On 21 November 2019, over two years after its commencement, the Federal Court of Australia handed down its monstrous 1500-page, 520,000-word decision in the medical product liability class action known as Gill v Ethicon Sàrl & Ors (No 5) [2019] FCA 1905. As is Federal Court practice in important, complex or public interest cases, the Court has provided a much easier to digest summary of their decision, which can be found here.

The Proceedings
This is a class action proceeding brought by three women, Kathryn Gill, Diane Dawson and Ann Sanders on behalf of over 1350 Australia women against Johnson & Johnson and two related companies. The case focuses on nine medical mesh devices made of the synthetic plastic polypropylene, which were designed for surgical implantation to treat stress urinary incontinence and pelvic organ prolapse (Mesh Devices).

Many of the women who were treated with these Mesh Devices started experiencing severe post-surgery complications, including chronic inflammation, chronic pain, infection, incontinence, hemorrhaging, leg weakness, psychological injuries and damage to surrounding tissues. It was determined that these complications were the result of the mesh eroding and imbedding itself in the surrounding tissue.

The applicants alleged the following:

  1. All the Mesh Devices had a defect (defect defined as “not such as persons generally are entitled to expect” under the Trade Practices Act 1974) and they were unfit for purpose;
  2. The information provided by the respondent in instructions and advertisement did not contain warnings about certain risks that the respondents knew or ought to have known about, and was misleading due to these omissions, as well as false statements and half-truths within that information;
  3. The respondents failed to take reasonable care when testing the safety of the Mesh Devices;
  4. The defects in the Mesh Devices caused injury to the applicants; and
  5. The respondents’ breach of duty of care and contravention of legislation caused the applicants injury.

Some of the statistics about this matter are truly staggering to hear:

  • 48 witnesses gave evidence, including 37 expert witnesses from 12 different academic disciplines.
  • In addition to the extensive expert reports and witness accounts, over 5,000 additional documents were submitted into evidence, totaling over 164,000 pages.
  • Extensive written submissions were given over the course of the trial, including almost 1,930 pages of closing submissions between the parties.
  • The trial was held from July 2017 to the end of February 2018. Closing oral arguments alone took 4 weeks to conduct.

The Decision
Her Honour, Justice Katzmann, made a number of statements in her summary as to her findings on the evidence:

Product Suitability

  • In the case of one of the Mech Devices, the respondents commenced studies on the prototype but went ahead and launched the product without waiting for the results of the studies.
  • That both the pre-market and post-market evaluations of the Mesh Devices by the respondents were lacking in multiple respects.
  • None of the Mesh Devices satisfied all the requirements to allow them to be marked “CE” (a mark that is a representation by the manufacturer that the device conforms to the requirements of the European Directive and its essential requirements) at any time.

Product Information

  • The respondents failed to properly inform doctors and patients of:
    • the limitations of the available information;
    • the potential risks that could eventuate; and
    • how they could be effectively be managed or remedied.
  • The respondents did not inform doctors or patients that the chronic inflammatory response to mesh implantation could be affected by autoimmune, connective tissue or similar disorders that can impact the immune systems response to healing.

Product Marketing

  • The respondents continued to promote and sell an old version of the Mesh Devices after a new and “improved” version were released, and they were publicly coy about what they did and did not know about the different product iterations.
  • Promotional material, which included product brochures, produced by the respondents both minimised the potential harm of the devices while at the same time exaggerating their benefits.

This is a landmark decision for product liability class actions in Australia. It is Australia’s largest women’s health class action and the decision will mean compensation for hundreds of women suffering due to the effects of the mesh implants. Johnson & Johnson are facing thousands of similar legal actions internationally, and the Australian decision could set the pace for other jurisdictions to follow.

Due to the length of the judgment, Her Honour decided to rule on damages in February next year, allowing time for the parties to read the judgment and make submissions regarding damage calculations, and allow for more women to join the class.