Medical Spa Lawyer
Paddy Deighan, the Premier Medical Spa Lawyer

Aug
19

I am frequently asked to comment on the distinction between what is medical and what is aesthetic (non-medical)….the lines are blurry but in my opinion, they are being violated on a daily basis. The practice of medicine is relatively easy to define….it is the diagnosis OR treatment of a medical condition.  Good, bad or indifferent, acne, rosacea, eczema are medical conditions. Some things may not be as clear…for example, treating “razor bumps” MAY not be medical, but on the other hand, those “razor bumps” are 

Pseudofolliculitis barbae  and then they would be medical. Frustrating…I know.

Additionally, the next level of analysis would be whether any medical device or product is being utilized in the treatment and of so, what federal classification is the device. Virtually all aesthetic lasers AND IPLs are Class II or Class IIb medical devices and they have to be owned and operated by licensed physicians (not RNs). Physicians may, in certain circumstances, delegate “operation” (but not ownership) to other individuals.

Botox

Many products are medical…Botox Cosmetic is a prescription drug…100% medical. The dermal fillers (Restylane for example) are all medical PRODUCTS (not a drug). They are still 100% medical but for a different reason.

In laser, you can look at two different types of scenarios…let’s use laser hair removal and the treatment of leg veins.  Laser hair removal is NOT a medical procedure. However, if the patient is hirsute because of polycystic ovary syndrome (PCOS), then it IS medical.  In this situation the treatment may not be medical but the device IS medical. Hence, laser hair removal IS medical.

Treatment of leg veins…this is both a medical treatment and a medical device. Two reasons not to perform this service.

With peels, it gets REALLY complex…one analysis would be to look at FDA guidelines. In 1996 the FDA concluded that “medical” is a product that penetrated the epi-dermal/dermal junction. They concluded that a 30% glycolic treatment achieves this. Prior to 1996, they mandated that a 40% glycolic solution achieved this. But what 30% glycolic? pure 30%, neutralized or buffered 30%?…remain unanswered. Soooo, if you utilize a 40% glycolic solution but you know that it is neutralized or buffered, then you are probably OK.

Jessner’s peels and most TCA peels are mid-to high level strength peels and they are medical. Sal acid is non medical unless in high strengths….hydro quinones are non medical if they are under 2%…we could go on for hours…topical anesthetics can be medical or non medical too…depending upon the strength and formulation (this is actually a HUGE issue)

The problem is that regulation comes in the form of….state statutes, state and federal case law, federal mandate (FDA, FTC), state boards of medicine, cosmetology and nursing, Attorney General reports and cases…WHEW. There is no ONE place to look!

Recently, there was a discussion and an esthetician commented to me that she contacted her state board in NH. They said that as long as she was certified, it was OK for her to perform the procedure (I do not recall the specific procedure, but on its face, it was medical …blade or syringe was utilized if I recall). That may have been true by NH board purposes, but federal law would disagree and Federal law trumps state law.

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

Jul
11

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance. 

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

 


The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine. 


Just because a product is marketed to you, does not mean that you are legally permitted to use the product or servoce. The laser companies would gladly sell a laser to my dog Stoli if he would pony up the money!!

Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com

Feb
24

Virtually every day, there is a story about something that we cannot eat or drink…or DRIVE. I am a car fanatic and when I travel to Europe, I see all of the fuel efficient and cool cars that we cannot have because of our burdensome regulations – Citroen, Alfa Romeo, Peugeot, Renault (most are French, perhaps THAT explains it – LOL), Opel (owned by GM) and Ford of Europe and Australia (will not export many types of cars to the US market). The Ford Falcon is still being produced…but not for use in the USA.

Anyway, I read on the internet today that NYC has now banned the delivery of 2 liter Coca Cola with PIZZA delivery. Hey, Bloomberg, guess what ya clueless bureaucrat, PIZZA ain’t real healthy either! Why don’t you ban delivery of that too? Eateries are now banned from serving soft drinks in a size larger than SIXTEEN ounces in NYC. Bloomberg has taken action against salt, sugar, trans fat, smoking and baby formula. While these may be noble causes, this is AMERICA and we are allowed to be unhealthy.  We are allowed to be a lot of things and it is not the government’s role to regulate BEHAVOIR!!

Coca Cola

Does this idiot think that DIET Coca Cola is healthy??? Many suggest that is may be unhealthier than regular Coca Cola…but in any event, who are these bureaucrats that keep ramming this stuff down our throats (pun intended). THIS IS AMERICA, and AMERICA is SUPPOSED to be synonymous with “freedom of choice”. Coca Cola has Ryan Seacrest as a spokesperson…is wholesome, pure Ryan Seacrest advocating bad behavior? Would he be beanned from drinking it in NYC?

