New Report Released On Defective Heart Devices And Implants

Monday, March 30, 2009

For Release:
March 30, 2009

Contact: Joanne Doroshow or Amanda Melpolder
(212) 267-2801


Patients Travel to Washington Tomorrow to
Urge Congress to Restore their Legal Rights


New York, NY –A new study released today by the national consumer rights group Center for Justice & Democracy finds that medical devices for the heart have caused thousands of needless injuries and deaths, yet patients currently have no legal recourse against reckless medical device manufacturers.

The release of the report, HEART SICK – Hazardous Heart Devices and the Importance of Litigation, comes one day before dozens of patients living with faulty medical devices head to Washington D.C. to urge Congress to restore their legal rights. These rights were taken away by the U.S. Supreme Court last year in a case called Riegel vs. Medtronic. That decision immunized negligent and irresponsible medical device companies whose defective devices injure or kill patients or force them to live knowing their device could fail at any moment.  Legislation has currently been introduced in both Houses of Congress to fix this Supreme Court decision.

“This study tells a devastating tale of greed, cover-ups and reckless behavior by some companies that manufacturer heart devices, such as pacemakers, defibrillators, heart valves and stents,” said Joanne Doroshow, Executive Director of the Center for Justice & Democracy. “Some of these devices were placed on the market without adequate testing. This has been with the acquiescence of the Food and Drug Administration, which has repeatedly been unable to properly oversee this hazardous industry.”

The study covers devices like those implanted in great-grandmother Bobbie Flowers from Ashdown, Arkansas, who is traveling tomorrow to Washington D.C. to urge Congress to change the law.  “In 2006, I had a defibrillator implanted in my heart and within two months I began experiencing painful erratic electrical shocks,” said Ms. Flowers.  “By the time I got to the emergency room, my children could only watch their mother suffer.  They couldn’t touch me or try to calm me down because I was getting shocked so violently.  Everyone thought I was dying, including myself.”  The Sprint Fidelis 6949 lead or wire, part of her defibrillator, had broken, which doctors replaced after a second heart surgery, not knowing the lead would be recalled.  The second lead eventually broke as well, violently shocking her again, requiring yet another invasive surgery. “I am hoping and praying that his new lead will work, but it is hard not to fear every morning when I wake up that I will experience this intense pain again,” she said.

"Heart devices have saved millions of lives, but hundreds of thousands have malfunctioned due to design and manufacturing defects that should have kept these devices off the market,” said report author Amanda Melpolder. “When they fail, the results for patients can be catastrophic. Only through litigation have patients and their families been compensated, and in many cases, lawsuits have been the only way information has come to light about some of the most dangerous heart devices.”

Click here for a full copy of HEART SICK
Click here for an Executive Summary (both PDF format)

For more information, go to


Doroshow Accepts AwardCJ&D Executive Director Joanne Doroshow accepts Esther Weissman Award from Bob DeRose, Past President, Worker Injury Law and Advocacy Group (WILG), on behalf of CJ&D, October 11, 2008.

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