Three women suffering severe and debilitating side effects and complications following the implantation of surgical mesh have successfully sued the suppliers and manufacturers of the surgical mesh in both consumer law and negligence, with the Federal Court of Australia finding the companies breached their duty of care in failing to adequately inform about the known, foreseeable and not insignificant risks.
Kathryn Gill, Diane Dawson and Ann Sanders (the applicants) brought a representative action against Ethicon Sàrl, Ethicon Inc and Johnson & Johnson Medical Pty Ltd (the respondents) following complications after surgery involving the transvaginal implantation of synthetic mesh, supplied, manufactured and distributed by the respondents. Each applicant underwent the implantation of the medical mesh device as part of treatment of stress urinary incontinence, vaginal prolapse and/or pelvic prolapse following childbirth.
The applicants commenced seven claims in the Federal Court of Australia against the respondents: four under Commonwealth consumer protection laws and three at common law in negligence. All claims were denied by the respondents. The applicants argued that the respondents contravened relevant provisions of the Trade Practices Act and breached its duties of care in that it failed to take reasonable care to evaluate the safety of the devices both before and after they were taken to market, and claimed damages for the injuries they allegedly suffered as a result.
The respondents denied the allegations and argued that “all surgical procedures present risks”. 
Her Honour Katzmann J found that the Ethicon companies as manufacturers were obliged to exercise reasonable care in the supply and marketing of the devices, and that duty extended to providing accurate information about the performance and safety of the devices. That duty was a continuing obligation to evaluate their safety, keep abreast of information about the nature and extent of potential complications, and to convey that information to users of the devices. 
Further, the duty of care owed by Johnson & Johnson Medical Pty Ltd as the supplier but not the manufacturer was to take reasonable steps to ensure that the information they conveyed about the devices was accurate, not misleading and sufficient to alert both medical practitioners and prospective patients about the true risks associated with the use of the devices.
The information about the potential risks in the instructions for use and promotional material provided by the respondents did not conform to the standard required of a reasonably prudent manufacturer or supplier in their position. It fell well short of capturing all known, let alone reasonably foreseeable, risks and was apt to mislead both doctors and patients about the safety and efficacy of the various devices. The risks were known, not insignificant, and on the respondents’ own admission, could cause significant and serious harm if they eventuated. A far more cautious approach was warranted than the respondents took. –
Accordingly, the court found that each of the respondents was negligent. Each of the applicants is now to make an election as to whether she wishes to receive damages under the Trade Practices Act or at common law: Gill v Ethicon Sarl (No 5) (2019) Aust Torts Reports ¶82-450;  FCA 1905