Medtronic’s recall of its Sprint Fidelis defibrillator lead has prompted various lawsuits against the company, widespread consumer panic and investigations into the company’s – and the Food & Drug Administration’s (FDA) – actions. So, what went wrong?

Medtronic dropped the first ball

Medtronic introduced the Sprint Fidelis, a slimmer version of their previous lead, the Sprint Quattro, in 2004. Although limited testing was required by the FDA, Medtronic conducted its own testing on the Fidelis. However, the company was never required to submit that testing to the FDA – something that many are now questioning.

According to reports, Medtronic had known about the faulty leads for quite some time before the October 15, 2007 recall. The company claims that the evidence was not enough to warrant a recall, but patients who have undergone implant surgery – especially recently – do not agree. Many suspect that there just might be more to it as, coincidentally, Medtronic has been in negotiations to purchase another company (Kyphon) that occurred in the same week as the recall.

FDA dropped the second ball

The FDA may have been just as culpable by dropping the second ball. It did not require the Sprint Fidelis lead to undergo any strict testing as it wasn’t considered significantly different from Medtronic’s previous Sprint Quattro model. Human trials were required for previous models – but not this time. The FDA has said that human trials wouldn’t have made any difference, but again – that’s little consolation to those who have been injured or died from being implanted with this lead.

Less than exemplary behavior

Most will agree that Medtronic’s and the FDA’s behavior were ‘less than exemplary’ in this situation and wonder why more wasn’t required – especially due to the serious nature of a product such as a lead which connects a defibrillator to someone’s heart. As such, congressional investigations have begun and several lawsuits have been filed already.

Have you been adversely affected?

Approximately 235,000 people may be affected by the company’s recall. Replacing a defective lead, although covered by the company, requires surgery and health experts say that the procedure is risky. If you’ve been adversely affected by Medtronic’s Sprint Fidelis lead, take action and contact an attorney to discuss your case. To contact an attorney near you whose practice focuses in this area of law, click here.