Medtronic’s recall of their Sprint Fidelis defibrillator lead (model numbers 6930, 6931, 6948 and 6949) is one of the largest medical recalls in history. In the weeks since the product was recalled in mid October, the company has been pointing fingers at the Food and Drug Administration (FDA) and vice versa. Regardless of who is ultimately to blame, it’s clear that consumers are the big losers in the end.

Unreliable approval process

The approval for Medtronic’s lead is issued by the FDA. However, that process has been criticized for being unreliable by those in the medical community and patients alike. The FDA requires that most drugs be tested on humans before they can be sold on the market – not so for this product. In fact, the FDA relied upon Medtronic’s limited data when deciding to approve the lead for sale, a move which many say is not much of a process at all.

The FDA has defended its approval of the lead saying that the Sprint Fidelis lead was similar to Medtronic’s older Sprint Quattro lead, only in a thinner version. Therefore, significant additional testing, or testing the product on humans, was not required.

Medtronic, on the other hand, has stated that it complied with FDA requirements and acted responsibly by pulling the product off of the market when it realized that the Fidelis might be defective. The former statement is true, but the latter is now being debated. Doctors and hospitals across the country such as the Minneapolis Heart Institute, Chicago’s Children’s Memorial Hospital and Boston's Brigham and Women's Hospital are reporting that they told Medtronic about these problems as early as January – ten months before the company issued the recall and took the product off of the market.

Ready, set, litigate

Lawsuits against the company have already begun and legal experts expect that there will be many more to follow. In those suits, plaintiffs are alleging that the company acted negligently by knowingly selling a defective product. Many have also alleged emotional distress in these suits as the ‘recall’ may mean having risky surgery to remove or replace their Fidelis lead with another model. One Texas plaintiff actually sued the company for theft after his lead was sent back to Medtronic and the company destroyed it.

If you or a loved one has been injured as a result of this product, contact an attorney whose practice focuses in this area to review your situation. To contact an attorney you, click here.