Is Justice Dangerous to Health
Dr Valerie Asche AM & The Hon. Austin Asche AC QC
I would answer this question in the negative because vaccines are the most powerful tool we have to prevent infectious disease.
To define two terms:
- Vaccination is the term for giving a vaccine (i.e. antigens).
- Immunisation is a term for receiving a vaccine and becoming immune to the disease by producing antibodies.
Some people use the terms interchangeably. Vaccines may have live avirulent micro-organisms, dead virulent, toxins altered to be non-toxic or sub-units such as modified protein or polysaccharide of the microbe.
Why are vaccines in such short supply?
There are now only 4 manufacturers in the US when in 1957 there were 26. We have one in Australia (CSL) producing influenza vaccine and Q fever vaccine. We also do import others under licence. Because fewer companies make vaccines, only limited supplies and reserves are available to meet a crisis. Costs following litigation have resulted in pharmaceutical companies abandoning making vaccines.
Public confidence in some vaccines is not high. For example, false litigation and publicity has led to the withdrawal of the vaccine against Lyme disease in the US. It was an extremely good vaccine.
Little research is being made into new vaccines – a summary of the reasons is as follows:
- Costs of manufacture
- Costs of trials
- Anti-vaccination lobby
I will describe some of the disasters:
(1) An Australian manufacturer, Commonwealth Serum Laboratories (CSL) had produced a prophylactic against diphtheria. It was an antitoxin raised in horses combined with the diphtheria toxin.
In 1928 at Bundaberg, Queensland, 21 children were given this mixture. Eighteen of them became ill and 12 died. In the first investigation which the Nobel Prize winner Macfarlane Burnet performed, he found the toxin of Staphylococcus aureus the cause of the deaths (as in toxic shock syndrome).
At that time, CSL delivered 10ml quantities of the preparation in rubber-capped bottles, without an antiseptic. Doses were withdrawn from one of the bottles, kept unrefrigerated, while being used over a number of days. No warning notice about multiple use of the product on different days had been sent from CSL. (I have a certificate sent to my school, from my parents prohibiting me from receiving this diphtheria vaccine, despite the fact that the general public feared diphtheria because of the high number of deaths in children.)
Result: An Australian Royal Commission recommended that biological products in containers for repeated use should have sufficient concentration of antiseptic to inhibit bacterial growth. Evidence showed that the method of supplying the preparation had been unsound. In Australia, litigation was rare: Royal Commissions were not.
A mercury compound, thimerosal was chosen at that time. It is ironical that this antibacterial has become controversial due to questions of its own toxicity. Hundreds of investigations have now been done on its toxicity with no clear result. As well, hundreds of cases in the American courts are pending, linking autism with thimerosal. This antibacterial has not been used in many vaccines since 2002.
Vaccines against diphtheria have been used for a 100 years and many examples can be quoted of accidents. In 1901 in St Louis, US, children died of tetanus after vaccination. It was found that one of the horses used to make the diphtheria antitoxin had contracted tetanus. Fancy a mild-wagon horse named Jim being immortalized. Rather like Typhoid Mary.
(2) 1930 in Lubeck, Germany, 251 infants received 3 doses of Bacillus-Calmette-Guerin (BCG) vaccine during their first 10 days of life. Seventy-two died of tuberculosis; 135 suffered from clinical tuberculosis; and 44 became tuberculin positive.
BCG is a bovine tuberculosis strain, Mycobacterium bovis, which has been attenuated by successive subculture in a glycerin-bile-potato medium. This was the first vaccine based on living bacteria.
An inquiry showed that the vaccine was contaminated with a virulent human strain, M. tuberculosis which had been stored in the same refrigerator. The two species are easily distinguished from each other. This was a preventable laboratory error that was never repeated.
Result: Legal action was taken against the manufacturers of BCG. All but two countries in the world (the US and the Netherlands) have given BCG to infants. This is because of the Lubeck disaster, the uncertainty of its efficacy, and prejudice against French manufacturers. (My connection with BCG is that my children received this vaccine soon after birth as I had TB as a teenager.)
