Medico-legal problems & consent in obstetrics

Aziza Ali NegmAssistant lecturer of Obstetrics and

GynecologyBenha faculty of medicine

• Obstetrics is a specialty that is widely perceived to be associated with a high risk of litigation.

• In the UK, it accounts for about 60–70% of the total (malpractice) sum paid by the NHS Litigation Authority (NHSLA) each year.

• Patients,and their families, who are involved in a litigation process often experience physical and emotional trauma, which might not be alleviated by financial compensation.

• Increasing malpractice claims and subsequent fear of being sued caused many physicians to exclude ‘obstetrics’ from their practice.

• litigation process can cause pain, suffering and distress to clinicians as well as to the patients and their families.

• The public is increasingly exercising its right to have a high quality of ‘patient-centred’ clinical care that is designed to

meet individual needs. • .

• However, lack of resources and funding mean that expectations are rising at a rate far above the ability of the healthcare system to meet the demand

Why obstetrics

• As pregnancy is perceived to be a natural phenomenon, any unexpected outcome is deemed to be due to medical negligence in the eyes of the public. Labour still remains a poorly understood, and often a misunderstood,

• Obstetrics is a unique specialty involving multi-professional and multi-disciplinary working.

• This requires effective communication and team working to optimize patient care.

• Interpersonal and interprofessional conflicts, lack of understanding and respect for each other’s roles can compromise patient care, leading to litigation.

• Communication failures can be vertical (i.e. failure to involve senior members of the same profession) or horizontal (i.e. failure to involve members of other professions/specialties

The presence of a fetus can cause difficulties in decision making as one has to balance the benefits to the mother while ensuring ‘no harm’ to the fetus. This can result in delay or inadequate treatment.

Lack of medical evidence can result in clinicians making decisions based on mathematical probabilities when determining the significance of variables involved. Such an approach is open to human error,especially when viewed with the ‘retrospectroscope’.

Although litigation is based on negligence, law often confuses human error with negligence.

• Failure to take a comprehensive history

and assign ‘risk’ can result in

inappropriate provision of antenatal care,

leading to unfavorable outcome.

• Patients might sue the practitioner

for failing to identify risk factors, the

management of which could have

altered the outcome.

• Venous thromboembolism resulting from failure to provide

thromboprophylaxis based on previous history

• drug-induced teratogenesis resulting from the physician failing

to take the patient’s drug history and advising accordingly.

• Sometimes,a clinician might not perform recommended

‘booking bloods’, or might not act on the results of the same.

This could result in a ‘missed diagnosis’ and lead to

suboptimal maternal or fetal outcome. .

• Transmission of human immunodeficiency virus (HIV)

might result from not following the guidelines for

antenatal screening, which would in turn lead to a

failure to institute anti-retroviral therapy, failure to

deliver by caesarean section based on viral load

and failure to ensure the mother avoided breast

feeding

• Obstetric ultrasound can be associated with considerable medico-legal activity. The majority of litigation is related to fetal anomalies and missing an anomaly during a routine ultrasound scan.

• Over-diagnosis (false positives) and unrecognized images that are visible in retrospect on the ultrasound images can lead to litigation.

• Common areas for malpractice claims are missing fetal heart malformation ,spine bifida, absent distal limbs and multiple pregnancy. Rarely, a clinician might fail to inform the patient regarding ultrasound findings or might not discuss all the options available.

Patient choiceThe ethical principle of autonomy dictates that the obstetrician has a duty to help the pregnant woman make informed decisions about her care, based on her values and goals.From a legal standpoint, the fetus has no rights. However, advances in prenatal care and fetal medicine have made many consider the fetus as a ‘patient’.

Any situation where maternal well-being or wishes contradict the interests of the fetus constitutes a maternal–fetal conflict.

For example, patients who are at ‘low risk’ might request invasive prenatal testing, which might have inherent risks of fetal loss; caesarean section for fetal indications might be declined, placing fetal life in jeopardy.

In such situations, the obstetrician has two options. These involve respecting the woman’s autonomy and privacy, which in turn precludes any approach to save the life of the fetus or to modify this absolute right of the woman for the benefit of the fetus.

Imposition of treatment in these circumstances can be considered as invasion of privacy and battery, except in a case where a woman has no ability to give informed consent.

• Approach to the Courts in various jurisdictions has been confused and contradictory. In 2004, a pregnant woman was judged to be legally culpable for the death of her fetus for rejecting the advice of her physicians to undergo a caesarean section.

