Pre Settlement Funding on Recalled Vaginal Mesh Implant Litigation
BREAKING NEWS: Ethicon, Inc., a unit of Johnson & Johnson and the manufacturer of several widely-used transvaginal mesh products, including the Gynecare TVT Secur System and Gynecare Prolift Pelvic Floor Repair System, announced today that it has decided to take these products off the market.
Vaginal mesh devices were designed to aid in Pelvic Organ Prolapse and Stress Urinary Incontinence. However, many lawsuits, studies and reports have been made that complications have risen due to the mesh implants. Two common complications are organ perforation and erosion. Many women now how seek for compensation for the emotional and physical pain that they are experiencing because of these side effects. The complications are not easily treated since they require surgery, sometimes even as much as five or more surgeries just to correct the damage that was done. Manufacturers are now facing millions worth of individual lawsuits and multidistrict litigations.
Vaginal Mesh Lawsuits and Litigation
Plaintiffs claim that the vaginal mesh devices were negligibly designed which cause serious side effects or complications. There have been 40,000 transvaginal mesh lawsuits filed against various manufacturers, as of January 2014. Some companies have resorted to pulling out their products entirely and voluntarily. These companies that are being sued include C.R. Bard, Ethicon (under the Johnson and Johnson umbrella), Boston Scientific, Coloplast Corp, Cook Medical, and American Medical Systems. The companies have been facing some additional 3,000 lawsuits per month in spite of being able to settle other cases. Many of the lawsuits have been filed in a muti-district litigation in the federal court of Charleston, 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 in the United States District Court for the Southern District of West Virginia are:
In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325);
In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326);
In re: Coloplast Corp., Pelvic Support System Products Liability Litigation (MDL No. 2387);
In re: Cook Medical, Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2440);
In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2187);
In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327);
In re: Neomedic Pelvic Repair System Products Liability Litigation (MDL No. 2511).
One of the early jury verdicts regarding these vaginal mesh cases happened after Christine Scott had sued C.R. Bard regarding her Avaulta mesh device. Her colon was perforated and had to undergo eight surgeries to correct the complication. She was given $5.5 million which included $500,000 for her husband since the device had ruined the sex life of the couple.
Legal cases from the six aforementioned companies that are being sued have been consolidated into separate multidistrict litigations in the U.S. District Court for the Southern District of West Virginia. All six MDLs are being held before Chief Judge Joseph R. Goodwin. There are over 22,000 lawsuits in the MDLs and state courts are still receiving thousands more in lawsuits. The Mentor Corporation’s ObTape vaginal sling were consolidated in a different MDL in the U.S. District Court for the Middle District of Georgia and is being supervised by Judge Clay D. Land.
American Medical Systems settled an undisclosed number of lawsuits for $54.4 million. The lawsuits were filed in state and federal courts. The settlement, on the other hand, was reached on June 2013, after the company estimated liabilities at $159.8 million. Thousands of mesh device cases were filed with claims that the company’s products led to complications. It was in May 2014 when American Medical Systems settled around 20,000 mesh claims up to $830 million. The amount will still be dependent on the number of participating claims.
The July 2013 trial of C.R. Bard revealed a lot of damaging evidence against the company; so much so that the jury voted in favor of the plaintiff. The jury deemed that Bard inadequately tested Avaulta implant in humans or even used specific care in terms of design. Jury also deemed Bard guilty of injuring the plaintiff by not informing her doctor about the risks of the device. The verdict was $2 million, including $250,000 in compensatory damages and the other $1.75 million in punitive damages because of the company’s negligence. Bard has been observed to settle numerous cases before the scheduled trial of respective lawsuits.
A California jury deemed Bard negligent in 2012. This time, the verdict was $5.5 million, including $5 million for the plaintiff’s expenses on medical services, pain and suffering. The rest of the verdict money was for her husband’s claim of loss of consortium. Bloomberg News announced in March 2014 that Coloplast settled $16 million for 400 lawsuits. The average payout would be $40,000 per plaintiff. A New Jersey jury awarded $11 million to a plaintiff against Ethicon in 2013, following claims of injuries caused by Gynecare Prolift.
According to the FDA, the institution has received almost 4,000 complaints of injury, death or malfunction that was associated with vaginal mesh device surgeries that were done between 2005 and 2010. In the thousands of women that have filed lawsuits in both state and federal courts, some have settled while others have resulted in favorable verdicts for the plaintiffs. By mid-2014, approximately 50,000 women have filed vaginal mesh manufacturers because of injuries cause by the products.
What is Vaginal Mesh?
Transvaginal mesh is a net-like implant that is used primarily to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. Transvaginal mesh devices are called as such due to the surgical technique used to implant the device, which literally means through the vagina. The size and shape of the mesh varies depending on the patient’s needs, as well as the organs involved. The mesh device may be put on the front, top or back wall of the vagina. Vaginal mesh devices are usually performed transvaginally. 3 of 4 surgeries in 2010 were performed this way.
Pelvic organ prolapse and stress urinary incontinence are conditions that appear in women usually after child birth, hysterectomies or menopause. POP is the condition wherein pelvic muscles are weakened and pelvic organs, usually the bladder, rectum, bowel and uterus) drop into the vaginal canal. The transvaginal mesh acts as a hammock to keep the organs up. For this case, mesh devices are implanted either transvaginally (a quicker, easier and less invasive procedure) or abdominally. SUI, on the other hand, is when the bladder leaks urine during times of increased physical activity, or anything that increases pressure on the bladder. For this condition, the mesh device supports the urethra when the pelvic muscles weaken. The bladder sling, as it is commonly called, or the vaginal tape is the most common surgery used to correct the condition. 80% of mesh surgeries in 2010 were transvaginal.
