Pharmalot has a report that's bound to be of special interest not just to medical injury lawyers around the country, but also to millions of Americans who have been implanted with a medical device. According to the report, a group of scientists at the FDA's Center for Devices and Radiological Health division have, in a letter to the House Energy and Commerce Committee, made dramatic charges about the "coercions" and "force" that they have been subjected to in order to speed up or bypass normal procedures before approval of medical devices.
The charges have been shocking enough to galvanize John Dingell, chairman of the Committee and Bart Stupak, Chairman of the Subcommittee on Oversight and Regulations to launch a probe into these allegations. According to the report, scientists were "ordered, intimidated and coerced" by higher-ups into modifying their recommendations for approvals in violation of standard FDA procedural practices. These coercion techniques included, the experts say, being forced to use unreliable evaluation processes, and accept data that was not procured through correct scientific means. All this was done, the letter alleges, to allow the faster approval of certain medical devices and products.
These allegations are deeply concerning to all citizens, but the tragedy is that this isn’t the first time frustrated scientists at CDRH have tried to bring this to the attention of FDA authorities. In May of this year, a similar letter with the same charge was sent to FDA officials, and in response, recommendations were made for the removal of some senior managers at CDRH. In that instance, investigating officers found "compelling evidence" that these charges were true. The fact that such allegations have been made again, this time in a letter sent to the ECC, indicates that the problem is more deep rooted than we think.
Corrupt FDA Practices and the Potential for Medical Injuries
Let's look at the implications of how this coercion of employees to rush through device safety approval procedures affects the ordinary citizen. Depending of course, on whether these latest charges are 100 percent true, and the number of years these unethical practices have been going on at the FDA, it's conceivable that thousands of people are walking around with unsafe, ineffective, or defective medical devices ranging from pacemakers and stents, to breast implants and intraocular lenses. The potential for injury through these devices is staggering, and the consequences for public safety are enormous. As long as the FDA continues to play with the health of ordinary Americans, we can hope that pharmaceutical companies that benefited from these unethical practices will be kept in check by medical injury lawsuits and other actions brought on the part of injured consumers.
Building a Medical Injury Lawsuit
Medical devices can cause serious injuries not just through faulty design and manufacture, but also because of failure to test these devices properly, or to provide proper instructions for their use. Injuries from a defective product can include adverse reactions to the product and life threatening complications.
Medical device litigation can be a complex and intensive process. If you have been injured by a defective device, you will need the help of an experienced medical injury lawyer to build your lawsuit. Contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.