Source: https://www.yalelawjournal.org/comment/a-first-amendment-approach-to-generic-drug-manufacturer-tort-liability
Timestamp: 2019-04-20 06:23:11+00:00

Document:
In 2011, the landmark case PLIVA, Inc. v. Mensing1 foreclosed many claims against generic drug manufacturers for harms caused by their products. In particular, Mensingheld that because the Food, Drug, and Cosmetic Act (FDCA) requires generic manufacturers to use labels that are “the same as” the FDA-approved brand-name label,2 the FDCA preempts state-law tort claims against these manufacturers for failing to communicate the potential risks of their products.
Mensing’s outcome has been subject to widespread policy objections. Generic manufacturers, now immune from liability, are consequently also insulated from incentives to warn patients and physicians of known risks. Patients with grave injuries find themselves unable to recover for the harms they have suffered. And brand-name manufacturers increasingly are forced to defend themselves in court from dubious legal theories pressed by plaintiffs who were harmed by generic products.
This Comment identifies a never-before-raised legal problem withthe FDA’s current labeling regulations, which, if resolved by the courts, could address the policy concerns arising from Mensing. In Mensing, the FDA interpreted its regulations to prohibit generic drug manufacturers from communicating independently with physicians about pharmaceutical risks. The outcome in Mensing was reached without any party raising the First Amendment issues surrounding generic pharmaceutical manufacturer liability. Yet the Supreme Court has held that the First Amendment applies to speech by pharmaceutical manufacturers: regulatory burdens on such speech must be justified by narrow tailoring to advance sufficient government interests.3 A recent Second Circuit case applying these principles, United States v. Caronia,4 illustrates how plaintiffs could seek tort damages from generic manufacturers once more. If Caronia’s reasoning is applied in the context of tort suits against generic manufacturers, those manufacturers will no longer be able to take refuge behind the FDA labeling regulations that currently prevent them from warning consumers about risks. In consequence, plaintiffs injured by generic pharmaceuticals would be able to recover from generic manufacturers for failure to warn when those manufacturers failed to communicate warning information to physicians.
This argument is all the more relevant given the ongoing discussion about whether and how to reform the regulatory regime in the wake of Mensing. The constitutional infirmity of the status quo provides an essential starting point for any future reform. A recent Advance Notice of Proposed Rulemaking by the FDA suggests that the agency is considering new regulations that would liberate generic drug manufacturers to alert customers to health risks, potentially undoing the federal preemption of state tort law established in Mensing.5 This early proposal can find validation not only from the policy advantages of restoring state tort claims against generic manufacturers, but also from the recognition that it would resolve an important, albeit thus far overlooked, tension in constitutional law. But it remains to be seen whether and precisely how the FDA will ultimately address the problems Mensingcreated.
Part I explains the regulatory environment and the Mensingdecision, which created the problem this Comment confronts. Part II turns to a different realm of pharmaceutical regulation: the uses for which manufacturers may market their products, as well as recent developments in speech jurisprudence declaring that pharmaceutical manufacturers have a right to communicate with physicians. Part III examines the contradiction of these divergent lines of cases and concludes that Mensing’s holding, based on an impermissible regulatory interpretation, must yield to the speech interests identified in Part II. Restoring the speech rights of manufacturers would vindicate First Amendment values, restore liability and the corresponding set of incentives for generic manufacturers to attend to their products’ safety, and allow injured patients to recover for the harms done to them.
This Part contextualizes the Mensingdecision and explains why it is so objectionable. Brand-name and generic pharmaceutical manufacturers face sharply differing obligations under federal law and regulations. These divergent regulatory regimes resulted in the problematic Mensingholding, which immunized generic manufacturers from tort liability. Mensingcreated an array of urgent problems without good solutions. Courts are wrestling with fraught liability questions and sometimes rendering decisions dubiously consonant with principles of tort law. And while injured plaintiffs and brand-name manufacturers fight these battles in courts throughout the nation, the generic manufacturers whose products actually injure consumers remain immune from suit.
