A plaintiff lawyer recently filed a case against our client in North Carolina. He has made a settlement demand that any rational observer would regard as ambitious to the point of outrageous. Despite that crazy number, we are on fairly friendly terms with the plaintiff lawyer. We jawbone at each other in a generally good natured way. The plaintiff lawyer told us that he reads this blog regularly. Very well then. He should read what follows and think on it when we cackle to him about how good (by which we mean reasonably receptive to the defense position) North Carolina law and judges (both federal and state) are.
Asby v. Medtronic, Inc., 2023 U.S. Dist. LEXIS 87496 (May 18, 2023), is an opinion once again demonstrating the value of TwIqbal. It is a surgical stapler case from North Carolina that was dismissed in its entirety, albeit without prejudice. The plaintiffs alleged that a surgical stapler (used to form a seal between two internal body structures) had become “stuck” and resulted in permanent injuries. The complaint included claimed for design defect, failure to warn, negligence, breach of implied and express warranties, and violation of North Carolina’s Unfair and Deceptive Practices Act (NCUDTPA). The defendant filed a Rule 12(b)(6) motion to dismiss. The court granted that motion.
As a kind of overture to the particular rulings, we should observe that the complaint was vague and inconsistent, alleging that the defendant supposedly manipulated adverse event reporting to avoid a recall – when a recall had already happened. Further, the plaintiffs made florid allegations about an FDA report that were refuted by the report itself, which was innocuous and did not focus on any particular product. Since the FDA report was referenced in the complaint, the court could consider it. The court sorted through the various claims, and such sorting did not go well for the plaintiffs.
The design defect claim (sounding only in negligence, because North Carolina does not countenance strict liability drug or device claims), flunked because it failed to plead an alternative design or to address statutory risk/utility factors. Under North Carolina law, a plaintiff alleging design defect must demonstrate either (a) the existence of a “safer, practical, feasible, and otherwise reasonable alternative design or formulation that could then have been reasonably adopted and that would have prevented or substantially reduced the risk of harm without substantially impairing the usefulness, practicality, or desirability of the product,” or (b) the product design “was so unreasonable that a reasonable person, aware of the relevant facts, would not use or consume a product of this design.” Interestingly, the North Carolina statutes set out factors to consider in determining whether a manufacturer acted unreasonably and, in addition to the usual risk/benefit issue, a key point is “[t]he extent to which the labeling for a prescription or nonprescription drug approved by the United States Food and Drug Administration conformed to any applicable government or private standard that was in effect when the product left the control of its manufacturer.” (Thus, even in mesh cases, FDA compliance is admissible in North Carolina.) The plaintiffs’ complaint in Asby not only “fails to identify how the design is inadequate, but the complaint also fails to cite alternative feasible alternative designs which were safer.”
What about FDA compliance? The plaintiffs alleged that the defendant concealed risks by choosing to submit reports through the non-public Alternative Reporting System (“ARS”) rather than the public-access Manufacturer and User Facility Device Experience (“MAUDE”). The plaintiffs also alleged that the FDA recall of the device was due to a design defect in the stapler device. But the plaintiffs’ claim about FDA reporting and the product recall was, as mentioned above, inconsistent and unsupported by the documents cited in the complaint. Claims about serious injury were refuted by the FDA’s recall, which was Class II (a recall of products that “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”) and did not reference any such serious injuries.
In North Carolina, learned intermediary principles apply to medical devices as well as to prescription drugs. The plaintiffs’ warning claim in Asby failed under the learned intermediary rule, as it was bereft of any allegation that the plaintiff’s surgeons “read or heard any of the defendant’s warnings regarding [the staplers], let alone relied on them.” In Asby, the plaintiffs’ allegations did “not move their failure to warn claim from possible to plausible.”
The Asby court also followed well established authority that “North Carolina law does not recognize an independent cause of action based on a failure to test or surveil one’s product after marketing.” Such allegations, as well as anything to do with design, inspection, promotion etc., “are subsumed by the Asbys’ failure to warn and ineffective design claims that the court already has dismissed.”
Then there are the usual warranty claims, meeting their usual and dismal fate. The stapler is a surgical device being used for its intended surgical purpose, so goodbye to the claim for implied warranty of fitness for a particular purpose. The use of the stapler in this case was not “peculiar or different from its ordinary use.” Then, as is common, the express warranty claim simply failed to state the terms of the supposed warranty. The complaint “never identifies any express warranty made by any defendant.”
Finally, we get to the NCUDTPA claim. We’d call it a make-weight claim, except that it imposes treble damages. (It is, after all, a statute modeled on federal FTC law, rather than product liability principles.) First, what amounts to a faulty breach of warranty claim is not necessarily a consumer protection violation. Second, the plaintiffs were not permitted to repackage an invalid failure to report claim as a consumer protection claim. In any event, claims under the NCUDTPA are subject to F. R. Civ. P 9(b)’s heightened pleading standard, and the complaint “fails to plead with sufficient particularity under Federal Rule 9(b) who made the representations, and the alleged content of these misrepresentations.” Finally, to the extent the plaintiffs asserted that the defendant had attempted to mislead the FDA itself (and that seems to be a big chunk of the complaint), that assertion was preempted under Buckman. (Dear Buddyroo Plaintiff Lawyer: please read this section of Asby with care. Half of your complaint is about alleged frauds on the FDA. North Carolina law does not recognize such a claim, and if it did, Buckman preemption would foreclose it.)
Our favorite all-time football player is Lawrence Taylor. He played at the University of North Carolina. We loved the way he squashed quarterbacks. And we love the way North Carolina courts squash bad drug and device complaints.