Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study
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Motion Filed to Centralize Vaginal Mesh Litigation in West Virginia December 12, 2011 Staff Writers Add Your Comments A growing number of women throughout the United States are pursing product liability lawsuits against various medical device manufacturers as a result of problems with transvaginal bladder mesh systems, which have been linked to reports of infection, vaginal erosion, pelvic pain and other complications. Some plaintiffs are now calling for the vaginal mesh litigation pending against four different companies to be centralized before one judge in the U.S. District Court for the Southern District of West Virginia. Motions were filed with the U.S. Judicial Panel on Multidistrict Litigation on November 28, calling for dozens of Boston Scientific pelvic mesh lawsuits, American Medical Systems (AMS) mesh lawsuits and Ethicon/Gynecare mesh lawsuits to be centralized before Chief Judge Joseph R. Goodwin, who is already presiding over all federal Bard Avaulta mesh lawsuits that were consolidated for pretrial proceedings. The plaintiffs are calling for the Panel to establish three new MDLs, or multidistrict litigations, in the Southern District of West Virginia, where Judge Goodwin can coordinate the litigation together with the Bard Avaulta cases. Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION All of the vaginal mesh lawsuits contain similar allegations involving defects with pelvic repair products used during transvaginal surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI), which caused women to experience painful and debilitating complications. In many of the cases, women are implanted with more than one product, which are often manufactured and sold by different companies. Therefore, plaintiffs have requested that currently unconsolidated litigation for vaginal mesh products sold by Boston Scientific, AMS and Ethicon/Gynecare be transferred to Judge Goodwin for coordinated handling. “The centralization of these actions in a single judicial district for coordinated and/or consolidated pretrial proceedings will promote the interests of justice,” argued plaintiffs in the Motions. “The transfer of these cases will conserve judicial resources, reduce litigation costs, avoid potentially inconsistent pretrial scheduling orders and substantive rulings, and will eliminate unnecessary duplicative discovery.” Plaintiffs argue that the claims being pursued against all of these manufacturers are substantially similar, and Judge Goodwin has already become familiar with the factual and legal issues presented throughout the cases and is uniquely positioned to handle the conflicts that may arise from cases involving individual women who received multiple devices from different manufacturers. Public awareness about the risk of vaginal mesh problems increased earlier this year, after the FDA issued warnings about an increasing number of adverse event reports associated with the products. In July, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment. The manufacturers have already begun coordinating their efforts in various vaginal mesh suits pending in courts throughout the country, according to a response filed in support of the transfer by another group of plaintiffs. In September, an FDA advisory panel was convened to review the potential health risks with vaginal mesh products. At the panel hearing, a majority of surgical mesh manufacturers joined together to create a “Transvaginal Mesh Working Group”, making a joint presentation to the committee and presenting a unified voice and position at the hearing. Tags: American Medical Systems (AMS), Bladder Sling, Boston Scientific, Boston Scientific Pinnacle Mesh, Ethicon, Johnson & Johnson, Surgical Mesh, Transvaginal Mesh, Vaginal Mesh, Vaginal Sling Image Credit: | More Vaginal Mesh Lawsuit Stories Study Finds Some Transvaginal Mesh Degrades Within 2 Months After It Is Implanted October 29, 2024 Supreme Court Rejects J&J Bid to Overturn $302M Vaginal Mesh Lawsuit Award February 23, 2023 Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study January 16, 2023 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. 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Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study January 16, 2023
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