(1) Medical Law

Medical Law - WHO

Health Law - WHO

Legal Medicine and Medical Law

Health Law - Wikipedia

Medical Law - Wikipedia


Origins and legacies

 An orthopaedic surgeon might have the same skills as a carpenter, but bone and muscle were and are regarded as being made of stuff importantly, if mysteriously, different from pine and plywood. Bone and flesh build boxes for souls. Mess with the boxes and you could affect the soul. That gives physicians and surgeons awesome, high-priestly power.

The accountability of medicine’s high priests Priests are a set-apart caste: they are expected to behave better than the hoi polloi. All priests serve in temples. Those in the temples dedicated to divinities are answerable to the divinities; and those (the doctors) who serve in the material temples of the human soul (by rummaging around inside chests or by putting leeches on limb stumps) are answerable to the body owners, or to the society that represents them. But there is a problem about such accountability. If you’re an inaccessibly high priest-if your work is beyond the ken of the people to whom you’re accountable-how can accountability be real?

The doctors persuaded the people that they, the doctors, had to regulate themselves on behalf of the people. The Hippocratic Oath, already extant in the 5th century BCE (and therefore probably borrowed by the Hippocratic School from some mystical Pythagorean ancestors), is the classic example. It’s a code drawn up by doctors, for doctors, and is policed, more or less, by doctors.

For most of the next two and a half millennia, the Hippocratic Oath, or one of its many variants, has been the law regulating the medical profession. But here’s the point: these codes are not laws in the usual sense of the world. They are sets of ethical principles: the rules of a very exclusive club. Only when self-regulation manifestly failed, or the law acquired a self-confidence it has rarely had, or it became politically desirable to question the propriety of self-rule by an esoteric elite, did the law think it either necessary or appropriate to intrude into the holy of holies where the white-coated, bloodstained priests stood with their votive knives. By and large, continental Europe was quicker to regulate doctors than were England, the British Commonwealth, or the US, but it is hard to generalize usefully about why this was. Both France and Germany, for instance, imposed legal duties of confidentiality on doctors far earlier than did Britain, but their motives for doing so were not necessarily the same. Catholic France was perhaps influenced by the analogy between the confessional and the consulting room. If so, the French duty of confidence might be an affirmation of the sanctity of the consultation rather than the human rights of the patient.

Germany, on the other hand, has always been keener than many nations on regulation for regulation’s sake. But everywhere, until the middle of the 20th century, medical practitioners enjoyed extraordinary social status, and a legal status bordering unacceptably on immunity. The Nazis changed this. Their doctors showed that a professional qualification did not imply a decent conscience.

The seeds of this recognition were sown in the French Revolution and the Great War, when the myth of the infallibility of the upper orders was comprehensively and bloodily exploded. But it’s one thing to realize that a moustachioed, titled general is an ass. It’s another to recognize that a doctor, pledged professionally to heal, and speaking words of fate in hermetic language, might be incompetent or downright evil. It took Mengele to teach the world that doctors couldn’t be trusted to regulate themselves. This was an important moment for the rule of law.

The world learned quickly. Immediately after World War II there was a proliferation of international declarations and professional codes, including the Declaration of Geneva, 1947 (revised 1968 and 1983) and the World Medical Association’s international code of medical ethics, 1949 (revised 1968 and 1983).

This change in the zeitgeist, crystallized in and evidenced by the codes, was fairly effective in regulating unconscionable conduct (although, as we’ll see, some abominable things still continued to happen in the world of medical research, particularly in countries and amongst populations who, it was thought, wouldn’t invoke the newly promulgated, if rather toothless, declarations). It was less effective in changing judicial attitudes towards well-meaning but technically inadequate clinical conduct. Judges still tended to regard an assertion of clinical negligence as a piece of insubordination: the thin end of the Marxist revolutionary wedge. The judges, after all, had been to the same schools as the doctors, and drank the same ancient claret. If the professional judgment of a doctor could be questioned, where would it end? Lawyers might be next in the firing line. This led to an abuse of one of the commonest tests for establishing a breach of duty-the ‘Bolam test’. This is the idea that a doctor is not negligent if what he has done would be endorsed by a responsible body of opinion in the relevant specialty. The abuse continues, although it’s on the wane. Constitutional lawyers would assume, and everyone else would hope, that it was self-evident that the law, not the doctors, set the standard by which doctors should be judged. It is not yet self-evident to judges everywhere. English judges have been particularly slow learners.


