PIP Implants

RULE 4.228 OF THE INSOLVENCY RULES 1986

NOTICE TO THE CREDITORS OF AN INSOLVENT COMPANY OF THE RE-USE OF A PROHIBITED NAME

THE HARLEY MEDICAL CENTRE LIMITED
(Company Number 01728619)
I, Melvin Braham, of 11 Queen Anne Street, London W1G 9LJ was a Director of the above named company on the day it went into administration. I give notice that I am acting and intend to continue to act in one or more of the ways to which Section 216(3) of the Insolvency Act 1986, would apply if the above-maned Company were to go into insolvent liquidation connection with or for the purposes of, the carrying on of the whole or substantially the whole of the business of the above-named Company under the following name: Aesthetic and Cosmetic Surgery Limited trading as the Harley Medical Group

Did you receive a notice from Mr. Melvin Braham, Mr. Pierre Guillot or Ms. Louise Braham, in the terms set out above?

Are you an Irish client of The Harley Medical Group, with PIP breast implants?

What is this notice, you ask?

Read on.

The Insolvency Rules

Under the Rules contained in the UK Insolvency (Amendment) Rules 2007, directors of companies such as The Harley Medical Centre Ltd. are obliged to publish a prescribed notice in the London Gazette

and

to notify every creditor of the company whose name and address is known [to the director] or is ascertainable by him on the making of such enquiries as are reasonable in the circumstances.

The Harley Medical Group was a trade mark of The Harley Medical Centre Ltd. of 11 Queen Anne St. in London.

The Harley Medical Centre Ltd. went into administration in the UK on 9th November 2012. The administrators sold some or all of the business of The Harley Medical Centre Ltd. to another company, Aesthetic and Cosmetic Surgery Ltd.

The “Harley” Notice

On 7th December 2012, Mr. Melvin Braham, Mr. Pierre Guillot and Ms. Louise Braham, all directors of The Harley Medical Centre Ltd. and also directors of Aesthetic and Cosmetic Surgery Ltd., published a notice in the London Gazette in the form seen HERE.

The Liquidation of The Harley Medical Centre Ltd t/a The Harley Medical Group

Subsequently, as it happened, The Harley Medical Centre Ltd. went into insolvent liquidation. (It also changed its name to THMC Realisations (2012) Ltd.)

Clearly, the “Harley” notice was intended to comply with the terms of the UK Insolvency (Amendment) Rules 2007 (seen HERE).

Did you receive the “Harley” notice?

McGarr Solicitors would like to hear from every Irish client of The Harley Medical Centre Ltd. to check the extent of compliance of Mr. Melvin Braham, Mr. Pierre Guillot and Ms. Louise Braham with the UK Insolvency (Amendment) Rules 2007.

EMAIL US!

We look forward to hearing from you by email at info@mcgarrsolicitors.ie

In the UK and Ireland, The Harley Medical Centre Ltd., trading as The Harley Medical Group, was a major seller and distributor of the defective PIP breast implants. The Harley Medical Group (Ireland) Ltd is currently before the Irish courts, looking to be put into liquidation. McGarr Solicitors is the only solicitors’ firm that has attended court for Irish PIP victims and argued for their clients’ interests in this application.

The Crime

1. The PIP criminal trial is currently at hearing in France.
2. McGarr solicitors act for a number of women victims of the PIP scandal. The scandal was the distribution and sale of sub-standard silicone breast implants. This post is a partial explanation of the current position of Irish PIP victims and related Irish legal activities.

The Harley Liquidation

1. The Harley Medical Centre Ltd. went into administration and then liquidation (and changed its name). This has all happened in the UK under the insolvency law of that jurisdiction.
2. The administrator promptly sold the business to, it appears, the shareholders of The Harley Medical Centre Ltd. and they have continued the business in the same premises using a new company. That company is continuing the use of the trade name The Harley Medical Group. Its directors are the defunct directors of The Harley Medical Centre Ltd.
3. There was an exception to the plan; the exception was in Dublin. The Harley Medical Centre Ltd. had a clinic at 5 Herbert Place in Dublin 2. We know this because it said so on its website. There was and is a plaque, effectively saying so, attached to the wall outside 5 Herbert Place. In addition, the contracts signed by Irish Harley customers stated that the contract was with The Harley Medical Centre Ltd.
4. It now appears that the leasehold interest in 5 Herbert Place Dublin 2 was held by another company, The Harley Medical Group (Ireland) Ltd. Despite its name, this company was formed and registered in the British Virgin Islands.

