Devices

Court Says Essure Suit is Preempted

A New York federal court has dismissed a suit against Bayer over its Essure implantable birth control device, holding that the plaintiff failed to allege a violation of federal law that parallels state law claims of negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranty. Attorney Rachel Weil (Reed Smith) writes in a Drug and Device Law Blog post that the plaintiff cited the Current Good Manufacturing Processes regulations, but failed to explain how the company had violated them with its Class 3 device that had secured PMA approval from FDA.

The court held that since the plaintiff had not identified any parallel federal law or regulation, the Medical Device Amendments expressly preempted her suit as a matter of law. “The court commented that it ordinarily would have allowed the plaintiff to amend her complaint to ‘attempt to allege a plausible claim that was not preempted,’” Weil writes. “But, in yet another layer of certainty, the court held that New York’s three-year statute of limitations barred the plaintiff’s claims.” She says this was the 24^th time an Essure suit has been dismissed on narrow or preempted grounds.

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