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Legal Issues and Medical Law Problems - Case Study
Sandra is 15yrs old She is pregnant but she has not told her parents and has disguised her pregnancy by wearing baggy clothes. She visits her GP, Dr Turner, for antenatal checks and has told him that under no circumstances should her parents be informed. When she is twenty five weeks pregnant an antenatal test shows that the foetus is suffering from a serious genetic condition.
Sandra wishes to have a termination and asks Dr Turner whether she can get an abortion at such a late stage in her pregnancy. Karen had a bad fall several years ago and has suffered intractable back pain ever since. She has tried complimentary medicine which has not helped.Finally she sees Mr Hutchins, a consultant at Freeside NHS TrustHospital. He advises her that she needs an operation. She agrees to theoperation but, unfortunately, she becomes paralyses as a result ofcomplications. The risk of such complications inherently arising in thecourse of such procedure is 5%. Dr Hutchins did not warn Karen of this risk. He considered that as she was desperate for treatment,information of such a risk would have put her off the operation, which he regarded as being in her best interests.
Identify and discuss the legal issues arising from all of the above facts.
The legal issues include confidentiality, autonomy, consent to medical treatment by children, disclosure of information in the consent process and clinical negligence. The legal principles are in plain type. Evaluation of the current state of the law is presented in italics.
The first issue to arise is of confidentiality. It concerns whether Dr Turner should inform Sandra's parents that he is providing her with medical care during a pregnancy. Sandra has told Dr Turner that in no circumstances should her parents be informed. It is greatly respected that information between a doctor and patient is treated as strictly confidential. This duty was established indirectly in Stephens v Avery. Information will only be divulged against the patient's wishes if there is a very substantial risk to public safety or personal harmor upon a court order. There is currently no statutory offence of breach of confidence but there may be a claim in equity. Information given in confidence is widely expected to remain so adding a common-law legal duty of confidentiality to the moral one in the doctor patient relationship. Confidentiality regarding a child is governed bythe outcome of the Gillick case which is detailed below during discussion on consent.
Importantly from the ruling in the Gillick case Dr Turner must make every effort in order to try to persuade Sandra to involve her parents. If Dr Turner assesses Sandra as Gillick competent with regard to the provision of patient care and with regard to not informing her parents and she cannot be persuaded to inform them then Dr Turner may so treat her and need not inform her parents. Confidentiality is governed by common law. Statute may be to advantage in prior clarification ahead of issues in this area although confidentiality in the medical setting is deemed so important since there is concern that without it people will not come forward for required medical care; therefore the introduction of legal rules by statute would be viewed in this context as most unwelcome.
An important issue is whether disclosure (of the fact of Sandra's pregnancy to her parents) is necessary in Sandra's best interests? In the case of an under-age patient the doctrine of necessity could be invoked whereby a technically unlawful disclosure was made without consent only if it was immediately necessary to safeguard the patient's life or health or to prevent serious deterioration but the doctor” must be prepared to justify such disclosure as being necessary to avoid a demonstratable risk of harm to the child”. We are not given any further information on the question to make these conditions likely to be fulfilled. So in this regard disclosure in Sandra's best interests would not be legal. This unsatisfactory legal area leaves the doctor very vulnerable following disclosure in what are often difficult clinical situations the infinite varieties of which make it difficult to envisage how this could be improved.
The issue of consent by a child to medial care arises since Sandra is15yrs old and therefore below the age of consent which is effectively16. Below this age parental consent is required unless the child is“Gillick competent”. This refers to the care Sandra is receiving fromDr Turner. The issues of consent to treatment by a girl under the age of 16 are asdetailed below. The issue of competence is also discussed. Sandra mayhave the required competence in order to validly consent to receiveantenatal care but not an operation. Competence does depend on thedetails of the situation of the medical treatment proposed. In practicethis is a sensible legal distinction and one which is workable inclinical practice.
