Devices

Court Upholds Device Exempt, Implied Preemption

Attorney Elizabeth Minerd (Reed Smith) says an Illinois federal court took the time to sort through a number of novel plaintiff allegations in a case involving a Mentor silicone breast implant and determined that almost all of them were either expressly or impliedly preempted. Minerd writes in an online post that ever since the 2008 Supreme Court decision on PMA medical devices in Riegel v. Medtronic, “plaintiffs have taken to loading their complaints with allegations of violations of federal requirements in an attempt to escape federal preemption.”

In the Illinois case, the plaintiffs asserted claims against the manufacturer if negligence, strict products liability (manufacturing and marketing), strict products liability (failure to warn), and loss of consortium.

Anticipating that the company would ask that the case be dismissed because of preemption, Minerd writes, the plaintiffs turned to novel theories attacking the defendant’s conduct of certain post-approval studies and patient follow-up required in the FDA PMA letter.

The court analyzed each of the five theories, and determined that they were either expressly or impliedly preempted. The post says the plaintiffs also alleged that the company had violated manufacturing standards based on allegations that the agency had cited it for non-compliance with manufacturing standards several times. The court said this theory was impliedly preempted because the plaintiffs failed to tie the alleged non-compliance with manufacturing standards to any state law claim that the specific device was defectively manufactured.

The court did allow one failure-to-warn claim to survive based on the plaintiffs’ allegation that the company was aware of a higher rate of implant ruptures than it reported to FDA. “Overall, a solid win for the defense that significantly narrowed the scope of the plaintiffs’ claims going forward,” Minerd concludes.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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