"…he is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art……Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view."
"Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other: but that is no basis for a conclusion of negligence."
"……the court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of opinion that the defendant's treatment or diagnosis accorded with sound medical practice……The use of these adjectives - responsible, reasonable and respectable - all show that the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular in cases involving, as they so often do, the weighing of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable or respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter……. …… if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible."
"25. ……….It seems to me that in the light of the case law the following principles and considerations apply to the assessment of such expert evidence in a case such as the present: i) Where a body of appropriate expert opinion considers that an act or omission alleged to be negligent is reasonable a Court will attach substantial weight to that opinion. ii) This is so even if there is another body of appropriate opinion which condemns the same act or omission as negligent. iii) The Court in making this assessment must not however delegate the task of deciding the issue to the expert. It is ultimately an issue that the Court, taking account of that expert evidence, must decide for itself. iv) In making an assessment of whether to accept an expert's opinion the Court should take account of a variety of factors including (but not limited to): whether the evidence is tendered in good faith; whether the expert is "responsible", "competent" and/or "respectable"; and whether the opinion is reasonable and logical. v) Good faith: A sine qua non for treating an expert's opinion as valid and relevant is that it is tendered in good faith. However, the mere fact that one or more expert opinions are tendered in good faith is not per se sufficient for a conclusion that a defendant's conduct, endorsed by expert opinion tendered in good faith, necessarily accords with sound medical practice. vi) Responsible/competent/respectable: In Bolitho Lord Brown Wilkinson cited each of these three adjectives as relevant to the exercise of assessment of an expert opinion. The judge appeared to treat these as relevant to whether the opinion was "logical"
“Speculum: Closed Cx”
“Speculum multips os’ In the multigravid woman the cervix tends to shorter than in the primigravid state and, although the internal os (opening into the uterine cavity) is closed, the external os (opening into the vagina) may allow a fingertip to be inserted into it. This condition is known as ‘multips os’. See later 9 Betamethasone is a steroid. . There was no pooling liquor. Amnistix were negative. The CTG was reactive. The impression was ‘early labour’ and Doctor Bett prescribed ‘betamethasone’.9 The note continues that the patient was requesting to leave, was strongly advised to stay, but still wished to go. The registrar was informed and the self-discharge form was to be signed. The self-discharge form is in the medical notes and is signed by Mrs Harris. It is recorded that betamethasone was administered at 20:40. From this it appears that Dr Bett’s examination was shortly prior to this.25th November 1995 – second admission 23:56: Midwifery notes Seemingly Mrs Dinsdale record that Mrs Harris arrived from home again complaining of contractions occurring one every two minutes. She was quite distressed at home. She needed to be reassessed and probably given analgesia. The notes says ‘? in established labour’. Blood pressure was 130/75, pulse 100. The note continues “Abdo does tense for short periods quite frequently, doesn’t seem to be as often as 2 minutes, but Lynn very uncomfortable.”
‘Nifedipine if dilatation of cervix greater than 4cm ‘as per protocol’
“26/11/95 – if Cx dilation <4 cms Nifedipine 10mg s/l Doctor Bett said that ‘s/l’ meant ‘sub-lingually’. 26/11/95 30 minutes later Nifedipine 10mg s/l 26/11/95 60 minutes later Nifedipine 10mg s/l - Call if BP less then 100/50 mmHg - If contractions cease then no further Nifedipine.”
“hypotensive and not contracting so not given.”
“13. Doctor Bett has recorded that Nifedipine should be given as per protocol. More than 22 years after the events I cannot now recall what protocol this is referring to, but it must have existed otherwise it would not have been agreed. I can confirm however, it would have been my standard practice to prescribe Nifedipine or other tocolysis to a mother who is 30 weeks in preterm labour with a view to suppressing labour. This would have been in line with my training and general practice at this time. 14. I understand it is alleged that the second dose of Nifedipine should not have been given at 01:35 on26th November 1995 . I see from the notes that I discussed the case with Doctor Bett at midnight but it is not noted whether we also discussed what the next steps in the mother’s care should be. I would have expected Doctor Bett to have called me if the clinical picture significantly changed. Otherwise, I would have expected her to continue to treat the mother as per our protocol and this must have included the second dose of Nifedipine if this was indicated. Had Doctor Bett called me to discuss giving a second dose of Nifedipine I am likely to have agreed that this was indicated because at 01:20 she has noted ‘abdomen still being painful (in waves)’. As there was evidence that Ms Harris was still experiencing contractions, I would have recommended continuing with Nifedipine to try and suppress the labour.”
