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Columbus, OH (PRWEB) May 01, 2014
The attorneys at Wright & Schulte LLC are reporting that a settlement may have been reached with Endo International Plc. and it’s subsidiary American Medical System, who are currently facing approximately 22,000 transvaginal mesh lawsuits, pending in (MDL No. 2325). Endo International Plc. announced in a statement that the vaginal mesh settlement agreement will cover what it called a “substantial majority” of the mesh litigation brought against its subsidiary American Medical Systems that contend their vaginal mesh implants led to serious injuries.
(In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325).
[ ap.org/dynamic/stories/U/US_ENDO_INTERNATIONAL_PELVIC_MESH?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT ]
[ bloomberg.com/news/2014-04-30/endo-pays-830-million-to-resolve-vaginal-mesh-suits.html ]
[ reuters.com/article/2014/04/30/us-endo-mesh-settlement-idUSBREA3T15F20140430 ]
In April of this year, the U.S. Food & Drug Administration (FDA) proposed new regulations to reduce the risks associated with surgical mesh used to repair of pelvic organ prolapse. According to the FDA press release, the agency proposed reclassifying these devices as “high-risk.” The new classification would subject the products to greater regulatory scrutiny, and require manufacturers to submit a premarket approval application to the FDA for evaluation of its safety and effectiveness.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm, FDA, April 29, 2014]
Mounting Vaginal Lawsuits Being Filed Against Manufacturers
According to Bloomberg News, After mounting vaginal mesh lawsuits were filed against the manufacturers of surgical mesh, the FDA recently ordered Endo, Johnson & Johnson (JNJ), C.R. Bard Inc. and 31 other vaginal mesh implant manufacturers to submit studies of rates of organ damage and complications that have purportedly been linked to the mesh implants. Bloomberg is also reporting that more than 70,000 vaginal mesh and bladder mesh devices were used in vaginal mesh procedure alone.
[bloomberg.com/news/2014-04-30/endo-pays-830-million-to-resolve-vaginal-mesh-suits.html, April 30, 2014]
Court records indicate that Endo and its subsidiary American Medical Systems are among several top medical-device manufacturers who are currently facing vaginal mesh lawsuits. Court documents show there are more than 50,000 transvaginal mesh lawsuits that have been filed in the U.S. District Court, Southern District of West Virginia by women who were allegedly injured by these products. The litigations include:
In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)
(In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation - MDL No. 2327)
In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326);
Since 2008, the U.S. Food & Drug Administration (FDA) has issued two health and safety alerts regarding the serious complications purportedly associated with vaginal mesh devices that are surgically implanted to support the urethra to treat urinary incontinence or to reinforce a woman’s weakened vaginal wall to treat pelvic organ prolapse. The 2008 safety alert was issued after the agency received 1,000 reports of transvaginal mesh injuries over a three-year period. Then in July 2011, the FDA issued an updated warning, after transvaginal mesh complications reported to the FDA had increased by a staggering five-fold. The FDA stated in its public safety warning that from 2008 to 2010, the most frequent purported complications reported to the FDA regarding transvaginal devices were pain, infection, bleeding, organ perforation, urinary problems and pain during sexual intercourse. The agency further noted the most common and consistently reported complications from vaginal and bladder mesh-related surgeries are the device’s erosion through the vagina. According to the FDA, mesh erosion requires several surgeries to repair and may not resolve the
[fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm, October 20, 2008]
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm, July 13, 2011]
Recent Vaginal Lawsuit Verdicts
So far, the manufacturers of surgical mesh products have lost every vaginal mesh lawsuit that has gone to trial. In July 2012, C.R. Bard was ordered to pay $3.6 million to another Avaulta plaintiff in a case that went to trial in California Superior Court. (Scott v. Kannappan, S-1500-CV-266034-WDE ) In March of this year, the New Jersey Superior Court jury hearing the nation’s first trial of an Ethicon Inc. transvaginal mesh lawsuit awarded more than $11 million to a woman injured by the Gynecare Prolift device.
(Gross v. Gynecare Inc., Atl-L-6966-10)
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free transvaginal mesh lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.