Medical Spa Lawyer
Paddy Deighan, the Premier Medical Spa Lawyer

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

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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

Aug
15

Very interesting…..I do a lot of stem cell research in Russia and Ukraine and a lot of DNA research in Iceland…distressed real estate pays the bills since the grant from the Federal Govt stopped being paid in 2009…anyway….I am planning on being in Urkaine at the end of the month and one of the graduate students commented that I will be there for a day of prayer.

I inquired what that was since I am familiar with most Russian and Ukrainian holidays (and they have a LOT of them-LOL)!!  It was explained to me that in their version of elementary school and high school, the students go to school on September 1 and it is called the “day of prayer”. They dress in black and white and carry candles to pray for success in the new school year.

I was floored by this since if you tried to do that here, various organizations would file a lawsuit so fast your head would spin around like Linda Blair in the Exorcist.

It is really tragic that people have more freedom in previously Communist countries than we do in many regards.  Also realize that they have religious diversity there too…Orthodox, Christian, Jewish, Muslim…pretty much the same mix that we have and yet they are able top come together for a “Day of Prayer” in school. No lawsuits, no bitterness and hatred…traditions honored, not torn apart.

paddy Deighan http://www.homesavers.pro

Aug
07

Today was another interesting day….a client called and asked my legal and scientific opinion on deer placenta. Apparently, a raw food/vegan guru, David Wolfe is touting it as the next great nutritional supplement.  The client indicated that she does seem to have thicker hair and better skin after taking this supplement for over a year.  The first clue that this was quackery was that the “nutritional supplement” costs only $60 per month. Placenta extract (let’s call it what they really want to say, “stem cells”) is really expensive to formulate and the conditions under which placenta extract are formulated are extreme.  There is no way that a legitimate source of animal placenta extract can be formulated and sold at such a price.

 

Secondly, why deer placenta??  Websites indicates that deer are a “higher order” animal and that it is appropriate to harvest placenta from such animals for human consumption.  Well, folks, sheep is the closest animal genome to the human genome. Porcine (pig) is second. So, why deer??

Third, the FDA regulates any animal extract as a drug and these product s hawked by Ron Teeguarden and David Wolfe are not FDA cleared. The agency would shut them down in a minute if they knew about the claims made for these products.  Teeguarden and Wolfe never mention the words “stem cells” because they probably know that the FDA utilizes proprietary software to search for such products. They are trying to avoid scrutiny …and as well they should because they are selling products that would be regulated and they are making outrageous claims.

 

Fourth, the harvesting of placenta extract is expensive. It requires rapid lyophilization of the tissue almost immediately after extraction.  Again, this is costly, time consuming and logistically challenging. I can all but guarantee that these nutritional supplements are not lyophilized.

 

Finally, and legitimate product that is placenta based, would and should be stored in a cold environment.  The stem cells derived from placenta extract cannot get warm or hot. They do not necessarily need to be cold, but they cannot get hot or even warm. The products sold by Teeguarden and Wolfe are shipped in a normal manner and hence, they get warm or hot at some point in the manufacturing or delivery process.  Any active cells have been deactivated by the time a consumer ingests the cells.

 

Save your money folks and do not be sucked in by claims made by pirates such as David Wolfe and Ron Teeguarden.

 

Paddy Deighan, J.D. PhD

http://www.medicalandspaconsulting.com

Jul
26

The Illinois Attorney General has filed a lawsuit against Nu U Medical Spas in the Chicago area. The issues presented are remarkably similar to many medical spas owned by non-physicians.  This case should be a warning to many in the industry.

The suit alleges that Nu U utilized deceptive marketing and that it is performing unsupervised medical treatments.  One of the concerns was over the spas’ use of Lipodissolve to “melt” fat. There are many issues with the use of Lipodissolve but the lawsuit focuses upon the fact that it is not FDA cleared and many organizations such as the American Academy of Dermatology, The American Society for Dermatologic  Surgery and the American Society for Plastic Surgery do not condone use of the product.  There is little evidence to support its use and a lot of evidence that it does little, if anything.

