Ethicon Transvaginal Mesh Lawsuit Pre Settlement Loans
Pre Settlement Funding on Recalled Ethicon Vaginal Mesh Litigation
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Ethicon, Inc., a subsidiary of Johnson & Johnson, is one of the many mesh device manufacturers that are facing thousands of lawsuits and much litigation today. Vaginal mesh device manufacturers have been sued by thousands of women after suffering from various complications associated with the device, such as organ perforation, vaginal bleeding and scarring, erosion of the mesh, extreme pain, among many others.
Patients who have received this mesh implants started to sue manufacturers with various claims including giving misleading information about the safety and effectiveness of the mesh devices, as well as allegations that the manufacturers breached their legal duty to ensure that such products were safe and effective. There are currently seven federal multidistrict litigations against multiple mesh implant manufacturers that are being overseen by Chief Judge Joseph Goodwin under the Southern District of West Virginia.
Multidistrict litigations regarding transvaginal mesh have reached over 60,000. The seven multidistrict litigations regarding transvaginal mesh products and their manufacturers that are being overseen by Chief Judge Goodwin are:
Eventually, Ethicon stopped manufacturing and selling many of its vaginal mesh implants under the Gynecare brand, upon the company’s announcement in June 2012. While Ethicon and Johnson & Johnson continue to deny that the decision was in fact a recall, many more lawsuits and litigations have been filed against the company by patients who have suffered severe complications after receiving the implants.
Ethicon Lawsuits and Litigation
Women who have filed lawsuits regarding transvaginal meshes claim that the manufacturers had legal duties to make sure that the products were safe and effective. Due to the complications experienced by these women after having the devices implanted, the plaintiffs have also alleged that the manufacturers gave false and misleading information about the safety and effectivity of the products.
Other lawsuits involve allegations against vaginal mesh manufacturers, such as active and intentional deception of the FDA, the medical community, patients, and the public with regard to the safety and effectiveness of the mesh products; failure to operate adequate and proper research and testing to gather information regarding risks associated with the vaginal mesh for treatment of pelvic organ prolapse conditions; failure to institute safe and effective methods for removing the mesh; and failure to adequately warn regarding probable complications and injuries.
Ethicon is involved in the federal multidistrict litigations in the Southern District of West Virginia being overseen by Chief Judge Joseph Goodwin after thousands of women and their families started suing major mesh manufacturers because of complications associated with the transvaginal mesh. Other companies involved in the seven multidistrict litigations being overseen by Judge Goodwin are C.R. Bard, American Medical Systems, Coloplast Corp., Boston Scientific Group, Cook Medical Inc., and Neomedic.
In fact, Ethicon was ordered to pay $5.5 million to Christine Scott and her husband after a jury verdict ruled in favor of Scott in a lawsuit against Bard in 2012. In 2013, a jury verdict required Ethicon to pay $11.11 million in compensatory damages for the injuries that Linda Gross sustained after using the company’s transvaginal mesh product. Gross had to undergo 18 revision surgeries.
Plaintiffs who opt to file a vaginal mesh lawsuit can claim compensation for damages such as medical expenses including those of additional surgeries, lost past and future wages, loss of consortium, loss of quality of life, and pain and suffering.
Johnson & Johnson wanted to enter the emerging market of mesh devices. Through its subsidiary, Ethicon Inc., the company was able to do so and come as one of the top leading mesh manufacturers in the United States. Ethicon created surgical mesh kits that were deemed easy to use as they provided doctors and surgeons of pre-cut mesh and the necessary tools for the implant procedure.
Almost instantly, Ethicon mesh kits were the preferred treatment option for pelvic organ prolapse and stress urinary incontinence. The Gynecare brands of Ethicon were deemed superior to traditional surgery, before doctors realized the many complications associated with the product line. Not only were post-surgery complications a prevalent issue, but the difficulty in the implanting procedure posed a great threat to mesh product sales.
As Ethicon’s Tension-free Vaginal Tape (TVT) is released in 1998, repairing or treating stress urinary incontinence becomes more frequent. In 2002, Ethicon released Gynemesh PS, which was the first surgical mesh product that was explicitly designed for Pelvic Organ Prolapse repair.
It was in June 2012 when Ethicon announced that the company would stop manufacturing and distributing vaginal mesh products after growing legal pressures and imminent concern from the FDA. These products include Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secure, and Gynecare Prosima Pelvic Floor Repair System Kit. Ethicon and Johnson & Johnson have both refused to refer to the decision as a recall. Thousands of lawsuits have been filed against the two companies after patients had incurred injuries that were caused by the vaginal mesh products.
Johnson & Johnson initiated sales of Gynecare Prolift Kit in 2005 for treatment of pelvic porgan prolapse conditions, without FDA marketing approval. Johnson & Johnson was ultimately scolded by the FDA for breaking regulations. However, the FDA still approved the Gynecare Prolift Kit in 2008.
Gynecare Prolift + M was created to avoid further complaints of vaginal scarring and perforation, as well as the intention to treat pelvic organ prolapse. The Gynecare Prolift + M was the first surgical mesh using plastic fibers that had the ability to be partially absorbed by body tissues in the United States.
Gyncecare Prolift + M is different than that of the Gynecare Prolift as the former has a less dense mesh and has larger holes intended to help healing post-surgery. The former’s mesh also resists folding and wrinkling. Unfortunately, in spite of the company’s efforts, the Prolift + M still had its complications such as erosion and shrinking – similar to the company’s other mesh brands.
Many women have experienced the adverse side effects from the vaginal mesh implants of Ethicon, such as organ perforation, vaginal bleeding and scarring, mesh erosion, difficulty in sitting, walking, and sexual intercourse, abdominal and pelvic pain, recurrence of stress urinary incontinence, and severe pain.
FDA Recalls and Warnings
Johnson & Johnson was under public scrutiny after selling one of the company’s vaginal mesh implant devices, the Gynecare Prolift Kit, for nine months after being ordered by the FDA to terminate advertising in August of 2007. Ethicon released the product in March 2005.
The FDA’s letter to the company stated that Johnson & Johnson could not market the device until adequate information was provided regarding 16 potential flaws. The FDA explained In the same letter that if the company marketed the products without adhering to the stated requirements, then the company would be in violation of the Federal Food, Drug and Cosmetic Act. However, the product was still approved by the FDA in May 2008 without sanctions.
The product was approved through the 510(k) premarket approval system of the FDA. The 510(k) system allows products to be released prior to approval so long as the products are “substantially equivalent” to other products that were already approved and released by the FDA. However, the FDA continues to claim that the 510(k) system was not applicable to this case due to the fact that the marketing and sales of the product initiated “without appropriate” clearance.
The FDA announced in July 2011 that vaginal mesh implants have shown that they are not any more effective than other non-mesh alternative procedures. The administration ordered vaginal mesh manufacturers to make further studies to find out any more possible serious side effects of the medical devices.
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