In brief

• On 21 November 2019 in a lengthy and careful judgment, the Federal Court of Australia found in favour of a representative action brought by three women who all suffered complications after surgery involving transvaginal mesh products.
• The devices were marketed as a safe, simple and effective surgical means to treat common medical issues including stress urinary incontinence and pelvic organ prolapse. Instead, the applicants experienced significant and adverse events with chronic and debilitating health consequences.
• The proceedings attracted 700 claimants, however, the Court acknowledged that up to 90,000 women could be affected.

Background

The proceedings concerned nine devices manufactured by two companies Ethicon Sarl and Ethicon Inc, which were marketed and sold by a related Australian company, Johnson & Johnson Medical Pty Ltd. The devices, made from polypropylene mesh, once inserted, caused serious and chronic complications.

The applicants alleged that the respondents, driven by commercial interests, contravened the Trade Practices Act 1974 (Cth) (TPA) and the Competition and Consumer Act 2010 (Cth) (ACL) and were liable to them in negligence.

Defective goods, failure to warn and misleading and deceptive information

The applicants made statutory claims under both the TPA and ACL. Katzmann J recognised that, if the applicants were successful on their claim that the goods were defective, then they were entitled to succeed on two other statutory counts: first, that the devices were unfit for purpose; second, that they were of unmerchantable quality.

Her Honour found that, at all times, the devices did not meet the standard that patients are generally entitled to expect and that, accordingly, each device had a defect within the meaning of the TPA and ACL.

In relation to warning of risks, where a medical device carries risks when used as intended, persons generally are entitled to expect that the manufacturer would provide medical practitioners with the information and warnings necessary to enable them to make a balanced, cautious and informed judgement about whether to recommend the treatment and consequentially, to enable their patient to make a similar determination as to whether they should consent to it.

The respondents argued that it was the responsibility of the medical practitioners (as learned intermediaries) to make themselves aware of any such risks from their review of sources including medical literature. The Court rejected those arguments.

The Court found that the manufacturer is best placed to provide that information, and it was clear that the respondents had knowledge of the serious risks associated with the intended use of the device, and the grave consequences if those risks eventuated, and these were not communicated adequately or promptly. As a result, the claimants suffered harm.

Negligence

The standard of care is determined by what a reasonable person in the position of the respondents would do in response to a reasonably foreseeable risk, affected by the gravity of the risk and severity of any consequences should the risk eventuate. For an implantable device, the level of caution required to be taken by a manufacturer is necessarily high. The applicants’ claims in negligence rested on the propositions that the respondents failed to undertake necessary safety evaluations for the devices or to provide adequate information about any associated risks.

The Court accepted that both the pre- and post-market evaluation of the devices was inadequate. In at least one case a device was put to market without clinical trials or comprehensive evaluation of safety. In other cases, studies were incomplete or inadequate and did not follow regulatory guidelines.

Responding to arguments by the manufacturers, the Court noted that a manufacturer’s duty of care is not discharged merely because it complied with the relevant regulatory requirements. The actions and inactions of a regulator or views expressed by professional associations, while relevant, are not determinative (noting the largely self-regulatory regime for approval of devices). Acceptance of that view would be to abrogate the responsibility of the manufacturer. In any event, the Court noted that the evidence of regulatory non-compliance resulting in action by local and international regulators was in this case indicative of the respondents’ failure to take reasonable care.

The Court found the evidence supported that the devices were brought to market with ‘unseemly haste’ and with a lack of attention to the safety of the women to whom they were marketed (at paragraph 3764). Post market surveillance did not include clinical follow up studies (at paragraph 3826). The respondents were found to have breached their duty of care where the risks were foreseeable, known and not insignificant, and had grave consequences.

The Court also accepted that the respondents had a duty to provide adequate information to medical practitioners and consumers on a continuing basis and not just when the devices came to market or were sold. Citing the decision of the Canadian court in Hollis v Dow Corning [1995] 4 SCR 634, the Court noted that this duty serves to correct the knowledge imbalance between the manufacturer and the consumer. Relying on a number of the above stated facts, the Court found the respondents breached this duty and were liable to the applicants in negligence.

The Court found that but for the respondents’ failure to warn of the pleaded complications, each applicant would not have consented to implantation of the device and instead pursued alternate treatment.

Damages and compensation

The Court found compensation and damages were payable to each applicant under the TPA and common law including damages for non-economic loss, past economic loss, future economic loss, interest, loss of superannuation benefits and future domestic assistance.

The Court also issued an injunction to prevent the respondents from supplying, promoting and distributing the devices without a revised warning in Australia.

Ethicon Sarl has appealed the decision to a Full Court of the Federal Court.

This article was published in Edition 1 of The Prescription.