The Harley Medical Group Dublin Liquidation

1. Now, this company also wishes to be liquidated. It had directors in common with The Harley Medical Centre Ltd. In other words, the two managements were the same.
2. It has chosen to apply for liquidation in Ireland, in the Irish High Court. In doing so it has claimed, in sworn testimony, that it is the entity that carried on the medical business conducted at 5 Herbert St. Dublin 2.
3. This is confusing. It also creates uncertainty; uncertainty as to the identity of the corporate body answerable to Irish Harley PIP victims.
4. Because The Harley Medical Group (Ireland) Ltd. made this claim to the High Court, the court directed that McGarr Solicitors (and other firms also) be put on notice of the petition to wind up The Harley Medical Group (Ireland) Ltd. McGarr Solicitors act for a number of Irish Harley PIP victims.

The Opposition to the Harley Dublin Liquidation

1. McGarr Solicitors have opposed the making of a winding up order for The Harley Medical Group (Ireland) Ltd.
2. In the UK, persons such as Harley PIP victims may, under UK law, apply to enforce their claims against any relevant insurance company carrying the Harley risk. This is not the case in Ireland.
3. So, if there is insurance cover for claims such as the PIP claims, and if each victim can prove damage and loss, it would be important to be able to make a claim against that insurer of Harley.
   
4. But which Harley would be the insured Harley? This question illustrates the damaging effect of the claim of The Harley Medical Group (Ireland) Ltd. Its claim that it is the company that sold and fitted defective breast implants to Irish women at least potentially undermines the right of those women to claim against the UK insurer of The Harley Medical Centre Ltd.
5. As it happens, the claimed, indeed assumed, “right” of The Harley Medical Group (Ireland) Ltd. to be wound up by the Irish courts is not obvious. It is not obvious because Irish law includes EU law and under the relevant EU law the available evidence shows that the place where The Harley Medical Group (Ireland) Ltd. might more properly be liquidated is the UK and not Ireland.
6. The available evidence shows, for instance, that the headed notepaper of The Harley Medical Group (Ireland) Ltd. recited that it had nineteen clinics, eighteen of which were in the UK. Oddly, they appear to be the same clinics that The Harley Medical Centre Ltd. had.
7. As it further happened, the lawyers for The Harley Medical Group (Ireland) Ltd., in submitting the petition to wind up The Harley Medical Group (Ireland) Ltd. denied that the EU insolvency regulation applied to The Harley Medical Group (Ireland) Ltd. and its petition. McGarr Solicitors disagree. We say the Regulation applies. We say that the available evidence establishes where the “centre of main interests” (“COMI”) for The Harley Medical Group (Ireland) Ltd. is, and its COMI is in the UK. Consequently, we say, the Irish high court does not have jurisdiction to wind up The Harley Medical Group (Ireland) Ltd. in “main proceedings”. That privilege lies with the UK courts. (Consequently, Irish PIP victims would then have the benefit of UK law and would be able to press any necessary claims against the insurance companies of The Harley Medical Group (Ireland) Ltd. as well as the claims against the insurers of The Harley Medical Centre Ltd.).
8. These are the questions now being decided by the Irish High court. Judgment is expected in about a week.
9. Meanwhile, we are continuing our investigations of the insurance cover bought by The Harley Medical Centre Ltd. We are doing this through correspondence with the liquidator of The Harley Medical Centre Ltd. Currently we believe that company was insured against claims such as those of Irish PIP victims. We have identified what we believe is the policy and the insurer that carried that risk

Harley Medical Group (Ireland) Limited is a company registered in the British Virgin Islands.

