FDA Looking at Ways to Improve Medical Device Safety
Last week, U.S. Food and Drug Administration (FDA) officials held what the New York Times called a “rare” meeting to discuss the many controversies surrounding the agency's device safety record; medical attorneys think the meeting is past due.
The director of the FDA’s Office of Device Evaluation, Dr. Donna-Bea Tillman, called for an “all hands meeting,” to include all scientists in the device evaluation section. Shockingly, a meeting like this has not been held at the FDA in years. Then again, when you consider the agency's medical device safety record, it really is not very surprising.
The meeting is the most recent in a series of developments surrounding the FDA's record in approving devices. At least 9 scientists this year wrote to Principal Deputy Commissioner, Dr. Joshua Sharfstein, alleging that approval procedures in the device section were being "severely distorted." The letter also alleged that scientists at the agency, who were raising their voice against such unethical practices, were facing retaliation by FDA higher-ups. The matter has been serious enough to warrant a Congressional investigation. Soon, the Institute of Medicine could also begin probing these serious concerns about the device section.
Things seem to be heating up at the medical device section of the FDA. Two things are apparent at this point:
- There are serious failures in the medical device division of the FDA.
- These problems are not going to be solved by mere patch-up work. Rather, the section needs a complete overhaul to root out unethical practices, and make approval processes corruption-proof.
Any changes that come about at the medical device division cannot be a day too soon.
Defective Medical Devices
It is the FDA's responsibility to protect American consumers from dangerous medical devices. If they fall down on the job and let corrupt individuals get in the way of important safety evaluations, we are all at risk.
If you or a loved one has been injured by a defective medical device, a medical injury attorney can help you recover physically, emotionally, and financially.
Contact a medical injury lawyer, at Arnold & Itkin LLP for a free consultation and to find the answers to any questions you might have.
.gif)
Medical injury lawyers
The device categories include several high risk devices like external defibrillators, pacemaker parts, and others that have been in the news for various 
Although the company says it has not received reports of death or serious injuries connected to the use of the catheters, the FDA has classified the recall a Class I. Generally, such a recall is issued when there is “a reasonable probability” that the use of a product can result in serious injuries or death. 3,000 catheters, 
In January, Baxter sent a letter to customers informing them of the failures in the pumps. The warning included an alert that the pump could overheat, resulting in fire and smoke if not properly cleaned. The letter also underscored the importance of proper battery care, pointing out that failure to do so could cause the device to malfunction.
It is not only ReGen Biologics Inc. and the safety, or lack of it, of Menaflex in question here. At the crux of the matter are the reliability and integrity of FDA approval processes. Email correspondence between staff members at the agency indicate that they removed certain lines from emails that could indicate ‘’special treatment for the device maker.’’ FDA critics are concerned about what they call the agency’s tendency to bow to device companies. The fast track process, in particular, has come under intense scrutiny. The process allows scientists to bypass clinical trials only when reviewing devices similar to existing ones. There is no explanation forthcoming about why Menaflex was approved under the fast track process considering it is the only device of its kind in the market. With the FDA behaving more like a corrupt government than the country's premier drug safety agency, it is fair to assume that .jpg)
Later that year, the .gif)
The allegations that Forest Laboratories Inc. concealed studies showing unfavorable results for Lexapro and Celexa seem to have received no attention by the FDA. On March 20th, the agency approved the use of Lexapro for use in adolescents. Lexapro is only the second antidepressant approved for use in younger patients..jpg)
On February 17th, a judge in Wisconsin dismissed a lawsuit filed by a 63-year-old man who needed surgery to remove a Medtronic device after the company warned that the batteries may suffer from a sudden depletion of power causing it to malfunction. Earlier this year, a judge in Minnesota dismissed hundreds of .jpg)
to pass it before Atlanta becomes the venue for the world's largest biotechnology conference in May. Earlier this year, Governor Perdue unveiled the legislation at a meeting of the Georgia Chamber of Commerce, outlining his intention of making it harder for victims to pursue civil liability claims against pharmaceutical companies. Basically, the bill grants immunity to drug and medical device manufacturers from any .gif)
