When we see a court dismiss a pharma product liability case on preemption grounds, we simply have to write about it. Otherwise, we’d be required to turn in our bar card, our defense hack card, and our friendly neighborhood DDL blogger card.
In Polson v. AstraZeneca Ltd. Partnership, 2023 WL 2770687 (D.Conn. April 4, 2023), the plaintiff had taken medicine to address constipation caused by opioid pain treatments. She alleged that the anti-constipation medicine caused her to suffer life threatening injuries, such as a perforated intestine and septic shock. Her first amended complaint included causes of action under Connecticut law for failure to warn, design defect, and breach of various warranties. The defendant moved to dismiss the entire complaint based on preemption. Remarkably, the plaintiff conceded that all the claims were preempted, but sought leave to file a second amended complaint with a single cause of action that “clarifies her claim for defective design of the drug.”
We cannot discern from the opinion why the plaintiff focused on the design defect claim. It is not as if that claim had the best chance of escaping preemption. In fact, it probably had the worst chance. That seems to be what the court thought, because it held that the redesigned design defect claim would still be preempted. The court thus granted the defendant’s motion to dismiss with prejudice – the court would not permit a futile amendment.
The proposed rewrite of the design defect claim was threadbare, alleging merely that the defendant manufactured the drug and placed it into the stream of commerce “in a defective and unreasonably unsafe condition.” How is the drug defective? In “design or formulation.” Dear plaintiff: can you do better than that? Apparently not. The Polson court observed that even putting aside preemption, the new and not-so-improved design defect claim would not pass the Iqbal pleading standard.
But the Polson court did not put aside the preemption defense. Rather, it wielded preemption like a mighty hammer smashing the design defect claim into tiny bits of nutmeg (because, as you surely know, Connecticut is the Nutmeg State). The plaintiff proposed to clarify that her design defect claim was premised on Connecticut’s consumer expectations test, as if that test would somehow relieve her of actually describing how the drug was defective. But that consumer expectations test still requires the plaintiff to allege that “the product was in a defective condition unreasonably dangerous to the consumer or user.” A product is unreasonably dangerous if it is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.” The product must fail to meet the “minimum safety expectations” of that product when used in an “intended or reasonably foreseeable manner.”
That consumer expectations test does not manage to circumvent preemption. If anything, that test rams right into conflict preemption. Such a claim, which necessarily insists on some sort of “amendment” of the drug’s design, is incompatible with FDA approval of the drug’s design. The FDA approves drugs only if they are “safe for use “under the conditions prescribed, recommended, or suggested in the proposed labeling.” The drug’s design may not be altered without prior FDA approval, which triggers impossibility preemption.
The Polson ruling is short and sweet. It seems inevitable and obvious. But the Polson ruling is particularly significant as there is very little drug preemption caselaw that discusses consumer expectation-based design defects. As defense lawyers, we fret endlessly over the consumer expectations test, worried that it is looser and plaintiff-friendlier than the risk-utility test. But perhaps (as is often the case) we are fretting too much.