Consumers have a right to know when any product is deemed unsafe or defective and responsible companies will inform their customers of potentially dangerous situations. That’s not always the case with medical device manufacturers – and the lack of information often puts their patients in grave danger. So, when are medical device manufacturers required to send out warnings to patients and doctors?

‘Dear Patient’ & ‘Dear Doctor’ letters

Neil Overholtz, a Florida attorney whose firm represents clients in medical device cases, explained when ‘Dear Patient’ & ‘Dear Doctor’ letters are required:

• ‘Dear Patient’ letters: Medical device manufacturers are not required to send out ‘Dear Patient’ letters unless the Food and Drug Administration (FDA) tells them to.
• ‘Dear Doctor’ letters: Medical device manufacturers are required to send out "Dear Doctor" or ‘Dear Healthcare Professional’ letters where appropriate – typically where there’s significant information regarding safety or effectiveness of a device. It’s one of those situations where the company knows that if they don't send it, they could be in trouble. Patient letters usually come out a little bit later than the doctor letters and they go through a lot more vetting than you would see with the initial "Dear Doctor" letter because they don't want to create panic.

He also said that, “Some companies don’t send out patient letters at all, so you wonder how these patients are going to find out about problems. In most cases, they’ll either hear about it on the news or from their doctor.”

Notification by letter not always ideal

When Medtronic recalled its Sprint Fidelis defibrillator leads, it did send out patient and doctor letters. However, notification by letter is not always ideal as many Medtronic patients never received the notification and didn’t find out about the recall until months later. Overholtz explained:

It's unbelievable. Months after the recall, some Fidelis patients are still saying that they just found out that their lead wires were part of the recall. Part of the problem may be that patients are supposed to follow up with their electro physiologist or treating cardiologist about every three months to have their device interrogated by a machine called a programmer.

The programmer just reads the information off the device and makes sure all the programs are working right. It's really just a computer. Then they can make a full adjustment if they need to with the programmer. Some patients don't follow up and some were subject to a time gap. The initial recall happened in October, so it was January before a lot of people found out. Unless doctors had a policy of calling all of their patients, it’s possible that many didn’t find out until their next check-up.

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.