Legal Issues and Contact Lenses

Negligence

Negligence or malpractice is the term used to describe all possible civil liabilities practitioners can incur as the end result of their professional services. Health professionals may be held liable if their patients suffer harm as a consequence of their health care.

There are two areas of law in which practitioners can be held accountable: civil and criminal law. For the purposes of this chapter, we will concentrate on civil law, which encompasses tort law.

The area of tort law pertaining to contact lens practice is negligence. An explanation of how negligence is determined is necessary to understand precedent case law. To make a successful claim of negligence, a plaintiff (the patient) must be able to prove that:

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  The defendant (the practitioner) owed the plaintiff a duty of care that the defendant breached by failing to exercise the necessary level of care.

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  The plaintiff suffered damage that was inadequately met as a result of the defendant's breach. This cannot be remedied, hence, damage in the form of monetary compensation would be the primary solution.

‘Duty’ is defined as ‘an obligation, recognised by law, to avoid conduct fraught with unreasonable risk of danger to others’.

On the issue of whether the practitioner (defendant) owed the patient (plaintiff) a duty of care, the plaintiff will need to establish foreseeability of harm and the proximity between plaintiff and defendant. There is thus a duty to ensure that one's acts do not cause foreseeable harm to another.

The foreseeability element will be established if the patient is a member of a class to whom damage was foreseeable. The foreseeability element is only part of establishing the existence of a duty of care. It is also necessary to show that the relationship between the parties had the necessary degree of proximity. A patient has a proximal relationship with a clinician because a patient would quite clearly be someone who would be injured by a failure on the part of the clinician to take reasonable care.

Standard of Care

What is it, and why is it applicable to everyday contact lens practice? There has been a flurry of recent precedent law in favour of letting each patient remain an individual and be treated as such. Prior cases emphasised the concept of paternalistic medicine whereby it was assumed that ‘the doctor knew best’. The shift to treating the patient as an autonomous being allows patients to make necessary decisions, provided they have at their disposal all material facts.

The standard of care required is one of reasonableness. In determining a breach of duty, did the practitioner act with the level of care that one would expect of a ‘reasonable person’? In the case of Bolam v Friern Hospital Management Committee (1957), the court considered the standard of care for doctors. Under the Bolam test, a practitioner:

…would not be negligent if he or she has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art…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.

This test had the effect of embodying the ‘reasonable man test’ or the ‘reasonable practitioner’. It was an objective test. This principle was approved by the UK House of Lords in respect of diagnosis, treatment and information disclosure. The Bolam test was applied in the case of Sidaway v Board of Governors of Bethlem Royal Hospital (1985) in its consideration of the provision of information. This case involved a plaintiff suffering damage as a result of a spinal operation. The plaintiff alleged failure of the surgeon to fully disclose the risks associated with the operation. The trial judge rejected the plaintiff's claim on the basis that, at that time, it had been established that a responsible body of neurosurgeons had agreed that their colleague's standard of disclosure was acceptable.

Under the Bolam test, the professional practices and opinion against which a clinician would be judged must be a ‘responsible body’, much like a ‘peer review committee’, but this need not be a substantial body of practitioners fitting contact lenses. For example, a small group of practitioners who fit keratoconic lenses may be considered ‘super-specialists’ in fitting complex gas permeable lenses; hence, for the purpose of the Bolam test, the defendant's actions would be judged against the opinion of this group of practitioners rather than against the whole group of practitioners who fit contact lenses generally.

However, the Bolam test has been criticised in subsequent cases in the UK, the USA and Australia. In the Sidaway case above, Lord Scarman rejected the Bolam principle in respect of the provision of information stating that:

…English law must recognise a duty of the doctor to warn his patients of the risk inherent in the treatment in which he is participating…The critical limitation is that the duty is confined to material risk. The test of materiality is whether in the circumstances of the particular case, the court is satisfied that a reasonable person in the patient's position would be likely to attach significance to the risk.

Likewise, the Canterbury v Spence (1972) case involved a 19-year-old suffering damage as a result of a laminectomy. The judge in that case considered the scope of the disclosure required of the physician. The definition of ‘scope’ was in terms of the patient's rights to self-determination and therefore propounded the concept that the degree of information depended on the needs of the particular patient and the particular procedure . He said:

A risk is thus material when a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy.

