Key points

  • The law does not require goods to be completely free from risk, but it does require manufacturers and suppliers to disclose those risks to the prospective consumer and to continually evaluate and advise of their safety.
  • Manufacturers of medical devices cannot avoid liability simply on the basis of:
    • being certified as meeting the applicable safety standards (e.g. under the Therapeutic Goods Act) due to the self-regulating nature of the medical devices industry; or
    • having their devices supplied via doctors and hospitals as “learned intermediaries”, as such intermediaries are entitled to believe that the manufacturer will have more knowledge about its own product than the medical community, and therefore does not excuse the manufacturer from its obligations to warn, even in circumstances where those risks may, or should be, known to the intermediaries.

Class action background

This was a class action against three companies, all members of the Johnson & Johnson group, relating to the safety of nine synthetic mesh implantation devices designed to alleviate either (a) stress urinary incontinence or (b) pelvic organ prolapse. The applicants claimed that the use of devices, and the techniques required to implant them, exposed patients to risks of significant and serious injury including chronic inflammatory reaction, extrusion or erosion of mesh into surrounding areas, infection, chronic pain, painful sex, recurrent prolapse or incontinence haemorrhage, and damage to surrounding organs.

The applicants claimed that the devices were defective, and that they were not adequately warned of the risks or safety evaluations of the devices and were therefore entitled to compensation. The companies all denied liability and vigorously defended the claims.

Evidence established that, at the time of each device being supplied, the companies were aware that they could cause the pleaded complications. It also became clear that the manufacturers had taken shortcuts with respect to the development by (1) launching some products without clinical evidence (2) relying on studies from select groups without waiting for long-term results and (3) engaging in “widespread and systematic” non-compliance with medical device industry regulatory requirements (which Her Honour noted was “largely self-regulating”) for both pre-market and post-market surveillance.

The Court found that all devices carried risks of complications that the companies admitted were clinically significant and for which no adequate warnings were given. The warnings provided, if any and even in their amended forms, consistently provided inadequate and misleading accounts of the associated risks. For example, warning of a minimal to slight “transient” or “transitory” inflammatory reaction when the companies knew it was often not minimal and never transitory, or warning that “as with all surgical procedures there is a risk of infection” implying that the devices carried no greater risk than other surgeries, that the device itself would not cause infection, and failing to mention the potential for late-onset infection.

Findings

  • The companies were in breach of the relevant Trade Practices Act provisions.
  • The companies owed a duty of care that extended to providing accurate information about the performance and safety of the devices, including warning of the relevant complications and required an ongoing duty to evaluate the devices safety and convey to the users (sufficient to alert both medical practitioners and prospective users about the risks and any shortcomings in the clinical evidence).
  • The manufacturers (but not the suppliers) had a duty to take reasonable care in design testing and evaluating the devices.
  • The companies had breached their respective duties.
  • The fact that the devices were supplied through a surgeon or “learned intermediary” did not excuse the manufacturers from liability with respect to risks and complications.
  • The Plaintiff’s must now elect whether to accept damages assessed in accordance with the TPA or at common law.

Read the decision here: Gill v Ethicon Sarl (No 5) [2019] FCA 1905 (21 November 2019)

For more information or discussion, please contact our Health Law team.