Physicians Must Consider The Pros And Cons Of Surgical Removal Before Heart Device Shocks Unnecessarily Or Fails To Work When Patient Needed Shock
(Posted by Tom Lamb at DrugInjuryWatch.com)
On February 23, 2009 the medical journal HeartRhythm made available online an article by Robert G. Hauser, MD, and David L. Hayes, MD, "The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failure", which pits these two prominent cardiologists against Medtronic, Inc., the company that made the Sprint Fidelis lead wires.
As you may recall, Medtronic was forced to recall its Sprint Fidelis lead wires in 2007 following hundreds of reports from patients with defibrillators who were being shocked unnecessarily or having their heart device fail to deliver any shock when one was needed.
According to the "Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads" issued by the FDA on October 15, 2007, the particular units that may have defective lead wires are:
Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.
The February 2009 Sprint Fidelis medical journal article by Drs. Hauser and Hayes was picked up quickly by The Wall Street Journal (WSJ) and The New York Times (NYT) as well as other media.
A February 23, 2009 WSJ article by Thomas M. Burton, "New Concern Is Raised About Medtronic Wires", explains the significance of the study underlying this Hauser and Hayes article published by HeartRhythm:
Drs. Hauser and Hayes evaluated patients at both of their hospitals, looking at a total of 3,037 defibrillator leads of varying models. A total of 94 leads failed. Seventy-two of the failures were Sprint Fidelis leads, out of 848 Sprint Fidelis leads implanted....
The doctors said they saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models. At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.
Medtronic says that its "all cause" failure rate for the Sprint Fidelis at three years is 4.6%, meaning that 95.4% of the devices would be working at that point.
In turn, a February 24, 2009 NYT article by Barry Meier, "Study Finds More Failure of Heart Device", provides some additional information from Medtronic and some commentary:
Medtronic released a statement on Monday saying it still believed its own figures were accurate. “It is important to note that data collected from center to center would be expected to vary,” Medtronic said. “We believe that our analyses are representative of overall Fidelis performance.”...
Two experts not involved in the Hauser-Hayes study said it was difficult to explain the discrepancies between the new report and Medtronic’s data.
Dr. Douglas P. Zipes, a cardiologist and the editor of Heart Rhythm, said one possibility for the discrepancy in malfunction rates might reflect the failure of many physicians to report component problems to Medtronic....
Another cardiologist, Dr. Charles Swerdlow of Los Angeles, said that the discrepancy between Medtronic’s data and the new study might be a result of physicians reading patient symptoms as caused by lead fractures when actual fractures had not occurred.
As many of you know, all Sprint Fidelis lawsuits filed against dismissed Medtronic that were pending in the federal court Sprint Fidelis MDL were dismissed on federal preemption grounds in January 2009. The U.S. District Court judge in Minnesota who made the ruling stated that he was simply following U.S. Supreme Court's Riegel vs. Medtronic ruling as precedent.
Just last week, however, we learned that some Congressmen and Senators are seeking to reverse by new legislation the effect of this Riegel preemption ruling by the Supreme Court. In his February 19, 2009 article, "Lawmakers Seek to Return Right to Sue Device Makers", NYT reporter Barry Meier informed us that:
Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.
A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.
The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.
We will continue to monitor the debate about actual failure rates for Sprint Fidelis lead wires as well as watch for developments in Washington as concerns the preemption of medical device injury lawsuits. We hope you stay tuned for our future reports on both issues.