Medical Spa Lawyer
Paddy Deighan, the Premier Medical Spa Lawyer


A bit off-topic but important nonetheless. Thousands of years ago, as far back as 3000 BC, the ancient Egyptians had developed a highly advanced system of writing using hieroglyphic symbols.

The used hieroglyphs for numbers as well.

A single line, for example, represented the number 1. Two strokes represented 2. Nine strokes for the number 9.

Since the Egyptians had not yet invented the “zero” in 3000 BC, representing the number 10 required a new symbol– a sort of upside down horseshoe.

So the number 99, for example, required eighteen different symbols: nine upside down horseshoes for the number 90, and another nine strokes for the number 9.

There was another symbol for 100, another for 1,000, and so forth.

The largest number in ancient Egypt was 1 million. As historian Will Durant wrote,

“The sign for 1,000,000 was a picture of a man striking his hands above his  head, as if to express amazement that such a number should exist.”

Today the national debt in the Land of the Free is just shy of $20 trillion.

It makes me wonder what symbol the ancient Egyptians would have used to represent such an absurd figure. Hope and change?

Even the concept of trillion is difficult for our minds to fully grasp as there is very little within our physical human experience which relates to it.

“Trillion” almost seems like a fantasy… a made-up number like “a bajillion” or “zillion”.

And yet, the debt is very real.

Of course, we’re told that the debt isn’t important.

Modern “experts” who win our society’s most esteemed prizes for intellectual achievement tells us that the debt doesn’t matter “because we owe it to ourselves.”

This is pitiful logic.

It’s true that “only” $6 trillion– 30% of US debt is owned by foreigners.

The rest is owned primarily by the Federal Reserve, Social Security trust funds, US banks, large US companies, and the federal government itself.

But I fail to see how this is relevant. A debt owed is a debt owed.

It’s not like the US government could simply default on the Federal Reserve in cavalier fashion; that would render the central bank completely insolvent and cause a major currency crisis.

Defaulting on the trillions of dollars owed to Social Security and other pension funds would effectively destroy the livelihoods of hundreds of millions of people.

Defaulting on the debt owed to banks in the United States would cause the biggest financial crisis in US history.

Defaulting on the $1+ trillion owed major US corporations would bankrupt a number of large businesses and cause a deep recession.

And defaulting on the Department of Defense would simply be idiotic; Congress would have to immediately bail out the military with emergency funds.

So it’s difficult to find any comfort in this “we owe it to ourselves” nonsense.

The truth is that the debt absolutely matters.

It’s not some casual rounding error; it’s a major issue that already sucks up hundreds of billions of dollars in tax revenue each year just to pay INTEREST.

And that’s at a time when the government’s average interest rate is just 2%… an all-time low.

But now interest rates are starting to rise from their historic lows.

The 30-year bond yield is proportionally 50% higher than its record low from just nine months ago.

It wasn’t even that long ago, just prior to the financial crisis in late 2007, that the government’s average interest rate was around 5%.

And even that number was considered incredibly low compared to previous decades.

Yet if the average interest rate returned to just 5% (which would still be FAR below the historic average), the government would spend more than $1 trillion each year just to pay INTEREST.

Naturally they’d have to borrow even MORE money, which would add even more to the debt and make their interest payments go up even more.

History is full of examples of debt bankrupting dominant superpowers, going all the way back even before the ancient Egyptians.

This time is not different.

Debt is a ticking time bomb. And in this case, given the widespread consequences across the world, the bomb is nuclear.

But it is incredibly foolish to ignore such a prodigious risk.

Imagine there’s literally a nuke sitting on your desk right now; you don’t know when it will go off… probably not for several years at least.

But would you honestly stick around to find out?

Sure, maybe by some miracle the situation will resolve itself. Maybe every foreign government wakes up tomorrow and simultaneously forgives US debt.

We can hope for the best.

But you won’t be worse off taking astute, conservative steps to distance yourself from such obvious risks… steps that make sense no matter what happens (or doesn’t happen) in the future.

Consider retirement, for example.

For many readers, you might still be decades away from retirement.

Given current data and trends, it’s entirely possible that the US government’s finances will have deteriorated into a default scenario by then.

Paddy Deighan


Health Risks Associated with Tattoos

Tattoos are an art, a way of self-expression. But if you’re not careful, they may also cause a string of health risks. This is why health authorities warn against the safety of getting tattoos, especially when tattoo inks are not heavily regulated by the FDA. Here are some health risks associated with applying tattoos to one’s skin.


  1. You may be allergic to ink or its materials.In May, NBC Newsreported that according to a new study conducted in New York City, 6 percent of respondents experienced skin problems more than four months after having tattoos applied to their bodies. Additionally, two-thirds of those who reported that they experienced rashes admitted to having allergies. Another study showed that red ink was linked to more rashes than other colors.
  1. You’re at risk for infections.The application of tattoos involves piercing the skin with a needle to inject colored ink below the skin’s surface, so you may be at risk for infections, especially if the parlor you’re getting a tattoo at is not clean. The FDA warns that dirty needles may pass infections such as hepatitis and HIV.

Dr. Marie Leger, a dermatologist at the New York University Langone Medical Center in New York City, also said that ink can also be contaminated by bacteria, which can pose a threat to your health. In 2012, an outbreak of skin infections spread in upstate New York, where a batch of grey ink which was contaminated with mycobacteria that caused Mycobacterium chelonae, was used. This type of bacteria is a relative of the mycobacteria that also causes tuberculosis and leprosy.

