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Faulty PIP Breast Implants, the CMO and assessing risk

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.

How Irish MEPs Voted on ACTA

Voted in Favour of ACTA

None

Voted Against ACTA

Emer Costello, Paul Murphy, Liam Alyward, Nessa Childers, Pat the Cope Gallagher, Marian Harkin, Phil Prendergast

Abstained on ACTA

Gay Mitchell, Mairead McGuinness, Sean Kelly, Jim Higgins

No Vote Recorded on ACTA

Brian Crowley,

Source, Pages 19-20.

Update: This post originally showed Phil Prendergast as not having a vote recorded. This was my error and I have corrected it above. Sorry about that Ms Prendergast!

PIP Breasts Implants: Response to the CMO Statement

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.

 

Statement by the Chief Medical Officer on PIP Breast Implants

“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”

Pandemrix

In 2009, the Irish Government, like the governments of other states, formed a policy to offer a vaccine to counteract the onset of the H1N1 2009 flu pandemic, colloquially called the swine flu.

The vaccine was offered through HSE clinics and general medical practitioners and was promoted by the state for the particular protection of young people. The state chose the vaccine brands to implement the policy. One vaccine chosen was Pandemrix, a vaccine licensed by the European Medicines Agency.

HSE clinics administered more than 900,000 doses of Pandemrix in 2009 and 2010 and the young people affected ranged in age from 5 to 21 years of age.

Not everyone was happy with Pandemrix; the German Medical Association, in October 2009, opposed the vaccine’s use in young people and pregnant women, saying that, since the risks of swine flu were lower than feared, it would be unwise to rely exclusively on new vaccines containing adjuvants if alternatives were available (they were).

It appears there was another very notable sceptic concerning Pandemrix; its manufacturer, GlaxoSmithKline.

In 2009, it said it hadn’t had the opportunity to collect a significant amount of data on the use of Pandemrix, but that it had experience with similar vaccines for seasonal flu, bird flu, as well as data on the use of adjuvants.

It now claims the Irish state furnished GlaxoSmithKline with an indemnity against any claims arising from adverse reactions to the use of Pandemrix. Such an arrangement, effective or not, is powerful evidence of the skepticism of GlaxoSmithKline about the safety of Pandemrix.

Sure enough, there was an unintended consequence of the vaccine programme; an increase in the incidence of narcolepsy appeared. The parents of affected Irish children associated it with the administration of Pandemrix. They were not alone. Finnish authorities also noted this consequence, following the delivery, by the state of Finland, of Pandemrix to the young people of Finland, also to counteract the H1N1 flu.

Those Finnish authorities launched an investigation.

Eventually, so too did the Irish authorities. Two reports, Finnish and Irish, now conclude that the explanation for the incidents of narcolepsy appearing after the vaccine programmes lies with Pandemrix.

Narcolepsy is a serious neurological sleep disorder. It is life-long and there is no known cure. It will affect the course of a person’s future life and occupational chances.

Lawyers are familiar with situations such as this. It is one where a problem is recognised or experienced by one or more private persons. They have sustained a loss or injury but it has followed from the actions or inactions of others.. Under the Irish constitution, the state is obliged to vindicate the … person… of its citizens. This means that a personal injury, inflicted by one person on another, demands a constitutionally mandated resolution.

Was narcolepsy inflicted on some young Irish persons?

An answer lies in the concept of “cause”, as understood by scientists. Another answer, perhaps the same one, lies in the same concept, as understood by lawyers.

We see this in the terms of the Irish report; it purportedly identifies a genetic element in the incidence of narcolepsy. Be that right or wrong, there must be some additional element besides Pandemrix, to explain these cases of narcolepsy. We know this from the fact that not every young person receiving Pandemrix developed narcolepsy. This implies a vulnerability on the part of those “unlucky” persons.

Lawyers refer to such cases as “egg-shell skull” cases; that is, a person might possess a vulnerability where a blow to the head, say, causes injury that a “normal” person would not suffer.

