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HSE CTIF

The title means “Health Service Executive Clinical Trial Indemnity Form”.

In Ireland a clinical trial (which covers the testing of proposed pharmaceutical products) must be approved by an Ethics committee (of a hospital, say) and the Irish Medicines Board.

Because of the legal complications of supplying products on which, effectively, no assurances of safety can (or will) be given, it is standard practice for “the Hospital”, “the Authority”, “the Investigator” and “the Sponsor” to sign a Health Service Executive Clinical Trial Indemnity Form, providing for the payment of compensation without proof of fault to the injured participant in the trial.

In short, if there is any doubt about the sale of such products by a Hospital to a patient the original circumstances of the supply of the product to the Hospital will be recorded in a HSE CTIF. It will exist in quadruplicate and in four places.

That’s good evidence.

Irish Foreign Policy

It would be really nice and reassuring if we could know what Ireland’s foreign policy is on some important matters. Recently, I heard the minister for Foreign Affairs and Trade on the radio; he asserted he was working very long hours and working hard. He said it was a privilege.

I was immediately concerned. The assessment of his work is not his to make; it is ours. He should, instead have reported on the issues, not on his workload.

With the exception of Finance, there is no other ministry like Foreign Affairs; there, departmental thinking must be conducted at the most fundamental level. Thinking like that tends to the abstract. So, it is only the exceptional case where it reveals sensitive State secrets. In short, it should be open and not secret.

Arguably, global warming is one of the most fundamental issue currently facing any state, not just Ireland. Global warming is also called “climate change”, but the idea that the globe is warming is a better idea. It more accurately describes the problem. It also hints at an underlying fact; humans have caused this warming. They are still doing so. We in Ireland are also doing it. Global warming is not a myth; it is real and so are its consequences.

It is a global issue, so it is an issue for the Minister of Foreign Affairs and Trade. The department acknowledges this. It effectively describes Ireland’s policy as one where we favour collective action to reduce global warming (maybe even reverse it). We also favour aid to poor countries suffering from the effects and consequences of global warming. Finally, we favour taking the collective action through the EU and the UN.

That’s it. That’s Ireland’s “policy” on global warming. That policy is insufficient. Furthermore, it carries no indication that anybody has actually thought about it.

Does Eamon Gilmore have a policy on a carbon tax, for instance? We don’t know.

Does Eamon Gilmore have a policy on granting licences for fracking in Ireland? We don’t know.

This latter point is of critical importance, not just in making a judgment on the minister and his department, but on what Ireland must now do and say in international forums. France and Germany have in effect, banned fracking. It is essential to ensure that the elements of those decisions having a bearing on global warming be understood and supported and that Ireland act effectively to restrain and restrict actions or activities promoting or adding to global warming.

So, what does Eamon Gilmore say in the Council of Ministers to rein in Poland and the UK in their rush to frack their countries (and us)? We don’t know.

There is no evidence that minister Gilmore or his department actually understands “global warming”. The evidence for this lies in an EPA study of fracking. That study is leisurely awaited by Pat Rabbitte the minister for Communications, Energy and Natural Resources before he decides his policy on fracking. In short, Ireland’s policy on fracking and global warming is “wait and see”.

Is that what we are doing in the Council of Ministers and in the UN?

Clearly, Pat Rabbitte thinks shale gas is a natural resource. He is wrong about that if it adds to global warming. The EPA study actually claims to be addressing “climate change”, but that is not correct.

Anyway, that question, are we planning to add to global warming, is a question for minister Gilmore, not some technical expert hired by a government agency. The EPA study is the wrong response; it is an effort to find what is irrefutably wrong with fracking; we should be requesting conclusive proof from the proponents of fracking that it is harmless.

By the time some unprecedented storm hits the western seaboard, causing phenomenal losses, our actions will be irreversible and the minister will be retired.

We are in trouble.

