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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.

Id. at **6-7.

So the Court could not apply preemption because it could not tell which device was used to treat the plaintiff, which for us raises several questions.  To begin with, we know the identity of the device at issue because the plaintiff identified it in his complaint.  And this was the Third Amended Complaint.  Maybe there really was a genuine question regarding the identity of the device, or maybe the plaintiff’s lawyers re-used an old complaint and forgot to change the name of the device.  We don’t know, but we think it is more likely that on their fourth try the attorneys took some care in identifying the most basic and elemental fact in the lawsuit.  We do not understand why the district court would not accept the complaint at face value, especially when a motion to dismiss is supposed to be determined on the facts as pleaded and the plaintiff had already taken numerous opportunities to amend.

We also do not understand the district court’s reasoning in permitting further discovery and why it mattered that the defendant had not examined the explanted device. The purpose of a motion to dismiss is to dispose of claims that fail on the pleadings before engaging in unnecessary and very expensive discovery.  Sure, the defendant had not examined the device, and the plaintiff’s doctor was not specific in his letter, but so what?  It is not the defendant’s burden to verify the complaint’s well-pleaded facts with extrinsic evidence when it moves to dismiss, and what about cases where the device is not available for inspection, such as when it was discarded or where it has not been explanted from the patient’s body? It cannot be that the defendant cannot assert federal preemption in cases involving implantable devices without first physically inspecting them.

The district court also held back because “the specific details, extent and scope of the federal requirements and/or regulations imposed by the PMA for the [device] are not yet fully developed in the record, and some areas may be specifically excluded from regulation.”  Id. at *11.  Maybe there is more to this than meets the eye, but we cannot understand why the “extent and scope” of federal regulation was not clear.  This again was a PMA device for which the FDA reviewed and approved the device’s design and instructions for use.  Moreover, the plaintiff was alleging garden variety claims—design defect, failure to adequately warn, and breach of warrant.

A final signal that something is not quite correct about this order is that the district court denied the defendant’s motion to dismiss also because the plaintiff pleaded his claims with sufficient detail under Twombly and Iqbal.  In doing so the court created a “Catch 22,” holding that the Third Amended Complaint was too vague to tell the identity of the device for purposes of preemption, but clear enough to plead claims under state law.  It seems to us the plaintiff cannot have it both ways:  If the Third Amended Complaint was clear enough to state a claim under state law, it was also clear enough to determine that federal law preempted those claims.  This result is contrary to the purpose of Twombly and Iqbal.

The district court denied the motion without prejudice to the defendant filing a motion for summary judgment “if following the completion of discovery, it appears that the device and any component parts are entirely regulated by the FDA, and that plaintiff cannot sustain a claim under state requirements that parallel federal requirements.”  Id. at *8.  Perhaps the defendant will move for summary judgment, and perhaps the district court will grant it.  But if that proceeding has to await “the completion of discovery,” this defendant has a legitimate reason to be disappointed.  Federal preemption is a powerful defense, as Bexis frequently reminds us, and where express preemption appears on the face of the complaint, the defendant should be able to put an end to litigation.  And when the plaintiff has already amended his complaint three times the dismissal should be without leave to amend.