Dangerous and defective medical devices - the majority of which are related to cardiac issues - may have wrongly sailed through the FDA approval process. Patients injured by these devices which were later recalled want to know why the FDA and manufacturers didn't do more testing in order to protect them.
Defective Medical Devices Should Have Been Better Tested
According to a new study published in the Archives of Internal Medicine, 80 of the 113 medical devices (71%) recalled due to dangers or defects from 2005 to 2009 were approved through the U.S. Food & Drug Administration's (FDA) 510(k) process - which does not require the same level of rigorous testing as the FDA's traditional pre-market analysis (PMA) process when a product is similar to one that already exists. A staggering 35% of those recalls had to do with cardiovascular devices - many of which required major surgery for implantation.
Defective medical devices such as the Medtronic Octopus Nuvo Tissue Stabilizer device, the AngioSculpt PTA Scoring Balloon Catheter and many others were recalled after after reports of possible or actual injuries - leaving patients asking why the FDA or manufacturers didn't do more testing. It''s an ongoing question according to product liability lawyers and one that often leads to product liability lawsuits.
Who's Ultimately Responsible For Your Injuries?
Although it seems clear that the FDA green-lighted many medical devices prematurely, medical device lawyers say that it's the manufacturers who are ultimately responsible. Many manufacturers know that the FDA's budget and reach are limited and use that to their advantage in order to get their products to market faster. However, when their products are later recalled, many of those same manufacturers point fingers at the FDA - saying that it ultimately had the final approval.
The bottom line is that juries do hold manufacturers responsible for defective products and compensate injured victims for lost wages, medical bills, pain and suffering and more - regardless of FDA action or inaction.