The issue of abortion incorporates principles of autonomy and theabsence of fetal rights. The fetus, although acknowledged legally as a“unique organism” has no rights in UK law, being not a legal person;Re F (in utero) (1988) and has; “no right of action....... until birth”Paton v British Pregnancy Advisory Service . Personal autonomy –that of the pregnant woman to decide what happens to her own body - isgiven overriding importance. Once an oocyte is fertilised it has allrequired genetic material to become human. Once implanted the embryohas the required conditions which may allow its genetic material todevelop into a human. “Viability” describes when the fetus couldsurvive independently from its mother. It is a North American derivedterm from the case Roe v Wade  whereby the American SupremeCourt decided that the three trimesters of pregnancy should be treateddifferently; in the first trimester it was the woman's decision whathappened to her own body, in the second trimester the state couldintervene e.g. in controlling where termination could legally takeplace and the third trimester where the fetus was “viable” and hadstate protection. The definition of viability was a medical one. The UKapproach, itself problematic, depends on the “capability of being bornalive” rather than “viability”. In C v S  a case which concerneda father trying to prevent a termination “capable of being born alive”was defined as ability to sustain life by breathing (or artificialventilation). There is still some variability about this but it isgenerally considered around 24 weeks gestation. The earliest birthgestation with long term survival is 22 weeks. There are more rights inlater gestations. Once the fetus is 24 weeks gestation or moretermination is only legal to prevent risk of grave damage to the lifeor health of the pregnant woman or there is substantial risk of serioushandicap in the child. Intentionally killing a fetus capable of beingborn alive is the offence of child destruction (in England and Wales)under the Infant Life (Preservation) Act 1929. The present abortion actfunctions to fulfil a need but the woman's autonomy is medicalised,doctors are continuing to be involved and fear the underlying problemis not being addressed satisfactorily, and the mechanics of theabortion act facilitate what in practice is abortion on demandutilising doctors to certify that it is in the woman's best interests.
Concerning whether abortion legal at 25 weeks gestation it is legalat any gestation in certain well defined circumstances following thechanges to the Abortion Act 1967 in 1990 which is now the Abortion Act1967 as amended by the Human Fertilisation and Embryology Act (HFEA)1990. In Sandra's case the relevant certified grounds would be “E”“that there is a substantial risk that if the child were born it wouldsuffer from such physical or mental abnormalities as to be seriouslyhandicapped”. Not all serious genetic conditions would fall into thiscategory. Therefore whether this ground is fulfilled depends on thegenetic condition and most whether there was a substantial risk ofserious handicap. Under clause E there is no upper gestational agelimit – it was removed by the 1990 amendment to the 1967 Act. To belegal termination two doctors must sign Certificate A and state in goodfaith that the statutory requirements are met; R v Bourne . TheAbortion Act 1967 as amended applies in England, Wales and Scotland,but not Northern Ireland. It is an enabling act; R v Smith ;rather than decriminalising abortion, it states under whatcircumstances it is not an offence. This Act provides that in relationto grounds C and D the certifying practitioner may take account of thepregnant woman's actual or reasonably foreseeable environment. Thechanges made to the Abortion Act 1967 by section 37 of the HumanFertilisation and Embryology Act 1990 came into effect on 1 April 1991and included a time limit of 24 weeks for abortions under statutorygrounds C and D. Statutory grounds A, B and E, F and G are without timelimit. The abortion must be performed by a registered doctor or ontheir instructions in an NHS hospital or other specifically approvedsite. Documentation must be completed afterwards and returned to acentral department for registration of the details and collection ofstatistics. A significant proportion of severe genetic abnormality isnot confidently diagnosable prior to 24 weeks of gestation. Iftermination is performed for substantial risk of serious fetalabnormality and the fetus survives it may be more seriously damaged bythe “abortion” process and the resulting extreme prematurity. The fetusonce it is born it acquires rights. Damage deliberately caused beforebirth to a fetus that survives to infancy is an offence because of theCongenital Disabilitiess (Civil Liability) Act 1976. In this regard “anumber of relevant cases have been investigated at the level of theCoroner's court but, so far as we know, no prosecutions have followedthe death of a living abortus.” In practice such diagnoses involvefetal medicine departments who perform fetocide in advance andimportantly and an integral part of the termination process. This factis acknowledged within the statute since data concerning this iscollected centrally. The current law with the 1990 modification of the1967 Act does address the difficult issues surrounding termination forsevere fetal abnormality and the legal evolutionary process hascontributed to the method of inclusion of fetocide in the medicalprocess. However exactly what amounts to a serious fetal abnormalityfulfilling the grounds for termination at late gestations are not byany means clear cut. Indeed they are highly controversial and haverecently involved public debate. A condition that one pregnant womanwould regard as causing the continuation of the pregnancy to beintolerable to the life of the ubsequent child may be different fromthe views of others. Ultimately the legal process requires the decisionof two doctors. They are not necessarily in a better position to decidethan is the pregannt woman herself. This legislation places fetalmedicine doctors in a difficult situation morally.
