Medtronic Sprint Fidelis Defibrillator Lead, Medtronic Web site
Medtronic’s Sprint Fidelis cardiac wire may be implicated in more than five deaths the company previously revealed.
An independent panel of physicians now says the death count is closer to 13. Medtronic hired a panel to pour through 89 of the more than 100 reports sent to the Food and Drug Administration.
Medtronic spokesman Chris Garland says, “The panel was able to make the determination that Sprint Fidelis may have been a possible or likely contributing factor in 13 patient deaths, total.”
On March 13, Medtronic sent a letter to physicians telling them about the 13 patient deaths and encouraging doctors to pay prompt attention when patients have a complaint. Leaving a properly performing lead intact was one option suggested and the “best choice for the majority of patients.”
Removing the defective lead from the body was associated with four out of 13 patient deaths. In about 96 percent of the time the lead performs correctly and in those cases should be left in the patient, said the panel.
The wire, attached to a defibrillator, was in the heart of some 270,000 patients when Medtronic stopped making the defective product in October, 2007. At that time the company estimated five people might have died as a result of its malfunction.
There are about 2,200 reports of serious injuries from the lead, reported to the Food and Drug Administration.
The company released information about the increased number of deaths after a federal judge earlier this year dismissed more than 700 consolidated cases against Medtronic, filed in U.S. District Court in Minnesota.
The cases were filed over the Sprint Fidelis lead which allegedly delivered either too many shocks or didn’t deliver an appropriate shock when needed to steady an irregular heartbeat. The cases charge product liability, negligence, fraud, and breach of contract, among other charges.
Judge Richard Kyle, cited last year’s Riegel decision in dismissing the lawsuits. In Riegel, the U.S. Supreme Court ruled in favor of medical device makers affirming they enjoy a shield since their products have FDA approval.
Critics thought Judge Kyle should recuse himself from the decision because his son, Richard Kyle Jr. works for Frederickson & Byron, a law firm which does corporate work for Medtronic.
But Judge Kyle told the Minneapolis Star Tribune he would not step aside because his son works on criminal defense cases and “does not now represent, and has never previously represented, Medtronic.”
Law firms typically put profits in a pool shared by partners.
After Judge Kyle’s ruling, Medtronic released the updated mortality report of 13 deaths the company considers related to the lead.
Medical Device Safety Act 2009
A March editorial in the New England Journal of Medicine (NEJM) says that “Patient safety can be ensured only when the makers of drugs and devices fully and openly disclose both the benefits and the potential adverse effects associated with an intervention.”
The editorial is written in support of the Medical Device Safety Act of 2009.
Litigation serves as a strong inducement for companies to avoid a failure-to-warn lawsuit or a design defect and because of Riegel, thousands of lawsuits have been thrown out of court by judges who deem they are preempted, says the editorial. “We contend that preemption will result in medical devices that are less safe for the American people.” #