In February of 2008, the U.S. Supreme Court, for the first time, immunized medical device companies from lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc., the Court found that those claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision ignores both congressional intent and 30 years of experience in which federal regulation, by the U.S. Food and Drug Administration (FDA), and tort liability, played complementary roles in protecting consumers from device risks. Over 1,490 individuals, harmed by their malfunctioning Medtronic defibrillators, were left without any legal recourse when a Minnesota federal district court dismissed their cases. The Medtronic defibrillator contains a Sprint Fidelis Lead (wire) that has been shown to fracture and dispatch potentially lethal shocks without warning.
“The hazard of the Medtronic[Sprint] Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer’s performance update,” doctors at the University of Rochester concluded in findings published in the January 2010 issue of the American Journal of Cardiology. The study found that the three-year survival rate of 426 Medtronic leads inserted in the hospital’s patients was 90.8%, meaning 9.2% failed. See link: medtronicheartleadrecall.com/mdsa.htm This follows a report from December 2009 which estimated the failure rate of the lead may eventually reach 30% of all patients! See link: medcitynews.com/index.php/2009/12/sprint-fidelis-lead-woes-continue-to-haunt-medtronic-industry-as-fda-takes-notice/
Bill Storm had a Medtronic defibrillator implanted in 2005 due to a heart defect. Two years later, Bill was awakened from sleep by several violent shocks and experienced the most excruciating pain he had ever felt in his life. Bill suffered 138 shocks before his doctor was able to disable the device. Click on this link to hear Bill tell his story. www.kintera.org/site/c.juISL9MSJvE/b.5154599/k.72AA/Bill_Storms_Story_Video.htm
On April 5, 2010, Guidant Corp., a subsidiary of Boston Scientific, pleaded guilty to criminal charges that it deliberately concealed problems with its implantable defibrillators. In November 2009, Boston Scientific announced that it would pay $296 million to settle the case on behalf of Guidant, even though the alleged infractions occurred prior to its $26 billion acquisition of the company. It was back in February 2002 that Guidant discovered a design flaw in the Vanek device, after receiving reports of failures. By April 2002, it had fixed the flaws and begun producing a corrected version of the device, but it didn't recall the defective products. "Instead, it continued selling its inventory of defective units without disclosing either to physicians or the public the design flaw or malfunctions that had led to device failures," wrote Judge Diane Wood of the U.S. Court of Appeals, adding that Guidant never mentioned defects in subsequent press releases and filings with the S.E.C. Minneapolis cardiologists opposed the settlement. See link: massdevice.com/news/minneapolis-cardiologists-oppose-boston-scientifics-guidant-settlement
The Court's decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from defective premarket approval of devices or inadequate safety warnings. It also removed one of the industry's most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians. “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” Wyeth vs. Levine. The Court premised its decision in Riegel on the theory that approval by the FDA adequately protects patients from unsafe medical devices, but that theory has proven false time and again. In the past year alone, patients have suffered serious injuries from defective FDA-approved devices or devices without adequate safety warnings, like implantable cardiac defibrillators and pacemakers. The trial court judge in Wyeth allowed the jury to consider evidence that the company complied with FDA requirements to support the assertion that it acted reasonably. But the judge also held - and the Supreme Court agreed - that compliance with federal regulations is not a complete shield from liability. Similarly, although medical devices manufacturers must comply with FDA regulations, compliance should not constitute a get-out-of-jail-free card for the manufacturer when evidence also exists that the product is defective or the company failed to provide adequate warnings.
On February 18, 2009, the Project on Government Oversight wrote an article entitled, "The FDA’s Deadly gamble with the Safety of Medical Devices." This article states that "The FDA’s mission – to protect the public health – depends on vigorous oversight and enforcement. When the FDA fails to enforce certain regulations, the consequences can be lethal. A 2007 report from experts in industry, academia and government concluded that the FDA is now understaffed and overworked.3 Some critics of the FDA suggest that manufacturers’ requests for evaluation of drugs and devices are processed by the FDA too hastily and with a bias towards approval. They see the FDA as frequently bowing to the wishes of the industry it regulates, and as susceptible to pressure by politicians who were influenced by industry lobbyists. Here's a link to that article: http://www.pogo.org/pogo-files/reports/public-health/safety-of-medical-devices/ph-fda-20090218.html
What is the Medical Device Safety Act?
