In accordance with the practice of the Federal Court in some cases of public interest, importance or complexity, a summary was prepared to accompany the orders made yesterday in Gill v Ethicon Sarl & Ors (No 5) [2019] FCA 1905 (available on AUSTLII).

Selectively drawing from that summary:

This is a representative (or class) action brought by three women: Kathryn Gill, Diane Dawson, and Ann Sanders, each of whom suffered complications after surgery involving the transvaginal implantation of synthetic mesh. The action is brought against three related companies, all members of the Johnson & Johnson group.

At the centre of the case are nine medical devices made from knitted polypropylene, a thermoplastic polymer. Five of the devices are indicated for use as surgical implants for women with stress urinary incontinence, four for use as surgical implants for women with pelvic organ prolapse.

The relevant medical devices used for the treatment of pelvic organ prolapse are known by the trade names Gynemesh PS, Prolift, Prolift+M, and Prosima.

The applicants made out their case as follows:

First, all of the Ethicon devices had a defect within the meaning of that term in the Trade Practices Act and none was fit for the particular purpose for which it was acquired or of merchantable quality. The Trade Practices Act provided that goods have a defect if their safety is “not such as persons generally are entitled to expect”. I will say more about this subject a little later. Except for the addition of the word “safety” before “defect”, the relevant provision of the Australian Consumer Law is identical.

Second, the information provided by the respondents in the instructions for use supplied with the devices and in promotional material they disseminated did not warn of certain risks of which the respondents knew or ought to have known and, in numerous respects, was misleading because of those omissions and because of false statements and half-truths contained in the documentation.

Third, the respondents failed to take reasonable care to evaluate the safety of the Ethicon devices both before and after they were taken to market.

Fourth, the applicants were injured because of the defect in the devices the respondents supplied to them and were therefore entitled to compensation.

Fifth, the applicants were injured because of the other contraventions of the legislation and the breaches by the respondents of their duties of care, and were therefore entitled to damages.

In the summary the trial judge made a number of brief statements as to findings on the evidence, including:

  •  In the case of Prolift, Ethicon started studies on a prototype but pressed ahead with the launch, without waiting until the studies had been completed.
  • The respondents did not inform doctors or patients of the limitations of the available information, all the risks that could eventuate, how they could be effectively managed, or how they could be remedied.
  •  They continued to promote and sell the older devices after the new and “improved” versions were introduced and they remained publicly coy about what they knew and did not know about all of them.
  • The expert evidence established that none of the Ethicon devices satisfied all the requirements for CE marking either at the time the marks were applied or at any relevant time thereafter.
  • The evidence established that the pre-market evaluation of the devices undertaken by Ethicon was deficient in numerous respects.
  • The evidence showed that Ethicon’s post-market surveillance was also deficient in multiple respects.
  • The promotional material, which included product brochures produced by both Ethicon and JJM, minimised the harm the devices could cause while at the same time exaggerating their benefits.
  • The respondents did not inform doctors or patients 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.

Final orders are not expected until February 2020.

Legal issues of general interest included:

EVIDENCE — where Civil Liability Act 2002 (WA) renders inadmissible evidence of injured person as to what she would have done if tortfeasor had not been at fault, whether evidence of this nature nonetheless admissible in a court exercising federal jurisdiction — whether s 5C(3) of the Civil Liability Act picked up by Judiciary Act 1903 (Cth).

See the discussion at [4456] – [4458].

DAMAGES — calculations of life expectancy — discount for vicissitudes — whether discounts for the ordinary vicissitudes of life should be made to damages for future out-of-pocket expenses or care/services — whether s 5D of the Civil Liability Act 2002 (WA) and s 52 of Wrongs Act 1958 (Vic) disturb principles in Watts v Rake [1960] HCA 58; (1960) 108 CLR 158 and Purkess v Crittenden [1965] HCA 34; (1965) 114 CLR 164 — whether under Trade Practices Act 1974 (Cth) and Wrongs Act 1958 (Vic) a 5% multiplier or discount rate applies to future out-of-pocket expenses and care/services or only to future economic loss — whether future services should be compensated at commercial rates.

See the discussion at [4906] – [4915].