Dobbs v. Jackson Women’s Health Organization

James M. Beck*

I. Why It Made the List

The monumental fallout from the Supreme Court’s first abolition of a constitutional right in modern times places FDA squarely in the crosshairs of the ongoing American culture wars. Already we have seen state-law attempts to ban distribution, prescription, and use of FDA-approved abortifacient drugs,[1] as well as an unprecedented attack on the FDA’s ability to approve such drugs.[2]

On the other hand, supporters of reproductive choice have affirmatively interposed FDA drug regulation, such as Risk Evaluation and Mitigation Strategy (REMS) requirements, against state actions to restrict abortion.[3] The President of the United States directed the Secretary of Health and Human Services (HHS), which oversees FDA, to “protect women’s access to critical medications for reproductive health care that are approved by the Food and Drug Administration—including . . . medication abortion.”[4] Depending on their political proclivities, future presidents could do the same or could demand that FDA do precisely the opposite.

Because of its likely impact on FDA over the coming years and decades, the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Org.[5] makes our list of the top Federal Food, Drug, and Cosmetic Act (FDCA)-related cases of 2022 even though it does not mention the FDA. One measure of Dobbs’ ongoing impact is that portions of this Article may well have become obsolete by the time it is published and distributed.

II. Discussion of the Facts, Holding, and Rationale

From the moment that the United States Supreme Court first recognized a federal constitutional right to privacy in matters pertaining to abortion in Roe v. Wade,[6] powerful political forces have sought to reverse that decision and once again to make abortion illegal, first in those states that these forces control, and eventually nationwide. It took almost fifty years, but the addition of three new anti-abortion justices to the Supreme Court during the administration of Donald J. Trump augmented the Court’s Roe opponents sufficiently that the 5–4 Dobbs decision resulted.

Dobbs was a challenge to a gestational-age-based Mississippi statute that prohibited all abortions after fifteen weeks of gestation[7] brought by the Jackson Women’s Health Organization (JWHO), which at the time was the sole remaining abortion provider in Mississippi,[8] and one of its physicians. The defendant was the state, in the person of certain state officials.[9] The district court, on the strength of Roe and its progeny, enjoined enforcement of the statute, and the Fifth Circuit affirmed.[10]

The Supreme Court reversed, expressly overruling Roe and several other Supreme Court decisions based on Roe.[11] The key holding in Dobbs was stark: the Constitution no longer supports any right of a pregnant woman to obtain an abortion.[12] All authority to regulate abortion now belongs to “the people,” through their elected representatives, both federal and state.[13] One of the regulating entities, although not mentioned in Dobbs, is FDA.

While the Constitution contains no express reference to a right to obtain an abortion,[14] it does confer a “liberty” interest against state restrictions under the Fourteenth Amendment.[15] Other constitutional provisions viewed as sources of a generalized individual right to privacy include the First, Fourth, Fifth, Ninth, and Fourteenth Amendments.

Dobbs examined Due Process-related protections for abortion in a historical context, as whether they were “essential to our Nation’s scheme of ordered liberty,”[16] and found no satisfactory basis in American history and tradition.[17] Finding a direct appeal to “liberty” interests inadequate, as “liberty” provided little guidance,[18] the Court’s historical analysis centered on abortion historically being considered a crime, both under English common law[19] and under state law at the time that the Fourteenth Amendment was enacted in 1868.[20] That straitjacket allowed the majority to enact its “own ardent views . . . about the liberty that Americans should enjoy” into law,[21] through its reasoning that the Court should be “reluctant” to recognize rights not mentioned in the Constitution.[22] The Court’s historical analysis supported its decision to overrule Roe and to allow states to re-criminalize abortion.

