May 2008 Update: Sprint Fidelis Lead Wire Failures Due To Design Flaw, Not Doctors

Medtronic Had Initially Suggested That It Was Implant Technique That Caused The Sprint Fidelis Malfunctions

(Posted by Tom Lamb at DrugInjuryWatch.com)

For today's post we have to thank Westby G. Fisher, MD, FACC, who is a board-certified internist, cardiologist, and cardiac electrophysiologist, as well as an associate professor of medicine, in Evanston, Illinois.

Dr. Fisher is better known to some of us as "Dr. Wes", the name of a blog that he began publishing in November 2005.

In his May 13, 2005 article, "Medtronic's Sprint Fidelis Defibrillator Lead Performance Update", Dr. Wes provides us with a summary of and link to the May 7, 2008 Medtronic update on the recalled Sprint Fidelis Model 6949 defibrillator lead.  Thereafter, he expresses this opinion:

The implications of these recommendations are far-reaching, for it now seems that the fault with the lead was not a physician implant technique problem as originally surmised, but rather a design flaw.

You should read this brief but informative May 13 post by Dr. Wes to see how he arrives at this opinion.

If, however, you want to do your own analysis of what caused the Sprint Fidelis defibrillator leads to malfunction or fail altogether, here's some material for you to start with:

• October 15, 2007 Medtronic Letter: "Urgent Medical Device Information Sprint Fidelis® Lead Patient Management Recommendations"
• May 7, 2008 Medtronic Letter: "Sprint Fidelis® Lead Performance Update (Models 6949, 6948, 6931, 6930)" 

Switching gears a bit -- for those of you who have not heard the bad news, yet -- on February 20, 2008 in the Riegel v. Medtronic case, the U.S. Supreme Court granted legal immunity to manufacturers of medical devices which had been approved by the FDA based on the legal doctrine of federal preemption.

But as Dr. Robert Hauser, of the Minneapolis Heart Institute, told a news reporter who was preparing a story about the Sprint Fidelis recall:  "Just because a device is FDA-approved does not necessarily mean it is safe."

It is my opinion that Congress should move quickly to pass legislation that would correct the Riegel decision by the Supreme Court.   

This legislation is needed because, in my experience, the possibility of becoming involved in product liability litigation is a significant incentive for the medical device manufactures to ensure that their products are safe for use by American patients.

I would like to hear what you think about this issue as well as my opinion about use of the federal preemption doctrine in this context.  You can do so by submitting a Comment, below, or by taking part in a poll on this issue -- "What if you were hurt by a drug and couldn't sue?" -- over on the HeyMonkeyBrain! part of Squidoo.

Comments

[Tom Lamb]

I agree with your feelings about the Riegel decision in which the Supreme Court ruled against patients and in favor of the medical device company.

The best thing that concerned citizens can do at this juncture is to contact their Representatives and Senators in Washington and ask them to support the proposed federal legislation that would serve to reverse the Court's preemption ruling.

For some background on this recently introduced legislation, see:

http://www.drug-injury.com/druginjurycom/2008/06/preemption-bills-would-restore-rights-of-patients-injured-by-faulty-medical-devices--legislation-would-overrule-us-supreme.html

Thanks for reading Drug Injury Watch.

Tom Lamb

[JESSE ATTUCKS]

It is a shame and disgrace that the US Supreme court would rule against those with little clout and funds to mount opposition to the ruling in regards to Sprint
Fidelis case. I'm one who is affected by this decision. Where can we turn???

[Tom Lamb]

To start, I hope your husband has recovered well.

His unfortunate experience is a good example of why preemption of medical device cases -- and, therefore, the Supreme Court's Riegel opinion in support of that legal doctrine -- is bad public policy.

It has been reported recently that before the July 4th Congressional recess there will be some federal legislation introduced by Rep. Frank Pallone (D-NJ) and Rep. Henry Waxman (D-CA) which would overturn the Riegel decision and, in turn, remove the preemption "obstacle" from the Sprint Fidelis litigation so that people like you and your husband could get legal compensation from the Medtronic -- which should be held legally liable for its defective product.

Please continue to advocate against the preemption of medical device and drug injury cases, as others like you are doing, and I will be doing, here.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Tyra Patterson]

My Husband was hurt by the flawed lead wire to the point it caused other health problems. He was shocked 18 times before the device was shut off. We have suffered emotionally and physically. I think the ruling should be overturned.