A new set of medico-legal tools


When the law, belatedly, dealt with the health-care professions, it did so using tools that had been made for other things. It used notions of contract that were originally devised to regulate the sale of wool, concepts of trusteeship that worked well enough in suppressing the skulduggery of executors, and ideas of duty that let ginger beer manufacturers know where they stood if they let snails die in their bottles. These ideas do not necessarily export well into operating theatres. The chance of successful export is not increased if the export is handled (as it was) by legal practitioners (barristers, solicitors, and judges) who know a lot about the conveyance of land, the rule against perpetuities, the construction of bills of lading, and the Oxford and Cambridge Boat Race, but nothing whatever about the circulation of the blood or the anatomy of the bile ducts.

It’s surprising that things worked out as well as they did. Long before it was possible to talk about a corpus of medical law, let alone a profession of medical lawyers, the courts, proceeding by more or less bad analogy with commercial and personal injury litigation, and by an instinct for fair play honed or ablated on the cricket field, did approximate justice in the relatively few medical cases that came before them.

No accurate figures exist for the number of medical cases brought in the various jurisdictions. One problem is simply that of definition. What’s a ‘medical case’? But whatever a medical case is, the number of them increased steadily after World War II, and then, after the 1970s, increased very rapidly indeed. The rise in the number of cases was paralleled by an increasing acknowledgement of medical law as a subject in its own right. The two acted synergistically. The more medical cases, the more law: the more law, the more public and professional recognition of the possibilities of medical litigation, and hence the more cases.

Lawyers, particularly in the US, went into a feeding frenzy. The profit motive isn’t always a friend of nuance, but even greedy lawyers are sometimes clever and imaginative, and the desire to win cases and boost reputations gave the judges a chance to mould a distinctive corpus of medical law. And they did.

England typically catches American colds and ideas about ten years after the Americans are immune to them, and it is certainly true that English (and Commonwealth) medical law has borrowed some central medico-legal ideas from the US. But the medico-legal community is more genuinely international and egalitarian than many other legal communities. Everyone wants to learn from everyone else. Authorities from other jurisdictions are cited with less apology and embarrassment in medical cases than in many others. Perhaps this is because medical law deals with the most fundamental questions about humans. Americans might convey land in a different way from the Vietnamese, but they’re born and they die similarly. Perhaps, too, it’s because the questions are terribly difficult, being laced bracingly with biology and metaphysics. This means that judges are grateful for all the help they can get. At any rate there has been promiscuous cross-fertilization (the cynics would say cross-infection), which has produced some exciting, vigorous hybrids.


The industry of academic medical law


Another important chicken-and-egg-type question relates to the role of academic lawyers. Medical law courses have been taught now for many years, but have mushroomed over the last decade. They have produced graduates who have gone on to swell both the numbers of medical cases litigated and the sophistication of the arguments ventilated in that litigation. This has given their old tutors more to write about, so generating a demand for more medical law textbooks and courses, and so on, if not ad infinitum, at least to the point of medical law having a recognized status both as an academic subject and a professional sub-discipline. In some ways this is a shame: respectability leads to petrifaction.

There was a swashbuckling, rather rag-tag feel about medical law twenty years ago. Now medical law has a paunch, a suit, and a mortgage. You used to be able to say anything. Now there’s a growing orthodoxy. When you get orthodoxy you get heresies and burnings.


Medical law and medical ethics: a tense but fecund marriage


Medical law, both in academic courses and textbook titles, often has a partner: medical ethics. The nature of the partnership is obscure and complex. Medical ethics purport to say what doctors should do: medical law purports to say what doctors should do, or else. But it’s not so simple. There are ethical courts-the disciplinary bodies-which have fearsome teeth. Lord Justice Hoffmann, in Airedale NHS Trust v Bland (1993), said: ‘I would expect medical ethics to be formed by the law rather than the reverse.’ At first blush it seems that he got it wrong. The influence of the Bolam test is profound. In many jurisdictions the liability of professionals is determined by professional peers. A clinician will not be negligent if he’s done something in a way that would be endorsed by a responsible body of clinicians in the relevant specialty. Often (for instance in the law of consent and confidentiality) discussions about what amounts to legally responsible conduct have a distinctly ethical flavour. The ethical guidelines from the relevant regulatory bodies will be cited, and experts will opine about whether a rightly oriented professional conscience could reach the same conclusion as the defendant. Ethics seem to lead the way.

