Sprint Fidelis wire leads are thin wires that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. Both devices work by monitoring heart rhythms and delivering an electrical shock to restore heart function when life-threating heart rhythms occur.

Unfortunately, Medtronic Sprint Fidelis leads are being recalled because they have been found to be prone to fracture in some patients, which would cause the defibrillator to deliver unnecessary shock or not to operate at all.

The lead is a thin plastic tube enclosing electrical wires and sensors. The risks associated with surgical removal, besides the possibility for infection, include potential perforation of the heart and the veins in the chest. There is also a slight danger of damaging the heart valve through which the lead is threaded.

There are still thousands of patients who have Medtronic's Sprint Fidelis leads left wondering if they should leave the wire lead in place and hope it does not fail or whether to have it extracted, sometimes at their own expense. Medtronic is limiting its contribution to wire lead removals to $800.00 for a procedure that can cost $12,500.00, and insurance companies appear to be dealing with coverage on a case-by-case basis.

We believe that people who suffered an adverse medical event following a breakage or failure of a Medtronic Sprint Fidelis heart lead wire are better served when an individual lawsuit is filed on their behalf. A serious injury or death case should not be filed as part of any Sprint Fidelis class action together with the claims of many other people who may have had different injuries caused lead wire malfunction.

Learn more at DrugInjuryLaw.com.

All Sprint Fidelis Federal Court MDL Cases Dismissed On Federal Preemption Grounds: U.S. District Court Judge in Minnesota Follows Supreme Court's Riegel vs. Medtronic Ruling As Precedent In Making His January 2009 Ruling

All of the Sprint Fidelis cases that are part of the federal court multi-district litigation (MDL) were dismissed in early January 2009 pursuant to a motion to dismiss that had been filed by the defendant, Medtronic, Inc.

From a January 6, 2008 company press release, "Court Rules in Favor of Medtronic in Fidelis Litigation," we get this summary:

Medtronic, Inc. (NYSE: MDT) reported that on Jan. 5, the United States District Court for the District of Minnesota dismissed with prejudice the Master Consolidated Complaint for Individuals and the Master Consolidated Complaint for Third-Party Payors relating to the multi-district litigation (MDL) involving Medtronic's Sprint Fidelis defibrillator leads on grounds of federal preemption. The Court issued a companion order that each case in the MDL will be dismissed with prejudice unless an individual plaintiff can establish his or her case survives the Court's preemption analysis based on claims different from those asserted in the master complaints.

In an exuberant January 6 article, "Sprint Fidelis Preemption Decision - Yessssss," the Drug and Device Law blog -- which typically has an unabashed company / defense perspective on issues like this -- trumpeted this January 2009 medical device preemption ruling:

In what will certainly be an early entry for one of the top ten decisions of 2009, Medtronic just won. The short of it:

Medtronic, the Defendant in this multidistrict litigation, asserts the same doctrine here, arguing that Plaintiffs' claims - sounding in negligence and strict products liability - are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. Having carefully considered the parties' voluminous submissions, the Court agrees.

In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, slip op. at 2.

The Drug and Device Law blog was kind enough to post the Court's ALL CASES MEMORANDUM OPINION AND ORDER (slip opinion) which was filed for the MDL cases that are part of In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation.

In June 2008 we first reported that the U.S. Supreme Court's Riegel preemption ruling would be negated by legislation sponsored by Democrats in Congress which, in effect, permits U.S. patients to sue medical device companies like Medtronic if their product causes harm, such as the alleged injuries caused by the defective Sprint Fidelis lead wires.

With this federal preemption motion to dismiss being granted by the Sprint Fidelis MDL Court in January 2009, we expect there to be a renewed push to get this type of legislation passed in Congress and then to President-elect Obama later this year.

Over time I have expressed consistently my opposition to any federal preemption of patient lawsuits against medical device or pharmaceutical companies.

For more information on how wide-spread the federal preemption issue is becoming, see Who is the FDA protecting: you or the pharmaceutical companies?

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