Congress must help victims of faulty device

Dear Sen. James E. Risch,

I am writing to let you know that as one of your constituents who is a victim of a faulty medical device, I would like for you to support the Medical Device Safety Act when it is reintroduced to this Congress by Rep. Frank Pallone.

I am one of the thousands of people who have a faulty lead implanted in my chest as part of my implantable cardiac defibrillator. This medical device is supposed to protect me from heart failure by either shocking my heart back into its rhythm or correcting the pace, as needed, but these faulty leads have caused hundreds of patients to experience repeated and powerful inappropriate shocks. For many of us, it is too dangerous to have them replaced, so we must live with these ticking time bombs in our chests just waiting to be unnecessarily shocked, or worse, not knowing if we will receive an appropriate shock, if needed. Isn’t it ironic that the device that should save a life could be the device to take the life?

My case is in danger because the device had prior FDA approval, and the Supreme Court decided in Riegel v. Medtronic that the manufacturer should receive immunity for certain FDA-approved medical devices. Just because the FDA says a medical device is safe doesn’t make it so. This device wasn’t safe and isn’t safe for me.

Congress now has the opportunity to fix this problem by adopting this bill that will allow me to seek remedy for my injury. If Congress does nothing, I cannot pursue my claim in court.

I would appreciate it if you could let me know whether or not you will support this bill by becoming a co-sponsor.

JERRY A. ROE

Sandpoint