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百名患者对澳大利亚Monash IVF 发起集体医疗诉讼

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来源:药闻社

本文来源于医业观察;

一百多名女性和男性已开始针对Monash IVF提起集体诉讼,声称国家生育专家可能因为缺乏准确性的基因筛选测试无意地毁掉了健康的胚胎。

从去年五月至今年十月期间,在Monash IVF 和Adelaide生殖中心就诊过的患者于周三已将起诉上述两家生殖中心的文件提交至维多利亚最高法院。

集体诉讼的患者试图通过诉讼寻求对经济损失及精神损失的赔偿。

一些患者及其伴侣正在寻求数千万美元的赔偿,其中一些人担心他们可能已经被夺去了有自己孩子的机会。

《时代》和《悉尼先驱晨报》展示的文件显示,通过一项目前已被暂停的无创PGT(niPGT)检测项目Monash IVF和Adelaide生殖中心可能将正常的胚胎归类为异常并丢弃。

这起诉讼是在生育专家所使用的新的无创胚胎植入前基因检测技术远不如最初设想的可靠的情况下发生的。

无创PGT(niPGT)检测于去年五月份由Monash IVF引入并在全国范围内进行推广,据悉,截止今年被叫停之前,该技术已被使用共达13000次。

Monash IVF于9月下旬对该无创项目进行回顾性分析时才意识到出了问题。

一名加入集体诉讼的墨尔本妇女去年在Monash IVF生殖中心接受了无创PGT(niPGT)检测项目,并有2枚胚胎被判定为异常,她说:“她曾经非常信任这里的医生”。

一名不愿透露姓名的39岁患者告诉记者:“他们声称这是一项尖端技术”。“他们握着你所有的希望,你把信任都给了他们,我真的十分气愤,一项不成熟的技术居然进入临床应用”。“他们并没有告知我们这项检测存在不确定性,并且这项检测远不如他们宣传的那么强大”。

  一名妇女称,她在Monash IVF进行人工授精前曾有过两次流产,她一直希望能给她小女儿生一个小弟弟或小妹妹。她说:“她顺利怀孕的障碍是找到健康的胚胎,想到那些被丢弃的胚胎可能有一个或两个是正常的让我非常心碎。这也非常让人恼火,我可能再也没有怀孕的机会了,而我不得不接受这个残酷的现实。”

基因筛查用于检测是否含有可能会遗传给下一代的基因突变,这可以判断孩子出生时是否具有衰弱性或致命的遗传疾病的风险。

集体诉讼的患者试图寻找经济损失和精神伤害方面的赔偿,他们中一些夫妇担心自己已经失去了要孩子的机会。

集体诉讼的成员来自维多利亚,新南威尔士,澳洲首都地区,加拿大北部,肯斯马尼亚,昆士兰以及南澳大利亚等地。

负责这一集体诉讼的律师代表Michel Margalit表示,可能有超过1000名Monash IVF病人成为该检测项目的受害者。

“我们事务所已经和超过100名索赔人谈过了,即使没有数千人,也可能有数百人受到了影响。”Margalit表示。

“对许多人来说,最强烈的伤害是他们浪费了最后一次生孩子的机会,这个消息只会加剧他们生育之旅的悲伤和痛苦。”

集体诉讼的主要原告是43岁的Danielle Bopping,Monash IVF告诉她,她最后一个被标记为异常的胚胎,实际上可能是可以存活的。来自澳大利亚首都的Bopping女士说:“体外授精就是一条漫长而艰难的道路。整个治疗过程中,心理的煎熬已经非常巨大了,发生这样的事,给患者带来的伤害更是雪上加霜。”

“有许多的女性受到伤害,这是不应该发生的。需要有人为这些受害者挺身而出。”

2018年,律师Michael Gorton牵头对维多利亚州的辅助生殖服务进行了一次具有里程碑意义的评估,此次集体诉讼正是发生在该评估之后。此次评估审查了是否有足够的保护措施来保护正在使用或打算使用辅助生殖治疗的人群。

调查发现,一些想要成为父母的人成了不法从业者的受害者,而在这些不法从业当中,其中就包括了一名故意将无法存活的胚胎植入病人体内的医生。

在另外一个案例中,临床医生被指没有披露设备故障,并引导病人相信他们的胚胎是自然死亡的。

外文链接:https://www.smh.com.au/national/class-action-lodged-against-monash-ivf-over-allegedly-bungled-screening-20201223-p56pse.html

原文如下:

Class action lodged against Monash IVF over allegedly bungled screening

More than 100 women and men have begun a class action lawsuit against Monash IVF following claims the national fertility specialist may have inadvertently destroyed healthy embryos through a faulty genetic screening test.

