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Recent Developments in Health Law

Did Failure-to-Warn Claims Against Generic Manufacturers Survive Mensing?

Published online by Cambridge University Press:  01 January 2021

Brenna Jenny
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Extract

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.

Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 1 , Spring 2012 , pp. 165 - 170
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

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See, e.g., PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2592–93 (2011) (Sotomayor, J., dissenting); Chemerinsky, E., “A Devastating Decision”, Trial 47 (2011): 54–56.Google Scholar
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Id., at 1196 (citing 21 C.F.R. §§ 314.70(c) (6)(iii)(A), (C) (2008) (“Changes in the labeling to reflect newly acquired information … [may be made] to accomplish any of the following [purposes]: (A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under § 201.57(c) of this chapter.”)). In 2008, the FDA clarified its “longstanding view” of when a label change under the CBE process is appropriate, amending § 314.70(c)(6) (iii)(A) to require that “newly acquired information” be premised upon “evidence of a causal association.” 73 Fed. Reg. 49,604, 49,605 (August 22, 2008). The FDA further commented that such “newly acquired information” – which includes not only new clinical studies but “new analyses of previously submitted data” – must be of a “different type or greater severity or frequency than previously included in submissions to FDA.” 73 Fed. Reg. at 49,604.Google Scholar
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See, e.g., Wyeth v. Levine, 129 S. Ct. 1187, 1217 (2009) (Alito, J., dissenting) (criticizing the majority for holding that “a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs”); Kinsley, M., “Wyeth v. Levine – When FDA Approval Isn't Good Enough,” Washington Post (March 13, 2009).Google Scholar
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Generic drug manufacturers need not go through the extensive application process which pioneer drugs must complete as a prerequisite to FDA approval. Instead, a company seeking to market a generic product files an abbreviated new drug application (ANDA) showing that the drug is bioequivalent to a reference listed drug, which is generally a brand-name version. See, e.g., Brief for the United States as Amicus Curiae Supporting Respondents at 2–4, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (Nos. 09–993, 09–1039, 09–1501), 2011 WL 741927, at 2–4. (citing 21 U.S.C. §§ 355(j)(2)(A)(ii), (iv) (2010)) [hereinafter cited as Brief for the United States Supporting Mensing].Google Scholar
See, e.g., Gaeta v. Perrigo Pharm. Co., 562 F. Supp. 2d 1091, 1096–98 (N.D. Cal. 2008); Morris v. Wyeth, Inc., 582 F. Supp. 2d 861, 866–68 (W.D. Ky. 2008) (collecting cases that had previously considered whether state failure-to-warn claims against generic drug manufacturers are pre-empted and noting that a majority of courts found pre-emption).Google Scholar
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011). Justice Thomas delivered the opinion of the court, joined by Justices Roberts, Scalia, Alito, and Kennedy. Justice Sotomayor wrote the dissent, joined by Justices Ginsburg, Breyer, and Kagan. Although the Court divided along familiar lines, the split was unique in that the typically more conservative Justices upheld federal power and agency expertise, while the traditionally liberal voting bloc championed states' rights.Google Scholar
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Id., at 15–16 (citing 21 U.S.C. § 355(j) (4)(G) (2010); 21 C.F.R. § 314.94(a) (8)(iii) (2011) (a generic drug's ANDA must contain “proposed labeling [that is] … the same as the labeling approved for the reference listed drug”); 21 C.F.R. § 314.150(b)(10) (2008) (the FDA “may … withdraw approval” of a generic drug if its labeling “is no longer consistent with that for the [reference listed drug]”)).Google Scholar
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Id., at 2576. Dear Doctor letters, also known as Dear Health Care Provider Letters, allow companies to disseminate “important new safety information” to health care practitioners. See generally U.S. Department of Health and Human Services, Food and Drug Administration, Dear Health Care Provider Letters: Improving Communication of Important Safety Information, DRAFT GUIDANCE (November 2010).Google Scholar
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Mensing, 131 S. Ct. at 2576. During the time period when Mensing and Demahy took metoclopramide, 2001–02, the FDA did not have statutory authority to require a drug company to change its label. Congress granted the FDA this authority in 2007. See Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009) (citing 121 Stat. 924–926). Prior to 2007, if a company refused to follow an FDA suggestion that it modify a brand-name drug's label, the only recourse for the FDA would have been the draconian solution of withdrawing the brand and generic drugs from the market, on the basis of their now-inadequate labeling. Brief for the United States Supporting Mensing, supra note 15, at 21–22. Aspects of the Court's opinion appear to interpret the role of the brand-name manufacturer in this pre-2007 label modification process as an extra hurdle. See Mensing, 131 S. Ct. at 2578 (“Here, what federal law permitted the Manufacturers to do could have changed … depending on the actions of the FDA and the brand-name manufacturer.”). However, the holding ultimately defines impossibility solely in terms of an entity's dealings with a federal agency. Id., at 2580–81 (“To decide these cases, it is enough to hold that when 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.”).Google Scholar
