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When we last reported on Beaver v. Pfizer, the plaintiff’s complaint alleging that the FDA “suggested” that the defendant’s drug be removed from the market had been dismissed because it was a preempted “stop selling” claim.  In any event, as we also pointed out, the plaintiff did not claim the condition that had purportedly prompted the FDA’s suggestion.  The plaintiff’s warning claim had also been dismissed for ignoring the learned intermediary rule.

Since then, however, the Fourth Circuit cut the pro se plaintiff a break – affirming because there was “no reversible error,” but modifying “to reflect dismissal without prejudice.”  Beaver v. Pfizer, Inc., 2023 WL 4839368, at *1 (4th Cir. July 28, 2023) (citing King v. Rubenstein, 825 F.3d 206, 225 (4th Cir. 2016) (pro se dismissals “should generally be without prejudice”)).

A represented plaintiff would probably have followed up that appellate ruling with an amended complaint, but this pro se plaintiff instead filed a second action, in state court, “again alleging negligence.”  Beaver v. Pfizer Inc., 2024 WL 234725, at *1 (W.D.N.C. Jan. 22, 2024) (Beaver II).  It was immediately removed, and assigned to the same judge who had dismissed the first action.

So the Beaver plaintiff was on her second action.

This has not a been a good season for number twos – at least in NCAA Division I women’s basketball.  The pre-season #2, UConn, promptly lost to then unranked NC State.  Then Iowa became #2.  Iowa promptly lost to then unranked Kansas State.  After that, UCLA rose to #2, and held that position for several weeks, before losing to #9 USC (that is Southern Cal, not #1 South Carolina).  That brought Iowa back to #2, but not for long – the Hawkeyes promptly lost to #18 Ohio State.  So UCLA returned to #2, but only for a week, as they promptly lost to unranked Washington State.  That made Kansas State #2, but only for a week, as the Wildcats lost twice, to unranked Oklahoma and again to #12 Texas.  Thus, in thirteen weeks, six #2 ranked teams have lost seven times.

And so did plaintiff Beaver (the Oregon State Beavers are, as of this writing, ranked #18).  Beaver II points out, as did we, that the FDA did not act because of her condition – her only basis for causation was “because her doctor recommended that she stop taking [the drug] due to her disease,” and afterwards her condition allegedly improved.  2024 WL 234725, at *2.  The plaintiff apparently learned nothing from the initial dismissal, because she once again alleged that she would not have been injured if the defendant had removed the drug from the market.  Id.  This same allegation yielded the same result – preemption.

Plaintiff asserts a negligence/products liability claim, which is a state law claim.  However, any state-law duty Defendant may have to withdraw [the drug] from the market is preempted because the only way to comply would be to cease production of the drug altogether, the precise theory the Supreme Court rejected in Bartlett.  Moreover, allowing a state-law duty to foreclose the sale of an FDA approved medication . . . would also frustrate the purposes of the FDA’s regulatory scheme.  For these reasons, Plaintiff’s “stop-selling” theory does not state an actionable claim for negligence.

Beaver II, 2024 WL 234725, at *3 (citation omitted).

This time around, however, the plaintiff also argued that the defendant “should have never sold” the drug in the first place, because it was “negligently designed.”  Id.  Thus, Beaver II addressed the pre-approval design defect theory we have repeatedly criticized. Beaver II agreed with us.  The “‘should have never sold’ theory is inconsistent with the Supreme Court’s ruling in Bartlett.”  Whether before or after FDA approval, “a pharmaceutical company cannot be made to cease acting to avoid liability.”  Id.  Any form of don’t sell theory is at odds with the FDCA, “as the FDA is tasked with determining whether a drug may be sold in interstate commerce.”  Id. (citation omitted).

Further, to state a claim under North Carolina law, the plaintiff’s negligent design theory must either allege an alternative design or that the design was “so unreasonable” that no reasonable person would “use or consume” it.  Id. at *3-4 (quoting N.C. Gen. Stat. §§99B-6(a)(1)-(2)).  Plaintiff alleged no facts to support either prong.  “Plaintiff has not made any allegations regarding the existence of a reasonable alternative design for [the drug], nor has she alleged that the drug is so unreasonably designed that a reasonable person would not use it.”  Id. at *4.  “[E]ven a pro se plaintiff . . . must allege sufficient facts ‘to raise a right to relief above the speculative level.”  Id. (quoting the aforementioned King decision).  Thus “Plaintiff’s second attempt to state a claim against Defendant for negligence based on these same facts,” was dismissed “with prejudice,” id., and we defense counsel have another good decision for why stop-selling, and never-start selling, claims are preempted.

And later today, we’ll find out who is unfortunate enough to be #2 for Week 14.