Public Health

Recent posts have been food oriented. If the posts or your food are, reportedly, sticking in your craw, you are using a figure of speech.

Humans do not have a craw, birds do. It is also known as the crop.

Just down the bird’s alimentary system is the gizzard. Food does not stick there. Chickens, for instance, store small pebbles in the gizzard to grind food, they not having teeth. It’s suggestive of their ancestry in the dinosaurs, some of whom swallowed rocks for the same purpose.

As a figure of speech to say something sticks in your craw is an old saying.

There was a time, recent in Ireland, where everybody had an intimate knowledge of the farmyard and they were familiar with the constitutions of chickens and their ways.

Now, entire industries can figuratively stick in our craw.

We are rightly worried about our beef burgers. The supposed international criminal conspiracy undermining the meat industry is easily located; it is the meat industry. But the meat industry is not unique.

Consider our bread. We have been suspicious about it for a long time. When white bread was invented or introduced it was popular with the rich; they felt more confident that they were not eating bread contaminated with mouse droppings or insects or their body parts. (Bleached excrement and beetle parts are OK?)

Then the rich became suspicious about white bread. It was of lower nutritional value. Indeed, all mass produced bread is of lesser value than homemade or artisan made bread.

These issues are sub-sets of a larger issue: we inhabit one environment, much of it engineered. Lots of things can go wrong and if one does many people will be affected.

The general legal principle (the law of negligence) means that the person or persons who engineer the environment will be answerable for the consequences when things go wrong (central bankers and politicians, generally, excepted).

We have tried to make some of those “engineers” more readily answerable for the hazards of parts of that environment.

Employers come to mind.

See HERE  for the advice from the UK Health and Safety Executive to employers about safeguarding employees (and others, partially) from infectious agents.

Some of the “engineers” are builders and we have recent reason to think about walls and the building of them. In Cowan v GAA and McInerney & Son Ltd. [1991] 1 IR 389 the court heard that the plaintiff, a spectator, was injured when part of a wall collapsed on him at Croke Park in 1985. The part of the wall not collapsed had dowels or rods in it; the collapsed part did not. The court inferred that the specification for the wall required rods in every part and therefore the second defendant was liable. The first defendant was also liable because it should have reviewed the safety of its premises with a general structural examination following two notable disasters in foreign public stadia in 1985

The Health and Safety Authority is a good institution but an odd one. It was established under the Safety, Health and Welfare at Work Act 2005. It has as its central purpose, as recited in Section 34 of that Act,

“to promote, encourage and foster the prevention of accidents, dangerous occurrences and personal injury at work in accordance with the relevant statutory provisions”

So, oddly enough, when some customers were killed and injured in the Connacht Gold shop in Longford, the Health and Safety Authority, as it has done before, stretched its remit to investigate the incident. Actually, that is an overstatement; at least one employee was injured in the incident.

The most notable case of the Health and Safety Authority extending its remit (to the benefit of all) was the road accident in May 2005 in which five schoolgirls died when a Bus Eireann bus crashed in a single vehicle accident.

The Authority prosecuted Bus Eireann, Meath County Council and a motor service company for the accident. The anti-braking system on the bus was disabled. The motor service company noted this and left it like that. The county council commenced roadworks at the place of the accident without making a safety plan. These circumstances, mostly the disabling of the ABS, resulted in the accident.

The presence of the bus driver, a Bus Eireann employee, made the bus a workplace and conferred jurisdiction on the Health and Safety Authority.

It would be a good idea to make the jurisdiction of the Health and Safety Authority general and not simply limited to places of work.

It is also time to reform the law on liability of occupiers of premises as laid down in the Occupiers Liability Act 1995.

This is the appropriate editorial to replace that of the Irish Times of 2nd February 2013.

The blame for Ireland’s faulty beef burgers lies with the relevant Irish meat processors and, maybe, with someone in Poland. The testing of the burgers showed two pertinent facts; the animal source of the burger content and the proportion coming from each animal type. Of the tested burgers, most contained trace elements of horse and/or pig. One did not. That one burger, from Silvercrest Foods Ltd., revealed that Silvercrest’s meat constituent of the burger was one third horse meat. The other burgers, with traces of adulteration, were evidence of contamination, probably from the factory machinery. The machinery, in its turn, must have been contaminated by the very same source as the Silvercrest  burger; the meat the processors had put through the machines and into the burgers. The fact that there were traces only in those other burgers was not a relief; it simply showed the adulteration had passed through the factory and was, or had been, in an earlier burger production run.

Why did it take the Minister so long to discover Silvercrest’s meat sources led to, inter alia, Poland?

