May 11, 2009 

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

Statement of Allison Zieve, Senior Attorney, Public Citizen*

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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