Laparoscopic surgery and the law

Gregory Kalu MRCOG

edical negligence litigation is an important issue ticcause of the rising cost of settlements and its M implication for the provision of healthcare

services. In its Fifth Report. the Commons Select Commit- tee on Public A )unts stated that, in 1997-1998, the National Health Service (NHS) paid out 579 million in

t ol‘ clinical negligence but still faced potential of 61.8 billion. Furthermore, liabilities to incid-

ents incurred but not reported could amount to a further 51 billion.’ As a result, the NHS Litigation Authority (NHSLA) has made data collection a key objective in a bid t o improve its records. At present, less than 5% of claims handled by the NIlSLA go to trial.

In 1997, obstetrics and gynaecology accounted for 70% of the Clinical Negligence Scheme for Trusts’ contingent liability by value, although the number of claims was more evenly distributed among the specialties.2 Medical Defence Union (MDU) data show that obstetrics and gynaecology is second only to orthopaedics and trauma in cost and frequency of claim settlement (H Goodwin, MDU, personal communication). The most expensive gynaecology claims are those for perforation of internal viscera (including vascular injury), which in the main arise from laparoscopic surgery. Small bowel perforation at 1aparoscopyiadhesic)lysis accounts for the highest award paid out so far (&210,000; legal costs not included) by the defence organisation.3 Injuries are often due to ‘blind’ insertion of sharp instruments into the abdomen at initial entry.4

The MDIJ’s laparoscopic surgery files for the UK for 1993-97 show that damage due to instrumentation occurred mostly with the trocar (39%) (see Figure 1) and that 77% of all intraoperative complications were only recognised postoperatively.

Jeremy Wright FRCOG

Figure 1. UK laparoscopic files notified to the MDU 1993-97: damage due to instrumentation (copyright The Medical Defence Union, 2000)

For informed consent prior to gynaecological laparo- scopic surgery, the risks of bowel and major vessel injury (see Figure 2) quoted should be 0.4/1000 and 0.2i1000, respective1y.j Higher rates have been reported in single- centre studies, with bowel injury occurring in excess of 3/1000 cases6 This still compares favourably with rates of 8.4/1000 at Iaparotomy and 7.3/1000 at vaginal surgery.’

In spite of these figures, it still appears that almost all laparoscopic accidents, unlike those occurring after classic surgery, will proceed to litigation.8 This may be partly explained by women who choose minimal-access surgery having higher expectations and being more particular about surgical outcome, especially the resulting aesthetic appearance.

Furthermore, if at a laparotomy (often undertaken because of significant pathology giving rise to clinical symptoms) injury such as an inadvertent enterostomy occurs, this is often immediately recognised and sutured. Such a mishap would usually he regarded as an accept- able risk of the procedure in a way that a similar injury at

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141139138

Common iliac arteryhein

External iliac artery/vein

Inferior epigastric artery

Uterine artery

Inferior vena cava

Right iliac artery

Abdominal aorta

Portal vein

Hepatic artery

Cystic artery

0 1 2 3 4

Frequency

7 8

Figure 2. UK laparoscopic files notified to the MDU 1993-97: type of damage (perforation of vessels) (copyright The Medical Defence Union, 2000)

laparoscopy (necessitating a second operation) would be regarded as negligent.

It is important to recognise that important differences exist between basic and advanced laparoscopic surgery. A significant proportion of adverse outcomes occur in the course o f basic laparoscopic surgery. Contributory- factors are:

0 The high numbers of basic laparoscopic procedures per- formed, mainly for pelvic pain and female sterilisation.

o Variable operator skills: trainees undertake a significant proportion of basic laparoscopy, whereas advanced laparoscopic surgery is performed by a small number of very skilled individuals.

a Patients’ acceptance of the increased risk of injury (and laparotomy) associated with advanced laparoscopy; this is probably the result of more in-depth counselling.

