Medical Device Safety Act of 2009

Date: March 5, 2009
Location: Washington, DC

MEDICAL DEVICE SAFETY ACT OF 2009 -- (House of Representatives - March 5, 2009)

Mr. BRALEY of Iowa. Madam Speaker, I rise in support of the Medical Device Safety Act of 2009. This legislation was introduced today, and I'm proud to be an original cosponsor.

The Medical Device Safety Act of 2009 is needed to ensure that every American patient has the ability to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products. It would also prevent these manufacturers from receiving total immunity from any claims simply by virtue of receiving a Food and Drug Administration device approval. This bill clarifies the intention of Congress to keep American patients safe by maintaining complementary systems to protect consumers through the FDA and American courts.

The need for this legislation was made evident in the Supreme Court's flawed decision in Riegel v. Medtronic, which completely ignored Congressional intent regarding the ability of injured patients to hold medical device manufacturers accountable for their injuries. This bill will restore Congress's original intent to allow injured patients to recover from their injuries caused by manufacturers of defective and dangerous medical devices.

It's important for Congress to promptly clarify its intent, because these types of issues continue to come up in courts around the country. Last Congress, I was proud to participate in a hearing in the Committee on Oversight and Government Reform which looked deeper into these types of issues. The medical safety experts agree that patient safety is compromised when we allow the FDA to have the final say on device safety. Strong state laws are critical to maintaining accountability for device manufacturers, and allowing the FDA to pre-empt these state laws is a surefire way to place sales over safety and profits over people.

The civil justice system and the federal regulatory system were always meant to complement each other. Both are necessary to adequately protect Americans. The FDA simply cannot do it alone, and we see examples of this all the time, from pacemakers to peanuts. The agency is understaffed and underfunded, and I support additional funding to help this critical agency. However, making the FDA the ``court of last resort'' on issues of life and death is a violation of the Bill of Rights and ignores over 200 years of Common Law precedents. This is just one more reason why Congress must pass the Medical Device Safety Act of 2009 to restore the balance between the civil justice system and the federal regulatory system that Congress intended when it passed the Medical Device Amendments of 1976.