
professionals performing them.

Having thus determined the "what" and the "who," the Task Force next considered the "where,"
meaning what type of facility is appropriate for medical spa procedures and how those facilities should
be regulated. Ultimately the Task Force concluded that medical spa facilities should be licensed by the
Department of Public Health (DPH) in a manner similar to the way DPH licenses medical clinics.

nonmedicalOther facility-based issues were addressed, including segregation of medical procedures from procedures, ownership models and requirements, employment of clinical directors and the sale
of goods.

The recomme'ndations of the Task Force include draft legislation that defines various terms developed
by the Task Force to describe medical spa regulation. It includes authorization and direction to DPH to
license medical spas for renewable terms of two years, similar to clinic and nursing home licensure
already performed by the Department. The legislation also sets forth requirements and restrictions for
medical spa ownership, staffing and inspection.

Much of the detail for medical spa licensure and operations would be further defined by regulations to
be promulgated by DPH. The legislation includes authorization to the DPH Commissioner to issue
such regulations, and the Task Force report includes guidance for the Commissioner regarding what
the Task Force would expect the regulations to contain.

The Task Force also recommends creation of a new Board of Registration of Aestheticians, and
charging that Board with the responsibility of regulating the prof;tssion. Currently aestheticians are
licensed by the Board of Registration in Cosmetology, but during its deliberations the Task Force
concluded that the skin care practiced by aestheticiis was sufficiently distinct from the hair and nail
care performed by cosmetologists as to warrant a licensing board specific to aestheticians and their
practice.

Other recommendations include changes to Board of Registration in Medicine policies to no longer
classify laser hair removal as the practice of medicine, and to eliminate a ban on the sale of goods from
physicians' off~ces.

The Task Force hopes this report and its recommendations will serve as a model, not just for the
Commonwealth, but for other states, to establish a comprehensive, coherent and regulatory structure
for medical spas.

One final note: the Task Force agreed early on that its recommendations would be a matter of
consensus among the members, each of whom represent different professions, regulatory boards and
points of view. Throughout its deliberations, a remarkable unity of purpose, commitment to patient
safety and thoughtful - not overbearing - regulation was the common goal. The Task Force was, !<>
O however, unable to reach consensus on two issues: creating a new Board of Registration in Aesthetics
and a new Advanced Aesthetician license (see Recommendations 6 & 7). The Board of Registration in Cosmetology, which currently licenses and regulates aestheticians and their practice opposes creating a
new licensing board, believing it to be unnecessary, duplicative and potentially harmful. While the
Cosmetology Board has indicated support for an advanced aesthetician license in the past, it has not
yet voted to create one, and the Board's Task Force members opposed the education and training $7
requirements recommended in this report. A majority of the Task Force and most, if not all, of the
dozens of licensed aestheticians who regularly attended Task Force meetings, respectfully disagree.
The Board of Registration in Cosmetology intends to file separate comments on these matters with the
legislative committees designated by Chapter 81 to receive this report.

by AuthorJeff, Medical Spa MD | Filed in , | Tagged
Comment2 Comments | |
Wednesday
11Mar2009

Patient Gagging & Your Plastic Surgeon?

Medical Spa MD hosts anonymous comments. I made the decision to allow that after some careful thought when I first launched the site. (Of course, almost all comments on the web are anonymous.)

There are both benifits and drawbacks to anonynimity. With the number of cease and desist letters I've received I'm aware that not everyone is happy when they're pilloried in public by namless commenters. Here's a story from the AP on doctors who are asking patients to sign what amounts to a gag order befor they'll treat them.

The anonymous comment on the Web site RateMDs.com was unsparing: "Very unhelpful, arrogant," it said of a doctor. "Did not listen and cut me off, seemed much too happy to have power (and abuse it!) over suffering people." Such reviews are becoming more common as consumer ratings services like Zagat's and Angie's List expand beyond restaurants and plumbers to medical care, and some doctors are fighting back.