Appeals to grounds other than the majority’s historical analysis fell on deaf ears. While “the great common-law authorities” of earlier centuries—Bracton, Coke, Hale, and Blackstone—only confirmed criminalization of abortion after “quickening,”[23] that absence of evidence was not evidence of absence, since these authorities did not suggest any limit on the power of the states to ban pre-quickening abortions as well.[24]

Nor was the Dobbs majority willing to consider constitutional protection for abortion as part of a broader “right” of personal “privacy” for “intimate and personal choices” that are “central to personal dignity and autonomy.”[25] Instead, “ordered liberty” prevailed, with the Court concluding that whatever “particular balance” the people of any particular state struck, through their political representatives, would suffice.[26] The notion of ordered liberty does not prevent “elected representatives from deciding how abortion should be regulated.”[27]

Further, no right to obtain an abortion could be justified as a component of a broader right to personal autonomy.[28] Such a right was too general to be cabined in any meaningful fashion.[29] Abortion is different because of the state’s converse “critical moral” interest in protection of the “potential life” represented by “unborn human beings.”[30]

Nor could constitutional protection of services be justified any longer by the doctrine of stare decisis. Dobbs considered five factors in deciding to overrule Roe and Casey:

  • The nature of the claimed error—deciding that Roe was “egregiously wrong and on a collision course with the Constitution from the day it was decided” and “short-circuited the democratic process.”[31]
  • Quality of the reasoning—finding that Roe created an “arbitrary” trimester scheme by engaging in judicial fact-finding rather than following the constitutional text, history, or precedent, while ignoring the effect of abortion on “potential life.”[32]
  • Workability of the result—holding that the previous “undue burden” test made it “impossible” to draw a “line between” permissible versus unconstitutional restrictions in an “evenhanded, predictable, and consistent” manner.[33]
  • Spillover effects—asserting that the Roe line of precedent distorted other “important but unrelated legal doctrines,” such as facial constitutional challenges, standing, res judicata, severability, statutory construction, and the First Amendment.[34]
  • Reliance on existing precedent—minimizing any reliance interest in the right Roe recognized as involving “unplanned activity” while discounting any attempts to weigh the relative importance of the interests of the fetus and the mother as both “speculative” and “substitut[ing judicial] social and economic beliefs for the judgment of legislative bodies.”[35]

Finally, the majority refused to be “affected” by what it considered the “extraneous” concern that the Dobbs decision would be viewed as an exercise of political, rather than judicial, power.[36] Because the prior Roe and Casey decisions had “fail[ed]” to “end the[] national division” regarding the abortion issue, that “national controversy” justified overruling those decisions because “there is no reason to think that another decision sticking with Roe would achieve what Casey could not.”[37]

Having overruled Roe and decided that procuring an abortion was not a “fundamental” constitutional right,[38] the Dobbs majority held that state abortion regulations were subject only to “rational basis” review, even though the issue itself was a matter of great social significance and moral substance. State abortion-related restrictions, like other health and welfare laws, enjoy a “strong presumption of validity.”[39] Courts should sustain such laws as long as they can find a rational basis between them and legitimate state interests. Because the Mississippi statute was supported by specific legislative findings, including that state’s interest in “protecting the life of the unborn,”[40] the necessary rational basis existed, and the challenge failed.

III.   Impact

The decision in Dobbs to abolish the previous constitutional protection afforded to abortion exposes FDA fully to that “national controversy,” since FDA approval is the basis for the availability of the drugs commonly used for medication abortions, chiefly mifepristone, misoprostol, and to a lesser extent, methotrexate.[41] Medication abortions now account for over half of all abortions in the United States.[42] Until 2023, FDA’s Risk Evaluation and Mitigation Strategy (REMS) for mifepristone imposed a requirement that patients obtain the drug in person at a certified provider, but the agency, under pressure of litigation,[43] eliminated in-person delivery, so that the drug can be dispensed by mail.[44]

Anti-abortion forces have commenced their own litigation, an unprecedented challenge to FDA’s approval, over two decades ago in 2000, of mifepristone,[45] which as of this writing remains pending. In Alliance for Hippocratic Medicine v. FDA (AHM), the plaintiffs allege that a Nineteenth Century statute, the so-called “Comstock Act,”[46] makes it illegal for FDA to approve any abortifacient drug—even though the FDCA post-dates that 1873 statute. Enacted primarily to exclude indecent material from being mailed, the Comstock Act made unmailable “[e]very article or thing . . . intended for producing abortion,” including any “drug” or “medicine.”[47]

