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Democrats Seek To Overturn Supreme Court Device Liability Decision

This article was originally published in The Gray Sheet

Executive Summary

Democratic leaders in Congress are vowing to craft legislation to effectively overturn the Supreme Court's ruling that PMA approval pre-empts a patient's right to sue device companies for personal injury

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If the Supreme Court favors "implied" federal pre-emption for FDA-approved pharmaceutical labeling in a case that will be heard by the court next month, some devices may receive additional protections too, lawyers suggest

Wyeth Supreme Court Case Could Have Impact On Device Suits, Lawyers Say

If the Supreme Court favors "implied" federal pre-emption for FDA-approved pharmaceutical labeling in a case that will be heard by the court next month, some devices may receive additional protections too, lawyers suggest

Capitol Hill In Brief

Import safety bill: A new draft of the drug portion of the proposed FDA Globalization Act crafted by the House Energy and Commerce Committee and posted on the panel's website July 28 indicates that Congress is continuing its work on the measure, but in separate pieces. The only language pertaining to devices in the draft is the requirement that each drug and device establishment have a unique identification number. However, the House panel is still interested in addressing imported medical device safety, and will most likely take up that section of the bill after the congressional recess ends on Sept. 8, a house staffer said. At a hearing on the act in May, Republican members of the committee's Health Subcommittee, including Rep. Joe Barton of Texas, supported an industry position on the bill that the device components of it should be removed and dealt with separately. Barton opposed requirements in the legislation calling for pre-market inspections of all class II 510(k) devices ("1The Gray Sheet" May 19, 2008, p. 4)

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