This post comes from the non-Reed Smith side of the blog.
Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases. Think of it like taking a shot on goal. The shot deflects off the goalie’s stick and goes wide – that’s express preemption. The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements. You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion. Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot. Wrong. No free shot. No empty net. All the obstacles remain in place. Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series. Go Capitals!).
While plaintiffs may have managed to sneak a few claims through in Angeles v. Medtronic, Inc., 2015 Minn. App. LEXIS 19 (Minn. Ct. App. Apr. 20, 2015), we ultimately believe they will be as helpful to the plaintiffs as the aforementioned Crosby’s 2 goals in the series against the Rangers were – useless.
We begin where we begin our discussion of all InFuse cases. The allegations are the same. Plaintiffs (here a consolidated group) underwent surgery in which components of the InFuse spinal fusion device were used off-label. The lower court threw out all their claims as preempted, except fraud which they tossed for failure to plead with particularity. Id. at *2. Plaintiffs argued that that decision was erroneous because it did not correctly consider that the landscape was altered by the off-label use and promotion of the device.
The analysis in Angeles isn’t all that different from what we’ve seen before either. But, it’s an appellate decision and that’s significant. The court started with express preemption and plaintiffs’ argument that it shouldn’t apply at all because the specific FDA requirements for the InFuse device do not apply when a component of the device is used alone. Id. at *8. In the battle of device v. use – device emerges victorious again. The FDA approves devices. PMA requirements are device specific. The FDA does not and cannot regulate how devices are used by surgeons, but the FDA is well aware that devices will be put to off-label uses. Put all that together, and you conclude, as the court did here, that “the FDA established specific federal requirements for the Infuse Device, even when [an InFuse component] is used alone.” Id. at *13-14. A variation on plaintiffs’ argument is that the PMA requirements should only apply when the device is put to its “intended use” as stated in its labeling. The corollary to that argument is that when a surgeon opts to use the device in a different manner, the PMA requirements somehow disappear. Not so said the court, acknowledging that plaintiffs support for this argument, the Ramirez case, has been rejected by almost every other court to consider the issue. Id. at *14-17.
Not successful in dodging express preemption in its entirety, plaintiffs move to step two in the usual InFuse case – their claims aren’t preempted because they are parallel violation claims. The court looks at each claim in turn – failure to warn, design defect, breach of express warranty. On failure to warn, plaintiffs, in short, allege that Medtronic should have warned of risks of off-label use. In other words, plaintiffs “allege that, while promoting off-label use of the Infuse Device, Medtronic should have given warnings that were different or additional to those required by the FDA.” Id. at *21. To succeed on this claim, the jury would have to find that Medtronic was required “to provide directions and warnings for off-label uses in addition to the FDA-required warnings.” Id. at *25. This is the exact opposite of a parallel claim. And, the icing on the cake is the court’s recognition that there is “no state-law duty to abstain from off-label promotion.” Id. at *24.
Unfortunately, the court didn’t extend that “no state-law duty” analysis far enough in our opinion. The court decided to divide failure to warn into failure to warn doctors and patients (the above claim) which is preempted and failure to warn the FDA which it concluded was not preempted. Stengel rears its ugly head again. Relying on the reasoning of the Ninth Circuit, the Angeles court found that Medtronic was required by the FDCA to report adverse events to the FDA. Therefore, the court determined that failure to warn the FDA was not expressly preempted because it paralleled federal law. So the court had to move on to implied preemption, where the question is whether the claim is “based in traditional state tort law.” Id. at *32. We haven’t done a review of Minnesota law, but we don’t think we are reaching too far to suggest you are unlikely to find a state law claim for failure to warn the FDA. But the court didn’t look that closely. Rather, it cited to a manufacturer’s general duty “to give warning.” Id. at *33. We don’t think that’s nearly enough to “moor” this claim in traditional state tort law. But the court did.
On the upside, the opinion expresses some real concern for the viability of this claim outside the preemption arena. First, the court acknowledged that plaintiffs barely pleaded the claim. Id. at *34 n.2 (one reference in one sentence in a 90 page complaint). Second, the court emphasized that upon remand the lower court was tasked with deciding whether the claim was sufficiently pleaded and to meet that burden, plaintiffs “must show how Medtronic’s alleged failure to warn the FDA about adverse events concerning the Infuse Device contributed to their injuries.” Id. at *33. Without the necessary details, the court was skeptical it could “determine whether timely reporting would have affected the off-label use” of the device in plaintiffs’ surgeries. We are fairly confident plaintiffs will have a difficult time pleading, let alone proving, this causation element.
Next the court quickly dismissed plaintiffs’ design defect claims as expressly preempted because to prevail, they “would need to show that the Infuse Device should have been designed in a way that is different than the FDA-approved design.” Id. at *36. Different equals preemption.
And, then the court lets another one by – express warranty. The reasoning isn’t unfamiliar in the InFuse cases. The court found that the basis for the express warranty claim is allegations that Medtronic voluntarily made misleading statements outside the confines of the product label (in its marketing and promotion) and that that is prohibited by state law (breach of warranty) and by federal law (FDCA prohibitions on false and misleading statements). Therefore, it survives as a parallel claim. Id. at *37-40.
But again, the court took no position on whether those claims were adequately pleaded. Id. at *41. We won’t be surprised to see a challenge on that basis after remand. And, we suspect that that challenge will look somewhat like Medtronic’s successful challenge on plaintiffs’ fraud claims. Here the court upheld the trial court’s decision that the “amended complaints do not identify who made the alleged false representations to the treating physicians, which medical journal articles were read and relied on by the physicians, or what false statements were contained therein.”
So, plaintiffs are left with a failure to warn the FDA claim that we already know is insufficient because it contains no causation allegations and an express warranty claim that we surmise suffers from the same deficiencies as plaintiffs’ fraud claims. A couple of shots snuck through, but we don’t see this case advancing in round two.