  1. You’re more prone to itching and redness from sun exposure.LiveSciencereports that according to a Danish study conducted in 2014, researchers found that 42 percent of tattooed sunbathers had adverse reactions, mostly due to sun exposure. Respondents reported swelling, itching and redness.

Additionally, when yellow ink is exposed to the sun for prolonged periods of time, the cadmium in the ink creates a reaction that can cause itching, redness and raised skin.

Not to mention that darker color tattoo ink will absorb more sun than natural skin tones and consequently, there is a greater risk of skin cancer.

  1. You may encounter difficulties getting MRI’s.The Huffington Postreports that those who sport tattoos may have problems getting magnetic resonance imaging exams, especially those with more black ink on their skin, because the ink contains iron oxide. In 2011, a case report showed that a professional football player’s black tattoo was “burned” while he was getting a MRI, and this resulted from electric currents forming in the iron in the tattoo ink.
  2. You may be at risk for nerve damage from carcinogenic nanoparticles found in ink. Health Impact Newsreports that according to a 2011 study published in The British Journal of Dermatology, nanoparticles can be found in tattoo inks, and black ink contains the smallest particles. The study also showed that some nanoparticles may be carcinogenic, or toxic enough to cause brain and nerve damage.

“Black tattoo inks are usually based on soot, are not regulated and may contain hazardous polycyclic aromatic hydrocarbons (PAHs). Part of PAHs possibly stay lifelong in skin, absorb UV radiation and generate singlet oxygen, which may affect skin integrity,” the study authors wrote. “Tattooing with black inks entails an injection of substantial amounts of phenol and PAHs into skin. Most of these PAHs are carcinogenic and may additionally generate deleterious singlet oxygen inside the dermis when skin is exposed to UVA (e.g. solar radiation).”

Paddy Deighan J.D. Ph.D


I have written many articles on what services are medical and which ones are spa.  Despite what appears to be a clear line, there is a lot of questions concerning this distinction. I respond to many threads on LinkedIn as they relate to this topic and I am a bit surprised at the misinformation and lack of understanding that medical treatments may only be performed in a “medical” environment.

Accordingly, I can add some additional thought to further clarify the distinction between spa and medical treatments.  If a product or service is such that the implements or device used in the treatment requires  or is recommended for sterilization, then the service is almost always medical.

I recently read a review of a micro-needling device.  The device suggested that the components be sterilized in an autoclave after use. This all but assures that the treatment is medical. If there is any possibility of infection or transmission of pathogens, then a treatment will be considered medical. You may recall from prior articles that I have written, that there are two many issues in regard to whether a product, treatment, or service is medical : 1). is the treatment or product intended to diagnose or treat a medical condition and 2). is there a medical device being utilized in the delivery of the treatment.

Professionals constantly say to me that the manufacturer states that the service or device is not medical.  The New Jersey in me would respond that it is not their license on the line when they state that.  From a more practical view, you can review the FDA position on a device.  Ask the manufacturer if the device is a Class II or higher medical device.  The FDA indication will be visible on the device packaging or the device itself. If the device is Class II or higher, it does not matter what the manufacturer is telling you – the device IS by its FDA clearance, a medical device.

In one instance, an esthetician advised me that her state cosmetology board advised her that it is acceptable for her to perform micro needling.  My response was that she needs to ask the medical board (or nursing board) and the FDA.  She will receive different answers from those entities.

As I am known to say…”the answer you receive depends upon the question that you as and with whom you inquire”.

Paddy Deighan J.D. PhD


The employee/Independent contractor scenario in spas and medical spas is very complex. The determination of whether a professional staff member is an employee or independent contractor is not easy to address. One thing that IS clear; the agreement that may be in effect is not the most significant issue. You can classify a professional staff member whatever you want to call them in an agreement, but this does not control the ultimate determination.


Many owners and professional staff want to be independent contractors but the reality is in many cases, the relationship is not sustainable. The Internal Revenue Service (IRS) has been looking at the spa industry more closely (possibly due in large part to tipping structures, but they are looking at the industry). The Service has been looking at many “tip” based businesses such as the taxi industry, restaurants and salons and spas.

The IRS has ruled sometimes that an independent contractor was really an employee because the business supplied TOWELS and LINEN! WOW!

A fundamental approach will be based on two key aspects of the relationship: 1. “control” over the professional staff members hours and days of service, and 2. requirement to utilize certain product lines or practice policies and protocols for certain procedures.

These are not easy issues to address because there are conflicting issues and goals. On one hand, the medical spa needs staff to be available during operational hours. It would be problematic to allow professional staff to decide the days and hours of service. However, providing schedule is a strong element of “control” over the staff member and this tends to be an employment situation.

The second issue is no less problematic.  A professional staff member may support a certain product line that is not offered by the facility. He or she may have a different protocol for a procedure.  The professional staff member may have his or her own protocols for a procedure – even something as seemingly straight forward as micro-dermasbrasion.  An ancillary concern is when there is a mixture of employees and contractors. The contractors may have more freedom to perform services and procedures and they deem appropriate and this can cause staff problems.

I address many such issues every day and please see my website

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.comMedical and Spa Consulting


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.


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


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


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



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


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


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.




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