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Compensation for Drug Injury 1674 BRITISH MEDICAL JOURNAL 22-29 DECEMBER 1979 second possibility would be to extend the law of contract so that an injured person could sue the manufacturer direct, but this would effect- Br Med J: first published as 10.1136/bmj.2.6205.1674 on 22 December 1979. Downloaded from ively be the same as introducing strict liability in tort. The third option of reversing the burden of proof in actions in tort would make little difference, the Commission thought. Thus the Pearson Commission, in common with the Compensation for drug injury Law Commission, the EEC, and the Council of Europe, came down in favour of introducing strict liability in tort for injury resulting from any product, including drugs. Strict liability, as defined by the commission, does not require the plaintiff to prove that the defendant was negligent and (in contrast with liability in negligence with reversed burden of proof) does not exempt the defendant if he proves simply that he was not negligent. The commission gave five reasons for favouring the introduction of strict liability. Firstly, it recognised that this was clearly the European trend. Secondly, it seemed right to extend the benefits now available to a pur- chaser under the law of contract to all con- sumers. Thirdly, a producer should be responsible in the fullest sense for his product and be willing to accept any claim for com- pensation resulting from damage just as he would accept praise for his product. Fourthly, the Commission hoped standards of safety would be raised. Fifthly, it thought that the producers were much better placed than consumers to arrange insurance for unforeseen injury. What will be the shape of the new law? A new law is currently being fashioned in the European Parliament. The EEC proposals are similar to those of the Pearson Commission, The second method of seeking redress for but they differ on some points. Most attention about to change. Dissatisfaction with the drug injury is through the law of tort. The should be paid to the EEC proposals as the present system has long been increasing, and plaintiff must prove negligence-not only that EEC legislation has precedence over British the thalidomide tragedy provided the final the drug was defective and caused the injury, legislation. http://www.bmj.com/ push. The Royal Commission on Civil Liability but also that the defendant had failed in his The EEC proposals state that: "The pro- and Compensation for Personal Injury duty of care because the injury was a fore- ducer of an article shall be liable for damage (Pearson Commission) was set up in 1973 to seeable consequence of the defect. Dissatis- caused by a defect in the article, whether or consider whether change was necessary and faction has been mounting for a long time with not he knew or could have known of the how it might be effected. Its 1978 report re- the law of tort as a basis for claiming compen- defect." The definitions of "producer," commended introducing strict liability in tort sation. The major criticism is of the concept of "defect," "article," and "damage" are crucial for injury resulting from all products, including fault itself-that a plaintiff must prove that to the interpretation of the law. drugs. The recommendations were in line with somebody was negligent if he is to receive The producer in the EEC proposals is the those produced in Europe by the EEC and the compensation at all. This inevitably leads to of the the producer finished article, producer on 28 September 2021 by guest. Protected copyright. Council of Europe. The EEC has now unpredictability and allows compensation only of any component, and anybody who repre- produced a draft directive (8 December, in certain circumstances, which often do not sents himself as the producer by putting his p 1525), which will probably become law in the apply with drug injury. Other drawbacks are name or trademark on the article. The supplier next few years. the complexity and expense of the system and of the article would be liable as the producer if the hostility that may result from action the original producer could not be identified. between people closely related professionally This means that a prescribing doctor would Existing system or otherwise. not be liable, but a dispensing doctor or a Consumers' organisations, academics, and pharmacist might be liable if he could not At present in the United Kingdom a person judges have all criticised the present system. identify the producer of a drug that he injured by a drug has two ways to attempt to The Pearson Report concluded that a major dispenses. claim compensation: through the law of problem is uncertainty. Some lawyers argue A product is defined as defective "when, contract or through the law of tort. Under the that the present tort system could be much being used for the purpose for which it is law of contract if a person is injured by a drug more rigorously applied and result in more apparently intended, it does not provide for then the seller is strictly liable-the injured frequent and generous compensation, whereas persons or property the safety which a person person does not have to prove negligence. But others doubt this. The commission concluded, is entitled to expect, taking into account all the the injured person can make a claim only if he in line with most other authorities, that change circumstances, including its function and the himself had bought the drug, and then only is essential. time at which it was put into circulation." against the seller. So a man injured by a drug This means that a producer could defend bought by his wife cannot claim, since the law himself if he had warned about a possible side of contract covers only the purchaser, and a Options for change effect and if the plaintiff had ignored instruc- man injured by a drug that he bought himself tions on when and how to take a drug. With in a chemist's cannot claim against the manu- Having decided that the present system for this law, a "state of the art" claim-when the facturer. Essentially, this law is irrelevant to compensation was inadequate, the Pearson producer can argue that at the time his product the problem of injury caused by prescribed Conimission considered four new options. was purchased nobody could have known of a drugs, which account for most drug-related Firstly, it dismissed a no-fault scheme as subsequently discovered side effect (as with injuries. financially and administratively impossible. A thalidomide)-would not be a defence. BRITISH MEDICAL JOURNAL 22-29 DECEMBER 1979 1675 A formidable bureaucracy might also result from the legislation. Pharmacists and dispens- ing chemists would need to keep precise Br Med J: first published as 10.1136/bmj.2.6205.1674 on 22 December 1979. Downloaded from _- details of all drugs dispensed-when they arrived in the shop, when they were prescribed, ' their batch numbers, etc-to avoid being inadvertently held liable as the producer because the actual producer could not be identified. Similarly, doctors and nurses giving injections may need to keep equally precise records. The costs of the legislation are difficult to estimate as they will occur in such diverse ways. Increased insurance premiums for drug companies will undoubtedly be passed on in drug costs; the cost of prescribing in packages prepared by the manufacturers may be con- siderable; and the cost of the bureaucracy and litigation may be immense. As the Royal College of Physicians observed, two classes of patients will be created: those with compensatable problems and those without. The few patients seriously injured by drugs will benefit, but most patients will suffer from the effects of defensive medicine if the new legislation is introduced. Alternate meetings of the European Parliament, where new laws are being drafted, are held in Strasbourg. What now? The Secretary of State has forecast that this legislation is unlikely to come into force for at The proposed EEC legislation excludes College of Physicians, the BMA, the Asso- least two years, and there is still room for articles that are "a craft or an artistic product ciation of the British Pharmaceutical Industry, negotiation. Nevertheless, drugs are unlikely when it is clear that it is not industrially the medical defence societies, and the Pharma- to be excluded from the legislation. The produced." Arguably, medicines prepared by ceutical Society have all expressed consider- thalidomide tragedy, reaction to which dispensing doctors might fall into this category. able concern about the inclusion of drugs in produced much of the pressure for change, is "Damage" includes death or personal this new legislation; all want drugs to be made too recent to allow that. But political pressure injury, damage to certain categories of a special case. and careful negotiating may result in the law property, and, crucially, "pain and suffering Their major argument concerns the complex being redefined to ensure that doctors are not and other non-material damage." problem of causation. Drugs are inherently dragged into unnecessary litigation. In contrast to the Pearson Commission capable of causing damage and when given to recommendations, the EEC proposals place a patients, each of whom is unique, already ill, limit on the total liability of the producer for and potentially capable of idiosyncratic damage caused by one product-the limit response, the effects are unpredictable. Any would be 25 million European units of injury observed may be caused by the illness, http://www.bmj.com/ account. There would also be a time limit: the the drug, or the interaction of the drug with plaintiff would have to take action within 10 another variable such as food, tobacco, or years from when the drug was distributed, and alcohol.
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