Medtronic Inc.’s recall of their Sprint Fidelis leads have prompted legal experts and patients to ask what Medtronic knew about the defective leads – and when they knew about it. Neil Overholtz, a Florida attorney who represents Fidelis patients, says that Medtronic absolutely knew about the problems with its lead wires up to a year before the recall – and did nothing.

What did Medtronic know and when did they know it?

In a recent interview, Overholtz told us that one of the biggest issues regarding the Fidelis recall is that Medtronic was simply not reporting adverse events. He explained, “The Company had been receiving adverse information from the Minnesota Heart Institute, one of the best heart institutes in the country, as far back as 2006 – but weren’t reporting it. The Institute basically told Medtronic that it had detected some very serious problems with the Fidelis leads and told the company that it wanted to discuss those problems so that Medtronic could do something about it. Unfortunately, Medtronic continued to keep their heads in the sand.”

Medwatch Reports aren’t what you might think

Medwatch Reports provide details about drugs and medical devices. Anyone can access this FDA database to see if any problems have been reported. So, why weren’t problems with the Sprint Fidelis made public sooner? According to Overholtz, they aren’t called Medwatch Reports because they’re about medical issues. He told us, “They're called Medwatch Reports because that's the program that Medtronic created to track adverse events. Medtronic is as sophisticated of a defendant as there could possibly be when it comes to how they report adverse events and how they defend these cases based on the report.”

“We’ve learned a great deal about how Medtronic and other medical manufacturer companies work through the discovery process. They are experts at trying to gain the system. These cases take on a much more serious tone in our opinion, but we are heavily committed to pushing these cases as far as they can go.”

Damages in Fidelis cases are more severe

The damages in the Medtronic Sprint Fidelis lead cases are much more severe – even for people that haven’t had anything happen to them yet. Overholtz continued, “There are a lot of people that can't get the surgery to remove the leads because their doctors feel like that the risk is just too great. Changing leads carries with it what most electro physiologists would say was at least a 5% mortality risk when you change the leads out. These leads were supposed to last for at least 15 to 20 years. Changing them in just two to three years simply wasn’t a risk that patients were willing to take – although many now find themselves in that situation.”

If you or a loved one has a Medtronic Sprint Fidelis lead, contact a qualified attorney to discuss your situation. For a free, no-obligation consultation, please click here.