Senate Panel Hears Testimony on Medical Device Liability

A U.S. Senate panel heard testimony recently from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent court ruling that protects device manufacturers from product liability lawsuits.

The hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions over the Medical Device Safety Act of 2009 addresses the overturning of the 2008 Supreme Court decision in Riegel v. Medtronic.

Here are some quotes from the hearing:

“This has had catastrophic consequences for ordinary Americans. While the FDA approval of medical devices is important, it cannot be the sole protection for consumers. I say that because FDA approval…is simply inadequate to replace the longstanding safety incentives and consumer protections provided by long-standing state tort law.”
–Sen. Tom Harkin (D-Iowa)

“FDA marketing clearance or approval of a medical device does not guarantee its safety.”
–Dr. William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston.

“The fact that it [a device] hurts someone doesn’t mean there’s a defect. It may save 999 lives, but hurt the thousandth life. That doesn’t mean it’s defective.”
–Peter Barton Hutt, a food and drug attorney in Washington and former chief counsel for the FDA

To watch the complete hearing, visit www.cspan.org/Watch/Media/2009/08/04/HP/A/21683/Senate+HELP+Committee+Hearing+on+Defective+Medical+Devices.aspx.