Similarly, in Reibl v Hughes (1980), in which a patient suffered a stroke following a left carotid endarterectomy and where medical evidence estimated the incidence of the complication as 10%, the judge stated:

To allow medical evidence to determine what risks are material and, hence should be disclosed and, correlatively, what risks are not material, is to hand over to the medical profession the entire question of the scope of the duty of disclosure, including the question whether there has been a breach of that duty…What is under consideration here is the patient's right to know what risks are involved in undergoing or forgoing certain surgery or other treatment.

In Australia, the rejection of Bolam came as a result of Rogers v Whitaker (1992), where the High Court considered the case of Maree Whitaker, who had been blind in her right eye since childhood. She had been referred to Dr Rogers, an ophthalmic surgeon, who recommended an operation on her damaged eye to prevent the possible development of glaucoma. The surgery was claimed to be likely to improve the vision in her damaged eye and also to improve its cosmetic appearance. Postoperatively, she developed sympathetic ophthalmia – a rare condition with an incidence of about 1 in 17,000. The result was a loss of sight in her left eye and almost complete blindness. The plaintiff sued for negligence, alleging that Dr Rogers had failed to warn her of the risk. She claimed that, had she been warned of this possibility, she would never have consented to the surgery. The High Court approached the task of the content of duty and its scope in these matters of ‘failure to warn’. In defining the factors involved in a doctor's duty to warn, the High Court repeated:

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 likely 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.

The evolution from Bolam to Rogers was gradual, and the courts came to hold the professions more accountable for adverse events arising out of their activities.

In Rogers, the High Court – in discussing ‘material’ risk – held that the subjective text was the model most appropriate when it stated: ‘a particular patient, if warned of the risk would find it of significance’.

Medical ethicists have since endorsed this patient-orientated approach. They see the consent process as a change from a single event of paternalistic beneficence to an integrated process of information sharing and informed decision making.

This standard is now a consent, based on an autonomous patient making an informed decision based on understanding.

Although the practitioner may in depth and comprehensively impart information, there is no guarantee that patients will understand all they have been told. Patients may also be presented with hard copy data in the form of information sheets, but the problem is that they may be too exhaustive and become incomprehensible. However, it is suggested that the provision of detailed brochures, as well as specific and detailed consent forms, is the minimum required in informing a group of patients for, say, an orthokeratology procedure. Patients may have unrealistic expectations of the result they would like to achieve and may be resistant to modifications or perceived compromises pre-discussed. On the other hand, the practitioner may be unreasonably optimistic in the portrayal of the outcomes. Many patients seeking to wear contact lenses are unrealistic in their appreciation of the visual outcome.

Likewise, a full appreciation of worst case scenarios should almost always be depicted to the patient, as visual loss is the common denominator and generally why we look after these patients in preventative practice.

Since Rogers v Whitaker, cases of medical negligence have come to include allegations of ‘failure to warn’, almost always as a part of a claim. The application of this negligence metamorphosis is not confined to contact lens practice but to all aspects of patient care. In this change in determining standard of care, we can see how Rogers v Whitaker (at least in Australia but similarly in most other countries) can influence all duty of care situations.

Failure to Give Advice on Alternative Modalities

Current legal thinking emphasises the critical role of patient autonomy in health care decision-making. This emphasis extends as far as creating an obligation for the practitioner to advise a patient about complementary and alternative visual corrections such as contact lenses.

The law imposes on the practitioner a duty to exercise reasonable care and skill, not only in examination, diagnosis and treatment but also in the provision of professional information and advice, being a ‘single comprehensive duty’.

It is the patient who must make the decision, but it is the clinician who holds the information on which the decision must be made. In Haughian v Paine (1987), it was ruled that ‘one cannot make an informed decision to undertake a risk without knowing the alternatives to undergoing the risk’. The area pertinent to the practitioner is the use of contact lenses as therapeutic devices rather than for simple cosmesis.

Consider the supply of spectacles to a moderate or severe keratoconic patient. In this case the practitioner may be considered negligent if he has not provided the optimal visual correction (contact lenses). The same would apply to an aphake or corneal graft recipient. Nevertheless this should be qualified by careful explanation about the trial of contact lenses, their effect, associated risks, complications of fitting, costs, time involved, etc. These must all be conveyed in such a way that patients have all the facts at their disposal. Should they opt not to undergo any form of contact lens fitting, that is their decision, but the practitioner has at least satisfied the minimum legal requirements under Rogers v Whitaker.

It is incumbent on the practitioner to do whatever is necessary for the patient's ocular well-being. Practitioners have a duty to investigate what needs to be prescribed and may also need to refer to someone more competent if their skill in a particular area is limited.