Long before Roe, appellate courts had interpreted the Comstock Act as applying only to otherwise “illegal” matter.[48] Since Congress subsequently granted FDA the power to approve drugs for marketing in interstate commerce without abortion-specific limitations,[49] that would seem to put the Comstock Act to rest.[50] Nonetheless, the district court[51] in AHM relied on the Comstock Act as prohibiting interstate sale of this FDA-approved drug.[52] The district court also excused the AHM plaintiffs’ extremely belated regulatory challenges to the original FDA approval of mifepristone.[53] However, the six-year applicable limitation period was reinstated on appeal.[54] Both the district court and Fifth Circuit opinions, however, took an extremely liberal approach to standing, potentially exposing future FDA drug approvals to collateral attack by any physician who might be inconvenienced by having to treat patients with adverse drug reactions.[55]

Both courts also disregarded an extensive 2008 investigation into FDA’s approval process that concluded FDA acted appropriately,[56] indicating their unprecedented willingness to disregard the usually rigorous arbitrary and capricious standard of review and thereby substitute their judgments for FDA’s scientific conclusions.[57]

As of this writing, the AHM decisions have been temporarily stayed,[58] but should the above aspects of those decisions stand, it would set a dangerous precedent that non-expert courts can essentially ignore FDA’s expert scientific judgments, reweigh the scientific evidence as they see fit, and retroactively revoke FDA marketing approval of regulated products. Given that mifepristone has been approved since 2000, the implication of such a decision on industry reliance interests and product innovation could be profound.

Abortion defenders are also seeking to utilize FDA decisions to advance their positions. Pursuant to FDA’s mandate to “promot[e] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products,”[59] it has approved abortion-related drugs as safe and effective and has created REMS and other requirements governing their use. Both FDA, under the current administration, and entities distributing these drugs are using FDCA preemption as a means to combat state restrictions on medication abortions post-Dobbs.[60]

Federal law can preempt even implied obstacles to FDA’s regulatory mandate.[61] “[N]ormally Congress would not want States to forbid, or to impair significantly, the exercise of a power that Congress explicitly granted.”[62] States cannot exercise their powers “to regulate the administration of drugs by the health professions . . . in a way that is inconsistent with federal law.”[63] State power to restrict distribution of disfavored, yet federally approved drugs has been subject to federal preemption as an obstacle to FDA power to issue such approvals.[64] Justice Alito, author of Dobbs, has recognized that “[w]here the FDA determines, in accordance with its statutory mandate, that a drug is on balance ‘safe,’ our conflict pre-emption cases prohibit any state from countermanding that determination.”[65]

In particular, recent state private bounty laws[66] can affect distribution of FDA-approved abortion-related drugs similar to the tort claims held preempted in Buckman.[67] Drug marketers’ “ability to comply with state law [would] depend[] on uncertain . . . third-party decisions,”[68] thereby impeding the prescription of FDA-approved drugs for FDA-approved indications. State-law citizen suits over drugs prescribed for FDA-approved indications likewise could create litigation-driven “skew[ing]” of “[t]he balance sought by the [FDA]” in a much more direct way than the claims in Buckman affected off-label use of FDA-approved drugs.[69] The same regulatory concerns that the Court expressed in Buckman would also support preemption of state-law claims that would impose liability for prescribing drugs for uses explicitly considered and approved by FDA.[70]

An independent basis of FDCA-based preemption has arisen in product liability litigation. Mutual Pharmaceutical Co. v. Bartlett[71] held preempted any purported state-law duties that allegedly required FDA-regulated entities to cease distribution of FDA-approved products altogether. “Even in the absence of an express pre-emption provision,” state law will “be impliedly pre-empted where it is ‘impossible for a private party to comply with both state and federal requirements.’”[72] While 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,” Bartlett “reject[ed] this ‘stop-selling’ rationale as incompatible without our pre-emption jurisprudence.”[73]