During pre-operative laparoscopy counselling. the following points should be raised:

Laparoscopy is a ‘blind’ procedure and therefore inadvert- ent injury may occur to internal structures, including bowel and vessels.

@ Operative laparoscopy carries an increased risk of dam- age to these structures because tissue dissection is a necessary and often integral part of it, in addition to the use of various instruments and energy sources.

@ Discuss alternatives to laparoscopic surgery, including medical treatment and conventional ‘open‘ surgery, that may be effective in treating the patient’s condition. This is necessary for a freely obtained and informed consent.

*As far as possible, the likely extent of surgery must be discussed and agreed with the patient prior t o the operation. The consent form should reflect this.

o Patients should be advised that, depending on the pro- cedure performed, shoulder pain, bowel dysfunction and colicky abdominal discomfort may occur, but it

should he emphasised that, postoperatively, relief from these symptoms is progressive Such symptoms should not worsen.

The irreversibility and risk of failure associated a-ith laparoscopic sterilisation should be discussed and recorded in the notes.

Practitioners of laparoscopic surgery may find the following a useful information checklist [note that specimen information leaflets are being posted on the British Society- of Gynaecological Endoscopy website (www.bsge.org.uk) and may be adapted to individual surgeons’ needs]:

Ensure that the most suitable operation for the individual patient is the one selected.

The principal surgeon must have the requisite laparo- scopic expertise.

The patient should have a full understanding of the limitations, benefits and risks of the proposed surgical procedure.

Keep clear, concise and accurate clinical notes.

Ensure adequate pre-operative work-up, which may include 11owel preparation.

Use safe technique at surgery.

Failure of the patient to make a steady postoperative recovery may be the earliest sign of visceral damage and should be investigated.

In the event of adverse outcome, prompt treatment is imperative and a mdtidisciplinary approach should be considered.

The circumstances of the adverse event should be explained to the patient hy the principal surgeon as soon as is practicable, with an apology where

Key points in reducing litigation risk include:

Adequate training and supen7ision.

Careful riskibenefit analysis of laparoscopic surgery as the treatment of choice fo r the individual patient.

Adequate patient counselling.

TJse of safe, recognised and previously described laparo- scopic technique (i.e. ‘hanging drop’ and saline return). It is worth mentioning that, even with meticulous atten- tion to the different techniques described to reduce visceral puncture at entry, there is no conclusive evidence that these reduce the risk.

Prompt diagnosis and treatment of complications related to surgery. Openness and honesty in the event of adverse outcome.

Continuous audit and evidence-based practice.

Awareness of changes in the law and Court practice.

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Laparoscopic surge~y and the law

MEDICAL NEGLIGENCE LJTIGATION: some cases in brief

Eyre v Measday [1986] 1 All ER 488

The gynaecologist Failed to advise a patient that her laparoscopic sterilisation carried a risk of failure. She became pregnant and, arguing that she expected to be 100% sterile, sued on the grounds of breach of contract. Having failed at the lower Court, she appealed. The appeal was dismissed, the Court ruling that, in the absence of an17 express warranty, it would be slow to imply against a medical man an unqualified warranty as to the results of any operation. See comment on Gold v Haringey Area Health Authority.

Gold v Haringey Area Health Authority [1987] 3 WLR 649

The health authority appealed against a judgement that was made against it for Failing to warn the patient that her sterilisation procedure carried a risk of failure. The Court of Appeal held that evidence at the relevant time was that a substantial body of doctors would not have warned of the risk of failure. The appeal was allowed. It should be noted that it has since become normal practice to warn uomen of the small risk cf failure associated with laparoscopic sterilisation and failure to do so may no longer he as easily defensible.

DeFreitas v O’Brien & Anor [1995] 6 Med LR 108

“he plaintiff appealed against the dismissal of her action for medical negligence on the grounds that the trial judge relied on too small a number of medical practitioners supporting the defendants’ orthopaedic and neurosurgical practice. The Court of appeal ruled that a small number cnuld well con- stitute a responsible body of medical opinion. The appeal was dismissed. The reader is referred to the case of Bolitho v City and Hacknv Health Authorl(y for an updated v i m on the role of the medical expert.

