Health professionals have a duty of care to their patients. This duty of care involves the provision of information as well as treatment. If there is a lack of care by the health professional and the patient is harmed, the health professional may be guilty of negligence. The standard of care expected has been set by other health professionals, but increasingly, the courts are deciding what is good practice
This article considers the common law issues associated with prescribing and the legal liability that can flow from it. A lawyer's interest in the prescribing of medicines would typically occur when a person supplied with a medicine suffered some illness or injury which he or she believed to be an adverse effect of the medicine.
The process by which medicinal drugs make their way to consumers is a complicated one and legal liability may accrue at a number of points in this process.
Firstly, the pharmaceutical company may be liable in respect of negligence associated with manufacture or marketing, although the common law liability in this respect has been substantially changed by amendments to the product liability provisions of the Trade Practices Act 1974 (Commonwealth). The Act allows persons injured by defective goods, including drugs, to claim for any damages that they have suffered. Defective goods are defined as goods whose safety is not such 'as the public are entitled to expect', having regard to a number of factors such as the use to which they are to be put and the warnings or instructions that are provided. However, the Act also provides defenses that manufacturers can rely upon e.g. if the defect was present only because there was a mandatory standard that the manufacturer complied with or the state of scientific or technical knowledge was such as to prevent the defect from being discovered. These provisions promise to make significant changes to everyday issues of liability in this field.1
The prescriber - such as a general practitioner - may also be liable on account of a decision to prescribe a particular drug at a particular dose to a patient or a failure to convey relevant product information to a patient.
Finally, the supplier of the drug - usually a pharmacist - may also be liable. Pharmacists are liable, both in relation to supplying the correct dose of the drug as prescribed, and also in ensuring that the drug is appropriate for the patient e.g. that no obvious prescriber error has occurred such as an adult dose mistakenly prescribed for an infant. This liability is both a safeguard against such an error and reflects the community expectation that the pharmacist is a skilled professional with duties and responsibilities that are independent of the prescriber's. The independent liability of the pharmacist was accepted in the 1988 British case Prendegast v Sam & Dee Ltd.2
Negligence and professional liability
Under Australian negligence law, persons are not strictly liable for the damages and injuries that they cause. Rather, they are liable when their conduct falls below a required standard. To be liable in negligence, a defendant (the person being sued) must owe a duty of care to the user of the product. The user must have suffered injury or loss as a result of that use and this injury or loss must have come about as a result of a lack of care on the part of the defendant. In other words, the defendant must be shown to be 'negligent' in not exercising the degree of care that should have been given. A successful plaintiff (as the person bringing the action) must show on the balance of probabilities (more likely than not) that the above points are true.
The standard of care required
The traditional position
All of the elements to a negligence action can present their own problems, but the most common tend to focus on whether or not the defendant's conduct fell below what might reasonably be expected. This raises the question - what standard of care is expected from a prescriber? The point is a crucial one.
The common law position on this question has traditionally been expressed in both England and Australia in the 1957 English decision Bolam v Friern Hospital Management Committee.3 This case involved assertions that both the standard of treatment and the information provided to the patient were deficient. The judge directed the jury in the following way. Firstly, he said that, in the case of clinicians, the test to be applied in determining the standard of care was that of the 'ordinary skilled man [clinician] exercising and professing to have that special skill'. In other words, the conduct of an allegedly negligent practitioner will be measured against that of an ordinary competent medical practitioner. The judge went on: 'A doctor is not guilty of negligence if he [sic] has acted in accordance with a practice accepted as proper by a responsible body of medical men'. Where two conflicting bodies of practice existed, the judge further directed that the jury was not obliged to determine which practice they believed to be the better. It was enough to find that the doctor's actions were in accordance with a practice 'accepted by responsible persons'.
The standard of care in the exercise of clinical judgement
Bolam's case has been highly influential in English and Australian law, but its principles are increasingly subject to question. In an action brought against the Red Cross in respect of contaminated blood products, Mr Justice Wilcox of the Federal Court said that 'whilst evidence of the practice usually adopted by persons in the position of a defendant will generally be of great assistance, and often decisive, the way must be left open to a plaintiff to persuade the court that the practice does not ensure an adequate standard of care'.5
Although this case is currently under appeal, it suggests that courts in Australia are now less likely to be influenced by what a body of responsible health care professionals would have done in the same set of circumstances as those being sued. Courts may thus be more inclined to make their own judgements, on the basis of evidence tendered, about what the reasonable standard might be in each particular case.
The standard of care in the provision of information
The provision of information by a prescriber is a necessary part of ensuring that a patient is properly consenting to a course of treatment. In this area, the change in thinking outlined above is well established: the law has shifted markedly away from the test of what responsible doctors do to what the 'typical' or 'average' patient expects. This shift may not be unreasonable - of all the aspects of the doctor-patient relationship, the provision of information sufficient to allow a patient to make informed decisions about treatment most obviously emphasises the patient sovereignty which should be at the centre of that relationship. In the much publicised High Court decision of Rogers v Whitaker, a case that involved an extremely rare complication (sympathetic ophthalmia) about which the patient was not warned before she agreed to a procedure, the Court made it quite clear that the information a clinician ought to supply to a patient was patient focused rather than clinician focused. The judges said:
'The law should recognise that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it'.6
However, in all cases, the prescriber's conduct is judged only by the information that he or she ought to have known about at the time. The prescriber's failure to heed information of adverse effects about which he or she had no reasonable way of knowing is not in itself evidence of negligence.7 In such a case, however, the pharmaceutical company might be held negligent if it failed to act positively on any data it knew about, or should have known about, or if it failed to pass the information on to prescribers and regulatory authorities.8
The prescriber's duty of care to his or her patient involves the exercise of clinical skills in diagnosing a condition and determining which, if any, drug is indicated and in what dose. It also extends to providing the patient with sufficient information to make an informed decision whether or not to take the drug, particularly in the light of any possible adverse effects or risks that might be associated with that choice. In particular:
- the clinical skills ought to be to the standard of a responsible body of prescribers, but, increasingly, Australian courts are likely to substitute their own determination of what is adequate in each case
- the information about the drug and any adverse effects of it should cover those points that a 'reasonable person in the patient's position' would want to know about9
Illegible prescriptions have been a source of legal liability for both pharmacists and prescribers. Courts have held both parties liable where a patient has been injured as a result of a badly written or misleading prescription. Prescribers should therefore welcome queries from pharmacists since they may avoid both injury to the patient and expensive litigation for all concerned.
