For Johnson & Johnson Medical (JJM), the Federal Court orders made on 6 March 2020 represent a comprehensive rejection of its:

  • denial of liability for negligence in failing to take reasonable care to avoid injury to consumers; and
  • denial that its Instructions for Use for pelvic mesh products failed to disclose or make adequate disclosure of a number of adverse effects and difficulties in use.

The orders are set out in Gill v Ethicon Sàrl (No 6) [2020] FCA 279, Federal Court of Australia (Katzmann J).

The Proceedings

To re-cap:

The proceedings were commenced on 15 October 2012 in the names of 3 Applicants, as representative proceedings. Their claim was based on: breaches of its common law duty of care to take reasonable care to avoid injury to consumers; and engaging in misleading and deceptive conduct and in supplying goods with safety defects, in breach of the Australian Consumer Law (s 9 & 18).

On 21 November 2019, the Court found that JJM had breached their duty of care and also the statutory breaches, and awarded damages – Gill v Ethicon Sarl: (No 5) [2019] FCA 1905.

A normal lawsuit for an unsafe product would have ended then and there. But in this case, two further orders were needed:

  • The first, a number of common questions needed to be answered, being on issues common to the representative group members.
  • The second, the form of the Instructions for Use which the Court was to make mandatory in the supply, distribution, marketing or promotion of the pelvic mesh devices.

On 6 March 2020 the orders made. The respondents are Ethicon Sàrl and Ethicon Inc of Switzerland, the manufacturers; and Johnson & Johnson Medical (JJM), the Australian sponsor and supplier. The Ethicon devices are the Stress Urinary Incontinence and the Pelvic Organ Prolapse mesh devices.

Order 1- The Common Questions

Biocompatibility issues

Q9:    Can the pores of the mesh used in the Ethicon devices deform and collapse under mechanical load?

A:    Yes.

Q10:    Does deformation and collapse of the pores of the mesh used in the Ethicon devices cause bridging fibrosis or fibrotic bridging?

A:    Yes.

Q11:    Is bridging fibrosis of clinical significance?

A:    Yes. It can cause or contribute to contraction of the mesh which, in turn, can cause complications such as mesh exposure, erosion, chronic pain and dyspareunia.

Negligence

Q12:    Did the respondents owe a duty of care to group members?

A:    Yes. The respondents owed a duty to take reasonable care to avoid injury to consumers.

Q13:    Did the manufacturers owe the group members a duty to take reasonable care in the design, testing, evaluation, supply, and marketing of the Ethicon devices?

A:    Yes.

Q14:    Did JJM owe the group members a duty to take reasonable care in the supply and marketing of the Ethicon devices?

A:    Yes.

Q15:    Did the manufacturers breach their duty of care to the group members by failing to undertake adequate pre-market evaluations of the safety and efficacy of the Ethicon devices?

A:    Yes.

Q16:    Did the manufacturers breach their duty of care to the group members by failing to undertake adequate post-market evaluations of the safety and efficacy of the Ethicon devices?

A:    Yes.

Q17:    During the period from the time of first supply in Australia of each of the Ethicon devices until 4 July 2017, did the respondents breach their duty of care to group members by failing to provide any adequate information, advice or warnings about the above-mentioned complications and the absence of any adequate clinical or other evaluation of the risks?

A:    Yes, throughout the period, except that they did not breach their duty of care by failing to warn of the risk of psychiatric injury.

The statutory causes of action

Q20:    Do the causes of action under the Trade Practices Act or the Australian Consumer Law apply to Ethicon Sàrl and Ethicon, Inc. even though they are incorporated overseas and neither has a place of business in Australia?

A:    Yes.

Misleading or deceptive conduct

Q21:    Between the first supply in Australia of the Ethicon devices and 4 July 2017 was the respondents’ conduct in marketing the Ethicon devices misleading or deceptive or likely to mislead within the meaning of s 52 of the Trade Practices Act or s 18 of the Australian Consumer Law?

A:    Yes.