The Running of Time

Our legal system contains the idea that time runs. What is meant by this, is that an event triggering a cause of action is the beginning of a window of opportunity to litigate a claim. By implication, the window has an end point as well as a start point. A plaintiff cannot successfully commence litigation until the triggering event (the suffering of a loss, usually) and cannot successfully commence litigation after the expiration of the time allocated by the Statute of Limitations for that class of claim.

Notoriously, Ireland diverged from the UK by establishing two (2) years as the window of opportunity for litigating claims for personal injury. We used to provide 3 years. The UK still has a three (3) year time period for such claims.

The facts of any particular case may complicate matters considerably. Frequently, a claim might be made in contract or in negligence or both, and there might also exist a claim under the Product Liability Directive (and therefore the Liability for Defective Products Act 1991)

The Statute of Limitations provides for 2 years for the claim in negligence and 6 years for the claim in contract. However, the courts have ruled that a negligence claim for personal injury may not be run under the law of contract because that would circumvent the shorter period of 2 years. It is permissible to plead the terms of the contract and to prove the breach but only if this is done in proceedings commenced within the 2 year period.

Time, for these purposes, commences to run when the plaintiff knew or should have known of the damage (and the identity of the defendant).

A claim under the Product Liability Directive (and therefore the Liability for Defective Products Act 1991) is treated differently. All rights conferred by the Directive on the injured person are extinguished on the expiration of the ten year period commencing when the product was first put into circulation. (“The Long-Stop”). Commencement of proceedings within the ten year period eliminates the long stop as a defence. This requires that a plaintiff knows or discovers the date when the product was first put into circulation in a timely fashion; the commencement of the circulation  might have happened years before the plaintiff was supplied with the product.

Within Ireland, it has been a live subject of discussion on the running of a time period while a plaintiff did not know that the time was running and could not possibly have discovered it. There is a strong argument that such a provision cannot be fair and therefore cannot be constitutional.

In the UK a similar argument was floated in the fetal anticonvulsant litigation with reference to the UK Human Rights Act 1998, but not pursued.

However times change and it is possible that the idea may surface in new circumstances.

Scientists

This office will be attending the BT Young Scientist of the Year exhibition in the RDS. I can remember seeing the work of one of the early winners; he had constructed a (working) model of the human digestive system, in glass and chemicals. I was incompetent to judge the work because there was in those days a bias against biology. Biology was not real science. Consequently, I cannot say if the model had a colon or not. I believe it did not but, not knowing any biology, I could see no flaw in the model.

In fact I think that there was no flaw in the model; nobody expected the model to perfectly correspond to a real human digestive system.

This kind of judgment or expectation is common. It’s a kind of wisdom. The wise judges of the exhibition recognised the merits of the digestive system model and nobody disagreed with, or challenged, this recognition.

After all. at that very moment, the scientific establishment was finalising the articulation of a Standard Model of the physical world of the very small. Like the human digestive model, it was incomplete. It still is incomplete. If the big guns of science can work like this, who are we to say otherwise?

Well, we, the “small guns” of science, are competent to make judgments on these matters, as much as anybody, as long as we remember the nature of the judgments we make. At any single instant of time, in any small location, there is a complexity of things and events beyond the possibility of perception. We do not perceive them and we manage to fumble along without doing so. Our fumbling is very odd. It is of the type that leads us to see faces, and other things, in rain clouds or in knotty floor boards. It also allows us to believe useful, false, things such as the idea that ostriches bury their heads in sand in the face of overwhelming reality.

The faces exist and do not exist and the ostriches bury their heads and do not bury their heads.

We saw an instance of this in the UK House of Commons the other day. The UK Prime Minister suggested that recent stormy weather and flooding may have originated in climate change. His backbenchers groaned in disapproval of that acknowledgment.

These are the same people who are responsible for opening up the UK to a licensing regime of fracking for shale gas.  For them, there is no evidence that fracking is problematic, let alone a disaster.

Eye-Watering

Who remembers the three Rs?

They are (or were) a political idea, or phrase. So, you went to school and, at a minimum, school would teach you “Reading, Riting and Rithmetic”. (School often fails at this),

It did not fail this writer.