(3) In the late 1950s, an employer in Geelong, Victoria, offered influenza vaccination to his staff. At that time multidose vials were used, also glass syringes and re-usable needles disinfected by boiling; hence, spores of bacteria were not killed.
Three workers died of Streptococcal septicaemia. It is believed that the worker, before the 3 deceased, had a Strep infection and this was transmitted to the following 3 by blood or tissue fluid aspirated into the needle. Changing the needle between injections does not prevent transmission, since the fluid in the needle may be sucked into the syringe.
Result: Professor Rubbo from Melbourne University collaborated with A E Atherton & Sons to produce an autoclave for medical practitioners to sterilise needles and syringes. As well, he advocated single use needles, syringes and vials and all staff (including himself) teaching medical students, advocated autoclaves and single use equipment. He demonstrated that suction occurs into the base of a syringe. Of course today, plastic disposable needles and syringes are used with some vaccines.
(4) The Salk vaccine (killed virulent viruses) for poliomyelitis has attracted an enormous amount of attention, followed by its replacement by the oral Sabin vaccine (living attenuated strains) and now the reinstatement of Salk in the US and Australia. Salk was first used in 1952, consisting of killed viruses from the three strains causing polio. The wrong calculation of time taken to kill the viruses by formaldehyde and use of poor filtration methods in manufacturing, led to thousands of polio victims, know as the “Cutter disaster”.
By 1954, many problems had been solved; Professor Rubbo decided on a huge publicity campaign for the Salk vaccine. He hired the Myer Mural Hall in Melbourne for one week and the staff from his Microbiology Department manned the exhibits.
The oral Sabin vaccine is cheap and is used in developing countries, but in the US and Australia, Salk is given to infants by injection. Sabin is only to be given if an epidemic is likely to occur.
On the 1st November 2005, the Australian Government funded childhood vaccines against 12 disease; all of the diseases cause serious complications and sometimes death. In Australia, all these 12 free childhood vaccines are given by injection. Free vaccine against hepatitis A was also available to Aboriginal and Torres Strait Islanders.
|Measles||Mumps||Rubella||H. influenzae type B|
|Hepatitis B||Meningococcal C||Pneumococcal||Chicken Pox|
From 1st October 2006, the GlaxoSmithKline vaccine against rotavirus was also issued free. The vaccine against human papilloma virus (cause of cervical cancer) is also issued free. Both these vaccines are of interest because of their Australian development.
Immunisation is the safest and most effective way of giving protection against a disease. Despite these rare and tragic failures, we must remember the past benefits of vaccination:
- Eradication of so many diseases in most parts of the world – small pox (except in 4 countries), diphtheria, measles, rubella and pertussis.
- The development of herd immunity so that epidemics do not occur if most of the population is vaccinated.
I hope our grandchildren live without the frightful epidemics of 100 years ago.
Vaccination against Litigation
If the cost of vaccines rises because stricter and more lengthy tests are considered necessary to ensure their safety, one can hardly argue with a principle based on public protection; the argument will be confined only to where the process can safely end.
If the cost of vaccines rises because stricter and lengthier tests are considered necessary to ensure their safety, one can hardly argue with a principle based on public protection; the argument will be confined only to where the process can safely end.
If the cost of vaccines rises because of litigation, the issue remains one of public protection; but in a divisive form, threatening the welfare of many for the benefit of the few.1
Cost of Health
Ultimately society, or more specifically, the taxpayer, pays for the sick or injured in the community. This is right and proper in a caring society which can afford these things.
Not surprisingly, many people have advocated a sort of universal scheme which would ensure that every injured citizen should get compensation on some graduated scale, irrespective of the need for a lawsuit to establish a claim. This, it is argued, would be more generally fair and just, not subject to the uncertain hazards of litigation and would do away with huge amounts of legal costs. This argument cannot be dismissed, although it may turn out to be more difficult than it sounds; and would I be the only person to contemplate vast herds of bureaucrats happily descending and clogging the arteries?