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.[74]

Because “statutory ‘mandate[s]’ do precisely the same thing” as tort suits insofar as they “require a manufacturer to choose between leaving the market and accepting the consequences of its actions,”[75] Bartlett analogized stop-selling tort liability to a state’s “directly prohibiting the product’s sale.”[76] Given FDA approval of prescription drugs, even one of the two Bartlett dissents expressed discomfort with stop-selling claims in this context.[77]

Since Bartlett, “‘an outright ban’ cannot be a viable alternative to sustain a [state-law] claim.”[78] Following Bartlett, courts across the country have almost universally rejected claims “that the defendants should never have sold the FDA-approved formulation of [their drug, because] such claims have been explicitly repudiated by the Supreme Court.”[79] Any 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,”[80] and “any argument that [defendant] should have stopped selling the drug is unavailing.”[81] Numerous courts have rejected allegations that state law can prohibit the sale of FDA-approved drugs.[82]

Under the Bartlett-based stop-selling rationale—”a straightforward application of pre-emption law”[83]—state efforts to prohibit or restrict mifepristone or other FDA-approved drugs used in medication abortions will be subject to substantial preemption challenge. What the Constitution prohibits states from doing indirectly through product liability litigation is even more problematic when done via “statutory legal mandate.”[84]

Express FDCA preemption will also find itself in the culture war crosshairs, should states seek to interfere with the availability of over-the-counter (OTC) emergency contraceptive drugs. OTC drugs receive protection from an express preemption provision,[85] but preemption is limited by a series of exceptions that states may attempt to rely on to maintain restrictions on emergency contraception. The most significant of these exceptions allows state regulation “that relates to the practice of pharmacy” or “that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such a drug.”[86]

Even before Dobbs, abortion-related political pressures have affected FDA’s science-based regulation of both abortifacient and contraceptive drugs.[87] Dobbs only ups the political ante. Just as abortion opponents will seek to prevent FDA from approving abortion-related drugs at all, conversely, supporters of reproductive freedom will seek to leverage the preemptive effect of FDA drug approval to nullify restrictive state laws. These pressures are not going to abate any time soon, so Dobbs deserves its place in the most significant food and drug cases of 2022.


*    James M. Beck is a Senior Life Sciences Policy Analyst at Reed Smith LLP.

[1]   See, e.g., Wyo. Stat. §35‑6‑120(a) (“it shall be unlawful to prescribe, dispense, distribute, sell or use any drug for the purpose of procuring or performing an abortion”); La. R.S. § 14:87.9 (“Criminal abortion by means of an abortion-inducing drug is committed when a person knowingly causes an abortion to occur by means of delivering, dispensing, distributing, or providing a pregnant woman with an abortion-inducing drug.”).

[2]   All. for Hippocratic Med. v. FDA, ___ F. Supp. 3d ___, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023) (purporting to invalidate FDA’s 1994 approval of mifepristone) (AHM I), stayed in part, 2023 WL 2913725 (5th Cir. Apr. 12, 2023) (AHM II), fully stayed sub nom. Danco Lab’ys, LLC v. All. for Hippocratic Med., ___ S. Ct. ___, 2023 WL 3033177 (U.S. Apr. 21, 2023). See discussion infra notes 45–58.

[3]   E.g., Genbiopro, Inc., v. Sorsaia, 2023 WL 3211847 (S.D.W. Va. May 2, 2023) (rejecting standing and other non-preemption dismissal arguments); Bryant v. Stein, No. 1:23-cv-00077 (M.D.N.C., filed Jan. 25, 2023) (subsequently voluntarily dismissed).

[4]   Press Relase, The White House, FACT SHEET: President Biden Announces Actions in Light of Today’s Supreme Court Decision on Dobbs v. Jackson Women’s Health Organization (June 24, 2022),

[5]   142 S. Ct. 2228 (2022) (Dobbs).

