The Federal Court has delivered a further judgment in the representative class action concerning transvaginal mesh products sold by Johnson & Johnson and manufactured by Ethicon Sàrl and Ethicon Inc.
The devices were intended for use in the treatment of female stress urinary incontinence and pelvic organ prolapse. In December 2019 we published an alert on Justice Katzmann’s s decision on liability (Gill v Ethicon Sàrl (No 5)  FCA 1905), in which her Honour found the three representative applicants had suffered complications as a consequence of surgical insertion of the products (the Principal Judgment). In that judgment, the applicants succeeded both in establishing negligence and in their pleaded statutory causes of action.
In the most recent decision in the proceedings, Gill v Ethicon Sàrl (No 6)  FCA 279, two matters remained in dispute: whether the Court should grant injunctive relief, and the common questions to be resolved in the proceedings.
In the Principal Judgment, her Honour found that injunctive relief was appropriate and foreshadowed the form of that relief: an injunction to restrain the respondents from supplying, distributing, marketing or promoting any of the devices that remain on the Australian Register of Therapeutic Goods without including a prescribed warning in any promotional material and instructions for use (IFU) relating to those devices. The prescribed warning states that implantation of the devices will elicit a chronic inflammatory response in all patients, and comprehensively sets out the adverse events which may result. The full form of the warning is at paragraph 28 of her Honour’s reasons.
Her Honour did not make final orders granting relief at the time of the Principal Judgment. The respondents continued to maintain their objection to the grant of an injunction on the basis that an injunction would not operate to benefit the group members and would require the ongoing supervision of the Court. In particular, the respondents argued that fixing the wording of the warning by the terms of an injunction would prevent the warning being updated to reflect changes in medical best practice and advances in scientific knowledge. The respondents also filed a solicitor’s affidavit confirming that, since the hearing, new IFUs had been issued for the devices, which picked up some (but not all) of the previously undisclosed complications.
In rejecting the respondents’ submissions on this issue, her Honour reiterated findings in the Principal Judgment that the purpose of an injunction is not only to benefit those who bring legal proceedings; rather, injunctive relief for a contravention of the Trade Practices Act or the Australian Consumer Law serves a broader public purpose. Further, her Honour found that that amendments that had been made to the IFUs since the Principal Judgment did not adequately warn of the potential for late onset complications and the risk of chronic inflammatory response.
For those reasons, her Honour granted the injunctive relief (with some amendments) foreshadowed in the Principal Judgment.
The common questions
In a representative proceeding, s 33H(1)(c) of the Federal Court of Australia Act 1976 (Cth) requires questions of law or fact common to the claims of the group members to be specified in the application commencing the proceeding or a document filed in support of such an application. As Katzmann J noted, whether a question is common to some or all of the group members is to be determined by a consideration of whether the question is one of fact or law in the proceeding and whether the answer will be useful in determining other claims brought by group members. Common questions relate to issues that are not peculiar to an individual applicant’s case, but rather are common to the representative party and the group.
The document the applicants filed at the time of publication of the Principal Judgment contained 72 questions. The respondents argued that a number of those questions were inappropriate because they were too granular, gave rise to confusion, or were repetitive.
In determining the questions for inclusion, her Honour considered whether including particular questions would reduce the risk of future disputes in the determination of the claims brought by group members and the incurring of unnecessary costs. Applying that test, her Honour refined the list to 31 common questions. In doing so, her Honour noted that the degree of granularity with which the questions are cast does not affect whether they are common to the group members.
Many of Justice Katzmann’s answers to the common questions restated or were conclusions necessitated by her Honour’s findings in the Principal Judgment. Although answered by reference to the three representative parties, the questions were framed to answer critical questions that would arise in claims of other group members.
Set out below is a selection of key issues that arise from the questions and answers.
Her Honour reiterated the finding that the devices caused a number of complications, including extrusion or erosion of the mesh into surrounding organs, infection, chronic pain, psychiatric injury, and complications associated with the removal of the implanted device, which may not be possible in all cases. Her Honour found that each of these complications was clinically significant and had the potential to occur many years after implantation. Further, her Honour found that it is not necessary for group members to prove the mechanism by which the devices caused the complications suffered following implantation.
Her Honour also restated that the respondents owed a duty of care to take reasonable care to avoid injury to consumers and characterised the content of that duty of care consistently with the Principal Judgment:
- the manufacturers (being the Ethicon entities) owed the group members a duty to take reasonable care in the design, testing, evaluation, supply and marketing of the devices. That duty included a duty to undertake adequate pre- and post-market evaluations of the safety and efficacy of the devices;
- Johnson & Johnson owe the group members a duty to take reasonable care in the supply and marketing of the devices; and
- all three respondents owed the group members a duty to provide adequate information, advice and warnings about the associated complications and the lack of clinical evaluation of that risk.
The respondents were found to have breached their respective duties.
Statutory causes of action
Justice Katzmann found that the respondents’ conduct in marketing the devices was misleading or deceptive or likely to mislead or deceive within the meaning of s 52 of the Trade Practices Act or s 18 of the Australian Consumer Law due to the minimisation of the risks associated with implantation and representations that the inflammatory reaction was possible and transitory.
Her Honour also reiterated that the safety of the devices did not meet the standard that patients are generally entitled to expect; that each device had a “defect” within the meaning of the Trade Practices Act and the Australian Consumer Law respectively; and that Ethicon and Johnson & Johnson are jointly and severally liable to compensate group members who suffered injury because of that defect.
The next stage
The answers to the common questions have significant implications for current and future group members. Although medical examinations and evidence will still be necessary for individual group members to establish a claim, the answers to the common questions mean there will be no need for group members to establish the existence of a duty of care or breach of that duty. Further, it will not be necessary for members to prove the mechanism by which the devices caused the complications suffered following implantation.
The respondents have until 3 April 2020 to file a notice of appeal from these orders or those that followed the Principal Judgment. You can read the full form of the common questions here.