But is it really so? Who drafts the guidelines? Often lawyers will have sat on the relevant committees, infusing the drafts with their wisdom and folly. Lawyers are often listened to with entirely unjustified deference. Through guidelines and through dinner party conversations, lawyers may wittingly or unwittingly influence the consciences of surgeons, nurses, and occupational therapists. Hoffmann LJ didn’t imagine that the law would exercise its influence like this, but he might have got it right after all.

Practising lawyers, though, tend not to be very philosophically literate or interested. And even if they are, they don’t usually have time for anything other than rule-of-thumb, case-by-case-basis pragmatism. This is frustrating in the law of contract: it can be quite literally deadly in the law of medicine, where every question, properly examined, is a version of the Psalmist’s: ‘What is man, that thou art mindful of him?’ If medical law is ruled entirely by the lawyers, it’ll be a clunking, mechanistic thing. To deal properly with its astonishing subjects (humans), it needs to be more reflective, polymathic, and multilingual than it is or than it ever realistically can be. It will always fail, but it badly needs the help of the philosophers to help it fail less abjectly and more coherently.


The enforcement of medical law


When health-care professionals are accused of doing something wrong, they might find themselves in jail, poverty, disgrace, or all three.


The journey to jail: criminal jurisdiction


Health-care professionals can find the collars of their white coats fingered by the police for many things. They can and do sexually abuse their patients. This seems to be a particular pursuit of general practitioners/family doctors and psychiatrists, no doubt because of the opportunities that those specialities give, rather than because the specialities attract a disproportionate number of sexual predators. They invent clinically implausible excuses for breast and vaginal examinations, drug or hypnotize their patients into compliance, and misuse clinical photographs.

They can, and do, get involved in various types of medically related fraud, from fiddling their expenses or claiming for work done on non-existent patients, to drilling out and filling healthy teeth.

There’s nothing quintessentially medical about the law relating to medical fraud. You can see the principles in any criminal law textbook. We meet the distinctively medical parts of sexual and other assaults, on consent. But when doctors and nurses kill, the law is particular, particularly interesting, and particularly controversial.

The law of medical murder and manslaughter is dealt later, on the end of life. There’s of course a big and loud debate about whether the state should prosecute doctors who deliberately and compassionately ‘ease the passing’ of manifestly competent patients who ask for help in dying.

But what about accidental killing? Are the big guns of the criminal law appropriately directed against doctors who simply make a mistake with lethal consequences?

Take two examples:

A patient is undergoing a serious abdominal operation. Unknown and unknowable to the surgeon, the patient starts to bleed badly. The blood pressure plummets. This would be easily correctable if the anaesthetist notices. But he doesn’t, since, bored by the long procedure, he’s doing the crossword. The patient has a cardiac arrest and dies.

A patient has an epidural catheter placed for pain relief. She screams out for a top-up of her anaesthetic dose. A hard-pressed nurse draws up the anaesthetic and injects it. She has not checked the bottle properly. The drug is a highly toxic cancer chemotherapy agent, and the patient dies. In both these cases the police are summoned. In both cases the family has an unanswerable claim for compensatory damages, and in both cases the clinicians involved are likely to be hauled before the relevant professional regulatory body. They may never work again. What’s to be gained from criminal proceedings?

It might be said that the taking of a life is always a serious business, and must be seen to be taken seriously by the state, rather than only by the individuals most closely involved. The state exists to safeguard the security of individuals: its appearance in the role of prosecutor in criminal proceedings is part of that custodianship responsibility and the mere fact of the prosecution (perhaps particularly where the forensic fuss seems out of proportion to the magnitude of the defendant’s default) is shouting something important about the sanctity of human life.

Then there are the arguments which rest on what the state’s responsibility entails. It entails a duty to investigate properly the deaths of its subjects (a responsibility embodied, for instance, in Article 2 of the European Convention on Human Rights). This is partly because investigation involves healthy catharsis, and partly so that the lessons of tragedy are not missed. The prevention of future fatalities is important in another way: the drama of criminal proceedings might cause other potential defaulters to be more careful.

