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Why Congress Should Pass the Medical Device Safety Act of 2009

S. 540 and H.R. 1346

Fact Sheet: Why Congress Should Pass the Medical Device Safety Act

The Medical Device Safety Act (MDSA) will restore patients’ ability to hold medical device manufacturers accountable for injuries caused by defective medical devices. Medical devices include artificial heart valves, implantable defibrillators, catheters, pacemaker wires, and, numerous other medical products.

The bill responds to a 2008 Supreme Court decision, Riegel v. Medtronic. That case held that a medical device manufacturer usually cannot be sued by injured patients if the Food and Drug Administration approved the device for marketing through its premarket approval (PMA) process. The Court’s decision has restricted consumers’ ability to seek compensation from device manufacturers. The Court has given device makers immunity from most product liability claims, and several courts have held that the immunity applies even where defects or other deficiencies become known after approval of the product. This bill has no impact on the authority or ability of the FDA to regulate devices; it merely reinstates the view that FDA regulation and state tort remedies are complementary.