FDAnews Drug Daily Bulletin
June 9, 2008 | Vol. 5 No. 112
Preemption Ruling Threatened by Draft Bill
While the U.S. Supreme Court is scheduled to hear a case in its next session on preemption for state lawsuits against a pharmaceutical manufacturer, key legislators are taking steps to block the court’s ruling on medical device preemption.
The court ruled earlier this year in Riegel v. Medtronic that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by devices with FDA premarket approval.
The Medical Device Safety Act of 2008 would counter the Supreme Court ruling by adding a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”
Pallone and Rep. Henry Waxman (D-Calif.), a co-sponsor of the draft bill, had threatened to introduce the legislation soon after the court’s decision in Riegel v. Medtronic.
In March, the Supreme Court affirmed a lower court ruling in Warner-Lambert v. Kent that favored patients claiming to have been injured by Rezulin (troglitazone), allowing them to bring a product liability case against Pfizer. Chief Justice John Roberts took no part in the 4-4 decision.The draft bill is available at www.fdanews.com/ext/files/FinalBill.pdf.
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