There remains, however, a public perception that, if a person is injured by a wrongful act, it is the wrongdoer who should be primarily liable, and there should be a personal right to take action.
It is now 75 years since Lord Atkin, supported by two Scottish Law Lords, and fervently opposed by the two orthodox English jurists who dissented, opened the floodgates (and this much abused phrase is entirely apt here for the most popular tort in legal history.2 Before we embark on the usual tirade about greedy lawyers pushing the bounds ever further out, we should also acknowledge the web of protection cast over us all, not necessarily because those who serve us are good, caring, people dedicated to the welfare of their fellow citizens (though no doubt they may be) but because they are highly attuned to the fact that some careless act or omission will conjure up a legal action, higher insurance premiums and nasty lawyer asking embarrassing questions. Nor should we cavil at the very proper duties cast on us as doctors or lawyers, though the High Court has very decently exempted counsel in court proceedings.
In a perfect world we may not need these protections; but in our present state of non-grace we do require some goad to good conduct; and just as Dr Johnson observed that the prospect of being hanged concentrates the mind wonderfully, so the prospect of being sued concentrates even a careless mind towards proper precautions.
The history of vaccines and their success in eliminating or controlling various diseases is well known. But that success did not come without incidental setbacks which caused grave illness or death to some individuals.3 And where it is alleged that the injury is caused by the negligence of the manufacturer or distributor of vaccines, care should be taken lest the result is wisdom after the event rather than what was reasonable in the known circumstances.
We have been given an excellent summary of the triumphs and vicissitudes of developers of vaccines. One observation arising out of the data collected in America is that pharmaceutical companies there are gradually abandoning vaccines and this is because of the number of successful lawsuits brought against them. This is disturbing because people might be deprived of protection which should be available to them. For reasons I shall give later, I do not consider that situation prevails or will prevail in Australia.
I am going to avoid one topic. I don’t propose, in the short space of this article to discuss the subject of product liability which seems to carry some uncertainties at this time, and I note that the High Court has reserved for a later occasion the question of that topic’s interaction with negligence.4
Have the tests and consequences of negligence been varied?
Some commentators thought the tort of negligence had become too all-embracing. Hayne J., of the High Court, in an article in the Australian Law Journal wrote:
“So effective has the march of negligence been, that many lawyers tend to see all forms of damage as potentially compensable through an action of negligence”.5
Thomas J.A. of the Supreme Court of Queensland remarked in 2001:
“I am concerned that the common law is being developed to a stage that already inflicts too great a cost upon the community, both economic and social”.6
As a result of these and other comments the Ipp committee was set up, chaired by Ipp JA of the Supreme Court of New South Wales. One of the terms of reference for the Committee stated that, “in recent times it has become too easy for plaintiffs in personal injury cases to establish liability for negligence”.7
Without going into too much detail, the report recommends a “capping” of damages in areas of non-economic loss (pain and suffering, loss of amenities and loss of enjoyment of life), and, basically, a return to the “Bolam” principle, subject to overall control by the court. In essence, the “Bolam” principle negates professional negligence if it can be shown that the process complained of was widely accepted by a significant number of respected practitioners in the field.
These recommendations, inter alia, have been accepted, in varying degrees, by the States and Territories. Insofar as they affect the law of negligence it appears that they suggest a more realistic approach to foreseeability, but do not otherwise defeat the general purpose of the action. I will refer to two cases to illustrate the point.
In Bryden v Chief General Manager of the Health Department 1986 Australian Torts Report 80-075, the defendant Health Department had conducted a mass inoculation in schools using BCG vaccine (i.e. protecting again TB). The plaintiff was an adult teacher encouraged to participate in the programme. Prior to the injection, he had suffered from rheumatoid arthritis, had been taking cortico-steroid tablets and likely to have been suffering from a disturbed immune system for a long time. He was chronically ill.
