Project #4389 - Medical Devices, FDA Loophole and Tort Law

In 1976 a federal law was created that intended to regulate medical devices through the Federal Drug Administration (FDA). In that law medical device manufactures were able to obtain, through lobbying efforts, a large loophole.  Under that law all a manufacturer has to do is establish that their device is “similar” to other medical devices being sold.  Under this law, there is no requirement that manufactures conduct clinical trials as they have to with drugs unless the device is considered to be “high risk”.   High risk devices are items such as heart defibrillators.

 

Johnson and Johnson Inc, through their wholly owned subsidiary, DePuy Orthopedics, began to produce all-metal hip replacement devices about a decade ago. They were able to do so without conducting clinical trials as to their safety or effectiveness.  Traditionally hip replacements are a combination of plastic and metal and they last about fifteen years before replacement surgery is required. The DePuy device is known as Articular Surface Replacement, began to be manufactured in 2005.

 

“…as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies.” NY Times, February 10, 2013.

 

Thousands of patients have had to undergo surgery to remove the Articular Surface Replacement product. The removals, in many patients, have occurred shortly after their implantation at a 1 in 8 rate. In those patients where the device has not failed the patients are showing blood evidence of high amounts of cobalt and chromium.

 

After five years of failure of a device that received no clinical studies or resulted in warning to surgeons using the device, Johnson and Johnson finally made available to doctors a warning on March 6, 2010. This warning stated that an Australian study indicated that the device might cause risk to those of “small stature”. In August of 2010 Johnson and Johnson decided to recall all of the Articular Surface Replacement devices that it had manufactured.

 

Under a new law the FDA has proposed requiring that manufacturers of artificial hips establish that they are safe and effective before they can be sold on the market. Industry lobbyists are currently both fighting the proposal and attempting to modify it if it is completely implemented.  The FDA itself says that it will most likely take a year before the rules are finalized.

 

 

 

 I want you to address the following issues:

 

1. Should these devices be regulated or should we allow the business ethics of the manufacturer to dictate product safety?  In other words do we have too much regulation of business as it is?

 

 

 

2.  How should our tort system react to this situation?

 

 

 

3. What ethical standards should control if a corporation knows that one of their products is causing harm?

 

Subject Law
Due By (Pacific Time) 05/01/2013 12:00 am
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