Medtronic Lawsuit: Defibrillator Class Action Lead Recall Lawyer
A lot of information is coming about about what Medtronic knew and when it knew with respect to the Medtronic defibrillator lead recall. The New York Times reports that Medtronic’s decision to “recall” the Sprint Fidelis defibrillator leads underscores the lack of safety monitoring in medical devices, as well as a design trend that may increase the risk of failure. The Times also interviewed a number of doctors who had the same message: you could have seen this coming.
The Sprint Fidelis leads, like all leads used with defibrillators, are wires that go from the defibrillator to the heart. Leads monitor the heart’s rhythm and also carry a shock to the heart if the heart falls out of rhythm. Since the Guidant defibrillator recall two years ago, there has been an increased focus on the defibrillators themselves. But there was no similar focus on the leads. While obviously defibrillators are a difficult product to recall, leads are virtually impossible in most cases, because the leads are threaded into the blood vessels. Tissue forms around the leads, which makes them difficult, if not impossible in many cases, to take out if there is a recall.
The Times article points out that Medtronic, at least until relatively recently, was “somewhat in the dark” because of the limited data about the extent of the Medtronic Sprint Fidelis lead problem. Dr. William Maisel, a heart device expert at Beth Israel Deaconess Medical Center in Boston, is quoted as saying that this was “another situation that was predictable” had Medtronic focused on collecting and interpreting post-marketing data. He described the first Medtronic warning in February as Medtronic and the FDA scrambling to catch up to a problem, instead of being on the front end of the curve. Dr. Ranjit Suri, a cardiologist at New York Hospital, said in the article that he and his colleagues had stopped using all smaller leads like the Medtronic lead, because of safety concerns. Minneapolis cardiologist, Dr. Robert G. Hauser, told the company that he believed there had been a troubling number of incidents in which defibrillators equipped with the Sprint Fidelis leads were firing inappropriately in patients. Dr. Hauser, one of the doctors who discovered the problem with the Guidant (now Boston Scientific) defibrillator published this summer in a study in the medical journal Heart Rhythm, recommending limiting the use of the Sprint Fidelis lead until Medtronic corrects the tearing problem. The study by Dr. Hauser, who is a consulting cardiologist with the Minneapolis Heart Institute Foundation, found that six Sprint Fidelis leads failed in 592 patients implanted at the Heart Institute between September 2004 and February, 2007. Medtronic's response, through a spokesman, was that the study "must be taken in context," as it hails from one center "and does not represent the total performance experience of the Fidelis lead." Let's go out on a limb and say that Medtronics is now singing a different tune.
The problem with the Medtronic lead is that it has a tendency, most likely because the leads are smaller than the technology can support, to crack, thereby distorting or destroying the signals being sent to and from the defibrillator. While the smaller lead may be easier for doctors to thread – which was one of the big selling points the Medtronic reps were pushing on cardiac surgeons - there was no evidence that the technology supported a smaller lead. St. Jude Medical, a Canadian pharmaceutical company that makes a competing lead, also has a smaller lead on the market. Either they found a way to make a smaller lead safer, or, because St. Jude has less market share, the data is simply not available to prove St. Jude’s leads have a defect. You have to remember that given the gravity of the risk, even a small number of defective leads is unacceptable. (If you are thinking that patients who need a defibrillator are at-risk patients who need to assume a risk, you have to understand that, historically, defibrillators have been remarkably free of defects until the profit margins in the ICD market went through the roof, which led to the companies racing defibrillators and their leads onto the market without ample proof of safety and efficacy.) There is no question that a thinner lead is better, all things being equal. The question was whether the Sprint lead was safe. Dr. Stephen Remole, an electrophysiologist with Metropolitan Cardiology Consultants was quoted back in July with a quote that sums it up the best: "It's kind of too bad, because it's a nice thin lead. But I agree with Dr. Hauser that, until this thing gets straightened out, we need to put a halt on the [Sprint Fidelis lead] implants." (There is an open question, however, as to the efficacy of the thinner leads as discussed here.) l
With respect to the post-market data, of the over 250,000 leads Medtronic allowed to be placed in patients, only 650 patients had Sprint Fidelis leads. ''The limitation is that the number is not sufficiently large to accurately capture rare events,'' said Dr. Charles Swerdlow, a cardiologist in Los Angeles whose credibility is enhanced by the fact that he is a consultant to Medtronic. As we have written on our injury lawyer blog, the FDA is essentially asleep at the switch on post-market studies, which put the burden on Medtronic to make sure these products were safe. Medtronic dropped the ball and five people have been killed, many others have been injured, and 250,000 have to live knowing that they have defective wires in their chest. This is a tragedy that could have and should have been averted.
Our Medtronic defibrillator lead recall lawyers are reviewing both individual and class action lawsuits for defective Medtronic lead cases throughout the country. If you want to discuss your case with our Medtronic defibrillator lead recall lawyers or get information on the class action lawsuit pending, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.
More News and Information on the Medtronic Lead Recall (class action lawsuit information)
Medtronic Lawsuit/Recall Questions and Answers (commonly asked victim questions)
What Does the Medtronic Class Action Mean to Me? (Medtronic MDL class action process)
The Medtronic MDL in Minnesota (specific information on the Medtronic MDL)
What is an MDL Class Action? (explanation of the MDL process)
Medtronic Letter to Patients with Recalled Lead (received from one of our lead recall clients)
Medtronic Lead Recall Lawyer Analysis of What Happened (discussion of problem)
Will Medtronic Follow the Merek Strategy of Resolving the Medtronic Lead Lawsuits?
Congress Responds to the Medtronic Recall (details of Medtronic congressional inquiry)
The Failure of the FDA in the Medtronic Recall (how the FDA's flawed system failed patients)
Free Consultation (free evaluation of your case at 800-553-8082 or by email)
