Close
Updated:

Congress Looks at Riegel v. Medtronic

On Wednesday, the House Committee on Oversight and Government Reform began hearings on the reversal of the Riegel v. Medtronic holding that preempted state tort claims regarding medical devices if the FDA granted the product a pre-market approval.

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 could 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 will send a bill to the floor soon but it is good to get the ball rolling on righting the wrong of Riegel v. Medtronic.

Contact Us