Against all this it can be said that there are plenty of other more appropriate ways of saying that lives are important and that the state cares. In most modern states inquests or other fatality investigations discharge the investigatory and, to some extent, the cathartic functions of a criminal trial. Regulatory proceedings ensure that individual doctors learn the lessons their own sense of guilt might not have taught them, and that wider risk management lessons are disseminated to the profession as a whole.

Adding yet another set of proceedings simply runs up costs that might better be spent on health care, delays the start of the grieving process, and panders to a prurient press. And yet patients’ families often want criminal proceedings. Revenge is an old and deep instinct.


The journey to poverty: civil claims for damages


Doctors are much more likely to be sued than prosecuted. The claim will typically be in the form: ‘You shouldn’t have done that. It’s caused me damage. I want compensation.’ Typical examples are negligence claims, claims based on consent, and claims based on confidentiality and privacy. In most jurisdictions these claims are tried by professional judges sitting alone. Those judges may or may not have any particular expertise in medical cases, but the trend worldwide is towards judicial specialization.

There are still jurisdictions (notably the US) where civil claims are commonly tried by lay juries. This scares the life out of defendants and their insurers. If you were an accountant, how would you like your ability to prepare a balance sheet judged by an innumerate panel, none of whom knows what a balance sheet is? It’s hard for the presiding judge to keep juries on a tight rein. They’re easily led by their noses and heartstrings rather than by the facts.

Where (as is common in the UK) the relevant health care has been given by a public body, the public body rather than the individual doctor concerned is likely to be the defendant. But even in the UK lots of health care is provided by private doctors or by family doctors (general practitioners, or GPs) who, although paid ultimately by the state, are sued in their own name. If the private doctor or GP has paid the necessary insurance premium, and the alleged malpractice falls within the terms of the policy (sexual misconduct, for instance, may well not), the insurer will indemnify the doctor and pay his

legal costs and, if he loses, those of the other side. So, generally, if he’s kept up his premium payments and has been ‘merely’ negligent, the doctor’s unlikely to lose his house.

Medical litigation is big business. And so, therefore, is professional indemnity insurance. Malpractice insurance premiums form a significant part of the total professional expenses of any doctor-and particularly those in specialties more likely to be sued (such as surgeons of various types) or in specialties likely to be sued for huge amounts of compensation (such as obstetricians, since brain damaged babies are expensive).

A 2011 study of US doctors showed that 75 per cent of physicians in ‘low-risk’ specialties, and practically all in ‘high-risk’ specialties, would face a malpractice suit at some time in their careers. But that doesn’t mean they will be successfully sued. The pattern is the same in the US as elsewhere: most claims don’t result in a payment to the claimant. More detailed statistics would be meaningless: they depend crucially on the mechanics of the compensation systems in the relevant jurisdiction. There have been strident calls for reform in many US states. Sometimes reforms have been enacted-typically along the lines of setting up special courts for malpractice litigation (on the assumption that they will deal with cases more speedily, so reducing costs, and will be less likely to be bamboozled by eloquent lawyers), reducing the length of time that a claimant has to bring a claim, and setting limits on compensation for pain, suffering, and loss of amenity (that part of the claim which is not capable of Scientifics quantification, and which juries sometimes assess in an over-sympathetic and wholly disproportionate way).


The journey to disgrace and unemployment: disciplinary and regulatory proceedings


An appearance before the profession’s disciplinary tribunal is what many health-care professionals fear most. They are unlikely, unless they are depraved, monstrously careless, or very unlucky, to find themselves before a criminal court. A civil claim for damages, although troublesome and embarrassing, is dealt with by the insurers. But a complaint that is explored before the regulatory body, almost certainly in public, can have much of the stigma of criminal proceedings, and, since it may lead to removal of the right to practise, can be financially devastating.

Most jurisdictions have some sort of self-regulation of the professions. It’s often done using a quasicriminal procedure, with investigation according to standard protocols, obligations on the part of the ‘prosecution’ to disclose everything material to the ‘defendant’, detailed charges, examination and cross-examination conducted as they would be in a criminal court, and a ‘sentencing’ stage, with provision for testimonials and other mitigation.

Regulatory tribunals are necessarily concerned with the confidence that the public has in the profession. A sanction such as suspension from practice or erasure from the register can be imposed simply because the public is outraged. This can make regulatory tribunals a sophisticated form of lynch mob-more responsive to the media’s call for a pound of flesh than they are to the rules of procedure or basic fairness. This is one reason why many of their decisions are reviewed by the courts exercising public law jurisdiction.


