Given what we saw in states such as Mississippi, Oklahoma, and Idaho even before the Supreme Court’s in Dobbs v. Jackson Women’s Health Org., ___ S. Ct. ___, 2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. At least one state already has such a law. La. R.S. §40:962.2.
States can exercise control (for good or ill) over medical practice, including the prohibition of illegal drugs. Whalen v. Roe, 429 U.S. 589, 597 (1977); Robinson v. California, 370 U.S. 660, 664 (1962). But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 21 U.S.C. §393(b)(1). Congress required the FDA to “protect the public health” by making sure that “drugs are safe and effective.” Id. §393(b)(2)(B).
“Pre-emption is not a matter of semantics. A State may not evade the pre-emptive force of federal law by resorting to . . . description at odds with the statute’s intended operation and effect.” Wos v. E.M.A. ex rel. Johnson, 568 U.S. 627, 636 (2013). On occasion, states have attempted to prohibit sale and/or use of non-abortion-related FDA-approved products, but with one exception, these efforts have not resulted in litigation. See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. St. L. Rev. 1, 16-22 (2016) (collecting examples).
However, one state’s attempt to prohibit doctors in that state from prescribing an FDA-approved opioid did produce interesting precedent (which we previously discussed here and here). Massachusetts was enjoined in Zogenix, Inc. v. Patrick, 2014 WL 1454696 (D. Mass. April 15, 2014) (“Zogenix I”), and Zogenix, Inc. v. Patrick, 2014 WL 3339610 (D. Mass. July 8, 2014) (“Zogenix II”), vacated in part on other grounds, 2014 WL 4273251 (D. Mass. Aug. 28, 2014) (after prohibition rescinded) (“Zogenix III”). The state (technically, a commonwealth) first tried an outright ban − allowing only an “abuse-resistant formulation” that the FDA had not approved − with the governor “empower[ing]” the public health department “to immediately prohibit the prescribing and dispensing of” the plaintiff manufacturer’s drug. Zogenix I, 2014 WL 1454696, at *1-2. The ban was preempted. “If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.” Id. at *2
The state then took another tack, enacting onerous “regulations limiting the prescribing and handling of” the drug that amounted to a “de facto ban.” Zogenix II, 2014 WL 3339610, at *1, 3. The disputed regulations ostensibly regulated how health care providers and pharmacists could prescribe and/or dispense the targeted drug. They required that the prescriber “certify” in a particular for of writing that “other pain management treatments have failed” and they limited its distribution “only” to pharmacists. Id. at *2. The plaintiff manufacturer argued, and the court agreed, that the state’s regulations were so restrictive that they effectively “banned [the drug’s] prescribing, ordering, dispensing, or administration.” Id. at *1.
Logically, that state action contradicted the FDA’s determination, essential to the FDA’s approval of that (or practically any) product, that the drug’s benefits outweighed its risks. The state could not interpose its “no,” where the FDA, exercising federal power, had said “yes.” This logical contradiction posed a significant “obstacle” to the exercise of the FDA’s authority to approve the products it regulates for marketing. “What is a sufficient obstacle is a matter of judgment, to be informed by examining the federal statute as a whole and identifying its purpose and intended effects.” Id. at *2 (quoting Crosby v. National Foreign Trade Council, 530 U.S. 363, 373 (2000)). The effective state-law ban of an FDA-approved drug necessarily “frustrated” the FDCA’s statutory scheme, requiring that the state’s power “must yield to the regulation of Congress.” Zogenix II, 2014 WL 4273251, at *2 (quoting Savage v. Jones, 225 U.S. 501, 533 (1912)).
- “to ‘protect the public health’ by ensuring that ‘drugs are safe and effective’”;
- to require that “[t]he FDA must approve new drugs before they are introduced to the market”;
- to create “a structured risk-benefit assessment framework” administered by the FDA;
- to preclude approval of any new drug “if [the FDA] concludes the drug is unsafe, or if there is insufficient information from which to determine whether the drug is safe”; and
- to “mak[e] available to the public” new drugs that “pass the [FDA’s] benefit-risk assessment” and thus “promote the public health.”
