131 S. Ct. 2567 (2011).Google Scholar

555 U.S. 555, 129 S. Ct. 1187 (2009).Google Scholar

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

555 U.S. 555, 129 S. Ct. 1187, 1191 (2009).Google Scholar

Promethazine hydrochloride is an antihistamine used to treat nausea. Id., at 1191.Google Scholar

Levine, 129 S. Ct. at 1196.Google Scholar

See, e.g., Altria Group, Inc. v. Good, 555 U.S. 70, 76–77 (2008).Google Scholar

Levine, 129 S. Ct. at 1196.Google Scholar

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

Levine, 129 S. Ct. at 1197. See also § 314.70(c)(7) (2008) (“If the agency disapproves the supplemental application, it may order the manufacturer to cease distribution of the drug product(s) made with the manufacturing change.”).Google Scholar

Levine, 129 S. Ct. at 1197–98.Google Scholar

Id., at 1198.Google Scholar

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

See, e.g., Almon, E. S., Note, “Preemption of State Failure-to-Warn Claims After Wyeth v. Levine: The Regulatory Function of State Tort Law,” University of San Francisco Law Review 45 (2010): 215–241, at 230–241; Senator Patrick Leahy, Press Release, Leahy Joins Kennedy, Others to Introduce Bill to Reverse Supreme Court Medical Device Decision (March 6, 2009), available at <http://leahy.senate.gov/press/press_releases/release/?id=0502041b-32de-409a-93d4–34e4bc05dd8d> (last visited February 2, 2012).Google Scholar

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

A drug used to treat disorders related to the digestive tract. Id., at 2572.Google Scholar

Id., at 2573.Google Scholar

Id., at 2575.Google Scholar

Brief for the United States Supporting Mensing, supra note 15, at 15.Google Scholar

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

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2576 (2011).Google Scholar

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

Brief for the United States Supporting Mensing, supra note 15, at 18.Google Scholar

Id., at 19.Google Scholar

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

Brief for the United States Supporting Mensing, supra note 15, at 20.Google Scholar

Mensing, 131 S. Ct. at 2578.Google Scholar

Id., at 2578–79. Cf. Wyeth v. Levine, 129 S. Ct. 1187, 1197 (2009) (“But absent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements. Wyeth has offered no such evidence. It does not argue that it attempted to give the kind of warning required by the Vermont jury but was prohibited from doing so by the FDA.”).Google Scholar

Mensing, 131 S. Ct. at 2578–79.Google Scholar

Id., at 2579.Google Scholar

Id., at 2581.Google Scholar

Id., at 2579.Google Scholar

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

See Schork v. Baxter Healthcare Corp., No. 4:10-CV-00005-RLY, 2011 WL 4402602 (S.D. Ind. September 22, 2011) (“[T]he United States Supreme Court had ruled in Wyeth v. Levine that state law claims against manufacturers of brand name drugs for failure to warn are not preempted by federal law. … In June, the Supreme Court held in PLIVA, Inc. v. Mensing that its holding in Wyeth did not extend to manufacturers of generic drugs. In other words, the Court found that state law claims against manufacturers of generic drugs for failure to warn are preempted by federal law.” (citations omitted)).Google Scholar

See Wyeth v. Levine, 129 S. Ct. 1187, 1197 (2009).Google Scholar

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

Mensing, 131 S. Ct. at 2576 (citing Brief for the United States Supporting Mensing, supra note 15, at 18).Google Scholar

Brief for the United States as Amicus Curiae at 17, Nos. 09–993, 09–1039, 09–1501 (8th Cir. 2009), 2010 WL 4339894, at 17 [hereinafter cited as Brief for the United States Urging Denial of Certiorari]. In this amicus curiae brief, the Solicitor General urged the Supreme Court to deny certiorari. The United States brief cited earlier was submitted in advance of oral arguments, after the Supreme Court had granted certiorari.Google Scholar

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

Brief for the United States Urging Denial of Certiorari, supra note 43, at 17.Google Scholar

Brasley-Thrash v. Teva Pharm., Inc., No. 10–00031-KD-N, 2011 WL 4025734 (S.D. Ala. September 12, 2011).CrossRefGoogle Scholar

Id., at 1, 3.Google Scholar

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

Brasley-Thrash, 2011 WL 4025734, at 1.Google Scholar

Id., at 2.Google Scholar

Id. (quoting 21 U.S.C. § 355–1(i) (2007) (“A drug that is the subject of an abbreviated new drug application under section 355(j) of this title is subject to only the following elements of the risk evaluation and mitigation strategy required under subsection (a) of this section for the applicable listed drug: For an applicable listed drug for which a drug is approved under section 355(j) of this title, the Secretary – (A) shall undertake any communication plan to health care providers required under subsection (e)(3) of this section for the applicable listed drug; and (B) shall inform the responsible person for the drug that is so approved if the risk evaluation and mitigation strategy for the applicable listed drug is modified.”)).Google Scholar

Id., at 3.Google Scholar

Id. (quoting Brief for the United States Urging Denial of Certiorari, supra note 43, at 17–18).Google Scholar

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (2011).Google Scholar

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