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News & Trends - Pharmaceuticals

Same device, same complications: Class action lawyers question local settlement

Health Industry Hub | December 5, 2022 |

Pharma News: Class action lawyers have questioned the logic behind a global pharma’s next steps to pursue a trial in the local courts despite an agreement of settlement overseas.

Slater and Gordon law firm has urged Australian women who have suffered health complications related to Bayer’s Essure contraceptive device to register for its class action ahead of the matter going to trial early next year.

The law firm filed proceedings against Bayer and its associated entities in the Victorian Supreme Court in December 2019, as it expects up to 7,000 women across the country are likely to be impacted by the complications believed to be linked to the device.

The permanent contraceptive implant, which was removed from the Australian market in 2017, comprised of a sharp, spring-loaded metal coil that expanded upon insertion into the fallopian tube. It was designed to cause chronic inflammation so the resulting in scar tissue would grow around the coils, blocking the tubes and preventing sperm from reaching the egg.

Evidence has emerged that suggests the device can corrode, break and migrate from the fallopian tubes, which it is alleged has led to many women suffering a range of injuries including perforation of their uterus, bowel and/or other organs.

Some women have also suffered severe pelvic or abdominal pain, heaving menstrual bleeding, headaches, fatigue and psychiatric conditions allegedly caused by the device. Symptoms such as pain during intercourse and the inability for some women to be intimate with their partners, is also believed to be linked.

Slater and Gordon Class Actions Senior Associate, Kylie Trounson, described the device as “a ticking time bomb” for many women who received it.

“We’ve obtained expert evidence that suggests this device was poorly conceived, poorly designed and it was not properly tested prior to it being introduced to the market, which is why we believe Australian women who have allegedly suffered injured caused by the device deserve compensation,” Ms Trounson said.

“The evidence which will be lead at trial will establish that the unique features of the device make it particularly unsafe given that it was designed to be placed in a remote and inaccessible part of the body. The device was also intended to remain in the body for life and is only removable by major surgery, usually a hysterectomy, which itself can lead to other health consequences including early menopause and the associated increased risks of osteoporosis, Parkinson’s disease, heart failure and early death.

“The initial clinical trials concentrated on whether the device was effective to prevent pregnancy. They were not designed to determine if the device was safe to stay in a women’s body for the rest of her life. The only study specifically designed to look at adverse events like pelvic pain and abnormal bleeding was ordered by the US Food and Drug Administration in 2016. This was after Essure had been on the market for 14 years in the US and even longer in Australia.

“We also allege that when Bayer became aware of problems associated with the device, in particular by 2014 and 2015 when the Irish and US regulators started investigating the device, the issues were not promptly or adequately investigated, and the device was not withdrawn from the market quickly enough to prevent other women from being injured.

“These women were owed a duty of care by the product manufacturers, and we will be arguing that this duty of care was breached.”

Ms Trounson said several hundred women had already signed up to the class action, but she expected many more Australian women would be eligible to join.

“We expect that there are Australian women out there who are suffering in silence or may not even realise that their health symptoms are related to the Essure device. It’s vital that all women who have the device in place, or who have had it removed, know about our legal proceeding so they can register with us and take steps that may be required to ensure their legal rights and entitlement to compensation is protected.”

Bayer announced in August 2020 it would pay AU$2.4 billion to settle the tens of thousands of Essure lawsuits involving women in the US who claimed the device caused serious health complications and similar class actions are also being pursued in the UK and Canada.

Ms Trounson said she did not know why Bayer and its associated entities were forcing Australian women to go through the delay and cost of a major trial in circumstances where they announced in 2020 they would settle all Essure lawsuits in the US.

“It’s the same device with the same flaws that caused the same serious health complications for women in Australia as it did in the United States. Why should Australian women have to prove the damage caused by this device, when Bayer and its associated entities settled in the US cases for the same harms, without trial and for, frankly, what are quite enormous sums of money.

“We stand ready to mediate and settle the case, but if the defendants won’t come to table, we’ll see them in court. We are not prepared to allow a leading multinational company treat Australian women less favourably than their American counterparts.”

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