Id. at *3 (various statutory citations omitted).
The state continued to run afoul of preemption in Zogenix II by “trying to make scarce or altogether unavailable a drug that the FDA, by approving it, has said should be available.” Id. Notwithstanding a state’s undisputed police power “to regulate the administration of drugs by the health professions,” no state may “exercise those powers in a way that is inconsistent with federal law.” Id. at *5. While states had considerable power to regulate the use of opioids as controlled substances, they could not exercise that power to bar the use of an FDA approved drug altogether through the chilling effect of what Zogenix II found to be a “vague” and “uncertain” regulatory scheme. The state “Defendants may interpret and enforce the challenged regulations in a way that obstructs the FDCA’s objectives,” however, they may also act more liberally. Id. at *5.
Finally, in Zogenix III, after the state rescinded that set of regulations and “promulgated new regulations” that “omit[ted] the conflicting, troublesome language” that amounted to a ban by other means, the new regulations “no longer offend[ed] the Supremacy Clause of the United States Constitution.” 2014 WL 4273251, at *1, 3. “The obstacle − mandatory preliminary prescribing of other [drugs] − has now been removed.” Id. at *3.
While the Zogenix litigation invoked so-called “purposes and objectives” preemption (see our discussion here), additional support for preemption of state-law bans of FDA-approved drugs under the rubric of impossibility preemption is found in product liability decisions that are the Blog’s primary focus. An absolute prohibition on the marketing of an FDA-approved product is the most extreme form of a purported state-law “stop selling” duty that the United States Supreme Court held preempted in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). “Stop-selling” claims are simply:
incompatible with our pre-emption jurisprudence. 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…. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless.
Id. at 488 (citation and quotation marks omitted). Importantly, Bartlett recognized that “statutory ‘mandate[s]’ do precisely the same thing” as tort suits in that they “require a manufacturer to choose between leaving the market and accepting the consequences of its actions.” Id. at 491. Bartlett went on to analogize imposition of stop-selling tort liability to a state’s “directly prohibiting the product’s sale.” Id. at 489 n.5. Even one of the two dissents in Bartlett expressed discomfort with stop selling claims.
The FDA is responsible for administering the relevant federal statutes. And the question of pre-emption may call for considerable drug-related expertise. Indeed, one might infer that, the more medically valuable the drug, the less likely Congress intended to permit a State to drive it from the marketplace.
Id. at 494 (but finding conflicting FDA positions on the particular issue before the Court) (Breyer & Kagan JJ., dissenting).
Thus, “‘an outright ban’ cannot be a viable alternative to sustain a [state-law] claim.” Trisvan v. Heyman, 305 F. Supp.3d 381, 405 (E.D.N.Y. 2018). “Insofar as the plaintiffs’ . . . suggest that the defendants should never have sold the FDA-approved formulation of [their drug], such claims have been explicitly repudiated by the Supreme Court.” Utts v. Bristol-Myers Squibb Co., 226 F. Supp.3d 166, 186 (S.D.N.Y. 2016). Likewise, in Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2021 WL 4472857 (D.S.C. Sept. 30, 2021), the plaintiff’s claim that the defendant’s drug “should have been banned . . . constitutes a ‘stop-selling’ theory, which courts have consistently found to be preempted by federal law.” Id. at *4.
Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), similarly preempted a state-law claim “that defendants should never have sold the[ir] FDA-approved [product] in the first place” was preempted under Bartlett as another variant of a “‘stop-selling’ rationale.” Id. at 300. Similarly reflecting Bartlett’s holding, preemption of demands based on state law that drug/device manufacturers refrain from selling their FDA-approved products is widespread. The court in Gross v. Pfizer, Inc., 825 F. Supp.2d 654 (D. Md. 2011), aff’d, 741 F.3d 470 (4th Cir. 2014), was “aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce.” Id. at 659. “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.” Id. Likewise, an appellate court in California “conclude[d] that plaintiff’s design defect claim that defendants should have withdrawn [the drug] from the market is preempted by the impossibility preemption analysis . . . in Bartlett.” Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127, 158 (Cal. App. 2017).
