Sprint Fidelis Wire Leads

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.

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, 2009 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?

This article originally appeared on Drug Injury Watch, which can be found at http://www.Drug-Injury.com.

A March 14, 2009 New York Times (NYT) article, "Medtronic Links Device for Heart to 13 Deaths", by reporter Barry Meier gave us the latest developments regarding the problems that gave rise to the October 2007 recall of Sprint Fidelis lead wires used in defibrillators.

Mr. Meier's March 14 NYT article was published a day after Medtronic sent a March 13, 2009 "Dear Doctor" letter, "Sprint Fidelis® Model 6949 Lead Performance". In that document, the medical device company states:

"Approximately 268,000 Fidelis leads have been implanted worldwide. The FDA's MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic's Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty.

"The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed."

Building upon this March 2009 Sprint Fidelis "Dear Doctor" letter, Mr. Meier adds some contextual information:

"The death statistics Medtronic released [March 13] underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.

"Along with fatalities, the F.D.A. has received about 2,200 reports of serious injuries related to the leads. Medtronic officials said they believed that reflected the number of people who had undergone surgery to have a failed lead replaced with a new one."

But the larger part of Mr. Meier's March 14 article has to do with a "new" FDA report that was provided to this NYT reporter by lawyers involved with product liability lawsuits concerning serious injury or death caused by the defective Sprint Fidelis lead wires. Here is how Mr. Meier describes that FDA report:

"[A] previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing....

"The F.D.A. report is based on a visit by regulators to a Medtronic facility in Mounds View, Minn., soon after the device was removed from the market, where the officials interviewed executives and inspected records.

"The report shows that by late 2005 the company had received 30 complaints about device fractures and had identified several possible ways in which the lead might be failing. About that time, the company opened an internal investigation into the problem, according to the report.

"What happened next is not clear, because the F.D.A. redacted portions of the report before releasing it. But the document indicates that Medtronic engineers met often about the problem throughout 2006 and that they performed a "statistical analysis of the three failure modes" of the lead in October of that year, the report states."

This FDA report is significant as regards some critical issues in any Sprint Fidelis lawsuit filed against Medtronic, specifically: (1) When did Medtronic first learn about the potentially fatal failures involving its Sprint Fidelis lead wire products; and, (2) What did Medtronic do about these Sprint Fidelis failure reports from that point time up until when the company finally issued its October 2007 Sprint Fidelis recall?

This article originally appeared on Drug Injury Watch, which can be found at http://www.Drug-Injury.com.