Linda Burrows v Forest Healthcare NHS Trust Court of Appeal 31/03/1999

Laparoscopic division o f omental adhesions to an abdominal scar (caused by previous abdominal surgery) resulted in accidental small bowel injury that was only recognised postoperatively. The surgeon who used only two port5 and cut through the small t3owel because he could not see properly was negligent for failing to use three ports. Wrative laparoscopy requires good access, visualisation and easy manapulation of internal structures. the latter requiring three or more ports.

CHANGES IN THE LAW AND COURT PRACTICE

The New Civil Procedure Rules (the ‘New Rules’)

Following a wide review of the civil justice system, Lord Justice Woolfs Access to Justice was puliished in July 1996. The resulting reforms were implemented in April 1999 as the New Civil Procedure K~iles.~

Medical negligence litigation came in for particular attention because of excessive delay and cost? which occur most often at the pre-action stage of disputes. A pre-action protocol was recommended to foster a culhu-e of openness? timeliness and co-operation between parties in the hope of settling disputes early and without recourse to litigation. One of the first initiatives of the Clinical Disputes Forum set up in April 1997 was the Pre-Action Protocol. Now part of the New Kules, the protocol serves as a code of good practice, providing a framework of timed steps to be adhered to in medical negligence cases.

Pre-Action Protocol A patient dissatisfied with a health service provider’s explan- ation of the circumstances surrounding an adverse outcome may consult a solicitor. Under the protocol, the solicitor may request relevant medical records, which the health service provider is expected to provide within 40 days.

If the plaintiff decides that there are reasonable grounds for a claim: then the facts of the claim with an offer to settle are sent to the health service provider.

A reasoned reply from the health service provider should follow within three months, stating whether the claim is admitted. This should also include a clear response to any offer to settle backed by evidence as to the value of the claim. Failure to adhere to the protocol may result in court sanctions.

Formal court proceedings by the claimant may only be issued if the parties fail to reach agreement on liability or cost issues, having exhausted the steps of the protocol.

THE EXPERT WITNESS The New Rules are designed to make litigation leaner, quicker and less contentious. The feeling was that partisan or ‘tame’ practitioners manipulated by lawyers to achieve a winning team populated the field of the expert witness.** This engendered distrust between parties to a dispute, slowed the pace but increased the cost of litigation.

Part 35 of the rules deals with the role of experts:

8 Overriding duty: part 35.3-(1&2) restates the overriding duty of the expert to the Court and not the instructing parties.

+ 35.341): ‘It is the duty of the expert to help the Court on matters within his expertise.’

+ 35.3-(2): ‘This duty overrides any obligation to the person from whom he has received instructions or by whom he is paid.’

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Court’s powers 4 Part 35.4-(1) ‘No party may call an expert or put in evid-

ence an expert’s report without the Court’s permission.’

+ Part 35.7-(1) ‘\X‘here two or more parties wish to submit expert evidence on a particular issue, the court may direct that the evidence on that issue is to be given by one expert only.’

The use of a join1 single expert in multi-track cases - a group to which most medical negligence litigation belongs - has been criticised not least because expert opinions niap differ significantly depending on specialty. For example, a surgeon acting as expert witness for a plaintiff with bowel injury at gynaecological laparoscopic entry Inay consider the ‘closed-entry technique’ inferior to the open ‘Hasson’ approach and therefore substandard practice. A gynaecolo- gist as expert witness is likely to hold a contrary view. Should the Court adopt the evidence of this plaintiffs expert, the position of the gynaecologist being sued could in fact be fatally weakened. Although the Hasson technique is popular with surgeons, conclusive evidence does not exist that it is inore protective against bowel injury.