In law, a vulnerability like that is not a bar to recovery of compensation. As lawyers say, “you must take your victim as you find him/her”.

This is where scientists and lawyers go their separate ways on the considerations of “cause”. A scientist is reluctant to attribute the word cause to one element in a chain of events; a lawyer is often and habitually not so reluctant if that element is proximate to the injury.

We see this in every personal injury civil action. The burden of proof on a plaintiff is to prove the case on the balance of probabilities. If the plaintiff proves that it is more probable than not that something done by the defendant has injured the plaintiff, he or she will succeed in the claim.

This is exactly what has been determined by the Irish and Finnish reports; it is probable that Pandemrix caused the cases of narcolepsy appearing in young people who got the vaccine.

Narcolepsy: Ireland

Several studies, including one Irish study, have associated an influenza vaccination, Pandemrix, with unusual cases of narcolepsy.

These are statistical studies; the causes of narcolepsy are obscure, but they include infections.

European public health authorities, including in Ireland, worry about seasonal influenza. In 2009 they worried about the variant H1N1. The response was to arrange for mass vaccination of populations.

At that time, Pandemrix, had limited approval for use as a vaccination. The details of the original approval are HERE.

This was described by the European Medicines Agency in these terms;

“Pandemrix was granted Marketing Authorisations in the EU in May 2008, with use being restricted to subjects aged 18-60 years in section 4.2 of the summary of product characteristics (SPC) due to lack of data outside of this age range.”

Despite this, during 2009 it was administered to at least 30.8 million people in Europe. Its history is to be found in this review of Pandemrix “Questions and answers on the review of Pandemrix…”

It received limited approval on 20th May 2008 because of outstanding issues. It was permitted to switch from conditional to full marketing on 24th June 2010 as can be seen in this Procedural History.

Within eight weeks of full authorisation the Swedish national authorities reported cases of juvenile narcolepsy following immunisation with Pandemrix and the Finnish authorities suspended its use, whereupon the European Commission sought, (27th August 2010), the opinion of the EU Committee for Medicinal Products for Human Use on these reports of narcolepsy.

The World Health Organisation’s Global Advisory Committee on Vaccine Safety has remarked of this,

“… an increased risk of narcolepsy had not been observed in association with the use of any vaccines in the past and that it did not appear that narcolepsy following vaccination against pandemic influenza was a general worldwide phenomenon.”

Nonetheless, the facts are now established; Pandemrix is the cause of a number of cases of narcolepsy in Ireland. Narcolepsy is a serious incurable disability. It has occurred in Irish young people and will affect their lives inescapably for the future. It will make the chances of getting and holding employment problematic. It may rule out the driving of motor vehicles. It would certainly rule out the flying of aircraft.

The liability for this, in law, is clear. The Irish state provided Pandemrix to the Irish population. There were various avenues of distribution. Many involved payment of a fee or fees. This implied the delivery of a commercial service. The services delivered to these patients were subject to the implied terms of the Sale of Goods and Supply of Services Act 1980.

GlaxoSmithKline Biologicals S. A. were the defined producer of Pandemrix. In producing Pandemrix GlaxoSmithKline Biologicals S. A. triggered the terms of the Liability for Defective Products Act 1990. Each of these pieces of Irish legislation renders the General Practitioners or HSE clinics and GlaxoSmithKline Biologicals S. A., (the producer), liable for patent and latent defects in the product. It is not necessary to prove negligence to succeed in these claims. It is also not necessary to prove that Pandemrix was the sole cause of these narcolepsy claims. In civil claims for personal injury the burden of proof on a plaintiff is to prove fault on the balance of probability.

The claims are for personal injury. The limitation period for personal injury claims is two years from the date of the accrual of the cause of action (the immunisation) or the date the patient knew or could reasonably know that she had been injured and/or the identity of the person injuring her. Failure to issue proceedings before the limitation period expires will render the claim barred.

 

DePuy Land

What a strange place is DEPUY LAND, the place inhabited by the people who work for “DePuy”, in its various corporate guises.

