A few weeks ago we brought you up to speed on the goings on around the country in the Infuse litigation. We’ve decided not to let the cases pile up again and so, today’s post is on the latest Infuse decision – Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013). Like most of the decisions this summer, this one is strong on preemption and ultimately, it dismisses most of plaintiffs’ claims.
Eidson actually involves two related cases – claims by Mr. Eidson and claims by Mr. and Mrs. Bell. The allegations are more or less the same. The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process. The system was approved as a medical device consisting of three parts (a spinal fusion cage, a bone graft substitute, and a spongy carrier) for use in anterior (through the abdomen) lumbar surgery. Both plaintiffs allege that the device was used off-label in their surgeries because it was implanted posteriorly (through the back) and without the spinal fusion cage. Eidson, 2013 U.S. Dist. LEXIS 144179, at *6-7. At the outset, both plaintiffs also abandoned their strict liability design defect claims as barred by California law. Id. at *57-58.
Plaintiff Bell’s implantation surgery was in 2005 and he alleges his injury was diagnosed in 2007. He filed suit in 2013 – well beyond the two year statute of limitations. So, the court dismissed all of Plaintiff Bell’s claims but granted leave to amend to allege facts related to the discovery rule for delayed accrual of a cause of action. Id. at *58-69.
As for Plaintiff Eidson, the court conducted an extensive substantive analysis of his claims. But, before we get to the heart of the matter, we want to take a minute to point out that this ruling is on a motion to dismiss. Therefore, TwIqbal should be in full force and effect and regardless of preemption – plaintiffs’ complaint should plead sufficient factual content “that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). We think that means that when a court has to say five times that based on plaintiff’s allegations it has to guess at the theory underlying plaintiff’s claims – plaintiff has not pled his claim with sufficient particularity. Eidson, at *28 (“Eidson does not clearly articulate the theory underlying this claim”); *29 (“Although it is not clear to the Court what theory underlies Eidson's fraudulent misrepresentation/fraudulent inducement claim, the Court surmises two possible theories”); *40 (“Based on the above allegations, it is not clear to the Court what theory underlies Eidson's strict products liability failure to warn claim. However, the Court surmises two possible theories”); *49 (“The allegations in Eidson's complaint with respect to his negligence claim do not clearly identify what theory underlies this claim”); *51 (“Although it is not clear to the Court what theory underlies Eidson's negligence claim, the Court surmises three possible theories”). Under TwIqbal, the court should not have to “surmise” multiple possible theories for plaintiff’s claims. The complaint should eliminate that type of guess work.
While it looks to us like the court had grounds to toss the whole thing and tell plaintiffs to start over – it didn’t do that. Instead, it conducted both Riegel and Buckman preemption analyses. If you are reading this post, you are most likely familiar with both cases and our myriad of musings on express and implied preemption. The Eidson court did a pretty good job of setting forth the history and progeny of both cases – and we won’t bore you by reiterating it here, you can take a look yourself. Eidson, at *18-29. We will note, however, that like in the earlier Infuse cases, plaintiff’s argument that Riegel preemption didn’t apply because only some components of the Pre-Market Approved medical device were used off-label, was not persuasive. Id. at *25 n.3. So, the court went on to examine each of plaintiff’s causes of action.
Labeling claims – the court “surmised” that plaintiff’s misrepresentation, strict liability failure to warn, and negligent product liability claims may be based in part on allegations that the warnings and labeling that accompanied the product should have been different. They found these claims expressly preempted as requiring warnings different from or in addition to those approved by the FDA as part of the PMA process. Id. at *31-32; *41-42; 52.
Failure to report adverse events – the court was bound by Stengel v. Medtronic Inc., 704 F.3d 1226 (9th Cir. 2013) (en banc) which allowed a negligent failure to warn claim on this basis. So, under Ninth Circuit precedent, plaintiff’s strict liability and negligent failure to warn claims based on a failure to report adverse events to the FDA survive preemption. Id. at *43-45; *53. However, both claims were dismissed because plaintiff failed to allege “how” the alleged failure to report caused his injury. Id. at *47-48; *54. “[T]he court has no basis to evaluate whether the failure to report may have had a causal effect on Eidson’s injuries.” Id. at *48. Finally, a little TwIqbal.
Off-label misrepresentations – the court concluded that this was a parallel violation claim. Some other Infuse courts have reached the same conclusion, including the other federal California Infuse case, Houston v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 108996 (C.D. Cal. July 30, 2013) (see earlier Infuse post). The argument is that if plaintiff claims that the defendant made fraudulent statements in marketing and promoting the Infuse device, such claims are traditional state-law claims that run parallel to the federal requirement that manufacturers’ representations “not be false or misleading.” Unlike the other Infuse decisions to find this claim not preempted, the Eidson court also found that plaintiff pled his fraud and misrepresentation claims with the specificity required by the Federal Rules. Eidson, at *37-39.
Off-label promotion – unlike the claim described above, this claim isn’t about omissions and misrepresentations. Here, plaintiffs allege that defendant acted negligently by promoting its product off-label, regardless of the truth of the representations. The court found this claim impliedly preempted under Buckman:
Here, Eidson's negligence claim based on off-label promotion is not based on any conduct that would give rise to a recovery under state law even in the absence of the FDCA. Defendants' conduct is only allegedly "negligent" because the FDCA bans off-label promotion. Thus, although styled as a negligence claim, the claim is in substance a claim for violating the FDCA and exists solely by virtue of the federal ban on off-label promotion. The state law claim does not exist independently of federal requirements.
Id. at *54-55.
“Other” violations – the court also tossed out plaintiff’s vague allegations that defendant “failed to comply with federal law and regulations,” id. at *56 (emphasis in original), finding it was simply not enough to overcome preemption.
So, what does all this mean? Plaintiff Eidson currently has his fraud/misrepresentation claims to the extent they are based on misrepresentations made in promoting the device (labeling claims are out). And, plaintiff might have his Stengel failure to report adverse event claims if he can amend his complaint to allege a causal nexus. It may not be a slam dunk, but it’s another in a growing line of cases to find the majority of off-label promotion claims preempted. We’re not going to argue with that.