• This was in contrast to another Court decision to refuse ordering a caesarean section, when doctors predicted that fetus would not otherwise survive

Medico-legal problems can also arise if a pregnant woman refuses

to follow medical advice, thereby placing her own life in jeopardy.

Classic examples include Jehovah’s witnesses refusing blood and

blood products, especially in the presence of placenta praevia or

massive hemorrhage, and patients refusing to undergo caesarean

section recommended for maternal interest. The latter includes

major degree placenta praevia, obstructed labour,

malpresentations, abnormal lie and any other condition that

implies that vaginal delivery is contraindicated

• In one instance, a woman diagnosed to have placenta praevia was ordered by a Court to undergo an ultrasound examination and to submit to a caesarean section if the placenta was still malpositioned.

Maternal request for an elective caesarean section, when there is no demonstrable obstetric and fetal indication, is a situation faced by many obstetricians. Caesarean section carries procedure-associated morbidity and mortality to the patient as well as to the fetus. Although, a patient might give informed consent, the validity of such informed consent for non-indicated surgery is unclear.

In the eyes of the law, complications arising from a major operation, which was performed without any clinical indication, would be hard to defend. In a health system with finite resources, it is important to ensure that a woman’s individual right to request a caesarean section does not compromise provision of care to women requiring medically indicated caesarean section.

A vast majority of malpractice claims during labour relate to failures in

intrapartum fetal monitoring resulting in adverse outcome. A review of

110 cases of obstetric litigation for cerebral palsy concluded that 70%

of claims were based on abnormalities of the cardiotocograph (CTG)

and its interpretation.The fourth Confidential Enquiry into Stillbirths

and Deaths in Infancy (CESDI, 1997) concluded that more than 50% of

perinatal deaths had avoidable factors pertaining to intrapartum fetal

monitoring, which are also found in cases of litigation.

Factors commonly associated with litigation include

misinterpretation of the CTG trace, inappropriate or delayed action, technique and equipment problems ,inappropriateuse of syntocinon, record keeping, communication issues and poor supervision.

VBAC section is becoming increasingly popular among women. It helps reduce caesarean section rates and has a success rate of about 40–60%.Malpractice claims arise due to the failure to warn women regarding the risks of scar rupture and its sequelae, which include fetal distress and—rarely—disability or death.

Maternal complications of scar rupture include risks of blood transfusion and, occasionally, hysterectomy. Injudicious use of oxytocin, failure to inform women of the increased risks of scar rupture with induction or augmentation of labour and failure to institute effective continuous electronic fetal monitoring can also lead to litigation.Failure to adhere to protocols, e.g. category 1 caesarean section requiring a decision to delivery interval of20–30 min, and violation of protocols might also attract litigation

• Caesarean section is one of the most commonly

performed operations in obstetrics and gynecology.

• It does have risks of anesthesia, injury to bowel,

bladder and great vessels.

• Rarely, the angular tears of the uterus might extend

into the broad ligament or involve the ureters.

• Unintended injuries to organs can prolong hospital stay

and involve other procedures, including colostomy

Obstetricians might be sued for negligence, especially if they have failed to warn their patients of the recognized complications or for failure to take precautionary actions (e.g. failure to catheterize the bladder before the procedure, failure to seek senior help).

Failure to recognize the complications intraoperative (e.g. bowel or bladder injury) might lead to complications(fistula, peritonitis) that are difficult to defend. Retention of placental tissue after a caesarean section, although rare,is indefensible, as is the retention of swabs or instruments in the peritoneal cavity. Injury to the fetus with the scalpel and failure to identify abnormal ovaries might be considered as ‘careless’ practice leading to poor defense.

Ventouse and forceps have remained in the obstetrician’s armamentarium, However, injuries arising out of their use can lead to litigation. Choice of these instruments should depend on the skill and experience of the operator as well as the clinical situation.

a failed double instrumentation, necessitating an emergency caesarean and resulting in a suboptimal fetal outcome, can be difficult to defend

Shoulder dystocia• traditional risk factors for shoulder

dystocia have no predictive value and infants at risk of permanent injury are virtually impossible to identify.

• shoulder dystocia still remains one of the important causes of obstetric litigation.

Other potential causes for medico-legal problems in obstetrics include wound breakdown (caesarean section and episiotomy), complications of perineal tears including anal incontinence, fistulae and dyspareunia.

Prevention of medico-legal problems in obstetrics

COMMUNICATION

DOCUMENTATION

TRAINING&EDUCATION

RISK MANAGEMENT

Communication

It is important to build a good

patient–doctor relationship

from the outset. This will have

a positive impact on history

taking, informed choice and

the consenting process

Women should be involved in every stage of the management process. Information leaflets on obstetric scanning, common anomalies and the choices that are open to women will help them make an informed choice.