“The term threatened preterm labour is often used to describe pregnancies complicated by episodes of clinically significant uterine activity but without cervical change.”
“clinical assessment on arrival was always complemented with cardiotocography. Urine analysis, laboratory investigations and ultrasound were performed when deemed appropriate.”
“This implies that a considerable amount of research will be necessary before the obstetrician’s diagnosis of preterm labour will become substantially better than the woman’s own diagnosis.”
“…because of the need for early management of suspected preterm labour, the diagnosis is commonly made in clinical practice before the above criteria are met, and hence the reported incidence of threatened and actual preterm labour may be open to question.”
“…any possible improvement in fetal outcome must be offset by the risks of exposing the mother and fetus to the hazards of treatment. This is particularly important in preterm labour since uterine activity often spontaneously abates. The judicious use of tocolysis is thus of paramount importance and these drugs must be administered in clinical practice with the same rigour that is required in research.”
“Remains uncomfortable – tightenings intermittent”. (iv) Professor Thornton’s interpretation of these notes was that Mrs Harris had been having contractions which had then stopped at about 0212 after two doses of Nifedipine He also referred to the midwife’s Antenatal In-Patient care Plan Note at a time before 0615 – see above (v) On3rd December 1995 Mrs Harris was admitted with a presenting complaint of “Tightenings every 2 minutes….staying same intensity”
“(1) In certain circumstances a court may be entitled to draw adverse inferences from the absence or silence of a witness who might be expected to have material evidence to give on an issue in an action. (2) If a court is willing to draw such inferences they may go to strengthen the evidence adduced on that issue by the other party or to weaken the evidence, if any, adduced by the party who might reasonably have been expected to call the witness. (3) There must, however, have been some evidence, however weak, adduced by the former on the matter in question before the court is entitled to draw the desired inference: in other words, there must be a case to answer on that issue. (4) If the reason for the witness's absence or silence satisfies the court then no such adverse inference may be drawn. If, on the other hand, there is some credible explanation given, even if it is not wholly satisfactory, the potentially detrimental effect of his/her absence or silence may be reduced or nullified.”
“30. There are three aspects to the claimant's submissions that demonstrate the difficulty that she has on this issue. First, Wisniewski is not authority for the proposition that there is an obligation to draw an adverse inference where the four principles are engaged. As the first principle adequately makes plain, there is a discretion i.e. "the court is entitled [emphasis added] to draw adverse inferences". An appellate court will be hesitant to interfere with the exercise of such a discretion given that it is being exercised in the knowledge of all the nuances of evidence that are in the knowledge of the judge who receives that evidence. Second, the judge in this case did not conclude that an absent witness had to be central to the case, he merely and correctly identified that the doctor in Wisniewski was central to that claim as the person who had failed to defend his clinical judgment. By comparison, the judge decided that Dr Hooper's role and hence evidence was tangential for the reasons I have summarised…. Third, there was an explanation for absence and that was a decision on proportionality grounds taken by the defendant i.e. this was not a case where a defendant or witness deliberately prevents or avoids the admission of evidence that would undermine their case. 31. There is also a further difficulty that the claimant must face. On21 August 2015 Master Roberts gave case management directions. The claimant sought a direction for disclosure of information about Dr Hooper but did not seek an order that she file and serve a witness statement. They could have asked for the latter. If the claimant was of the view that Dr Hooper's evidence was as important to her case as is now asserted and that an adverse inference would be appropriate in Dr Hooper's absence, they could have asked for a direction which contained the warning that an adverse inference may be drawn if the evidence was not provided. Even without such a direction, the claimant could have made arrangements to obtain evidence from Dr Hooper themselves.”