All manufacturers are required to submit annual reports containing information relating to the safety, effectiveness, and appropriate labeling of approved drugs.11 Brand-name manufacturers, unlike generic manufacturers, are also responsible for the “accuracy and adequacy” of the label of a drug12 and may modify its label to reflect new information. The FDA then approves or denies the manufacturer’s label modification through the “Changes Being Effected” (CBE) process.13 A generic manufacturer, in contrast, is responsible only for ensuring “that its warning label is the same as” the FDA-approved brand-name label.14 This reinforces the fact of actual chemical equivalence by ensuring that doctors and patients perceivethe therapeutic identity between formulations.
In Mensing,the Court confronted the problem arising from these conflicting requirements. The plaintiffs were prescribed the brand-name drug Reglan and, after taking an approved generic formulation, developed a severe neurological disorder.17 They alleged that, despite evidence that the labeling didn’t adequately warn of the risk of this reaction, neither brand-name nor generic manufacturers had revised the drug label or advised the FDA.18 Had the plaintiffs taken brand-name Reglan, they would have been entitled to seek recovery under state-law failure-to-warn claims, assuming proof of their allegations.19 As the plaintiffs took a generic formulation, however, they—properly—brought the same claim against the generic manufacturer.
The plaintiffs made three principal arguments supporting the claim that generic manufacturers, despite the duty of sameness, could have satisfied their duties under state tort law. First, the plaintiffs argued that generic manufacturers should have themselves requested that the FDA approve a revision to the label shared by both the brand and generic versions of the drug at issue.20 The Court rejected this argument. As this option still required the FDA’s acquiescence to accomplish any change in warning, the manufacturer still could not have satisfied state-law duties on its own.21 Thus, the plaintiffs could only succeed on the basis of theories that afforded generic manufacturers an independentcapacity to comply with the requirements of state tort law.
Yet Mensingitself leaves open an alternative path to liability that the parties did not brief and the Court did not consider: the First Amendment’s limits on regulation of manufacturers’ speech. Part II surveys recent developments in speech jurisprudence and identifies the freedom of pharmaceutical manufacturers to communicate with physicians. If the First Amendment forbids the FDA’s interpretation regarding Dear Doctor letters, a more principled route for recovery exists. When speech is free, failure to speak may create liability.
This Part considers the recent developments in First Amendment analysis of regulations limiting the speech of pharmaceutical manufacturers. Part III argues that these principles forbid the FDA interpretation at issue in Mensing.
Sorrell fundamentally reframed the constitutional status of pharmaceutical marketing. The case says at a minimum that pharmaceutical manufacturer speech has First Amendment value; open communication between manufacturers and physicians is an important aspect of the free flow of ideas in society. Nor is Sorrell’s holding limited to the question of manufacturers’ access to and use of specific information about doctors. On the contrary, a recent Second Circuit case demonstrated that Sorrell’s innovation extends through the broader regime governing the speech of pharmaceutical manufacturers. In United States v. Caronia,57the Second Circuit applied Sorrell in the context of off-label drug marketing, one area in which federal regulations have traditionally imposed extensive restraints on pharmaceutical manufacturers’ speech. Caronia provides further weight to the Sorrell proposition: federal regulations of pharmaceutical speech must satisfy a heightened level of scrutiny. The Second Circuit concluded that off-label marketing regulations as currently written cannot do so. Careful analysis of Caronia’s reasoning suggests that the FDA’s regulations on generic pharmaceutical speech also offend the Constitution.
Caronia is interesting in its own right as an illustration of how speech principles are altering the landscape in multiple regulatory contexts. It also demonstrates the vitality of the Sorrell standard and its relevance for the regulations the Court considered and accepted in Mensing. The First Amendment analysis announced in Sorrell and applied in Caronia offers a way to shift liability for pharmaceutical harms back to generic manufacturers. Relitigating Mensingbased on Sorrell—this time bringing a meaningful attack against the validity of the FDA’s interpretation of its regulations regarding Dear Doctor letters—should invalidate that interpretation and afford generic manufacturers the freedom and duty to provide physicians with truthful warning information about potential harms. In turn, plaintiffs should be able to recover on tort claims against generic drug manufacturers who fail to do so. Part III explores this First Amendment approach to Mensing.
