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Capitol Hill Roundup: Many Med-Tech Issues Are In Play For 2008

This article was originally published in The Gray Sheet

Executive Summary

Health care may not have been the most debated issue on Capitol Hill in 2007, but it was close, and issues impacting the medical technology sector were in abundance

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The device lobby is trying to build a broader coalition in patient and physician communities to maximize its leverage during what could turn out to be the industry's most challenging period on the policy front in years

Going Grassroots In Health Debate: New AdvaMed Head Aims To Grow Base

The device lobby is trying to build a broader coalition in patient and physician communities to maximize its leverage during what could turn out to be the industry's most challenging period on the policy front in years

Pre-emption prevails in California cases

California appellate courts rule in favor of FDA pre-emption of state tort liability claims involving PMA-approved devices in two separate cases Jan. 16 and Jan. 11. The case of Blanco v. Baxter, decided in California's fourth district, involved a patient who received a PMA-approved Baxter Edwards-Duromedics model 9120 mitral bileaflet heart valve and later died from a complication. In Jessen v. Mentor, decided in the second district, a plaintiff was implanted with a Mentor testicular prosthesis that had not been filled with saline prior to its implantation. Separately, a U.S. Supreme Court review of a PMA pre-emption case (Riegel v. Medtronic) remains ongoing (1"The Gray Sheet" Jan. 7, 2008, p. 10)

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