[6]   410 U.S. 113 (1973).

[7]   Miss. Code §41-41-191.

[8]   Jackson Women’s Health Org. v. Currier, 349 F. Supp. 3d 536, 538 (S.D. Miss. 2018), aff’d, 945 F.3d 265 (5th Cir. 2019), rev’d, 142 S. Ct. 2228 (2022) (“Jackson I”).

[9]   Initially, the lead defendant was Mary Currier, chief officer of the Mississippi Department of Health, who was then succeeded in that position by Thomas E. Dobbs.

[10]  Jackson I, 349 F. Supp. 3d at 543–44; Jackson Women’s Health Org. v. Dobbs, 945 F.3d 265, 276–77 (5th Cir. 2019), rev’d, 142 S. Ct. 2228 (2022).

[11]  Dobbs, 142 S. Ct. at 2242. In addition to Roe v. Wade, 410 U.S. 113 (1973), the Dobbs majority overruled or abrogated: June Med. Servs. L.L.C. v. Russo, 140 S. Ct. 2103 (2020); Whole Woman’s Health v. Hellerstedt, 579 U.S. 582 (2016); Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833 (1992); Colautti v. Franklin, 439 U.S. 379 (1979); and Doe v. Bolton, 410 U.S. 179 (1973).

[12]  Dobbs, 142 S. Ct. at 2242.

[13]  Id. at 2257.

[14]  Id. at 2245.

[15]  The Fourteenth Amendment’s equal protection provision is not part of the analysis. See Bray v. Alexandria Women’s Health Clinic, 506 U.S. 263, 273–74 (1993); Geduldig v. Aiello, 417 U.S. 484, 496 n. 20 (1974).

[16]  Dobbs, 142 S. Ct. at 2246 (quoting Timbs v. Indiana, 139 S. Ct. 682, 686, 203 L.Ed.2d 11 (2019)) (internal quotations omitted).

[17]  Id. at 2248–54.

[18]  Id. at 2247.

[19]  Id. at 2249–51.

[20]  Id. at 2254 (concluding that when the Fourteenth Amendment was adopted in 1868, three-quarters of the states criminalized abortion at any stage of pregnancy). Cf. id. at 2241 (observing that twenty states had liberalized their laws by the time Roe was decided).

[21]  Id. at 2247.

[22]  Id. (citing Collins v. Harker Heights, 503 U.S. 115, 125 (1992)).

[23]  Id. at 2249–50.

[24]  Id. at 2250 (citing a “proto-felony-murder rule” as “a way in which a pre-quickening abortion could rise to the level of a homicide”).

[25]  Id. at 2257 (citations and quotation marks omitted).

[26]  Id.

[27]  Id.

[28]  Id. at 2258.

[29]  Id. (“Those criteria, at a high level of generality, could license fundamental rights to illicit drug use, prostitution, and the like.”).

[30]  Id. at 2261 (“The exercise of the rights at issue in [other Fourteenth Amendment due process decisions] does not destroy a ‘potential life,’ but an abortion has that effect.”).

[31]  Id. at 2265.

[32]  Id. at 2265–72.

[33]  Id. at 2272–75.

[34]  Id. at 2275–76.

[35]  Id. at 2276–78.

[36]  Id. at 2278.

[37]  Id. at 2280.

[38]  Id. at 2279.

[39]  Id. at 2284 (citing Heller v. Doe, 509 U.S. 312, 319 (1993)).

[40]  Miss. Code §41-41-191(2)(b)(i).

[41]  See Medication Abortion, Guttmacher Inst. (Apr. 13, 2023),

[42]  Rachel K. Jones, Elizabeth Nash, Lauren Cross, Jesse Philbin & Marielle Kirstein, Medication Abortion Now Accounts for More Than Half of All US Abortions, Guttmacher Inst. (Feb. 24, 2022),

[43]  See Am. Coll. of Obstetricians & Gynecologists v. FDA, 506 F. Supp. 3d 328 (D. Md. 2020) (maintaining injunction against in-person requirement).

