The Federal Court of Australia has given medical device suppliers notice that it will apply high safety standards for medical devices, in the decision of Gill v Ethicon Sarl (No 5) [2019] FCA 1905 (21 November 2019) (Katzmann J).

The judgment, which consists of 5,827 paragraphs (1,500 pages), came after many weeks of hearings in which liability was denied. The action was vigorously defended.

After an introduction, we will outline the findings made on ARTG registration, pre-market evaluation, post-market surveillance and product information; and why manufacturers and suppliers are liable for defective goods, misleading and deceptive conduct and negligence at common law.

Introduction

This was a class action concerning nine medical devices, five used for the treatment of stress urinary incontinence and four used for pelvic organ prolapse, in women.

The pelvic-mesh devices were all made using knitted polypropylene, a thermoplastic polymer (see image at end). They are implanted with an invasive surgical procedure. They cause and continue to cause inflammation when implanted. They were designed to allow the body’s tissues to grow through and around the mesh over time.

In terms of safety, as a biomaterial intended for permanent implantation, they should not degrade in the body and should not have an adverse impact on the body’s tissues or systems.

The devices were manufactured by Ethicon Sàrl and Ethicon Inc, both foreign companies, and were supplied by Johnson & Johnson Medical (J&JM), an Australian company. The companies were all part of the Johnson & Johnson group (J&J).

Over 90,000 of these devices have been supplied in Australia since 1999.

The three representative applicants experienced chronic pain due to mesh erosion and perforation about six months after the implant. They undertook surgery to remove some of the mesh, but continued to suffer chronic pain, infections and other symptoms. 

ATRG registration

The devices were registered on the Australian Register of Therapeutic Goods (ATRG).

J&JM registered the devices relying on the “CE” mark, which signified that the device conformed with the 14 “essential” requirements listed in European Directive 93/42/EEC.

The Court found that the medical devices industry is largely self-regulating: the manufacturer decides if the requirements have been met and applies the “CE” mark. The TGA (Therapeutic Goods Administration) accepts the “CE” mark as evidence for registration. The manufacturer is not required to demonstrate independent pre-market testing of the safety or efficacy of the device.

In this case, the expert evidence established that none of the devices satisfied all of the requirements for CE marking at the time of registration or afterwards.

The deficiencies in the pre-market evaluation and post-market surveillance

The evidence established that the pre-market evaluation was deficient by reason of:

  • No or no adequate clinical trials were conducted to assess the relative safety and efficacy of the devices in comparison to other forms of surgical repair. No trials were conducted of a large representative group and for a sufficient period of time. All they had were studies conducted by surgeons on select groups of patients.
  • The documentary records for design history and technical files had critical documents missing.
  • No overarching, cohesive risk management system was in place.
  • The clinical evaluations of all the devices did not satisfy the requirements for CE marking.

The evidence established that the post-market surveillance was deficient by reason of:

  • It was passive or reactive, when it should have been proactive.
  • Risk management was problematic, in that the procedures did not conform to regulatory requirements and no genuine risk analyses were carried out.
  • Clinical evaluation reports did not comply with regulatory requirements and were not routinely or regularly prepared.
  • The system for complaints reporting and analysis was inadequate.

Product Information – instructions for use and promotional material

The Court found that few of the complications or inadequacies of the clinical evaluations of the devices were disclosed in the instructions for use issued with the devices or in the promotional material. For example:

  • The inflammatory reaction was described as “minimal to slight”, “transient” or “transitory”.
  • The first version of the instructions issued did not warn of the risk of mesh erosion. Later versions did list erosion and extrusion as possible ‘transitory foreign body response’, which was misleading or deceptive because it represented this would occur soon after the devices were implanted, when J&J knew it could occur years later.
  • Until the regulators intervened, J&J represented that existing infections could be “potentiated” when in fact the devices could cause infection.
  • The risk of chronic pain was not disclosed. The information given was that “some mild pain” may occur 24 or 48 months after surgery. In fact, integrated mesh and tissue contracts or shrinks causing chronic pain.
  • Doctors or patients were not informed that the chronic inflammatory response to implantation could be affected by the presence of autoimmune, connective tissue and like disorders which affect the immune response to healing.

The Court dismissed J&J’s argument that surgeons would be expected to inform themselves of the risks associated with the use of the devices, so to overcome the deficiencies in the product brochures. The Court said that not only could they rely on the ARTG registration but also the instructions for use “for complete contraindications, warnings, precautions and adverse reactions”.

Liability

Defective goods: The Court found that all of the devices carried risks that were clinically significant, against which no adequate warnings were given, and about which doctors and patients could have been misled. They were therefore defective and not fit for purpose.

None of the devices satisfied the essential requirements for CE marking.

The pelvic organ prolapse kits were only ever suitable for use in the context of a clinical trial to treat severe cases or where other treatment had failed or if there was a high risk of recurrence or in highly experienced hands for a select group of patients.

Misleading and deceptive conduct: under the Australian Consumer Law this conduct was established in terms of the instructions for use and marketing material.

Negligence: The obligations of the J&J companies were to exercise reasonable care in the supply and marketing of the devices. They breached their duty as reasonably prudent suppliers/manufacturers by failing to conduct adequate pre-marketing evaluations, by failing to conduct adequate post-market evaluations, and by failing to provide any adequate information, advice or warnings about complications and any adequate, clinical or other evaluation of risks. The risks were known, not insignificant and could cause significant and serious harm if they eventuated.

The Court assessed damages. There will also be declaratory and injunctive relief.

Being a representative (or class) action, the Court is empowered to make declarations as to liability. The Court will assess damages for each applicant for each person who joins the action separately (instead of awarding a lump sum to be divided amongst the class).

Conclusions

How did this happen? The marketers prevailed!

The Court found that the J&J companies “were so driven by commercial interests (to beat their competitors to market) that they neglected to undertake the investigations reasonably necessary to inform themselves and the community of the extent, if not also the nature, of the risks posed by the devices.”

The attempt to deflect liability upon the treating surgeons failed (the ‘intervention’ defence). The Court said that surgeons were entitled to rely upon the instructions for use and could not be expected to have knowledge of risks not disclosed.

The duty of care extended beyond the period before the devices were brought to market and was “a continuing obligation to evaluate their safety, keep abreast of information about the nature and extent of potential complications, and to convey that information to users of the devices”.

The supply of pelvic organ prolapse devices has been discontinued.

The stress urinary incontinence devices continue to be supplied, on strict conditions imposed by the TGA including the requirement to provide annual reports which include records of all complaints and adverse events received, to report all adverse events, and that instructions for use clearly indicate as ‘warnings and precautions’ that the use of the devices may result in bladder perforation, severe chronic pain and groin pain. 

The Prolift Total, Anterior and Posterior mesh implants (pelvic floor repair systems) from Instructions For Use