New studies question FDA’s medical approval process

The US Food and Drug Association (FDA) has come under fire once again this week. Two independent studies were published that are critical of the agency’s approval process for medical devices. These findings may prove to have long lasting effects in the US justice system. A court case decided in 2008, Riegel versus Medtronic, concluded that approval from the FDA grants companies that produce medical devices free and clear of lawsuits resulting in injuries from their products.
A new report released by a personal lawsuit information site, AboutLawsuits.com, stated, “One study, conducted by researchers from the University of California and published this week in the Journal of the American Medical Association, found that two thirds of approved devices only went through one clinical trial before being unleashed on the market, and most of those trials involved less than 300 subjects. The other study, conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center, will be published in the upcoming issue of the American Journal of Therapeutics, indicating that about 40% of the studies used to decide what devices are approved lack clear definitions of safety requirements.”
These studies follow hot on the heels of other lawsuits with dire consequences that involved FDA approved drugs. Recent headlines featuring tragic birth defects caused by FDA approved antidepressants such as Zoloft and Paxil have shaken consumer confidence in the agency’s standards. Even seemingly benign medicine with the FDA’s seal of approval is causing grave concern. A good example is the popular denture creams, Fixodent and Poligrip, which are currently facing litigation for zinc poisoning.
The FDA’s jurisdiction over food and food additives released into the marketplace has also caused grave misgivings among the American people. Approval for both artificial flavor enhancers MSG and aspartame has unleashed a storm of controversy that has spanned decades. The lawsuits connected to these additives promise to haunt the public for years to come.
The FDA stands on unsteady ground with the public that it is bound by law to serve. The Supreme Court may have to look elsewhere for confirmation of the product safety of medical devices that US citizens rely on for assistance. Until then, the public would be prudent to exercise caution before placing their faith blindly in FDA approved product.