Devices

Federal Court Says HDE Case Preempted

A Nevada federal court has held that PMA preemption extends beyond medical devices approved through the traditional PMA process to include those approved under a humanitarian device exemption (HDE). Attorney John Sullivan (Cozen O’Connor) writes in an online blog post that the case involved an implanted device intended to treat gastropareses. The plaintiff ultimately suffered medical complications and brought suit asserting “the usual lineup of defect and other claims,” Sullivan writes.

The court granted Medtronic’s motion to dismiss the suit based on PMA preemption. It held that under Riegel, the claims would be preempted if the device had been approved under the PMA process, the device implanted in the plaintiff was an HDE device, and that there was no real dispute that HDE devices are subject to the FDA PMA process. The Riegel decision used an HDE device as an example of a device subject to the PMA process, the article points out.

The court dismissed the plaintiff’s defect, warranty, and fraud claims because each was based on Medtronic’s allegedly flawed design, manufacture, production, and distribution of the device, all of which are issues addressed in the PMA review process, Sullivan writes. It did give the plaintiff an opportunity to re-plead parallel violation claims that were based on Medtronic’s alleged failure to report certain events or risks to FDA.

“Plaintiff’s limited (and likely short-lived) victory does not overshadow the key ruling [of the case],” Sullivan concludes. “PMA preemption applies to HDE devices. This is the first decision of this kind that we’ve seen. With it now on the books, we will watch how other courts treat this additional application of PMA preemption.”

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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