Devices

Appeals Court Rejects Bard Preemption Defense

The 9th Circuit Court of Appeals has rejected device preemption arguments from C.R. Bard in a product liability lawsuit involving the company’s G2 Intravascular Filter. The panel of judges affirmed a lower court’s ruling in favor of the plaintiff and rejected Bard’s motion for summary judgment that argued the federal Medical Device Amendments of 1976 preempted all state-law claims.

The appeals court was reviewing a 2018 Arizona federal court decision that awarded plaintiff Sherr-Una Booker $3.6 million in damages due to alleged injuries suffered because of the device.

The panel held that Bard’s preemption argument “failed because plaintiff’s claim rested on an asserted state-law duty to warn of the risks posed by the particular design of Bard’s G2 Filter, and the FDA had not imposed any requirements related to the design of that device or how a device of that design should be labeled.” Bard also argued that the lower court erred in denying summary judgment on plaintiff’s negligent failure-to-warn claim because Georgia law did not recognize a duty to warn of the comparative risks posed by different products. They held that “Georgia courts had not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning.” The panel concluded that the district court correctly allowed a jury to decide the warning’s adequacy.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome