For Immediate Release

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Phone: 202-588-1000

Congress Must Restore Rights of Consumers to Hold Medical Device Makers Accountable

Statement of Allison Zieve, Senior Attorney, Public Citizen*

WASHINGTON - On Tuesday, the Health Subcommittee of the U.S. House Committee on
Energy and Commerce will hold a hearing on the Medical Device Safety
Act of 2009 (H.R. 1346)    - legislation that would restore important
consumer protections eliminated by the U.S. Supreme Court decision in Riegel v. Medtronic.

In the February 2008 Riegel ruling, the court held that the
1976 law that gives the Food and Drug Administration authority to
regulate medical devices also immunizes manufacturers of many medical
devices from liability for injury caused by their products. 

The Medical Device Safety Act would restore the right of injured
patients to seek traditional state common-law remedies for injuries and
deaths caused by medical devices, as Congress intended when it enacted
the 1976 law. Tomorrow, members of Congress will hear from witnesses
about the societal costs of immunizing medical device manufacturers
from accountability for design defects and inadequate warnings.

The possibility of being held liable for injuries their products
cause creates a valuable incentive for manufacturers to make their
products as safe as they can, to revise labels as soon as they become
aware that they are inadequate and to remove unsafe products from the
market. By eliminating this possibility, the Supreme Court decision
removed a significant layer of consumer protection, which makes passage
of the Medical Device Safety Act so essential.

*Allison Zieve, a senior attorney at Public Citizen, argued on behalf of the Riegels before the U.S. Supreme Court in Riegel v. Medtronic.


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Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

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