Justice Katzmann of the Federal Court of Australia has found in favour of three women in a representative action against Johnson & Johnson and related company Ethicon in relation to complications the Court found the women had suffered as a consequence of surgical insertion of transvaginal mesh products. The devices were hoped to be a simple surgical means of treating common medical issues following childbirth, but since their introduction, women have experienced complications, including mesh exposure and erosion causing chronic pain, infection, incontinence, and irreparable damage to the urethra and vaginal wall.
The decision is significant not only for the more than 1,300 Australian women registered as group members, but for the thousands of related actions filed in the US, the UK and Canada.
On 21 November 2019 Katzmann J of the Federal Court of Australia handed down the decision of Gill v Ethicon Sàrl  FCA 1905, a representative proceeding concerning nine urogynaecological devices developed and manufactured by two foreign companies Ethicon Sàrl and Ethicon Inc (the Ethicon entities, both part of the Johnson & Johnson group of companies), which were ultimately marketed and sold by a related Australian company, Johnson & Johnson Medical Pty Limited (J&J). The devices (the Ethicon Devices) were made from polypropylene mesh and were used to treat women suffering from pelvic organ prolapse or stress urinary incontinence in Australia, both common complications of childbirth.
The three applicants commenced proceedings against the two Ethicon entities and J&J under Pt IVA of the Federal Court of Australia Act 1976 (Cth) on behalf of themselves as well as other women who suffered complications following the implantation of the Ethicon Devices. The applicants alleged that the respondents contravened various provisions of the Trade Practices Act 1974 (Cth) (TPA) and the Competition and Consumer Act 2010 (Cth) (CCA) and were liable in negligence. At the commencement of the trial there were approximately 700 women registered as group members, however Katzmann J at the outset of her judgment acknowledged the group could be large as there were more than 90,000 Ethicon Devices supplied in Australia and the class was open.
The applicants claimed that the Ethicon Devices had caused a long list of complications, including chronic inflammation, extrusion or erosion of the mesh into surrounding organs, infection, chronic pain, pain during sexual intercourse, urinary incontinence, recurrence of prolapse, and damage to surrounding organs and nerves. The respondents did not dispute that the complications could be caused by the Ethicon Devices, nor that the complications were clinically significant; however, the proceedings hinged on the magnitude and gravity of the risks, and the obligation of the respondents to disclose them.
After canvassing large swathes of medical literature and expert evidence in relation to the pleaded complications, Katzmann J ultimately found the respondents had failed to adequately disclose the risks associated with the Ethicon Devices. Her Honour considered that the respondents had not provided adequate warning about all risks, had not provided adequate information about the probability of the risks arising or the severity of the risks.
The applicants’ case in negligence was that each of the Ethicon Devices could cause a number of potentially serious complications, yet the Ethicon entities failed to:
- undertake adequate pre- or post-market evaluation of safety and efficacy of; and/or
- provide adequate information about the risks associated with the use of the devices or the level of evaluation of them.
On the first claim, Katzmann J accepted that both the pre- and post-market evaluation of the Ethicon devices was insufficient to discharge the respondents’ duty of care. On the claim relating to the adequacy of information provided, although conscious of the possibility that the applicants’ evidence could be tainted by hindsight, her Honour found that, but for the respondents’ failure to warn of the pleaded potential complications and extent of evaluation, each applicant would not have consented to implantation of the device and instead would have pursued other treatment options.
Manufacturer’s duty of care
The Ethicon entities, as manufacturers, were found to have a duty to take reasonable care in the design, testing, evaluation, supply, and marketing of the devices. That duty extended to providing accurate information about the performance and safety of the devices, including warnings about potential complications and contraindications. The duty was not confined to the period before the devices were made or placed on the market - the obligation to evaluate safety and keep abreast of information about the nature and extent of potential complications continued, together with the obligation to provide accurate information to patients.
Although J&J did not manufacture the devices, it was in the same corporate group as the Ethicon entities, promoted and supplied the devices to Australian hospitals and doctors, and was the sponsor of the products for the purposes of the TG Act so as to have an obligation to properly understand associated risks. J&J’s duty of care was found to be co-extensive with the Ethicon entities’, with the exception that her Honour did not consider J&J’s duty extended to undertaking clinical evaluations of the Ethicon devices.
