Not fit for purpose – Synthetic mesh products defective
In a class action involving at least 1350 women, the Federal Court was asked to consider whether manufacturers and suppliers had contravened consumer protection legislation in respect of the sale of nine medical devices designed to be surgically implanted in women to alleviate either stress urinary incontinence or pelvic organ prolapse.
- Were the respondents liable under the Trade Practices Act (TPA) and Australian Consumer Law (ACL) for supplying goods not fit for purpose to Australian consumers?
- Were the pre-market evaluation, post-market monitoring, and information provided to consumers in relation to the products adequate?
- Were any parties other than the respondents capable of having liability attached to them in negligence, such as the operating surgeons or the Therapeutic Goods Association (the TGA)?
The three named claimants, representing the class, alleged they began to suffer from severe complications following the implantation of synthetic mesh devices. The devices were designed and developed by the respondents, Ethicon Sarl, Ethicon Inc and Johnson & Johnson, and made out of a knitted thermoplastic polymer.
It was alleged that the respondents were in violation of state and Commonwealth consumer protection legislation, as the products were allegedly not fit for their designed purpose, and the information provided with the products allegedly failed to adequately inform or warn of potential risks of use (amounting to misleading and deceptive conduct). Additionally, the claimants argued that the failure of the respondents to adequately clinically evaluate or monitor the products prior to or after release, as well as failing to inform either doctors or patients of the products’ risks, amounted to a breach of their common law duty of care.
The trial judge, Katzmann J, found in favour of the claimants in both their statutory and common law claims, holding that the respondents failed to comply with either relevant statutory or regulatory frameworks or their ethical duties owed to consumers.
With regard to the negligence action, Katzmann J found the respondents to be negligent and in breach of their duties of care in three ways. Firstly, her Honour held that the respondents failed to undertake adequate pre-market evaluation of the products. The European scheme governing medical goods is largely self-regulated. In this case, the products were found by the manufacturer to have passed relevant European compliance standards despite little evidence of requisite clinical data or investigations having taken place. Her Honour was critical of the manufacturer, finding it prioritised its “commercial needs” over the viability of the product.
Secondly, the respondents failed to effectively monitor the products after their release onto the market. Katzmann J noted that the continued post-market evaluation of a product is an “uncontroversial” aspect of a manufacturer’s duty, as well as being a regulatory requirement. Evidence led at trial showed the respondents had no coherent plan for gathering post-market clinical data, and their monitoring systems were generally deficient.
Finally, Her Honour J found that the information and warnings issued with the products were inadequate to allow for appropriate evaluation of their risks, and “fell well short or what was reasonably required”. Evidence adduced at trial led to a finding that not only were the risks of the complications pleaded by the claimants reasonably foreseeable, they were also known to the respondents at the time of their release to the market, who still neglected to warn of them in product materials.
The respondents, specifically the supplier, were also found to be in violation of their statutorily-imposed obligations, with both the defective nature of the products and the surrounding promotional material each amounting to breaches of the TPA and ACL. The failure of the supplier to adequately disclose known product risks, and in many cases to disclose risks at all, was central to this finding.
In assessing the statutory claims of the claimants, Katzmann J considered the arguments of the respondents that the risks of a medical product ought to be known to the supplying surgeon, and therefore places upon the surgeon the obligation to inform the plaintiff of these risks. Her Honour rejected this defence, noting that the supply of goods to the consumer through a surgeon “does not excuse the manufacturer from its obligation to warn of the risks attendant upon the use of its products”, particularly in circumstances where the warning by the manufacturer to the surgeon is inadequate. No claim was made against the surgeons.
Her Honour was critical of the TGA for relying on the European certification of the product and failing to carry out an independent assessment in circumstances where there was no independent assessment of whether the product met the European standard.
The Court has reserved its decision on the award of damages, requiring the claimants to elect whether to receive damages at common law or in accordance with the TPA.
Implications for you
While it is the obligation of the manufacturer and supplier of medical products to ensure that its products comply with all relevant statutory and regulatory standards at the time a product enters the market, this case considers the extent of the duty owed to consumers and suggests that it extends to ensure compliance with relevant legislation and regulation over time through evaluation and monitoring of the products performance.