Quality testing should be an integral part of bringing a life-saving medical device or healing pharmaceutical drug to market. A new study published by the Archives of Internal Medicine, however, indicates that the Food and Drug Administration (FDA) has unwittingly approved the sale of some untested devices, many of which were high-risk for use in patients. An alarming number of both medical devices and prescription drugs have been recalled recently for being both dangerous and defective for use within, or consumption by, unknowing patients.
Analyze This
The Archives of Internal Medicine (AIM), which is an international peer-reviewed medical journal, recently published the results of their analysis of untested, defective medical devices previously approved by the FDA. The study states that the FDA permitted the sale and use of tens of millions of unsafe devices, many high-risk, which were never tested in humans for their effectiveness. To make this conclusion, researchers reviewed high-risk devices recalled from 2005 to 2009 and noted whether the FDA performed a device review.
The FDA uses two methods of review to approve most high-risk medical devices, which are the premarket approval (PMA) test, which is more meticulous, and the 510(k) test, which is more lax on its clinical testing and manufacturing inspection requirements. According to the AIM study, the FDA cleared 71 percent of 113 recalled high-risk devices using the 510(k) method, which is geared more towards low-risk devices. The FDA used the PMA method to approve only 19 percent of the recalled devices, which included human tests and after-market safety studies.
Recalled for Defects
The AIM study findings point to obvious defects in the FDA medical device approval process, defects which could be fatal for some patients. Many of the recalled devices studied by researchers included life-saving technologies, such as cardiovascular devices of both external and implantable defibrillators. Other recalled devices, like the DePuy hip replacement system, have also had issues with proper testing and trials. These devices even went to market without prior FDA approval, which is another example of how the FDA review process needs an overhaul.
There are also a multitude of prescription drugs that the FDA has issued warnings about or recalled in the last few years, which may be dangerous or otherwise defective. Some of these drugs include Chantix, NuvaRing, Avandia, Yaz, Yasmin, Ocella, Accutane, Alli, Byetta and Reglan. Even if these and other types of drugs were tested by patients during drug trials, they could also cause serious and unexpected side effects for some people, so being aware of this fact could prevent further injury or death due to defective drugs.
Liability Issues
For both medical devices and pharmaceutical drugs, there seems to be an issue with the FDA approving untested products and allowing them to be sold to unsuspecting consumers. The device manufacturers, pharmaceutical companies and the FDA are all to blame for less than thorough testing and investigation efforts, but in the end it is the patient who suffers for their combined carelessness. If you or your loved one was the victim of a defective device or drug, contact a local product liability attorney with experience in dangerous drug and defective device litigation.
