What normally happens

Drugs and certain medical products are generally subject to a fair amount of testing before they are allowed to be sold. In most cases, the manufacturer will conduct testing and provide that information to the Food and Drug Administration (FDA). The FDA will then review that data and do additional testing of its own. The process varies depending on the product, but that's the basic procedure.

What happened here

Actually, that should read – what didn't happen here. Medtronic's Sprint Fidelis lead was basically a thinner version of their Sprint Quattro lead which was already on the market. The company conducted some testing on the product, but health experts have reported that what was done wasn't nearly enough. The FDA's approval process in this case was equally as poor. It did not require testing in humans and allegedly relied on the limited information it was provided by Medtronic. The FDA has said that because the Fidelis model was so similar to the Quattro model, that significant additional testing was not needed – something that is now being investigated.

Henry Waxman, a California Congressman, recently requested information from the FDA on how it handled the Medtronic debacle that affects over 170,000 patients in the United States alone. Those patients must now undergo additional monitoring – at a minimum. Some patients who have Fidelis model numbers 6930, 6931, 6948 and 6949 may have to undergo risky surgery to have their leads replaced.

Was the product rushed to market?

Health care experts have reported that both doctors and patients were anxious to have thinner defibrillator leads for years before the Fidelis came onto the market in 2004. Analysts speculate that Medtronic, who had a significant share of the defibrillator market already, may have rushed the product to market in order to gain a greater market share that its competitors.

It's important to note that these are only speculations; however, if true, patients who now must undergo surgery and live in fear of being unnecessarily shocked or having their leads not shock them when needed (as many patients have reported) have plenty to be upset about.

If you have one of the leads mentioned above and would like a free consultation with an attorney, please click here. You will be put in touch with an attorney who understands the serious nature of the Medtronic lead recall and the details of how it is being handled.