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Congress Must Restore Patients’ Rights to Hold Medical Device Makers Accountable

Aug. 4, 2009

Congress Must Restore Patients’ Rights to Hold Medical Device Makers Accountable

Statement of Allison M. Zieve, Director, Public Citizen Litigation Group*


As the Senate Health, Education, Labor and Pensions Committee meets today to discuss issues surrounding the safety of medical devices, we remind them that while medical devices can be important tools for saving lives or enhancing quality of life, these products can also pose serious risks. When medical devices are defectively designed or marketed without adequate labeling, they can cause grave injury and death to patients. To restore patients’ rights to hold device manufacturers accountable when their products cause injury, Congress must pass the Medical Device Safety Act of 2009 (S. 540, H.R. 1346). Without this legislation, patients’ ability to seek compensation from medical device manufacturers for injuries caused by the most risky devices is severely limited.

In 2008, the Supreme Court held in Riegel v. Medtronic, Inc. that a 1976 law giving the Food and Drug Administration (FDA) authority to regulate medical devices immunizes manufacturers of the riskiest devices from liability for injuries and deaths caused by their products. This ruling removed a longstanding consumer protection for patients – the ability to hold medical device makers responsible for design defects and for failures to warn about hazards associated with their products. No other industry is so free from accountability to consumers.


Although the FDA regulates device manufacturers, premarket scrutiny cannot ensure that products will perform as intended. No matter the strength of FDA’s review, some devices will be defective; some labels will be confusing or inadequate; and some injuries are unavoidable. And when injuries occur, lawsuits are a patient’s sole means of obtaining compensation for lost wages, medical bills, and pain and suffering. At the same time, consumers’ ability to bring cases seeking damages for injuries complements the regulatory system by creating a valuable incentive for manufacturers to make products as safe as possible, to revise labels as soon as they become aware that they lack needed warnings or are otherwise insufficient, and to remove unsafe products from the market as promptly as possible.


*Allison M. Zieve, director of Public Citizen Litigation Group, argued on behalf of the Riegels before the U.S. Supreme Court in Riegel v. Medtronic.