The United States Judicial Panel on Multidistrict Litigation has ordered that all federal lawsuits involving the Mentor ObTape Transobturator Sling be consolidated in the U.S. District Court for the Middle District of Georgia for pretrial proceedings as part of an MDL, or Multidistrict Litigation.
Mentor Corp. currently faces at least 22 ObTape lawsuits pending in 12 different Courts. The cases have been filed by women who have suffered severe complications allegedly caused by a defective design in a vaginal bladder sling previously sold by Mentor to treat stress urinary incontinence.
The Mentor ObTape Sling contains a “nonwoven” design, which has been found to block essential nutrients and oxygen, potentially resulting in severe pain, vaginal extrusions, urinary tract erosion or infection.
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Learn MoreIn October 2008, Mentor filed a petition with the Panel on Multidistrict Litigation to consolidate all of the ObTape lawsuits that are currently pending or may be filed in the future. They asked that all of the cases be centralized before one judge for coordinated pretrial litigation in the Western District of Oklahoma or, in the alternative, in the Northern District of Oklahoma or Northern District of Ohio.
At a hearing on the petition November 20, 2008, attorneys representing women who have filed these lawsuits opposed the formation of an MDL, arguing that the litigation only involves one defendant and there are currently only a limited number of ObTape law firms investigating cases. However, they asked that if an MDL was formed, that the cases be transferred to the Middle District of Georgia, where the most cases are currently pending and the first ObTape lawsuit was filed.
There are currently 5 cases pending in the Middle District of Georgia, with 4 in the Middle District of Florida, 3 in the Western District of Oklahoma, 2 in the District of New Jersey and one each in the Western District of Missouri, Central District of California, Northern District of Georgia, Eastern District of New York, Southern District of Georgia, Eastern District of Louisiana, Northern District of Ohio and Northern District of Oklahoma.
The MDL Panel found that consolidation was appropriate in these cases, as they involve common questions of fact and that centralization in an MDL would help avoid inconsistent pretrial rulings in different Districts, duplicate discovery and would conserve the resources of the Court and the parties.
“All 22 actions share factual issues as to whether Mentor’s ‘ObTape’ brand transobturator sling, a device used to treat female stress urinary incontinence, was defectively designed and/or manufactured, and whether Mentor failed to provide adequate warnings concerning the device,” wrote Judge John G. Heyburn, II, Chairman of the Panel on Multidistrict Litigation in the Transfer Order entered December 3, 2008.
The cases will be assigned to U.S. District Judge Clay D. Land in the Middle District of Georgia, who the panel indicates has the time and experience to handle the MDL.
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4 Comments
LindaMarch 13, 2011 at 10:02 pm
I had a Mentor Trans-Obturator Tape sling inserted in May of 2004 (lot #031017E, Catalog # REF93-4000, Serial#AD080067, Experation Date 9/30/2005) and by the 6 week check up I had a chronic Candida infection that my Urologist treated for about a year. He treated me with several series of Diflucan, some of which were the normal dosage, but in others he gave me doubled the doseage for 2 wee[Show More]I had a Mentor Trans-Obturator Tape sling inserted in May of 2004 (lot #031017E, Catalog # REF93-4000, Serial#AD080067, Experation Date 9/30/2005) and by the 6 week check up I had a chronic Candida infection that my Urologist treated for about a year. He treated me with several series of Diflucan, some of which were the normal dosage, but in others he gave me doubled the doseage for 2 weeks at a time. Following each course of antifungals the infection (and associated symptoms) appeared to subside, just to return within a few weeks. Finally, after a year of on and off treatments, he looked at me and my husband and said "what do you want, I don't know what else to do". So I went home, called back his office, and told his receptionist that I was going to another urologist. After examining me and following multiple tests the second urologist said that the sling was not working and that if he were in my shoes, "he would have the sling reinserted". I sort of lost it because I wished that I hadn't had it inserted in the first place. Then I sought a Gynecologist/Urologist who was (referred to me for by my gynecologist) and after a lenghthy series of test and exams he told us that in his opinion the sling was not working at the time, and "it had never worked". He identified the sling as the source of my repeated infections, and set me up for surgery to remove the sling. Following the surgery he stated that it had been very difficult to remove the sling because a lot of it was already embedded in the tissue by then. He also continued to order series of antifungals. By 2007, and while still suffering chronic discharge and other medical complications, I sought the help of yet another urologist (#4). He explained to me that he had so far inserted eight (8) Mentor slings and six (6) had eroded. He further indicated that the only possible solution was to operate getting out as much of the sling as possible. Unfortunately this procedure could have other complications up and including death. At that point I went home and cried and tried to move on with my life. By 2006 I started looking for information and all I could read about were complications. that women in the UK have endured an unmitigated nightmare following the insertion of the Mentor Slings. I also read that there was absolutly no testing of the Mentor Sling in the U.S. before the FDA approved the device. . In the meantime, my physical and mental health have continued to deteriorate. Due in part to the helplessness and hopelessness of the whole situation, I've become very depressed requiring treatment with multiple antidepressants. In 2009 I went to an endocrynologist because I am suffering from dangerously high blood pressures (in the range of 200/120) and my hair is falling out. They tested me thinking I had an adrenal tumor because of my symtoms. (octreotyde scan) it was negative for tumors. However, I continue to have problems with night sweats, fevers, aching joints, headaches and other problems. I am going to visit my family physician next week for candida infections on my skin and most of the hair on the top of my head is fallen out. This is the same infection that I was diagnosed with 6 weeks after my surgery I'm not sure how this infection has seen it's way to my outside skin, I only hope that it is not in my blood at this time. I will ask him if he thinks I should have my blood tested for this candida infection. These past 7 years have been a total nightmare for myself and my family. I have been from one doctor to another and hopefully I can have something done so I don't have to suffer as much like I said before "I feel very hopeless and helpless" I feel so angry that none of these complications were explained to me before the original surgery and why would the FDA allow this to happen without testing before. Thank You for hearing me out.
SharonMarch 25, 2009 at 11:10 pm
I had obturator transvaginal tape procedure in June 05. I started having a burning feeling in my bladder that would wake me up at night, after urination, the pain subsided. Now the pain has escalated, I have bladder infection, and very fregent urination.
ObTape Bladder Sling Lawsuit Filings Continue as Mentor Wins First Trial : AboutLawsuits.comJanuary 7, 2009 at 6:09 pm
[...] of the United States Judicial Panel on Multidistrict Litigation on November 20, 2008, all federal Mentor ObTape bladder sling lawsuits were consolidated for pretrial proceedings and centralized in the U.S. District Court for the Middle District of [...]
MoganDecember 5, 2008 at 10:04 pm
It's all about human life. Mentor Corp to be punished for it's defective designation/productions.