Devices

Limits of Device Preemption Described

Attorney Cliff Rieders (Rieders, Travis) says the Supreme Court has laid out several types of state law tort claims about medical devices that are preempted by federal law. In a Legal Intelligencer blog post (free subscription required) that traces medical device preemption relating to products approved through PMAs and 510(k)s, Rieders says that courts have “made room for state law ‘parallel’ claims as not preempted under Riegel under very narrow circumstances.” He reviews several of these court decisions, including a case involving statements made by a manufacturer representative during surgery that were not preempted. He says that case made clear that medical device manufacturers are not insulated from common law negligence claims based on the preemption doctrine when the manufacturers have representatives who interact with physicians and are present at surgical procedures. “Preemption does not provide immunity, especially where the Class 3 or other medical device developer becomes engaged in medical care, beyond merely placing the product in the stream of commerce,” he 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