The Medical Device Safety Act of 2009, Senate Bill 540 and House Resolution 1346, follows the Supreme Court's decision in Wyeth v. Levine. The bill was introduced by Democratic Reps. Frank Pallone, Jr., of New Jersey and Henry Waxman of California. This bill, along with a companion bill introduced by Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT), would nullify the Court’s ruling in Riegel by adding language to the Medical Device Amendments of 1976 to make clear that the law does not prohibit suits against device companies, and would thereby place medical devices and drugs on a level playing field with respect to patient lawsuits.It will restore injured patients’ ability to bring claims for injuries caused by defective medical devices. The bill will also reconcile the legal regime used for device manufacturers with the one used for drug manufacturers, in light of the Supreme Court’s 2009 decision in Wyeth v. Levine. That decision confirmed that Food and Drug Administration (FDA) marketing approval of prescription drugs does not bar patients’ state-law claims seeking damages for harm caused by those products. The Court’s reasoning in Wyeth touches on the core purposes of the Medical Device Safety Act -- to hold medical device manufacturers accountable for negligence and intentional wrongdoing.On April 9, 2009, the editors of the New England Journal of Medicine endorsed the Medical Device Safety Act in an editorial. They stated: "Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts." Here's a link to that article article: nejm.org/doi/pdf/10.1056/NEJMe0902377
On April 13, 2010, the Hufffington Post published an article stating that faulty medical devices are costing taxpayers billions of dollars that should be paid by the manufacturer, but because of the complete immunity status device manufacturers enjoy from a Supreme Court decision, taxpayers are left with the bill. Here's a link to that article: huffingtonpost.com/anthony-tarricone/defective-medical-devices_b_535611.html
The FDA regulates both medical devices and prescription drugs, but the law treats them differently.
The FDA approves both medical devices and prescription drugs, but as the law now stands, failure-to-warn and design-defect lawsuits are preempted for medical devices but not for drugs. This perplexing state of affairs defies all logic. To address this inconsistency and to improve the safety of medical products, Congressmen Henry Waxman (D-CA), chair of the House Committee on Energy and Commerce, and Frank Pallone (D-NJ), chair of the Health Subcommittee, recently introduced the Medical Device Safety Act. This bill, along with a companion bill introduced by Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT), would nullify the Court’s ruling in Riegel by adding language to the Medical Device Amendments of 1976 to make clear that the law does not prohibit suits against device companies, and would thereby place medical devices and drugs on a level playing field with respect to patient lawsuits.
The Medical Devise Safety Act was introduced in both the Senate and House on March 5, 2009
Medical Device Safety Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit specified provisions preempting state and local requirements for medical devices intended for human use from being construed to modify or otherwise affect any action for damages or the liability of any person under state law. It makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act.
Send a support letter to Congress, right now!
Sending a support letter to Congress is extremely easy and can be done electronically, with a single click. The Alliance for Justice has created an electronic petition that urges Congress to swiftly pass the Medical Device Safety Act of 2009. There is no age requirement for this, so a petition can be signed by all members of your family who are old enough to read and have an email account. Urge all of your friends and relatives to sign it as well. Click on the following link. https://secure3.convio.net/afj/site/Advocacy?cmd=display&page=UserAction&id=157
S.540: Medical Device Safety Act of 2009 is sponsored in the Senate
Here's a link to the Senate MDSA bill: govtrack.us/congress/bill.xpd?bill=s111-540
The Sponsors of this bill are listed below along with their phone and fax number.
Sponsor: Patrick Leahy [D-VT] (202-224-4242, 202-224-3479) Cosponsors: Jeff Bingaman [D-NM] (202-224-5521, 202-224-2852) Barbara Boxer [D-CA] (202-224-3553, 202-224-0454) Sherrod Brown [D-OH] (202-224-2315, 202-228-6321) Roland Burris [D-IL] (202-224-2854, 202-228-3333) Robert Casey [D-PA] (202-224-6324, 202-228-0604) Christopher Dodd [D-CT] (202-224-2823, 202-224-1083) Richard Durbin [D-IL] (202-224-2152, 202-228-0400) Russell Feingold [D-WI] (202-224-5323, 202-224-2725) Dianne Feinstein [D-CA] (202-224-3841 202-228-3954) Kirsten Gillibrand [D-NY] (202-224-4451, 202-228-0282) Kay Hagan [D-NC] (202-224-6342, 202-228-2563) Thomas Harkin [D-IA] (202-224-3254, 202-224-9369) Tim Johnson [D-SD] (202-224-5842, 202-228-5765) Claire McCaskill [D-MO] (202-224-6154, 202-228-6326) Jeff Merkley [D-OR] (202-224-3753, 202-228-3997) John Reed [D-RI] (202-224-4642, 202-224-4680) Jay Rockefeller [D-WV] (202-224-6472, 202-224-7665) Bernard Sanders [I-VT] (202-224-5141, 202-228-0776) Charles Schumer [D-NY] (202-224-6542, 202-228-3027) Tom Udall [D-NM] (202-224-6621, 202-228-3261) Sheldon Whitehouse [D-RI] (202-224-2921, 202-228-6362)
H.R. 1346: Medical Device Safety Act of 2009 is sponsored in the House of Representatives
Here's a link to the same bill, sponsored by the House: govtrack.us/congress/bill.xpd?bill=h111-1346
The Sponsors of this bill are listed below along with their phone and fax number.
