Medical Device Safety Act of 2008

• by MRSNO1MAX
• 2009-01-28 12:01:23
• Batteries & Leads
• 1857 views
• 2 comments

January 28, 2009




Senator William Nelson
United States Senate
716 Senate Hart Office Building
Washington, DC 20510

RE: Medical Device Safety Act of 2008

Dear Senator Nelson:

The purpose of my letter is to express my dismay that the proposed Medical Device Safety Act of 2008 has yet to be implemented. The current ruling under Riegel v. Medtronic gives manufacturers of FDA-approved medical devices complete immunity from liability for deaths and injuries. This protects these medical conglomerates even if they do not provide proper warnings to their patients when problems are discovered; effectively eliminating all accountability and leaving the most vulnerable of our population defenseless.

I am a 62 year old woman who has suffered from heart-related health issues for 10 years. In 1999, I suffered a heart attack and went into cardiac arrest twice. That same year, I underwent open heart surgery. On several occasions, my family was told that I would not survive. I am a wife, mother and grandmother and am not yet ready to leave my family. So in May of 2005, I underwent surgery to have a pacemaker/defibrillator placed to protect my heart from the ravages of congestive heart failure. After that I did well and was very pleased that my family could stop worrying about me.

Later, I began hearing reports that the leads used in my surgery were discovered to be prone to breakage. Such an occurrence would give me very low odds of survival should I have an incident, as I am completely dependent upon my pacemaker/defibrillator. Imagine how disconcerting it was to hear that the device I thought had given me my life back may end up being the cause of my untimely death. My first thought was to contact Medtronic. I was told by their representative that I had very little need for concern and that the media had created hysteria where none was warranted. Even my cardiologist told me that I should not worry, so I began to relax.

But the news did not get any better. There were more reports of people dying due to leads breaking. Some people were even experiencing shocks from these defective leads. I just had to have a second opinion for my own peace of mind. I made an appointment with a cardiologist who specializes in this type of surgery, who stated that I needed to have my leads replaced immediately. I had the surgery in March of 2008 and initially responded well. However, in April of 2008 I had to have a second surgery because one of the new leads moved and pierced my heart.

I guess you can say that I'm one of the lucky ones. I’m still alive – no thanks to Medtronic. I also have health insurance to help with the astronomical expenses of these procedures. Many people in my position do not have that luxury. But even with this advantage, my medical expenses have brought us to the brink of bankruptcy. I had been eagerly anticipating retirement and a time of ease and leisure with my husband. Now, because I need both the insurance coverage and the money, I don’t know if or when that will ever happen.

Riegel v. Medtronic sets a dangerous precedent that will allow other manufacturers to speed through the FDA approval process and not worry about the consequences of equipment that has not been properly tested. The Trident prosthetic hip and the Prodisc spinal implant are perfect examples of what will happen in the future if victims of defective devices are not given remedies for their injuries. Why should medical manufacturers spend the extra time and money to ensure that their products are safe when they will not be held accountable? Are we to assume that they will do so only because of an ethical obligation?

I urge you to support the Medical Safety Device Act of 2008 and allow the state tort laws to do the job that they are meant to do – protect the concerns of private citizens. Thank you for your time and consideration.

Sincerely,



Nancy C. Summers