This post is from the non-Reed Smith side of the blog.
We’ve been reporting on individual InFuse cases that have been chopped down by defendant swinging a preemption axe of sorts. One by one, the cases have toppled. Occasionally, a branch or two hangs on, but they’re often too weak or flimsy to survive for long. But yesterday, the Western District of Tennessee took a bulldozer to 141 InFuse cases. The decision strikes a decisive blow to plaintiffs’ off-label promotion theories, while reinforcing the predominance of preemption in PMA medical device cases.
The decision was entered in Hafer v. Medtronic, Inc., No. 2:13-cv-02340-JTF-dkv, slip op. (W.D. Tenn. Apr. 13, 2015), but applies to the entire group of InFuse cases that were consolidated before a single judge in that jurisdiction. The allegations are essentially the same as we’ve seen in other InFuse cases, discussed here. Namely, that plaintiffs’ surgeons opted use the InFuse device, a multi-component spinal fusion medical device, in an off-label manner. In so doing, say plaintiffs, they were not implanted with a PMA approved device and so preemption should not apply.
Plaintiffs make one argument we haven’t seen pushed in many of the InFuse cases -- the whole is not equal to the sum of its parts. Plaintiffs allege that because their surgeons mixed InFuse components with components from other spinal devices (not all PMA approved), that the FDA requirements that attach to the InFuse device should not likewise attach to its components when used separately. Hafer, slip op. at 10-11. The court didn’t agree. Because the InFuse components that plaintiffs’ off-label allegations focus on were “designed and sold in accordance with the PMA,” the PMA federal requirements apply. Id. at 19.
The court begins its preemption analysis with a nice discussion of how express and implied preemption intersect in PMA device cases to leave plaintiffs with only a narrow gap for a non-preempted parallel violation claim – one that alleges defendant violated the FDCA (to avoid express preemption) but is not a claim seeking to enforce the FDCA (to avoid implied preemption). Slip op. at 14-18. Off-label promotion does not change that analysis. Express preemption still applies because federal requirements are applicable to devices, not particularuses of devices. Id. at 18. “As such, if there are requirements applicable to the device, off-label use/promotion will not remove federal preemption.” Id. Similarly, “any claim based solely on off-label promotion would thereby be impliedly preempted.” Id.at 17. We couldn’t have said it better ourselves.
The court then applied the analysis to each of plaintiffs’ claims. It shouldn’t come as a surprise that failure to warn claims were dismissed as expressly preempted. Id. at 22. But even better, the court rejected failure to warn based on failure to report adverse events to the FDA as impliedly preempted. Id. at 23. Design defect claims suffered the same fate. A jury finding that the device was unreasonably dangerous would be inconsistent with the FDA’s risk/benefit analysis that approved the design and would therefore provide requirements different from or in addition to federal requirements. Id. at 23-24. Moreover, the court addressed another aspect of plaintiffs’ “components” theory. Plaintiff alleged that InFuse should only be sold as a “package.” But again the court found that would be a requirement “different from or in addition to federal requirements, and such requirement would further inhibit the practice of medicine.” Id. at 25.
Plaintiffs’ fraud and misrepresentation claims based on statements made or not made in the FDA-approved labeling were preempted – like failure to warn. Id. at 20-21. Where such claims are based on misrepresentations made during “promoting and marketing of the Infuse device” they thread the needle of being state law based claims that parallel federal requirements against false and misleading advertising and therefore are not preempted (fairly typical of the InFuse cases overall). Also fairly typical – plaintiffs’ claims didn’t meet the heightened pleadings requirements of Rule 9(b).
The court likewise found plaintiffs’ breach of express warranties of safety and effectiveness (based on the device labeling) and breach of implied warranties claims expressly preempted. Not preempted are claims for breach of express warranties voluntarily made to plaintiffs. However, plaintiff did not adequately plead those claims – they don’t allege what specific warranties were made to plaintiffs and their physicians or how those warranties became a basis of the bargain. Id. at 28-29. So, plaintiffs are being given a chance to re-plead their fraud, misrepresentation, and breach of express warranty claims.
Finally, plaintiffs allege a general negligence claim which the court couldn’t really decipher. If it is negligent failure to warn – it is covered by the court’s failure to warn ruling. If it is negligent design – it is covered by the court’s design decision. If it is negligent misrepresentation – it is covered by the court’s misrepresentation decision. So, that leaves “negligence based solely on Defendant’s failure to comply with federal law or solely illegal off-label promotion (i.e. negligence per se).” That claim is implied preempted. Id. at 26.
This is a great decision knocking out the heart of a large chunk of plaintiffs’ claims in a large chunk of plaintiffs’ cases and it does so in a way that makes it clear that allegations of off-label use really don’t make a difference – preemption is still the name of the game.