Devices

Court Says Lap-Band Claims Preempted

An Alabama federal court has ruled that a plaintiff’s claims against Allergan over its Lap-Band weight loss PMA device are preempted under federal law. Attorney Michelle Yeary (Dechert) writes in an online blog post that the claims the court ruled on involved negligence, failure to warn, and negligent or fraudulent misrepresentation. “Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion (of the Lap-Band into a patient’s stomach), studies revealed a higher complication rate,” Yeary says.

The post notes that to survive preemption, the plaintiff’s claims had to show that the state law duties the company allegedly violated and for which damages are sought are “genuinely equivalent” to the federal requirements imposed on the device. “Only when the state and federal duties are parallel will plaintiff’s claims not run afoul of the provision of the Medical Device Amendments that a state not impose requirements that are ‘different from or in addition to’ federal requirements,” Yeary writes.

She reviews the judge’s disposition of each of the plaintiff’s claims and says the court allowed the plaintiff to amend the complaint, but her quick review of the amended document shows it appears to contain most of the same allegations and deficiencies the court has already addressed, meaning it will likely lead to another round of preemptions.

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