An issue arises as to whether Dr Turner must support Sandra's requestfor termination of pregnancy under the Abortion Act 1967. Terminationfor the statutory requirements requires the signatues of two doctors.One of these is often the patient's general practitioner. Interminations for substantial risk of serious fetal abnormality it ismore often the situation that two hospital doctors sign. If Dr Turnerhad a conscientious objection to Sandra having a termination this isallowed by the “conscience clause” of the Abortion Act 1967 whichstates he/she has a duty to refer the patient to an alternative doctorregarding this issue “failure to do so would almost certinly beregarded as medical negligence.” Conscientious objection is onlyrelevant to the procedure itself and the decision to support therequest.
A key issue concerns whether Sandra, as a child under 16 and “isbelow the age of consent” can give valid consent. A child becomes anadult at the age of 18 (the age of consent). However at 16 consent totreatment is still valid under s.8 Family Law Act 1969. Sandra is 15and is a “minor” since she is under 18 s.1(1) Family Law Reform Act1969 and s 105 Children Act 1989. Whether she can give valid consentfor medical treatment (including the termination of pregnancy) dependson whether she is “Gillick competent” after the important decision inGillick . There are a number of components of the decision inGillick. Gillick competency is where the doctor decides that the childhas a significant understanding and intelligence to enable him or herto understand fully what treatment is proposed. The degree ofunderstanding required does depend on the seriousness and complexity ofthe condition and treatment therefore “competence” is not all ornothing but depends on the situation. An important aspect is that inorder to achieve consent via Gillick competence there must be failureto persuade Sandra to involve her parents. Additionally it is importantthat the treatment is in Sandra's best interests. This latter aspect isalso problematic since individuals do have very differing views ontermination for fetal abnormality and in the present scenario Sandrawould be making such a decision without having had the opportunity todiscuss it with her family; she is at risk of subsequent regret of herdecision. This puts the doctor in a difficult decision to decidewhether termination really is in her best interests.
The situation regarding consent to medical treatment by a child isan interesting area of the law. In the progress of the Gillick casethrough the courts in the various stages of appeal had alternatingdecisions, ultimately to the House of Lords. Mrs Gillick won her casein the Court of Appeal where the decision was such that doctors couldnot prescribe the oral contraceptive pill to girls under the age of 16without informing the girl's parent(s). The medical professionconsidered this was a very difficult decision to live with practically.Therefore the case was taken to the House of Lords. The subsequentdecision whereby doctors could prescribe and treat girls under 16without the parent's knowledge depended on the girl's understanding ofthe proposed treatment and that attempts to persuade her to inform herparent(s) had failed. The decision was welcomed by the medicalprofession and the mechanics of the decision for Gillick competency arein wide use today. So wide that any further challenge to the concept inthe foreseeable future would be unlikely to succeed. This is despitethe fact that during the legal process more judges decided in favour ofMrs Gillick than against her. This reflects the mechanism of the appealsystem. The Gillick decision is relevant to both areas ofconfidentiality in those under 16 in medical consultations and alsotheir ability to consent to medical treatment. The increasing autonomyafforded the child, though welcome, does result in some uncertaintywithin the law.
