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

(Posted by Tom Lamb at DrugInjuryWatch.com)

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. 

Now we want to hear what you think about this federal preemption issue.

6 responses to “All Sprint Fidelis Federal Court MDL Cases Dismissed On Federal Preemption Grounds”

  1. Ron Avatar
    Ron

    I was told by my Doctor that the failure rate for the Sprint Fidelis has increased dramatically over the past year.
    He has scheduled me to see the Medtronics
    representive on a more frequent basis.
    As time marches on I’m sure the problem
    will increase and with the departure of
    a lot of the “dead wood” in Washington, D.C. people are hopeful that “change” will come.

  2. Tom Lamb Avatar

    Ron:
    It’s a bad coincidence that just when the number of failures involving Sprint Fidelis lead wires may be increasing, the legal remedy to those patients injured or kill by this defective product has been taken away.
    For medical devices, especially, there needs to be a legislation change, as the courts are only interpretting the current statutory language. Hopefully the new regime in DC will act, soon, to pass legislation in the first part of 2009 that will restore the legal rights of people who are injured by defective medical devices.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  3. Kenneth Wilde Avatar
    Kenneth Wilde

    On 9/11/09 I went in to have my medtronic device replaced because the battery had gone dead after only 3 years instead of the 4-7 it was supposed to last for. My cardiologist recommended I have the sprint fidelis lead replaced while he was at it. When the old lead was removed my heart began to bleed into my pericardial membrane requiring the doctor to make an incision below my sternum and place a catheter in my chest to drain the 12 ounces of blood I bled out ,which would have caused heart failure. I spent 2 nights in ICU and another night in a regular hospital bed. I am misssing 2 weeks of work over this. I was given a number to call to discuss re-imbursement for the lead replacement costs but this will probably go to my health insurance company. I am told by the attorney representing me in my suit against the manufacturer I have no recourse because of the courts decision ,so as for my pain and suffering and lost wages I’m just SOL.
    Kenneth Wilde

  4. Tom Lamb Avatar

    Kenneth:
    Assuming that you did not already have a Sprint Fidelis lawsuit filed and then dismissed by the federal court MDL judge, you may still have an opportunity to file a lawsuit against Medtronic — if and when the Mecical Device Safety Act of 2009 passes Congress and is signed into law by the President.
    You can keep track of this particular piece of pending legislation by using this link:
    http://www.govtrack.us/congress/bill.xpd?bill=h111-1346
    If you would like to discuss your possible Sprint Fidelis case, feel free to contact me.
    I wish you a complete and speedy recovery from this recent surgery.
    Tom Lamb

  5. Janice Dedham Avatar
    Janice Dedham

    Let’s hope the legislation is passed. Like Kenneth, my first defibrillator battery failed after 2 years and had to be replaced. Now it’s just over 2 years later and the replacement is dead. Now I am facing adding a new lead wire. This involves going through the ribs and collapsing a lung, as my faulty lead wire is on the outside of my heart. This is how it was installed the first time around nearly five years ago and I have never had such a painful experience- I felt like I had been kicked in the side by a horse. I am very upset about facing this again because I know EXACTLY what it’s going to feel like. Plus, the first time around I had severe complications – swelling around the heart and PE’s (blood clots in my lungs). It took forever just to resolve those two issues and I am very concerned it could happen again. All for a faulty lead wire. I don’t know if I have any fractures in the wire (seeing cardiologist this week) but I will tell you that the distress, fear, and uncertainty is just as bad. It’s like a bad flashback. I am only 51 years old with four grandchildren, I’d like to stick around for awhile. Thank you for listening.

  6. Tom Lamb Avatar

    Janice:
    Thank you for taking the time to share with us your unfortunate experience as regards the failed defibrillator battery replacement surgery. Certainly, I can understand your anxiety about having to have another similar surgery.
    As you stated, let’s hope the Medical Device Safety Act of 2009 — or some legislation to the same end, i.e., to reverse the Riegel opinion which serves to shield Medtronic, and other device manufactures, from legal claims by patients seeking “accountability” — becomes law in the near future (it has already taken to long, as I’m sure you would agree).
    I wish you the best in all aspects going forward. Let me know if we can be of any further assistance to you, now or later.
    Tom Lamb

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