Members of the Senate want to ensure that medical devices which patients rely on to stay alive and healthy are working properly. Patients as well as medical professionals testified before the Senate Health, Education, Labor and Pensions Committee (HELP) Tuesday to express support for the Medical Device Safety Act of 2009.
Each witness provided different insight into an issue that Sen. Ted Kennedy (D-Mass.) sought to address over 30 years ago. He worked on the Medical Device Amendments Act, a bill that gave the Food and Drug Administration (FDA) authority to regulate medical devices.
Sen. Tom Harkin (D-Iowa) said last year’s Supreme Court decision in Reigel v. Medtronic, Inc., gave corporations immunity from lawsuits which involve endangering consumers with unsafe devices.
“The upshot is that negligent corporations are not held accountable, victims cannot receive fair compensation and consumers are at risk. Unfortunately, this has had catastrophic consequences for ordinary Americans,” said Harkin.
Michael Mulvihill was one of the patients who testified. He received 22 electric shocks within a span of 53 minutes from a faulty Medtronic defibrillator. The defibrillator had been implanted in him a little over a year ago to help address an irregular heart beat and pulse rate.
Mulvihill said, “My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead, and that Medtronic is held responsible for the injuries it has caused other patients like me.”
Sen. Harkin believes people should maintain the ability to sue when injured and, in turn, encourage manufacturers to use “utmost care” and improve the safety of their devices.
“The threat of [product] liability is the safety net that helps repair problems when the FDA or manufacturers fail to warn consumers properly,” said Harkin.
Other members of the panel felt that the “Medical Device Safety Act of 2009” could stifle some important progress in the realm of innovation.
Michael Roman, an amputee, testified that in the time span of just five years, the changes in spinal cord stimulator technology have made a “huge difference” in his life and that of his family.
“But what if Congress had enacted the Medical Device Safety Act in 2001? For me, I’m sure it would have been game over,” said Roman.
Committee members say the purpose of the Act is to ensure the safety of consumers.
Senate Looks To HELP Those Hurt By Defective Medical Devices
Members of the Senate want to ensure that medical devices which patients rely on to stay alive and healthy are working properly. Patients as well as medical professionals testified before the Senate Health, Education, Labor and Pensions Committee (HELP) Tuesday to express support for the Medical Device Safety Act of 2009.
Each witness provided different insight into an issue that Sen. Ted Kennedy (D-Mass.) sought to address over 30 years ago. He worked on the Medical Device Amendments Act, a bill that gave the Food and Drug Administration (FDA) authority to regulate medical devices.
Sen. Tom Harkin (D-Iowa) said last year’s Supreme Court decision in Reigel v. Medtronic, Inc., gave corporations immunity from lawsuits which involve endangering consumers with unsafe devices.
“The upshot is that negligent corporations are not held accountable, victims cannot receive fair compensation and consumers are at risk. Unfortunately, this has had catastrophic consequences for ordinary Americans,” said Harkin.
Michael Mulvihill was one of the patients who testified. He received 22 electric shocks within a span of 53 minutes from a faulty Medtronic defibrillator. The defibrillator had been implanted in him a little over a year ago to help address an irregular heart beat and pulse rate.
Mulvihill said, “My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead, and that Medtronic is held responsible for the injuries it has caused other patients like me.”
Sen. Harkin believes people should maintain the ability to sue when injured and, in turn, encourage manufacturers to use “utmost care” and improve the safety of their devices.
“The threat of [product] liability is the safety net that helps repair problems when the FDA or manufacturers fail to warn consumers properly,” said Harkin.
Other members of the panel felt that the “Medical Device Safety Act of 2009” could stifle some important progress in the realm of innovation.
Michael Roman, an amputee, testified that in the time span of just five years, the changes in spinal cord stimulator technology have made a “huge difference” in his life and that of his family.
“But what if Congress had enacted the Medical Device Safety Act in 2001? For me, I’m sure it would have been game over,” said Roman.
Committee members say the purpose of the Act is to ensure the safety of consumers.