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» Medical Device Safety Act of 2009

H.R. 1346: Medical Device Safety Act of 2009

 

Summary of H.R. 1346

The Medical Device Safety Act of 2009 amends the Federal Food, Drug, and Cosmetic Act to permit legal recourse for dangerous and defective medical devices that have been approved by the U.S. Food and Drug Administration (FDA). This Act will be retroactive in effect and applicable to any civil action pending or filed on or after the date of enactment.

 

Reason for H.R. 1346

The Medical Device Safety Act of 2009 was introduced to reverse the U.S. Supreme Court’s decision in Riegel v. Medtronic, Inc.

In February of 2008, the U.S. Supreme Court made medical device companies immune from state lawsuits brought by patients who are injured by dangerous and defective medical devices. In Riegel, the Court found that those claims were barred by a preemption clause included in the Medical Device Amendments of 1976. The Court took the view that approval by the FDA adequately protects patients from unsafe medical devices.

This decision ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks. Up until the Bush administration, FDA has always viewed state product liability cases as an important supplement to the Agency’s regulation of medical devices and as an added layer of protection for consumers.

The Court’s decision in Riegel has left consumers without any ability to seek compensation for their injuries, medical expenses, or lost wages resulting from injuries caused by defective premarket approval devices or inadequate safety warnings. It also removes the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.

 

Get Involved

Contact your U.S. Senators and U.S. Representative about H.R. 1346. Find your U.S. Senator at http://www.senate.gov/ and U.S. Representative at http://www.house.gov/.

 

Track the Progress of HR 1346

http://www.govtrack.us/congress/bill.xpd?bill=h111-1346