As the number of legal actions against DePuy Orthopedics over the failure of their ASR hip implants continue to increase, consumers understandably are wondering how this could have happened in the first place. Aren't such products supposed to be approved by the Food and Drug Administration before they are allowed on to the market? And isn't such approval supposed to be granted only after extensive testing?
The takeover of our government and the regulatory agencies that are supposed to protect consumers by powerful corporate interests that place profits over human life is no secret. This has been largely ignored by "low information" voters and uneducated people who want that "dang gummint outta thar lives" – at least until now. As the result of this corruption is now affecting their lives personally however, more and more sick and injured consumers and their families are hopefully waking up the fact that we have all been sold out to Corporate America.
However, when it comes to FDA approval of devices such as the ASR hip implants, the real truth is more complicated – and even shocking.
While it is true that agencies such as the FDA have been largely fallen under the control of the very industries they are supposed to be regulating, a large part of it has to do with procedures that have been in place for some time. One of these what is known as 501(k) Clearance. This section provides "...requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance...this allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified."
Read the last part of that carefully. This is a loophole of biblical proportions. Essentially, if a pharmaceutical company such as DePuy says that their device is "substantially equivalent to a similar item that has already been approved and is currently on the market, there is no need for it to have undergone safety testing. Devices and drugs that are covered by the FDA fall into one of three categories, or "classes." Class I consists of things such as oral hygiene products; these need not have FDA clearance but must meet certain standards. Class II devices include hearing aids, materials used to fill dental cavities, and diagnostic tests. Class III devices are those such as pacemakers; they are permanently implanted into the body surgically and/or are necessary for the patient's survival. It is such devices that must get "premarket approval" under Section 501(k).
Hip implants fall into the third category. However, just because these devices received such approval means little. All DePuy had to do was convince the FDA on its application that their implants were basically the same as other implants that have been on the market for the past 30 years.
It was less expensive and thus better for the corporate bottom line than actually doing safety studies... even if a few people had to get sick and even die and a few court settlements had to be paid out.
Hopefully, corporate criminals like DePuy are learning otherwise. unfortunately, the FDA is continuing with business as usual; according to an article at 4-Traders.com, the FDA has yet again granted 510(k) clearance for another DePuy Orthopedics device, an artificial knee replacement – and stock for parent company Johnson & Johnson has taken a bit of a jump as a result.