Tuesday
Aug042009
Senate Looks To HELP Those Hurt By Defective Medical Devices
Tuesday, August 4, 2009 at 6:04PM
By Courtney Ann Jackson - Talk Radio News Service
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.
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.
Reader Comments (5)
Mr Harkin's allegiance lies with the legal prfession, as do most of our legislators. This is just cover to avoid the tort reform so badly needed. "In 1972, Tom and Ruth graduated in the same class at Catholic University of America Law School in Washington, D.C." - from the Harkin website.
NOTHING MADE BY HUMANS IS PERFECT EVER!!!!! 2% of every medical device fails. That means 98% work. I wonder if Mr Mulvihill still has a device in him. Or does he now feel he can do without it.
James apparently works for medtronic. People can and do screw up and make defective products. There were recalls on those defibrillaters and read the news on what goes on at Medtronic's Puerto Rico factory. It was cited a bunch of times for lack of quality control and they had a high school grad deciding if defects constituted a medical problem. They also had to recall insulin devices that were defective and have caused people to keel over like flies. There's an inherent flaw that people against this bill ignore: They only gained immunity last year! That means Roman's medical devices were made in the "stifling" climate he's afraid will magically appear. The ability to hold people to the fire for making crap never stopped innovation in the last couple centuries in America. Postulating that suddenly overturning a ruling that just occurred in 2008 will bring medical innovation to a grinding halt is catastrophic-level hyperbole and silliness. Common sense, people.
Why would a law protecting the public from unsafe medical devices stem the flow of new tech.? Until blanket immunity was granted mere months ago, there was no stemming or halting "new technology". This arguement makes no sense. From 2005 Mr. Roman enjoys the results of the new technology, that has improved his life, did being held accountable in 2005 halt or delay his medical device? Medtronics cannot expect blanket immunity, when they have put so many lifes in danger, and destroyed peoples lifes. If Medtronics gets away with this, it is sending the wrong message to mega companys like Medtronic, that lifes and safety are not more important and making billions of dollars is much more important then safety. All in the name of progress. Yeah sure. Its all about the money it seems
Medtronics should not be allowed to kill, harm and endanger people, and then scream " we are being sued to much" protect our creative flow. And Judge Kyle who ruled in favor of preempt in this case needs to be taken off the suit, as his son is on the board of Medtronics. Shame Shame Shame. Go Ted.
I have a pacemaker from a different company. It has given me the confidence and security to drive my infant child around without worrying my heart will stop. I see both sides to this argument. Nothing is perfect but I want it to be as close to perfect as possible if it is my life we are talking about. I also don't want to have to wait for new technology for years and years because a company now has to run a clinical study for 15 years before asking for approval and marketing a product for fear of being sued. And even when they do everything correctly, people will still want to sue. If a company does everything it can to ensure product safety then they should be protected. If they break the law they should be punished. What we can't do is punish them because a product that they designed, tested, and was FDA approved showed problems after being used over time. No company can predict perfectly how a product will function in the body 3, 5, or 20 years down the road.