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Radiant Life Technologies - about whom I have submitted several complaints (see here and here) - have taken the unusual step of publishing their correspondence with the Advertising Standards Authority (ASA).
Publishing private correspondence is not something I would usually consider, even when it's already available elsewhere.
However, it would be a pity of the letters were to suddenly disappear. On this occasion, I think there's a decent public interest argument to be made in favour of preserving a copy of them. They're reproduced here under the "Fair Use" provisions of international copyright law.
There are five letters, not all of which are dated. The first of which is a letter from the ASA, notifying the advertisers of the complaint, and asking for a swift response. (One section of the letter is reproduced here).
"Please respond to the complaint. The CAP Code requires marketers to hold documentary evidence for their claims before submitting an ad for publication. Please give us all the substantiation and information you would like us to have. It is for you to decide what to submit, but we suggest you send us evidence that coMra-Therapy is a breakthrough treatment and evidence to substantiates claims about how the therapy works. We also need your comments on whether the identified claims in the Complaint Notification could discourage seeking essential treatment for serious medical conditions. We will be happy to receive anything else you think is relevant."
The reply comes from an unnamed "Attorney at the Supreme Court". Alas, which "Supreme Court" the "Attorney" is "at" is far from certain.
Nigeria, perhaps? I don't think the "Attorney" can be referring to the British Supreme Court. After all, over here we normally refer to our lawyers as "solicitors".
"Dear Ms xx,
My name is xx; I am the Legal Adviser of the company “Radiant Life Technologies” (RLT).
Ms xx has forwarded me your letter to her. I am responding to you on behalf of my client, RLT, and I wish to state the following:
My client has its residence in the E.U. and is bound by the laws and regulations of the E.U.. As far as I know, your organisation does not have jurisdiction over my client. Your jurisdiction has to do with the advertising space inside the sovereignty of the U.K.. My client does not have any disputes or any interest in any way whatsoever within the space of your jurisdiction.
However, there have been verbalised certain allegations against my client, allegations which cannot be left unaddressed.
The product RLT is trading has been gone through all the required by law procedures and has acquired the necessary by E.U. law certification along with the right to bear the mark “CE” on the product itself.
Furthermore, RLT has acquired a series of Quality Systems known as “ISOs”. Those Quality Systems were not mandatory but they have been acquired anyway, in order to ensure the final customer/user that the product is perfectly safe and performs as claimed. At the same time, the technology that led to the creation of the RLT product has been properly submitted and claimed as “patented technology”, according to international law.
The entire process above has been long and laborious and has been performed through my law offices and under my personal and close supervision. It is not the intention of anyone in RLT to repeat this process and to prove again what has already been established in front of the proper and relevant E.U. authorities.
As far as discouraging people from seeking medical treatment for serious conditions, my legal thesis is the following:
According to the international law, as accepted and implemented by the United Nations, one of the basic, fundamental and irrevocable human rights is each individual’s right to choose the means for its own healing.
The more serious the condition is, the more motivated the individual becomes to search and explore all the possible options offered for its own healing. Then, the decision to choose the best available option is entirely his/hers. This is known as “the principle of informed consent”.
The enactment of the above right presupposes responsible and adult individuals. This is actually the case for all human rights. How could it be possible for anyone to discourage another human being from seeking treatment for an ailment, which he/she suffers from? Such a mentality is treating the individual as a “vegetable” unworthy of its own rights.
Finally, I cannot help but to point out something that I find most alarming.
If you go here you may find one of the numerous internet blogs. This particular blog however, has published the complaint you are referring to before it even reached your office.
I would never perpetuate internet rumors as to whom or what lies behind such “blogs”. Nor do I wish to reside upon what has reached the attention of various RLT representatives concerning the owners of this blog or their motivations.
In my profession, I deal with facts. So, let’s examine some objective facts.
a) One internet blog is attacking my client. It is a blog that advertises that its sole purpose is to defame any healing method that does not follow the healing model promoted by certain pharmaceutical companies.
b) That same internet blog is publishing a complaint against my client before it even reaches you.
c) Then, your organisation and its reaction are being taken for granted and what is about to follow is actually being announced online before it takes place.
Do you see something wrong with this picture?
Having stated the above, I would like to repeat that my client has no dispute within the space of your jurisdiction.
