C.R. Bard Forbidden from Using 510(K) Compliance as Evidence in Transvaginal Mesh Trial, Judge Orders
Whether or not C.R. Bard complied with federal regulations for getting its vaginal mesh implants to market likely does not matter to a woman who allegedly sustained vaginal spasms and other serious complications because of them, and is decidedly irrelevant to the trial of her transvaginal mesh lawsuit.
A West Virginia federal judge Ordered on February 6th that evidence related to C.R. Bard’s adherence of the U.S. Food and Drug Administration (FDA)’s 510(k) process is barred from the upcoming trial, after determining that it does not prove the safety and effectiveness of its Avaulta devices. The mesh manufacturer can, however, include evidence related to claims the plaintiff has filed against the doctor who implanted her with the company’s pelvic mesh, that allege injuries that arose out of the surgeon’s care. This is relevant to C.R. Bard’s defense of its products, the Order states.
Plaintiff Alleges Vaginal Spasms, Pain in Vaginal Mesh Lawsuit
The plaintiff in this case, which was filed directly into a federal transvaginal mesh litigation (MDL) underway in the U.S. District Court, Southern District of West Virginia, sustained injuries that were allegedly caused by the Avaulta Plus Anterior Support System and Avaulta Plus Posterior Support System, which she received as a treatment for pelvic organ prolapse. Following implantation of these devices, the woman experienced vaginal spasms, damage to her vagina, ureter and rectum, as well as kidney reflux, urinary tract infections, lower pelvic pain, incontinence, chronic constipation and kidney stones, according to her transvaginal mesh lawsuit.
The plaintiff in this case charges C.R. Bard with negligence, failure to warn, manufacturing defect and punitive damages, among other claims, and seeks compensation for out-of-pocket medical expenses, lost wages and other damages that were allegedly incurred by her injuries.
Claims included in this transvaginal mesh lawsuit are similar to thousands of others involving C.R. Bard’s Avaulta mesh products that are now pending in West Virginia federal court. As of January 15, nearly 10,100 cases had been filed in the litigation by women who similarly allege the company’s failure to warn about complications that may result from use of its products. C.R. Bard lawsuits are also pending in a consolidated proceeding underway in New Jersey’s Bergen County Superior Court, which included 1,667 on February 7th.
Contact a Transvaginal Mesh Lawyer
As the nationwide litigation involving C.R. Bard mesh lawsuits continues to heat up, the time is now to file a claim of your own. Call us now to pursue a vaginal mesh lawsuit: (877) 779-1414.