Congressmen and Senators are proposing the Medical Device Safety Act of 2008 to protect patients from dangerous and defective devices. Medical-device industry leaders say it will lead to confusion and affect medical care.
U.S. Representatives Frank Pallone, Jr., and Henry Waxman introduced legislation in the House that will reverse a U.S. Supreme Court decision earlier this year involving medical devices. A companion bill will be introduced in the Senate by Edward Kennedy and Patrick Leahy.
The legislation is response to the Riegel v. Medtronic Inc. ruling in February 2008 where the Supreme Court ruled that patients injured by FDA-approved devices can't collect damages if manufacturers complied with government standards.
The Congressmen and Senators state that the proposed Medical Device Safety Act of 2008 protects patients from dangerous and defective devices by "correcting the Court's flawed interpretation of the Medical Device Amendments act of 1976." The new legislation explicitly clarifies that state product liability lawsuits are preserved.
Stephen J. Ubl, president and CEO of AdvaMed, released a statement regarding the introduction of the Medical Device Safety Act of 2008.
"The Congress provided express preemption authority relative to FDA device approvals in 1976 because lawmakers recognized that a central, expert authority at the federal level would best serve the interests of public health and safety for all Americans.
"A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients.
"The Supreme Court’s 8-1 decision in Riegel v. Medtronic reaffirmed what most Federal courts have regarded as settled law since 1976 -- that the FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology.
"This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.”
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