On Wednesday, the House Committee on Oversight and Government Reform begins hearings on the reversal of the Riegel v. Medtronic holding that state tort claims regarding medical devices were preempted if the FDA granted pre-market approval for a medical device.
Pharmaceutical drug manufacturers have been on a real hot streak of late before this conservative Supreme Court. They are looking to extend their streak by asking the Supreme Court to extend the preemption umbrella to pharmaceutical drugs in Wyeth v. Levine, which is expected to be heard this fall. Congress has the opportunity to cut this pro-business Supreme Court off at the knees although I doubt they could get a bill past President Bush. Things may change in 2009.
The star studded cast of witnesses includes Dennis Quaid (whom I imagine will speak to the heparin overdose of his twins), William Maisel, (Medical Device Safety Institute), Aaron Kesselheim (Harvard Medical School’s Division of Pharmacoepidemiology), David Kessler (former FDA head), David Vladeck, (Georgetown law professor who has written on preemption) Gregory Curfman (New England Journal of Medicine editor); Christine Ruther (drug company consultant) and State Representative David Clark (Republican state legislator from Utah who I suspect is in favor of preemption).
Again, I don’t suspect that this committee is going to try to send a bill to the floor anytime soon but it is good to get the ball rolling on righting the wrong of Riegel v. Medtronic.