If Sandra does involve her parents and they do not agree to theabortion then the Family Court will decide, and if Sandra hassufficient understanding it is likely that her view will takeprecedence .
Regarding genetic counselling there are issues about whetherinformation can be given in the event of justified enquiries of bloodrelatives without Sandra's consent. The aspects of medical treatment,confidentiality and consent apply here also. A serious geneticcondition may have implications for the wider family (those who areblood relatives of Sandra or her partner). Consent may be sought fromher regarding whether she should inform these relatives either de novoor at the time of some future request from them. The same issues hereinterplay; the issues that her parents may be unaware of the fact ofthe pregnancy complicate further the decision making process forSandra. Patient confidentiality is respected in the genetic counsellingenvironment and no information will be released to others (includingfamily) without Sandra's consent. The consent issues regarding Sandra'sage apply as before.
An important issue is whether failure to warn of the risks ofundergoing a surgical procedure is necessarily negligent. In Smith vTunbridge Wells failure to warn of risks was held to be negligentdespite expert evidence being given which supported not giving awarning. In Pearce it was held to be necessary to inform patientsregarding significant risks that would be expected to influence thedecision of the reasonable patient to undergo treatment. The GMCrecommends full disclosure where possible. Clearly the case law showsthere is a need to warn but the extent of this need is not clear and itstill is not clear today despite considerable changes the decisions ofthe courts recently.
A contemporary issue concerns just how much information should bedisclosed as a part of the process of taking consent. There have longbeen arguments against full disclosure, by the doctor to the patient,including the concern that it may harm the patient by causing anxiety;however it cannot be confidently known that harm will result and thistherefore may not be good grounds for withholding information. Further,patients may prefer to leave the decision to the doctor however thisalso cannot be known to be the case until after the information hasbeen given. Lack of patient understanding cannot be assumed and fulldetails should be possible in simplified terms. The previous medicalpaternalistic approach is outdated, particularly so in the area ofconsent.
In favour of full disclosure is patient autonomy; the right todecide necessitating full knowledge of the facts. Patient autonomy hasan overriding influence in this area of law. It is very difficult todecide just how much information should be provided. Relevantresponsible bodies influenced by case law and by the relatively recentproblems in Bristol and Alderhay have produced guidance in line withgreater information giving to involve the patient to a much greaterextent than previously in decision making relevant to medical care.
In Sidaway the Bolam test (“a doctor is not guilty of negligence ifhe has acted in accordance with a practice accepted as proper by aresponsible body of medical men skilled in that particular art”) wasevoked to decide how much information should be give i.e. the amount ofinformation disclosure supported by a responsible body of medicalopinion. The application of the Bolam test to information giving inconsent has been criticised because it is difficult to apply toinformation giving in retrospect. This area of law regardinginformation giving in the consent process is a true junction betweenmedicine and law and the details are presently evolving through thecase law process. As far as the Bolam test was justified in Sidaway itcould be modified by Bolitho allowing the court to decide what islogical. In Sidaway it was considered that a risk of at least tenpercent of a serious problem should be disclosed and held that a riskof less than one percent need not be. In Sidaway the House of Lords wasdivided on whether to follow the Bolam principal for consent or whetherto move away from this towards the prudent patient approach. The formerview predominated. It was some time later before in Pearce there was amove toward the prudent patient test, an objective test giving theamount of information the reasonable patient would like to know. InLybert it was held that the information given needs to beunderstandable by the patient. It is not necessary that the patientbeing given information that the doctor believes will actually harmthem or again if the patient exercises their autonomy in deciding notto have the information.
An important issue concerns what constitutes valid consent. There is nolegal principle in England and Wales of informed consent (it isactually a North American concept ). Consent is a defence to the tortof battery (touching without consent). Patient involvement in thedecision to undergo medical treatment is now well recognised and hastaken on a greater meaning than a pure defence. The process of consentis amalgamated to duty of care, breach of which is so important foractions in negligence.