Each package of the vaccine contained a warning against it sue for immuno-suppressed individuals or the chronically ill. No warning or intimation of any kind was given to him. He became badly ill after the injection.
His Honour found against the defendant on the issue of negligence and awarded damages.
Although this case was determined before the amendments inspired by the Ipp report nothing turns on that, save that the damages would now have been less. This was a plain case of negligence, and nothing special turns on the fact that the illness was vaccine induced. The defendant argued that, because of the rarity of the response, it was not reasonably foreseeable, but that seems clearly negated by the warnings given on the vaccine package.
The case falls well within the ambit of what constitutes negligence.
I turn to the far more complicated case of Graham Barclay Oysters v Ryan 2002 211 CLR 540. This case, at first instance and on two subsequent appeals, was considered by 11 judges in all. The facts and the conclusion in law to be drawn from them were the subject of intensive discussion.8 There was a great deal of scientific evidence. I will try to summarise the facts and the reasons, but I fear the summary will be about as adequate as telling you that Anna Karenina is a novel about an adulterous wife who was late for the train.
The plaintiff and others had contracted hepatitis A after consuming oysters cultivated by the defendants in Wallis Lake in the Northern Coast of NSW. There was evidence that oysters grown in the area had the potential, at certain times, to collect and concentrate viral particles due to a discharge of faecal material from effluent sources around the lake. There was evidence that the local Council and the State Government had statutory powers relating to the management of the lake.
The grower had taken precautions by withholding sale of the oysters for several weeks until, on its estimation, the contamination would have ceased, and by testing samples of oysters for E.coli. Extensive scientific evidence was given as to the degree of precautions that could or should have been taken, and the debate ranged between the “could” and the “should”.
The trial judge found against all three defendants, i.e. the growers, the Council and the State.
On appeal, the Full Court of the Federal Court, by majority, allowed the appeal of the Council, but, again by majority, dismissed the appeals of the State and the growers.
On appeal and cross-appeal to the High Court, their Honours were in full agreement that, in the circumstances, neither the State nor the Council owed a duty of care to the consumers.
The important finding was whether the growers had been negligent. By majority9 the decision was that they had not been negligent. This seemed to involve their Honours overturning a question of fact so found by the trial judge, an exercise which an appeal court is traditionally reluctant to undertake. But, as Gleeson C.J., quoting Haynes J. in an earlier case, observed:
“Although a finding of negligence (or absence of negligence) is conventionally described as a finding of fact, it also involves a normative judgement.”
The important word here is “normative”, and it enabled the majority to take a different and, if I may be bold enough to say so, a more comprehensive and scientifically informed view of the facts, paying particular attention to the state of knowledge at the time and the precautions which the growers did, in fact, take. In all the circumstances then known, the growers had taken reasonable care.
Now it is notoriously unwise to draw statements of principle from a series of individual judgments which are not precisely similar, but I will venture a tentative suggestion that the views of the majority of the High Court do point to a realistic appreciation that, in negligence claims, particularly in a scientific field still developing one should not whip the present with the future.
One commentator has remarked that the High Court has constructed a “unifying theory”:
“It is emphasised the general principle that the existence of a duty of care and its extent will depend on what is reasonable according to community standards.”10
Unless or until a State or Territory enacts legislation for automatic compensation for any injury, the tort of negligence, as it now appears, should remain. Manufacturers and distributors of vaccines should not expect exemption from clear cases of negligence, but should be protected by the courts from liability from incidents which could not, in the state of present knowledge, be expected or if the stops which are submitted as necessary to be taken are, in all the circumstances, unreasonable.11 This is the essential difference between Bryden and Barclays.