They're asking patients to agree to what amounts to a gag order that bars them from posting negative comments online.

"Consumers and patients are hungry for good information" about doctors, but Internet reviews provide just the opposite, contends Dr. Jeffrey Segal, a North Carolina neurosurgeon who has made a business of helping doctors monitor and prevent online criticism.

Some sites "are little more than tabloid journalism without much interest in constructively improving practices," and their sniping comments can unfairly ruin a doctor's reputation, Segal said.

Segal said such postings say nothing about what should really matter to patients — a doctor's medical skills — and privacy laws and medical ethics prevent leave doctors powerless to do anything it.

His company, Medical Justice, is based in Greensboro, N.C. For a fee, it provides doctors with a standardized waiver agreement. Patients who sign agree not to post online comments about the doctor, "his expertise and/or treatment."

"Published comments on Web pages, blogs and/or mass correspondence, however well intended, could severely damage physician's practice," according to suggested wording the company provides.

Segal's company advises doctors to have all patients sign the agreements. If a new patient refuses, the doctor might suggest finding another doctor. Segal said he knows of no cases where longtime patients have been turned away for not signing the waivers.

Doctors are notified when a negative rating appears on a Web site, and, if the author's name is known, physicians can use the signed waivers to get the sites to remove offending opinion.

RateMd's postings are anonymous, and the site's operators say they do not know their users' identities. The operators also won't remove negative comments.

Angie's List's operators know the identities of users and warn them when they register that the site will share names with doctors if asked.

Since Segal's company began offering its service two years ago, nearly 2,000 doctors have signed up. In several instances, he said, doctors have used signed waivers to get sites to remove negative comments.

John Swapceinski, co-founder of RateMDs.com, said that in recent months, six doctors have asked him to remove negative online comments based on patients' signed waivers. He has refused.

"They're basically forcing the patients to choose between health care and their First Amendment rights, and I really find that repulsive," Swapceinski said.

He said he's planning to post a "Wall of Shame" listing names of doctors who use patient waivers.

Read the entire article here

So... where to come down? The right to criticize and protect yourself, or additional protections for individuals who may be the recipient of negative comments.

Sona, Solana, Dermacare, medical spa frachises and consultants, RealSelf.com, Cutera, Thermage, Lumenis... these companies have taken some heavy hits around here from disgruntled docs. Would you want unhappy patient to have a high profile forum like this one that they could use to damage your reputation and business?

by AuthorJeff, Medical Spa MD | Filed in , | Tagged
Comment15 Comments | |
Wednesday
11Mar2009

Laser treatment? Skin clinic? Who's in charge here?

It’s happened in Florida and now in Massachusetts. State legislators and physicians are trying to establish some guidelines and laws to protect the public from sustaining injury by unlicensed or untrained service providers.

We’ve read the of the lipodissolve horrors where people are offering lipodissolve, laser treatments and botox in their garage for heaven’s sake! It’s hard to believe it has come to this, but cosmetic medicine has turned into a “cash cow” for anyone!

I’m getting so sick of the turf wars amongst doctors of which specialty should be doing what... I mean seriously... can’t you all get along? Instead of fluffing your feathers to establish dominance over cosmetic medicine you should ban together to eliminate the bottom feeders who are performing services in their garages to protect the practice that IS cosmetic medicine! These are the people who are ruining your reputations! The unskilled, the unlicensed, money grubbers (and yes, I am also including lawyers here!)!

Let us also not forget that nurses and aestheticians are fighting over positions as well. There’s no certifying board for aesthetic nurses, or medical aestheticians. Here’s a funny story... when I started our medical spa with my husband years ago, I contacted both the heads of the nursing board and the cosmetology board. Since I hold both licenses I asked if I was allowed to perform a facial. I was told it’s a gray area. The nursing board said I could, in fact, perform a facial under the direct orders of a physician if the facial were deemed medically necessary. What physician do you know who will write an order for a facial? What physician wants to manage facials, and waxing, and massage, and the products which are dispensed? The cosmetology board said I could not perform a facial because the practice isn’t licensed or inspected by the board.

