Slam-Dunk Express Preemption Decision from the District of Arizona

Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).

This decision involved the Scandinavian Total Ankle Replacement device (“STAR”).  The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a).  This was Plaintiff’s second bite at the apple:  The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim.  See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023).  After striking out in round one, Plaintiff fared no better in round two.

Plaintiff’s amended complaint asserted two claims for strict liability and negligence.

The strict liability claim rested on an allegation of manufacturing defect.   Many litigants make the mistake of thinking that a claim for manufacturing defect gets a free pass under Riegel.  Not so.  Here, with Plaintiff’s strict liability manufacturing defect claim, he alleged that the manufacture of the STAR device “deviat[ed] from the pre-market approved specifications.”   Skinner, 2024 WL 3639296, *4.  Specifically, Plaintiff alleged that his device “was subject to material degradation of the polyethylene component of the device, causing the plastic within the device to fracture.”  Id.  This was not enough to state a non-preempted manufacturing defect claim.  

To state a parallel claim for manufacturing defect, “a plaintiff must show that the defendant deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.”  Skinner, 2024 WL 3639296, *4.  Following Weber v. Allergan, Inc., 940 F.3d 1106, 1112 (9th Cir. 2019), a decision we discussed here, the Skinner court held that a parallel manufacturing defect claim cannot be shown through a res ipsa loquitur theory.  This is logical, because Class III approval does not constitute a “guarantee that every device manufactured in that process will work.’” Id. (quoting Weber, 940 F.3d at 1111).  A device malfunction therefore “does not necessarily mean that the medical device was manufactured in a manner violating federal law.”  Id.

The allegations in Plaintiff’s amended complaint rested on nothing more than res ipsa.  In particular, “Plaintiff does not allege specifically how the STAR device deviated from the pre-market approved design, he merely infers that it did because ‘the plastic within the device…facture[d].’”  Id. (emphasis the court’s).  Setting aside res ipsa and ignoring the conclusory allegations, there was nothing left but a plainly preempted claim.

The court next addressed the Plaintiff’s amended negligence claim.  Plaintiff founded his negligence claim on two theories:  (1) negligence in “failing to develop, conduct, control and monitor product processes to ensure that the STAR device conformed to the pre-market specifications”, and (2) negligence in “fail[ing] to report the [increased risk of fracture and material degradation] to the FDA during the premarket approval process.”  Id. at *5.

The negligent failure to report to the FDA claim was DOA because Arizona does not recognize such a duty.  A parallel claim requires not just the violation of a specific federal requirement, but also a corresponding state law claim that parallels the federal requirement. The court then turned to the claim for negligence in “failing to develop, conduct, control and monitor product processes to ensure that the STAR device conformed to the pre-market specifications.”  Setting aside whether state or federal law would even recognize such a claim, the court concluded it was insufficiently pleaded.  Other than res ipsa loquitur, which the court had already rejected, “Plaintiff’s Second Amended Complaint is severely lacking in any detailed allegations of how exactly 21 C.F.R. § 820.70 was violated.”  Id. at *6.  Under Twiqbal, labels and conclusions were not enough, and that was all Plaintiff had. 

Finally, the court denied Plaintiff’s request for a third bite at the apple, concluding amendment would be futile since the Plaintiff had all the necessary information and still couldn’t plead a claim. 

No more chances for this Plaintiff.  The case was dismissed with prejudice.