The Victorian Supreme Court has dismissed a class action against Bayer for an allegedly defective contraceptive device, called 'Essure'. Justice Keogh found that the group had failed to provide evidence supporting their claim that the contraceptive device was causally linked to their major health issues.
In issue
- A class action in the Supreme Court of Victoria was brought against Bayer AG and its related entities for alleged harm from the implant of a contraceptive device alleged to have been suffered by over 1400 women. On 10 December 2024, Justice Andrew Keogh found for Bayer concluding that many of the injuries suffered could not be causally linked to a defect in the contraceptive device, but rather were commonplace for women of 'reproductive age'.
The background
The Essure contraceptive device is a permanent contraception implant. It is a soft, flexible insert placed into the fallopian tubes which following a period of time, forms a barrier due to deliberate inflammation around the inserts.
The device was developed by Conceptus Inc and was approved for use in the United States in 2002. Conceptus Inc was acquired by Bayer in 2013. The device was available in Australia from around 2001 until 2017. The device was withdrawn from the market following a hazard alert issued by the Therapeutic Goods Administration (TGA).
Members of the class, represented by Slater & Gordon, were implanted with the device prior to 31 December 2018. Members of the class alleged chronic pelvic pain (CPP), abdominal pain, metal allergy, ongoing inflammation, abnormal uterine bleeding, dysmenorrhea with some requiring hysterectomies as a result of the device.
The action was brought off the back of a settlement of multi-district litigation in the US related to the device in the sum of USD$1.6 billion.
The decision at trial
The actions brought in the class action included:
- that Essure had a defect (within the meaning of s 75AC Trade Practices Act (TPA); s 9 Competition and Consumer Act (ACL),
- that Essure was not of merchantable or acceptable quality (within the meaning of s 74D TPA; s 54 ACL), and
- that Bayer was negligent in the design, manufacture, supply, and distribution of Essure in Australia.
The factual allegations included that the defendants failed to give adequate warnings about any inherent defects in the device such as the risk of ongoing chronic inflammation, given that its purpose was to trigger an inflammatory response.
Justice Keogh found that conclusions drawn from histological and corrosion studies as well as expert evidence adduced by the lead plaintiff on behalf of the class failed to establish causation, but was rather, 'far from compelling'. He concluded that the evidence neither showed that the device caused the harm complained of, nor the specific injuries suffered by the lead plaintiff. Instead, Justice Keogh found that epidemiological evidence did not show an increased risk of CPP and dysmenorrhea following device implantation. He accepted evidence adduced by Bayer to the effect that abnormal bleeding and pelvic pain were common in pre-menopausal women and that several unidentified factors could be responsible. Moreover, Justice Keogh rejected the argument that the device could migrate, fragment, or corrode following implantation – he found that the device was made up of robust materials, which could only break under immense pressure, such as during removal.
Furthermore, Justice Keogh found that the negligence claim was not dependent on the existence or otherwise of a foreseeable risk of harm. Rather, he considered that the critical issue was whether the defendants managed the inherent risk in a reasonable manner, by providing adequate warnings about the risk with the product. He added that medical devices carry an inherent risk and as such, merely posing a risk to users does not constitute unacceptable quality. Justice Keogh accepted that the Bayer defendants had provided sufficient information regarding the possible risks associated with implantation and that any further details were the gynecologists’ responsibility to provide.
Implications for you
The case is further evidence that large settlements and jury verdicts for medical device mass torts in the United States do not necessarily equate to success for plaintiffs in Australia given more stringent causation tests and fewer jury trials for product liability cases in most Australian jurisdictions. That said, Justice Keough’s decision and some of his reasoning does run counter to some other medical device class actions in recent years. It remains to be seen whether the judgment will be appealed.
