Preemption
Senators Pick Up Preemption Rollback
To the House of Representatives' initiative to reverse the Supreme Court's Riegel v. Medtronic decision, now add a bill from senators Edward Kennedy (D–MA) and Patrick Leahy (D–VT). In August, they circulated the Medical Device Safety Act of 2008 to undo FDA preemption of state lawsuits brought against medical device companies marketing FDA-approved premarket approval devices. Six additional senators initially signed on as cosponsors. Read more...
Protecting PMA Devices and Their Makers
In February 2008, the U.S. Supreme Court decided that medical devices that receive premarket approval (PMA) from FDA are protected from product liability lawsuits brought in state courts. However, members of Congress have introduced legislation to overturn the Court’s decision and to make PMA devices vulnerable to attack. Read more...
