More than 1,400 women who suffered chronic pelvic pain and abnormal bleeding have lost a class action lawsuit against pharmaceutical giant Bayer over a contraceptive device.
On Tuesday, a Victorian judge rejected the womens’ claims that the contraceptive device caused major health problems, ruling that the allegations made by the group were “far from compelling”.
Justice Andrew Keogh said the group’s allegations against Bayer failed to prove that the Essure implants led to adverse effects like their heavy bleeding and serious chronic pain.
“I’ve largely accepted the defendant’s submissions,” said Justice Keogh.
“Chronic pelvic pain and abnormal uterine bleeding commonly affect women of reproductive age. There is a broad range of potential causes of both disorders.”
Bayer’s device, Essure, was a permanent contraceptive system, which involved inserting two metal coils into a woman’s fallopian tubes. It was designed to cut the soft tissue of the inner walls, which would trigger an inflammatory response to promote scar tissue and block the tubes to prevent pregnancy.
The product was commercially available in Australia from about 2001 to 2017. It was discontinued in 2017 after the Therapeutic Goods Administration (TGA) issued a “hazard alert”.
It’s believed that Bayer sold 750,000 Essure devices internationally before it was taken off the market.
Following Justice Keogh’s decision, Bayer said in a statement that “women who currently have Essure may continue to confidently rely on the device.”
It’s a decision that has shocked many, with the women involved in the class action voicing grief surrounding accountability for their serious pain.
“Collectively crushed is putting it politely,” one of the women, Sioux Bettiens, told the ABC, adding that there is “a little bit of disbelief, a little bit of anger, a lot of frustration”.
“So many of us really thought that the evidence was profound. It was fairly stratforward. It was all there. What did the judge not pay attention to?”
Another woman said: “We’ve been injured by this device, and the pharmaceutical companies should be held responsible. We’re very appalled and disgusted with this.”
The class action was spearheaded by Victorian woman Patrice Turner, who had the Essure device inserted in 2013. Following the insertion, Turner said she experienced severe pelvic pain and heavy uterine bleeding.
Five years later, Turner underwent a hysterectomy at age 32, which she said resolved her severe pain and bleeding.
Turner and the other class action members alleged Bayer Australia and other companies involved in the Essure device’s creation and marketing breached a duty of care.
A similar case was brought by a group of women in the United States against Bayer, which resulted in the pharmaceutical giant agreeing to a $US1.6 billion settlement. However, that settlement had no impact on the Australian case.
Justice Keogh’s judgement is set to be formalised in the coming days, with an appeal possible next year.