Public law jurisdiction


Many important decisions in medical law turn on whether a public authority (typically a local or national health-care provider) has acted lawfully. Examples might include a decision not to fund a particular type of treatment, to permit research on embryos, or to produce national guidelines setting out the criteria that should be used in deciding whether or not to withdraw life-sustaining treatment.

The way in which such questions are litigated depends very much on the quirks of the jurisdiction concerned. In the US, Germany, and South Africa, for instance, the constitution is likely to be invoked; in Israel, the basic laws. In the UK there is a broad provision for judicial review of administrative action. In the UK and other countries which are signatories of the European Convention on Human Rights, national laws or the means of their implementation can be challenged in national courts for alleged non-compliance with the Convention, with eventual recourse to the European Court of Human Rights in Strasbourg. Many cases with a medical taste have found themselves there. Many other jurisdictions have similar arrangements.

Human rights language is particularly common in medical law. It’s not surprising. Medical cases often invoke the most fundamental questions we can ask about human beings, their relationship to their bodies, and their relationship to the other bodies that comprise the societal soup in which they swim.


Jurisdiction over patients lacking capacity


Some of the most legally difficult, emotionally agonizing, and politically explosive decisions in medical law involve the court making decisions on behalf of those who cannot make decisions for themselves—for instance children and permanently or temporarily incapacitous adults. Judges regularly order the compulsory sterilization of the mentally incompetent, permit doctors to tie a struggling Jehovah’s Witness child to a table and give her the life-saving blood transfusion that her parents think will cause her to be hurled into the lake of fire for eternity, and tell doctors to withdraw artificial nutrition and hydration from unconscious patients (often over the protestations of the patients’ families), so killing them.

Treatment decision cases are extreme, dramatic examples of a benevolently paternalistic jurisdiction with which everyone’s familiar. Every day, all over the world, thousands of judges in family courts decide whether it will be best for a child to live with his mother or father. The same or similar judges, applying the same or similar criteria, decide whether it is better for the child to live or die. Judges regularly decide whether an incompetent adult’s career should be allowed to take money from the patient’s account. To decide whether a doctor should be allowed to take her ovaries out of her pelvis is a very similar process.


A one-stop shop for resolving medical law disputes?


There is much wasteful duplication in medical litigation. If a doctor kills a patient by negligently clamping the wrong vessel during surgery, he might find himself, in respect of that single mistake, prosecuted for gross negligence manslaughter, pursued for damages by the patient’s relatives and estate, watching his back at an inquest, and fighting for his registration before a regulatory tribunal.

And that’s not to mention other internal enquiries at the hospital, which might involve review of his employment contract. If he contends, as part of his defence, that the hospital was dangerously understaffed, it’s perfectly possible that the issue of resource allocation might be discussed in one of the public law reviewing courts.

This multiplicity of proceedings makes no one but the lawyers happy. The doctor might have to give identical evidence five or six times, the relatives will have to hear the same distressing story over and over again (putting their grieving on hold until the lawyers have picked the case clean), and many expensive independent experts might be commissioned to comment on the same set of facts. It’s possible that different tribunals might come to wholly different conclusions. The judge in the civil proceedings might decide that there was no negligence at all and that the doctor is an exemplary surgeon, but the disciplinary panel that the doctor was grossly negligent and should never practice again.

Can’t it all be done in one set of proceedings, depriving the lawyers of their brief fees, the doctor of his stress, and the relatives of their distress?

The answer is no. Although they start with the same set of clinical facts, each of these types of proceedings has its own distinct objectives and corresponding procedures. They are not always compatible with the objectives and procedures of the others. The criminal proceedings, for instance, use a different definition of negligence from the civil proceedings, and have a higher standard of proof. The assessment of damages in the civil claim is a sophisticated process involving evidence about matters that are wholly irrelevant to any of the other jurisdictions. The inquest, concerned to learn lessons that will prevent the repetition of the tragedy, will inquire much more broadly into the background of the case than will the other tribunals.

That’s not to say that something can’t be done. Some European jurisdictions run criminal and compensatory inquiries to some extent along the same channel. We can learn from them. But, sadly, so long as we acknowledge that all the various objectives are legitimate, most of the lawyers will continue to be paid.






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