Action against the manufacturer
Sometimes, an action may be taken against the manufacturer (or possibly importer) as well as the supplier. For example, the contract might not give the injured person the necessary legal rights or the manufacturer may be better able to meet large claims because it is adequately insured. There are statutory rights against manufacturers and importers under the Trade Practices Act 1974 (Cth) [TPA] under the Manufacturers Warranties Act 1974 [MWA] [s 4]. It will certainly be appropriate to consider suing a manufacturer who has made misleading statements in advertising the product [TPA s 65D] [MWA s 8(1)].
Manufacturers are usually sued for breach of the warranties and provisions contained in the Trade Practices Act 1974 (Cth), or for negligence [TPA ss 65C, 68A, 74B, 74D]. The extent to which negligence, or carelessness, must be proved varies from case to case. It commonly involves satisfying the court that it was more probable than not that the plaintiff's 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. Where a person is injured by defective goods manufactured after 9 July 1992 it is only necessary to show that the product caused loss or damage. Once this is established it is up to the manufacturer or importer to show that the product was not defective [Trade Practices Act 1974 (Cth) Part VA].
If a number of people have been injured by the same product it is now easier to take a class action (make a claim as a group) [Trade Practices Act 1974 (Cth) s 75AQ and the Federal Court Rules].
Liability may be found if the drug or device was not properly tested, if sterilisation and safety control measures were inadequate, or if the company failed to warn users of adverse reactions. The manufacturer is also liable for the negligent acts of individual employees.
The court will cnsider the extent to which consumer were warned of potential hazards by information attached to the product.
In the case of therapeutic products, much of the relevant information will be given to the consumer by the doctor. It is unclear whether or to what extent a warning provided by the manufacturer but not passed on to the consumer allows the manufacturer to escape liability.
In a claim of negligence, the manufacturer may argue that the claimant voluntarily accepted the risks associated with the product or medical procedure or was careless in using it. A further difficulty confronting a claimant receiving a drug or device in a hospital or clinic is in proving that the damage or harm complained of has been caused by the product and not by the hospital or clinic. In other words, fault may lie with those administering treatment rather than with the product itself. 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 on the result of the case. These difficulties may be not only legal but also practical, such as the difficulty of obtaining evidence needed for success in the case.
To defend a claim, the manufacturer must usually show both that the consumer was aware f and understood a particular risk, and that he or she consciously decided to tak the risk, or was reckless about whether or not a harmful result might occur.
The Dalkon Shield (IUD), formerly manufactured by A.H. Robins Inc., has been linked with pelvic inflammatory disease, spontaneous septic abortion, perforation, sterility, premature hysterectomy and even death. Over 14,000 women have taken legal action against the company. Approximately (US)$378.3 million has been paid in damages, and Robins claims that legal fees and other costs have amounted to $107.3 million. The A.H. Robins company has entered into a bankruptcy administration in the United States. All IUDs expose women to a greater risk of pelvic inflammatory disease, but particular defects associated with the shield significantly increased the risk. The problems were largely to do with the multi-filamented tail string of the IUD which facilitated the growth of bacteria normally found in the vagina and acted as a wick drawing this bacteria into the sterile uterus. It was alleged that the methods of production and sterilisation were inadequate, the testing and evaluation periods were unacceptably brief and claims made about the effectiveness and safety of the device were false. Although the company ceased distributing the Shield in Australia in 1975 (1974 in the U.S.) only in late 1984 were consumers notified of the risk.