The Victorian Supreme Court recently dismissed a class action on behalf of more than 1,400 women who received Bayer’s Essure contraceptive device.
The decision attracted significant publicity, including criticism from the Victorian Premier.
It left the women shocked and disappointed, particularly since Bayer had settled a similar claim in the United States for US$1.6 billion.
So why did the Victorian class action fail?
What’s Essure?
Essure offered an alternative to more invasive permanent contraceptive procedures such as tubal ligation.
The device was implanted into the fallopian tubes. This triggered an intended inflammatory response that blocked the tubes, preventing passage of sperm and ova.
In Australia, the device was implanted by gynaecologists. More than 3,000 devices are thought to have been implanted into Australian women.
In 2017, Essure was voluntarily withdrawn from our market after increasingly publicised concerns regarding safety, including in the US.
The US class action was settled out of court, enabling Bayer to avoid setting a legal precedent for similar claims in other jurisdictions.
Relevant US laws are different from those in Australia. Consequently, settlement of the US claim has only limited value in determining the likely outcome of litigation in Australian courts.
What went wrong with the device?
Lead plaintiff Patrice Turner began experiencing abnormal uterine bleeding, heavy periods and pelvic pain within a few years of using Essure.
She ultimately required a hysterectomy, which removed the Essure devices and resolved her symptoms.
Diego Fedele/AAP
Other class members experienced similar symptoms, with many also requiring hysterectomies.
The claim relied on three causes of action:
- Essure had a safety defect which caused the plaintiff’s injury
- Essure wasn’t of the quality consumers would reasonably expect
- the defendants were negligent in Essure’s design, manufacturing and distribution. The alleged negligence included inadequately disclosing risks to patients considering Essure or who had already received Essure.
All causes of action required the plaintiff to prove a causal connection between her harm and the device.
What did the court find?
Proving causation in legal disputes is often complex and technical. That is particularly so in cases where medical or other interventions allegedly cause or exacerbate injury or disability, where harms can also potentially be caused by other factors.
In dismissing the class action, Justice Andrew Keogh found the extensive expert evidence did not demonstrate that Essure caused either the harms experienced by the class members generally, or by the plaintiff specifically. That evidence drew on a wide range of medical and scientific disciplines.
Justice Keogh found for Bayer, noting pelvic pain and abnormal uterine bleeding are common in pre-menopausal women, and there is a range of potential causes of each.
The 827-page judgment emphasised that medical devices, which are “inherently dangerous or known to carry a risk of harm”, cannot be expected to be “risk-free”. A device does not have a “safety defect”, nor is it of unacceptable quality, simply because it poses a risk to consumers.
Tyler Olson/Shutterstock
Similarly, in considering the negligence claim, the critical consideration was not whether the defendants shouldn’t have produced Essure when there was a foreseeable risk it could cause harm.
Rather, it was about whether the defendants acted reasonably in managing that risk, including providing sufficient information about the risks associated with Essure.
Justice Keogh found the defendants did act reasonably, providing:
adequate warnings of the established Essure risks in the PTMs [physician training manuals] and IFUs [instructions for use]. It was reasonable to expect that treating gynaecologists would provide information and warnings about the established risks to their patients based upon their own specialist skill, expertise and experience and the information provided by the defendants.
So what happens now?
The plaintiff has until early 2025 to appeal the decision.
An appeal would require establishing that the judge erred in his interpretation and application of the law, rather than simply arguing that the outcome is wrong.
Significantly, health professionals should give Justice Keogh’s findings on warnings much thought.
Doctors potentially face more litigation related to medical devices if they do not appropriately provide patients with more extensive and customised warnings than the standard warnings by the manufacturer about risks associated with particular devices.
Could something like this happen again?
Regulatory frameworks governing medical devices have been significantly strengthened since Australia’s Therapeutic Goods Administration first approved Essure in the 1990s.
Increased publicity and successful class actions related to other problematic medical devices have resulted in significant reforms designed to reduce large-scale patient harms.
Medical devices carry inherent risks. These can only be managed rather than eliminated entirely without limiting access to devices and other interventions which may benefit significant numbers of patients.
However, given the court’s findings that the evidence did not indicate Essure caused the plaintiff’s harms, under the strengthened regulations for medical devices, a product like Essure could potentially meet the current requirements for sale in Australia.