However, the main issue that I want to discuss is one that affects many medical spas, especially the non-physician owned ones.  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. Many non-physician owned medical spas have non-medical personal injecting dermal fillers such as Restylane, Juvederm and Collagen without a doctor’s order. In fact, more often than not a doctor does not even see the patient prior to the procedure. In The Nu U matter, the Attorney General found that fact despite its outward claims, Nu U allegedly “fails altogether to monitor and evaluate patients by licensed physicians.”

Another interesting aspect of the case is something that I routinely blog about: The corporate practice of medicine. The Illinois Attorney General argues that the Nu U Medical Spas have violated the Illinois Corporate Practice of Medicine Statute. Forty-five of the fifty states have such statutes and they are violated openly and routinely.  These are serious statutes with severe criminal and civil penalties and I am at a loss to figure out why so many violate these statutes on a daily basis. Oops, I do know why…it is called profit!!

The Illinois Attorney General has filed a lawsuit against Nu U Medical Spas in the Chicago area. The issues presented are remarkably similar to many medical spas owned by non-physicians.  This case should be a warning to many in the industry.

The suit alleges that Nu U utilized deceptive marketing and that it is performing unsupervised medical treatments.  One of the concerns was over the spas’ use of Lipodissolve to “melt” fat. There are many issues with the use of Lipodissolve but the lawsuit focuses upon the fact that it is not FDA cleared and many organizations such as the American Academy of Dermatology, The American Society for Dermatologic  Surgery and the American Society for Plastic Surgery do not condone use of the product.  There is little evidence to support its use and a lot of evidence that it does little, if anything.

However, the main issue that I want to discuss is one that affects many medical spas, especially the non-physician owned ones.  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. Many non-physician owned medical spas have non-medical personal injecting dermal fillers such as Restylane, Juvederm and Collagen without a doctor’s order. In fact, more often than not a doctor does not even see the patient prior to the procedure. In The Nu U matter, the Attorney General found that fact despite its outward claims, Nu U allegedly “fails altogether to monitor and evaluate patients by licensed physicians.”

Another interesting aspect of the case is something that I routinely blog about: The corporate practice of medicine. The Illinois Attorney General argues that the Nu U Medical Spas have violated the Illinois Corporate Practice of Medicine Statute. Forty-five of the fifty states have such statutes and they are violated openly and routinely.  These are serious statutes with severe criminal and civil penalties and I am at a loss to figure out why so many violate these statutes on a daily basis. Oops, I do know why…it is called profit!!

http://www.medicalandspaconsulting.com

Jul
26

I recently blogged about stem cell applications and it is prudent to discuss an issue that applies to any new medical technology and advancements. The question is: “when can I as a medical provider, introduce new technology, especially if it is not yet FDA cleared”?

This is a very important question. The answer is difficult and there are never any guaranteed correct answers. The law in the USA is typically a moving target. For one thing, the law necessarily lags behind technology (in every aspect of technology – not just medicine). However, medicine is a bit different because we have the FDA to protect patients and provide a process for clearing products and services for treatment. The problem is that it is a time consuming process.

This discussion starts with the fact that the FDA does not have jurisdiction over physicians. It regulates devices and products and the claims that may (or may not) be made about them. The FDA cannot interfere with the physician’s “independent medical judgment”. Accordingly, physicians are free to utilize a product or a device in a manner that they believe will prove beneficial for a patient. They must uphold their Hippocratic Oath to “do no harm” and clearly, the physician should be able to indicate and articulate why the treatment or procedure was performed on a patient.

A physician should study the science and if he or she reasonably concludes that this treatment or product will benefit the patient within the physician independent medical judgment, then it may be acceptable to perform the treatment or procedure. It would also be beneficial to illustrate that peers are doing it as well to help indicate a standard of care for the particular use.

The problem with a new, non-FDA cleared treatment is the marketing of it. The internet has made it easier for patients to find you but it has also made it easier for the FDA to find you! It is tricky and difficult to market new technology, but as I am known to say, “There is always a way!”

Visit Me at http://www.medicalandspaconsulting.com