We’ve read Kaiser v. DePuy Spine, Inc., ___ F. Supp.2d ___, 2013 WL 2006122 (M.D. Fla. May 14, 2013), which granted a motion to dismiss with prejudice on grounds of PMA preemption. Kaiser involves an artificial spinal disc; this was plaintiff’s second shot at pleading nonpreempted claims – the defendant’s first motion had been granted as unopposed but allowing an amended complaint. So the plaintiff, when filing the amendment in Kaiser, did so knowing full well what would happen.
So do we all. The plaintiff attempted to plead a "parallel" violation claim, and the defendant argued in return that he hadn’t done so.
The key allegation was that the "Defendant failed to design, test, manufacture, market, sell, promote, label, and/or distribute the [device] implanted in Plaintiff's spine in accordance with the PMA requirements determined by the FDA." Id. at *1. That didn’t work; it was TwIqballed, and rightly so, as being entirely generic and fact-free. "Plaintiffs cannot simply incant the magic words." Id. at *4.
Only in one place had the plaintiff done any better, alleging that the "PMA requires that the [device] be designed, tested, and manufactured with [components] that, when surgically implanted in a patient's spine, will provide natural motion in the lumbar spine." Id. at *1. Plaintiff advanced the providing of "natural motion" as some sort of FDA performance standard for the device, and claimed a violation in that the device eventually failed to do this. Id. at *5. There was only one problem with that – the plaintiff invented this purported FDA standard from whole cloth. It didn’t exist.
Plaintiff does not allege that the FDA ever adopted formal performance standards and regulations requiring the [device] to "slide and otherwise restore natural motion." In fact, in its PMA memorandum, the FDA identified the specific performance standards that apply to the [device], and it specifically recognized that the [device] conformed to all of these standards. None of those standards identified in the PMA memorandum were alleged to have been violated in Plaintiff's amended complaint.
Kaiser, 2013 WL 2006122, at *5. In helpful, but case specific, footnotes (that we’ve omitted), the court took judicial notice of the "performance standards" that the FDA’s "public records" stated were applicable. Id. at *5 nn. 1-2.
We find Kaiser’s reliance on "performance standards" to be quite interesting. Although Kaiser doesn’t cite Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012), Walker also limited the parallel violation exception to Riegel preemption to FDA performance standards applicable to the device. Because plaintiffs can’t make up performance standards the way the plaintiff in Kaiser tried to do, it’s a firm, fixed standard that a complaint either satisfies or does not. Because performance standards are bright lines, we’d like to see more courts adopt this boundary for the definition of parallel claims.
The plaintiff’s purported parallel claim also failed from the opposite direction – from the state law side. Kaiser alternatively held that the violation claims failed as a matter of Florida law, since that state does not allow a plaintiff to bring a private cause of action to enforce FDA regulations under the guise of negligence per se:
[D]istrict courts in this Circuit have consistently held that private actions like Plaintiff’s that seek to enforce violations of FDA regulations are barred because Florida does not recognize such causes of action.
2013 WL 2006122, at *5. So with respect to the "parallel" claim in Kaiser, one line wasn’t really parallel and the other line didn’t exist at all.
Finally, plaintiffs’ last ditch attempt to seek yet another amended complaint also failed. Some states allow warranty claims in the absence of privity, and some states don’t. Florida doesn’t. Id. at *6. Kaiser thus got nowhere – time to abdicate and flee to the Netherlands.