C.R. Bard Settles 75 Transvaginal Mesh Lawsuits in MDL

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Another series of transvaginal mesh lawsuits has reportedly been settled by C.R. Bard that were part of a federal multidistrict litigation (MDL) in West Virginia federal court. Multidistrict litigation is a process created to streamline a case by having similar complaints with numerous plaintiffs plead their case in one court under one judge. This lowers court costs, allows a generally faster outcome, and is typically more efficient.

About 5,700 product liability claims are pending against C.R. Bard in the U.S. District Court, Southern District of Western Virginia, where U.S. District Judge Joseph R. Goodwin is the presiding judge. Judge Goodwin is also presiding over MDL lawsuits involving pelvic mesh devices made by American Medical Systems, Inc., Ethicon, Inc., Boston Scientific Corp., Cook Medical, Inc., and Coloplast Corp.

75 Cases Settled

In June, Judge Goodwin dismissed 75 C.R. Bard vaginal mesh lawsuits, all with prejudice. Court documents reveal that the dismissed cases have been “compromised and settled” for an undisclosed amount, reports Law360.

This settlement is the most recent transvaginal mesh settlement reported in the C.R. Bard litigation. Judge Goodwin dismissed 149 cases in April that were compromised as well, and settled for undisclosed amounts.

In July 2015 C.R. Bard reportedly spent $200 million to resolve 3,000 transvaginal mesh lawsuits, according to Bloomberg News. Plaintiffs involved in those suits each allegedly received $67,000. A smaller group of cases had been settled in 2014 for approximately $43,000 for each plaintiff, according to Law360.

The national personal injury law firm Parker Waichman LLP has extensive experience in medical device litigation. Attorneys at the firm are available to answer any questions about filing a transvaginal mesh lawsuit.

Transvaginal Mesh Risks

Transvaginal mesh (TVM) is a medical device that is surgically implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), not uncommon occurrences in older women. These conditions are meant to be improved when additional support is provided by the mesh implant for sagging pelvic organs and muscles.

Complaints have been reported with allegations that TVM devices have caused women infection, bleeding, severe pain, erosion of bodily tissue, dyspareunia (difficult or painful sexual intercourse), painful scarring, as well as other injuries. Women have also sued the manufacturers, including C.R. Bard, for these adverse reactions that generally require surgical removal of the device.

To remove the transvaginal mesh, some women have undergone multiple surgeries, but in some cases, the damage has allegedly been permanent. On occasion, the mesh has caused irreversible injury, including nerve damage.

Over time, the transvaginal mesh has failed in numerous ways, often eroding through the vaginal wall or skin. Allegations have been made of sharp edges of mesh protruding through the vaginal wall after having migrated from the original insertion location. This has caused excruciating pain and has altered the lives of women who suffer from a malfunctioning transvaginal mesh device. Women have described their pain including an inability to sit, stand, or lay in a position for more than a few minutes at a time.

FDA Statistics

As far back as 2008, the U.S. Food and Drug Administration (FDA) warned that TVM devices had been implicated in over 1,000 serious injury reports for the previous three-year period. The FDA reports that in July 2011, it had received over 2,800 more adverse event reports involving TVMs, including cases of injury, malfunction, and death. More than 1,500 incidents were linked to pelvic organ prolapse repairs, and 1,271 were connected to stress urinary incontinence repairs.

The agency’s 2011 alert also said that the FDA no longer considered TVM complications following POP repair to be rare, the opposite of its former position. The FDA added that it doubts that prolapse repair with transvaginal mesh offered any additional benefits when compared to traditional non-mesh repair.

In 2016, the FDA introduced new rules that, among other changes, made transvaginal mesh implants ineligible for the FDA’s 510(k) fast track clearance program. This process allows a new device to come to market without the stringent testing required of new products provided it can show it is “substantially equivalent” to another product already approved by the FDA.

The agency has reclassified TVM from a moderate-risk device to a high-risk device. This means that TVM device manufacturers must go through the FDA’s rigorous pre-market approval process and submit data proving the devices are safe and effective.

Legal Help for Transvaginal Mesh Implant Recipients

If you or someone you know suffered injuries or complications due to transvaginal mesh implants, you may have valuable legal rights. Parker Waichman personal injury attorneys offer free, no-obligation case evaluations. For information, please contact us at 1-800-YOURLAWYER (1-800-968-7529).