Corporate Counsel reports: Corporate America has generally argued that the federal government should prevail over the states when they have conflicting laws and regulations. The question of who trumps whom is now before the U.S. Supreme Court, which has agreed to hear five cases involving preemption. The five preemption cases before the Supreme Court involve product liability, transportation of dangerous substances, labor, and other issues.
New York University law professor Catherine Sharkey is one of those who hope that the high court can settle the debate. "Almost every scholar and litigant calls [the existing standards on preemption] a muddle, a mess," Sharkey says. In her view, the Supreme Court "is poised to begin to fashion a kind of framework for preemption jurisprudence."
First out of the box is Riegel v. Medtronic Inc., which was argued before the justices on December 3. At issue: whether a provision in the federal Food, Drug, and Cosmetic Act forecloses suits that claim injury from a medical device approved by the Food and Drug Administration if the actions are based on state law.
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New York Times reports on the product liability cases before the Supreme Court, which consider preemption issues relating to drug and cigarette labeling requirements.
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From the FDA News Drug Daily Bulletin (Jan. 29, 2008): The U.S. Supreme Court will hear a second drug preemption case to decide whether the FDA’s authority to regulate labeling of a Wyeth drug preempts Vermont state law for product liability.
The court granted Wyeth’s request for writ of certiorari for Wyeth v. Levine. The company filed the request after the Vermont Supreme Court awarded $6.8 million to Diana Levine, a professional musician who received Wyeth’s antinausea drug Phenergan (promethazine) in a hospital during treatment for a migraine headache.
The drug was mistakenly injected into an artery, causing injuries that “quickly and irreversibly” led to the amputation of her right arm, according to the Public Citizen Litigation Group, Levine’s co-counsel.
Public Citizen said the court should deny review because Levine’s claim was not preempted by FDA drug labeling regulations and there is no conflict among appellate courts.
For Wyeth v. Levine, the petitioner’s brief is due Feb. 25, and the respondent’s brief is due March 24.
Friday, February 1, 2008
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