Today we bring you a third case in one week regarding prosthetic hip implants. Here and here we reported on courts correctly ruling that plaintiffs had not adequately pleaded product liability claims involving their hip prostheses and/or that federal law expressly preempted claims involving devices approved through the FDA’s rigorous Premarket Approval (“PMA”) process. We wish we were coming to you today with another dismissal order, thus completing a weekly trifecta. Regrettably, today’s post more resembles the children’s game duck, duck, goose. And today’s case is the goose—an order denying the manufacturer’s motion to dismiss as “premature” even though the plaintiff alleged treatment with a PMA device.
In Frederick v. Smith & Nephew, Inc., No. 1:13 CV 1220, 2013 U.S. Dist. LEXIS 170938 (N.D. Ohio Dec. 4, 2013), the plaintiff attempted to allege state-law tort claims over a PMA-approved prosthetic hip device known as the Birmingham Hip Resurfacing System (“BHR”), which the plaintiff identified in his Third Amended Complaint by name. From our point of view, this means express preemption under the Medical Device Amendments, but the district court saw it differently in an order that raises more questions than answers.
We do not know what the plaintiff’s first three complaints said, but by the time the plaintiff got around to his third amendment, there appears to have been no doubt on which device was used and who manufactured it. The BHR System’s manufacturer therefore moved to dismiss the complaint on the basis that the plaintiff’s state-law claims were expressly preempted, and also because the plaintiff did not adequately plead his claims under Twombly and Iqbal. Id. at *4. The district court correctly observed that federal law preempts state-law claims regarding PMA devices to the extent that state law imposes requirements different from or in addition to FDA requirements. Id. at *5. The court also recognized that the first step in express preemption analysis is to determine whether the federal government has established requirements or regulation applicable to the medical devices in question. Id. at *6.
From this point, however, the district court took a wrong turn and ruled that it was “premature” to apply express preemption because discovery was not complete. According to the court,
[D]iscovery is not complete and the defendant conceded to the Court that it has not examined the device and any component parts utilized in plaintiff’s original surgery. [The plaintiff’s doctor’s] letter does not specifically identify the . . . device and any component’s used in plaintiff’s surgery. Devices and component parts for which the FDA has not established regulations or requirements are not preempted by the MDA. It is premature to conclude at this stage of the lawsuit that the PMA letter issued by the FDA for the [device] preempts all of plaintiff’s claims.