Federal Preemption Rules and Insufficient Pleading Results in Dismissal of Plaintiff’s Off-Label Claims


In a recent decision issuing from the Central District of California, the court evaluated requirements pertaining to federal preemption and pleading, and granted Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.’s (defendants) motion to dismiss for failure to state a claim.  Houston v. Medtronic, Inc., -- F. Supp. 2d --, 2013 WL 3927839 (C.D. Cal. July 30, 2013). 


In Houston, the plaintiff alleged personal injuries following an alleged off-label use of an InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device (the device).  Id., 2013 WL at *1.  The FDA approved the device for implantation from the abdomen and in conjunction with the LT-Cage.  Id.  The plaintiff alleged that the device was implanted from her back and, without the use of the LT-Cage, constituted an impermissible off-label use.  Id.


The plaintiff specifically raised six causes of action: (1) fraudulent misrepresentation and fraud in the inducement; (2) strict product liability – failure to warn; (3) strict product liability – design defect; (4) strict product liability – misrepresentation; (5) product liability – negligence; and (6) breach of express warranty.  Id., 2013 WL 3927839 at *2. 


Express and Implied Preemption of Product Liability Claims
The court recognized that the plaintiff’s state law claims are expressly preempted where the claim establishes a requirement “different from, or in addition to” federal regulations.  Id., 2013 WL 3927839 at *4-*5.  A claim is not expressly preempted, however, where the claim provides a “damages remedy for claims premised on a violation of FDA regulations,” known as a parallel claim.  Id., 2013 WL 3927839 at *5 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008); Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 (9th Cir. 2013) (en banc)). 


The plaintiff’s claims may be impliedly preempted where the claim is brought “to enforce an exclusively federal requirement and was not grounded in traditional state tort law.”  Id., 2013 WL 3927839 at *6 (quoting Stengel, 704 F.3d at 1235). 


In this case, the court determined that both strict product liability claims required the defendants to take affirmative steps in addition to existing federal regulations, and accordingly, both causes of action were expressly preempted.  Id., 2013 WL 3927839 at *8-*9.  With respect to the plaintiff’s negligence claim, the court found that it was subject to express preemption, and further noted that “any negligence claim based solely on illegal off-label promotion is impliedly preempted.”  Id., 2013 WL 3927839 at *8. 


Insufficient Pleading of Fraud and Warranty Claims
Fraud claims are subject to heightened pleading requirements: “In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  Fed. R. Civ. P. 9(b).  Particularity includes the “time, place, and specific content of the false representations as well as the identities of the parties of the representations.”  Houston, 2013 WL 3927839 at *3. 


The plaintiff’s complaint, however, was devoid of the particularities required to survive a motion to dismiss.  The plaintiff’s breach of express warranty claim was similarly deficient for failing to provide the details required to sustain a breach of warranty claim under California law.  Id., 2013 WL 3927839 at *11.


The court dismissed the plaintiff’s complaint with leave to amend, noting that leave to amend should be granted unless it finds that amendment of the pleading would be futile.  Id., 2013 WL 3927839 at n.12.  The plaintiff has 30 days to file an amended complaint, but based on the court’s analysis, the plaintiff must file a complaint with substantively informative allegations to survive any subsequent motion to dismiss.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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