What is Liability
Separation Liability
Liability for drug induced injuries did not become an issue of general concern until quite recently. However, a number of drug-induced problems from thalidomide in the 1960s to Opren and diethylstilbestrol in the 1970s have caused widespread public disquiet and led to increasing awareness of issues to do with liability. In psychiatry, concern in the UK focuses on the question of benzodiazepine prescribing, while in the US the paramount issue concerns the occurrence of tardive dyskinesia in individuals taking neuroleptics. The question has become an emotive one with some commentators who survey the problem referring to the appalling frequency of drug-induced injury, while others comment on its astonishing tray (1). Whatever the absolute frequencies, contrary probably to public belief, the evidence suggests that the larger the pharmaceutical company, the better its practice regarding drug safety is likely to be (2).
Drug-induced problems may stem from toxic effects of a drug, or toxic effects caused by an impure additive, or from allergic reactions to the drug or its additive. Problems may also stem from over prescribing. For instance, in the case of someone who dies from a resistant bacterial infection, a relative could claim that the subject’s death arose in part from the excessive prescription of antibiotics that in its own right brings about the production of resistant infections. In the case of neuroleptics, problems may be brought about by the overuse of these drugs but this overuse, far from being solely promoted by drug companies stems in part from the current politics of mental health – deaths have stemmed from rapid tranquillisation often by harassed staff in psychiatric units.
In general, the question of liability is something of a rolling log on which companies, prescribers and drug takers try to maintain a footing. In addition to attempting to produce increasingly safe compounds, companies try to restrict liability by hedging their data sheets with warnings and lists of side effects, so that if something goes wrong either the prescriber or the consumer will be to blame – on the basis that they were warned beforehand if they chose to notice. Against this, in the pursuit of markets, rather than make novel compounds, they often manufacture drugs closely related to other compounds on the market in an attempt to gain a share of what is obviously selling well. This minor manipulation of a molecule may confer no additional therapeutic benefit but may produce unsuspected side effects.
When it comes to determining whether a particular drug has been responsible for a particular injury, it can be extremely difficult to decide with confidence what has actually happened. Questions that arise are, for example, whether it is known that the individual actually did take the drug that supposedly caused the problem? Did they take anything else? Was there any pre-existing disorder that the individual may have had that made an unfortunate reaction to a compound more likely? – if there was, then obviously neither the drug company nor the prescriber can be held entirely responsible.
The majority of drug induced disorders resemble disorders that happen naturally anyway. For example, benzodiazepine withdrawal produces anxiety. Anxiety is common. One can question whether all that is happening in the case of withdrawal is re-emergence of the anxiety that led to the individual being put on treatment in the first instance. In the case of tardive dyskinesia, dyskinesias that are indistinguishable from those caused by the drugs occur in individuals who have never had neuroleptics. Even the limb deformities produced by thalidomide occur naturally. Drug-induced injury often involves the change in frequency of something rather than an entirely novel development. For reasons such as these, the occurrence of adverse events on a drug are rarely taken automatically as indicating that the drug has caused the problem. It is usually necessary to wait some years after a drug has been on the market to establish whether particular problems are happening any more frequently than they were happening before.
Even if it is agreed that the drug has caused the problem, questions arise as to whether the prescriber should have prescribed for the problem in the first instance? If not then they share a part to blame. Did the taker implicitly or explicitly agree to turn the risk that is involved in all drug taking? Did they contribute to their own injury in anyway – altering the salt in their diet perhaps while they were on lithium.
In the case of a possible suicide consequent on antidepressant- or neuroleptic-induced akathisia, for example, it is not clear exactly where blame might lie in individual cases. From a company point of view, it is probably not possible given our current state of knowledge to produce antidepressants or neuroleptics that will never produce akathisia or dysphoria and hence the drug-induction of suicidal behaviour is at present an inherent risk of drug-taking. The onus is more likely in many respects to lie on prescribers to warn patients of this possible side effect and what to do should it develop.