If Karen wishes to litigate regarding lack of information givenabout her surgery beforehand she cannot effectively use the lawrelating to assault and battery but instead must use the tort ofnegligence. For assault and battery all that need been shown istouching without consent; in the North American case of SchloendorffJustice Cardozo explained; “Every human being of adult years and soundmind has a right to determine what shall be done with his own body: anda surgeon who performs an operation without his patient's consentcommits an assault”. Whilst battery, if the conditions are fulfilled(and they seldom are in the healthcare setting) is relatively easy toprove negligence is generally very difficult to prove. It is unusual tobring for a claim for battery because of lack of consent for medicaltreatment to succeed. Where there was consent in general terms it washeld in Chatterton that consent was real and a claim in battery wasunsuccessful.
Valid consent requires that the patient is competent to make a decisionon whether to go ahead with the proposed treatment, there must besufficient provision of information to the patient, and the patientmust decide under their own fee will and not be under duress, sinceduress vitiates consent. Competence itself is split up into threeparts; firstly the patient must understand the information given;secondly they must believe the information and be able to retain theinformation long enough to make a decision; and thirdly they must beable to reason their way to a decision. These three parts compromisecapacity. This capacity is a legal concept. It seems incongruous thatthe doctor is involved in assessing the patient's competence to decidewhether they can give valid consent and yet a major component iscapacity which is a legally determined aspect.
The fact that Karen signed a consent form (she almost certainly did)for her operation is evidence that there was consent but it is notproof that the consent was actually valid or that enough informationwas given to her to facilitate the validity of the consent. Just howmuch information to give was a legal decision in the American case ofCanterbury “[it] demands a standard set by law for physicians ratherthan one which physicians may or may not impose upon themselves” thisconcept is not in widespread use since there is a move away from thedoctor being the person to decide how much information to give to thepatient having sufficient information for their requirements. InSidaway the approach taken was that the amount of information that itwas necessary to give to a patient for consent purposes related to theduty of care provided by the doctor (one of the components of the tortof negligence) these was a very negative way of presenting information.It uses consent as protection for the doctor against a charge ofbattery; consent here is used in a legal fashion. The subsequent andpreferable approach is “medical consent” to give the amount ofinformation the patient requires. This “patient enabling” “medicalconsent” as well as empowering the patient ultimately provides anenhanced legal consent of protection for the doctor especially in lightof the way case law has been developing.
The question arises as to whether Karen has a claim in the tort ofnegligence for being inadequately informed of the risk of theoperation. The requirements of the tort of negligence are thattripartite. Firstly there must be duty of care, secondly there must bebreach of that duty of care and thirdly causation must be satisfied bythe claimant showing the breach of duty of care caused the injurycomplained of in a way that was reasonably foreseeable (thus alsosatisfying the remoteness test). The duty of care in the most easy oneto satisfy (in the NHS setting) since it arises as soon as Mr Hutchinsoffers to treat Karen. The standard of medical care generally uses thetest outlined in the case of Bolam “that of the ordinary skilled manexercising and professing to have that special skill” he does not needthe have the highest level of skill possible. The second limb of Bolamis that the doctor acts “in accordance with a practice accepted by aresponsible body of medical opinion”. Bolam medicalises what should bea legal concept; that of negligence since it is the medical professionitself that decides whether or not a particular member has beennegligent. In Joyce it was stated that clinical practice could only berespectable if it could withstand analysis. The case of Bolitho putthe decision on whether a practice acceptable to a responsible body ofmedical opinion was sufficiently based on logic to negate a claim andwent a considerable way towards bringing the decision about negligenceback into the legal sphere.
