Rights and Remedies in Health Product Safety

‘Health’ products are commonly used to cure or alleviate conditions and symptoms of ill health. Whether prescribed by a doctor or not, the benefits of these products must be weighed against the possible risk of side effects. With some products, the ill effects experienced by users have been so great that the products have been taken off the market and public warnings issued. Unfortunately, this does not always occur in time and many people have suffered serious and sometimes permanent injury. These people have a legal right to seek compensation from the manufacturer and anyone else involved in the design, testing, production and marketing of the product.

Recovery of compensation for injury caused by faulty or unsafe health products is complex. It may also be emotionally disturbing and time consuming. Accordingly, those who feel they have suffered as a result of using health products, should not only receive early medical advice but also legal advice.

Most people harmed by health products will want monetary compensation for personal injury, and sometimes for economic losses such as lost wages and expenses. Additional remedies such as replacement and/or remedial treatment; injunction against future supply or treatment; withdrawal from use; prosecution; setting of safe standards; and adequate warnings and modification of marketing methods may also be appropriate.

Action Against the Supplier

Usually there is a contract involved in the supply of a health product. The contract, which need not be written, is between the supplier (for instance, the chemist) and the user. If a product is faulty, or not fit for the purpose for which it was sold, the contract is breached.

A breach of the terms of the contract is sufficient to bring an action. There need not be any carelessness involved unless the term alleged to be broken incorporates a test of proper care, for example, ‘that the supplier of the services and product shall exercise reasonable care’. In cases involving the sale of goods, the injured person usually relies on the protection offered by legislation such as the Sale of Goods Act 1896 (Tas), or Schedule 2 of the Competition and Consumer Act 2010 (Cth). Schedule 2 is known as ‘the Australian Consumer Law’.

Action Against the Manufacturer

Sometimes action may be taken against the manufacturer (or possibly importer) rather than, or as well as, the supplier. For example, the contract might contain a clause excluding or limiting liability, or the manufacturer may be better able to meet large claims and will be adequately insured. It may be appropriate to rely on statutory rights against the manufacturer (or importer), for example, under the Australia Consumer Law. It will certainly be appropriate to consider suing a manufacturer who has made misleading statements in advertising the product.

Manufacturers are usually sued for breach of the warranties and protections contained in the  Australian Consumer Law, or for negligence. The extent to which negligence, or carelessness, must be proved varies from case to case and this is a matter for the person’s solicitor. It commonly involves satisfying the court that it was more probable than not that the injury was caused by the negligence of the manufacturer. In the case of things ‘dangerous in themselves’ or inherently dangerous, such as poisons, the duty of care is strict and can become almost absolute, amounting to a guarantee of safety.

Liability may be found if the drug or device was not properly tested and evaluated, if sterilisation and safety control measures were inadequate, or if the company failed to warn of adverse reactions within a reasonable time after release of the drug. The manufacturer is also vicariously liable for the negligent acts of individual employees.

The court will consider the extent to which consumers were warned of potential hazards by information attached to the product or given verbally to the consumer. In the case of therapeutic products, much of the relevant information will be passed to the consumer by the doctor. It is unclear whether and to what extent a warning provided by the manufacturer, but not passed on to the consumer, allows the manufacturer to escape liability.

When the faulty product is not the sole cause of the damage, difficulties and complexities arise which can have an impact not only on the amount which may be recovered, but also whether the particular person or body sued has any liability at all. These difficulties may be not only legal but procedural, such as the collecting of evidence to successfully pursue the claim.

Time Limits

One of the many difficulties confronting claimants in health product liability cases is the time limits within which action can be brought. It is often a long time after treatment with a health product before the injured person is aware of the true nature of the injury, or that it was caused by the product in question, and that there may be a cause of action and remedy available. If action is not taken promptly, the claim might be statute barred and lost. Time limits on the right to bring an action are created by legislation and delay can affect the right to certain remedies such as injunctions.

The date the action first arose is often difficult to determine accurately, and can differ depending upon whether it is being taken:

• in tort, such as personal injury;
• for breach of contract; or
• for breach of statutory duty.

With the Limitation Act 1974 (Tas), for personal injury, it is the date on which the action is discoverable (the injury occurs or the plaintiff becomes aware of the harm) that marks the start of the clock. This means that it is when the person was able to identify that there was a problem, and a potential action. For example, if a person became aware of fertility problems arising from a product only 10 years after using the product, when consulting a doctor, then it is from the date of that meeting that time begins to run. In contract, the cause of action arises when the term of the contract has been breached. The time limit can be extended in certain circumstances, for example, if fraud is involved or where the claimant is under a disability. However, marking the date on which an action became discoverable can be difficult.

Other legislation has limitation periods applicable to actions brought under them. Whenever reference is made to any legislation in determining a claimant’s rights, care should be taken to search for a limitation section in that statute. An example is the three year limitation period under the Competition and Consumer Act for manufacturer’s liability.

Getting Help

A person injured will need a solicitor, and it is wise to find one who is proficient in the area of product liability law. You can contact the Legal Aid Commission, the Law Society or a community legal centre for useful advice about suitable solicitors. Remember that taking this type of legal action may cost a great deal of money.

Alternatively, you may be able to take legal action against the company in another country such as the United States, whose contingency fee system allows for people with low incomes to initiate proceedings at no initial cost to themselves. However, initiating an action in another country also has its complications.

If deciding to sue overseas, it will probably be necessary to find a lawyer in that country with suitable expertise or familiarity with this product to act on the person’s behalf. An Australian solicitor may be retained as an agent of the overseas lawyer. If litigation has already been commenced in another country, there will probably be considerable information worth obtaining through lawyers or other sources.

It may also be the case that there are a number of persons injured by the same product. If so, the cost of research could be borne equally between plaintiffs who could also be joined together for the purposes of the legal proceedings. There are now law firms in mainland capital cities which specialise in these sorts of large-scale international product-liability class actions. The Legal Aid Commission or the larger Tasmanian law firms should be able to assist in contacting such firms.

Finally, it is important to remember that in medical cases there is always the problem of possible alternative causes of the injury. It is very important that the patient clearly recount their physical and emotional injury, collect detailed medical records, and analyse the illness before taking legal action.

Case Study: The Copper 7 class-action

The problems of proving negligence against the manufacturer are illustrated in the Denzin v Nutrasweet case which was finally decided in February 1999. Ms Denzin and eight other plaintiffs, who in turn represented another 200 claimants, had taken an action against the manufacturer of the intra-uterine contraceptive device known as Copper 7. They claimed that because of the negligence of the manufacturer the devices had caused the claimants to suffer from pelvic inflammatory disease which in turn resulted in various complications such as ectopic pregnancy, septic abortion and impaired fertility.

The hearing of the evidence in the case took over eight months and required analysis of countless epidemiological studies and expert reports, with the plaintiffs trying to prove that the devices had caused the claimants’ injuries. The matter was complicated by the fact that, as the claimants acknowledged from the start of the case, pelvic inflammatory disease could be caused by a number of factors. The claimants’ argument was that it was enough for them to prove that the manufacturer’s negligence resulted in their being placed at greater risk of developing this disease.

The claimants failed on a number of grounds. The court held that the manufacturers had not been negligent and had not breached any duty they may have had to warn the claimants of the risks in using the devices. Further it was held that the argument mounted by the claimants’ lawyers was wrong in that it was not sufficient merely to show that the risk of suffering pelvic inflammatory disease was increased with the use of Copper 7 devices; the claimants still had to show that the use of the devices had probably resulted in that risk eventuating.