THE 1998 HUMAN RIGHTS ACT Only a brief discussion of this Act, which came into force on 2 October 2000, is possible, although it is likely t o impact significantly on medical negligence litigation.

While awaiting the developnient of a substantial body of case law on the new Act as applied to niedical negligence litigation, it is expected that the provisions of Articles 2, 3 and 8 are the most likely to lie of relevance to laparoscopic surgery:

Article 2: the right CO life.

Article 3: the right not to be subjected to toi-ture,.. . inhuman or degrading treatment.

Article 8: the right t o respect for private and family life, home and correspondence.

The concept of ‘informed consent’ where the doctor largely determines the scope of information given tc) a patient may have to give way to a situation where the patient has to be told ’everything’.

I3owel injury necessitating a midline incision and, in particular! a colostomy riiay result in action under Article 3 as degrding treatment, more so if pre-operative counsel- ling was inadequate.

Confidentiality issues come under Article 8, but these are not specific t o laparoscopic surgery.

It is worth noting that, in a recent case, the use o f experimental equipment for sterilisation was held to be in breach of Article 3 by the European Commission even though the operation was successful.’2

STANDARD OF CARE AND EXPERT EVIDENCE To succeed in clinical negligence litigation, the claimant (plaintif0 must establish:

the existence of a duty of care breach of that duty (liability) causation, which requires proof that, on a balance of probabilities. the negligent act materially contributed to the injury.

The cases of Bolam and Bolitho have largely defined the law in medical negligence litigation and are therefore crucial to understanding the latter.

Stmdard of care in medical negligence litigation was def- ined in the 1957 case of Bolam u F W 7 n Hoqilal Manage- ment Committee by Justice McNair as follows: ‘The test as to w-hether there has been negligence or not is not the test of the man on the Clapham omnibus.. . The test is the standard of the ordinary skilled man exercising and professing to have that special skill’ (%lam

A doctor is not negligent if ‘he has acted in accordance with a practice accepted as proper by a responsible body of medical opinion., .a doctor is not negligent.. .merely because there is a body of opinion that takes a contrary view.’

In the earlier case of H u c b v Cole,I4 failure to treat septic spots with antibiotics, resulting in puerperal sepsis, was held to he negligent despite a responsible body of medical opinion in support of the doctor, the trial judge stating: ‘...that other practitioners would have done the same is a very weighty matter.. .on his behalf.. .but is not conclusive. The Court must.. .see whether the reasons given for putting a patient at risk are valid.’

Despite this case, Bobnz held sway in judicial decision- making. If the Court accepted the views of the defendant’s experts as representing those of a responsible body of medical opinion, the plaintiff-patient could not succeed.

Muynard U West Midlands Regional Health Authom‘[q5 provided fiirther clarification and support for the Bolam test when Lord Scarman opined that: ‘negligence is not estab- lished by preferring one respectable body o f professional opinion to another. Failure to exercise the orcfinary skill of a doctor is necessary.’

Plaintiffs faced a formidable hurdle in trying t o prove medical negligence. Any number of experts? it was argued, could lie found to defend a doctor’s actions. Courts avoided challenging expert medical opinion, believing themselves insufficiently experienced to do so.

The decision in Bolitho v City G Hackrq Health Authorit>J6 may change the face of medical litigation. Decided in 1997, it was the first medical negligence case heard by the House of Lords for nearly two decades. Tts importance lies in the unusual application of causation to Bolarn and the redefinition of the medical expert’s role.

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Cuse sunimuty. Two-year-old Patrick Holitho underwent surgery for a patent ductus arteriosus at the end of 1983. He \\.as re-admitted to hospital on 16 January 1994 with .acute Ix-eathing problems. On the second day of re-admission he suffered acute episodes of respiratory distress culminating in cardiac arrest. Between attacks and prior to the fatal attack, Patrick appeared to recover fully. Paediatric review was sought unsuccessfully on two occasions.