So, here is some of my arithmetic;

Irish Water paid €50,000,000 to consultants for, “reports” (I think), in one year.

Days in one year = 365. Hours in one day = 24. Total hours in one year, 365 x 24 = 8,760.

Divide €50,000,000 by 8,760 = €5,707.76

So, assuming non-stop, full, productive writing over the year, the consultants were charging, and being paid, an hourly rate of €5,707.76.

Is this what politicians and judges mean when they talk of “compensation culture”?

Mistakes

What does it mean to make a mistake?

To make a mistake is to be wrong. Luckily, there’s a book on that. I recommend that book; in fact it’s some time since I read it and it’s time to read it again.

However, being wrong is not the subject of this post. There is a sub-set of being wrong; it is to be ignorant. So, the re-formulated question is; what does it mean to be ignorant?

It means you are normal. It is a normal part of the human condition. It is a mistake not to acknowledge this. (Another mistake!).

These are not mysteries; we refer to our mistakes as “a big mistake” or “a small mistake”. So we know that the quality of a mistake is important and, in the case of ignorance, that some aspects of ignorance are more significant than others. Ignorance can have qualities; it can be culpable, it can be innocent, it can be incorrigible. There have been very many instances recorded of ignorance. Take the medicinal use of leeches, for instance.

A leech is a blood-sucking worm. For at least 2,500 years, leeches were used by medical doctors to treat illness. This was based on a theory of human health that envisaged the necessity of relieving a patient of blood to restore health.

That theory was wrong and the beliefs of the doctors were false. The significance of this mistake is that it occurred in the equivalent of somebody’s study or schoolroom. It did not take place “in the field”, so to speak. The person who started the error had made a theoretical error. We know that the error was powerful; it captured the minds of every learned person into modern times and its correction had very powerful effects. To remember and record this erroneous belief is valuable.

The ancient theory of human health was well-meant. It aspired to be a comprehensive response to a persistent problem – human illness. In that sense, it was a good mistake. It was a pity it lasted so long.

Lawyers, or some of them, know all about mistakes like this. Just think about what lawyers say about evidence; there is always room for more of it. They say this obliquely, when they say that something is proved on the balance of probabilities or proved beyond a reasonable doubt.

These are scandalous standards. They imply absence of evidence and a shocking readiness to act in its absence.

But, like the use of leeches, these standards are well-meant, as long as we remember that they are provisional in use.

What does this mean?

It means that some decisions need more evidence than others. One of those decisions is the decision to judicially kill someone. In Europe it has been decided that we never have enough evidence to do that. In Ireland, it was decided that the use of nuclear power to meet Ireland’s energy needs was wrong; Dessie O’Malley’s policy to put a power station in Wexford was abandoned.

At that time, it could have been said that his opponents lacked evidence for their position, but that is exactly the point that lawyers are making with their scandalous standards. There is almost always evidence missing. Even scientists, who generally think they are working to a standard of “no doubt”, are actually working to a mere approximation of the truth.

What is of the greatest importance is to recognise that some decisions are qualitatively different to others.

Take fracking, for instance. This is a method of recovering natural gas from shale. It was developed by Halliburton, a US company that featured centrally in the Deepwater Horizon oil spill in the Gulf of Mexico.

Relatively speaking, very little is known of the effects of fracking. However, there are indications that it is, potentially and actually, a serious contributor to global warming. The gas in the shale is methane gas. It is a “greenhouse” gas; it promotes global warming. Fracking breaks the shale and releases the gas into the crevices and cavities of the shale. The gas is then free to find its way to the surface of the earth, possibly along the exploration channel and possibly elsewhere.

There is considerable evidence that fracking is a source of pollution, especially to water supplies. But that is not the real point.

The point is that fracking is an unknown quantity in its effects and that some, at least, of those effects could be catastrophic.

When a catastrophe will result if you are wrong, it behoves you to avoid doing anything that might precipitate the catastrophe.

