They said they would, and now they have: two Democratic Congressmen have introduced a bill that explicit allows consumers to sue medical device makers under state law. You'll recall that in February the U.S. Supreme Court ruled that patients injured by defective devices can't sue because the FDA's approval preempts state law. The ruling angered some congressional reps, who said that lawsuits play an important role in keeping companies honest and protecting patients. So, they've put together the Medical Device Safety Act in the House; a companion Senate bill is set for introduction by Sen. Ted Kennedy and Sen. Patrick Leahy.
This bill doesn't affect drugmakers; pharma companies, unlike device makers, aren't covered by a statute that implies preemption. But the Supreme Court is expected to rule in a pharma preemption case this fall. We'll have to wait and see what that ruling is--and whether Congress might step up to reverse it, too.
- read the Pharmalot item
ALSO: Medtronic announced that William A. Hawkins, the company's chief executive, has been named to the additional position of chairman, effective August 21. Report