Standard of care and the ‘learned intermediary’
The fact that medical practitioners owe patients a duty of care did not absolve the Ethicon entities, as manufacturers, from informing prospective patients, directly or indirectly, of the nature and extent of the potential risks associated with the devices. This meant that the respondents were expected to take into account the possibility that the medical practitioner might fail to inform the patient of the associated risks. Further, the Ethicon entities’ duty of care was not discharged by compliance with relevant regulatory requirements.
The evidence established that the associated risks were not insignificant, were foreseeable, and (as admitted by the respondents) could result in serious harm. The exercise of reasonable care, here, required warnings to be provided to prospective users (including the applicants and their treating physicians, and the hospitals to which devices were distributed) about the potential complications.
Application of the TPA and CCA to foreign corporations
The applicants made statutory claims under both the TPA and CCA. Katzmann J noted that any differences in wording that appear in the comparable provisions of those Acts were, at the material time, inconsequential. Her Honour rejected the respondents’ threshold submission that the statutory causes of action did not apply to the two Ethicon respondents, as they were incorporated overseas and neither has a place of business in Australia. Her Honour considered that the legislation applies to conduct engaged in within Australia by a corporation, and that this condition was met in the present case because supply of the Ethicon devices took place in Australia – the devices were received in Australia by an Australian company (J&J), delivered to Australian hospitals and doctors, and implanted in women in Australia.
Were the Ethicon Devices defective?
The substance of the applicants’ statutory claims was threefold: first, that the devices were defective; second, that they were not reasonably fit for the purpose for which they were acquired; and third, that they were not of merchantable or acceptable quality. It was common ground that, if the devices were found to be defective, the applicants would also succeed on the second and third statutory claims.
The Judge noted at the outset that, where a medical device exposes consumers to a risk of significant harm, the device will have a defect unless accompanied by warnings sufficient to alert patients to that risk. The applicants argued that the following circumstances should be taken into account in determining whether the Ethicon Devices were defective:
- the allegation that the devices caused the pleaded complications;
- the availability of alternative forms of treatment, which are at least of comparable efficacy;
- the allegation that the respondents failed to warn of the extent of clinical evaluation;
- the fact that neither condition (stress incontinence nor prolapse) is life threatening; and
- that the implantation surgery is elective.
In considering the question of the level of safety persons are entitled to expect, her Honour held (and the respondents largely accepted) that the same standard applies for a medical device intended for permanent implantation in the body as for a drug – that is, to the extent the device is known or believed to have side-effects (especially serious ones), the supplier of the device must provide medical practitioners with information or warnings sufficient to permit a balanced, cautious and informed judgment to be made (citing Peterson v Merck Sharpe & Dohme (Aust) Pty Ltd (2010) 184 FCR 1 at ).
Although Katzmann J accepted the proposition that the law does not require that goods be absolutely free from risk, her Honour found that the safety of the devices did not meet the standard that patients are generally entitled to expect and that, accordingly, each device had a “defect” within the meaning of the TPA and the ACL respectively. In coming to this conclusion, her Honour had regard to the nature and extent of the risks associated with the devices, the deficiencies of the warnings that were provided , the failure to comply with the requirements for CE marking, and the way in which the devices were marketed.
Her Honour went on to find that the applicants had each suffered damage that was caused by the failure to provide adequate warning, and that Ethicon and J&J were jointly and severally liable to compensate the applicants (and other group members) who had suffered injury because of that failure. Her Honour also found that the respondents’ conduct was misleading or deceptive, or was likely to mislead or deceive, in particular because the information in the brochures the respondents provided to patients and surgeons about the devices omitted warnings about the risks of complications, the gravity of those risks, and the limited evaluation of the devices.
The majority of claims as to which injuries and disabilities were caused by the implants were uncontested. Her Honour’s assessment as to the amount of damages payable to each applicant under the TPA and common law ultimately included damages for non-economic loss, past economic loss, future economic loss, interest, loss of superannuation benefits and future domestic assistance.
Katzmann J also indicated she would make declaratory and injunctive relief, including an injunction preventing the respondents from supplying, distributing, marketing or promoting any of the devices that remain on the ARTG without including a warning in the Instructions for Use for each of those devices and any promotional material relating to those devices.
The claims in these proceedings mirror those being brought in actions overseas, meaning the aftermath of the decision – including whether the J&J companies appeal – will be watched closely around the world. Closer to home, a second Australian class action, brought by 850 women against American Medical Systems, a manufacturer of a similar product, was also filed in January this year in the Federal Court. A hearing date has not yet been set, but no doubt the prospects of settlement in that proceeding will be heavily influenced by the outcome in these proceedings.