Use of a local counselling service is vital. Jehovah’s Witnesses need to be counselled about the risks of massive blood loss and the options available to them. Their wishes should be respected and the standard form can be filled-in in advance

There must be a clear policy on caesarean section for maternal request and any psychological reasons, including fear of vaginal birth, should be explored and counseling offered. Patients can be referred to another obstetrician for a second opinion or counseling. Dedicated patient information leaflets should be available for VBAC section.

It is also essential to ‘debrief’ the patient after an unexpected or untoward outcomeand to explain honestly what went wrong.

In cases of medical negligence, an internal enquiry should be held and its findings, as well as the actions taken to prevent similarincidents in the future, should be communicated to the patient.

Apart from financial compensation, patients resort to legal action because they want to find out what happened, why this occurred and to prevent future occurrence. Hence, honesty, timely explanation, empathy shown for the unexpected outcome irrespective of liability and efforts to identify what went wrong may prevent litigation

Effective communication should be promoted between all healthcare professionals and effort should be taken to improve ‘team building’. Multi-disciplinary meetings and ward rounds can help to improve communication and increase understanding and respect of each others’ roles. Communication in an emergency should be unambiguous and effective. Staff should be aware of the protocols,including the ‘categories’ of caesarean section.

Documentation

It is often said that, from a medico-legal standpoint,

‘ good documentation is good defense,

poor documentation is poor defense

and no documentation is no defense’.

• It is very important to document the discussion with the patient and the management plan that is jointly agreed upon. Consenting processes should be robust and the risks should be clearly explained and documented.

For caesarean section on maternal request for non-medical reasons, rare complications like maternal death, future risks of scar dehiscence and its implications, as well as placenta praevia and accreta, will need to be documented. Codes can be used to help preserve patient confidentiality, while alerting healthcare professionals of the need for special care. This can be used in pregnancies complicated by HIV infection.

• During labour, it is important to document CTG and vaginal examination findings, as well as to incorporate the entire clinical picture so as to provide optimum care. Verbal consent should be obtained for procedures like episiotomy and instrumental vaginal deliveries.

• During labour, it is important to document CTG and vaginal examination findings, as well as to incorporate the entire clinical picture so as to provide optimum care. Verbal consent should be obtained for procedures like episiotomy and instrumental vaginal deliveries.

In an emergency, if the patient is unable to give consent, her next of kin should be involved. Although, it is not legally binding, this is a good practice that might help avoid future litigation.

In shoulder dystocia, the manoeuvres and exact timing should be documented. In the light of current evidence, it is very important to document whether it is the anterior or posterior shoulder that is impacted. The number and duration of pulls in instrumental vaginal deliveries need to be documented, as well as cord blood gases.

The ‘normality’ of the tubes and ovaries, the swab and instrument count as well as the ‘emptiness’ of the uterine cavity should bedocumented in the operation notes for caesarean section.

Obstetric practice requires the possession of intrinsic

specialty-specific skills that need to be developed by

training and re-training.

Skills pertaining to obstetric ultrasound, interpretation

of CTG, instrumental vaginal deliveries, caesarean

section and management of obstetric emergencies like

shoulder dystocia are essential pre-requisites for safe

obstetric practice, hence they help reduce litigation.

Increasing the presence of consultants in the labour

ward can improve supervised training. CTG and

caesarean section meetings, mandatory skills and

drills training and simulated drills in the labour ward

are very useful in reducing mistakes that might lead

to litigation. New staff should have an induction

programme tailor-made to their needs and targeted

training should be offered for them to fulfil their

roles.

Risk management

It is important to nurture a ‘no blame’

culture, where all the staff can learn

positively from mistakes and avoid

similar mistakes in the future.

Training, support and 'mentoring’ should be

readily available for those who require them.

Clinical effectiveness should be improved by

the use of evidence-based guidelines and

protocols.

It is also important to update the guidelines

according to the ‘current’ evidence as the use of

clinical guidelines to aid in the legal determination of

negligence is increasing.

There are reports of Courts using clinical practice

guidelines to effect judgment without calling experts.

Clinical audit should be used to assess the quality

of obstetric care and deficiencies should be

identified and recommendations should be made to

improve practice. The use of central systems for

viewing CTG traces (‘neighborhood watch’) might

help increase the recognition of CTG abnormalities.