About a month ago, we were notified by McCann Fitzgerald, solicitors for the Harley Medical Group (Ireland) Limited of their client’s application to the High Court in Dublin seeking to wind up the company.

As solicitors representing women suffering as a result of having been supplied with faulty PIP breast implants by the Harley Medical Group, we were made notice parties to that application at the direction of Judge Laffoy in March.

Today and last week we were the only solicitors for PIP recipients who turned up to represent their clients in the hearing of this application.

Our counsel argued that the Centre of Main Interests (called the COMI) of the company was not in Ireland and was probably in the UK. He also argued that the Harley British Virgin Islands company had failed to take account of the EU’s Insolvency Regulation in applying for a winding up in Ireland.

He cited, as evidence of our contention that the real COMI was the UK, the fact that the Harley Medical Group used the year of establishment of the UK company on its brass plaque at its Dublin office, that the contracts with its patients cited the UK company as the contracting party and that the UK website cited Dublin as just one of 19 clinics, with all the rest being in the UK.

This is significant because, if we are successful in our argument, Harley’s application to be wound up in Ireland will be declined and, logically, the Harley company should seek to be wound up in the UK instead. That would be of benefit to PIP victims, because the UK has laws allowing injured parties to directly sue the insurance companies of liquidated companies for compensation.

At the end of our submissions, counsel for Harley Medical Group (Ireland) Ltd made some short points in response, acknowledging he was answering a tightly argued legal case.

The Judge reserved judgment, which is expected within the next two weeks.

Tomorrow, the 8^th April, in Court 3 in the Round Hall of the Four Courts, a company called Harley Medical Group (Ireland) Ltd (“The Company”) is appearing before the High Court seeking to be wound up. The company is registered in the British Virgin Islands, with an office in Ireland at 5 Herbert Place.

This is the second time this matter has been before the Court. In March Ms. Justice Laffoy ordered that a number of parties- including our office- be put on notice of the application. In addition, further details of the company’s insurance arrangements were to be furnished.

We were placed on notice because we represent a group of women who were customers of the Harley Medical Group and received faulty breast implants made by a French company called PIP. The implants were made with industrial grade silicone (apparently intended, amongst other things, to fill mattresses) rather than the medical grade silicone which they were held out to be.

After receiving a copy of the Harley Medical Group (Ireland) Ltd’s affidavit seeking the winding-up, our office wrote to the Company and requested details of their insurance arrangements. A supplementary affidavit was delivered by email to our office at approximately 5pm on Friday, 5th April..

We will be making response on behalf of our clients in this matter in court on Monday.

However the State also has questions to answer in this matter.

The Chief Medical Officer

On the 3^rd July 2012, Dr. Tony Holohan, the State’s Chief Medical Officer issued a statement.

“Despite intense discussions with and ongoing and clear pressure from the CMO’s Office in relation to one provider, the Harley Medical Group, that provider has failed to provide an appropriate care package for its clients. The Department is not satisfied that the Harley Medical Group will fulfil their obligations in an acceptable manner”

He went on to assure the women affected by this failure that the state would not leave them without access to affordable medical attention.

“it has been decided that necessary care required by the affected recipients of these implants should be made available via an alternative route, i.e. the NTPF.”

However, despite mention of a September date for the details of this provision to be published, the National Treatment Purchase Fund website makes no mention of any such care package. In addition, none of our clients have been contacted with the details of any National Treatment Purchase Fund provision for their medical needs.

It appears that, eight months from the declared date when a solution would be published and ten months from when it was announced, nothing has actually happened.

Irish Medicines Board

Furthermore, the advice and information issued by the Irish Medicines Board -who are responsible for the regulation of medical devices such as implants in Ireland- on the issue of PIP implants have been incomplete to the point of being misleading. The IMB has consistently sought to minimise the data relating to the real and quantifiable risk to women who have been implanted with PIP silicone.