Q22:    Why was the respondents’ conduct misleading or deceptive or likely to mislead or deceive?

Throughout the period from the first supply in Australia of the Ethicon devices to 4 July 2017, the respondents falsely represented that the inflammatory reaction generated by implantation was transitory rather than permanent and possible rather than certain, and exaggerated the benefits of the devices and minimised the risks associated with implantation.

DEFECTIVE GOODS

Q24:    Did the SUI devices or any of them have a defect within the meaning of s 75AC of the Trade Practices Act and a safety defect within the meaning of s 9 of the Australian Consumer Law in that their safety was not such as persons generally are entitled to expect?

A:    Yes, all of them because, taking into account all the relevant circumstances, including the way in which and the purposes for which they were marketed, the use of the CE mark in relation to them, the deficiencies in the warnings and other information supplied by the respondents they exposed women to significant risks of injury against which inadequate precautions were taken and in respect of which misleading representations were made.

Order 2 - The Instructions for Use (IFU)

Prolene mesh is designed to, and will invariably elicit in all patients, an acute inflammatory reaction followed by a chronic inflammatory response. The chronic inflammatory response will result in continuously regenerating scar tissue within and surrounding the implant for as long as the implant remains in the body. The scar tissue will cause the mesh to contract to some degree in all patients. It is not possible to predict the severity of the chronic inflammatory response in any individual patient. …

The adverse events which may result include:

(a)    infection;

(b)    erosion of the mesh into the vaginal canal resulting in infection which may be difficult to treat, cause offensive vaginal discharge and pain;

(c)    erosion of the mesh into surrounding organs such as the bladder, urethra or rectum which may cause pain and damage those organs;

(d)    damage to nerves in the scar tissue surrounding the implant or elsewhere;

(e)    chronic pain, which may be severe;

(f)    dyspareunia, which may be severe and may become chronic;

(g)    apareunia;

(h)    leg weakness;

(i)    de novo or recurrent urinary incontinence;

(j)    difficulty voiding; and

(k)   vaginal discharge.

Adverse events may occur years after implantation. The risk will endure for as long as the implant remains in the patient.

Each of these events may occur regardless of the skill of the surgeon.

While the true incidence of these complications is unknown, they are not rare.

Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms. Removal of part of the implant can be difficult. Removal of the whole of the implant may be practically impossible. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of stress urinary incontinence.

Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.

The Instructions For Use form is to be introduced in 2 stages – on 20 March 2020 for patient information leaflets and promotional material and on I July 2020 for all instructions (including on the packet) and will apply only to the Stress Urinary Incontinence devices, the Pelvic Organ Prolapse devices having been withdrawn from the market. The order permits ‘the above advice or advice to the same effect’ to be included.

Comments

  1. The damages awarded to the Applicants were:

Sanders - $757,372; Gill - $1,276,113; Dawson $555,555.

The damages included non-economic loss, loss of earnings and superannuation, domestic assistance, out of pocket expenses and interest on these sums.

Multiplied by more than 1,350 members in the class action, the cumulative damages will be substantial.

  1. JJM objected to the proposed Instructions For Use until the very end:

JJM gave ‘evidence that, since the IFUs are used throughout the world, amending them in foreign jurisdictions may require consultation and approval by regulatory authorities, which may involve a significant period of time’.

Justice Katzmann dismissed this argument as speculative. But in making it, JJM underlined the international significance of this decision, which will support claims for compensation for defective pelvic mesh devices around the world.

JJM argued the new IFUs it issued were in accordance with the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017 (Cth) (Schedule 1 cl 13A) and that the job of regulating the sale of medical devices should be left to the regulators – Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ASIC). It also argued that a court order was ‘blunt and inflexible’.

Justice Katzman dismissed this argument, stating that the new IFUs did not give sufficient warning, the order has flexibility by allowing words ‘to the same effect’ to be included, it applies only in Australia and it is appropriate for the Court to make the order because it was in the public interest.

The conclusion is that the Court will substitute its own IFU for any IFU registered with the TGA in appropriate cases.