With my regards
xx
Attorney at The Supreme Court"
It's clear the "Attorney" was upset by the contents of my complaint, but it's something of a mystery why he is seeking legal redress from the ASA. Perhaps he believes I am some kind of Double Agent?
The next letter from the "Attorney" comes after the ASA have upheld my complaint. Here, the legal threats are rather less nuanced, except this time it's the ASA themselves who are threatened with the lawsuit.
"Dear Ms xx,
I have just been informed that A.S.A. has published on its official web space, the following text, which refers to my client, "Radiant Life technologies" (hereinafter referred to as RLT):
http://www.asa.org.uk/ASA-action/Adjudications/2011/2/Radiant-Life-Technologies/TF_ADJ_49755.aspx
In reference to the above publication, I would like to state the following for the record:
1) As for the jurisdiction issues, I am referring you to my previous letter.
2) Under the legal name of my client, you have placed a U.K. address. This address is NOT an RLT residence or address, either legal or otherwise.
3) In your "Assessment" section, under "Upheld 1" you state:
"Whilst we noted the product had a CE mark, we understood that a CE mark demonstrated that a product conformed to the essential health, safety and environmental requirements set out in EU directives, but that a CE mark did not allow advertisers to make any health or medical claims on behalf of their product. In the absence of any evidence to support the efficacy claims made in the ad, we concluded that the ad was misleading."
4) The above statement is in direct violation of all E.U. legislation on the CE mark on medical devices. It defies the very essence and purpose of a CE mark.
Once a medical device acquires the CE mark, it is free to be sold to any E.U. member state without any further procedures/requirements. This is the case for the U.K. as well. All CE marked medical devices may be traded and sold freely within the sovereignty of the U.K. without any further procedures.
The reason for this is that the device efficacy has already been proven in front of an E.U. accredited Notified Body during a very long, detailed and laborious process. Only then does the device acquire the CE mark for medical devices. Therefore there is no further legal obligation to prove its efficacy, yet again, to any other authority/organisation.
5) The above statement defies plain common sense.
You acknowledge the fact that a CE marked medical device may be legally traded in the U.K.. However, according to your line of reasoning, it may not make any efficacy claims! So, according to you, for what purpose are medical devices supposed to be sold? Recreation?
6) The above statement is in direct violation of your own Code.
In order to justify your assessment, you are referring to CAP Code Clauses and more specifically to Clause 12.1. This Clause states:
"Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA or EMEA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings." (the underlining is mine)
Therefore, a CE marked medical device may, after all, make actual efficacy claims even according to your own Code.
This also proves the malignant intent behind ASA motives. ASA states one thing in its CAP Code, in order to be compatible with E.U. legislation, while in practice it implements the exact opposite, selectively of course.
7) As for "Upheld 2" in your "Assessment" I only have to say this:
Low intensity medical laser devices have been on the market for over half a century. In those 50 years, there are ZERO recorded side effects. This is a scientific fact proven over and over again so many times that it has become common ground.
On the other hand, you will not find ONE SINGLE chemical pharmaceutical substance without a long list of side effects, a list comprised by the very people who are placing such a substance on the market. This is also a scientific fact so well known that is common ground as well.
So, what further "proof" do you require and what, in the above common ground knowledge is exactly "unsubstantiated"?
8) As for your "complainant" I am referring to what I've already stated in my previous letter to you regarding this professional "complainant". In your prejudiced and selective approach you have chosen to ignore those allegations. However, they are there for the record.
9) I have repeatedly stated that you do not have enforcement jurisdiction on RLT.
However, you have made a publication in an official web space stating that the RLT medical devices are ineffectual, while you know perfectly well that RLT has ZERO legal obligation to prove to you the efficacy of its devices.
This causes harm to the legal interests of my client and makes ASA liable for compensation.
Therefore:
-Due to the fact that ASA is in direct violation of all relevant E.U. legislation on medical devices and CE marks
-Due to the fact that ASA defies plain common sense that needs to be implemented so that any market may function properly
-Due to the fact that ASA is in direct violation of CAP Code, which it supposedly implements
I clearly state for the record that I reserve fully all legal RLT rights against ASA and especially, but not solely:
-The RLT right to calculate and define any harm it may suffer due to your above publication and claim it in a Court of Law at any convenient, for RLT, time.