Caronia destabilizes one of the critical assumptions animating Mensing. The Court in Mensingaccepted the FDA’s interpretation that generic manufacturers may not send Dear Doctor letters to inform physicians of possible risks.78 This conclusion is unsurprising, as respondents failed to contest seriously the FDA’s interpretation of its regulations. Rendered without the benefit of briefing or argument on the merits of the underlying interpretation, the Dear Doctor section of Mensingamounts to nothing more than recognition of Auer deference in the absence of an argument to the contrary.79 However, in light of Sorrell and Caronia, the Dear Doctor interpretation cannot endure, and the Mensingholding based on that interpretation should be reconsidered. Generic manufacturers should have the ability to send such letters, and, correspondingly, they should face liability for harms caused by their failure to do so.
Admittedly, were the Court compelled to confront the contradiction between Sorrell and Mensingthat this Comment identifies, it might avoid the confrontation by limiting Sorrell such that its apparently broad expansion of speech rights would not extend to cover speech designed to communicate risks to doctors. However, if Sorrell is to apply anywhere beyond its facts, this context seems appropriate. The Court’s concerns in Sorrell regarding Vermont’s speech regulation are squarely relevant. The FDA’s interpretation serves to bar one category of actor from engaging in speech available to all other actors, based solely on concerns regarding the potential effect of such speech when wielded inappropriately. Sorrell’s declaration that “speech in aid of pharmaceutical marketing” is a form of protected expression was no mere flight of rhetoric: it was a recognition that the free flow of information “has great relevance in the fields of medicine and public health, where information can save lives.”84 That observation is even more sharply true in the context of pharmaceutical risk than in the area of prescriber information that Sorrell examined. The freedom and obligation to send Dear Doctor letters—and the corresponding imposition of liability for the injuries of harmed plaintiffs attributable to manufacturers’ failure to send such letters—would lead to better-informed doctors and lower incidence of pharmaceutical harm. Sorrell should thus apply to Dear Doctor letters, and the FDA interpretation should receive heightened scrutiny.
Of course, the FDA’s interpretation would still survive First Amendment analysis if it were narrowly drawn to directly advance appropriate interests. After all, the speaker- and content-based analysis above could invalidate the entire generic labeling regime, in the absence of adequate justification. The interests behind the duty of sameness—safeguarding patient health by ensuring therapeutic equivalence and decreasing healthcare costs by increasing availability of cheap generic formulations—are of high moment. Fortunately, the sameness requirement directly advances these goals by simplifying the entry of generic manufacturers and guaranteeing that FDA-approved warnings are exactly reproduced. Nor are the regulations badly drawn. The burden on manufacturer speech, limited to the content of the label, goes no further than necessary to further the interests involved. In short, the generic labeling regime should withstand any First Amendment attack.
The FDA interpretation to which the Court deferred in Mensing, extending the sameness obligation to all communications from generic manufacturers, is another matter. The FDA justified this interpretation based on the risk that permitting generic manufacturers to send letters to doctors independently would create the perception that the generic formulation was not therapeutically identical to the brand-name version.85 Ensuring therapeutic equivalence, both perceived andactual, is the heart of the generic regulatory regime and could justify speech burdens. For example, the FDA interpretation would surely survive if it only barred misleading communications that created such a perception.86 But a Dear Doctor letter providing truthful, impartial information about both brand and generic formulations would pose no risk of false or misleading communication.
The FDA could alternatively defend its interpretation as seeking to advance its overall goal of ensuring patient safety. If so, the interpretation would fail constitutional muster more seriously. Content-based speech restrictions cannot be justified even by the “fear that people would make bad decisions if given truthful information.”89 The FDA interpretation, even worse, prevents physicians from making gooddecisions based on true information. Thus, the FDA interpretation violates the First Amendment rights of generic manufacturers andworks to the detriment of public health.
For these reasons, the Dear Doctor interpretation cannot survive the analysis that Sorrell requires and Caronia applied. The Court should instead construe the regulations to avoid constitutional violations. Rather than accepting the FDA’s broad reading, the Court could adopt the narrower interpretation identified above: only misleading letters implying an advantage to one class of drugs should be forbidden. Truthful, impartial letters simply setting out health risks should be classed as communications protected by the Constitution.
Once no longer precluded by federal regulations from satisfying their duties under state tort law, generic manufacturers would then also face tort liability for neglecting to send such letters when they possessed sufficient evidence of adverse reactions. Patients who suffer harm from generic formulations should be able to recover on meritorious tort claims against generic manufacturers who fail to communicate warning information.
