C.R. Bard Appeal Rejected in Transvaginal Mesh Case
Posted on behalf of D'Amico & Pettinicchi, LLC on Jan 22, 2016 in Product Liability
In a victory for plaintiffs against transvaginal mesh makers, the U.S. Court of Appeals of the Fourth District rejected an appeal by C.R. Bard to overturn a decision against them in a one of the largest mass torts in history.
Transvaginal mesh has been in use since 2002 to treat pelvic organ prolapse. The condition is caused by internal organs falling and protruding into the walls of the vagina. It is common after childbirth, when the walls of the vagina are weakened.
However, the mesh used has caused serious complications, including urinary tract infections, incontinence, hematoma, scarring and intense pain. As a result of the complications, over 70,000 legal claims have been filed against various manufacturers.
Grounds for Rejection
The company's appeal argument centered on the Food and Drug Administration's 510(k) classification of the device. They claimed that because the product fell under that classification, the product was safe and they should have been able to tell the jury that.
An amicus brief filed against them argued that the FDA's 510(k) classification merely established that a device is substantially similar to products already on the market and is not an evaluation of its safety.
The court rejected the appeal on the grounds that "the 510(k) procedure is of little or no evidentiary value." The decision was not only a victory for plaintiffs against C.R. Bard, but also for anyone who may have a product liability lawsuit, since it will discourage companies from hiding behind the classification to avoid litigation.
FDA Classification System at Center of Debate
Products that are classified as 510(k) do not have to undergo clinical trials or submit paperwork demonstrating the safety of their products before being sold on the market.
Transvaginal mesh products were able to fall under the 510(k) status as a result of being "substantially similar" to other surgical mesh products commonly used in hernia operations.
However, the surgical procedure for vaginal mesh is different than abdominal mesh procedures and involves a different part of the body.
As a result of the ongoing transvaginal mesh litigation, lawmakers are asking the FDA to reconsider its classification system.
If you or a loved one has suffered due to a defective medical device, you may be entitled to compensation. Call the experienced product liability attorneys at D'Amico & Pettinicchi for a free consultation today. We will fight for your justice.