Sprint Fidelis Case Highlights Industry and FDA Failures

Waltham, MAIn an article in the March 6 edition of the New England Journal of Medicine, Dr. William H. Maisel says that a flawed medical device approval process at the federal Food and Drug Administration (FDA) and deliberate foot dragging by Medtronic Inc. made the Sprint Fidelis lead debacle far worse than necessary.

Maisel says, "The large number of affected patients, the billions of dollars at stake in the ICD market, and the controversy surrounding the timing of communication with physicians and patients about the lead's performance highlight the shortcomings of the regulatory system for medical devices and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them."

The defective Sprint Fidelis lead used in Medtronic's implantable cardiac defibrillators (ICDs) was approved by the FDA in 2004 under a fast-track process. In October 2007, Medtronic recalled the Sprint Fidelis after five reported patient deaths and many more reports of fractured leads. Patients whose Sprint Fidelis leads have fractured have experienced both unnecessary hearts shocks from their ICDs and failure to deliver live-saving shocks at all. Patients with Sprint Fidelis leads must choose between replacing them through risky open-heart surgery or (as Medtronic advises) leaving them in place and hoping for the best.

The "supplemental" process that led to FDA approval of the Sprint Fidelis relied only on mechanical bench testing of the leads, with no clinical trials performed or required. Medtronic had only to prove—on the basis of its own bench tests—that the Sprint Fidelis performed substantially the same as the thicker Quattro lead it replaced.

The trouble is, once in use in actual human beings, the Sprint Fidelis didn't perform as advertised. As early as March 2007, Maisel says, Medtronic was notifying doctors of a "limited number" of Sprint Fidelis failures. They estimated the failure rate at 1.1 percent, based upon a two-year after-market survey of fewer than 100 patients. Maisel calls this sample size "grossly underpowered to detect even a moderate increase in fracture rate in the Fidelis as compared with its predecessors."

In May 2007, Medtronic applied to FDA for approval of design and manufacturing changes to the Sprint Fidelis and received approval two months later. Meanwhile, Maisel says, "Already-manufactured leads remained on hospital shelves and continued to be implanted."

"By October 2007," Maisel adds, "Medtronic had confirmed the occurrence of 665 fractures in returned leads, five patient deaths to which a Fidelis lead fracture may have contributed, and a 2.3 percent fracture rate within 30 months of implantation [more than twice the original estimate].... Medtronic then voluntarily recalled the product and requested the return of unused leads." This was a full seven months after Medtronic knew they had a problem with the Sprint Fidelis.

The bottom line, according to Maisel, is this: "According to its mission statement, the FDA is 'responsible for protecting the public health' and for 'helping the public get the accurate, science-based information they need.' Unfortunately, the agency is failing to fulfill that mission.... Remarkably, we have consumer protections for airline passengers, cable-television customers, and cellular-telephone users, but few for patients who receive life-sustaining medical devices." He advocates swift and strong congressional action to rectify this bizarre and dangerous situation.

In the meantime, LawyersAndSettlements wants to hear from you if you're a victim of Medtronic's deception and the FDA's negligence.