The fact that the public does not know the full facts relating to the adulteration of its food is the responsibility of the Minister for Agriculture and Food. It is unacceptable that the Minister persists in implying that unwittingly eating horse and pig meat is not a food safety issue. The public did not choose to eat horse or pig in the circumstances in which it ate those meats; the Minister is wrong to imply that the public does not know what is good for it, or that its loss of control over its food is not a big deal. Strictly, the Minister seems to think frozen burgers are fungible protein sources.

It is galling that Tesco is acting as the Minister should have acted; applying severe but appropriate sanctions to the guilty. Of what is Silvercrest guilty? It, reputedly, breached its contract with Tesco. It was limited under that contract to sourcing its meat from Irish or British suppliers. That contract would not have failed to stipulate that the meat was to be beef meat. When Silvercrest supplied Tesco it knew that the burgers, or some of them, were not in accordance with contract. Every such supply to Tesco involved a misrepresentation by Silvercrest. Unwittingly, presumably, Tesco in its turn misrepresented the contents of the burgers to its customers. In fact each of those misrepresentations was really a misrepresentation of Silvercrest to each consumer. Tesco was just a conduit of the falsehood. To suggest that this was a failure of quality control is, to be charitable, poor judgement. What Tesco describes as a “breach of trust” is clearly a breach of contract and a breach of Section 41 of the Consumer Protection Act 2007. It is an unsettled point whether it was also a breach of Section 42 of the Consumer Protection Act 2007.

It is disturbing that the Polish authorities are challenging the Silvercrest and Ministerial narrative of events. If Poland is not the source of the horse meat, what is the Minister going to do about that, resigning aside?

Noted in the Irish Times, 2nd February 2013, page 15.

 “With no evidence of fraud…”

This phrase means there was no evidence of deceit by Silvercrest Foods Ltd. There was in fact deceit. Tesco was deceived as to the sources of the burger meat; it described it as a breach of trust.

My online dictionary defines “fraud” as:

“a person or thing intended to deceive others, typically by unjustifiably claiming or being credited with accomplishments or qualities”

When the Food Safety Authority of Ireland tested a range of Irish frozen beef burgers, purchased from Irish and British supermarkets, it found evidence that they contained horse meat and/or pig meat.

It found that the source of the offending meat was the respective manufacturer of the beef burger. In the case of Silvercrest Foods Ltd. almost 30% of one burger constituted horse meat.

These facts were sufficient evidence to prosecute the various manufacturers (and the retailers).

Prosecutions are necessary because of the overriding objective of securing the safety of consumer food in the EU. If you are a manufacturer it is easy to ensure the safety of the food produced in your factory; you make sure that your sources are safe.If you fail to do this you should be prosecuted.

Under EU law Ireland is obliged to prosecute for breaches of EU law and the known facts were evidence of breaches of EU law and Irish law. The person responsible for ensuring there are prosecutions is the Minister for Agriculture and Food. That means there will be no prosecutions because he has shown he does not agree with the law.

He thinks that negligence is insufficient to get a conviction or even to bring a prosecution. He implies that proving knowing and deliberate adulteration of food is what is required to bring a prosecution and get a conviction but this is not and should not, be the case.

His is the latest in a long line of Irish failures. Ireland is an extreme example of a noted problem; regulatory capture. When a regulated industry (such as banking) exerts sufficient influence, its regulator becomes its champion and defender instead of its regulator.

Here we go again.

The Medical Council is the professional governing body for doctors in Ireland.

It describes its role as being “responsible for protecting the public by promoting and better ensuring high standards of professional conduct and professional education, training and competence among doctors. Doctors must always be guided by their primary responsibility to act in the best interests of their patients.”

To aid Doctors in meeting those responsibilities in difficult situations, the Medical Council has produced The Guide to Professional Conduct and Ethics for Registered Medical Practitioners.

It deals with the expected norms of professional conduct and practice and aims to help guide its member doctors to making good decisions.

Section 21 deals with the issue of Abortion.

Section 21.1 reads

21.1 Abortion is illegal in Ireland except where there is a real and substantial risk to the life (as distinct from the health) of the mother. Under current legal precedent, this exception includes where there is a clear and substantial risk to the life of the mother arising from a threat of suicide. You should undertake a full assessment of any such risk in light of the clinical research on this issue.

Section 21.2 deals with information about abortions.

Section 21.3 deals with the duty to provide care and support for women who have had abortions abroad.

Section 21.4 states

21.4 In current obstetrical practice, rare complications can arise where therapeutic intervention (including termination of a pregnancy) is required at a stage when, due to extreme immaturity of the baby, there may be little or no hope of the baby surviving. In these exceptional circumstances, it may be necessary to intervene to terminate the pregnancy to protect the life of the mother, while making every effort to preserve the life of the baby.

This is the standard by which medical professionals should be judged, by their own regulatory body and by the rest of us.

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.

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 20^th May 2008 because of outstanding issues. It was permitted to switch from conditional to full marketing on 24^th 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, (27^th 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.

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 17^th 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?