Medical Spa Lawyer
Paddy Deighan, the Premier Medical Spa Lawyer

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

Jul
26

It seems that my blogs regarding esthetician injectors of Botox® Cosmetic and dermal fillers such as Restylane® and Juvéderm® have become a contemptuous topic of conversation. I received a call from a cosmetic surgeon in Texas and this prompted me to further elaborate on the issue that I have presented. Accordingly, I wanted to elaborate.

The first area of explanation is that there is no license in any state for a “medical aesthetician”. It is a term that was created several years ago to identify estheticians working in a medical setting (physician office or hospital). I have advocated that estheticians not utilize the term because it is arguably deceptive. The public (the clients and patients) would likely believe that a person utilizing this term has higher scope of practice and can perform more medically oriented procedures. The Federal Trade Commission (FTC) has addressed issues such as this in the past and it consistently maintains that utilization of such terms is deceptive to the public.

Additionally, in most states, the esthetician license is not recognized in a medical practice or hospital. Most boards of cosmetology maintain that a physician is not the appropriate supervisor for cosmetology. Accordingly, estheticians working in most medical settings are doing so under the physician delegation principles within the particular state.

States have varying regulations on physician delegation. Arguably in some instances and in some states, a physician could delegate any medical procedure to any individual. However, this rationale is based upon state delegation laws. Federal law would prohibit much of the conduct that we are experiencing in the medical aesthetics area. I hesitate to even utilize the term “federal law” in this regard because it is not so much a particular regulation or statute that is a problem. The federal issues are the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) that are at issue. The brief explanation of why estheticians and others are not able to inject Botox Cosmetic and dermal fillers such as Restylane and Juvederm is that in the case of Botox Cosmetic, it is a prescription drug and in the case of the dermal fillers, they are medical devices. Injectors are also utilizing syringes and exposing the patient to a potential for bleeding and these additional issues necessarily mandate that estheticians not inject substances.

http://www.medicalandspaconsulting.com