We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway.  When we say long-held, we mean it, because we had a few of the first cases where this theory was put forward in earnest.  Back during the diet drug litigation, we had cases with very significant alleged injuries and a colorable argument that the label was inaccurate as to the risk of the plaintiffs’ injuries.  However, their lawyers were a bit nonplussed when each prescribing physician testified that even the plaintiff’s desired warning would not have changed the decision to prescribe the medication to the plaintiff.  So, the lawyers came up with a way to get around the obvious lack of proximate cause for failure to warn (and other impediments under the laws of Pennsylvania and Ohio).  If the drug had not been sold at the time, then it did not matter what the prescribers thought.  The failure to withdraw the drug was, they reasoned, the proximate cause of each plaintiff’s injuries.  In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician).

In one of our longest non-Bexis posts, we detailed the ten year journey from the rejection of this claim, to its limited acceptance, to the recognition that such a claim would be preempted.  The short version is that the Sixth Circuit in Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) (Pennsylvania law), mucked things up and cases like Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281 (6thCir. 2015), Tersigni v. Wyeth Ayerst Pharms., Inc., 817 F.3d 364 (1st Cir. 2016), and In re Zantac (Ranitidine) Prods. Liab. Litig., 510 F. Supp. 3d 1034 (S.D. Fla. 2020), helped restore some sanity.  The Supreme Court provided strong assists with PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013).  Since the appellate decisions in Wimbush and Lance, few courts have expressly recognized a “stop selling” cause of action for FDA-authorized medical products.  Others have gone straight to finding that any such claim would be preempted.  [A listing of these decisions in the context of generic drugs is included here.] Relatively few have recognized a claim and found it not preempted, but they have generally analyzed preemption first, which is not how you do it.  [Some discussion of preemption of state “stop selling” actions outside of product liability are here, here, and here.]  Sometimes, the analysis is broken up between pre-approval and post-approval periods, with courts being somewhat more likely to find pre-approval claims preempted.  A post-approval “stop selling” claim is pretty much indistinguishable from a “failure to recall” claim, which had been pretty widely rejected by various states as to various types of products before Wimbush and Lance.

Plaintiffs rarely stop trying just because the weight of authority is against them.  In Beaver v. Pfizer Inc., No. 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C. Mar. 6, 2023), the plaintiff faced a motion to dismiss on her proposed claims for post-approval failure to recall and failure to warn with a well-known prescription anti-inflammatory medication.  She lost, but two wrinkles make this extra interesting to us.  First, she was pro se, which means she benefitted from a more liberal pleading standard.  Second, her case was dismissed with prejudice on her first complaint.  The de facto three strike rule has been one of our bête noires for a while.  The Beaver judge deserves a warm hand clap (or tail thwack) for not falling for either trap.

Plaintiff claimed to have taken took defendant’s medication for fifteen years before she was diagnosed with chronic kidney disease.  Apparently having nothing to allege related to studies suggesting the drug causes chronic kidney disease or that defendant should have included more or different warning about kidney risks, she based her allegations on the risk of heart attacks and strokes, neither of which she had.  Indeed, she claimed FDA told the defendant to remove the drug from the market because of those risks in 2005, the year she was first prescribed it.  Plaintiff might have spent a few minutes on the internet before drafting her complaint or responding to the motion to dismiss, because her allegations were clearly bunk.  Although the notorious Public Citizen group had filed a citizen’s petition in January 2005 to have all COX-2 inhibitors, including defendant’s medication, removed from the market, FDA followed the vote of an advisory committee and kept the medication on the market with changes to the label and a recommendation of a post-marketing study.  There was a similar endorsement in 2018.  There were also warnings about kidney risks in the physician labeling and a medication guide through plaintiff’s use of the drug, contrary to her allegation that the label did not “contain a warning about potential kidney damage.”  The Beaver court might have taken judicial notice of some or all of these facts (easily ascertainable from https://www.fda.gov), but it did not need to do that to kick the case.

On the stop selling claim, Beaver went right to preemption without evaluating whether North Carolina has such a claim or conducting an Erie analysis to predict whether it would adopt it.  That gnaws at us, but the preemption analysis was simple and toothsome.  It quoted from Bartlett on impossibility preemption and the rejection of the argument that it “could be avoided because [the] pharmaceutical company could comply with seemingly irreconcilable state and federal laws by ceasing production of the drug altogether.” 2023 WL 2386776, *3.  Because the drug “was and continues to be an FDA-approved medication [] allowing a state law duty to nonetheless prohibit sale would frustrate the purposes of the FDA’s regulatory scheme.”  Id. (citing Gross v. Pfizer, Inc., 825 F. Supp. 2d 654, 659 (D. Md. 2011)).  Thus, plaintiff asserted “the precise ‘stop-selling’ rationale explicitly rejected by the Supreme Court and, accordingly, the Plaintiff has failed to state a claim of negligence based on this theory.”  Id.  Direct and, as we noted above, with prejudice.

The failure to warn claim fared no better.  North Carolina law requires unreasonable conduct and, of course, proximate cause, but the complaint mere offered “formulaic recitation of the third element [risk of harm from an inadequate warning] of the failure to warn test under North Carolina law, which is inadequate to state a claim.”  Id. (citing Twombly).  North Carolina has also adopted the learned intermediary doctrine by statute, with an exception when the FDA requires “direct consumer warnings or instructions.”  Plaintiff did not allege the exception or the basic elements of a physician-focused warnings claim.  So, this claim was also dismissed with prejudice.

We cannot say the Beaver plaintiff would have gotten past a motion to dismiss had she retained a competent lawyer.  Such a lawyer might have told her not to sue at all.  But sue she did, so Beaver ends up as another case rejecting the silly stop selling theory of liability for an FDA-approved drug.