This post is from the non-Reed Smith side of the blog only.
Even on a slow week, we can count on one litigation to infuse our inbox with blogging opportunities. The decision comes from a federal court in Arizona, the birthplace of Stengel, so it’s not the type of infusion we’d prefer. But this week we are not picky.
Fortunately, this InFuse decision – Arvizu v. Medtronic Inc., 2014 U.S. Dist. LEXIS 118122 (D. Ariz. Aug 25, 2014) – doesn’t break new ground in bad territory. It simply follows the 9th Circuit’s Stengel precedent, and it also finds certain off-label promotion allegations sufficient to survive preemption. That’s nothing we haven’t seen before from 9th Circuit courts, and something we’ll doubtless see again.
The allegations were typical. Plaintiff underwent an operation involving an off-label use of the InFuse Device (Class III, so subject to Riegel Preemption), had complications, and later sued, alleging a whole host of parallel violation claims. The court found three of plaintiffs’ claims – fraudulent misrepresentation, strict liability misrepresentation, and violation of Arizona’s consumer protection statute – to be based in fraud: “they allege that Defendants ‘fraudulently concealed and misrepresented information’ about the off-label uses of the Infuse Device.” Id. at *16 (quoting the complaint). The court held these claims to be parallel to FDA requirements given that the FDA prohibits false and misleading promotion. So the claims survived defendant’s motion to dismiss.
The court also accepted plaintiffs’ “failure to warn the FDA” claim. Id. at *19-20. This one always gets to us because no state’s law really has such a claim. It’s a creature of FDA regulation. And, even if a state did have such a claim, we believe that it would run smack dab into Buckman implied preemption because providing required information to the FDA is an area for the FDA itself to enforce, not private litigants. But the 9th Circuit’s Stengel opinion holds otherwise, and so 9th Circuit district courts must follow.
But there are positive aspects to the Arvizu decision. The court found plaintiffs’ claim that the defendant didn’t provide an adequate warning to plaintiff or his physician to be preempted under Riegel. That’s by no means a groundbreaking decision. But it’s right. The court also found plaintiffs’ design defect claims to be preempted. Id. at *20-21. That’s a no-brainer too. The FDA approved the InFuse Device’s design, and any state-law attempting to require a different design is clearly preempted.
Even better, the court held that plaintiffs’ claim that defendant should have disclosed that it was promoting the InFuse Device off-label was not cognizable. Id. at *22-23. This is the most gratifying, aspect of the court’s decision. Any such claim is impliedly preempted under Buckman. If it existed, it would be based entirely on the FDCA and the FDA’s regulatory regime. There is no “off-label” without FDA regulation and approval. Accordingly, the claim is an improper attempt to privately enforce the FDCA:
Plaintiffs’ claim are impliedly preempted because they ‘exist solely by virtue’ of FDCA requirements. Allowing Plaintiffs’ claims to go forward would be essentially authorizing an impermissible action to enforce the provisions of the FDCA that prohibit misbranding.
Id. at *22. That’s right. This is not a parallel claim. It’s an FDCA claim, which by definition is an improper attempt to privately enforce the FDCA. Now, we believe that this very same argument applies to the Stengel claim that the court allowed. But we’re nonetheless gratified to see the court accept it as to this claim.
The plaintiff also made warranty claims. The court dismissed them because plaintiff made no factual allegations showing that the alleged warranties were made directly to the plaintiff. Id. at *22-23. Without such privity, the warranty claims don’t exist. That’s a nice holding too, and one that we believe can be useful in other cases.
So there it is. Another infusion from the InFuse litigation. The lay of the land in the 9th Circuit got no worse, and maybe it got a little better.