Huh?

With the economy the way it is, it’s no wonder everyone is jumping on the “medical spa” bandwagon! I mean, it’s like an ATM machine with no fees and no penalties. The perspective boards are all looking at each other and wondering who’s responsibility it is to be monitoring them.

The time is now upon us where legislation will take precedence, once again, on how we perform medicine and who may perform it. The powers that be will decide for us exactly if IPL is a medical device, or not. If the removal of a sunspot or tattoo can be removed by a physician, PA or nurse. Who may do cosmetic procedures, what training they must have and what certifications must be obtained prior to plucking an eyebrow (I digress, but you get my point).

Although we agree that certain treatments be performed or directly supervised by a physician, the fact is, there are many other services that aren’t deemed medical in nature. Should a physician be controlling those as well?

No current board has jurisdiction over all professions within a medical spa or laser clinic so, most likely, a new board will emerge with regulations, standards and licensing fees to add to our current practice.

It will take a few years to establish a task force and develop legislation for most states. But when all is said and done, what will arise is higher fees for service for the client, more inspectors showing up on our doorstep, higher licensing fees and insurance rates, and less control, once again, on how we treat our patients.

Are you ready for another government agency to take control of YOUR profession?

by AuthorPaula D. Young RN: Medical Spa | Filed in , , | Tagged , , ,
Comment28 Comments | |
Monday
23Feb2009

Medical Spa MD is threatened with a lawsuit... again.

I received the following letter in the mail today from attourney Nancy Rader Whitehead who is  representing John Buckingham of Solana and Karla Keene who I've never even heard of that I know.

Evidently John Buckingham and Karla Keene have taken issue with comments that have been made about them in the Medical Spa MD forums and have hired a lawyer to threaten me with (gulp) personal liability exposure if I don't take down the comments they don't like. Here's the letter. I've reproduced it below in text.

Re: Defamatory Content on medicalspamd.com

Dear Mr. Barson:

   Please be advised that this firm represents John Buckingham and Karla Keene. Over the last several months, your website has included posting by various unidentified persons, who use the screen names "Burned," "Justcurious," "this should be good," "What a joke" and various other names. These postings contain defamatory, disparaging comments regarding Mr. Buckingham and Ms. Keene. Moreover, it appears that you have intentionally removed postings which contain favorable information regarding Mr. Buckingham and Ms. Keene. These actions by you could expose you personally to liability. We demand that you remove the negative comments, and refrain from allowing any further postings of inappropriate material regarding Mr. Buckingham or Ms. Keene.

Very truly yours,

Nancy Rader Whitehead

cc: John C. Buckingham, Jr.
     Karla Keene

Let's start here:

First, this isn't the first time that Medical Spa MD has been threatened with lawsuits, cease and desist letters, and phone calls from lawyers.

It seems that whenever someone doesn't like what people are saying about them in public, their first reaction is to try to back-door the platform that's being used to disseminate the information. These kinds of suits have become increasingly common as a way of combating free speech on the internet. It used to be that if someone said something unkind, it didn't matter that much since only a few people would hear about it. The net changed all of that and now someone who's unhappy with you or your business can be found by everyone so those who illicit alot of negative comments tend to have a rougher go of it. In this case John Buckingham and Karla Keene.

Let's look at their claims against Medical Spa MD:

From the nastygram above:

Moreover, it appears that you have intentionally removed postings which contain favorable information regarding Mr. Buckingham and Ms. Keene.

First, let me state this very clearly: To the best of my knowledge I have never removed a comment from Medical Spa MD that did not violate the Terms of Use for vulgarity, spam etc. (Spam is regularly removed.)  The accusation that I've removed any 'favorable information regarding Mr. Buckingham and Ms. Keene' is an utter falsehood, without merit of any kind... and untrue. It never happened. Not once. Not ever.