In July 2012, the Irish Medicines Board issued a statement in response to the most comprehensive study of the evidence of risk from PIP implants to date. That study was done by an expert group for the NHS. You can read the data amassed in that report here.

That data showed that

• PIP Breast Implants were up to six times as likely to rupture as standard implants.
• The expert group were projecting up to 30% failure rate by 10 years for PIP implants.
• Furthermore, the NHS studied records of women who had had both normal and PIP breast implants removed. It found that women with PIP Implants were 4.6 times as likely to have inflammation and/or lymphadenopathy than women with normal implants. They were 23.3 times as likely to present with lymphadenopathy alone.

Here’s how the Irish Medicines Board described the findings of this report in February 2013

“The Medicines and Healthcare Regulatory Agency (MHRA) in the UK publishing the final test results for PIP breast implants. The report concluded ‘that the silicone contained in PIP breast implants does not pose a risk to human health’.”

The Irish Medicines Board has never made any mention of the reported increased rupture risk, and, despite having noted the publication of the NHS report, made no reference to the evidence it demonstrated of increased risks of lymphadenopathy and/or inflammation. We have had women who have contacted our office in the year since that report was with the IMB, describing the symptoms of lymph node inflammation who had been unaware of the established connection with PIP implants.

As late as July 2012 the Chief Medical Officer was still ending his public statement on PIP implants with an assertion that “the risk of rupture is low”.

On Monday the 8^th April The Harley Medical Group (Ireland) Ltd will be returning before Ms. Justice Laffoy to provide her with further information. We will be there to represent our clients.

However, we also know that it is our clients’ wishes that the State should keep its promises and take seriously its duties to inform and assist all the women caught up  in this scandal.

UPDATES:

The Harley Medical Group (Ireland) Ltd seek winding-up over implant claims
-8th April 2013
A report of the first day of hearing of the Harley Medical Group (Ireland) Ltd’s directors’ application to the High Court to wind up the company.

The Harley Medical Group and PIP Victims’ claims
- 24th April 2013.
Discussion of what evidence we have relating to the insurance policies covering the Harley Medical Group.

Harley Medical Group (Ireland) Ltd liquidation application
-29th April 2013
A report on the 2nd day of hearing of the Harley Medical Group (Ireland) Ltd’s application to the High Court to wind up the company.

The Harley Medical Group- who are they really?
- 30th April 2013
A discussion of the issue of corporate identity around the companies using the trading name The Harley Medical Group.

The Harley Medical Group- Did you get this Notice?
-02nd May 2013
In Nov/Dec 2012 PIP victims might have received a legal notice from the former directors of the UK company the Harley Medical Centre Ltd. If you didn’t, we’d like to hear from you.

This post concerns a matter returnable before the Irish High Court on 8^th April 2013.

A company named The Harley Medical Group (Ireland) Ltd. has applied to the court for an order compulsorily winding up the company. McGarr Solicitors, by order of the court, has been made a notice party to the application and has received copies of the application with its grounding affidavit and exhibits.

We are notice parties because we act for a number of women fitted in Ireland with PIP breast implants. These breast implants, notoriously, are substandard. They contain industrial grade silicone rather than medical grade silicone. They were manufactured in France but supplied to consumers in many jurisdictions.

One of the main suppliers in Ireland of PIP breast implants trades or traded as The Harley Medical Group from 5 Herbert Place, Dublin 2.

The Harley Medical Group is a trademark registered in the UK. It is owned by The Harley Medical Centre Ltd., a UK registered company, now in liquidation. The jurisdiction of that liquidation is the UK.

The Harley Medical Group (Ireland) Ltd. is a company formed in the British Virgin Islands and with its registered office there.

In its application to the High Court, it is, effectively, claiming that its “centre of main interest” (“COMI”) is Ireland. Specifically, it claims that it, (and, by implication, not The Harley Medical Centre Ltd.) was the supplier of services, (and PIP breast implants), to Irish women, from 5 Herbert Place Dublin 2.

It is not possible for us to disclose, in this post, our intended response to the application to the High Court.