I have stated it before and I will state it again…it is not the politicians’ fault that these things happen; it is OUR collective fault for electing these well-intentioned, but delusional idiots. Nothing will change until we have a better quality of politician…and who would want to run the way the media eviscerates anyone short of Mother Teresa (God rest her soul). Oops, I said “God”…now the media will eviscerate me for writing a religious blog…

 

Paddy Deighan J.D. Ph.D

http://www.homesavers.pro

http://www.medicalandspaconsulting.com

 

Jan
19

I was minding my own business working out. The TV was on HLN and I was watching a Jane Velez piece on a University of Wisconsin-Madison study. In these experiments, baby monkeys are separated from their mothers right after birth and later subjected to scary tests to provoke fear and anxiety. The monkeys are then killed and dissected and their brains are studied.

Wanna know the truly scary part. WE ARE PAYING FOR THIS!!!  It is a federally funded study!!!

As a scientist, let me make the conclusion for these hapless researchers. Taking a baby monkey (or any animal) away from its mother at birth and then subjecting it to fear will cause what reaction???? Hmmm, lets cypher on this one (a la Jethro Bodine)……Hey, I got it!!! HOW ‘BOUT NOT A GOOD REACTION!!!!

THERE, you idiots just saved millions of taxpayer dollars.

Kinda reminds me of when I was asked to comment on a Michigan State study. They spent one a and a half years and millions of taxpayer dollars studying the effect of obesity upon diabetics in the Puerto Rican community.

My response: “Ladies and gentlement thank you all for coming,,,,as you know, Michigan State spent millions of dollars and one and a half years studying the effects of obesity on diabetics in the Puerto Rican community…I will summarize the results: “IT DOESN’T HELP” Thank you all for coming!!! LOL

 A doctor in NY still has not spoken to me years after that presentation!!

 

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

Jan
16

Lance Armstronmg is all over the news…what he did was a disgrace to himself and our nation. However, he has done a lot of good for a lot of people. That part is genuine and true.

Here is the part that I do not understand. The United States Postal Service is running in the red to the tune of BILLIONS of dollars per year, YET, they have spent $30 million sponsoring Armstrong’s racing team??? WHOA!! What benefit is there to the USPS in sponsoring a cycling team?? How about NONE, zero, natta??

The USPS closes 10% of its locations during the past two years yet they are sponsoring a CYCLING team??  While I am on the subject, they closed 10% of their locations but did not lay off ONE person!!!! Small wonder they are running in the red!!!

Paddy Deighan J.D. Ph.D

http://www.homesavers.pro

Jan
14

Ethical Considerations in an Aesthetic Medical Practice

There is no question that aesthetic medical providers face a higher risk of professional liability. Aesthetic medical providers take great care in selecting appropriate liability insurance coverage. However, it is equally true that such providers also face a greater risk of ethical allegations and they can come from a variety of sources (unlike liability that typically stems from the provider – patient relationship). Ethical allegations can result from advertising or conduct unrelated to your practice of medicine. Additionally, aesthetic medical patients have higher expectations from aesthetic medical procedures and they demand a higher level of outcome and expectation. If they do not receive their expected outcome, it is your fault!! Many attorneys that represent disgruntled patients in a professional negligence matter will suggest that the patient file ethics violations first. If there is a finding of ethical violations from the state, the attorney will utilize this finding to allege negligence in the liability claim.  Attorneys can argue that it is “unethical” to utilize a medical device or product in an “off label” manner. Virtually every aesthetic medical provider utilizes medical products and devices in an “off label” manner (Botox Cosmetic, dermal fillers and many laser procedures are examples). The attorneys will instruct the client/patient to file the ethics complaint that alleges that the treatment was “off label” and therefore unethical, per se. Accordingly, aesthetic medical providers are at a higher risk of ethics complaints than their traditional medical colleagues.

I have discovered that most aesthetic medical providers are not clear on what they should do if they have an ethical situation.

The first consideration in this discussion is patient selection.  If your instincts tell you that a particular patient may expect too much or have unrealistic expectations, do not treat them!  I advise providers that “it is not the patients that you treat that will make you successful, it is the patients you choose NOT to treat that will make you successful.” Marketing 101 dictates that it takes 10 successful patients to get one referral but it only takes one disgruntled patient to lose 10 patients. Many ethical issues arise out of unrealistic expectations of the patient. Avoiding certain patients from the outset will substantially lower your risk of ethical allegations. Patients complain to a medical board because they are not happy in the result and of course it is the provider’s fault.

In regard to patients, document EVERYTHING in the chart…and document proximate to the time of the discussion with the patient. Do not document a chart a week after the patient discussion!

The next significant source of ethical situations is advertising.  We can devote an entire series on this topic, but for the purposes of this article, understand the advertising and issues are highly correlated.

