Australian women lose class action against Bayer over birth control device Essure
A Victorian judge has ruled that a group of Australian women's allegations over the Essure birth control device were "far from compelling". (Conceptus Inc/AP)
In short:
A group of more than 1,400 women have lost a class action lawsuit against Bayer, with a judge ruling they failed to prove the female contraceptive device Essure led to major health problems.
Australian women had began signing up the class action in 2018, complaining of crippling pain, heavy bleeding. Some required a hysterectomy.
What's next?
The judgement is set to be formalised in coming days, with an appeal possible next year.
More than 1,400 women have lost a class action lawsuit against pharmaceutical giant Bayer, with a Victorian judge rejecting their claims that a female contraceptive device caused major health problems.
On Tuesday afternoon, Justice Andrew Keogh ruled the allegations made by the group were "far from compelling", and failed to prove that the Essure implants led to adverse effects like heavy bleeding and serious, ongoing pain.
Essure was a permanent contraceptive system which involved inserting two metal coils into a woman's fallopian tubes. (Bayer Healthcare)
Essure was a permanent contraceptive system, which worked by inserting flexible, metal coils into a woman's fallopian tubes. It was designed to cause scarring and block the tubes.
The product was commercially available in Australia from about 2001 to 2017.
Justice Keogh's judgement was a definitive win for Bayer, which was defending the case. The judge knocked back claims that Essure was defective, a product of poor quality and that its manufacturers were negligent in its design.
"I've largely accepted the defendant's submissions," he said.
"Chronic pelvic pain and abnormal uterine bleeding commonly affect women of reproductive age. There is a broad range of potential causes of both disorders."
About 20 of the women involved in the case, including Tanya Davidson, were in court to see the decision handed down.
Tanya Davidson, who was a member in the class action, urged other women seeking contraception options never to have anything inserted. (ABC News: Kristian Silva)
"Before insertion, I had no issues whatsoever. And post insertion, it all started … how do you say that the evidence isn't there?" Ms Davidson said outside court.
Ms Davidson urged other women seeking contraception options never to have anything inserted into their bodies and to conduct their research.
"I did something for myself, and it backfired," she said.
Another woman, who identified herself as Nina, held back tears as she angrily denounced the court's ruling.
"We've been injured by this device, and the pharmaceutical companies should be held responsible," she said. "We're very appalled and disgusted with this."
Justice Keogh's judgement is set to be formalised in the coming days, with an appeal possible next year.
"If there's another day to fight we'll be here to fight it," Ms Davidson said.
Australian women began signing up to the class action, run by law firm Slater and Gordon, in 2018.
Women who spoke to the ABC complained of crippling pain and heavy bleeding caused by the devices. Some suffered allergies to nickel in the coil, while others required a hysterectomy — or removal of the uterus — to rid themselves of the implant.
Mediation between the parties failed, sending the case to a 12-week Supreme Court trial last year.
The class action was spearheaded by Patrice Turner, a now-38-year-old who had the Essure devices inserted in 2013.
Patrice Turner, pictured arriving at the Supreme Court last year, spearheaded the class action. (Diego Fidele/AAP)
Ms Turner said she suffered "severe, sharp and stabbing pain in the pelvis and lower abdomen" and bleeding, which led to her undergoing a hysterectomy five years later.
"We are profoundly grateful for the courage of lead plaintiff Patrice Turner in giving evidence in this proceeding on behalf of the group," Slater and Gordon said in a statement.
"We want to thank the 1,400 women who stood with Patrice in bringing the class action. We will now carefully review Justice Keogh's judgement."
In 2018, Bayer refused to release its Australian sales figures, with the ABC estimating it to be more than 3,000 between 2005 and 2017.
In a statement, Bayer said it stood by the product, which was supported by "an extensive body of research" including 10 clinical trials and 150 studies involving more than 280,000 women.
"Bayer welcomes today's decision by the Court as it is in line with the science-based profile of the safety and efficacy of Essure, a permanent contraceptive device for women," the company said.
"The health and wellbeing of women who rely on our products is our greatest priority. Women who currently have Essure may continue to confidently rely on the device. If a woman with Essure has questions or concerns about the device, then we encourage her to speak to her healthcare professional."
The Therapeutic Goods Administration (TGA) issued a "hazard alert" for the product in 2017, although the manufacturer said it was being withdrawn from the Australian market for commercial reasons.
Bayer was sued by women who had experienced similar complaints while using the product in the United States, and agreed to a $US1.6 billion settlement. However that settlement had no impact on the Australian case.
"This decision to settle in the US reflects factors unique to the American mass tort legal system, including the high costs of US litigation, and did not include any admission of wrongdoing or liability by Bayer," the company said.