Therapeutic goods such as medical devices are required to comply with relevant Australian standards prior to their supply in the Australian market. Medical products, such as medications, implants, and modern medical devices or gadgets, are critical components of healthcare. Defective and/or negligent implantation of medical devices can cause serious injury to the recipient of these devices. The legal field of medical product liability comes into the picture when these items cause harm or injury to the patients. Medical product liability in Australia entails holding the relevant stakeholders, such as manufacturers and healthcare practitioners, accountable for injury caused by defective or unsafe medical products.

What is medical product liability?

Medical product liability refers to the legal obligation or responsibility of the product manufacturers, sponsors, and other relevant stakeholders when the medical products cause injury or harm to the patients. It applies when defective, unsafe or improperly labelled medical products cause injury or lead to adverse health outcomes.

Types of medical product liability claims include the following:

Design defects: A flawed medical device design making it unsafe or harmful when used as intended can give rise to this type of claim.

Manufacturing defects: Medical device defects as a result of the manufacturing process, resulting in a defective or faulty or dangerous product for its intended use, can lead to a manufacturing defect claim.

Warning or labelling issues: In Australia, medical device manufacturers and sponsors need to provide the relevant information, including warnings about the potential device risks & recommended use instructions with the device in order to comply with the applicable regulatory provisions. Failure to provide such information can result in a claim of this type..

Negligent clinical management: Clinicians can be held liable for medical product-related injuries if they negligently prescribe, administer, interfere with or monitor the use of medical products.

If you or someone you know has suffered a medical injury due to a defective medical implant or device, it is important to seek legal advice as soon as possible as the limitation periods or time limits generally apply.