Finally, ethical situations can arise from conduct in your personal life that is entirely unrelated to the practice of medicine. Even Driving While Intoxicated charges have resulted in providers facing the state medical board. The trend is toward more scrutiny.

There is a global ethical issue that many aesthetic providers fail to consider and it can be very damaging.  I will state in advance that this seems totally unreasonable, BUT you have a duty to disclose to your state medical board and certification board any conduct which may become an ethical issue in the future. If something occurs in the office that MAY put you in an ethical conundrum, you have to report it. Failure to report it can give rise to additional sanctions or loss of board certification. Affirmatively reporting also decreases the risk of severe sanctions for alleged unethical situations because you cooperated in advance.

I strongly recommend that whenever you feel that you are in an ethical conundrum, write to the state medical board and ask for their guidance.

This is very powerful.  They cannot charge you with an ethical violation if they participated in the course of action! They may choose not to respond to your query, but the fact that you sought their guidance and counsel is very compelling.

So, What DO I Do When I am Notified of an Ethical Investigation?

If you receive a letter from your state board licensing board, pay strict attention to the action items that the board is requesting. The boards typically ask for a response within ten days.  I suggest that you formulate an initial response that acknowledges receipt of the allegation and tactfully denies that any unethical conduct was conducted.  Also indicate that your initial response is a preliminary one. You will provide a more thorough reply after you review the chart and interview any staff members that were involved in the patient care. I should also mention that any of your staff can create unethical situations and the medical provider is responsible for these too. Everything stated in this article pertains to the medical providers and staff since you are responsible for their conduct. An example of provider ethical liability for a staff member is when a staff member divulges confidential information.

I suggest that you send a definitive response about thirty days after your initial reply. Do NOT wait for the state board to ask for the additional response. The definitive response will include your version of an incident as well as any supporting documentation. It is important to interview staff members that may have engaged the patient and include a summary of their version of the incident. The fact that you thoroughly investigated the matter prior to response will go a long way toward a successful outcome. It is prudent that you do not say anything negative about the patient!  Remember that if the patient has anger issues, unrealistic expectations or other psychological issues, you should not have treated them! Refer to the disgruntled patient with empathy and respect in all of your correspondence.  Express sorrow that the patient feels that something unethical occurred.

You may not receive any additional correspondence from the state licensing board for a long period of time (a year is not unusual).  This does not indicate that the board is no longer pursuing the matter. The entire process can take up to three or four years. It is also prudent to hire an attorney to represent you. Many physicians indicate to me that they are afraid to hire an attorney because it may appear that they are guilty.  There is nothing further from the truth. There are procedural guidelines and rights that you have and it is proper to hire an attorney to represent you. The state boards expect this and it is the responsible thing to do.

ethics_6d7x

 

 

Another aspect of ethical allegations is that you have a duty to report the allegation to your certification board and most organizations to which you are a member.  The certification boards require this as a condition of your board certification or membership. Failure to report alleged ethical violations will frequently result in loss of board certification!! This also applies to member organizations such as the American Society of Plastic Surgery (ASPS) or the American Academy of Dermatology (AAD). In fact, if you read the regulations of certification boards and member organizations, you will see that you have to report a wide variety of events such as Driving While Intoxicated or alleged insurance fraud from even a home owner’s insurance claim.

In order to comply with the licensing board or member organization requirements, you only need to send a letter that indicates that an allegation has been made against you and that you are appropriately responding to the allegation and that you believe there is no merit to the allegation. You will probably never hear from them again, but you will have complied with the requirements for certification or membership. Most of your colleagues have not complied with these notice requirements, and if you do comply, there is a much greater chance that nothing will happen to your certification or membership.

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

 

 

Jan
01

Everyone has a system…professional gamblers have a system…anyone directly in sales has a system that they must follow. However, most medical spa professionals do not have an organized, structured system. I have developed what has been working exceptionally well for me.

I designate 1-2 hours each day on SEO and networking. I refer to this as “BLETWORKING” because it involves my blogs. Many people advocate doing this first thing in the morning. MY sustem is that I do this late at night because this is peaceful time. The phone is not ringing; the TV is not blarring; I put on my favorite music and away I go. I will state at this point that I do the blogging myself. Many delegate this to a trusted employee but I feel that it must come from me. I do delgate posting the blogs to other websites and social neworking sites to staff members.

Here is the system:

1. First, I write a blog and upload it to <a href=”http://blogger.com”>Blogger</a&gt;. I then copy and paste the blog onto my <a href=”https://plus.google.com/u/0/115846738448091297386″>Google + account</a> and also my wordpress blog. This enhances my exposure and takes little time.