Lawyers have a solution to such cases; the burden of proof (that fracking is harmless) should lie on the proponents of fracking, not on its opponents (that fracking is harmful) and we should not forget; absence of evidence is not evidence of absence.

 

The Depuy hip recall US MDL settlement – FAQs

What is the issue?

In August 2010, Depuy, a US conglomerate, owned by Johnson & Johnson “recalled” some of its medical products. The recall included the Depuy ASR XL Acetabular System, a type of artificial human hip.

These hips are fitted to consumers in the course of major surgery in hospitals. The recall was of the unused products; the used products were in patients. In fact, many of the hips were failing early and the patients were undergoing early, avoidable, difficult and dangerous revision surgery, involving pain and suffering from the failed hips and the surgery.

Often the physical failure of the hip is itself preceded by the release of chromium and cobalt ions into the patient’s bloodstream; these come from the abrasion of one part of the hip on another, wearing down the metal surfaces and releasing them into the patient’s body.

What happened then?

These facts and circumstances led to the commencement, around the world, of many legal claims for compensation and costs against the Depuy conglomerate, including in Ireland.

In the US, many of those claims were consolidated, effectively, in Multi-District Litigation (“MDL”) in Ohio.

On 19th November 2013, the plaintiffs’ lawyers and the defendants’ lawyers settled the MDL.

What was the MDL?

The litigation was not a class action. The Federal court system centralised all Federal US cases arising from the failure of the Depuy artificial hips in the Federal court in Ohio. So, every plaintiff in the Federal court system had his or her case transferred to Ohio for a hearing, potentially.

What actually happened?

The lawyers for these plaintiffs co-operated in selecting cases to be brought to trial in Ohio. As the date for the hearing of the first trial approached, the lawyers made progress in the negotiation of a settlement and concluded it on 19th November 2013. See the terms HERE.

What does it mean for Irish plaintiffs?

The settlement expressly covers only US litigation by US citizens. An Irish plaintiff, even in a US claim, will not be able to accept the settlement terms with Depuy, as a right. This is even more the case if the Irish plaintiff has issued, or intends to issue, proceedings outside the US, in Ireland, say.

Every Irish plaintiff must still, unless Depuy admits liability (or settles), prove his or her case against Depuy. The facts of each case will determine when and if time begins to run against Irish consumers of Depuy products, within which to issue proceedings. (Claimants should urgently consult a solicitor to resolve this question). If time has expired it is inconceivable that Depuy will settle such late claims.

Where the claim is not late, a plaintiff might reasonably infer that Depuy will settle such claims in Ireland; after all, the MDL settlement is valued in billions of dollars and outcomes, like that, imply liability by defendants like Depuy, do they not?

There is no certainty that Depuy will act in that fashion and Irish claimants should urgently seek advice from a solicitor.

Feeling Lousy

No, this post is not about hangovers. It’s about evidence. Ideas as to what is evidence have varied, somewhat, over time. (SPOILER ALERT)

For instance, “Murder comes to Pemberley” by P. D. James,  features a trial scene. Mr. Wickham, a character from Jane Austen’s “Pride & Prejudice” is on trial for murder. The implied date of the trial is approximately 1804. The UK lacked a police force at that time. The local magistrate has performed the police function and he has made the decision to charge Mr. Wickham with the murder of Lieutenant Denny.

The trial is in the local assizes court and the magistrate and his witnesses constitute the evidence against Mr. Wickham.

There are certain known and agreed facts. Lieutenant Denny is dead and he died from a head injury. In fact he had more than one head injury. He was last seen entering a wood, followed by Mr. Wickham. Mr. Wickham was located in the wood with the body, having dragged it some distance from where he found it, he said, with the injuries. He also claimed to have seen somebody fleetingly in the wood and he fired Denny’s pistol at that person but missed.

As always, the prosecutor is an experienced barrister. Luckily for Mr. Wickham, Mr. D’Arcy has arranged legal representation, by a barrister, for Mr. Wickham. That was an unusual element of Mr. Wickham’s trial. Only about twenty years before Mr. Wickham’s trial did criminal trials begin to feature defence lawyers. (They were barristers; solicitors had not come into being).