The benefits of this conclusion are numerous. It allows plaintiffs to recover for their injuries. It harmonizes tort law with respect to pharmaceutical injuries: patients will no longer confront the absurd prospect of suing brand-name manufacturers whose products they never purchased. Nor will courts face a decision between a principled application of causation requirements and the desire to see individuals compensated for preventable injuries. Generic manufacturers can exult in liberation from the First Amendment burdens of speech restraints. Far better, the manufacturers actually responsiblefor substantial injuries will be held to account, resting the costs of accidents on their most natural bearers. And the proper allocation of these costs will drive generic manufacturers to keep physicians informed of potential adverse reactions, decreasing the incidence of injuries as a whole.
This is a moment of great opportunity for solving the problems left by Mensing. A line of recent major cases continues to articulate and secure the First Amendment’s protections in this area of the law. Simultaneously, the FDA is reconsidering the regulations that provided the basis for decision in Mensing, no doubt influenced by the roar of commentary deriding the policy consequences of the Mensingholding.
No policymaker or legal commentator, however, has yet appreciated Mensing’s constitutional difficulties, independent of its undoubted negative policy consequences. This Comment has identified a contradiction between Mensingand free speech jurisprudence. The Mensingholding is unstable and should not endure: it assumed the validity of a regulatory interpretation that violates the Constitution. Whether through the courts or via regulatory reform, vindicating the speech interests at play here will also solve the conundrum of what to do with injured plaintiffs after Mensing.
Though resolving these problems may require bold lawyering, the argument stands on firm ground. First Amendment principles, as announced in Sorrell and applied in Caronia, cannot permit the FDA interpretation at issue to survive. Generic manufacturers shouldface liability when they possess critical safety information and fail to communicate it.
131 S. Ct. 2567 (2011).
21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G) (2012).
Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011).
703 F.3d 149 (2d Cir. 2012).
21 U.S.C. § 355(j)(2)(A)(iv) (2012); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675 (1990).
21 C.F.R. § 314.81 (2013) (brand-name manufacturers); id. § 314.98 (generic manufacturers).
Mensing, 131 S. Ct. at 2574 (citing 21 U.S.C. §355(b)(1), (d) (2006)).
21 C.F.R. § 314.70(c)(3), (c)(6)(iii)(A), (c)(7) (2013).
Mensing, 131 S. Ct. at 2573, 2575.
Brief for the United States as Amicus Curiae Supporting Respondents, supra note 20, at 15-16.
Auer v. Robbins, 519 U.S. 452, 461 (1997).
Mensing, 131 S. Ct. at 2575-76.
21 C.F.R. § 200.5 (2013).
Mensing, 131 S. Ct. at 2576.
Brief for the United States as Amicus Curiae Supporting Respondents, supra note 20, at 18.
21 C.F.R. § 202.1(l)(2) (2010).
Brief for the United States as Amicus Curiae Supporting Respondents, supra note 20, at 19.
Brief for Respondents Gladys Mensing and Julie Demahy, supra note 20, at 37.
See, e.g., Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340 (S.D. Ala. 2010).
Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994).
Demahy v. Schwarz Pharm., Inc., 702 F.3d 177, 184 (5th Cir. 2012).
Weeks, 2013 WL 135753, at *20 (Murdock, J., dissenting).
131 S. Ct. 2653 (2011).
21 U.S.C. § 355(d) (2012).
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 613 (1973).
21 U.S.C. § 352(f) (2012).
21 C.F.R. § 201.128 (2013).
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).
Caronia, 703 F.3d at 165.
Id. at 169 (Livingston, J., dissenting).
PLIVA, Inc. v. Mensing,131 S. Ct. 2567, 2576 (2011).
See Auer v. Robbins, 519 U.S. 452, 461 (1997).
Mensing and Sorrell were announced on June 23, 2011.
Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2659 (2011).
Such restrictions seem to run against the logic of Sorrell. See id. at 2670-72.
See Sorrell, 131 S. Ct. at 2672; United States v. Caronia, 703 F.3d 149, 167 (2d Cir. 2012).
Sorrell, 131 S. Ct. at 2670 (quoting Thompson v. W. States Med. Ctr., 535 U.S. 357, 374 (2002)).
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Off. Info. & Reg. Affairs, http://www.reginfo.gov/public/servlet /ForwardServlet?SearchTarget=Agenda&textfield=0910-AG94 (last visited Sept. 23, 2013).