Sponsor: Rep. Frank Pallone [D-NJ6] (202-225-4671, 202-225-9665)
Cosponsors: Donna Christensen [D-VI] (202-225-1790, 202-225-5517) Eleanor Norton [D-DC] (202-225-8050, 202-225-3002) Joe Baca [D-CA43] (202-225-6161, 202-225-8671) Tammy Baldwin [D-WI2] (202-225-2906, 202-225-6942) John Barrow [D-GA12] (202-225-2823, 202-225-3377) Howard Berman [D-CA28] (202-225-4695, 202-225-3196) Sanford Bishop [D-GA2] (202-225-3631, 202-225-2203) Timothy Bishop [D-NY1] (202-225-3826, 202-225-3143) Earl Blumenauer [D-OR3] (202-225-4811, 202-225-8941) Leonard Boswell [D-IA3] (202-225-3806, 202-225-5608) Robert Brady [D-PA1] (202-225-4731, 202-225-0088) Bruce Braley [D-IA1] (202-225-2911, 202-225-6666) George Butterfield [D-NC1] (202-225-3101, 202-225-3354) Lois Capps [D-CA23] (202-225-3601, 202-225-5632) Russ Carnahan [D-MO3] (202-225-2671, 202-225-7452) Kathy Castor [D-FL11] (202-225-3376, 202-225-5652) Gerald Connolly [D-VA11] (202-225-1492, 202-225-3071) John Conyers [D-MI14] (202-225-5126, 202-225-0072) Joe Courtney [D-CT2] (202-225-2076, 202-225-4977) Kathleen Dahlkemper [D-PA3] (202-225-5406, 202-225-3103) Artur Davis [D-AL7] (202-225-2665, 202-226-9567) Danny Davis [D-IL7] (202-225-5006, 202-225-5641) Diana DeGette [D-CO1] (202-225-4431, 202-225-5657) William Delahunt [D-MA10] (202-225-3111, 202-225-5658) Rosa DeLauro [D-CT3] (202-225-3661, 202-225-4890)Lincoln Diaz-Balart [R-FL21] (202-225-4211 202-225-8576) Mario Diaz-Balart [R-FL25] (202-225-2778, 202-226-0346) John Dingell [D-MI15] (202-225-4071, 202-226-0371) Michael Doyle [D-PA14] (202-225-2135, 202-225-3084) Chet Edwards [D-TX17] (202-225-6105, 202-225-0350)
Sam Farr [D-CA17] (202-225-2861, 202-225-6791) Bob Filner [D-CA51] (202-225-8045, 202-225-9073) Bill Foster [D-IL14] Al Green [D-TX9] Gene Green [D-TX29] (202-225-1688, 202-225-9903) Raul Grijalva [D-AZ7] (202-225-2435, 202-225-1541) John Hall [D-NY19] (202-225-5441, 202-225-3289) Deborah Halvorson [D-IL11] (202-225-3635, 202-225-3521) Alcee Hastings [D-FL23] (202-225-1313, 202-225-1171) Martin Heinrich [D-NM1] (202-225-6316, 202-225-4975) Brian Higgins [D-NY27] (202-225-3306 202-226-0347) James Himes [D-CT4] Maurice Hinchey [D-NY22] (202-225-6335, 202-226-0774) Rubén Hinojosa [D-TX15] (202-225-2531, 202-225-5688) Mazie Hirono [D-HI2] (202-225-4906, 202-225-4987) Paul Hodes [D-NH2] ) (202-225-5206, 202-225-2946) Tim Holden [D-PA17] (202-225-5546, 202-226-0996) Steve Israel [D-NY2] (202-225-3335, 202-225-4669) Jesse Jackson [D-IL2] (202-225-0773, 202-225-0899) Sheila Jackson-Lee [D-TX18] (202-225-3816, 202-225-3317) Eddie Johnson [D-TX30] (202-225-8885 202-226-1477) Henry Johnson [D-GA4] (202-225-1605, 202-226-0691) Timothy Johnson [R-IL15] (202-225-2371, 202-226-0791) Walter Jones [R-NC3] (202-225-3415, 202-225-3286) Patrick Kennedy [D-RI1] (202-225-4911, 202-225-3290) Mary Jo Kilroy [D-OH15] (202-225-2015, 202-225-3529) Suzanne Kosmas [D-FL24] (202-225-2706, 202-226-6299) Dennis Kucinich [D-OH10] (202-225-5871, 202-225-5745) James Langevin [D-RI2] (202-225-2735, 202-225-5976) Barbara Lee [D-CA9] (202-225-2661, 202-225-9817) Daniel Lipinski [D-IL3] (202-225-5701, 202-225-1012) David Loebsack [D-IA2] (202-225-6576, 202-226-0757) Zoe Lofgren [D-CA16] (202-225-3072, 202-225-3336) Nita Lowey [D-NY18] (202-225-6506, 202-225-0546) Ben Luján [D-NM3] (202-225-6190, 202-226-1528) Stephen Lynch [D-MA9] (202-225-8273, 202-225-3984) Edward Markey [D-MA7] (202-225-2836, 202-226-0092) Doris Matsui [D-CA5] (202-225-7163, 202-225-0566) Carolyn McCarthy [D-NY4] (202-225-5516, 202-225-5758) Jerry McNerney [D-CA11] (202-225-1947, 202-225-4060) Gregory Meeks [D-NY6] (202-225-3461, 