Devices

DoJ Questions Court Ruling on Device Preemption

The Justice Department has told the 3^rd Circuit Court of Appeals that a federal district court decision in a case involving Smith & Nephew hip replacement and resurfacing procedure medical devices held that some tort claims are expressly preempted, when they are not. “To the extent these claims are not expressly preempted, they would be subject to ordinary principles of implied preemption if that issue were properly preserved in this appeal,” the department said in response to an appeals court invitation to address the application of express- and implied-preemption principles in the case

The department notes that the company did not raise implied preemption in its motions before the district court, and also did not raise it in its original appeal briefing. It suggests that the appeals court could properly determine that the issue of implied preemption is not before it.

If the court decides to reach the issue, the department letter says, state law medical device claims that are not expressly preempted remain subject to challenge on implied preemption grounds in certain circumstances.

The department says that where a device is subject to device-specific federal requirements, express preemption preempts state requirements “with respect to” the device that are different from, or in addition to, the federal requirements. But state requirements with respect to other components not subject to device-specific federal requirements fall outside the scope of the law and are not expressly preempted, it says.

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