March 6, 2009
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When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and Pallone. We did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.
February 19, 2009
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In a 7-0 ruling that it said was dictated by last year’s U.S. Supreme Court ruling in Reigel v. Medtronic, the Wisconsin Supreme Court dismissed a products liability claim against Medtronic relating to one of its defibrillator models.
Two justices wrote a concurrence (agreeing with the result, but) criticizing the reliance it places on the FDA’s PMA process, citing criticism of that process from within the Agency itself:
It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices.
However, the concurring justices are mistaken to rely on the cited concerns. The GAO and “dissident” scientist concerns, as I understand them, were about devices approved through the 510(k) process, not the PMA process, but only PMA-approved devices are exempt from State tort liability under Reigel v. Medtronic. Medtronic v. Lohr specifically denied preemption for 510(k)-approved devices.
That is not to say that as a matter of institutional competence, I believe the FDA is better suited than the courts to assess post-approval device safety. I don’t think we have the data to make that assessment. Certainly if the FDA is expected to competently act as the final arbiter of product safety, it would need more funds, and perhaps revisions to post-approval regulations. Or maybe Waxman will succeed and legislate tort un-reform.
Read our other posts on this topic.
February 10, 2009
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Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices. Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with respect to labelling of FDA-approved drugs. Together, these two cases could reshape liability for products under the FDA’s purview in a way that looks very much like tort reform, and therefore, have seemed ripe for a legislative response. A story in yesterday’s Minneapolis-St.Paul Star Tribune includes a statement from Rep. Henry Waxman, D- Calif. that
Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and “protect Americans from dangerous medical devices.”
and notes that Barack Obama was one of the cosponsors of the Senate bill introduced last year to address the issue. more analysis after the jump…