202-226-4169 ) Charles Melancon [D-LA3] (202-225-4031, 202-226-3944) Michael Michaud [D-ME2] (202-225-6306, 202-225-2943) Bradley Miller [D-NC13] (202-225-3032, 202-225-0181) Jerrold Nadler [D-NY8] (202-225-5635, 202-225-6923) Glenn Nye [D-VA2] (202-225-4215, 202-225-4218) John Olver [D-MA1] (202-225-5335, 202-226-1224) Ed Perlmutter [D-CO7] (202-225-2645, 202-225-5278) Chellie Pingree [D-ME1] (202-225-6116, 202-225-5590) Laura Richardson [D-CA37] (202-225-7924, 202-225-7926) Thomas Rooney [R-FL16] (202-225-5792, 202-225-3132) Ileana Ros-Lehtinen [R-FL18] (202-225-3931, 202-225-5620) Steven Rothman [D-NJ9] (202-225-5061, 202-225-5851) Lucille Roybal-Allard [D-CA34] (202-225-1766, 202-226-0350) Bobby Rush [D-IL1] (202-225-4372, 202-226-0333) Loretta Sanchez [D-CA47] (202-225-2965, 202-225-5859) John Sarbanes [D-MD3] (202-225-4016, 202-225-9219) Janice Schakowsky [D-IL9] (202-225-2111, 202-226-6890) Adam Schiff [D-CA29] (202-225-4176, 202-225-5828) Robert Scott [D-VA3] (202-225-8351, 202-225-8354) Albio Sires [D-NJ13] (202-225-7919, 202-226-0792) Louise Slaughter [D-NY28] (202-225-3615, 202-225-7822) Pete Stark [D-CA13] (202-225-5065, 202-226-3805) Bart Stupak [D-MI1] (202-225-4735, 202-225-4744) Betty Sutton [D-OH13] (202-225-3401, 202-225-2266) Harry Teague [D-NM2] (202-225-2365, 202-225-9599) Lee Terry [R-NE2] (202-225-4155, 202-226-5452) Bennie Thompson [D-MS2] (202-225-5876, 202-225-5898) Dina Titus [D-NV3] (202-225-3252, 202-225-2185) Peter Visclosky [D-IN1] (202-225-2461, 202-225-2493) Debbie Wasserman Schultz [D-FL20] (202-225-7931, 202-226-2052) Henry Waxman [D-CA30] (202-225-3976, 202-225-4099) Anthony Weiner [D-NY9] (202-225-6616, 202-226-0218) Peter Welch [D-VT] (202-225-4115, 202-225-6790)
The Medical Device Safety act bill is still in the first step in the legislative process. Introduced bills and resolutions first go to committees that deliberate, investigate, and revise them before they go to general debate. We anticipate it will likely take until the end of 2011 before the passing of this bill will have the possibility of becoming a reality. We are fighting a very tough battle here as the medical device industry is spending millions of dollars lobbying against the passage of the Medical Device Safety Act. Therefore, we need to rally around this cause in a major way and send Congress our electronic letters of support for MDSA to counteract the lobbying efforts of our opposition. We strongly encourage you to call or email all of your friends, neighbors and relatives and tell them to visit PassMDSA.org so they can learn all of the facts and join us in this extremely important letter writing campaign. Also, if you have a Facebook, Twitter, or any other social networking page or website, please put a link on there to PassMDSA.org. Through these additional efforts we can bring a tremendous number of people to this site and dramatically increase the volume of support letters sent to Congress.
MDSA Coalition Allys
The good news is that we are launching a massive effort, along with the help of many major organizations. We're very excited about the long list of organizations who support MDSA. The MDSA Coalition is in the process of developing alliances with these organizations in an effort to pressure Congress into passing the, much needed, Medical Device Safety Act. We are especially pleased that AARP is a very strong supporter, as they have over 40 million members. A letter writing campaign by AARP members could go a long way towards accomplishing our mission. Additionally, we are pursuing partnerships with all of the organizations listed below.