2. Then I share the blog on <a href=”http://www.linkedin.com/profile/view?id=13844343&trk=hb_tab_pro_top”>LinkedIn</a&gt;, my FaceBook business page, Twitter and Google + and my <a href=”https://medspalawyer.com/”>Wordpress account</a>

3. Next, I upload the blogs into multiple Twitter accounts that are specific to certain areas of the medical spa industry – Twitter accounts designated for medical spa lawyer (@medispalawyer), med spa attorney(@medspaattorey) , health lawyer (@healthcareEsq) and (@healthlawyer2) and medical spa consultant (@medicalspaconsu)

4. Then I add them to Tweet Adder and allow the automated system to tweet the blog throughout the day from all three sites (Google +, Blogger and WordPress).

This entire process takes 1-2 hours only and I can do these things at my convenience.

This process has become my #1 method for obtaining new clients in all of the categoties listed above!!
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<a href=”http://medicalandspaconsulting.com”>Paddy Deighan, J.D. Ph.D</a>

<a href=”http://www.medicalandspaconsulting.com”>http://www.medicalandspaconsulting.com</a&gt;

 

Dec
23

HAH, didn’t think that it was possible to enjoy Christmas cookies in a reasonable manner did ya?? Well, there is one way that I have found that really helps. Celestial Seasons makes a variety of Christmas cookie teas. They not only taste like the cookies they mimic, but they smell like them too!! The whole house can smell like Christmas Sugar cookies by brewing this tea: Celestial Seasons Sugar Cookie Sleigh Ride Tea . There are many great flavors such as ginger bread and candy cane too. Of course there is always Starbucks Christmas blends too!

So, if you are trying to watch your calories but you want to enjoy the flavors of Christmas, these teas are the ticket. Disclaimer: This is not a paid endorsement for Celestial Seasons LOL

holiday_v2_CS_SCSR_3D

 

 

Paddy Deighan J.D. Ph.D

http://www.homesavers.pro

Dec
20

I know that we are inundated on a daily basis with SEO opportunities and opportunities to market our particular area of expertise. It is difficult to know which ones are out best options.  Today, I discovered one that looks promising and it is early enough to get a strategic opportunity with them.

The opportunity is from Zintro.com . It only took a few moments to complete a profile. An hour after I enrolled, I received a message on LinkedIn .  The referral  was from a very good contact with an immediate need for services that I render. The agent that contacted me was very relieved and I was obviously happy too. So it seems that Zintro is a worthy new option for many of us.  I suppose in these days of multi-level marketing and skepticism, I should disclose that I do not receive anything for mentioning them!! LOL  I do not receive bonus points, coupons for a free oven mitt or even a personalized eyeglass case from a referral to them!!

One of the things that I liked about the website is that there are unlimited opportunities to describe your area of expertise to maximize your exposure. You can literally fill in the fields with anything that you want and that enables you to focus upon a geographical area for example. Many opportunities such as this try and push you into pre-defined categories via a drop down menu.

Zintro must have decent SEO opportunity – at least with LinkedIn because I received the referral within an hour of uploading my profile.

It is a goal for many of us to optimize our time spent on SEO, Social networking and online marketing.  It may make sense to give Zintro a try. I already received a great referral and I hope that you do too!! Good luck, Merry Christmas and Happy New Year!!

 

Paddy Deighan J.D. Ph.D

http://medicalandspaconsulting.com

 

Sep
07

It never ceases to amaze me how many medical products are marketed for
use to the non-medical market.  There are
so many skin care products making outrageous claims and product manufacturers
making claims about their devices and all the while, marketing them to people who
cannot legally perform services with the device. This problem is more prevalent
today than ever before and this is counter intuitive since there has never been
more regulation in the health industry and the FDA has stepped up compliance.

 

I have previously written about skin care products that claim to alter
and repair DNA (this is really funny because it is so outrageous); other
products that claim to treat rosacea (even though when you read the package insert
it refers to treating “redness”) and devices that are marketed to the aesthetic
market when they are being offered to treat medical conditions.  Sometimes the problem is that the device is a
medical device being offered to non-medical markets. Other times the problem is
that the device is treating medical conditions or the use of the device is such
that it constitutes the practice of medicine.

 

I was reading Day Spa magazine today and I ran across an advertisement
that I have seen for MANY years. It was for the Lamprobe. Interestingly enough,
I met the owner about ten years ago and asked how he is marketing the device to
the non-medical market. He had an unsatisfactory answer.  It is not my intention to malign any
particular product, but this one typifies the problem.

 

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol
deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia.  Very interesting. An esthetician can treat
NONE of these proposed uses.  How can
this product be ethically marketed to the non-medical aesthetic market when the
user cannot legally perform the treatments?
Virtually all of these proposed uses are outside the scope of license of
an esthetician and they are clearly and squarely within the parameters of
medicine.

 

Paddy Deighan JD PhD

http://www.medicalandspaconsulting.com