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We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege.  Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.

One of the states as to which federal courts have predicted the rejection of failure-to-recall claims is New Hampshire.  That decision, Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789 (D.N.H. Sept. 14, 2010) (“Bartlett I”), arose in an unusual posture due to a quirk of state law.  Punitive damages are not available in New Hampshire, except as something called “enhanced compensatory damages.  Id. at *1.  So plaintiff also alleged failure to recall as a way to claim that the defendant should have stopped selling its generic drug altogether:

[Defendant] did not even need the FDA’s permission to stop selling [the drug].  It could have done so unilaterally at any time.  The reason that [defendant] has inserted the FDA as a middleman is that “almost all of the opinions which have addressed the issue have found that there is no common law duty to recall” products from the market, even if they are unreasonably dangerous.

Id. at *19 (quoting 5 L. Frumer & M. Friedman, Products Liability, §57.01[4], at 57–9 (2010)).  That’s also exactly what our earlier recall post demonstrated.  Strict liability only demands compensation “for the damage caused by unreasonably dangerous products, not necessarily that [defendants] remove such products from the market.”  Bartlett I, 2010 WL 3659789, at *10 (citation and quotation marks omitted).  Thus, plaintiff “lengthened the chain of causation to include the FDA in an attempt to overcome the lack of any duty on [defendant’s] part to stop selling [its drug].

Unfortunately for the plaintiffs in Bartlett I, while the strict liability verdict they had received was being appealed, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), happened.  Since they were also suing over a generic drug, plaintiffs had to abandon their strict liability claims as preempted by Mensing, so they fell back on their failure-to-recall claim, which they then simply called “stop selling.”  They got away with this in the Court of Appeals, but not in the Supreme Court.  In Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (“Bartlett II”), and the Supreme Court held that claims demanding that a defendant “stop selling” an FDA-approved product were necessarily preempted.

In Bartlett II the Supreme Court recognized that common-law “stop-selling” claims against FDA-approved prescription drugs are inherently preempted, because they conflict with FDA’s product approval authority.  Initially, Bartlett II reaffirmed that “[e]ven in the absence of an express pre-emption provision, the Court has found state law to be impliedly pre-empted where it is impossible for a private party to comply with both state and federal requirements.”  Id. at 480 (citation and quotation marks omitted).

Bartlett II flatly rejected the contention that a drug manufacturer “could escape the impossibility of complying with both its federal- and state-law duties by ‘choos[ing] not to make [its FDA-approved drug] at all.”  570 U.S. at 488.  “[T]his ‘stop-selling’ rationale [i]s incompatible with our pre-emption jurisprudence.”  Id.  The Bartlett II decision explained:

Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability.  Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless.

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases.  In every instance in which the Court has found impossibility pre-emption, the “direct conflict” between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.

Id. (citation and quotation marks omitted).

Consequently, “the mere fact that a manufacturer may avoid liability by leaving the market does not defeat a claim of impossibility.”  Id. at 489 n.5.  Such litigation conflicts with FDA authority fully as much as a state “statutory mandate” that “directly prohibit[s] the product’s sale.”  Id.  State-law tort litigation, such as this, that “require[s] a manufacturer to choose between leaving the market and accepting the consequences of its actions,” is preempted.  Bartlett, 570 U.S. at 491.

Since Bartlett II, state-law tort claims that would “require[]” the manufacturer of an FDA-approved drug “to exit the market” have been uniformly preempted, however pleaded.  Drager v. PLIVA USA, Inc., 741 F.3d 470, 476 (4th Cir. 2014); accord Hernandez v. Aurobindo Pharma USA, Inc., 582 F. Supp.3d 1192, 1213 (M.D. Fla. 2022). (“any argument that [the defendant] should have stopped selling the drug is unavailing”).  Here are a bunch more cases for the same proposition.  Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127, 162-63 (Cal. App. 2017) (OTC drug); Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 300 (6th Cir. 2015) (“never start selling” claim); Beaver v. Pfizer, Inc., 2024 WL 234725, at *3 (W.D.N.C. Jan. 22, 2024); GenBioPro, Inc. v. Sorsaia, 2023 WL 5490179, at *8 n.10 (S.D.W. Va. Aug. 24, 2023) (FDA REMS, anti-abortion statute); Bossetti v. Allergan Sales, LLC, 2023 WL 4030681, at *5-6 (S.D. Ohio June 15, 2023); Beaver v. Pfizer, Inc., 2023 WL 2386776, at *3 (W.D.N.C. March 6, 2023), aff’d, 2023 WL 4839368 (4th Cir. July 28, 2023); In re Zantac (Ranitidine) Products Liability Litigation, 548 F. Supp.3d 1225, 1252–53 (S.D. Fla. 2021); Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2021 WL 4472857, at *5 (D.S.C. Sept. 30, 2021); Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *9-10 (D. Haw. Aug. 31, 2020); Javens v. GE Healthcare, Inc., 2020 WL 2783581, at *6 (Mag. D. Del. May 29, 2020) (claim that defendants should have marketed a different product), adopted, 2020 WL 7051642 (D. Del. June 18, 2020); Drescher v. Bracco Diagnostics, Inc., 2020 WL 1466296, at *5 (D. Ariz. March 26, 2020); Mahnke v. Bayer Corp., 2019 WL 8621437, at *5 (C.D. Cal. Dec. 10, 2019); Trisvan v. Heyman, 305 F. Supp.3d 381, 405 (E.D.N.Y. 2018); Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 678 (S.D.N.Y. 2017), aff’d, 919 F.3d 699 (2d Cir. 2019); In re Lipitor Atorvastatin Calcium Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761, 771 (D.S.C. 2016); In re Fosamax Products Liability Litigation, 965 F. Supp.2d 413, 420 (S.D.N.Y. 2013).