Alliance for Justice
afj.org
Alliance for Retired Americans (ARA)
Alliance for Justice
afj.org
Alliance for Retired Americans (ARA)
American Association for Retired Persons (AARP)
aarp.org
American Medical Women's Association (AMWA)aarp.org
Center for Medical Consumers Clearinghouse on Women's Issues
Community Catalyst
communitycatalyst.org
Consumers UnionDES Action
Families USA
Friends of Residents in Long Term Care
Government Accountability Project
National Asian Pacific American Women's Forum
National Association of Consumer Advocates
National Capital Area Union Retirees
National Conference of State Legislatures
National Multiple Sclerosis Society
nationalmssociety.org
National Organization for Women (NOW)
now.org
nationalmssociety.org
National Organization for Women (NOW)
now.org
Women's International Public Health Network
Women's Research and Education Network
The MDSA Coalition will be in frequent communication with all of these organizations to remind them to urge their members to visit passmdsa.com -- to learn all about the Medical Device Safety Act and exactly what actions they need to take in order to help make MDSA become a reality. To further support this effort, be sure to tell and email everyone you know to visit PassMDSA.org. Help us win this battle to get the MDSA bill passed!
We are seeking volunteers to post the message, "Support the Medical Device Safety Act". To learn more, go to passmdsa.org." We plan to get this message posted on hundreds of message boards and chat rooms -- particularly those that are medical related or are likely to be seen by senior citizens. Please let us know if you are willing to help us out in this important cause.
These are just some of the many comments and stories we've received from visitors
Robert J. Mason: I live in constant fear having been shocked by device in my chest that is defective and has been recalled by Medtronics.
Robert Beuter: It's about time that something is done to protect the american public from health hazard medical devices. Manufracture's should held liable for medical products that cause injury to people who have them implanted in them!!!!
Nancy E. Bowling: This is LONG OVERDUE
Duane Horner: I believe Medtronic should be held responsible for thier actions as I am one with the 6949 wire on recall and I've been shocked several times and had it shut off.
Leroy Cagle: I can't believe I am paralyzed on one side and require home health care because of a Medtronic catheter granuloma and there is no help from the company who made the error.
Shelly Afthim: I'm 39 years old, my Medtronic leads are starting to fracture, need to have lead extraction surgery.
Christine Little: The Medtronic device misfired and killed my husband on our way to see a movie. He was revived but died 5 days later. Now I have no financial support.
Frank A. Cusumano Sr.: I was a victim of (Medtronic implanted defibrillator) fractured lead wires and suffered 39 inappropriate and extremely powerful and excruciating painful shocks to my heart in May of 2008. According to the ER doctors I almost died.
Douglas Duane Davis: I am also one of the victims of Medtronic and as of now My lead has not failed but I live day by day in the fear that it will fail and shock me for no reason, or that it will not shock my heart when required.
Erica Pendergrass: In memory of Samantha McGookin. Please pass this bill.
Sarah McCuller: This almost killed my son-in-law. Plus him being shocked for no reason is unbelievable!!!
Donna M. Breuer: One of these Medtronic devices literally demolished two years of my life. At 79, I don't have that many years to throw away.
Richard Paul: I had my Medtronic Sprint Fidelis lead extracted safely by an open heart surgeon after it fractured and shocked me in excess of 36 times. Mark wasn't so fortunate. We need to get The Medical Device Safety Act passed in Congress and The Senate to prevent this from ever happening again. Corporate greed is evil and very real. As long as they know they have immunity from the courts, this will continue. For us, our children and grandchildren, please pass this bill.
Joan Turnidge: Our son, Mark, died tragically during a fractured Medtronic lead extraction in January. He was a wonderful, wonderful person. He was so positive and funny and nice. Can't say enough to express my horrible sadness. It has been so devastating and life changing.
Jessica Jaderston: In memory of Michael in Minnesota whose life was lost due to a faulty defibrillator.
Nancy D. Crosby: My husband was a victim of a malfunction of a Medtronic device.
Cherri Howard: My brother has this defective Medtronic device implanted in his chest and is in fear for his life every single day!!!
Tory Martin: I'm 25 years old with a ticking time bomb wired to my heart.
Debbie Crowdrey: Our great friend almost died when his Medtronic lead fractured. Please Congress and Senate, pass this bill to ensure the safety of all people who are the recipients of medical devices. here has to be a check and balance system in place.
Mary Hunter: I have the implantable Medtronic pacemaker defibrillator combination. I was shocked more than 20 times in September 2007 because the lead wire fractured. I could not believe that the company knew that this device was defective and chose to risk the lives of thousands of people like myself who trusted the device to help save my life, and on Septtember 5th almost took my life.