“..if contractions cease then no further Nifedipine”
“Hypotensive and not contracting so not give.”
“Contractions, (irregular) settled whilst on labour ward with nifedipine/pethidine treatment given breakfast”
“but Lynn very uncomfortable”
“Brief History of Tocolysis …………. 12. As nifedipine increased in popularity in the 1990’s, ritodrine was essentially phased out. The Royal College Guidelines from 2002 state that if a tocolytic drug is used ritodrine no longer seemed the best choice… Oxytocin Antagonist 13……………Thus, in the 1990’s the only licenced treatment was ritodrine which was considered to be associated with more adverse effects than nifedipine…….. General comments on case 16………..She was given nifedipine which was standard practice at the time. Although ritodrine was licenced for use as a tocolytic, it was associated with marked maternal side effects and was falling into disrepute……I consider that nifedipine should have been used in preference to ritodrine at this time given the data available. Indeed I consider that a significant proportion of obstetricians would have used nifedipine in this situation. Given the major competitor for nifedipine (atosiban) was not licenced until 2000, nifedipine was the first choice tocolytic at the time. I therefore consider that the management of Mrs Harris with nifedipine was appropriate and consistent with standard practice…… Comments on amended particulars of claim (undated) …. (ii) it was contrary to the 1997 Protocol to use tocolysis continually ……… The administration of nifedipine was favoured over the use of ritodrine given the marked maternal side effects of the latter. Therefore, even if the protocol had been available and it suggested that ritodrine should be used, I consider that it would have been outdated and nifedipine should have been administered as was widely undertaken at the time….. (c) Despite the fact that the Defendant was not part of (or conducting its own) clinical trial ………. Atosiban was not licenced until 2000 so this was not a viable alternative. It follows that the only alternatives in 1995 were to give ritodrine (associated with marked side effects), nifedipine (which required further evaluation), or no treatment which was considered (and still considered by some) not to be ethical. Thus, nidfedipine was the only sensible option at the time despite there being no high quality evidence of efficacy or improved outcomes… (d) (ii) Failed, negligently and in breach of the 1997 Protocol, to start an intravenous infusion running before instituting Nifedipine treatment…. ….. In 1995 it was considered that maternal fluids were relatively contraindicated in preterm labour. This was because ritdorine was falling into disrepute and there had been a number of serious maternal side effects (including maternal deaths) reported. It was considered that this was in part due to pulmonary oedema which was exacerbated by administration of maternal fluids….”
“The timing of this trial 51 indicates that there was clinical equipoise of the use of nifedipine and ritodrine at that time”
“There is still controversy concerning the use of the drug.”
“Its use should be confined to appropriate trials at present but its apparent safety justifies continuing investigation.”
“Current drugs used are beta-mimetics….calcium channel blockers…”
“These guidelines were produced under the direction of the Scientific Advisory Committee of the Royal College of Obstetricians and Gynaecologists as an educational aid to obstetricians and gynaecologists. These guidelines do not define a standard of care, nor is it intended to dictate an exclusive course of management. It presents recognised methods and techniques of clinical practice for consideration by obstetricians/gynaecologists for incorporation in to their practices. Variations of practice taking into account the needs of the individual patient, resources and limitations unique to the institution or type of practice may be appropriate”
“Many consider that the recommendation for the use of Nifedipine remains on inadequate evidence, especially with regard to safety.”
“There is little reliable information about current clinical practice but it is likely that Ritiodrine hydrochloride..remains most widely used.”
“Studies comparing ritodrine with nifedipine in the management of preterm labour suggest a similar tocolytic efficacy but fewer maternal side effects and no adverse fetal side effects with nifedipine.”
“Site a venflon and start infusion of Hartmann’s solution.”
“If contractions reduce substantially repeat Nifedipine...”