See H.R. Rep. No. 98-857, pt. 2, at 9 (1984) (identifying the “policy objective of getting safe and effective generic substitutes on the market as quickly as possible after the expiration of the patent”).
Drug Price Competition & Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. 98-417, 98 Stat. 1585 (codified as amended at 21 U.S.C. § 355(j) (2012)).
But see Lars Noah, Adding Insult to Injury: Paying for Harms Caused by a Competitor’s Copycat Product, 45 Tort Trial & Ins. Prac. L.J. 673, 678 n.21 (2010) (collecting popular and professional discussion of the bioequivalence standard’s efficacy).
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2583 (2011) (“Currently, all States have some form of generic substitution law.”).
Mensing, 131 S. Ct. at 2574 (emphasis added) (citing 21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G) (2006)); 21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7) (2013).
Wyeth v. Levine, 555 U.S. 555 (2009) (holding that the FDCA does not preempt state-law failure-to-warn claims and that brand-name manufacturers can be held liable for failures to warn).
Mensing, 131 S. Ct. at 2578; Brief for Respondents Gladys Mensing and Julie Demahy at 28-30, Mensing, 131 S. Ct. 2567 (Nos. 09-993, 09-1039, 09-1501). The FDA put forward the same argument in support of the plaintiffs. Brief for the United States as Amicus Curiae Supporting Respondents at 15, Mensing, 131 S. Ct. 2567 (Nos. 09-993, 09-1039, 09-1501).
Mensing, 131 S. Ct. at 2581 (“[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”).
Brief for Respondents Gladys Mensing and Julie Demahy, supra note 20, at 34; see also id. at 33-35 (describing how the CBE process could “lead to a temporary difference in labeling”).
Mensing, 131 S. Ct. at 2576; Brief for the United States as Amicus Curiae Supporting Respondents, supra note 20, at 18.
Mensing, 131 S. Ct. at 2576 (“Mensing and Demahy offer no argument that the FDA’s interpretation is plainly erroneous.”).
Id. at 2581(“We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing . . . and others similarly situated.”).
See, e.g., Wyeth, Inc. v. Weeks, No. 1101397, 2013 WL 135753 (Ala. Jan. 11, 2013), reh’ggranted (June 13, 2013); see also Editorial, Innovator Liability, Take Two, Wall St. J., Sept. 5, 2013, http://online.wsj.com/article/SB10001424127887323324904579042850978337502.html.
The weight of authority is astounding. See, e.g., Gardley-Starks v. Pfizer, Inc., 917 F. Supp. 2d 597, 604 n.4 (N.D. Miss. 2013) (noting that “sixty-six decisions applying the law of twenty-three different jurisdictions [have held] that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product”).
Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), reh’ggranted (June 13, 2013); see Editorial, supra note 42.
Id. at 2670. Vermont also sought to defend the law at issue in Sorrell on the ground that it protected physician confidentiality. Id. at 2668-70. The Court rejected this argument as largely specious, observing that the regulation simply “is not drawn to serve that interest.” Id. at 2668. Given that “pharmacies may share prescriber-identifying information with anyone for any reason” other than marketing, and given the existence of additional broad exceptions, the Court found that the regulation “d[id] not in itself advance privacy interests.” Id.
Sorrell also concluded that the Vermont law failed the traditional Central Hudson standard for restrictions on commercial speech. Id. at 2667-68 (citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 566 (1980)). For this reason, in part, the content of the Sorrell standard awaits elaboration by the lower courts and future cases at the Supreme Court itself to clarify how much more rigorous than Central Hudson the “heightened” scrutiny announced in Sorrell will be, and in what circumstances it will apply.
21 U.S.C. § 396 (2012) (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”).
21 C.F.R. §§ 201.5, 201.128 (2013) (including among “directions for use,” which constitute the total “intended uses” of the drug as offered on the market, items such as “oral, written, printed, or graphic advertising”).
United States v. Caronia, 576 F. Supp. 2d 385, 401-02 (E.D.N.Y. 2008), vacated, 703 F.3d 149 (2d Cir. 2012); see also id. at 401 (noting that misbranding prohibitions are “one of the ‘few mechanisms available’ to the FDA to ensure that manufacturers will not seek approval only for certain limited uses of drugs, then promote that same drug for off-label uses, effectively circumventing the FDA’s new drug requirements” (quoting Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 72 (D.D.C. 1998))).
