We are back “stateside,” after a trip to London and Florence.  We loved both, especially the Tower of London, Highclere Castle (used for the filming of Downton Abbey – how very cool to walk through the rooms we watched with such pleasure for six seasons) and, of course, the breathtaking David.  But this is pretty much all you need to know about us:  the whole time, we wished we were in a small Western Pennsylvania town that was hosting a five-day dog show.  Our gorgeous Standard Poodle puppy, Luca, arrived at this show a few points shy of his A.K.C. championship.  He emerged victorious – he is now Ch. Tivin Dreamcatcher, pending official confirmation.  So we spent most of our vacation hovering over our phone.  But he won, with or without us, and we are overjoyed (and are thrilled to have him back home!). 

Today’s plaintiff did not win, on two separate grounds.  In Neto v. Bristol-Myers Squibb, et al., 2023 WL 3689533 (D. Conn. May 26, 2023), the plaintiff’s decedent died from hemorrhage after taking the defendant’s anticoagulant medication.  The plaintiff, appearing pro se, alleged that the defendant did not warn of the danger of “hemorrhage, or in turn, death” from taking the drug.  Neto, 2023 WL at *1.   The defendant moved to dismiss the Complaint, arguing that the plaintiff had not stated a claim under the Connecticut Products Liability Act (“CPLA”) and that, even if she had adequately pled her claim, the claim would have failed as a matter of law.  (The plaintiff did not file an opposition to the Motion to Dismiss.)

Failure to State a Claim under the Connecticut Products Liability Act

To state a CPLA claim, as the court explained, a plaintiff must allege that:

1) the defendant was engaged in the business of selling the product; 2) the product was in a defective condition, unreasonably dangerous to the consumer or user; 3) the defect caused the injury for which compensation was sought; 4) the defect existed at the time of sale; and 5) the product was expected to and did reach the consumer without substantial change in condition

Id. at *2 (citation omitted).  In other words, the plaintiff was required to plead that the defendant’s drug was defective and that the defect proximately caused her decedent’s injuries.  Because an inadequate warning was the alleged “defect,” the plaintiff was required to establish both that the warning was inadequate and that, “if adequate warnings or instructions had been provided, the claimant would not have suffered the harm.”  Id. at *3 (citation omitted).   (This is our beloved “warnings causation” doctrine.)

The defendant argued that: 1) the plaintiff pled no facts to show that that drug was defective, or that any defect existed at the time the decedent purchased the drug; and 2) the Complaint was silent as to whether the defendant provided any warnings to the decedent’s physician and how such a warning was inadequate; and 3) the plaintiff failed to plead facts showing warnings causation.   The court agreed, holding that the Complaint failed to provide any facts showing that the drug was defective and pled no facts about the warnings provided to the physician “which, in turn, could show that the provided warning was purportedly inadequate.”  Id. 

With respect to warnings causation, the court emphasized that, under Connecticut’s learned intermediary doctrine, a plaintiff must plead that an adequate warning would have altered the doctor’s decision to prescribe the drug.  But the Neto plaintiff “fail[ed] to allege any reason for the decedent’s doctor to prescribe [the drug] to him or provide the reason why any warning would change the prescriber’s decision.”  Id.  And so, the court held, the Complaint failed to state a claim under the CPLA.

Other Grounds:  Warnings Adequate as a Matter of Law, and Preemption

The defendant argued that the claim would fail as a matter of law even if the plaintiff had adequately pled a CPLA claim, because: 1) the warnings were adequate as a matter of law; and 2) the claim was preempted under the doctrine of impossibility preemption.  And the court agreed with both arguments.

Adequacy of the Warnings

The plaintiff argued that her decedent would not have taken the drug if the defendant had “warned that [the drug] could lead to hemorrhaging, or, in turn, death.”  Id. at *4 (citation omitted).  But, at the time the plaintiff’s decedent took the drug, the package insert included a black box warning that “major or even fatal” bleeding was a potential side effect.  Id. (citation omitted).   As the defendant argued, the label “warned that the most common adverse reactions [were] fatal and nonfatal hemorrhage from any tissue or organ.”  Id.  Because these were “precisely the maladies that the decedent allegedly suffered,” the defendant argued that “drug labels squarely contradict[ed] Plaintiff’s allegations that [the defendant] failed to warn of these risks.”  Id. (citations omitted).  The court agreed, holding that, because the label “clearly and adequately warned of the very side effects suffered by the decedent,” id. at *5, the warnings were adequate as a matter of law. 

Preemption

The court explained that, under the Second Circuit’s excellent Gibbons decision, discussed here, a plaintiff could state a claim for failure to warn that was not preempted by the FDCA only by “plead[ing] a labeling claim that defendants could have corrected using the [Changes Being Effected, or] CBE regulation” which permits a manufacturer to change a label without FDA approval in the face of newly-acquired information.  Because this is the only circumstance in which a manufacturer can change a label unilaterally, Gibbons held that other inadequate warnings claims are preempted under the doctrine of impossibility preemption.  In this case, the label already included black box warnings of the very injuries the plaintiff’s decedent allegedly suffered, and there was no allegation that “the risk of fatal hemorrhaging was of a different type or greater severity or frequency than that already included in the FDA-approved label.”  Id. at *6 (internal punctuation and citations omitted).  In other words, there was no newly-acquired information – and the Complaint did not suggest otherwise – and therefore no ability to change the label using the CBE procedure.  The court concluded, “Accordingly, to the extent that the Plaintiff alleges . . . that the currently FDA-approved label is insufficient, any such claim is preempted by federal law, and thus must be dismissed.”  Id.

No great surprises here – this pro se plaintiff had no case, and this decision double-underscores that reality.  Stay safe out there.