I have met John Buckingham. I spoke on a panel with him at an aesthetics conference, and I've met him at other conferences. I have never done business of any kind with him and don't have any axe to grind.

I don't even know who Karla Keene is.

These actions by you could expose you personally to liability.

This is a common tactic that lawyers use to intimidate. I've attached some information dealing with this further on in the post. Click the 'read more' link at the bottom to get a crash course on your rights on the internet but here are some crib notes:

Defamation
The law of defamation balances two important, and sometimes competing, rights: the right to engage in free speech and the right to be free from untrue attacks on reputation. In practice, the filing or even the threat to file a lawsuit for defamation has sometimes been used as a tool to shut down legitimate comments on the Internet.

John Doe Anonymity
Do you post to a public message boards or discussion areas on websites such as Yahoo, AOL or Raging Bull? Do you use a pseudonym, fake name or a "handle"? Has someone asked the host of the discussion or your ISP to turn over information about you or your identity? If so, then the John Doe/Anonymity section may answer some of your questions.
Topic maintained by Stanford Center for Internet & Society

Protest, Parody and Criticism Sites
The Internet, which offers inexpensive access to a worldwide audience, provides an unparalleled opportunity for individuals to criticize, protest and parody.

Question: May someone other than the person who originally made the defamatory statement be legally liable in defamation?

Answer: One who "publishes" a defamatory statement may be liable. However, 47 U.S.C. sec. 230 says that online service providers are not publishers of content posted by their users. Section 230 gives most ISPs and message board hosts the discretion to keep postings or delete them, whichever they prefer, in response to claims by others that a posting is defamatory or libelous. Most ISPs and message board hosts also post terms of service that give them the right to delete or not delete messages as they see fit and such terms have generally been held to be enforceable under law.

Question: Can an ISP or the host of the message board or chat room be held liable for
defamatory of libelous statements made by others on the message board?

Answer: Not in the United States. Under 47 U.S.C. sec. 230(c)(1) (CDA Sec. 230): "No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider." This provision has been uniformly interpreted by the Courts to provide complete protection against defamation or libel claims made against an ISP, message board or chat room where the statements are made by third parties. Note that this immunity does not extend to claims made under intellectual property laws.

Question: Must an ISP or message board host delete postings that someone tells him/her are defamatory? Can the ISP or message board delete postings in response to a request from a third party?

Answer: 47 U.S.C. sec. 230 gives most ISPs and message board hosts the discretion to keep postings or delete them, whichever they prefer, in response to claims by others that a posting is defamatory or libelous. Most ISPs and message board hosts also post terms of service that give them the right to delete or not delete messages as they see fit and such terms have generally been held to be enforceable under law.

So there's that. But wait, there's more:

We demand that you remove the negative comments, and refrain from allowing any further postings of inappropriate material regarding Mr. Buckingham or Ms. Keene.

I guess they're taking that tone for a reason but I certainly can't understand it. This is the first contact of any kind that I've received and If I were them I would have just asked. Perhaps they feel that a threat might work better than just asking nicely. I don't know. Whatever their concerns I don't think that this tack will serve them well. As far as I know, the bruhaha that once swirled around Solana was gone. I don't think that there have even been any recent comments about it. Perhaps that's part of the plan; wait for the activity to subside and then get the comments removed.

I love that last sentence about demanding that I 'refrain from allowing any further postings of inappropriate material regarding Mr. Buckingham or Ms. Keene". I guess that 'inappropriate' is defined as whatever they don't like.

Here's my offer; Provide me with something! Send me a list of the comments you want removed and why they're untrue and I'll look into deleting them if. Give me something. Don't just threaten to sue me. First, if you've been on the site you'll know that won't work, and second, having these public conversations is not in your best interest.

What to do? Here's my advice to John Buckingham and Karla Keene and anyone else in a similar situation. It's something I learned long ago in the days of stand up comedy in NYC: Don't ever argue with the guy holding the microphone. Ever.

