On October 30, 2007, the Wall Street Journal summarized the events leading up to the recall of the Medtronics Defibrillator Lead Recall. According to the article, Medtronics first became aware of the problems with the lead wires when problems with the Sprint Fidelis 6949 surfaced back in January. This was when doctors at the Minneapolis Heart Institute decided that they would no longer use the device, because six patients had come back to the Institute reporting that they were experiencing unnecessary shocks. However, it was not until after an October 7th meeting at Medtronics that the company stopped selling its malfunctioning product. The company also cited five deaths in the three years its product was on the market.
The FDA, which has come under fire from Congress and others for not more closely monitoring medical device manufacturers, will no doubt receive increased criticism for its failure to move more quickly to take this product off the market. Dr. Daniel Schultz, Director of the FDA, is quoted as saying that despite having information about the malfunctioning device, “there was nothing we could point to specifically to say this is a violative product that needs to come off the market.” The article discussed the speculation that the FDA did not require that this product have pre-market clinical trials or post-market studies, because it was similar in design to earlier products.
As I have written elsewhere, the problem in the vast majority of the cases is not the timing – even if flawed – of the recall, because this is not a recall. In most cases, these Sprint Fidelis lead wires cannot be recalled anyway because they cannot safely be taken out of a patient. For people that had wires implanted between January and October, the delay is a real issue. But for the majority of the over 250,000 people who have these leads, the negligence claim against Medtronics will focus primarily on the fact that the Sprint leads were on the market in the first place.
First and foremost, if the reports are true that there were no clinical trials, because the new leads were similar in designs to the old leads, Medtronics and the FDA completely ignored patient safety. The Medtronics Sprint Fidelis leads are almost half the size of traditional leads. This is not a similar product, it is a technological innovation and Medtronics marketed these leads as such. But when you have a new product, as these defibrillator leads were, you have to adequately test the product to be sure it is safe, especially before you allow a quarter of a million of them to go on the market for insertion into people’s chests to monitor their hearts. It really is as simple as that.
The second problem is the failure of adequate post market studies. This is a Medtronics fault, of course, but is also a systematic flaw in the FDA itself. Safety and speed have been called the yin and yang of the regulation of drugs and medical devices and there is some measure of truth to this. We all want safe medical devices that have been tested, but, particularly with serious medical conditions, we want immediate access to breakthrough drugs.
In 1992, it was possible that the pendulum had swung too far toward safety. The most notable example was the slow speed with which new AIDS medications were being brought to the market. The Prescription Drug User Fee Act in 1992 represented a deal between the FDA and the drug industry. Pharmaceutical companies agreed to pay millions of dollars in fees, and the FDA guaranteed that drug and medical device reviews would be completed within a year for fast track drugs.
But all of this new FDA money was for clinical trials and other pre-market efforts. The pharmaceutical companies made no investment into the post-market safety once the drug or medical device was on the market. So what happened at the FDA? The agency became a pseudo private agency and the influence of the pharmaceutical companies rose dramatically. At FDA advisory committee meetings, they begin by asking the doctors to put on the record their conflicts of interest. Today, it seems 90% of any panel has some tie in with a pharmaceutical company. While the FDA still looked at drugs and medical devices after they were put on the market, this branch of the FDA became the black sheep with insufficient funding, which obviously led to those post-market people at the FDA being overworked and underappreciated. You know how the story goes from here.
This is exactly what has happened in the Medtronics defibrillator lead recall cases, which should soon be certified as a class action. This will likely cost Medtronics over a billion dollars in lost revenues, litigation costs, and payouts in settlements and verdicts in a class action and individual lawsuits.
If you are looking for a Medtronics recall lawyer to assist you in your defibrillator recall claim, our lawyers are representing patients with these Medtronic defibrillators with defective leads throughout the United States and Canada. Fill out this brief form if you need additional information or would like us to review you case, or call us at 800-553-8082. You can also click here for answer to questions about the Medtronics defibrillator recall that many of our clients are asking.
