We’ve said it before, and we’ll say it again: Plaintiffs will now regularly plead that their state law claims against device manufacturers run “parallel” to the FDA’s requirements and so are not preempted under Riegel v. Medtronic, 128 S. Ct. 999 (2008).
And we’ve said it before, and we’ll say it again: We think that’s wrong.
We’re not sure that this purported loophole to Riegel even exists; if it does, there are many ways to overcome it.
But we’ll be watching this line of cases closely, since it strikes us as a big chunk of the new preemption ballgame (at least in the context of medical devices).
The Kansas Supreme Court has now entered this fray, although in a tangential way.
In Troutman v. Curtis, 2008 Kan. LEXIS 327, No. 94,667 (Kan. June 20, 2008), plaintiffs claimed to have been injured by the defendant’s suturing device used in cardiac catheterization procedures. The trial court granted defendant’s motion for summary judgment based on preemption, and the appellate court affirmed.
The case reached the Kansas Supreme Court after Riegel had come down. Plaintiffs thus jumped to the “parallel requirements” ship, insisting that they had pleaded that the defendant had violated the FDA’s regulations as part of plaintiffs’ negligence claims.
The Kansas Supreme Court agreed (although the two of us would not necessarily) that claims that a device manufacturer violated FDA requirements are not preempted under Riegel. Id. at *6. The Kansas Supreme Court also found that plaintiffs’ awfully vague petition pleaded a “parallel requirements” claim. The petition “was minimally adequate to leave this avenue for relief open.” Id. at *13. But the court found that the plaintiffs had offered no proof of violations of FDA regulations in opposition to the defendant’s motion for summary judgment, and the trial court acted within its discretion by granting “summary judgment without further discovery.” Id. at *15.
The case thus turns on a procedural point — whether the trial court abused its discretion by denying plaintiffs a chance to take more discovery before deciding the defendant’s summary judgment motion — but we confidently predict that this is a harbinger of things to come.
We’ll see more and more allegations in medical device cases that defendants violated FDA regulations. And, depending on the result in Wyeth v. Levine, the same battle may soon come front and center on the drug side.