A federal court in the Ninth Circuit has held that PMA preemption extends beyond claims involving medical devices approved through the more traditional PMA process.It now also includes claims involving devices that were approved under the FDA’s humanitarian device exemption, or HDE.See Brandt v. Medtronic, Inc., 2016 U.S. Dist. LEXIS 43512 (D. Nev. Mar. 31, 2016).For those of us who didn’t know, HDE applies to devices that treat or diagnose conditions that affect fewer than 4,000 people per year.The device implanted in the plaintiff in Brandt was an HDE device intended to treat gastropareses, a relatively rare stomach condition that leads to chronic nausea and vomiting.Id. at *1.The plaintiff ultimately suffered medical complications and brought a lawsuit asserting the usual line-up of defect and other claims.
The court granted Medtronic’s motion to dismiss based on PMA preemption.The court held that, under Riegel, plaintiff’s claims would be preempted if the device had been approved under the PMA process, the device implanted in plaintiff was an HDE device, and there was no real dispute that HDE devices are subject to the FDA’s PMA process.Id. at *8.In fact, the Riegel decision itself used an HDE device as an example of a device subject to the PMA process.Id. n.2 (citing Riegel v. Medtronic, 552 U.S.312, 318 (2008)).
Accordingly, the court applied PMA preemption.The Court dismissed plaintiff’s defect, warranty and fraud claims because each was based on a Medtronic’s allegedly flawed design, manufacture, production and distribution of the device, all of which are issues squarely addressed in the FDA’s PMA review process.Id. at *9.The court further held that, even if plaintiff’s claims were read to allege that Medtronic misled the FDA, they would still be preempted under Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001).Id. at *11.
Now, this isn’t quite the end of this case.The court gave the plaintiff an opportunity to replead her parallel violation claims, which were based on Medtronic’s alleged failure to report certain events or risks to the FDA.But plaintiff’s limited (and likely short-lived) victory does not overshadow the key ruling of Brandt: 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.