Last week Zubeidat Narges (the “Plaintiff”) submitted a claim in the District Court in Lod, Israel against the American multinational company (the “Defendant”), which is one of the world’s leading manufacturers of medical products, drugs and medical equipment. The plaintiff submitted the claim on behalf of herself, and also with a request for the Court to certify the claim as a class action suit for NIS 6 billion (about US$1.7 billion) against the Defendant on behalf of an estimated 60, 000 women in Israel who, it is alleged, experienced the same difficulties as her because of complex gynaecological procedures performed using the Defendant’s allegedly faulty products.
The plaintiff asserts that in August 2006 a surgical procedure to relieve vaginal pain was performed on her at the medical centre “Bnei Zion”, whereby soft synthetic vaginal supports were implanted in her body namely a “PROLIFT MESH” produced and marketed by the Defendant. According to the statement of claim, PROLIFT MESH is a form of synthetic netting used in light gynaecological surgical procedures to provide support for the female pelvic organs of the body. The purpose is to prevent prolapse, or collapse, of the pelvic organs, a condition known as POP which is described as a condition where the uterus may fall into the vagina as a result of the weakening of the tissues of the pelvic area. It is a relatively common phenomenon occurring in up to 25% of women and can in extreme cases be very painful.
The statement of claim alleges that since 1996 there were many reports, worldwide, of women who had PROLIFT MESH implanted and then suffered profuse vaginal discharge and associated damage to their body, including bleeding, bed sores, recurring infection, perforation of the urinary tract during installation, incontinence and severe pain.
According to the plaintiff the Defendant had marketed the product PROLIFT MESH since March 2005, including in Israel, without the approval of the US Food and Drug Administration (the “FDA”). The statement of claim further states that in March 2012 the FDA itself issued a statement stating that the Defendant had marketed the PROLIFT MESH product without their approval. The statement of claim also states that about six years after beginning to market the PROLIFT MESH product the Defendant began to recall the product from its distribution channels and then discontinued it. Finally the statement of claim points out that many lawsuits have been asserted elsewhere against the Defendant and substantial settlement arrangements already achieved.
In this case the plaintiff asserts that the material implanted into her body caused her, and many other women in Israel, severe harm. In her own case, the plaintiff asserts that most of the known risks associated with the material did in fact occur, and she suffered form increased pain in the lower abdomen, recurring infection, increased bleeding, bed sores, and damage to the urinary tract.
The plaintiff is also seeking to represent all the estimated 60, 000 women in Israel who were also affected because of the PROLIFT MESH product supplied by the Defendant. Damages are sought in the average amount of NIS 100, 000 (about $28, 000) per patient and the aggregate claim, if class action status should be approved, is therefore NIS 6 billion, or about US$1.7 billion.