This year has seen many decisions in the InFuse litigation and we’ve tried to highlight the key rulings.  See here and here.  They mostly have been very strong preemption decisions and this month’s addition to the collection is no exception – Cook v. Coe, No. 1-13-CV-245210, slip op. (Cal. Super. Nov. 15, 2013). 

First, a quick reminder that the InFuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process.  So, aside from purported “parallel violation” claims, plaintiff’s claims should be preempted under the trilogy of Lohr, Riegel, and Buckman.  Despite the overwhelming precedent preempting almost all state law tort claims involving PMA medical devices, plaintiff Cook argued that Medtronic could not overcome the “basic presumption against preemption.”  Cook, slip op. at 4.  The court gave plaintiff a quick history lesson on medical device preemption and simply found plaintiff’s argument without merit.  Id. at 4-6. 

So, like the earlier InFuse decisions, the heart of plaintiff’s claims is supposed violations of the FDCA.  Two of these were common themes in the other InFuse cases:  off-label promotion and failure to submit adverse event reports to the FDA.  The latter is unfortunately an easy call.  This is California and therefore, governed by Stengel v. Medtronic Inc., 704 F.3d 1226 (9th Cir. 2013) (en banc).  So, plaintiff’s claims based on a failure to report adverse events to the FDA survive preemption.  However, such claims were dismissed without prejudice for failure to plead sufficient facts to show an alleged violation or to establish causation.  Cook, slip op. at 12-13.   

As to off-label promotion, the Cook court broke down the various types of alleged off-label promotion and found almost all of them preempted.  To the extent plaintiff’s off-label promotion claims turn on statements or omissions in the warnings and labeling that accompanied the product, the claims are expressly preempted because

requiring Defendants to alter the Infuse Device’s warnings and label in order to provide extra warnings beyond those already approved during the PMA process would impose labeling and warning requirements different from, or in addition to federal requirements for the Infuse Device.

Id. at 8 (citation and quotation marks omitted).  Also expressly preempted were plaintiff’s claims based on an alleged failure to warn that the device had not been approved for off-label use.  Such a claim “effectively seeks to write in a new provision to the FDCA:  that physicians and medical device companies must affirmatively tell patients when medical devices have not been approved for a certain use.”  Id. at 11 (citation and quotation marks omitted).  The FDA has never adopted such a rule.  Since there can be no claim for violating a regulation that doesn’t exist, plaintiff’s claim on this basis is also expressly preempted.

That leaves two additional off-label promotion claims and here the court followed the lead of Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013) (see prior post).  The first is a negligence claim based on an allegation that defendant violated the FDCA by promoting the device for an off-label use.  Because this claim “exists solely by virtue of the federal ban on off-label promotion,” it is not based on any conduct that would give rise to a recovery under state law.  In other words, the claim “does not exist independently of federal requirements.”  Cook, slip op. at 9.  Therefore, it is impliedly preempted under Buckman as an improper private FDCA cause of action.

The court, however, distinguished “non-negligence claims based on Medtronic’s alleged misrepresentations and omissions made while promoting off-label uses.”  Id. at 12.   The court simply cites Eidson without explanation, but here is what we’ve learned from other courts who have found that this off-label claim may survive preemption.  The argument is that if plaintiff claims that the defendant made fraudulent statements in marketing and promoting the device, such claims are traditional state-law claims that run parallel to the federal requirement that manufacturers’ representations “not be false or misleading.”  But, while the claim survived preemption, as with the Stengel claim, plaintiff failed to plead it sufficiently.  So, it too was dismissed without prejudice.  Cook, slip op. at 13.

That brings us to a parallel violation claim that we don’t believe has been explicitly addressed in the prior InFuse cases – failure to supplement the PMA.   Plaintiff argued that Medtronic knew about the “new indications” for the device and was negligent in failing to submit a PMA supplement for these additional indications.  Id. at 9-10.  The court found this claim to be both expressly and impliedly preempted.  First, plaintiff alleged that a manufacturer is required to comply with the conditions imposed by the FDA in the PMA process.  Plaintiff did not allege that a manufacturer has a continuing duty to submit a PMA supplement.  Id. at 10.  Therefore, “any state law claim based on a failure to seek a PMA supplement would impose requirements different from or in addition to federal requirements, and thus are expressly preempted.”  Id.  Or, if you aren’t satisfied with that ruling, the court also acknowledged that failure to supplement claims have been found to be impliedly preempted as “essentially fraud-on-the-FDA claims.”  Id. at 10-11.