Unluckily for Mr. Wickham, the judge is from the old school; he sees little role for the defence barrister and prevents him from trying to restrain the prosecutor. The prosecutor introduces evidence of Mr. Wickham’s persistent failures to pay his tradesmen’s bills. “Evidence” like that is in fact the prosecutor’s case against Mr. Wickham. Mr. Wickham is not a likeable person and is generally not liked.

Mr. Wickham, apparently, gives evidence himself of what happened. His evidence goes down like a lead balloon. There are two reasons for this.

Firstly, he should not have been allowed to give evidence. The then law of evidence would have deemed him incompetent to give evidence because of interest. It was only in 1898 that this rule was changed for criminal defendants. For civil cases, it was changed in 1851. It was presumed that a defendant could not be expected or trusted to give reliable evidence when so much was at stake for him in the trial. Therefore he was, or should have been, precluded from doing so.

Secondly, his evidence was not the explanation that everybody wanted. How had Lieutenant Denny died? In fact, in offering his evidence, Mr. Wickham was, in an unexpressed manner, conceding that he had to prove something about the death of Lieutenant Denny and that that had to be exculpatory of him.

He failed in his proofs and failed to exculpate himself. Consequently, he was convicted. (That’s all, about “Murder comes to Pemberley”, in case you have not yet read the book or seen the TV series.)

What, in modern times, is good evidence?

The answer, as in 1804, is that it depends on the audience.

Here is my current favourite item of evidence.. We suffer from two small pests. They are head lice and pubic lice. The lice are exclusive to humans. The head lice have cousins; those cousins are found living on chimpanzees. The pubic lice have cousins also; they are found living on gorillas. Analysis of the genetic differences between the lice shows that our head lice diverged from the chimpanzee lice five million years ago. Our pubic lice diverged from the gorilla lice about 3.3 million years ago.

The divergence date of five million years from chimpanzee lice is significant and consistent with the estimated date of divergence of humans and chimpanzees.

The divergence date of 3.3 million years from gorilla lice is not consistent with the estimated date of divergence of humans and gorillas.

Put succinctly, one piece of evidence supports the contention that humans and chimpanzees had a common ancestor; the other piece of evidence supports the idea that early humans and gorillas were in close contact

It is not evidence that gorillas gave their lice to humans (or that humans gave their lice to gorillas).

The National Archives and The Department of Justice’s living history

by William Murphy

The National Archives are governed by legislation.

S8 of the primary National Archives Act 1986 sets out the requirement on Government departments to hand over files after 30 years.

Geraldine Kennedy in The Irish Times has reported on the surprising lack of new information in the files to be released this year on the GUBU phone tapping scandal of 1983;

“There are six phone-tapping files in all: four from the Department of the Taoiseach and two from the attorney general’s office. There is no file from the Department of Justice, where all of the activities took place. When questioned about the absence of any files from the department, an official in the National Archives volunteered that the department said it had neither the manpower nor the time to supply them in time.”

This is not one of the legally permissible reasons not to deposit state papers into the National Archive.

We know this, because in 1998, the Regulations governing the details of the transfer of records to the National Archives under the National Archives Act were signed. Section 5 reiterates the Act’s time limits

“5. (1) Records which are to be transferred in accordance with the provisions of the Act shall be transferred to the National Archives not later than the end of the year in which they become 30 years old.”

The full list of those records should have been transferred to the National Archives in advance, by last September 2013

“5 (2)(a) On or before 1 September each year, unless alternative arrangements have been approved in advance by the Director, each Department of State shall send to the Director one or more schedules listing all records which will be 30 years old as determined by Regulation 4(1) before the 1 January next occurring, and which have not already been included in a schedule previously prepared under this Regulation.”