[44]  See Questions and Answers on Mifepristone for Medical Termination of Pregnacy Thorugh Ten Weeks Gestation, U.S. Food & Drug Admin. (Jan. 4, 2023),

[45]  See supra note 2.

[46]  18 U.S.C. §§ 1461–62.

[47]  Id. § 1461.

[48]  E.g., Davis v. United States, 62 F.2d 473, 475 (6th Cir. 1933); Youngs Rubber Corp. v. C.I. Lee, 45 F.2d 103, 108 (2d Cir. 1930).

[49]  E.g., 21 U.S.C.A. § 355(d) (listing grounds for refusing a new drug application).

[50]  See GenBioPro v. Sorsaia, 2023 WL 3211847, at *7 (describing Comstock Act as a “widely abrogated 19th century statute which the federal government will not enforce”).

[51]  The AHM litigation is before Judge Matthew J. Kacsmaryk, a Trump appointee, with a reputation as an activist conservative jurist, particularly opposed to legal abortion.

[52]  AHM I, 2023 WL 2825871, at *18–19.

[53]  Id. at *9–12.

[54]  AHM II, 2023 WL 2913725, at *12–15.

[55]  AHM II, 2023 WL 2913725, at *7 (plaintiff “doctors have had to devote significant time and resources to caring for women experiencing [the drug’s] harmful effects. This harm is sufficiently concrete”); AHM I, 2023 WL 2825871, at *4 (plaintiff physicians, and by extension the associational plaintiffs in which they are members, “have standing because they allege adverse events . . . from [the drug] can . . . place enormous pressure and stress on doctors during emergencies and complications”) (quotation marks and footnote omitted).

[56]  U.S. Gov’t Accountability Off., GAO-08-751, Food and Drug Administration: Approval and Oversight of the Drug Mifeprex (Aug. 2008) (“The approval process for [the brand-name version of mifepristone] was consistent with the processes for the other [similarly] restricted drugs.”).

[57]  AHM II, 2023 WL 2913725, at *16–18; AHM I, 2023 WL 2825871, at *24–28.

[58]  Danco Lab’ys, 2023 WL 3033177, at *1. Two justices would have denied the stay and thus allowed partial nullification of FDA’s regulation of mifepristone to go into effect. Id. at *1–2 (Alito & Thomas, JJ., dissenting).

[59]  21 U.S.C. § 393(b)(1).

[60]  FDA drug approval “is tantamount to a required license to sell the drug or device in the United States.” Talley v. Danek Med., Inc., 179 F.3d 154, 160 (4th Cir. 1999).

[61]  E.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 (2001) (“fraud claims attacking submissions to FDA presented an obstacle to FDA’s regulatory scheme by “skew[ing]” the “delicate balance of statutory objectives” that FDA pursued); United States v. Sullivan, 332 U.S. 689, 698 (1948) (states cannot impose prohibitory labeling requirements on FDA-approved drugs ).

[62]  Barnett Bank of Marion Cnty., N.A. v. Nelson, 517 U.S. 25, 33 (1996).

[63]  Zogenix, Inc. v. Patrick, 2014 WL 3339610, at *4 (D. Mass. July 8, 2014), vacated in part on other grounds, 2014 WL 4273251 (D. Mass. Aug. 28, 2014). In Zogenix, state regulations that effectively “banned [the drug’s] prescribing, ordering, dispensing or administration” were preempted because they interfered with FDA’s previous balance of competing safety and availability factors for an opiate drug. Id. at *1, 5. After the state repealed the offending regulations, the injunction against their enforcement was lifted. Zogenix, Inc. v. Patrick, 2014 WL 4273251 (D. Mass. Aug. 28, 2014).

[64]  See Pharm. Rsch. & Mfrs. of Am. v. District of Columbia, 406 F. Supp. 2d 56 (D.D.C. 2005) (state law creating a private right for any “any affected party” to sue for excessive drug prices preempted due to conflict with the purpose and execution of federal patent laws governing drugs).

