[Congressional Record (Bound Edition), Volume 154 (2008), Part 11]
[Extensions of Remarks]
[Pages 15740-15741]
[From the U.S. Government Publishing Office, www.gpo.gov]




                FIGHTING AGAINST FAULTY MEDICAL DEVICES

                                 ______
                                 

                         HON. ANTHONY D. WEINER

                              of new york

                    in the house of representatives

                         Tuesday, July 22, 2008

  Mr. WEINER. I rise today in support of the recently introduced 
Medical Device Safety Act of 2008. This much-needed legislation would 
restore an injured consumer's ability to hold negligent medical device 
manufacturers accountable for product-related deaths and injuries.
  The Medical Device Safety Act addresses the problems created by the 
Supreme Court's February 20, 2008, decision in Riegel v. Medtronic. 
This decision stripped away essential consumer rights by supplying 
device manufacturers with total immunity from liability.
  It's difficult to see the reasoning behind this special treatment for 
device manufacturers when you consider what happened to Bridget Robb. 
In May 2005, Ms. Robb was diagnosed with nonischemic, viral 
cardiomyopathy and congestive heart failure. To prevent her from

[[Page 15741]]

dying from a fatal arrhythmia, she had a Medtronic cardiac 
defibrillator and pacemaker implanted in her chest. On December 31, 
2007, a wire in Ms. Robb's defibrillator broke, causing the device to 
send a strong electric current to her heart. Ms. Robb suffered 31 
electric shocks in 13 minutes in front of her 6-year-old daughter. 
Medtronic knew about this defect, but issued only a voluntary recall. 
Since this frightening experience, Ms. Robb has undergone two surgeries 
to replace her defibrillator and goes to doctor's appointments almost 
weekly for follow-up appointments and testing.
  Prior to the Supreme Court's decision in Riegel, the FDA and State 
courts protected consumers, like Ms. Robb, together. Since Riegel, 
consumers only have the FDA to protect them; and the FDA has 
insufficient resources to do so effectively. The Medical Device Safety 
Act ensures that consumers like Bridget Robb will be able to seek legal 
recourse for their injuries and reiterates Congressional intent that 
State laws must work hand in hand with Federal regulations to protect 
consumers.
  For these reasons, I urge support for Congressman Pallone and 
Congressman Waxman's bill, H.R. 6381. I look forward to working towards 
passage of this legislation and restoring these, critical, basic 
consumer protections.

                          ____________________