The news is out that the Supreme Court (SCOTUS) passed on the chance to hear Medtronic v. Stengel, one of the more recent cases tackling FDA’s preemption of state tort law for PMA devices, so maybe it’s time for a preemption check-up.
First, it may be instructive to ask “why not Stengel?” The case had bounced from a district court (which dismissed the suit against Medtronic) to the U.S. Ninth Appeals Court, which handed it back to the lower court after seeming to suggest the plaintiff’s attorneys have little chance of success. One might assume Medtronic would let it go at that, but the company nonetheless applied for cert, which the Supreme Court took the better part of a year to consider.
Medtronic may have figured it had little to lose by taking the case to Washington, but the company might also have imagined the odds were long that the Court would grant cert in the first place. Either way, next up is Medtronic v. Caplinger. The company’s Infuse bone morphogenic is alleged to have been the subject of off-label discussions between the company and doctors (specifically about anterior versus posterior access to the spine), which is a somewhat different set of issues than those brought forth by Stengel, which was a failure-to-warn claim for an infusion pump presumably used on label.
Also on tap for Medtronic (why is it always Medtronic?) is Coleman v. Medtronic, which according to this analysis was decided for the plaintiff in a rather qualified fashion. Not much has happened since the California Court of Appeals (a state court) decided the case in January, but one assumes it would end up in Ninth Appeals should it graduate to the federal level.
The interesting thing about Caplinger is that it presents the third federal appeals court venue (Tenth Appeals Court) for preemption of the past four years or so and hence might trigger another examination of preemption at SCOTUS (bear in mind that the last time the Supreme Court examined this issue was Riegel in 2008, another Medtronic case, and another case in which Allison Zieve of Public Citizen represented the plaintiff).
A quick tally of the two concluded appeals court cases leaves us with one case that probably had no chance of changing anything (Stengel), and one that was probably a long shot to change things had the Supreme Court heard it, namely the Sprint Fidelis electrophysiology lead litigation decided in the Eighth Appeals Court four years ago affirming preemption.
The losing party in Caplinger will appeal for cert, there’s no question about that. If SCOTUS passes again, it will likely hear from the loser in Coleman should that case get through the federal appeals system. Given the foregoing, it seems unlikely the Supreme Court will take Caplinger if Tenth Appeals affirms preemption. None of this argues, however, that SCOTUS wouldn't pass on Caplinger if the case takes a very limited swipe at preemption.
On the other hand, the Supreme Court may feel it's time to act if Coleman hits the appeals court system and generates a decision that seems to add yet more noise to the preemption question.
Absent any change to the overall make-up of the Supreme Court, we might assume any preemption cases the Court takes would come out reinforcing at least the principal tenets of preemption. Still, there is a tremendous amount of activity and groups like Public Citizen seem determined to put an end to preemption.
About the only thing the layperson can say conclusively about all this is that any decision at SCOTUS on this question in the near future won’t change things much. A death or retirement of one of the conservative jurists while President Obama is still in office would torque the situation drastically, but that might be the only window for ending preemption over the next decade, given the voters’ collective penchant for switching parties in the White House every eight years.
All the same, one would be well advised not to fall asleep on this issue.