In this episode of the Beasley Allen Report, host Gibson Vance visits with fellow Beasley Allen attorney Danielle Mason to discuss the Mass Torts Section of the firm and safety issues facing consumers. Mason believes one of the biggest problems concerning drugs and medical devices at this time is the Food and Drug Administration (FDA)’s medical device approval process. Currently, if a device is classified as a class one or class two medical device, the FDA does not require the device to be tested by humans before being put on the market. Instead, the drug or medical device manufacturer will be asked to show how the product is “similar” to other products that have already been approved by the FDA, allowing it to receive “preclearance.” As a result, the only way these defective drugs and devices earn the FDA’s attention is after multiple injuries or deaths have been reported during usage. An example of this would be the transvaginal mesh (TVM) litigation, which deals with the degradation of mesh implanted in a woman’s body to attempt preventing treat pelvic organ prolapse and stress urinary incontinence, both of which can occur in women as they age. But TVM has been associated with serious risks including mesh erosion, infections and chronic pain. Some women had to undergo multiple surgeries to remove the mesh, and many do not fully recover.
February 6, 2014