“If an ANDA applicant believes new safety information should be added to a product's labeling, it should contact FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised.” 57 Fed. Reg. 17,950, 17,961 (April 28, 1992). The generic manufacturers and the FDA disagreed over whether this language imposed a duty on generic companies to approach the FDA if they are aware of safety information that should be addressed through a label change. Because the Court found pre-emption, it did not decide the issue. Mensing, 131 S. Ct. at 2576–77.Google Scholar
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The dissent criticized this distinction as nothing more than a matter of timing. In either scenario, according to the dissenters, whether a company is able to obtain a permanent label change is dependent upon FDA approval: For generic companies the approval occurs prior to the label change going into effect, for brand-name companies the approval occurs after the label change goes into initial effect. Claiming that only companies in the former position are “dependent on the exercise of judgment by a federal agency” is a false dichotomy. The dissent would have simply focused the inquiry on whether the defendant company could have obtained that FDA approval. As in Levine, the defendant companies in Mensing had not produced evidence indicating the FDA would have disapproved the label change, and thus under the dissent's view, they were not entitled to a defense of impossibility pre-emption. See id., at 2587–88 (Sotomayor, J., dissenting).Google Scholar
See Schedin v. Ortho-McNeil-Janssen Pharm., Inc., No. 08–5743 JRT, 2011 WL 3837104 (D. Minn. August 26, 2011) (Mensing, which found “impossibility pre-emption of state law failure to warn claims [against] generic manufacturers,” does not “apply to brand-name manufacturers.”).Google Scholar
See Mensing, 131 S. Ct. at 2580–81 (“To decide these cases, it is enough to hold that when 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.”).Google Scholar
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Smith v. Wyeth, Inc., No. 09–5460, 2011 WL 4389211 (6th Cir. September 22, 2011) (“The Supreme Court held unequivocally, however, that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug's label, thus barring the plaintiffs' state-law tort claims.”).Google Scholar
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Id., at 17. See also supra note 22. When a generic company sends out a Dear Doctor letter, is it thus put in a position analogous to a company utilizing the CBE process: In both situations the company is vulnerable to subsequent FDA disapproval. The FDA in both scenarios has permissive, rather than mandatory, authority to withdraw a drug if it is disagrees with the appropriateness of the label change or communication. See id. and Wyeth v. Levine, 129 S. Ct. 1187, 1197 (2009). The Supreme Court expressed skepticism in Wyeth v. Levine over “the very idea that the FDA would bring an enforcement action against a manufacturer for strengthening a warning.” Id. While the Supreme Court discounted any likelihood of the FDA exercising its permissive authority in response to a CBE label change, the FDA's comments regarding the importance of generic companies maintaining consistent labels indicates withdrawal is more than merely a hypothetical repercussion of creating inconsistent labeling, even if a generic manufacturer does so as an incidental byproduct of providing supplemental information. See Brief for the United States Supporting Mensing, supra note 15, at 15–16.Google Scholar
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PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011). As of 1985, the Reglan label warned that tardive dsykinesia “may develop” in patients, and that use of the drug for longer than 12 weeks had “not been evaluated and cannot be recommended.” In 2004, the brand-name manufacturer of Reglan asked the FDA to approve its proposal to strengthen the warning label, and the FDA approved a new label stating that use of the drug “should not exceed twelve weeks.” The FDA on its own initiative sought a more stringent warning in 2009, and ordered the addition of a black box warning cautioning that “[t]reatment with metoclopramide can cause tardive dyskinesia … [and treatment] for longer than 12 weeks should be avoided in all but rare cases.” Id. at 2572–73.Google Scholar
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Brasley-Thrash, 2011 WL 4025734, at 3. The District of South Carolina has also indicated some receptiveness to this claim. See Fisher v. Pelstring, No. 4:09-CV-00252-TLW, 2011 WL 4552464, at 8–9 (D. S.C. September 30, 2011) (denying defendant PLIVA's motion for summary judgment because a jury could find that PLIVA should have done more to warn the plaintiff's prescribing physician about metoclopramide's risk of tardive dyskinesia, including sending a Dear Doctor letter describing recent label changes to Reglan and its generic counterparts).Google Scholar