Documents were filed in the Supreme Court of Victoria on Wednesday against Monash IVF and the Adelaide Fertility Centre on behalf of patients who attended the clinics between May last year and October this year.

Members of the class action are seeking compensation for economic loss as well as pain and suffering.CREDIT:LOUISE KENNERLEY

The patients and some of their partners are seeking tens of millions of dollars in compensation, with some fearing they may have been robbed of their chance of having children.

The documents, seen byThe AgeandThe Sydney Morning Herald, claim Monash IVF and Adelaide Fertility Centre may have incorrectly classified potentially healthy embryos as abnormal before discarding them through a now-suspended non-invasive genetic testing program.

The lawsuit comes amid revelations that new, non-invasive preimplantation genetic testing technology used by the fertility specialist is significantly less reliable than first thought.

The non-invasive PGT-A test was introduced nationally by Monash IVF in May last year and was believed to have been used up to 13,000 times before it was suspended this year.

Monash IVF became aware of a fault only when it undertook a review of the program in late September.

One Melbourne woman, who joined the class action after two of her embryos were labelled abnormal following a non-invasive genetic screening test by Monash IVF last year, said she had put her faith in her doctors at the clinic.

"They said to me, 'This is cutting-edge technology,' " said the 39-year-old, who did not want to be identified. "They hold all your hope and you give them your trust. I feel really, really angry that a technology was rolled out which wasn't ready to be rolled out.

"I wasn't given the information around the potential uncertainty of the test and that it was not as robust as they claimed it to be."

The woman suffered two miscarriages before undergoing in vitro fertilisation at Monash IVF, and had dreamt of giving her young daughter a sibling.

"The barrier for me to becoming pregnant is finding normal embryos, and to think that one of those embryos, or two of those embryos, could have been OK is heartbreaking," she said.

"It is also infuriating as well. I might never get another chance now to become pregnant and I have to live with that."

Genetic screening is used to detect gene mutations that could be passed on to children, which can determine the risk of the child being born with debilitating or deadly genetic conditions.

Members of the class action are seeking compensation for economic loss as well as pain and suffering, with some of the women and couples fearing they may have lost their chance to have children.

The class action members come from Victoria, NSW, the ACT, Northern Territory, Tasmania, Queensland and South Australia.

Margalit Injury Lawyers managing principal Michel Margalit, who is leading the class action, said more than 1000 Monash IVF patients could be victims.

"Our firm has now spoken to in excess of 100 claimants. There are potentially many more hundreds, if not thousands, of people who have been impacted," Ms Margalit said.

"For many, the resounding feeling is that they wasted their last opportunity to have a child. The news delivered to the patients has only exacerbated their grief and mental anguish around their fertility journey."

The lead plaintiff in the class action is Danielle Bopping, 43, who was told by Monash IVF that her last embryo, which had been labelled abnormal, may have in fact been viable.

Ms Bopping, from the Australian Captial, does not have children.

She said: "IVF is such a long and difficult road. The emotional impact of going through treatment is hard enough ... and then to have something like this happen has just compounded everything that we were already dealing with.

"There have been so many women impacted and it just doesn’t sit right. Someone needs to stand up for the many women who have been impacted."

The lawsuit comes after a landmark review of assisted reproductive services in Victoria was led by lawyer Michael Gorton in 2018. It examined whether there are enough safeguards to protect people using, or intending to use, assisted reproductive treatment.

The inquiry found some would-be parents had fallen victim to rogue operators, including one doctor who allegedly knowingly transferred an unviable embryo into a patient.

In another case, clinicians allegedly failed to disclose equipment failures and instead led patients to believe their embryos had succumbed naturally.

Monash IVF has been contacted for comment.

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