Obtaining Valid Consent

Consent is a process during which the professional provides adequate and accurate information concerning a procedure to a patient that allows them to reach a considered decision.

approaching consent

Before seeking a woman’s consent for a test, treatment,

intervention or operation,

you should ensure that she is fully informed, understands the nature

of the condition for which it is being proposed, its prognosis, likely

consequences and the risks of receiving no treatment, as well as

any reasonable or accepted alternative treatments.

• In preparing women for invasive procedures, you

should bear in mind at all times that this process may

be stressful for them.

• You should give information and obtain consent at a

time and in a manner that is appropriate.

• Adequate privacy must be ensured for information giving.

Women should not be given important information or asked

to make decisions at the same time as undergoing procedures

• it is preferable to ensure that the patient has received an

unbiased interpretation of the doctor’s explanation.

• All women aged 18 or over are considered to have capacity to

give consent unless there is evidence to the contrary. For

young women and children under the age of 16, consent can

be obtained from a parent or those with parental responsibility.

scope of consent• With the exception of an unanticipated emergency, the

practitioner should not exceed the scope of the authority given by

the patient. The classic example of this is abdominal

hysterectomy for postpartum hemorrhage to save life. In such

cases, the opinion of an experienced colleague or other specialist

must be sought before undertaking additional procedures.

• where possible, prior consent to treat any problem that could reasonably be expected to arise should be obtained and documentation of any procedures to which the patient would object or would prefer to give further thought before proceeding should take place.

Consent by women in pain and in labour:-• When consent has to be obtained from a woman

during painful labour, such as to perform a vaginal examination, episiotomy, operative delivery or to site an epidural, information should be given between contractions.

Consent to be sterilised should not be obtained while a woman is in labour, but an exception to this may be made if the woman has been fully informed during the antenatal period and has had an opportunity to ask questions of a senior doctor and already provisionally agreed.Consent to participate in research during labour will be addressed in a separate paper.

Consent for assisted vaginal deliveries, emergency caesarean section and perineal repairIn the emergency situation, verbal consent should be obtained which should be witnessed by another care professional. Obstetricians and the witness to verbal consent must record the decision and the reasons for proceeding to any emergency delivery without written consent

a woman who is deemed to have capacity to consent refuses assisted delivery or caesarean section, even after full consultation and explanation of the consequences for her and for the fetus, her wishes must be respected.

Following either a normal or assisted vaginal delivery, it is acceptable to obtain and document verbal consent for what is anticipated to be a straightforward perineal repair under local anaesthesia. If a more extensive repair under local anaesthetic or one under regional or general anaesthesia is to be performed then written consent should be obtained.

Ultrasound examination in pregnancyWritten consent for ultrasound screening is not currently considered necessary but women should be given the opportunity to request further information and such a discussion should be clearly documented in the patient record

obtaining legal advice

Doctors should seek legal advice where a woman lacks capacity to consent to a medical intervention which is non therapeutic or controversial: for example, sterilization.

Multimedia images

It is important to note that these images of laparoscopic findings, ultrasound pictures and X-rays do not require additional consent for use as part of the care record as consent for care purposes is implicit in the consent given for the procedure. If it is proposed that the image may be used for education or teaching,

If the woman will be recognisable from the image, this must be made clear to her before she gives consent.

Training

Explicit consent of women is required for the presence of students:l during gynaecological and obstetric consultationsl in operating theatres as observers and assistantsl performing clinical pelvic examination; written consent must be obtained for pelvic examination of anaesthetised women

Tissue samples

Following fetal loss after 24 weeks of gestation and in some cases before 24 weeks when analysis of fetal remains is required, written consent should be obtained for procedures on the fetus including samples for testing or retention of any tissues for later tests,

Should consent be verbal or written?• It is a common misconception that

consent has to be written for it to be valid. In fact consent must be written only when the law requires it.

Failure to take consent

• If consent is not obtained in cases where it should be and the patient has come to harm, this could lead to legal claims for assault or battery, which could proceed to criminal charges in rare instances

• Obstetrics is a risky business and many obstetricians and midwives dread the day they have to face litigation.

• identifying and avoiding the underlying factors that may contribute to litigation and maintaining a very high standard of clinical care may help avoid obstetric tragedies and hence, litigation.

The key principles for consent to be valid are:24

l The patient must have capacity to make an informed decision:¡ considered competent to give consent¡ able to understand information provided¡ can communicate their decision.l Consent must be provided voluntarily:¡ In most cases the decision to provide or withhold consent should be by the patient themselves.¡ The patient should not be coerced or influenced by carers, family or friends.l The patient should be fully informed of the following by carers with enough time allowed to reflect and ask questions:¡ benefits and risks of the intended procedure¡ alternative management strategies¡ implications of not undergoing the proposed treatment.