In a blog post a few weeks ago on the Medtronic recall, I noted that I thought Medtronics was doing the right thing, acting conclusively without equivocation once the decision to recall the leads was made. Apparently, the FDA agrees. Medtronic has been praised by the FDA for ordering the recall in the “absence of conclusive data.”
I agree with part of the premise, but I disagree that there is an “absence of conclusive data.” Medtronic has confirmed 665 chronic fractures in returned leads already. Exactly how many people have to die or have their lives put at risk before the FDA believes that there is conclusive data? Does anyone wonder why Congress feels compelled to investigate what the FDA has done in its oversight role in the Medtronic recall?
While Medtronic may have acted decisively, which is commendable, there is increasing evidence that it should have acted sooner to get in front of the problem. According to Dr. Sidney Wolfe, director of the health research group at Public Citizen, Medtronics waited too long to act. “Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year?” wrote Dr. Wolfe in a letter to the FDA, pointing to data that shows that 1,194 associated injuries had been reported – up from 296 injuries reported in the first 10 months of 2006, a 400% increase.
Congress is also concerned. Iowa Senator Charles Grassley wrote in a letter to the FDA that it appears “Medtronic was aware of the potential lead fractures several months before suspending sales of the Sprint Fidelis defibrillation leads. I am concerned that action may not have been taken in a timely fashion in this case as well.” Dr. William Maisel, who specializes in medical devices for the heart in Boston, told the New York Times that Medtronic’s warning to doctors in March, which told doctors of some early fracture reports, is another example of medical device companies’ failure to get out in front of the problem. “What is frustrating here is that this was another situation that was predictable,” Dr. Maisel told the paper. The Minneapolis Heart Institute apparently also knew where this was headed even before Medtronic’s initial warning and discontinued using defibrillators with these leads back in February.
While the speed at which Medtronic acted is certainly an issue that will be addressed in the litigation, the core problem is not the speed at which these companies act to recall. Instead, the root problem is that medical device manufacturers, like Medtronic, rush these products to market because of the huge profit margins defibrillators provide to those who can gain market share. In the last fifteen years, companies selling cardic medical devices have been on the rise. The stock price of one of Medtronic competitors, Canadian-based St. Jude Medical Inc., rose 232 percent between November 2002 and January 2006. Like we saw the housing boom, these kind of great rewards lead people to take risks they should not take.
The same thing happened just a few years ago. In June 2005, Guidant, which has since been bought by Boston Scientific, also recalled its defibrillators. It certainly appears the Guidant defibrillators were rushed onto the market, as well. Reportedly, the clinical trial data on these leads was not reviewed by the FDA. I really have a hard time believing this is true. If it turns out to be true, and there is a lot of investigation to be done both by Congress and by Medtronic defibrillator lead recall lawyers, it underscores once again that the fox is guarding the medical device hen house.
The competitive advantage these defibrillators had is that the Medtronic Sprint Fidelis lead was the smallest and thinnest wire Medtronic offered, which was alluring to doctors implanting defibrillators, because a thin lead is easier to thread through blood vessels. So Medtronics had a powerful hook to sell this new advance. But while the technology was superior, there was no longitudinal history of safety or efficacy. It is not surprising that Medtronics has now turned to an older lead, the Quattro lead, which has a more complete safety profile.