Maryland Lawyer Blog

The Medtronics defibrillator lead failures have again raised the issue of whether the FDA’s testing procedures are sound. A congressional oversight committee will review the FDA’s testing procedures for the Medtronics recalled wire component of its defibrillator, which has been linked to at least five patient 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.

Certainly, the FDA needs to do its part in analyzing the safety efficacy data on these products. But it the end, the burden lies with Medtronics 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 Medtronics defibrillator recall lawyers that are representing the victims will hear one defense theme over and over: “FDA approved.” The solution to this problem would be to exclude evidence of the FDA approval; 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. I think this is a reasonable solution to this unfair hurdle that plaintiffs’ pharmaceutical lawyers must face in every case.