[65]  Wyeth v. Levine, 555 U.S. 555, 609 (2009) (citing Buckman, 531 U.S. at 348) (dissenting opinion).

[66]  See Tex. 2022 SB 8 (permitting citizens to file suit against anyone who knowingly aids or abets an abortion).

[67]  Buckman, 531 U.S. at 353.

[68]  PLIVA, Inc. v. Mensing, 564 U.S. 604, 623 (2011) (plurality opinion).

[69]  Buckman, 531 U.S. at 348.

[70]  Id. at 350–51.

[71]  570 U.S. 472 (2013).

[72]  Id. at 480 (citations and quotation marks omitted); see also id. at 493 (“the FDCA’s treatment of prescription drugs includes neither an express pre-emption clause,” but “[t]hat federal law forbids [a drug manufacturer] to take actions required of it by state tort law evinces an intent to preempt”).

[73]  Id. at 488.

[74]  Id. (citation and quotation marks omitted).

[75]  Id. at 491.

[76]  Id. at 489, n.5.

[77]  Bartlett, 570 U.S. at 494 (“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.”) (Breyer & Kagan, JJ., dissenting).

[78]  Trisvan v. Heyman, 305 F. Supp. 3d 381, 405 (E.D.N.Y. 2018).

[79]  Utts v. Bristol-Myers Squibb Co., 226 F. Supp. 3d 166, 186 (S.D.N.Y. 2016).

[80]  Silver v. Bayer Healthcare Pharms., Inc., 2021 WL 4472857, at *4 (D.S.C. Sept. 30, 2021) (recognizing that “[t]he Supreme Court has rejected the ‘stop-selling’ theory as incompatible with preemption jurisprudence because if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless”) (quoting Bartlett, 570 U.S. at 488) (internal quotation marks omitted).

[81]  Hernandez v. Aurobindo Pharma USA, Inc., 582 F. Supp. 3d 1192, 1213 (M.D. Fla. 2022).

[82]  Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281, 300 (6th Cir. 2015) (claim “that defendants should never have sold the[ir] FDA-approved [product] in the first place” preempted under Bartlett); Drager v. PLIVA USA, Inc., 741 F.3d 470, 476 (4th Cir. 2014) (state law cannot “require[]” the manufacturer of an FDA-approved drug “to exit the market”); Trejo v. Johnson & Johnson, 13 Cal. App.5th 110, 147 (2017) (“claim that defendants should have withdrawn [the drug] from the market is preempted”); Beaver v. Pfizer, Inc., 2023 WL 2386776, at *3 (W.D.N.C. Mar. 6, 2023) (“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”); In re Zantac (Ranitidine) Prods. Liab. Litig., 548 F. Supp. 3d 1225, 1252–53 (S.D. Fla. 2021) (defendants “not required to stop selling ranitidine in order to comply with federal law while avoiding liability under state law”); Evans v. Gilead Scis., 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); Drescher v. Bracco Diagnostics, Inc., 2020 WL 1466296, at *5 (D. Ariz. March 26, 2020) (quoting and following Bartlett); Mahnke v. Bayer Corp., 2019 WL 8621437, at *5 (C.D. Cal. Dec. 10, 2019) (same); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. & Prods. Liab. Litig., 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 Prods. Liab. Litig., 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”).

[83]  Bartlett, 570 U.S. at 493.

[84]  Id. at 491.

[85]  21 U.S.C. § 379r.

[86]  21 U.S.C. § 379r(c)(1). This subsection has yet to be addressed, or even cited, in any judicial opinion. Whether subsection (c)(1) would permit a state to require a prescription for an OTC drug that, like some forms of emergency contraception, FDA has specifically determined should be available without a prescription is uncertain. Even without express preemption, however, implied conflict preemption could also apply in such circumstances. Buckman, 531 U.S. at 352 (“neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles’”) (quoting Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000)).

[87]  U.S. Gov’t Accountability Off., GAO-06-109, Food and Drug Administration: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual 13 (Nov. 2005).