Devices

NC Federal Court Upholds Preemption in Essure Case

A North Carolina federal court has ruled that a case involving Bayer’s Essure birth control medical device is preempted. Attorney Michelle Yeary (Dechert) writes in an online blog post that the plaintiff tried to get around traditional failure-to-warn preemption by arguing that the failure to warn was premised on failure to provide adverse event reports to FDA as a non-preempted parallel claim.

However, Yeary says, the court was not persuaded by a 9^th Circuit Appeals Court approval of such an approach in Stengel v. Medtronic, and found that the requirement to report adverse events exists under the Federal Food, Drug, and Cosmetics Act (FFDCA) rather than state law, and thus the failure to warn claim was being brought because the defendants allegedly failed to meet those reporting requirements. Where a claim is being brought solely based on a violation of the FFDCA, Yeary writes, that is implied preemption under Buckman. The court also analyzed the claim under state law and said it didn’t hold up because the plaintiff’s allegations did not support a finding of causation.

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