Once we see a court docket dismiss a pharma product legal responsibility case on preemption grounds, we merely have to jot down about it.  In any other case, we’d be required to show in our bar card, our protection hack card, and our pleasant neighborhood DDL blogger card.  

In Polson v. AstraZeneca Ltd. Partnership,  2023 WL 2770687 (D.Conn. April 4, 2023), the plaintiff had taken medication to deal with constipation brought on by opioid ache remedies. She alleged that the anti-constipation medication brought about her to undergo life threatening accidents, similar to a perforated gut and septic shock. Her first amended grievance included causes of motion below Connecticut legislation for failure to warn, design defect, and breach of varied warranties.  The defendant moved to dismiss your entire grievance based mostly on preemption.  Remarkably, the plaintiff conceded that every one the claims have been preempted, however sought depart to file a second amended grievance with a single reason for motion that “clarifies her declare for faulty design of the drug.”  

We can not discern from the opinion why the plaintiff centered on the design defect declare. It’s not as if that declare had one of the best probability of escaping preemption. The truth is, it most likely had the worst probability.  That appears to be what the court docket thought, as a result of it held that the redesigned design defect declare would nonetheless be preempted. The court docket thus granted the defendant’s movement to dismiss with prejudice – the court docket wouldn’t allow a futile modification.  

The proposed rewrite of the design defect declare was threadbare, alleging merely that the defendant manufactured the drug and positioned it into the stream of commerce “in a faulty and unreasonably unsafe situation.”  How is the drug faulty?  In “design or formulation.”  Pricey plaintiff: are you able to do higher than that?  Apparently not. The Polson court docket noticed that even placing apart preemption, the brand new and not-so-improved design defect declare wouldn’t cross the Iqbal pleading customary. 

However the Polson court docket didn’t put apart the preemption protection.  Fairly, it wielded preemption like a mighty hammer smashing the design defect declare into tiny bits of nutmeg (as a result of, as you absolutely know, Connecticut is the Nutmeg State). The plaintiff proposed to make clear that her design defect declare was premised on Connecticut’s client expectations take a look at, as if that take a look at would one way or the other relieve her of really describing how the drug was faulty. However that client expectations take a look at nonetheless requires the plaintiff to allege that “the product was in a faulty situation unreasonably harmful to the patron or consumer.”  A product is unreasonably harmful whether it is “harmful to an extent past that which might be contemplated by the atypical client who purchases it, with the atypical information frequent to the neighborhood as to its traits.”  The product should fail to satisfy the “minimal security expectations” of that product when utilized in an “meant or fairly foreseeable method.”

That client expectations take a look at doesn’t handle to bypass preemption. If something, that take a look at rams proper into battle preemption. Such a declare, which essentially insists on some form of “modification” of the drug’s design, is incompatible with FDA approval of the drug’s design.  The FDA approves medicine provided that they’re “secure to be used “below the situations prescribed, really helpful, or recommended within the proposed labeling.”  The drug’s design is probably not altered with out prior FDA approval, which triggers impossibility preemption.   

The Polson ruling is brief and candy.  It appears inevitable and apparent. However the Polson ruling is especially important as there may be little or no drug preemption caselaw that discusses client expectation-based design defects.  As protection attorneys, we fret endlessly over the patron expectations take a look at, fearful that it’s looser and plaintiff-friendlier than the risk-utility take a look at.  However maybe (as is usually the case) we’re fretting an excessive amount of.