The FDA has classified various mesh devices into four categories:
Non-absorbable synthetic – considered permanent implants due to the fact that they stay in the body for an indefinite time. More than 50% of FDA-approved mesh devices fall into this category and are made of plastic or polyester, with polypropylene as the most popular plastic used to make the device. 91% of this category is made from polypropylene.
Absorbable synthetic – due to the nature of materials, this category of mesh devices lose strength and degrade over time, and is not designed for long term use. The patient’s new tissue growth at the implant site helps keep the repair robust.
Biologic – materials used in biologic mesh devices are made from animal tissue, either from cow (bovine) or pig (porcine). The mesh devices are specifically disinfected for use in the human body, and like the absorbable synthetic, also degrades over time.
Composite – A combination of any of the three other categories.
While many post-surgery complications can vary from severe bleeding to infection to synthetic mesh cutting through vaginal walls, most claims that were filed against mesh device manufacturers were because of erosion and organ perforation complications post-surgery.
Transvaginal Mesh Post-Surgery Complications
Erosion is a process wherein the vaginal mesh degrades through the female body’s soft internal tissues. This is an extremely painful complication that may also result in extrusion or protrusion – meaning the mesh is discernable externally. Vaginal erosion often advances painful sexual intercourse, sometimes making intercourse impossible. Urinary tract infection may also arise, which can cause recurrent infections.
In 2010, a Cochrane review evaluated more than 3,500 participants in trials with different surgical procedures for POP. It was then found that there is a 10% erosion rate when vaginal mesh devices were used. The FDA reported in 2011 that this complication is one of the most commonly reported impediments for both transvaginal POP surgeries and SUI surgeries. The reported average rate of vaginal mesh erosion at a year post SUI surgery with mesh is about 2%.
In most cases, removing the mesh is the only solution to erosion; however, it is not always possible. Doctors used the metaphor of cutting gum out of hair as a comparison for removing mesh.
Organ perforation is the infiltration of the wall of a hollow organ in the body. Because the mesh erodes through tissues, it has the possibility of puncturing the organs. The bladder is the most commonly perforated organ but it also usually affects the urethra, bowel, or rectum. There are rare instances wherein the perforation happens during the implantation surgery itself. Between 20008 and 2010, 5.8% of prolapse mesh surgeries involved organ perforation. Severe cases of this can result in infections and breathing difficulties. Most of the time, surgery is required and the mesh might have to be removed and even bowel resection, colostomy and blood transfusion. Urine or waste can make its way into the drug stream when organs are punctured, and this can cause fatality from septic shock.
FDA Warnings, Reports and Vaginal Mesh Recalls
The FDA has warned patients with SUI that any surgery to treat this condition endangers the patient due to risky complications that may occur, even involving supplementary surgery at times. One possible complication that may arise from surgeries to treat SUI is vaginal mesh erosion, particularly when using mesh slings. When this complication occurs, the patient may possibly need to go through more surgery to solve the erosion.
The FDA also advises patients who have gone through surgery to treat SUI to continue with yearly check-ups and care post-surgery. The FDA also advises these patients to seek professional medical help If and when further complications occur like persistent vaginal bleeding or discharge, pelvic or groin pain or pain during sexual intercourse.
It was in July 2011 that the FDA provided updated safety communication about serious impediments associated with transvaginal mesh devices to treat POP. This included the discussion of how the devices cause serious complications and that these are not rare. It was also stated in the memo that it was still unclear if transvaginal POP repairs using mesh devices are more effective than that of traditional repair, without using mesh devices. In this review, the October 2008 FDA Public Health Notification was also mentioned, further supporting the claims of vaginal mesh devices having severe health and effectiveness issues.
The Obstetrics and Gynecology Devices Panel of the FDA recommended in September 2011 that these surgical mesh devices (for POP) be moved to class III from class II, and require premarket approval (PMA). Back in January 2012, the FDA also ordered manufacturers of surgical mesh devices to conduct postmarket surveillance studies, to handle concerns regarding specific safety and effectiveness related to the device with respect to usage for transvaginal repair of POP. After the issuance of the postmarket surveillance study orders, some manufacturers of surgical mesh devices voluntary recalled and withdrew their products to be sold in the market.
In April of 2014, the FDA had a news release with the institution submitting proposals to tackle the issue of risks associated with surgical transvaginal mesh to repair POP. In short, the FDA has concluded the clear risks involved with vaginal mesh to repair pelvic organ prolapse and are moving to address the risks for more safe and effective products. FDA is suggesting that instruments used for surgical vaginal mesh devices be moved to a different classification, from class I (low-risk devices) to class II (moderate-risk devices), while also proposing to reclassify surgical mesh devices used for POP treatment from class II to class III (high-risk device). These proposals, however, do not include surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications.
FDA actions only took place after women across the country experienced a range of complications after surgery. Many experts and consumer activists are demanding that these devices be recalled and banned, as well as many others calling for a new legislation to prevent future harm to more women.
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