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The 9th U.S. Circuit Court of Appeals has handed down an important medical device preemption opinion as it affirmed a $3.6 million award against Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard in a bellwether lawsuit case over inferior vena cava filters.Bard’s lawyers had argued that when FDA reclassified intravascular filters as Class II devices, the agency’s special controls for such devices provided preemption against lawsuits for Bard’s G2 IVC filter. A U.S. District Court judge in Arizona should have granted Bard’s summary judgment motion involving Sherr-Una Booker’s lawsuit, Bard said.
The 9th Circuit disagreed in the opinion it handed down yesterday: “We assume, without deciding, that the special controls are requirements, but we nevertheless conclude that they are not ‘specific’ requirements ‘applicable to a pa…