However, we understand that the Court has directed the applicant company to disclose details of the insurance cover it had for claims such as those made by Irish women fitted with PIP breast implants.

We share the Court’s concern and interest in that topic and expect, in due course, to report our full response to the application, under the privilege attaching to court reports.

We have already written critically about the Chief Medical Officer’s proposal to decide how, where and whether women with PIP Breast Implants should receive medical attention.

However, this is not the only problem with the State’s medical establishment’s response to the PIP Breast Implant scandal.

RTE, the Irish Times and other news organisations included a similar reassuring coda to their reports.

According to the department and the Irish Medicines Board, there is no evidence of increased risk of cancer for women with PIP implants, while the risk of rupture is low.

– Irish Times

The first claim- that there is no evidence of an increased risk of cancer is unquestionably, happily, true. Large scale expert studies have found no additional risk of cancer associated with the PIP Breast Implants.

But the same study, from the NHS in the UK, found that PIP Breast Implants were up to six times as likely to rupture as standard implants.

The NHS study also tentatively estimates up to 30% failure rate by 10 years for PIP implants.

By any reckoning, this is not a low risk of rupture.

Furthermore, the NHS studied records of women who had had both normal and PIP Breast Implants removed. It found that women with PIP Implants were 4.6 times as likely to have inflammation and/or lymphadenopathy than women with normal implants. They were 23.3 times as likely to present with lymphadenopathy alone.

Women should be reassured about the lack of evidence of a cancer risk from PIP Breast Implants.

But the evidence of real risks should not be ignored if women are to be empowered to make an informed decision about actions they should take about their own bodies.

The Chief Medical Officer (CMO has today taken the unprecedented step of issuing a joint statement with the National Treatment Purchase Fund (NTPF) regarding the treatment of women who were given faulty PIP Breast Implants.

In that statement the CMO has acknowledged that the Department of Health will no longer accept assurances given to him by the Harley Medical Group that they will fulfill their obligations in an acceptable manner.

RTE and other news organisations are presenting this statement as a promise that the State intends to “assume responsibility for cost of PIP implant removal”.

This is simply not what the CMO/NTPF have said. They say that they intend to “make suitable arrangements with appropriate facilities to provide such consultation and follow-on support as required.” That is not the same thing as paying for the access to those facilities.

What we do know from the statement is that if you are a woman with PIP implants any services made accessible by the state, on whatever payment terms, will be conditional on the following;

1. You will not be permitted to choose the surgeon with whom you will consult. Instead, the National Treatment Purchase Fund will decide the identity of that surgeon.
2. You will not get radiology (ie a scan) without the surgeon’s agreement
3. Your implants will not be removed without the agreement of the surgeon.

Taken together, the right any woman has to decide what happens to her own body is being ignored by the CMO and NTPF under these conditions. It remains your right to insist that the PIP implants should come out as a matter of your choice.

“Since concerns were first raised in March 2010 regarding the issue of breast implants, provided by the now defunct French company Poly Implant Prosthese (PIP), the clear priority of the Department of Health has been to try and ensure that the three treating clinics involved in the issue provide professional and appropriate care to their affected clients. However despite intensive efforts, by the office of the Chief Medical Officer, such appropriate care on the scale required has not been forthcoming.

Accordingly the Department has now commenced work on sourcing an alternative service via the National Treatment Purchase Fund (NTPF). This will encompass surgical consultation, radiology if required and removal of implants if this is deemed clinically necessary.   The NTPF will make suitable arrangements with appropriate facilities to provide such consultation and follow-on support as required.

It is important to identify the resources required for this work and the plan is that by September a clear view of such capacity and the means of access to it would be available.

The Chief Medical Officer met with the clinics to attempt to ensure that best practice and patient support was paramount in the service provided to concerned recipients of PIP implants.  Despite intense discussions with and ongoing and clear pressure from the CMO’s Office in relation to one provider, the Harley Medical Group, that provider has failed to provide an appropriate care package for its clients.  The Department is not satisfied that the Harley Medical Group will fulfil their obligations in an acceptable manner.

