TGB's Tim White says victims of medical negligence and faulty medical products may look to sue manufacturers and distributors instead of practitioners.
TGB’s Tim White says victims of medical negligence and faulty medical products may look to sue manufacturers and distributors instead of practitioners.
Medical negligence compensation claims are becoming increasingly challenging for injured patients.
There have been a number of significant recent decisions, including a decision by the High Court, which has made the requirements for a successful medical negligence claim against medical practitioners much more difficult.
No liability for medical practitioners?
The Courts are showing a reluctance to impose liability on medical practitioners relating to injuries patients have sustained through medical treatment.
The recent High Court decision of Wallace v Kam (2013) HCA 19 was a unanimous decision by the High Court of Australia, imposing a very vigorous application of the principles of causation in duty to warn cases. It is a well-established legal duty that medical practitioners must inform patients about material risks associated with proposed treatment (this principle was well explained in the earlier High Court case of Rogers v Whitaker (1992) HCA 58).
In order for a patient to be fully informed before making a decision about proceeding with a particular surgical procedure or with taking medication, a doctor must inform patients about all material risks associated with the proposed treatment or the prescribed medication. Since the decision of Rogers v Whitaker there have been numerous cases proceed to trial that have considered whether or not a medical practitioner has negligently failed to disclose a material risk, which subsequently arose and caused a patient to sustain an often serious injury.
In the case of Wallace v Kam, the patient underwent surgery on his lower back. There were various risks associated with the procedure, but two particularly relevant risks – one relatively minor, and the other more serious. The more serious risk could result in permanent spinal nerve damage, which would cause permanent loss of leg function. The doctor did not raise either of these two risks to the patient prior to him undergoing the surgery. Subsequent to the surgery, the patient’s lower back pain did not improve, but one of the risks materialised; namely the more minor issue of neurapraxia.
The High Court ruled that the doctor was not liable to Mr Wallace because he would have undergone the surgery, even if he was advised of the minor risk. Bearing in mind that he was not warned of this risk prior to undergoing the surgery. When questioned in the trial if he would have proceeded with the surgery, if he is aware of this risk, he answered that he would. It is a difficult case for patients and consumers, in the sense that if a risk materialises, even if a doctor has not made the patient aware of that potential risk, the doctor still will not be liable for the loss or damage that results from that risk occurring. There have been numerous other failure to warn cases more recently in Australia, that have adopted this strict and narrow approach by the High Court. Some of those cases include Odisho v Bonazzi (2014) VSCA 11 and Nigan v Ham (2011) WASCA 211.
Injured people may turn to manufacturers and distributors
As the above cases reveal, the Courts have been increasingly reluctant to impose liability on the medical practitioner for failing to disclose the relevant or material risk. Often these claims become highly complicated due to aspects of causation. It may mean that patients will need to look to the manufacturer or supplier of the medical device or product to recover their losses.
For example, it may be a patient injured during a surgical procedure, such as a knee replacement, rather than proceeding against the medical practitioner, the claim is brought against the manufacturer or supplier of the prosthesis. The claim would be based on the prosthesis being defective or not of merchantable quality.
Very different obligations exist in claims against manufacturers or suppliers compared to medical practitioners. Liability arises potentially under either the Trade Practices Act (TPA) or the Competition Consumer Act (CCA). Both of these pieces of legislation can impose strict liability on a manufacturer or supplier of a medical device. This legislation is likely to provide a better remedy.
Regarding the supply of medication in particular, there is a huge amount of litigation in the United States against the manufacturers. A failure to warn at all, or adequately, of adverse side effects or complications from medication, can result in liability against the relevant manufacturing company. For example, in the United States there is litigation involving a huge range of medications including; Biox, Yaz, Yasmin, Accutane, Actos, Effexor, Lexapro, NuvaRing, Pradaxa, and the list goes on.
In Australia, either the TPA or CCA impose a strict liability on manufacturers of medical devices or drugs but such a high standard is generally not imposed on medical practitioners. It will be interesting to see if litigation in Australia takes the direction that has occurred overseas and manufacturers are more increasingly sued.
However, the great difficulty for injured people who want to pursue a supplier or manufacturer is that it is not a mandatory requirement for such a company to have product liability insurance cover. This means that unless the company has sufficient assets, it is unlikely that any consumer will be able to recover the compensation from the company (without adequate insurance).
Many importers that supply medical devices are small to mid-sized businesses that have minimal, if any, assets. Accordingly, unless there is product liability insurance cover, obtained by the supplier, it is almost impossible for a consumer to successfully recover their losses from the company.
Despite numerous medical devices being classed by the Therapeutic Goods Administration as Grade III (high risk), suppliers are still are not required to have product liability cover. This includes suppliers of breast implants, an orthopaedic prosthesis, heart stent or valve, and the list goes on. Unknowingly, a consumer/patient could be being operated on by medical practitioner who has obtained a high risk device from a small supplier with no product liability insurance and if the product fails the patient is unlikely to have any successful remedy against the supplier.
There is a drastic need to change this huge loophole for consumers, and it needs to come from the Therapeutic Goods Administration or through legislative changes that make it mandatory for a supplier or manufacturer, of at least a Grade III medical device, to have current product liability insurance cover. Until this problem is corrected there will be ongoing examples of consumers being left out to dry and not able to claim compensation for serious injuries they incur due to product failures.
Given the numerous issues and options for medical negligence victims to consider, it is crucial to seek legal advice. Each case will have its own set of circumstances, and an experienced personal injury lawyer can guide you through the process.
If you have been harmed due to a faulty medical device or other medical negligence issue, contact your nearest TGB location for a free initial interview.