-The RLT right to inform the E.U. Commission as well as all relevant E.U. authorities of all your violations of E.U. legislation, of your devaluing of the CE mark and of your illegal claims that the efficacy of all CE Certified Medical Devices need to be re-proven to the ASA.
Regards
xx
Attorney at The Supreme Court"
One begins to wonder if the "Attorney" actually knows anything about law at all. The Consumer Protection Regulations (2008) is one piece of legislation that never seems to have landed in his in-tray.
The fourth letter is the ASA's response. It's a rather elegant rebuttal of the "Attorney"'s delusions, and I commend its author.
"Dear Mr xx
Your client: Radiant Life Technologies
Thank you for your email of 14 April.
I note that you state you have only just been informed of the adjudication which was published on the website. You will recall that we sent you a copy of our final adjudication on 3 February with an accompanying letter that explained it would be published on our website on 16 February. I have attached a copy of that email for your information.
For ease of reference, I shall respond using the numbering in your email.
Points 1 and 9:
I have already addressed this matter in my email to you of 9 December 2010 and is addressed in the adjudication.
Point 2:
Your client was asked to provide an address in our letter addressed to Ms Delmar of 29 November 2010. We did not receive a response from her or from you but we found the address listed as that of a UK representative of RLT on xx; we found that information on that website on 9 December 2010. I have attached a screen shot for your information.
Points 3 to 6:
We consider our assessment makes clear that your client is not allowed to make whatever medical claims they like just because it is a certified medical device. CE marked medical devices may make medical claims provided they hold the scientific and clinical data to substantiate them.
Point 7:
Our assessment makes clear why we considered the ad breached the Code on that point.
Point 8:
I have already addressed that point in my email of 9 December 2010.
We disagree that we have stated that RLT medical devices are ineffectual; our adjudication states that we had not seen any evidence to substantiate your client’s claims.
We have noted the further comments you have made in your letter.
Yours sincerely"
Sadly, the correspondence is brought to an in the last of the five letters, an apoplectic rant dated 14 April.
Thank you, eventhough your latest mail is NOT a response to mine.
You state:
"We consider our assessment makes clear that your client is not allowed to make whatever medical claims they like just because it is a certified medical device. CE marked medical devices may make medical claims provided they hold the scientific and clinical data to substantiate them."
My client, RLT, is "allowed" to make its claims because it does actually hold the required medical/scientific data and it has submitted that data to the relevant authorities.
My client has ZERO legal obligation to prove anything to YOU.
ASA is NOT a registered authority to pass judgement on medical/scientific data required for certified medical devices. All such relevant authorities are registered, recognised and catalogued by the E.U. legislation and ASA is NOT among these authorities.
You know this perfectly well because I have quoted from your own CAP Code, which very clearly states that CE Certified medical devices may make all relevant efficacy claims, full-stop. This CAP Code statement is direct, without any provisions or requirements of any sort or in any way whatsoever.
I repeat, yet once more for the record, that RLT is a bearer of legal rights based on E.U. legislation, which in this case is compatible with the U.K. legislation as well.
Ms xx with this letter I feel the need to truly thank you, honestly and without any sense of irony.
With our latest correspondence you have established for RLT the OBJECTIVITY of the legislation violations on behalf of ASA.
I do not have to ponder anymore on your motives or labour to provide any relevant Court of Law with the necessary proof as to where you were coming from.
ASA has caused direct and multiple VIOLATIONS of all relevant E.U. and U.K. legislation on medical devices. Those violations have been specifically pointed out to you in my previous letter. You have chosen to ignore those allegations and come back to me with an unexplained persistence that it is your right to break the law. As if your ASA "Assessments" are a source of creating new laws!
You have consciously and repeatedly overextended your jurisdiction and in an illegal manner have become self appointed experts on medical devices and medical/scientific data. You have published your illegal allegations towards RLT on a web space claiming you are an authority on such decisions, while you know perfectly well that you are NOT.
All I need to do now, in order to establish my case, is define the illegal harm you have caused to the legal interests of my client.
Since you have zero enforcement authority on RLT and due to the fact that it is an RLT prerogative to choose the time and the place, I shall do so in a convenient for RLT time in front of a relevant Court of Law.
Regards
P.S. It is not my intention to perpetuate a correspondence that goes nowhere. You obviously have no intention of addressing any essential issue. Therefore, should you choose to come back with a repetition of the same, I wish to state upfront that I shall ignore your letter."