Consequently it has been decided that necessary care required by the affected recipients of these implants should be made available via an alternative route, i.e. the NTPF.

The CMO met with members of the PIP Action Group on Monday 2nd July, 2012 and advised them of the proposed initiative.  He will meet with them again in September to discuss progress on the matter.

It should be noted that the Chief Medical Officer, in conjunction with the Irish Association of Plastic Surgeons, has issued updated guidelines for those considering cosmetic surgery procedures; it is strongly recommended that the advice is considered before deciding on such surgery.

The advice from the Irish Medicines Board (IMB) and the Department of Health continues to be that there is no evidence of increased risk of cancer for women with this brand of implant, the risk of rupture is low and anyone with a concern about their breast implants should discuss the matter with their GP or surgeon.

Further press statements will issue as soon as possible.

ENDS”

The following is an open letter sent today to the Chief Medical Officer regarding the PIP breast implants issue, following up on our earlier letter of the 8th May, to which we have yet to receive a substantive response.

*******

Our Ref: EMcG Your Ref;   21^st May 2012

Dr. Tony Holohan

Chief Medical Officer

Department of Health

Hawkins St.

Dublin 2

Fax: 6710148

Dear Dr. Holohan,

We write this as an open letter to you and will put it on our website.

We refer to our previous letter of 8^th May 2012.

As you know we are instructed by a number of women that have been fitted with defective breast implants manufactured by Poly Implant Prothèses (PIP) and in connection with their claims for personal injuries arising therefrom.

In that capacity and because you are leading the state’s response to the predicament of our clients and we perceive you as being of goodwill to our clients we would be obliged if you would supply us with the following information:

1. Are you satisfied that the PIP breast implants did not conform with the prohibitions on putting them into service in the state or selling them, contained in the European Communities (Medical Devices) Regulations, 1994 as amended by the European Communities (Medical Devices) (Amendment) Regulations, 2001?
2. If so, what steps, if any, does the state intend to take arising from that view?
3. Did the Irish Medicines board issue a licence under Regulation 3 of the Medicinal Products (Licensing and Sale) Regulations, 1998 for the placing on the market and sale of PIP breast implants?
4. If so, to whom was the licence(s) issued?
5. Were the PIP breast implants subject to the terms of Regulation 5 (1) (c) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 as amended by the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008, and required a prescription?
6. Do you know if there were generally such prescriptions associated with the fitting of the breast implants?
7. Are you satisfied that any advertising for the sale of defective PIP breast implants was in breach of Regulations 6 (1), 7, 9, 11 (1) (b) and 12 (1) (b) of the Medicinal Products (Control of Advertising) Regulations 2007?
8. If so, what steps, if any, does the state intend to take arising from that view?

We await hearing from you in due course.

Yours faithfully,

___________________

McGarr Solicitors

The following is a letter sent today from our office to the Irish Medicines Board today seeking a copy of a report drafted by Covance Laboratories of Harrogate, North Yorkshire analysing the composition of faulty PIP breast implants.

This link leads to the Daily Star article referred to in this letter.

*******

Our Ref: EMcG Your Ref;   21^st May 2012

The Chief Executive

Irish Medicines Board

Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.
Fax: 676 7836

Dear Sir,

We write this as an open letter to you and will put it on our website.

We are instructed by a number of women that have been fitted with defective breast implants manufactured by Poly Implant Prothèses (PIP) and in connection with their claims for personal injuries arising therefrom.

We understand that Covance Laboratories of Harrogate, North Yorkshire have completed a report into the constituent parts of the PIP breast implants. This is recorded in a newspaper report of the UK “Daily Star” of 13^th May 2012. The report quotes a spokesman for the UK Medicines and Healthcare Products Regulatory Agency as saying that the report is published on the website of the Agency.

We have been unable to locate the report on that website and would be obliged if you would use your good offices with the Medicines and Healthcare Products Regulatory Agency to get a copy for us. Publishing it on your website or providing a web link would be very acceptable.

We await hearing from you in due course.

Yours faithfully,

___________________

McGarr Solicitors