Litigation over medical device manufacturers and preemption is currently before the U.S. Supreme Court.
Medtronic, Inc. believes that it should not be subject to state law product liability lawsuits because the Food and Drug Administration (FDA) is ultimately responsible for approving medical devices. However, legal experts say that the litigation may have more to do with manufacturing defects than preemption.
Attorney Neil Overholtz
Florida attorney Neil Overholtz is an expert on medical device issues. According to Overholtz, “We don’t feel as though the preemption issue is critical to these cases. We believe that there is a manufacturing issue here from a quality assurance standpoint. Not all of these leads fail. It has to do with the final way that the lead is put together. It actually requires manual labor to weld the end of that lead together.”
“Other companies that manufacture leads, such at St. Jude, weld the lead and also put a cap over it – almost like a clamp – that holds the lead together. Medtronic’s Sprint Fidelis leads have a weld at the end, but that's all. If that weld isn't done properly, it's going to fray and that's where you'll run into problems. So, in essence, we believe that the Medtronic cases are really manufacturing defect cases that will survive no matter what the U.S. Supreme Court rules about preemption.”
The complications of replacement
Overholtz told us that another issue concerns patients that have complications while replacing defective leads – which may also be part of the litigation. He provided the following example, “We recently had a client who was going to have new leads installed. When she went in for surgery, her doctors realized that they could not take the current leads out of her heart because it was going to cause too much damage. So, they decided to leave those in and add a second set of leads. However, they had complications while adding those leads and ended up removing the second set altogether. So, basically, she is living with the first set of leads that they know are defective and could fail at any time. What’s worse is that this patient is also experiencing multiple shocks from the device – and there’s really nothing she can do besides go through another risky surgery.”
Patients deserve legal redress
Overholtz said that he’s met many people who have these defective devices and that some have driven over 2,300 miles to meet with him in person. He continued, “Typically, clients will just call us or send us their paperwork. Most don’t want to spend a whole afternoon meeting with their lawyer about their case. However, many Medtronic patients did. They really believe that they've been injured by this company and they want to get real redress. Legally, they should have it.”
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.