It's good advice. Take it.

Read on for more information about these kinds of CyberSlapp suits and where the law comes down on free speech and other issues around this:

Click to read more ...

by AuthorJeff, Medical Spa MD | Filed in
Comment7 Comments | |
Sunday
18Jan2009

Laser Hair Removal in New Jersey

Via a comment via Andrew D. Swain, Esq.

In New Jersey, laser or IPL hair removal can only be performed by a physician, and the term physician is defined as a person holding a plenary license issued by the New Jersey State Board of Medical Examiners.

New Jersey has consistently recognized that the use of a laser or light based device on a patient’s skin can only be used by a licensed physician. The use of a laser or light based device in a physician’s office is regulated by the State Board of Medical Examiners.

The State Board of Medical Examiners reviewed prior inquiries to determine whether non-physicians can use laser or IPL devices for hair removal. According to published Minutes, the Board has determined that only licensed physicians can use such devices for hair removal. On June 20, 2003, the Physician Assistant Advisory Committee of the New Jersey Board of Medical Examiners expressly stated that laser hair removal can only be performed by a physician.

The June 20, 2003 minutes stated:

b. The Committee reviewed a fax from Wanda Cooper, Sona International Corporation inquiring (1) as to whether a physician assistant is considered a nurse and therefore subject to the ruling of the Board of Medical Examiners regarding Thermolase laser; (2) as to whether the Board of Medical Examiners governs the Physician Assistant Committee and (3) whether a physician assistant can perform laser hair removal under the direct supervision of a physician.

As to the first question, it was the consensus of the Committee that physician assistants are not nurses.

As to the second question, the Board of Medical Examiners governs the Physician Assistant Advisory Committee.

As to the third question,consistent with the determination made by the Board of Medical Examiners, physician assistants may not perform Thermolase laser hair removal as these procedures are deemed the practice of medicine and may not be delegated to a nurse or any other licensed health care professional other than a "physician".

A letter will be sent to Ms. Cooper so advising along with a copy of the statutes and regulations which govern the practice of physician assistants in the State of New Jersey.

On September 19, 2003, the Physician Assistant Advisory Committee of the New Jersey Board of Medical Examiners expressly stated that laser hair removal can only be performed by a physician, and that IPL photofacial or IPL procedures would be referred to the Medical Board to determine their position.

The Board stated:

c. The Committee reviewed a fax from Bryan A. Manhardt, PA-C, Allergy Asthma & Sinus Center, Somerville, NJ 08876, inquiring as to whether procedures for Microderm abrasion, Laser hair removal, IPL photofacial, Botox injections and Collagen injections can be performed under the supervision of a physician. The Committee determined, as to Laser hair removal and Botox Injections, consistent with the determination made by the Board of Medical Examiners, physician assistants may not perform these treatments as these are deemed the practice of medicine and may not be delegated to a nurse or any other licensed health care professional other than a "physician".

As to procedures Microderm abrasion, IPL photofacial and Collagen injections there is no policy statement from the Board of Medical Examiners at this time. A letter will be sent to Mr. Manhardt so advising, along with a copy of the draft proposal as it relates to these procedures which is not yet law.

d. The Committee reviewed a letter from Dr. Edwin P. Schulhafer, Allergy, Asthma & Sinus Center, inquiring as to whether nurses, physician assistants or nurse practitioners in the State of New Jersey can perform the following procedures: Laser hair removal; Laser skin rejuvenation; Endomology; Intense Pulse Light (not a laser but a visible light); Botox injections; Collagen injections and Microdermabrasion.

It was the consensus of the Committee that, as to Laser hair removal and Botox Injections consistent with the determination made by the Board of Medical Examiners, physician assistants may not perform these treatments as these are deemed the practice of medicine and may not be delegated to a nurse health care professional other that a "physician". The Committee has no jurisdiction over nurses and nurse practitioners. This inquiry will be referred to the Board of Nursing.