Robert W. McClain: My wife was harmed by a medical device and she was left holding the bag physically. We both were left holding the bag emotionally and financially. I now have a much better understanding of what the Medical Device Safety Act is all about. I would seriously like to see Congress do the right thing; pass this bill and protect the citizens of the United States of America!
Carlo Nuzzi: My father had a Medtronic Pacemaker Defibrillator with a Sprint Fidelis lead that malfunctioned from the first and had to be turned off and on. He died on February 29, 2008 when the implant first shocked him inappropriately and then did not function further until after his death. I still have the cursed thing and it's alarm goes off every morning. My mother and I have been devastated by his loss, caused by the very device that was supposed to save him.
Susan Green: My brother-in-law suffered in excess of 30 shocks from this faulty Medtronic device and they cannot sue the manufacturer for their incompetence? Why can Hospitals, Doctors, & Nurses can be sued and not the Manufacturer of the device that they are implanting in the patient. Does that make sense? I don't think so. Please pass this bill immediately. This is just not right.
Catherine Sutch: My husband had a Medtronic Sprint Fidelis lead break last year. After having inappropriate shocks due this, he underwent surgery to replace the lead. Complications during this surgery led to open heart surgery. At 26 this is not something we should have had to go through. All people with faulty medical devices deserve to have their story heard in a courtroom.
Evelyn Hughes: I have one of the recalled Medtronic leads and am paced almost 100% of the time. Now I have to wait and see if something is going to happen??? Adding extra stress to an already unhealthy heart is not a good thing and I understand that Medtronic did not disclose the problem for months after Japan recalled the lead. This is not right.
Bob Puckett: I too am a recipient of a Medtronic Fidelis lead. After 2 1/2 years of worrying on Jan. 29th 2010 my fears were realized when at 10:00 am, while having a cup of coffee, I got shocked 6 times. A week later a new lead was installed. Five days later I was dismissed from the Hospital with a blood clot in my left arm and a supply of coumadin. From there it took me 6 or 7 months to regain where I was after my last Heart Attack in May of 2005. MDSA needs to be passed and passed now.
Jackie Cook: My brother-in-law suffered 37 debilitating inappropriate shocks from his Medtronic Sprint Fidelis lead resulting in 2 life-threatening surgeries and much pain and anguish. Should Medtronic be held responsible - YES. Vote your conscience, Congress. Listen to your constituents and vote "YES" on the Medical Device Safety Act.
Suzanne McClain: I too have been harmed by a device, for which I am unable to hold anyone accountable! This is ludicrous!
Louise Blank, RN: Shame on Medronics for manufacturing an unsafe device. Do they stop to consider what their product might do to the patients that need their help. This injustice to patients is horrible & unforgiveable. This practice must be stopped to ensure the safety of future patients.
Beverly Stotts: Physicians, nurses, and hospitals all are responsible and liable for their actions or omissions. Medtronics is PROFITING from the patients but not LIABLE! What a corporate dream. Congress must implement change.
Janet Macomber: Patients need to be able to trust medical devices and the manufacturers. Receiving a recall letter two months after a product has failed and losing your loved one is not ok. referring to the Medtronic thread in other msgs. this must be regulated better. thx for your efforts.
Aurora Siegl: My 61 year old husband has the recalled lead. He has an implanted Medtronic pacemaker/defibrillator device. We are very concerned about the increase in fractures and failures. He had a recent hospital stay in February 2009 after receiving 3 shocks in less than 1 minute. Thank you for allowing for making it easy for me to sign the petition.
We are seeking volunteers to post the message, "Support the Medical Device Safety Act". To learn more, go to passmdsa.org." We plan to get this message posted on hundreds of message boards and chat rooms -- particularly those that are medical related or are likely to be seen by senior citizens. Please let us know if you are willing to help us out in this important cause.
These are just some of the many comments and stories we've received from visitors
Robert J. Mason: I live in constant fear having been shocked by device in my chest that is defective and has been recalled by Medtronics.
Robert Beuter: It's about time that something is done to protect the american public from health hazard medical devices. Manufracture's should held liable for medical products that cause injury to people who have them implanted in them!!!!
Nancy E. Bowling: This is LONG OVERDUE
Duane Horner: I believe Medtronic should be held responsible for thier actions as I am one with the 6949 wire on recall and I've been shocked several times and had it shut off.
Leroy Cagle: I can't believe I am paralyzed on one side and require home health care because of a Medtronic catheter granuloma and there is no help from the company who made the error.
Shelly Afthim: I'm 39 years old, my Medtronic leads are starting to fracture, need to have lead extraction surgery.
Christine Little: The Medtronic device misfired and killed my husband on our way to see a movie. He was revived but died 5 days later. Now I have no financial support.