But in the case of someone who is severely depressed or psychotic, it will commonly be very difficult to determine with any degree of certainty all the links in the chain of events that leads to an attempt at suicide. For all of the above reasons, it is likely to be all but impossible to establish in court that a particular drug or company was clearly responsible for what may appear to be a drug-induced injury. Similar considerations apply to some of the most important side effects of psychotropic drugs, such as the demotivation brought about by neuroleptics for example.
There are three principles that can be applied to all drug-taking (3,4):
First principle: No drug or drug treatment can be guaranteed in advance to be entirely safe. Risks are inevitable and justifiable provided they are not disproportionate to the purpose which the treatment is supposed to serve. At present society as a whole deems that risks such as tardive dyskinesia may be justifiable against the backdrop of an otherwise irremediable illness such as schizophrenia, but what of tardive dyskinesia consequent on the prescription of a neuroleptic for anxiety or a sedative neuroleptic as a hypnotic?
Second principle: No party can reasonably be blamed for doing its best, even if injury is one of the consequences. The issue here of course may depend on being able to show that one has done one’s best and herein lies the importance of documenting advice given etc.
Third principle: Responsibility is carried by anyone on whom one is entitled to rely. This includes the nurses who hand out medication, who have a responsibility to get the drug and dose right, the pharmacist to dispense the right medication, and potentially anyone who acts as an authoritative source of advice regarding the benefits or hazards of medication.
Risks and benefits
The idea that one of the cardinal principles of medical practice is that a healer should ‘first of all do no harm’ is appealing but very poor description of medical practice. In the case of drug treatment, no treatment is possible unless the risks are taken. No drug is safe. Treatment is a matter of weighing the risks and benefits. The discovery of anaesthesia crystallised with dilemma. When first introduced (and still today) there were some people who it was known would die from the anaesthetic: there were many who had problems with the idea that one would intentionally put some lives at risk in order to benefit others. But the same is true of pretty well all treatments today. There is therefore a need to treatment such that it is justifiable to take certain risks. For example in the case of someone with cancer it may be justified to take the very considerable risks associated with chemotherapy. But it would not reasonable to give chemotherapeutic agents to someone with a cold or depression.
The antihypertensives provide a good case. There are very few people who absolutely need antihypertensives to lower malignant increases in blood pressure caused by hypertensive disease. However, there are legions of people who have some elevation of blood pressure. And elevations of blood pressure are associated with increased risk of heart attacks or strokes as a consequence. Some individuals may only have elevations of blood pressure owing to the anxiety of attending their doctor. Elevations of blood pressure are, furthermore, only an indication that a disease process may be operative. One option in such cases is repeated monitoring with a recourse to treatment only if the situation worsens. For those with minimal increases in blood pressure, the risk of likely problems is so small that one can legitimately ask whether the cost in side effects (impaired sexual functioning) is worth it.
Until recently calculations of risk/benefit were made by the consumer. Now in the case of the anti-hypertensives, they are typically made for their patients by clinicians, who are often on automatic pilot. A great deal of prescribing is almost automatic; it is difficult for it not to be when for instance the latest research indicates that hypertension is a risk factor for heart disease for example and there happens to be available a means of mitigating the risk. It takes considerable discrimination to appreciate that the risk may be quite minimal and the available drug may have its own attendant risks. And even greater skill to impart this state of affairs to patients. In such circumstances it behoves all the members of a health team to have a good grasp of what drugs can and can not do as some rather than others may be able to influence particular patients.
References
- Dukes MNG, Swartz B: Responsibility for drug-induced injury. Amsterdam: Elsevier Press, 1988.
- Braithwaite J: Corporate crime in the pharmaceutical industry. Routledge and Kegan Paul; 1984.
- Consumer’s Association: Risk-benefit analysis of drugs in practice. Drugs Therapeut Bull 1995, 33:5.
- Dukes MNG: Social, economic and pharmacological aspects. In Psychotropic drug development. Edited by Healy D, Doogan DP. London: Chapman and Hall; 1996.