The problem reported in America in a book such as “The Cutter Incident” is unlikely to arise in Australia. The differences in Australia from the American scene are as follows:
- American juries are prone from time to time to award very large sums, often staggeringly large sums, for what are known as “punitive” damages.12 The idea seems to be to teach a wealthy corporation to behave itself. Australian cases, on the other hand, have traditionally discouraged heavy damages in this area, following similar discouragement by the English courts.13
- The recent amendments to the law of negligence (and, it would appear, to actions under the Trade Practices Act) “cap” the damages that can be awarded under certain heads.14
- The Commonwealth Serum Laboratories are the only manufacturers of vaccines in Australia, although they also distribute vaccines made in Europe. It is realistic to assume that any damages awarded will eventually come out of the public purse. This should not excuse it from the sort of plain negligence shown in Bryden, but it will enable the court to balance the duty conferred with the breach alleged. Furthermore, it is an extremely professional body with a deserved reputation. It is unlikely to make the sort of errors which would justify an action for negligence under the present tests.
- Australian courts and professional legal bodies outlaw the practice of contingent fees, although some allowance is now made for recovery of proper legal fees on a contingent basis. If American lawyers support contingent fees as a way of ensuring that indigent plaintiffs can get their claims to court, then our system of legal aid, though not perfect, will achieve the same result without the added costs.
- The contemporary approach to negligence would appear to acknowledge that one should not be wise after the event.
Let our American friends keep their law. It’s not ours.
1. Two excellent books on the history of vaccines and the problems arising in their development are: The Cutter Incident by Paul A Offit MD, 2005. Yale University Press & Vaccine by Arthur Allen, 2002. W.W. Norton & Co, NY.
2. Donoghue v Stevenson – 1932 AC 562.
3. See the books referred to in footnote 1.
4. See generally, Hals. Laws of Australia – Vol 21(2) pp.338-500; and article by Wayne Guild “Consumer Protection – Developments in Trade Practice Law in Australia 1990-2001” 77. ALJ 446. As to the High court deferring the question as to whether, and if so, how far the provisions of the Trade Practices Act might “pre-empt” the common law, see Graham Barclay Oysters v Ryan – 2002 - 211 CLR 540, Per Gleeson CJ at 552; Gummow and Hayne JJ at 591; Gaudron J at 570; Kirby J at 621.
5. Hayne J. “Restricting Litigiousness” – 77 ALJ 381.
6. Thomas J.A. in Lisle v Bruce – 2001 – 34 MVR 206 at 207.
7. The Ipp Report was released on 2/10/2002, and the full text can be found on Google.
8. At first instance the case is reported at 1999 – sub. nom. – Ryan v Great Lakes Council – 1999 – 102 LGER 123. The appeal to the Full Court of the Federal Court is reported sub. nom. Graham Barclay v Ryan and ors – 2000 – 102 FCR 307 : 177ALR 18. The evidence, including the scientific evidence, is examined at length by Wilcox J at first instance, and equally carefully examined by Their Honours in the Full Court, including a judgment of Lidgren J of 121 pages.
9. Gaudron, McHugh, Gummow and Hayne JJ. Diss. Gleeson CJ. Kirby and Callinan JJ.
10. Hon. Desmond Derrington – 2004 – 78 ALJ 595.
11. c.f. Dovuro Pty Ltd v Wilkins – 2003 – 215 CLR – 317.
12. Or “exemplary” damages. Luntz – “Assessment of Damagers” 3rd ed. 1990 (Butterworths), comments (at pg64) that, “In America one reason” (in jury assessment of damages) “is to ensure the plaintiff is fully compensated after the attorney’s contingent fee has been deducted from the damages awarded.” !!!
13. Rookes v Barnard 1964 AC 1129, per Lord Devlin at 1227; Browne v Cassell & Co. 1972 AC 1027; XL Petroleum v Caltex Oil – 1985 – 155CLR 448.
14. The legislation is not uniform in all States and Territories. But c.f. Skene and Luntz – “The Effect of Tort Law Reform on Medical Liability” – 79. ALJ 345.
Copyright 2007. Greek/Australian International Legal and Medical Conference.
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