All agreed that there had been a breach of duty in the failure of the paediatrician to attend. Experts f i x both parties agreed that intulmtion w-ould have prevented cardiac arrest but the defence argued that, had the paediatrician attended, she would not have intubated Patrick, who appeared to recover fully between episodes of respiratory distress.

To succeed in this case, the plaintiff had to prove that the breach of duty resulted in Patricks injury (causation). In applying causation to Bolam, the Lords had to determine whether an omisioiz (not inhibating) as opposed to a positive act was defendable under the Bolam principle. Unanimously, they ruled that it was reasonable to expect that Patrick should not have been intubated. The plainhff s case failed.

Referring to medical experts, Browne-Wilkinson stated: ‘The Court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis because he leads evidence from a number of experts who are genuinely of the opinion that the defendant’s treatment or practice accorded with sound practice’ . . ‘The Court has to be satisfied that the exponents of the body of medical opinion relied upon can demonstrate that such opinion has a logical basis . . . the Judge accept- ing a body of opinion as responsible . . . will need to be satisfied that . , the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter.’

EXPERT CONSENSUS An international group of gynaecologists/surgeons with a special interest in laparoscopic surgery met in Middles- brough in March 1999. The result was a consensus clocu- ment on laparoscopic entry techniques,17 an implicit recognition of the fact that injuries at laparoscopy occur most commonly at entry.

The group acknowledged the need to identify optimum methodology and equipment to ensure that major complications are reduced to a minimum and to determine the best ways to identlfy complications in order to minimise the consequences.

If periumbilical adhesions are suspected, ‘Palmer’s point’ entry is recommended at closed taparoscopy. This is the space immediately below the ninth intercostal space in the mid-clavicular line18 (see Figure 3). It is important to exclude a splenomegaly before insertion of the needle at this site.I9

Consensus opinions backed by relevant medical colleges provide guidance and may he seen by the courts

I -1 - I \ Figure 3. Location of ‘Palmer’s point’: the space immediately below the ninth intercostal space in the mid-clavicular line

as representing the views of a responsible body of opinion - effectively, therefore, reference points in judicial decision-making.

Laparoscopists involved in litigation may find that they have to provide a satisfactory explanation to the Court for practice that differs widely from a consensus view.

Expert witnesses who are expected to have extensive experience in the area of judicial interest are likely to have contributed to such a consensus document. Should this not be the case, there would be a requirement to prove to the Court that an opinion differing from a consensus view is more logical and redSOnable. Such an opinion would have to be sufficiently robust to withstand rigorous scrutiny made in the light of available data and current experience.

CONCLUSIONS In an increasingly litigious climate, patients for laparo- scopic surgery must be offered adequate pre-operative counselling and, as far as possible, provided with information 1 eafl ets.

As a general rule, adequate training is necessary before embarking on any laparoscopic procedure.

In the event of an adverse event; prompt response and openness may reduce the likelihood of litigation. Even with the best possible practice, mishaps will occur and in these circumstances, reliance will have to be placed

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RISK MANAGEMENT Laparoscopic surge~y and the law

on accurate and detailed notes both of preoperative counselling and the procedure itself.

e Gynaecologists should keep abreast of legal develop- ments that are likely to have an impact on clinical practice

AUTHOR D E T W Gregory Kalu MRCOG, Consz~ltcwzt, Department o f Obstetrics and Gynaecology, Princess Royal Hospital, Lewes Road, Ha-).nrards Heath RHl6 4EX. UK (corresponding author)

Jeremy Wright FRCOG. Corzsidtant Obstetrician and Gynaecologzst, St Peter's Hospit~l Chertscy, UK

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10 Jackson C. The uses and abuses of experts and their evidence. Joiirrzal ofPeno7ial l~viir~ Lilgation 2000; 1: 19-29

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RISK MANAGEMENT Fregory Kaly, Jeremy Wright