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Vincent Gesuele
2 years ago
Transvaginal Settlements In late June 2017, device maker C.R. Bard settled 75 transvaginal mesh lawsuits that were organized in the federal multidistrict litigation (MDL) underway in West Virginia federal court. The terms of the agreement are confidential. According to court records, approximately 10,000 cases are pending against C.R. Bard in the West Virginia MDL. Approximately […]
Transvaginal Settlements In late June 2017, device maker C.R. Bard settled 75 transvaginal mesh lawsuits that were organized in the federal multidistrict litigation (MDL) underway in West Virginia federal court. The terms of the agreement are confidential. According to court records, approximately 10,000 cases are pending against C.R. Bard in the West Virginia MDL.
Approximately 5,700 product liability claims are pending against C.R. Bard in the United States District Court, Southern District of Western Virginia, in which federal lawsuits involving the C.R. Bard’s transvaginal mesh devices before U.S. District Judge Joseph R. Goodwin. Judge Goodwin is also presiding over MDLs involving pelvic mesh devices manufactured by:
Judge Goodwin dismissed 75 C.R. Bard vaginal mesh lawsuits on in June 2017. All were dismissed with prejudice. Court records indicate that the dismissed cases were “compromised and settled” for an undisclosed amount, according to Law360.com. Meanwhile, in April 2017, Judge Goodwin dismissed 149 cases that were compromised and were settled for undisclosed amounts. In May 2017, Judge Joseph R. Goodwin said that 97 lawsuits “have been compromised and settled.” A case dismissed with prejudice is a case that is dismissed permanently and cannot be brought back to court.
As of April 2016, seven MDLs consisting of approximately 70,000 cases were pending in West Virginia over alleged pelvic mesh implant injuries. For example, device maker Ethicon faces approximately 23,000 as part of its MDL, court records indicate, according to Law360.
In January 2016, C.R.Bard lost its appeal of a jury’s $2 million verdict in a bellwether case in which it was found \that the device maker was liable for the woman’s injuries allegedly due to the C.R. Bard device when the Fourth Circuit found the trial court appropriately decided which evidence to exclude. C.R.Bard had argued that evidence involving the Avaulta Plus transvaginal mesh device was appropriately excluded. The plaintiff won the MDLs first bellwether trial in 2013 involving alleged injuries associated with the Avaulta Plus on which the plaintiff was awarded $1.75 million in punitive damages. When compared to the $250,000 in compensatory damages, the punitive damages were not excessive. The lawsuit was one of four bellwethers from the West Virginia MDL. The appeal was heard in the U.S. Court of Appeals for the Fourth Circuit, according to Law360.
In July 2015, Bloomberg News reported that C.R. Bard had spent $200 million to resolve 3,000 transvaginal mesh lawsuits. Involved plaintiffs reportedly received $67,000 each. A smaller group of cases were settled in 2014 for approximately $43,000 per plaintiff.
The transvaginal mesh lawyers at Parker Waichman LLP are well versed in transvaginal mesh litigation. The firm has decades of experience in medical device litigation and continues to offer free legal consultations to individuals who have questions concerning filing a transvaginal mesh lawsuit.
Both SUI and POP are conditions that are generally seen in women who are middle-aged and who have given birth. Pregnancy impacts muscles and other abdominal tissues that hold the body’s organs in place. These muscles and tissues weaken as women age, especially due to the previous stress tied with pregnancy and carrying babies full-term. The weakening may cause the female body’s internal organs to sag and press against the uterus.
SUI is the involuntary release of urine during normal, everyday activities, including sneezing or laughing. POP takes place when the organs of the pelvis prolapse, or drop, from their intended location, bulging into the vagina.
Traditional treatments involve creating a sling to treat POP and SUI and using a woman’s own tissue during invasive surgery. The use of surgical mesh laparoscopically has been used in POP, SUI, and abdominal repair. Transvaginal mesh has led to complications similar to those seen with abdominal surgical mesh.
Pelvic mesh is meant to reinforce the strength of the pelvic walls and counteract sagging organs and has become increasingly controversial over safety concerns given the thousands of transvaginal mesh lawsuits filed against various mesh makers. Pelvic mesh injury reports have added to safety concerns and women have similarly alleged that transvaginal mesh implants caused them serious, often permanent injuries.
In 2008, the federal regulators issued a warning that transvaginal mesh devices were involved with more than 1,000 serious injury reports during the prior three-year period. In July 2011, the agency revealed that it had received more than 2,800 additional adverse event reports related to the medical devices, including cases of injury, death, and malfunction. More than 1,500 incidents were tied to POP repairs and 1,371 were associated with SUI repairs.
An FDA’s 2011 alert noted that it no longer considered transvaginal mesh complications following POP to be a rare injury, which was a reversal of its prior position, according to Law360. The FDA also indicated doubt that POP repair with transvaginal mesh offered any additional benefits when compared to traditional non-mesh repair.
The agency reclassified pelvic mesh devices like those in the many, various lawsuits as being high-risk devices that must undergo the agency’s most stringent safety evaluation before being put on the market. In 2016, the federal regulators issued new rules that, in part, made transvaginal mesh implants ineligible for the agency’s 510(k) clearance program. This program allows a medical device to come to market in the absence of human clinical trials when a manufacturer is able to show that the device is “substantially equivalent” to another product that had been previously approved by the FDA, even if that product was voluntarily recalled or was never assessed for safety. Meanwhile, numerous transvaginal mesh plaintiffs have noted that their devices were cleared through the 510(k) route, to a previously approved medical device.
If you or someone you know suffered injuries related to the use of a transvaginal mesh implant, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).