Well before Bartlett, the inherent conflict between FDA product-approval authority and state-law failure-to-recall claims demanding removal of FDA-approved products from the market had supported preemption.  As early as 1982, a purported Massachusetts state-law claim demanding recall of an FDA-approved product was preempted in National Women’s Health Network, Inc. v. A.H. Robins Co., 545 F. Supp. 1177 (D. Mass. 1982).  “No court has ever ordered a notification and recall campaign on the basis of state law.”  Id. at 1181.  The FDA has the sole “discretion” to require recall of a product that it approved.  Id. at 1181.

[E]ven if there were state law authority for a notification and recall campaign, such authority would be preempted by the FDCA for the same reasons that there is no implied right of action….  [A]ny state law which would put these same powers in other hands must be deemed foreclosed….  Since the federal interest in this area is “dominant” and the regulatory scheme is “pervasive,” preemption must follow.

Id. (citations omitted).  Similarly, federal preemption has precluded claims in automotive cases that state law could force recalls of cars and trucks where the federal government has not done so, or to a greater extent.  See Cohen v. Subaru of America, Inc., 2022 WL 721307, at *38 (D.N.J. March 10, 2022) (collecting cases).

The same was true of medical device cases before the Supreme Court’s 2008 recognition of broad express preemption in pre-market approved medical device cases.  See Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  In Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005), the plaintiffs’ proposed failure-to-recall claim “undermine[d] their preemption arguments, because those claims assert that Defendant has duties independent of any obligations … to comply with applicable federal regulations.”  Id. at 424-25 (quotation marks omitted).  “Any claim … that Defendant … failed to recall a product without first going through the PMA supplement process” was “futile” because it necessarily diverged from the FDA’s recall-related requirements.  Id.  Differing FDCA and state-law recall obligations pertaining to the same FDA-regulated products inherently conflict:

[F]ederal regulations place a duty on manufactures to inform the FDA of problems, and a duty on the FDA to recall [such products].  Plaintiffs’ proposed duties would add to this scheme by requiring the manufacturer to notify patients of potential defects or to pull possibly deficient devices from the market.  Therefore, a state action for failure to notify or recall would impose an additional requirement from those prescribed by federal law; such a cause of action is preempted.

Hunsaker v. Surgidev Corp., 818 F. Supp. 744, 754 (M.D. Pa. 1992), aff’d, 5 F.3d 1489 (3d Cir. 1993).

Given that failure-to-recall claims were preempted by FDA medical device approval even prior to Riegel, a fortiori, post-Riegel medical device cases continue to hold failure-to-recall claims preempted.  Sundaramurthy v. Abbott Vascular, Inc., 2023 WL 2311661, at *3 & n.3 (D. Mass. March 1, 2023) (following Cupek); Poozhikala v. Medtronic, Inc., 2022 WL 610276, at *5 n.4 (C.D. Cal. Jan. 31, 2022) (FDCA recall is a voluntary action that state law cannot make mandatory); Bryant v. Thoratec Corp., 343 F. Supp.3d 594, 604-05 (S.D. Miss. 2018) (preempting claims that “Defendants should have sooner issued a recall”; preemption not defeated because “the FDA permits voluntary recalls”); Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129, 185 (D.D.C. 2018) (state-law recall claim that ignored FDA supplementation requirements preempted); Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443, 451-52 (E.D. Pa. 2011) (state-law claim that FDA recall should have included unrecalled products preempted); Franklin v. Medtronic, Inc., 2010 WL 2543579, at *6 (Mag. D. Colo. May 12, 2010), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010) (same as Poozhikala); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1159 (D. Minn. 2009) (“claims alleging that [defendant] should have recalled the [product] sooner than it did are … preempted”), aff’d, 623 F.3d 1200 (8th Cir. 2010).

A failure-to-recall claim necessarily alleges that the defendant should not have sold, at the time of the plaintiff’s purchase or use,  a product that the FDA had authorized to be sold.  The only way to avoid liability, under this theory, is not to have sold the product at all.  Thus, it is merely a “stop selling” claim with the extra element of hypothetical FDA action added, as Bartlett I recognized.  When the same plaintiffs took the same claim to the United States Supreme Court, it was held preempted in Bartlett II.