Contraceptive lawsuit against Bayer fails

The Victorian Supreme Court has dismissed a class action against Bayer for an allegedly defective contraceptive device. Justice Andrew Keogh found that the group had failed failed to establish a causal connection, despite claims of chronic pelvic pain, metal allergy, and other complications requiring medical intervention.

Essure, a permanent contraceptive implant, functions by inducing deliberate inflammation in the fallopian tubes, effectively forming a barrier over time. Originally developed by Conceptus and approved in the US in 2002, Bayer acquired Conceptus in 2013, making the device available in Australia from 2001 until its withdrawal in 2017 following a safety alert from the Therapeutic Goods Administration (TGA).

Represented by Slater & Gordon, the class action argued that Bayer had inadequately warned about potential risks, citing settlements in the US totalling USD$1.6 billion related to similar claims. However, Justice Keogh concluded that the evidence presented did not convincingly prove that Essure directly caused the reported injuries, including chronic inflammation and reproductive complications.

Addressing allegations of device migration or corrosion, Justice Keogh emphasised the robustness of Essure’s materials under normal conditions, dismissing claims of inherent defects without substantial scientific backing.

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 chronic pelvic pain (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 considered that the critical issue was whether Bayer 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 gynaecologists’ responsibility to provide.

“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,” commented lawyers from Barry Nilsson.

It remains to be seen whether the judgment will be appealed.

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