Patients with medical devices subject to a recall are usually in the dark about what device was recalled, why it was recalled and what to do about the recall – and through no fault of their own. Medical device manufacturers often label recalls as ‘product advisories’ or ‘field actions’ in an attempt to downplay the issue with patients. Attorneys whose practices focus in this area of law may be able to provide patients with the data they need to make informed decisions.

Overcoming uncertainty

The uncertainty attached to most medical device recalls is often more than patients can handle. Patients with Medtronic’s Sprint Fidelis defibrillator lead wires know full well that overcoming that uncertainty is very difficult to do. Neil Overholtz, a Florida attorney whose firm represents medical device patients, explained:

Patients don't know whether their device is ever going to manifest an actual failure. They also don't know whether their doctor may say, ‘Mr. Smith, I just don't believe that we should continue to let this lead wire stay inside of you. I don't have confidence in it.’ This is true even when their doctor initially told them, ‘We're just going to leave it alone and monitor it.’ Doctors may change their minds on how to proceed at any time.

Without having that knowledge, contacting an attorney is something patients need to do. They may have a very valuable claim. The company has sold them a product that violates Food and Drug Administration (FDA) regulations. It's now a recalled device and they have a claim that's started to run. If they never have any significant complications or trouble from the actual device beyond their psychological concern, their claim’s statute of limitations or prescription period could expire.

Contacting an attorney doesn’t necessarily mean filing a lawsuit. According to Overholtz, “Patients can just call and talk to us about their situation and we can tell them what’s going on.”

Many patients don’t realize that they have compensable claims

Overholtz believes that many patients have compensable claims – even those who have not had their devices replaced. He continued, “The truth is that patients need to have their lead wires replaced, but the only reason why they're not having them replaced is because the risk of replacement surgery is so great. Each doctor feels differently about whether or not patients should replace lead wires – and that’s why patients should contact an attorney now.”

“It's going to be a long fought litigation. I don't think that there's going to be a time when patients will be asked to release their claim without knowing what's going to happen to them. They’ll be able to decide whether or not they want to settle their case or go to trial without having suffered a significant loss of failure, needing replacement surgery or whatever that injury might be.”

If you or a loved one has been injured by a defective medical device, contact an attorney whose practice focuses in this area of the law. To contact a qualified attorney for a free, no-obligation consultation, please click here.