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

This article was originally published in The Gray Sheet

Executive Summary

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

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Supreme Court Hears Wyeth v. Levine Drug Pre-Emption Case

U.S. Supreme Court justices focused their questioning during Nov. 3 oral arguments in the case of Wyeth v. Levine on the specific risk-benefit trade-off for the drug in question, but also addressed broader principles of FDA policy

Supreme Court Hears Wyeth v. Levine Drug Pre-Emption Case

U.S. Supreme Court justices focused their questioning during Nov. 3 oral arguments in the case of Wyeth v. Levine on the specific risk-benefit trade-off for the drug in question, but also addressed broader principles of FDA policy

Division at FDA over preemption

One week before the Supreme Court is scheduled to decide a major FDA drug law pre-emption case, Wyeth v. Levine, which is expected to result in some implications for devices, the House Government Oversight Committee throws more coals onto the fire of a drug and device law pre-emption dispute Oct. 29 by releasing a report, "1FDA Career Staff Objected To Agency Preemption Policies," stating that key FDA career staff strongly objected to drug labeling regulations generated by Bush administration appointees that would preempt state drug liability lawsuits. The report charges that "the agency's actions have undoubtedly helped shield drug manufacturers from liability," and publicizes an internal memorandum by Jane Axelrad, Associate Director for Policy at FDA's CDER, in which she warns her political appointee superiors that a 2008 drug labeling rule preventing drug makers from adding additional safety information to labels "is not, as it purports to be, consistent with the agency's role in protecting the public health" ("2The Gray Sheet" Oct. 13, 2008, p. 25)

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