Frank A. Cusumano Sr.: I was a victim of (Medtronic implanted defibrillator) fractured lead wires and suffered 39 inappropriate and extremely powerful and excruciating painful shocks to my heart in May of 2008. According to the ER doctors I almost died.
Douglas Duane Davis: I am also one of the victims of Medtronic and as of now My lead has not failed but I live day by day in the fear that it will fail and shock me for no reason, or that it will not shock my heart when required.
Erica Pendergrass: In memory of Samantha McGookin. Please pass this bill.
Sarah McCuller: This almost killed my son-in-law. Plus him being shocked for no reason is unbelievable!!!
Donna M. Breuer: One of these Medtronic devices literally demolished two years of my life. At 79, I don't have that many years to throw away.
Richard Paul: I had my Medtronic Sprint Fidelis lead extracted safely by an open heart surgeon after it fractured and shocked me in excess of 36 times. Mark wasn't so fortunate. We need to get The Medical Device Safety Act passed in Congress and The Senate to prevent this from ever happening again. Corporate greed is evil and very real. As long as they know they have immunity from the courts, this will continue. For us, our children and grandchildren, please pass this bill.
Joan Turnidge: Our son, Mark, died tragically during a fractured Medtronic lead extraction in January. He was a wonderful, wonderful person. He was so positive and funny and nice. Can't say enough to express my horrible sadness. It has been so devastating and life changing.
Jessica Jaderston: In memory of Michael in Minnesota whose life was lost due to a faulty defibrillator.
Nancy D. Crosby: My husband was a victim of a malfunction of a Medtronic device.
Cherri Howard: My brother has this defective Medtronic device implanted in his chest and is in fear for his life every single day!!!
Tory Martin: I'm 25 years old with a ticking time bomb wired to my heart.
Debbie Crowdrey: Our great friend almost died when his Medtronic lead fractured. Please Congress and Senate, pass this bill to ensure the safety of all people who are the recipients of medical devices. here has to be a check and balance system in place.
Mary Hunter: I have the implantable Medtronic pacemaker defibrillator combination. I was shocked more than 20 times in September 2007 because the lead wire fractured. I could not believe that the company knew that this device was defective and chose to risk the lives of thousands of people like myself who trusted the device to help save my life, and on Septtember 5th almost took my life.
Robert W. McClain: My wife was harmed by a medical device and she was left holding the bag physically. We both were left holding the bag emotionally and financially. I now have a much better understanding of what the Medical Device Safety Act is all about. I would seriously like to see Congress do the right thing; pass this bill and protect the citizens of the United States of America!
Carlo Nuzzi: My father had a Medtronic Pacemaker Defibrillator with a Sprint Fidelis lead that malfunctioned from the first and had to be turned off and on. He died on February 29, 2008 when the implant first shocked him inappropriately and then did not function further until after his death. I still have the cursed thing and it's alarm goes off every morning. My mother and I have been devastated by his loss, caused by the very device that was supposed to save him.
Susan Green: My brother-in-law suffered in excess of 30 shocks from this faulty Medtronic device and they cannot sue the manufacturer for their incompetence? Why can Hospitals, Doctors, & Nurses can be sued and not the Manufacturer of the device that they are implanting in the patient. Does that make sense? I don't think so. Please pass this bill immediately. This is just not right.
Catherine Sutch: My husband had a Medtronic Sprint Fidelis lead break last year. After having inappropriate shocks due this, he underwent surgery to replace the lead. Complications during this surgery led to open heart surgery. At 26 this is not something we should have had to go through. All people with faulty medical devices deserve to have their story heard in a courtroom.
Evelyn Hughes: I have one of the recalled Medtronic leads and am paced almost 100% of the time. Now I have to wait and see if something is going to happen??? Adding extra stress to an already unhealthy heart is not a good thing and I understand that Medtronic did not disclose the problem for months after Japan recalled the lead. This is not right.
Bob Puckett: I too am a recipient of a Medtronic Fidelis lead. After 2 1/2 years of worrying on Jan. 29th 2010 my fears were realized when at 10:00 am, while having a cup of coffee, I got shocked 6 times. A week later a new lead was installed. Five days later I was dismissed from the Hospital with a blood clot in my left arm and a supply of coumadin. From there it took me 6 or 7 months to regain where I was after my last Heart Attack in May of 2005. MDSA needs to be passed and passed now.
