Bayer case unravels
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The Supreme Court of Victoria has dismissed a class action lawsuit against pharmaceutical giant Bayer.
The case, brought by over 1,400 Australian women, alleged that the permanent contraceptive device Essure caused serious health issues, including chronic pelvic pain and heavy bleeding, sometimes requiring hysterectomy.
Essure was marketed in Australia from 2001 until 2017 as a non-surgical alternative to tubal sterilisation.
In a recent decision, Justice Andrew Keogh ruled the claims lacked sufficient evidence to prove that Essure was defective or that its design was negligent.
The court found no causal link between the device and the health problems cited by the plaintiffs.
Justice Keogh described the plaintiffs’ evidence as “far from compelling”, pointing out that conditions such as chronic pelvic pain and abnormal bleeding are prevalent among women of reproductive age for various reasons unrelated to Essure.
The Essure device consists of metal coils designed to be inserted into the fallopian tubes, where it causes scarring to block the tubes and prevent pregnancy.
Patrice Turner, the lead plaintiff, described experiencing sharp pain and abnormally heavy periods in the years after having Essure implanted. Ultimately, she underwent a hysterectomy at 32, resolving her symptoms.
Turner argued that the device’s design, which intentionally caused an inflammatory response, posed inherent risks.
She also cited concerns over potential corrosion of the device’s metal components, which she alleged could exacerbate health issues.
Bayer’s defence centred on evidence showing that the device’s inflammatory response was consistent with a normal healing process.
The company also presented comparative studies involving over 100,000 women, which demonstrated no increase in chronic pelvic pain or bleeding among Essure users compared to those undergoing laparoscopic sterilisation.
Additionally, the court acknowledged that while risks of migration, perforation, or metal leaching existed, these were considered rare and appropriately disclosed.
A key aspect of the plaintiffs’ case was the assertion that Bayer failed to adequately warn about the device’s risks.
Justice Keogh, however, accepted Bayer’s claim that its warnings complied with regulatory requirements and that further information was provided through training materials for gynaecologists performing the procedure.
This verdict is a major win for Bayer, which has faced similar lawsuits internationally. In recent years, Bayer has paid out billions of dollars to settle claims involving women who allege device-related injuries.
Justice Keogh’s judgement highlighted the challenges of proving causation in cases involving medical devices, particularly where common symptoms have numerous potential causes.
The decision leaves questions about how adverse reactions to medical devices are evaluated and the burden of proof required to establish fault.
