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.
Small Business Owners Make Case For Insurance Reform Before Senate HELP Committee
Small business owners testified in front of the Senate Health, Education, Labor and Pensions Committee Tuesday in an attempt by the committee to find methods for reducing the ever-increasing health insurance costs facing small businesses.
“Today, I’m announcing my own investigation into the pricing practices of health insurance companies that sell policies to small businesses,” said Sen. Tom Harkin (D-Iowa), HELP Committee Chairman. “Health insurance companies should open their books, explain to the American people why they support a health insurance market for small businesses that is so dysfunctional and so lacking in transparency.”
Harkin argued that the legislation presented by the Senate would create health insurance exchanges that pool small business together and increase competition, also making health insurance more transparent.
“Small businesses pay 18 percent more then large businesses for exactly same insurance plan and coverage. The [exact] same policy,” he said.
Art Cullen, editor of the Storm Lake Times in Storm Lake, Iowa, accepted a $5,000 deductible on services provided by a hospital in order to keep costs manageable for his small business. The deductible forces cancer patients covered by the policy to pay $2,500 out-of-pocket for a shot at a local hospital - or to drive to the next town in order to pay $25 for the same shot at a clinic. The insurance prices, he said, drive down the potential revenue that the town could have earned from treating the patient at the local hospital.
“We need more insurance competition in the rural marketplace by knocking down state cartels,” he said. “We need to know that a single health catastrophe will not bankrupt us and bring down everything we have worked for over the past 20 years.”
Kansas Insurance Commissioner Sandy Praeger, Chair of the National Assn. of Insurance Commissioners, said that the cost of health care is rising rapidly and that insurance companies have little ability to address the issues.
“The challenge moving forward will be to overhaul the delivery system to promote prevention, quality and results-based care to encourage healthy lifestyles and to eliminate waste and fraud in the system,” said Praeger. “The difficulties in the small group market, as in the individual market, are ultimately the result of medical spending that has outstripped the ability of most Americans to pay for it.”