Pamela Townshend: I think it is absolutely UNACCEPTABLE that Medtronics is not being held acountable for their products. My husband was shocked 56 times a year to the day (October 15, 2008) that Medtronics put out their so called findings on the Sprint Fidelis leads along with their recommendations for patient management. My husband was advised that it was too risky to remove the re-called lead however a year later patients were being called by his doctor and they were given the CHOICE to have theirs removed. If they declined my husband and his case were used as an example to try and sway them. It is unfortunate that my husband didn't have a choice and something needs to be done NOW! I can not tell you what a horrible experience it is to be awakened at 2:15 am with your husband being shocked repeatedly screaming and pleading for help and there is nothing you can do. Not to mention trying to explain to our children what is going on and assure them that Daddy will be ok.
Barney Cook: Medical Manufacturers should be held ACCOUNTABLE, RESPONSIBLE & LIABLE for the manufacturing of faulty medical devices. They should not be able to "HIDE" under the blanket of FDA Preemption. Congress, THIS IS OUTRAGEOUS!!!!
Jackie Cook: My brother-in-law suffered 37 debilitating inappropriate shocks from his Medtronic Sprint Fidelis lead resulting in 2 life-threatening surgeries and much pain and anguish. Should Medtronic be held responsible - YES. Vote your conscience, Congress. Listen to your constituents and vote "YES" on the Medical Device Safety Act.
Suzanne McClain: I too have been harmed by a device, for which I am unable to hold anyone accountable! This is ludicrous!
Louise Blank, RN: Shame on Medronics for manufacturing an unsafe device. Do they stop to consider what their product might do to the patients that need their help. This injustice to patients is horrible & unforgiveable. This practice must be stopped to ensure the safety of future patients.
Beverly Stotts: Physicians, nurses, and hospitals all are responsible and liable for their actions or omissions. Medtronics is PROFITING from the patients but not LIABLE! What a corporate dream. Congress must implement change.
Janet Macomber: Patients need to be able to trust medical devices and the manufacturers. Receiving a recall letter two months after a product has failed and losing your loved one is not ok. referring to the Medtronic thread in other msgs. this must be regulated better. thx for your efforts.
Aurora Siegl: My 61 year old husband has the recalled lead. He has an implanted Medtronic pacemaker/defibrillator device. We are very concerned about the increase in fractures and failures. He had a recent hospital stay in February 2009 after receiving 3 shocks in less than 1 minute. Thank you for allowing for making it easy for me to sign the petition.
Katherine Coburn: A defective Medtronic defibrillator wire caused my sister's device to go off 65 times on the street manhattan, NY. This almost killed and definitely traumatized my sister. If we can regulate asprin so stringently why not defibrilllator wires?
Louise Kennedy: Companies should be held liable for the safety and efficacy of their products.
Debbie Mullis: My friend almost died when his defibrillator went off over 30 times for no reason other than his lead broke. Medtronic should be held responsible for all the pain, anguish, and expenses that he had to endure. Please pass this bill immediately, Congress. Hold the manufacturers accountable for producing a faulty product.
Marilyn Smallman: My brother was shocked inappropriately over 25 times when his lead fractured to his pacemaker/ICD. Congress and The Senate, please pass The Medical Device Safety Act to protect the innocent victims of faulty medical devices.
Marilyn Smallman: My brother was shocked inappropriately over 25 times when his lead fractured to his pacemaker/ICD. Congress and The Senate, please pass The Medical Device Safety Act to protect the innocent victims of faulty medical devices.
Christine Lynch, RN: My good friend was shocked 37 times inappropriately from his Sprint Fidelis lead. Unless The Medical Device Safety Act is passed by Congress & The Senate, and signed by President Obama, he has no recourse regarding his horrendous medical expenses. Please write to your respective Congressmen/Women and Senators, and enourage them to pass this important bill as soon as possible.
Rachel Wells: My husband has been injured by this device and almost died and also needed to have 2 extra very dangerous surgeries and why would you give medical manufacturing company a free ride to injure people with no recourse.
Photo of faulty medical device victim
Susan was involved in a tragic car crash in which she lost control of her vehicle and crashed violently, breaking her neck. The cause of this crash was a faulty medical device. She is now mostly paralyzed from the neck down. (This photo was taken in 2004) If you would like to see recent photos of Susan, send an email to: jeffpeterson@usa.com
The MDSA Coalition was founded by Jeff Peterson, a consumer rights advocate out of Minnesota. Jeff was drawn to this cause after his sister suffered a catastrophic injury as the result of a faulty medical device. We dedicate this mission to her and the many thousands of other defective medical device victims. The sole purpose of The MDSA Coalition is to facilitate the passing of the Medical Device Act of 2009. With the help of millions of people who support our cause, we believe our mission can and will be accomplished! Visit PassMDSA.org frequently to see updated information. We thank our many volunteers who are spreading the news about passmdsa.org. This blog can also be accessed at PassMDSA.com
We welcome your comments and personal stories.
You may contact us by email at: mdsacoalition@usa.com.
Your support is greatly appreciated,
The MDSA Coalition
