Fulgenzi v. Pliva, Inc.

867 F. Supp. 2d 966, 2012 U.S. Dist. LEXIS 45620, 2012 WL 1110009
CourtDistrict Court, N.D. Ohio
DecidedMarch 31, 2012
DocketCase No. 5:09CV1767
StatusPublished
Cited by7 cases

This text of 867 F. Supp. 2d 966 (Fulgenzi v. Pliva, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Fulgenzi v. Pliva, Inc., 867 F. Supp. 2d 966, 2012 U.S. Dist. LEXIS 45620, 2012 WL 1110009 (N.D. Ohio 2012).

Opinion

OPINION AND ORDER

SARA LIOI, District Judge.

Before the Court is the motion of Defendant PLIVA, Inc. (PLIVA) to dismiss all claims on the ground of federal preemption. (Doc. No. 61.) Plaintiff Eleanor Fulgenzi (Plaintiff or Fulgenzi) opposes the motion (Doc. No. 63), and PLIVA has filed a reply (Doc. No. 64). PLIVA has also filed a Notice of Supplemental Authority. (Doc. No. 66.) At the parties’ request, the Court stayed the matter pending a ruling from the United States Supreme Court in two consolidated eases. It was anticipated that a ruling in these cases would resolve the question of whether regulations promulgated by the Federal Drug Administration (FDA) relating to the labeling of generic medication preempt state laws that may require generic drug manufacturers to provide more stringent safety warning labels on their products.

On June 23, 2011, the Supreme Court issued its decision in PLIVA, Inc. v. Mens[968]*968ing, — U.S. -, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), wherein the Court held that state-law causes of action alleging that generic manufacturers of prescription medication failed to provide adequate warnings on their labels relating to possible risks and side effects of the mediation are preempted by federal law. Id. at 2572-73. Following the ruling, PLIVA filed the present motion to dismiss. Because the Supreme Court’s ruling in Mensing forecloses the state law claims raised in the Second Amended Complaint, PLIVA’s motion to dismiss is granted and this case is dismissed.

I. BACKGROUND

Pursuant to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et. seq., the FDA is charged with the responsibility of approving new drugs. See 21 U.S.C. § 355(a); Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 196, 125 S.Ct. 2372, 162 L.Ed.2d 160 (2005). A manufacturer seeking to market a new drug must file a New Drug Application (NDA) with the FDA. 21 U.S.C. § 355(b). As part of its application, the manufacturer must demonstrate through pre-market trials and other relevant evidence that the drug is safe, and that the proposed labeling properly sets forth the correct dosage and possible risks. The NDA requires, among other things, that the manufacturer supply the agency with “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use” and “specimens of the labeling proposed to be used for such drug.” § 355(b)(1).

In contrast, drug manufacturers seeking to market a generic drug must file an Abbreviated New Drug Application (ANDA). The ANDA procedure, codified as amended in the Hatch-Waxman Act, 21 U.S.C. § 355, sets forth an expedited review process. To obtain approval, the manufacturer must demonstrate that the generic drug it seeks to market is approved as a listed drug, meaning that the new drug is the functional equivalent of a name-brand drug already approved by the FDA. 21 U.S.C. § 365(j)(2). “One of the benefits to manufacturers who opt for the ANDA procedure is that they are required only to conduct ‘bioequivalency’ studies that establish that the generic and the reference-listed drug are pharmaceutically equivalent....” Stacel v. Teva Pharms., USA, 620 F.Supp.2d 899, 905 (N.D.Ill.2009). So long as the manufacturer can demonstrate that the generic drug is the pharmaceutical equivalent of its name-brand counterpart, the generic manufacturer need not duplicate the pre-market trials conducted by the name-brand manufacturer. This advantage serves the purpose of the Hatch-Waxman Act to increase the availability of low cost generic drugs. See id. at 907.

Federal regulations further require that “[a generic drug’s] [l]abeling (including the container label, package insert, and, if applicable, Medication Guide) proposed for the drug product must be the same as the labeling approved for the reference listed drug, except for changes required because of differences approved under a petition filed under [21 C.F.R.] § 314.93 or because the drug product and the reference listed drug are produced or distributed by different manufacturers.” 21 C.F.R. § 314.94(a)(8)(iv). The FDA can reject an ANDA application if the information submitted by the generic manufacturer is “insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the listed drug....” 21 C.F.R. § 314.127(a)(7).

According to the Second Amended Complaint, metoclopramide is a medication pre[969]*969scribed to treat symptomatic gastroesogphageal reflux and acute and recurrent diabetic gastric stasis. (Second Amended Complaint (SAC) at ¶ 19, Doc. No. 60.) The FDA first approved metoclopramide, under the name-brand Reglan, in 1980. The drug has been available in its generic form since 1985. Mensing, 131 S.Ct. at 2572. Emerging studies have shown that extended use of metoclopramide can lead to a condition known as tardive dyskinesia, a severe neurological disorder, which presents symptoms that include involuntary and uncontrollable movements of the head, neck, and face, as well as grotesque facial grimacing and tongue thrusting. Patients who take metoclopramide for extended periods of time are 29 percent more likely to contract this incurable neurological disorder. Id. at 2572 (internal citations omitted).

In light of this risk, warning labels for the drug have been strengthened several times. In 2004, the FDA approved a label adding the warning that “[t]herapy should not exceed 12 weeks in duration.” Mensing, 131 S.Ct. at 2572-73 (quoting Physician’s Desk Reference 1635-36 (41st ed. 1987)). In 2009, the warning on the label was strengthened further by the addition of a black box warning — the strongest available under the FDA regulatory scheme — stating that “Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible.... Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.” Id. at 2573 (quoting Physician’s Desk Reference 2902 (65th ed. 2011)).

After taking metoclopramide for an extended period of time, Fulgenzi alleges that she developed tardive dyskinesia. (SAC at ¶ 17.) Fulgenzi initially brought the action against certain manufacturers of the generic metoclopramide and the namebrand Reglan. At the core of all of Fulgenzi’s claims is the basic assertion that the drug manufacturers should have provided warnings alerting doctors and patients to the heightened risk of developing neurological complications from long-term use of metoclopramide.

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Bluebook (online)
867 F. Supp. 2d 966, 2012 U.S. Dist. LEXIS 45620, 2012 WL 1110009, Counsel Stack Legal Research, https://law.counselstack.com/opinion/fulgenzi-v-pliva-inc-ohnd-2012.