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Again the Medtronics defibrillator lead failures have again raised the issue of regarding the FDA’s procedures. A United States Congressional oversight committee will review the FDA’s testing procedures for the Medtronics recalled wire component of its defibrillator and their cause of at least five individuals' deaths. In an letter to FDA Commissioner Andrew von Eschenbach, Henry Waxman (D-CA) requested a thorough timeline of the recall and an overview of how FDA approves so-called "supplemental" parts of medical devices. "Please describe the process by which FDA approves all  defibrillator leads," Congressman Waxman's letter states. "Specifically, please explain whether FDA would approve a defibrillator lead under a distinct (pre-market approval) or as a supplement to a PMA for another device." Waxman also cited reports that the FDA did not require Medtronic to submit clinical trial data on these recalled leads and requested an explanation for the FDA's failure to do so.
Many in Washing now believe that the FDA needs to do its part in analyzing the safety efficacy data on these products, and thus do more. However many believe the problem is in the design, for in the end, the burden lies with Medtonics Corporation to do all that it can to make a safe product. The race to get these products on the market is furious. Medtronics and other medical device companies selling defibrillators rush out new defibrillators that may be technologically superior, but with no proven history of safety and reliability, because they want more market share. The FDA does not have time, energy, manpower, whatever, to properly evaluate the safety of the product. Yet at trial, you can bet that their lawyers will fight at every turn the lawyers representing the victims.  And you can bet that they will tumpet the same old defense theme over and over: “FDA approved.”

A viable long term solution this problem would be to make it the law that evidence of a FDA approval is irrelevant for it is of limited probative value to demonstrate safety of the product, and it is likely to mislead the jury, because they may incorrectly assume the FDA approval process is more vigorous than it really is in real life.  Additionally, the drug companies should not be allowed to use their lobbyist in pushing the speed of some drug approvals and in some cases even worse.

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