The issue therefore arises as to whether Karen can prove causation withregard to inadequate information given to her during the consentprocess. There are three parts to causation. There must be injury, thisinjury must be foreseeable, and this must have occurred as a result ofthe breach of the duty of care. The doctor might have breached theirduty of care but this need not be the actual cause of the harm sufferedby the patient. This point is well illustrated in the case where apatient was sent home in breach of duty of care and died from arsenicpoisoning. The death would have occurred despite the breach in view ofthe fact that there was no available effective treatment for thecondition. Karen must prove causation to succeed in her claim. InBolitho failure to attend in breach of duty of care did not cause thedamage since no treatment would have been given (this itself was heldto be reasonable) had the doctor attended and negligence was notestablished. Karen's paralysis as a result of complications was aforeseeable injury resulting from the surgery since the risk was fivepercent; and as such this was a reasonably foreseeable consequencewhich also satisfies the remoteness test.
To be successful in a claim of negligence Karen must show thatinadequate information about the risk of surgery was given to her andif she had been given the adequate information she would not haveconsented, and therefore she would not have had the operation and wouldnot have suffered the harm. On the facts we are told that Karen hadsuffered intractable back pain for several years following her originalinjury and that she had tried complimentary medicine which did not helpand that finally saw Dr Hutchins. Dr Hutchins may state, as outlined inthe question, that Karen was “desperate for treatment”. By this a courtwould infer that she had been in pain for a long time and othertreatments had failed to give relief. Someone in this sort of positionwould be more likely to go ahead with a treatment which had seriousrisks than someone who had suffered relatively little. This will impedeKaren to some extent when she will necessarily will have to prove, onthe balance of probability, that she would not have gone ahead with thesurgery if she had known about the five percent risk of paralysis. Thecourt will use the “prudent” patient test. It will very much depend onhow convincing Karen is on this point. This is a difficult area sincehindsight is irrelevant and it is always difficult to provide evidencefor a decision that someone would have made in differentcircumstances. Such evidence may convince that if there had been awarning of risk of serious complication the surgery would not have goneahead as planned or would have been deferred to minimise risk ofunsuccessful outcome . For these reasons this is an unsatisfactory areaof medical law.
A further issue arises as to whether Karen has a claim in the tort ofnegligence for negligently performed surgery. Karen might have a claimin the tort of negligence for the performance of the surgery and/or forthe management of her subsequent complications aside from any consentissue. We are told from the question that the paralysis resulted fromcomplications that occur in five percent of similar operations. We donot know, and the litigation process would include consideration of thefacts concerning, whether paralysis occur in five percent of operationsof this type or alternatively the complications occur with a frequencyof five percent but only in a small proportion of these is theresubsequent paralysis. We also do not know whether there were anyfactors in her medical situation making surgery less risky or even morerisky for her. If the risk was higher in her particular case then thiswould be relevant to the consent issue. If the risk was less then onewould need to access figures from this particular surgeon's outcomedata to see if there was a statistically significant difference in hisfigures form the average bearing in mind case mix. Additionally thelitigation process would consider whether there were aspects of DrHutchin's surgery or practice which were unusual possibly inherentlyand unjustifiably risky and which could amount to breach of duty ofcare. It is accepted that the operation carries an overall five preventrisk of the complication but if other factors as mentioned above couldhave contributed to a significantly higher risk then a claim mightsucceed in proportion to the degree of risk conferred by the negligentaction. If the negligent action could merely be found to make amaterial contribution the award of damages may be made in full.Showing that breach of duty might possibly have caused the resultingparalysis is insufficient the burden of proof would be on Karen toshow that breach of duty of care caused the paralysis.
A final issue is whether Karen has any claim in contract. In any actionin view of Crown indemnity the hospital NHS trust is sued on behalf ofthe doctor. Under the principle of vicarious liability the employer isresponsible for the action of its employees when acting in the courseof their duties. If Karen had her operation under the NHS the aboveapplies and no action would be available in contract. However if shecame out of the NHS and had her treatment privately then she could sueDr Hutchins personally. He/she would have private insurance. Karencould sue in contract in addition to tort. The requirements ofcontract are fulfilled in the private healthcare setting since there isan offer, acceptance and consideration (the fee) in addition to theintention to be legally bound.
The issues discussed are particularly important within clinicalpractice today. Although case law and statute have evolved in response to changes in clinical care they also act to guide clinicians.
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