As to laser skin rejuvenation, Endomology, Intense pulse light (not a lser but a visible light), Collagen injections and Microdermabrasion, there is no policy statement from the Board of Medical Examiners at this time. A letter will be sent to Dr. Schulhafer so advising along with a copy of the draft proposal as it relates to these procedures which is not yet law.

On April 16, 2004, the Physician Assistant Advisory Committee of the New Jersey Board of Medical Examiners expressly stated that IPL devices used for hair removal can only be performed by a physician.

The published minutes from April 16, 2004 stated:

b. The Committee reviewed a letter from Jason Staback, PA-C, inquiring as to whether it is legal for physician assistants in the State of New Jersey to use IPL (Intense pulse light) device for the purpose of hair removal, made by Palomar. He stated that it is categorized as a category 2 device. It was the consensus of the Committee that a letter be sent to Mr. Staback advising based on the limited facts presented, consistent with the determination made by the Board of Medical Examiners, physician assistants may not perform laser treatments as these procedures are deemed the practice of medicine and may not be delegated to a nurse, or any other licensed healthcare professional other than a "physician". To the current time, the performance of microdermabrasion and glycolic acid peels have also been considered the practice of medicine but unlicensed personnel have been permitted to perform theses procedures under the supervision and direction of a physician . However, please be advised that the Board is further investigating this latter issue and obtaining opinions from appropriate expert professionals. If the Board promulgates a regulation in this regard in the future it will be noticed in the New Jersey Register. Mr. Staback will be so advised.

On September 17, 2004, the committee stated:

The Committee reviewed a letter from Thomas Geary, PA-C, inquiring as to whether a physician assistant in the State of New Jersey can perform hair removal, tatoo removal and resurfacing if the supervising physician is a D.O. The Committee determined that based on the limited facts presented, consistent with the determination made by the Board of Medical Examiners, physician assistants may not perform laser treatments as these procedures are deemed the practice of medicine and may not be delegated to a nurse, or any other licensed healthcare professional other than a "physician".

In New Jersey, a physician cannot delegate laser hair removal procedures, laser skin resurfacing, or laser skin rejuvenation, to a physician’s assistant, a nurse, or any other licensed healthcare professional other than a "physician", which is defined as a licensed medical doctor. This position was stated on October 21, 2005, May 18, 2007, and reaffirmed again in September 2007. See Minutes, Physician Assistant Advisory Committee, September 21, 2007.

As recently as January 15, 2008, the New Jersey Board of Nursing did not approve of a licensed practicing nurse to administer IPL therapy. The Nursing Board Minutes stated:

Re: Inquiry from Doug Doyle, Esq., questioning whether Licensed Practical Nurses may administer “intense light pulse” therapy.

The Committee reviewed the e-mail and an article regarding Intense Pulse Light Therapy (IPL). The article stated that “IPL systems work on the same principles as lasers in that light energy is absorbed into particular target cells with color (chromophores) in the skin. The light energy is converted to heat energy, which causes damage to the specific target area.”

The Board of Nursing does not have regulations regarding administration of intense pulse light. On November 16, 2004, the Board of Nursing discussed this issue and made a motion to refer the issue to the New Jersey Board of Medical Examiners concerning the use of medical light–emitting devices (Lasers).

Consistent with the Board’s decisions of November 16, 2004, the Committee recommends that Mr. Doug Doyle’s question be forwarded to the New Jersey Board of Medical Examiners for review and comments.

As of 2008, the New Jersey Board of Medical Examiners consistently has taken the position that the use of laser or IPL device is the practice of medicine.

You can search the website of the New Jersey Board of Medical Examiners to review meeting minutes to update the above research. http://www.state.nj.us/lps/ca/bme/minutes/bmemin.htm. And, you and your employer should consider consulting an attorney or the medical board in your state for further clarification.

by AuthorJeff, Medical Spa MD | Filed in , | Tagged ,
CommentPost a Comment | |
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