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Defective Medical Products

Medtronic Sprint Fidelis Death Cases: Families Deserve Compensation

In a letter to doctors dated March 13, 2009, Medtronic Inc. told doctors that 13 deaths may be associated with the Medtronic Sprint Fidelis lead and that 4 of these deaths were associated with lead extraction:

The Panel [Medtronic’s Independent Physician Quality 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.¹

Even as Medtronic is acknowledging that their Sprint Fidelis lead has led to patient deaths, the company refuses to compensate the families for their loss.

In the name of decency and justice, the legal wrangling to avoid responsibility to these families should end, and Medtronic should fairly, fully and adequately compensate these families. Read about the tragic case of the Turnidge family. A mother is left to raise two young sons alone. Our lawyers are representing the Turnidge family and several other Sprint Fidelis shock victims and their families in Medtronic lawsuit cases.

In the same letter to doctors, Medtronic acknowledge that FDA has received reports of 107 deaths that “include allegations that the Fidelis lead may have caused or contributed to a patient death”:

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.¹

Medtronic states on its website that its mission, “penned more than 40 years ago,” is “to alleviate pain, restore health, and extend lives.”² If this really is the mission of the company, Medtronic’s goal in these 107 death cases should not be to avoid liability at all costs. Medtronic should take a caring look at the cases and compensate deserving families. This is the right thing to do.

References:
1. Medtronic Letter to Doctors: http://www.medtronic.com/product-advisories/physician/sprint-fidelis/PHYSLETTER-2009-03-13.htm.
2. Medtronic Mission Statement: http://www.medtronic.com/about-medtronic/index.htm.

Posted March 2009.

Labels: Medtronic defibrillator lead, Medtronic defibrillator lead lawsuit, Medtronic defibrillator lead recall, Medtronic lawsuit

Medtronic Sprint Fidelis Case Highlights Need for Legislation to Nullify Riegel v. Medtronic

Last month, Mark Turnidge, a 33-year-old husband and father, died after doctors removed a fractured Medtronic Sprint Fidelis lead from his body. Medtronic had recalled Sprint Fidelis leads due to the fracturing problem in 2007 after over 200,000 patients had Sprint Fidelis leads implanted in their bodies.

Wendy Turnidge, Mark Turnidge’s wife, told The New York Times that Medtronic offered her $800. She turned it down. According to the Times story, her attorney, Fred Pritzker, said he is considering suing the hospital and Medtronic. Pritzker and his law firm PritzkerOlsen have filed a number of claims for other Sprint Fidelis patients in Minnesota state court. Pritzker told the Times that recent U.S. Supreme Court ruling in Riegel v. Medtronic made it likely that a state judge would reject such cases.

In Riegel v. Medtronic, the Court held that the pre-emption clause in The Medical Device Amendments of 1976 “bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.”

Fairness, decency and justice would require Medtronic to compensate Mr. Turnidge’s family for his death. But U.S. District Courts are citing Riegel v. Medtronic and the MDA’s pre-emption clause to bar families like Mr. Turnidge’s from suing Medtronic.

Our law firm believes in justice and opposes this sweeping use of the MDA and Riegel v. Medtronic to deny people their day in court. Thankfully, some federal legislators are looking at this problem and taking steps to give patients back the right to sue when they are injured by a defective medical device. According to The New York Times:

But now, some members of Congress want to give potential plaintiffs like Ms. Turnidge a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.

A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.

The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

Most people assume any product approved by the FDA is safe. Wendy Turnidge and many others know this is not true. We ask that you support any efforts to nullify Riegel v. Medtronic. Wendy Turnidge is going to be raising her sons alone. She deserves justice.

Posted February 2009.

Labels: Medtronic defibrillator lead recall, Medtronic lawsuit

Medtronic Defibrillator Lead Recall and Lawsuit

Medtronic Defibrillator Lead Injury?

Medtronic, Inc. suspended distribution of its Sprint Fedelis Leads. These electrodes (thin wires) connect an implanted defibrillator directly to the heart. Medtronic reports that some of the leads have fractured resulting in either unnecessary shocking or to not operate at all. The recalled leads have the following model numbers: 6930, 6931, 6948 and 6949. If you have one of these leads and suffered problems because of it, please contact our firm for legal assistance. Read more about the Medtronic recall and a Medtronic lawsuit.

PritzkerOlsen, P.A.
Suite 2950 45 South 7th Street
Minneapolis, MN 55402
888-377-8900
fhp@pritzkerlaw.com
www.pritzkerlaw.com

Labels: Medtronic defibrillator lead, Medtronic defibrillator lead lawsuit, Medtronic defibrillator lead recall

Pritzker Olsen attorneys have appeared on national television and have been quoted by national publications, including The New York Times, The Wall Street Journal, Associated Press and Lawyers USA. Attorneys Fred Pritzker, Elliot Olsen and Eric Hageman have been named "Super Lawyers" by Law and Politics magazine (2008 and previous years). Attorney Fred Pritzker is also listed in the current edition (2008) of The Best Lawyers in America. To contact Pritzker Olsen Attorneys, please call 1-888-377-8900 (toll free) or submit the firm's free consultation form.

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Firm News

AV Preeminent Rating by Martindale-Hubbell

Attorneys Fred Pritzker and Eric Hageman have been given the highest rating by Martindale-Hubbell for attorney, AV Preeminent. An AV® certification mark is a significant rating accomplishment - a testament to the fact that a lawyer's peers rank him or her at the highest level of professional excellence.

Adjunct Teaching Position At U of M Law School

Attorney Brendan Flaherty has accepted an adjunct teaching position at the University of Minnesota Law School. For the 2011 spring semester, Flaherty will teach a course entitled "Practice and Professionalism," which will introduce students to foundational lawyering skills and professional responsibility issues.

Attorney Elliot Olsen Speaks at Conference

Attorney Elliot Olsen recently spoke at the Seventh Annual LifeScience Alley Conference in Minneapolis on Preemption and the Future of Medical Device Litigation. He appeared with Randall Pattee of Lindquist and Vennum and Jean Lance, VP of corporate legal and general counsel for Boston Scientific.

Named Super Lawyer

In recognition of their achievements, Attorneys Fred Pritzker, Elliot Olsen and Eric Hageman were named "Super Lawyers" by Law & Politics magazine. According to Super Lawyers, "The objective is to create a credible, comprehensive and diverse listing of outstanding attorneys that can be used as a resource to assist attorneys and consumers in the search for legal counsel."

Brendan Flaherty Named a Rising Star

In recognition of his achievements, Attorney Brendan Flaherty was named a 2010 Rising Star by Minnesota Law & Politics. Only 2.5 percent of the state’s lawyers are included on the list, which highlights Minnesota’s best up-and-coming legal talent.

Fred Pritzker Listed in The Best Lawyers in America

Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.

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