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 particular device.'”
“We emphasize that the problem with Bard’s preemption argument is not simply that the FDA did not prohibit Bard from adding additional warnings. … Instead, the preemption argument fails because Booker’s claim rests on an asserted state-law duty to warn of the risks posed by the particular design of Bard’s G2 Filter, and the FDA has not imposed any requirements related to the design of that device or how a device of that design should be labeled.”
The 9th Circuit also found that Bard failed in its argument that Georgia law did not recognize a duty to warn of the comparative risks posed by different products failed. Bard’s challenge to the punitive damages award also failed.
The opinion affirms the federal jury verdict finding Bard liable for negligent failure to warn, awarding $1.6 million in compensatory damages and $2 million in punitive damages.
“The 9th Circuit properly rejected Bard’s attempt to avoid liability with a preemption defense. That ruling will keep the courthouse doors open to injured patients,” said David Frederick, part of the Kellogg, Hansen, Todd, Figel & Frederick team that argued the case for Booker.
A BD spokesperson said the company doesn’t comment on pending litigation.