Fast-tracking medical device approvals is tying up a $2 million jury verdict. The plaintiff in a transvaginal mesh lawsuit won a $2 million award, but now the award is under question in an appeals court.
The defendant in the case, transvaginal mesh manufacturer C.R. Bard, argues that the verdict needs to be voided. The company contends that evidence presented to the jury was incomplete.
During the trial, both parties didn’t mention how the transvaginal mesh device under question received its approval from the US Food and Drug Administration (FDA).
With most transvaginal mesh products, companies received approval via the 510(k) process.
What’s a 510(k)?
Think of the 510(k) as a template system. A medical device manufacturer submits their transvaginal mesh device to the FDA for approval. That device wins approval due to its rigorous testing, and it becomes the template for future products.
Future transvaginal mesh devices can apply for FDA approval using the 510(k) process, and can cite similarity to that first device that received FDA approval.
In the case of transvaginal mesh, citing similarity was enough to bring these defective products to consumers.
Too many modifications
However, there comes a point when medical devices have been modified so much, they can no longer be considered similar to the first device with FDA approval. This alone should require the manufacturer of the highly-modified device to conduct rigorous research to determine safety.
This wasn’t the case for most transvaginal mesh devices, and is the reason why women all over the world are stepping forward to hold manufacturers like C.R. Bard, Ethicon, American Medical Systems, and Boston Scientific accountable.
We can help you step forward.
Are you ready to share your transvaginal mesh story? We’re here to listen, and to help you.
Our experienced transvaginal mesh lawyers are available to discuss your case during a free consultation. We’ll guide you through your legal options, compensation eligibility, and whether filing a transvaginal mesh lawsuit is the right decision for you.
Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim form.
We look forward to hearing from you soon.