Prescribing and product information
It is important to consider how the regulatory controls, in particular, the Commonwealth Therapeutic Goods Act 1989, affects the common law duties of care. The objects of the Act are to 'promote the development of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods.'10 Its focus is largely on the pharmaceutical manufacturers and specifies that one of their legal obligations is to ensure that they provide prescribers with all of the necessary information to enable prescribers to make proper therapeutic choices for their patients. Part of the legislative scheme established by the Act is the requirement that product information be provided by manufacturers in relation to drugs made by them and which they are seeking to market in Australia. This information, known as 'PI', is defined by the Australian Guidelines for the Registration of Drugs as 'information sufficient to ensure the safe and effective use of the drug under nearly all circumstances'. It is intended as a simple and objective statement of the drug's usefulness and limitations. Potentially, it is a valuable source of data about the parameters within which the drug should be prescribed. However, it is also recognised that the information is not necessarily the last word on the subject and concern has been expressed about the appropriateness of adhering to the product information in every case and also the liability of those who prescribe outside the approved indications.11
The formal requirements of the Therapeutic Goods Act 1989 have no legal applications in themselves to prescribers acting in the course of their work (even where the Act's provisions might appear to apply to them) since they are exempted from them insofar as the care of individual patients is concerned.12 However, it would be open to a court to conclude that a prescriber ought to have acted in accordance with the requirements of the Act if compliance with the Act amounts to what a court considers to be a reasonable standard of care. This raises the question of whether departure from the relevant PI might be seen as negligent if a person was injured by the drug. At first glance, given the formal nature of the PI and the purpose for which it exists, there is a strong argument that prescribers ought to follow the PI. However, compliance is not mandatory and, on either test of negligence discussed above, it does not follow that a failure to adhere to the PI will make a prescriber negligent. For example, there may be doubt about the appropriateness of the PI for a particular drug and a responsible body of prescribers may believe, or a court may be convinced, that, either in general terms or in the particular case at hand, it was appropriate to depart from the terms of the PI for that particular drug or for a particular patient. Thus, prescribing for a non-approved indication will not necessarily leave a prescriber vulnerable to a negligence action. Further, the information may be superseded by more recent knowledge. In such a case, if it is reasonable to argue that the prescriber ought to have been aware of that new knowledge, a plaintiff might even argue that a prescriber should have departed from the PI.
From the prescriber's perspective, the relevant PI is an influential guide to the drug in question and, as is the case with any code or guideline which does not carry with it a mandatory obligation to comply, it would, as a general rule, be wise to follow the requirements of the PI. Therefore, whilst failure to follow them may not be tantamount to an admission of negligence, prescribers must, in these cases, be able to justify to both colleagues and a court why they departed from the standard information scheme as provided through the legislation.
The following statements are either true or false.
1. If prescribers do not prescribe a drug for an unapproved indication, they cannot be negligent in the treatment of that indication.
2. Pharmacists may be liable for any harm that results from dispensing an incorrect dose, even if that dose was ordered by the prescriber.
Answers to self-test questions
- See sections 75AC, 75AD and 75AK of the Trade Practices Act 1974.
- Court of Appeal unreported. See the recent article 'Pharmacists' liability for drug-induced injury' by J. Crawford (J of Law and Medicine 1995;2:293-309).
- Bolam v Friern Hospital Management Committee 2 All ER 118.
- E v Australian Red Cross Society (1990)99 ALR 601 at 650.
- This case is currently on appeal and raises a number of important medicolegal issues including the duty to attend in an emergency. See the discussion in CCH Aust Health & Medical Law Reporter 77-098.
- Rogers v Whitaker (1992) 175 CLR 479.
- This was established in the English case Roe v Minister of Health 2QB 66.
- See also the statutory obligation imposed by section 29A of the Therapeutic Goods Act 1989 (Cth) which requires a person 'in relation to whom therapeutic goods are registered' to notify the Secretary, as the regulatory authority, at once of adverse information relating to those goods that the person becomes aware of. This information is specified in the section and includes unintended harmful effects when used as recommended. Very serious penalties apply for noncompliance.
- See the recent article 'Nervous shock after learning of the side effects of a drug' by A. Morrison (Aust Product Liability Rptr 1995;6:67-8)
- Section 4
- This information, its position in the regulatory scheme of drug approval and issues of liability for prescribers have been discussed in 'Product information: what does it define?' by M.L. Mashford (Aust Prescr 1994;17:15-7) and 'Product information: a pharmaceutical industry perspective' by H.O. Wooller (Aust Prescr 1995;18:19-21).
- Section 34(2) and also regulation 18 and Schedule 8 of the Therapeutic Goods Regulations.