It surely is a lawyer-free zone. We can infer this from a Field Safety Notice on the website of the Irish Medicines Board. The notice is the provincial edition of a world-wide notice to DePuy customers. The customers have bought a DePuy “product” and there are quality issues with the product.

What’s the product?

It’s called the DePuy FREEMAN Cemented Femoral Hip Stem and the customers are big hospitals with orthopaedic services.

The hospitals are big because they do big operations, like cutting off the top of a patient’s thigh bone (the femor) and then sticking a metal spike (the “stem”) down the centre of the bone to create a new ball-and-socket in the patient’s hip.

Now, it turns out that this is problematic. As DePuy expresses it in the Field Safety Notice (“FSN”), (Which is dated 17th April 2012):

“…However, research has led DePuy to conclude that, when used in combination with a MoM articulation DePuy’s cemented, polished, CoCro femoral hip stems, including the FREEMAN Cemented Femoral Hip Stem could exhibit excessive corrosion of the polished surfaces which are within the cement mantle.”

The significant word in that statement is “could”. It is in fact an understatement.

The FSN is the outcome of DePuy investigations started in 2007. The investigations started, as the FSN notes, because actual real people had suffered the consequences of DePuy product failures and had to have the products taken back out of their bodies. These were big operations.

In short, “could”, in the FSN, should read “would”.

Furthermore, this problem remained as a trap for those patients fitted with the “DePuy FREEMAN Cemented Femoral Hip Stem” between 2007 and 2012, a time during which Depuy was looking into the problem.

These patients are, and were, guinea pigs for DePuy. They are left with the consequences of the product failure without having ever consented to run the risk of that failure.

Of course, in law, DePuy, and the patients’ big orthopaedic hospitals are liable, for different reasons, to compensate the patients for these product failures.

That’s the theory; but, if there are no lawyers in DEPUY LAND, who is to alert the patients to the existence of their right to make a claim?

Letter to UK Secretary Of State for Justice re recent case regarding extradition to the UK and indeterminate sentencing.

The Right Honourable Kenneth Clarke MP QC

Secretary of State for Justice

Ministry of Justice

102 Petty France
London
SW1H 9AJ
United Kingdom

 

RE:  The Minister for Justice & Equality v GN

Dear Minister,

We refer to the above. Your administration reference is, we believe, Criminal Appeal Office Reference Number 200702371 A8; Indictment Number T20057096.

The respondent, GN is our client.

We act for him arising from a request from the UK Serious Organised Crime Agency for his extradition. As you no doubt know, in Ireland, requests for extradition are processed in the High Court at the behest of the Minister for Justice and Equality.

This has now been concluded in the case of our client and the High Court has declined to order our client’s extradition to the UK.

We are sending the judgment of the High Court to you under closed cover and commend it to you.

The issue in the case was the legal standing of indeterminate sentencing in the UK. We are aware that this is a current and controversial issue in UK politics and public administration.

We urge you to accept the conclusions of the Irish High Court and to act accordingly. In short, we urge you, on behalf of our client, to cease any further efforts to seek his extradition to the UK.

This will have the beneficial effect of relieving Ireland of any implied obligation to appeal the High Court judgment to the Supreme Court. This course of action will also relieve our client of stress and anxiety while the outcome of any such appeal is awaited. It will also relieve Ireland of the expense of prosecuting and defending any such appeal.

We look forward to your favourable responses.

Yours faithfully,

________________

McGarr Solicitors

 

Reply received from Newspaper Licensing Ireland Ltd re Women’s Aid

We have received a reply today from Newspaper Licensing Ireland Ltd to our letter on behalf of Women’s Aid.

We will be making reply on behalf of our clients shortly.

Letter to the Chief Medical Officer seeking further information about PIP Breast Implants’ regulatory status

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;   21st May 2012

 

Dr. Tony Holohan

Chief Medical Officer

Department of Health

Hawkins St.

Dublin 2

Fax: 6710148

 

Re: PIP Breast Implants


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 8th 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

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