Caronia, 703 F.3d at 152. Though Sorrell involved the speech rights of a corporation, the Second Circuit had no trouble applying the speech standard Sorrell established in an individual’s criminal prosecution. The relevant regulations apply equally to speech either by the manufacturer directly or its representatives, 21 C.F.R. § 201.128 (2013), and the Second Circuit treated the prosecution of Caronia individually as “criminaliz[ation of] the promotion of off-label drug use by pharmaceutical manufacturers,” Caronia, 703 F.3d at 164, presumably on the theory that off-label promotion is ultimately “by” the manufacturer whether conducted via corporate mailings or by individual sales representatives as agents of their corporate employer.
Caronia, 703 F.3d at 165. The panel majority also held in the alternative that the regulations failed the less-restrictive Central Hudson test for commercial speech, Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 566 (1980), because the regulations did not directly advance the government interest and narrower options existed. Caronia, 703 F.3d at 165-69.
See, e.g., John N. Joseph et al., Is Sorrell the Death Knell for FDA’s Off-Label Marketing Restrictions?, J. Health & Life Sci. L., Feb. 2012 at 1; Erin E. Bennett, Comment, Central Hudson-Plus: Why Off-Label Pharmaceutical Speech Will Find Its Voice, 49 Hous. L. Rev. 459, 461 (2012); Isabelle Bibet-Kalinyak, Note, A Critical Analysis of Sorrell v. Ims Health, Inc.: Pandora’s Box at Best, 67 Food & Drug L.J. 191, 240 (2012); Thea Cohen, Note, The First Amendment and the Regulation of Pharmaceutical Marketing: Challenges to the Constitutionality of the FDA’s Interpretation of the Food, Drug, and Cosmetics Act, 49 Am. Crim. L. Rev. 1945, 1946-47 (2012); Gayland O. Hethcoat II, Note, Regulating Pharmaceutical Marketing After Sorrell v. IMS Health Inc., 15 Quinnipiac Health L.J. 187, 201-02 (2012).
See Government Will Not Appeal 2nd Circuit’s Ruling in Caronia, FDA Enforcement Manual Newsl., Feb. 2013, at 1; Jose P. Sierra, Government Takes a “Pass” on the First Amendment, Lexology (Jan. 31, 2013), http://www.lexology.com/library/detail.aspx?g=5818423f -2878-42d9-8bae-afc3342969cc.
Petitioners in Mensingmade one reference to the First Amendment in their merits brief, but on an unrelated topic, referring to whether or not manufacturers may request that the FDA reconsider the warning information approved for a given drug. Brief of Petitioners PLIVA, Inc. et al. at 48, Mensing, 131 S. Ct. 2567 (Nos. 09-993, 09-1039, 09-1501). This Petition Clause analysis was uncontested before the Court and is unrelated to the validity under the Free Speech Clause of the FDA’s interpretation of its Dear Doctor letter regulations.
Cf. Teva Pharm. USA, Inc. v. Superior Court, 158 Cal. Rptr. 3d 150, 152-53 (Ct. App. 2013) (rejecting a generic manufacturer’s Mensing-based preemption claim when “the brand-name drug label was updated but the generic drug manufacturers failed to update their products’ labels accordingly”); id. at 162 (collecting comparable cases).
See, e.g., United States v. Harkonen, 510 F. App’x 633 (9th Cir. 2013) (unpublished) (upholding a fraud conviction for false pharmaceutical promotional materials).
* First of all, my thanks to Richard Luedeman, Matt Rubenstein, and Ben Eidelson for their patience, flexibility, and wonderful suggestions as this project grew more complicated than we had anticipated. I owe a great deal to many people. Judge Guido Calabresi taught me about torts. Professors Heather Gerken, Jed Rubenfeld, Jack Balkin, and Dean Robert Post taught me about the First Amendment. I got half of this idea from the incomparable Linda Greenhouse, who told me about Caronia. Kannon Shanmugam, among many other things, gave me the other half when he told me to explore Mensing and its progeny. Judge Katherine Polk Failla hired me, which was really nice of her, and made it possible for me to finish many rounds of revision. And my parents, of course.

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