Only if a certificate of the kind set out in law (below), signed by a designated senior civil servant from the Department of Justice and countersigned by the Department of the Taoiseach, has been accepted by the National Archives as justified may files be withheld. There are only three reasons why a certificate may be granted, listed at S8(4)(a),(b) and (c). Not enough time or manpower isn’t one of them. (As an aside, ‘not enough time’ seems like a surprising reason to explain why you haven’t done something foreseeable for the last 30 years.)

And that Certificate should also have been sought “On or before the 1st September” (per Regulation 7(1)(a)) by the Department of Justice.

I suppose the only thing that remains to be asked of the National Archives is whether a Certificate, of the sort set out below (taken from Appendix 5 of the National Archives Regulations) was sought, countersigned by the Department of the Taoiseach and accepted as justified. If not, the next set of questions would have to be for the Department of Justice.

(Oh, and the signatory of the 1988 Regulations? One Charles J Haughey, Taoiseach.)

 

Appendix 5

National Archives Act, 1986, Regulations, 1988

RETENTION OR WITHHOLDING FROM PUBLIC INSPECTION OF
DEPARTMENTAL RECORDS PURSUANT TO SECTION 8(4)
Form for use by Certifying Officers

CERTIFICATE
I hereby certify, pursuant to section 8(4) of the National Archives Act, 1986, that to
make the record(s) or part or parts thereof or class or classes of records described
below in the attached schedule available for public inspection would
(Quote one or more of the reasons for not making records available specified in
section 8(4).)
Records referred to above:

____________________________
Certifying Officer
Department/Office/Court:
Date:

CONSENT
I consent to the making of this certificate.
I do not consent to the making of this certificate.
(delete as appropriate)

_____________________________
Consenting Officer
Department of the Taoiseach
Date:
REVIEW DATE
Date not later than which the record(s) must be reviewed (day, month, year, 5 years
hence):
Notes:

Two Dublin Cinemas that show the connection between show business and academia

Show business is very old.

Arguably, the first philosophers were in that business. If what you say is important, you need to ensure that as many people hear it as is possible. Socrates, for instance, worked in the Athenian Agora. He had at least one location there where he conducted his dialogues; it was in the metal-working stall of a friend. This was a modest affair in comparison to the then current big entertainments, sport and the theatre, but the potential for growth was considerable.

We know this because Plato, a pupil of Socrates, established the Academy, an institution of learning and Aristotle, a pupil of Plato, established the Lyceum, also an institution of learning.

Arguably, they were each still in the business of show business.

Show business knows this; in 1922 there was a Lyceum cinema in Mary St., in Dublin and in 1965 there was an Academy cinema in Pearse St.

We now refer to higher learning as “academic”, but modern higher learning was forged in the Lyceum because Aristotle’s surviving written works outstripped all others of his time (and outnumbered them absolutely, also) and because the activities of the Lyceum were dissimilar to those in the Academy. Aristotle was a phenomenal worker, being, among other things, what we would now call a biologist. No other known person of the ancient world had such an interest (Galen excepted). Reputedly, Alexander the Great ordered the collecting of specimens to be sent back to Aristotle for study.

The Academy continued Plato’s focus on the ideal forms; these were the perfect abstracted archetypes of everything. They could not, by definition, be found in the natural world. The entertainment value of this must have lacked something, but there is a type of “academic” to whom this appeals.

That academic will not, currently, be running a blog or engaging with life on twitter.

Not for them the original call of show business to philosophers, where the important thing was to be heard.

Those academics will simply recede into obscurity. There is a growing trend for academics to blog. As Inger Mewburn and Pat Thomson of the London School of Economics and Political Science have recently written:

“But in our minds the answer to the question “Should I blog?” is now a clear and resounding “Yes”, at least, if conventional indicators of academic success are your aim. Blogging is now part of a complex online ‘attention economy’ where social media like Twitter and Facebook are not merely dumb ‘echo chambers’ but a massive global conversation which can help your work travel much further than you might initially think. But all this reverberation made us wonder: in the future, what will be the fate of academics who don’t make the time to blog or tweet?”