In Bertini v. Smith & Nephew, Inc., 2014 U.S. Dist. LEXIS 35837 (E .D.N.Y. March 17, 2014), the Eastern District of New York applied preemption to a device case that involved off-label use, even though the device didn’t receive FDA Pre-Market Approval (“PMA”) and wasn’t really used off-label.  Confusing?  Maybe. But once untangled, it’s very, very good.

The plaintiff had a total hip replacement.  Id. at *4.  His doctor implanted the Smith & Nephew R3 System, which had received FDA §510(k) clearance.  Id.  The R3 System ultimately failed, and the plaintiff had revision surgery.  Id. The plaintiff and his wife then sued, claiming that the R3 device’s liner had loosened from the device’s acetabular shell.  Id. But §510(k) clearance of the R3 System does not trigger preemption.  Only PMA does.  So where does preemption enter the story?

Well, it enters through the approval of another Smith & Nephew device: a hip resurfacing system. Id.  Unlike the R3 System, the hip resurfacing system received PMA.  Id. More important, the liner from the R3 System also did – for use with the hip resurfacing system.  Id. at *3-4.  In other words, although the R3 System itself did not receive PMA, its liner later received PMA to be used with another system.

And that’s how preemption enters.  The plaintiffs’ claims targeted the R3 liner.  It had loosened.  The plaintiffs also pointed toward a locking mechanism that was intended to keep the liner in place inside the acetabular shell.  Id. at *13.  While multiple parts of the R3 System are implicated in plaintiffs’ claims – the liner, the acetabular shell and the locking mechanism – the court determined that preemption was in play because the R3 liner, which had gone through the PMA process, was integral to each of those claims:

[P]laintiffs would be unable to show that the R3 acetabular shell and its locking mechanism alone proximately caused plaintiffs’ injuries, because plaintiffs have plead that the R3 System and the R3 metal liner together were the cause of plaintiff’s injuries.  Plaintiffs would have to prove that the R3 acetabular shell did not stay attached to the R3 metal liner, without being able to argue, as they have repeatedly throughout this litigation, that this failure to attach was due in large part to the R3 metal liner improperly loosening from the R3 acetabular shell.  Therefore, if a claim involving the R3 metal liner’s alleged defect is preempted, the entire claim should be dismissed because plaintiffs will be unable to sufficiently plead the remainder of that claim.

Id. at *14 (emphasis added).

With that, plaintiffs’ design defect, warning, implied warranty, and negligence claims were preempted – not a bad result for a device that did not receive PMA.  The plaintiffs’ fraud claims were also dismissed for failure to plead sufficient facts.

And how did off-label use play a role in this decision?  Well, the plaintiffs argued that preemption shouldn’t apply because the R3 liner received PMA only for the hip resurfacing system, not the R3 System implanted in plaintiff. In other words, even though the R3 device had received §510(k) clearance, the liner’s use in the R3 System was off-label from the use for which it had received PMA.  But preemption doesn’t focus on use.  It focuses on whether the FDA approved and regulates the device.  More important, there’s simply nothing wrong with off-label use.  It’s necessary for the practice of medicine.  The FDA recognizes that and knows it when it approves a device:

Plaintiffs stress that although the R3 metal liner was approved through the PMA process, it was only approved for use with the [hip resurfacing system], but defendant nonetheless marketed the R3 metal liner to be used with the R3 System.  However, preemption analysis is not concerned with how a particular device is used or whether there are federal requirements imposed on a particular use of the device.  Rather, preemption is focused on whether there are federal requirements applicable to the device itself.  Indeed, “‘off-label’ usage of medical devices (use of a device for some other purpose than that for which it has been approved by the FDA) is an accepted and necessary corollary of the FDA’s mission to regulate . . . without directly interfering with the practice of medicine,” Buckman Co., 531 U.S. at 350, 121 S. Ct. at 1018; see also United States v. Caronia, 703 F.3d 149, 153 (2d Cir. 2012) (“Once FDA-approved, prescription drugs can be prescribed by doctors for both FDA-approved and – unapproved uses; the FDA generally does not regulate how physicians use approved drugs.”).  That the R3 metal liner was approved for use with the [hip resurfacing system] does not affect defendant’s preemption argument under the MDA, since the specific component at issue received PMA.

Id. at *17-18 (certain citations omitted).

So the court applied preemption to device claims that involved a device that hadn’t received PMA and off-label use that wasn’t all that off-label.  In more practical terms, the Bertini decision illustrates that claims can still be preempted, even if the device received only §510(k) clearance, so long as the alleged defect involves a part of the device that received PMA.  It’s also another opinion that forcefully states that off-label is appropriate and shouldn’t alter the preemption analysis.