Keratoconus is a classic example where special expertise and advice are required. Practitioners should not assume that contact lens correction is automatically essential and should consider whether corneal cross-linking would be of benefit instead of contact lenses. Alternatively, if the visual acuity is reasonable with spectacles, the patient may be happy to wear this correction, and exposing the patient to the potential complications of contact lenses could leave the practitioner at risk. Similarly, if patients are unable to attend for regular aftercare, potential ocular damage could result, so again contact lenses should not be advised.

How much information should be given and should a lens trial be conducted so that the patient fully understands what to expect? The patient must be given a realistic idea of what to expect when wearing rigid lenses, the risks involved and also an understanding of the variation in such factors as individual corneal sensitivity in determining success or failure. As mentioned earlier, practitioners must be pragmatic with their patient's understanding of the limits of treatment. Equally, they must not allow themselves to become so enthusiastic about correcting the person's vision that the end result is a disappointed patient whose expectations are not met.

The contact lens fitting philosophy used could possibly influence future corneal scarring. Should RGP lenses be fitted with apical clearance or apical touch, for example? What is important here is that whichever technique is used, the practitioner must adhere to and become clinically competent at fitting the chosen philosophy. Under the Bolam principle, the practitioner would not be required to explain the type of fitting design or the possibility of scarring as this would be considered clinically acceptable by an expert group of ‘sub-specialists’. If we apply Rogers v Whitaker, the practitioner must explain possible and probable visual outcomes as well as the possibility of corneal scarring. Scarring would be considered a material risk in undergoing a keratoconic fitting, especially if, as mentioned earlier, the patient had reasonable vision with spectacles.

These examples are for therapeutic purposes; what of the situation where a person wears contact lenses for cosmetic reasons only? Is there a duty to at least advise of alternative lenses such as daily wear silicone hydrogels (compared with conventional hydrogels), or does the practitioner say nothing? This situation would be harder to contest by a plaintiff patient, as the long-term implications have not been quantified significantly to measure possible future harm or damage to the patient.

Contact Lenses and Transmissible Diseases

In an era when it is understood that diseases may be transmitted by fluids, practitioners should be cautious for themselves, their patients and the actions of their patients.

Diseases that can readily be transmitted by fluid should always be considered when fitting contact lenses (see UN, WHO (2012); and also Chapter 4 ). These include new variant Creutzfeldt–Jakob disease (vCJD) and human immunodeficiency virus (HIV). It is safest to use lenses that can be discarded after a single trial. For patients requiring conventional soft lenses, an appropriate disposable diagnostic lens can still be used and ordered with alterations in back optic zone radius (BOZR) or total diameter (TD) for the final fit.

In the UK, rigid lenses should be disposed of after use for a single patient where possible. Complex rigid lenses that cannot easily be replaced after a single use must be cleaned thoroughly and then soaked in a solution of 2% sodium hypochlorite for 1 hour at room temperature (College of Optometrists guidance). There is no specific advice on cleaning soft trial lenses for reuse; single use is recommended wherever possible. The first RGP lens can be ordered empirically or from topography with an exchange warranty and the final lens parameters adjusted subsequently.

Lenses that pose the greatest risk are cosmetic lenses. Plano coloured lenses can be bought at unregistered outlets in many countries and may fit poorly. Friends often exchange them to try different ‘looks’. Hence, when there is no regulation on their supply, it is difficult to control their use and the potential risk of serious infection.

The Contact Lens Prescription

What is it, and what obligations are imposed on the practitioner for releasing such information?

In the UK, it is a legal requirement to provide the patient with his or her contact lens prescription once the practitioner judges the lenses to be satisfactory. In the USA, it is mandatory that a contact lens prescription be released immediately after the examination is completed.

To release a contact lens prescription, the practitioner must first determine:

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  lens parameters

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  suitable wearing schedules

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  the replacement frequency.

The prescription must allow the patient to obtain lenses elsewhere (see below), but it should not be viewed as one-way traffic for so-called consumer rights. However, practitioners must protect themselves from liability arising from incorrect dispensing and product liability.

A contact lens prescription should contain the information necessary for the patient to have the prescription properly dispensed and should include the following:

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  name of the lens manufacturer

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  type of lens and mode of wear

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  power

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  BOZR and TD

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  date the prescription was dispensed and its expiry date

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  date of patient's last examination

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  replacement frequency if applicable

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  clinician's signature and name (and registration number in the UK).

However, only the practitioner can determine when a contact lens fitting is actually completed. Only then can the patient be handed a copy of the lens prescription. Until such a time, there is no obligation to provide the patient with the prescription.