In Mayor & City Council of Baltimore v. GlaxoSmithKline, LLC, 2022 WL 537004 (Md. Cir. Jan. 28, 2022), a municipality sought to prohibit the marketing of an entire class of drugs because they were allegedly “inherently dangerous even when taken as directed and when appropriately stored.” Id. at *4. That claim was “impliedly preempted” because it was grounded on the contention that the defendants “would violate their duty under [state] law by simply marketing [their drugs] in its FDA-approved form and with its FDA-approved label. In other words, they would have been required to stop selling” their products. Id.
Numerous other courts reject allegations that state law can prohibit the sale of FDA-approved drugs. Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *9-10 (D. Haw. Aug. 31, 2020) (quoting and following Bartlett); 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 was “clearly preempted by federal law), adopted, 2020 WL 7051642 (D. Del. June 18, 2020); Mahnke v. Bayer Corp., 2019 WL 8621437 at *5 (C.D. Cal. Dec. 10, 2019) (quoting and following Bartlett); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761, 771 (D.S.C. 2016) (“any claims that Defendant should have simply stopped selling the drug to women . . . is preempted”); Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 678 (S.D.N.Y. 2017) (claims that “challenge the FDA’s approval of . . . [an] indication . . . are preempted”) (quoting 73 Fed. Reg. 49603, 49606 (FDA Aug. 22, 2008)), aff’d, 919 F.3d 699 (2d Cir. 2019); In re Fosamax Products Liability Litigation, 965 F. Supp.2d 413, 420 (S.D.N.Y. 2013) (Bartlett “preempted the possibility of [state law] claims based on a [drug manufacturer’s] failure to stop selling the product”). But see Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 537-38 (6th Cir. 1993) (pre-Bartlett decision allowing what was essentially a stop selling claim) (applying Kentucky law).
A couple of other cases we’ve blogged about also bear on state-law attempts to ban FDA-approved products. First, in a non-product liability application of Bartlett, the court in Exela Pharma Sciences, LLC v. Sandoz, Inc., 486 F. Supp.3d 1001 (W.D.N.C. 2020), held that a competitor could not attack the FDA’s discretion to allow a product on the market on an emergency basis through a “memorandum of discretion.” Id. at 1008. The Excela decision analogized the plaintiff’s attack on the legality of the defendant’s FDA-approved importation of its product to a Bartlett-style “stop-selling” claim:
[T]he FDA issued a Memorandum . . . allowing the Defendant temporary permission to import and sell its [drug] product. Notwithstanding the Defendant’s permission from the FDA, a viable [trade practices] claim related to the import and sale of [that] product would have nonetheless forced the Defendant “to leave the market or accept tort liability.” This is precisely the type of claim that . . . must be preempted.
Id. at 1015 (quoting Drager v. PLIVA USA, Inc., 741 F.3d 470, 479 (4th Cir. 2014)). Consequently, any claim “assert[ing] that the only way to comply with state law would have been for the Defendant to leave the market notwithstanding the Defendant’s compliance with the FDA’s directives” is preempted. Id.
Finally, for historic reasons we discussed here, the FDA, for a long time (this now seems to be changing) allowed the marketing and sale of homeopathic products despite considerable questions about their efficacy. In 2015, private plaintiffs, wielding state-law causes of action, attempted to enjoin the continued sale of homeopathic products market despite the FDA allowing them to be sold. Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015). That injunctive claim was impliedly preempted.
Plaintiffs’ suit seeking to change the labeling requirements of Defendant’s homeopathic medication conflicts with federal policy and should be impliedly preempted. . . . [T]he Court additionally finds that allowing the claim for injunctive relief to go forward would undermine the purpose for which Congress enacted the uniformity provision and thwart the Food and Drug Administration’s ability to carry out its oversight of marketing of homeopathic products.
Id. at *5.
As our past posts indicate, we’ve always been interested in the preemption of state-law “stop selling” claims. But before, that had been in our capacity as defense counsel in prescription medical product liability litigation. Post-Dobbs, it’s personal as well. Because, as this post makes crystal clear, FDCA-based preemption can be a pro-choice position.