The Essure contraceptive device has caused some women to develop chronic pelvic pain. Why did their class action lawsuit fail?

Victorian Supreme Court recently released class action lawsuit on behalf of over 1,400 women who received the Bayer Essure contraceptive device.

The decision received wide publicity, including: criticism from the Premier of Victoria.

It left women shocked and disappointed, especially since Bayer settled a similar claim in the United States for $1.6 billion.

So why did the Victorian class action fail?

What is Essure?

Essure provided an alternative to more invasive, lasting contraceptive procedures such as tubal ligation.

The device was implanted into the fallopian tubes. This triggered an intentional inflammatory response that blocked the fallopian tubes, preventing the passage of sperm and eggs.

In Australia, the device was implanted by gynecologists. Above 3,000 devices They are believed to have been implanted in Australian women.

In 2017, Essure was voluntarily withdrawn from our market following increasing publicity of safety concerns, including: in the USA.

The U.S. class action lawsuit was settled out of court, allowing Bayer to avoid setting a legal precedent for similar claims in other jurisdictions.

Right US regulations are different from those in Australia. As a result, the settlement of the US claim is of only circumscribed value in determining the likely outcome of the dispute in the Australian courts.

What went wrong with the device?

Lead plaintiff Patrice Turner began experiencing abnormal uterine bleeding, ponderous periods, and pelvic pain within several years of using Essure.

She ultimately required a hysterectomy, which removed the Essure devices and resolved her symptoms.

Other class members experienced similar symptoms, and many also required hysterectomies.

The claim was based on three causes of action:

1. Essure had a safety defect that caused the plaintiff’s injuries

2. The quality of Essure was not what consumers could reasonably expect

3. Defendants were negligent in the design, manufacture and distribution of Essure. The alleged negligence included improper disclosure of risks to patients considering Essure or to patients who had already received Essure.

All causes of action required the plaintiff to prove a causal connection between her damage and the device.

What did the court find?

Proving causation in legal disputes is often complicated and technical. This is particularly crucial in cases where medical or other interventions are alleged to cause or worsen injury or disability, and the damage may also potentially be caused by other factors.

In dismissing the class action, Judge Andrew Keogh found that extensive expert evidence did not establish that Essure caused the harm suffered by class members generally or the plaintiff specifically. This evidence was based on a wide range of medical and scientific disciplines.

Judge Keogh said for Bayer that pelvic pain and abnormal uterine bleeding are common in premenopausal women, and each has many potential causes.

The 827-page judgment stressed that medical devices that are “inherently risky or known to carry a risk of harm” cannot be expected to be “risk-free.” A device does not have a “safety defect” or be of unacceptable quality simply because it poses a risk to consumers.

Similarly, in considering the negligence claim, the key issue was not whether the defendants should not have produced Essure when there was a foreseeable risk that it might cause harm.

Rather, the issue was whether the defendants acted reasonably in managing these risks, including providing sufficient information about the risks associated with Essure.

Judge Keogh found that the defendants had acted reasonably, stating:

Appropriate warnings about identified Essure risks in PTM [physician training manuals] and IFU [instructions for use]. It was reasonable to expect that treating gynecologists would provide their patients with information and warnings about the identified risks based on their own specialist skills, knowledge and experience and the information provided by the defendants.

What will happen now?

The plaintiff has until early 2025 to appeal this decision.

An appeal would require a finding that the judge erred in his interpretation and application of the law, rather than simply maintaining that the result was wrong.

Importantly, health professionals should consider Judge Keogh’s findings regarding warnings carefully.

Physicians could potentially face more medical device-related lawsuits if they fail to adequately provide patients with more extensive and more tailored warnings than the manufacturer’s standard warnings about the risks associated with specific devices.

Could something like this happen again?

The regulatory framework governing medical devices has been significantly strengthened since the Australian Therapeutic Goods Administration first approved Essure in the 1990s.

This has resulted in greater publicity and successful class action lawsuits involving other problematic medical devices significant reforms designed to reduce harm to patients on a vast scale.

Medical devices carry inherent risks. They can only be treated, not completely eliminated, without limiting access to devices and other interventions that could benefit a significant number of patients.

However, given the court’s findings that the evidence did not establish that Essure caused the plaintiff’s harm, under enhanced medical device regulation, a product such as Essure could potentially meet the current requirements for sale in Australia.